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Science Technology and Human Rights

LL.M. · SEMESTER 3

Strictly as per the University of Mumbai LL.M. syllabus in force

For LL.M. students of the University of Mumbai and all its affiliated law colleges

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munotes.in Group 4 Human Rights Law

Science Technology and Human Rights

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Contents

Module I

  1. What This Paper Is About 1
  2. What a Human Right Is 5
  3. The Right to Share in Scientific Advancement 9
  4. Privacy and Health in the Universal Declaration 13
  5. The Right to Science in the Covenant 17
  6. The Duty to Conserve, Develop and Diffuse Science 21
  7. Freedom Indispensable for Scientific Research 28
  8. International Co-operation in Science 36
  9. The Right to Health in the Covenant 42
  10. General Comment 25 and the Content of the Right 49
  11. Availability, Accessibility, Acceptability and Quality 57
  12. Participation in Scientific Progress 62
  13. Benefit Sharing 69
  14. Dual Use: the Same Technology Both Ways 78
  15. Scientific Temper as a Fundamental Duty 84
  16. Science Under Article 21 90
  17. Education and the Diffusion of Knowledge 98
  18. The Directive Principles on Health and Work 103
  19. The Environment in the Constitution 110
  20. The Scientist: Rights and Responsibilities 116
  21. The Precautionary Principle 122
  22. How a Technology Becomes a Rights Question 129
  23. Privacy and Surveillance 136
  24. Bodily Integrity and Intervention Without Consent 142
  25. Equality and the Digital Divide 149
  26. Health and Medical Technology 155
  27. Work, Automation and Livelihood 160
  28. Expression and Information Technology 166
  29. Environment and Technological Harm 172
  30. Weapons, Warfare and the Right to Life 179
  31. Biotechnology, Genetics and Human Dignity 185
  32. Artificial Intelligence and Decisions by Machines 191
  33. Reproductive Technology and Autonomy 196
  34. Forensic Science and the Rights of the Accused 201
  35. Technology and the Rights of the Child 206
  36. Technology and Persons with Disabilities 212
  37. Access to Medicines and Patents 218
  38. The State's Duty to Regulate Technology 224
  39. Remedies When Technology Causes Harm 229

Module II

  1. What Medical Law Is 234
  2. The Doctor and the Patient 239
  3. The Right to Health Under Article 21 244
  4. Emergency Treatment and the Duty to Treat 250
  5. Informed Consent: the Principle 256
  6. Informed Consent: the Indian Standard 261
  7. Consent for a Person Who Cannot Consent 267
  8. Medical Confidentiality and Its Limits 273
  9. Health Data and Privacy 279
  10. Medical Negligence: the Civil Action 284
  11. Medical Negligence: the Criminal Standard 289
  12. Medical Services Under Consumer Law 294
  13. Compensation and How It Is Measured 299
  14. Regulating the Profession 304
  15. Regulating the Hospital 310
  16. Drugs, Standards and Control 315
  17. Clinical Trials and Research on Patients 320
  18. Access to Medicines: Price and Patent 327
  19. Organ Transplantation: the Scheme of the Act 333
  20. Brain Stem Death and the Law 339
  21. Transplantation: Regulation and Registration 344
  22. Trade in Organs and Its Punishment 350
  23. Termination of Pregnancy: the Act 356
  24. Abortion, Autonomy and the 2021 Amendment 363
  25. Sex Selection: the PCPNDT Scheme 369
  26. PCPNDT: Registration and Authorities 376
  27. PCPNDT: Offences and Enforcement 382
  28. Assisted Reproductive Technology: the Scheme 389
  29. ART: Donors, Consent and the Commissioning Couple 395
  30. ART: Authorities and the National Registry 402
  31. ART: Offences and Penalties 408
  32. Surrogacy: the Scheme of the Act 414
  33. Surrogacy: Clinics, Registration and Procedure 422
  34. Surrogacy: Boards and Appropriate Authorities 428
  35. Surrogacy: Offences, and the Rights Question 434
  36. Mental Health: Capacity and the Advance Directive 441
  37. The Nominated Representative 448
  38. The Rights of a Person with Mental Illness 454
  39. HIV: Consent, Testing and Treatment 461
  40. HIV: Confidentiality and Disclosure 468
  41. HIV: Ombudsman, Courts and Remedies 476
  42. Euthanasia, the Living Will and Dying with Dignity 483
  43. Public Health Powers and Epidemics 490
  44. Medical Examination, Medical Evidence and the Accused 496
  45. The Unborn, the Newborn and the Law 502

Module III

  1. What Ethics Adds to Law 509
  2. Human Experimentation Before Nuremberg 514
  3. The Nuremberg Code 519
  4. The Declaration of Helsinki 525
  5. Research Ethics Committees 531
  6. Free and Informed Consent in Research 537
  7. Vulnerable Participants and Exploitation 543
  8. Research Carried Out in Developing Countries 549
  9. Placebo, Standard of Care and After the Trial 555
  10. Registration, Publication and Research Integrity 562
  11. The Genome and Human Dignity 568
  12. The Genome: Rights of the Person Concerned 574
  13. Research on the Genome and Its Limits 580
  14. The Genome: Solidarity and Implementation 587
  15. Genetic Data: What It Is and Why It Is Special 594
  16. Genetic Data: Collection and Consent 601
  17. Genetic Data: Access, Privacy and Quality 608
  18. Genetic Data: Use, Storage and Benefit Sharing 614
  19. The Bioethics Declaration: Scope and Aims 621
  20. The Bioethics Declaration: the Core Principles 627
  21. The Bioethics Declaration: Society and the Future 633
  22. The Bioethics Declaration: Applying the Principles 640
  23. The Bioethics Declaration: Promotion and Final Provisions 647
  24. Benefit Sharing, Biopiracy and Traditional Knowledge 655
  25. Precaution, Risk and Dual-Use Research 665
  26. The Ethics of Emerging Technology 674

Module IV

  1. The Information Society and Human Rights 682
  2. Access to the Internet 688
  3. The Right to Information 696
  4. Privacy as a Fundamental Right 705
  5. Informational Privacy and the Proportionality Test 712
  6. Data Protection: Scope and Consent 720
  7. Data Protection: Duties of the Data Fiduciary 729
  8. Data Protection: Rights and Duties of the Data Principal 737
  9. Data Protection: Exemptions and the Board 745
  10. Data Protection: Penalties, Appeals and the Rest of the Act 755
  11. Surveillance, Interception and Monitoring 765
  12. Speech Online and Its Limits 774
  13. Intermediaries, Safe Harbour and Takedown 781
  14. Internet Shutdowns 792
  15. Cybercrime: the Scheme of the IT Act 801
  16. Identity Theft and Cheating by Personation 808
  17. Violation of Privacy and Obscene Material Online 814
  18. Cyber Terrorism: Section 66F 822
  19. Investigation, Jurisdiction and the Transnational Problem 830
  20. Digital Identity and Biometrics 838
  21. Children Online 846
  22. Disinformation, Elections and the Public Sphere 854
  23. What a Normative Response Is 861
  24. The 1975 Declaration: How It Came About 868
  25. The 1975 Declaration: What It Obliges States To Do 874
  26. Article 15 of the Covenant Read Whole 882
  27. General Comment 25 as the Authoritative Reading 889
  28. The UNESCO Trilogy of 1997, 2003 and 2005 897
  29. Professional Self-Regulation as a Normative Response 904
  30. The Regional Response: the Council of Europe 910
  31. Special Procedures and the Special Rapporteur 917
  32. Reporting, Treaty Bodies and Enforcement 923
  33. India and the International Response 929
  34. The Gaps in the International Response 936
  35. Technologies That Did Not Exist in 1975 944
munotes.in

Module I

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Chapter One

What This Paper Is About

Syllabus topic 1, "Interrelationship of Science, Technology and Human Rights"

In one line

This paper asks what happens to human rights when human beings learn to do things they could not do before.

In the wording a student can write in an exam: Science, Technology and Human Rights studies the relationship between the growth of scientific knowledge and its practical applications on the one hand, and the legal protection of human dignity, freedom and equality on the other. It examines science both as a means of realising human rights and as a source of new threats to them, and it studies the response of national legal systems and of the international community to that double character.

Science and technology are not the same word

The syllabus names science and technology separately, and the distinction is not decoration.

Science is organised knowledge about the world, and the method by which that knowledge is produced and tested. It is an activity of finding out. When a laboratory establishes that a particular gene is associated with a particular disease, that is science.

Technology is the application of that knowledge to do something. It is an activity of making and using. When the same knowledge is turned into a test that can be sold to an insurance company, that is technology.

The law treats them differently because they raise different questions. Science raises questions about freedom: may the State stop a researcher from asking a question, and must it fund the asking? Technology raises questions about harm and access: who is hurt when this is used, and who is left out when it is not available to them. A student who blurs the two will answer a question about the freedom of the scientist with material about the regulation of a product, which is a different topic.

Why the law has this subject at all

For most of history the law had nothing in particular to say about scientific progress, because progress was slow enough that the ordinary law of the land absorbed it. That stopped in the twentieth century, and it stopped for two reasons that pull in opposite directions.

The first reason is that science began to deliver on a scale that made its benefits a matter of justice. Antibiotics, vaccines, sanitation and mechanised agriculture did not merely make life more comfortable; they made the difference between living and dying, and they made it unequally. Once a treatment exists, the fact that a person cannot get it stops being misfortune and becomes a distribution that somebody chose. That is the point at which a lawyer becomes interested.

The second reason is that science began to injure on a scale the ordinary law could not answer. The medical experiments carried out in the concentration camps, the atomic bombings of 1945, and the industrial disasters of the decades that followed were not ordinary wrongs done by ordinary means. They were done with the best knowledge available at the time, sometimes by the people best qualified to have it, and often lawfully under the law then in force. That combination is what a human rights framework exists to catch.

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What This Paper Is About

What the paper actually covers

MU prints six topic labels and nothing else, so it is worth stating plainly what those six ask for, because the shape of the paper is not obvious from its name.

ModuleTopicWhat it asks
I1The relationship in principle: how science and rights bear on each other
I2The relationship in practice: what specific developments have done to specific rights
II3Medicine and the Law: the one field the syllabus examines in depth
III4Ethics: the standards that bind researchers where the law does not reach
IV5Information technology, privacy and cyber terrorism
IV6The response of the international community

Notice what that structure is doing. Modules I and III are about principle, Modules II and IV are about the law of two particular fields, and Module IV closes by asking whether the international response has been adequate. An examiner can therefore ask a purely conceptual question, a purely statutory question, or a question that runs across both, and this book is built so that any of the three can be answered from it.

What this paper is not

It is not a science paper. No question will require you to explain how a polymerase chain reaction works. You must understand a technology well enough to see which right it touches, and no further.

It is not a general human rights paper. Your group has five other papers for that. Here, a right is discussed because a scientific or technological development bears on it.

It is not a medical jurisprudence paper. Medical jurisprudence, in the older sense, is about medical evidence in criminal trials. Module II is about the legal regulation of medicine and the rights of patients, which is a different subject with some overlap.

A worked example, to show the method

Take a single technology and run it through the questions this paper asks. A hospital installs a system that reads scans and reports whether a tumour is present.

Which rights does it engage? The right to health, because it may find cancers earlier. Privacy, because it processes the patient's medical images. Equality, because the system was trained on data from one population and may be less accurate on another. The right to a remedy, because if it is wrong it is not obvious who is answerable.

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What This Paper Is About

Who bears the duty? The hospital, as the body that chose to deploy it. The manufacturer, whose product it is. And the State, whose duty to protect means it must regulate both.

Is the benefit shared? If the system exists only in private hospitals in three cities, the technology has widened a gap rather than closed one, and Module I's right to enjoy the benefits of scientific progress is engaged directly.

What does the international framework say? The 1975 Declaration requires States to extend the benefits of science to all strata of the population and to protect them from the misuse of scientific developments. The Bioethics Declaration of 2005 requires risk assessment and ethics committees.

Every one of those four questions is answered somewhere in this book. That is the method the paper is testing.

What beginners get wrong here

Treating the subject as a list of technologies. It is not. A student who memorises facts about cloning, artificial intelligence and surveillance, and learns no framework, cannot answer a question about a technology the syllabus does not mention. The framework is the point; the technologies are examples.

Assuming science is the villain. The instruments in Module IV say the opposite. The right to enjoy the benefits of scientific progress is a human right, and a State that fails to develop and diffuse science is in breach of it. A one-sided answer loses marks.

Confusing ethics with law. Module III exists because much of what is objectionable in this field is not unlawful. Saying that something "violates human rights" when what you mean is that it is unethical, and not distinguishing the two, is the commonest weakness in answers on this paper.

Quick revision

  • Science is knowledge and method; technology is application. Freedom questions attach to the first, harm and access questions to the second.
  • The subject exists because science both delivers unequally and injures in ways ordinary law could not answer.
  • Six printed topics: relationship in principle, relationship in practice, medicine, ethics, information and cyber terrorism, and the international response.
  • The method: which rights are engaged, who bears the duty, is the benefit shared, what does the international framework say.
  • Not a science paper, not a general human rights paper, not medical jurisprudence.

Test yourself

1. Distinguish science from technology, and say why the distinction matters in law. Science is organised knowledge and the method of producing it; technology is the application of that knowledge to do something. The distinction matters because science raises questions of freedom, chiefly the researcher's freedom to inquire and the State's duty to support inquiry, while technology raises questions of harm and of access, chiefly who is injured by a use and who is excluded from a benefit.

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What This Paper Is About

2. Why did human rights law become interested in scientific progress only in the twentieth century? Because progress became fast enough and powerful enough to matter in two ways at once. Its benefits became large enough that unequal access became a question of justice rather than of luck, and its harms became large enough, and were often inflicted lawfully by qualified people, that the ordinary law of wrongs could not answer them.

3. A State refuses to fund any medical research at all. Which limb of this subject is engaged? The right to enjoy the benefits of scientific progress, and specifically the State's duty to conserve, develop and diffuse science. This is the limb that shows the subject is not only about restraining science but also about requiring it.

4. Is this paper asking you to decide whether a technology is good or bad? No. It is asking you to identify which rights a technology engages, who owes duties in respect of it, whether the benefit and the risk are fairly distributed, and what the legal and ethical frameworks require. The evaluation follows from that analysis; it does not replace it.

Contents This chapter on its own page

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Chapter Two

What a Human Right Is

Syllabus topic 1, "Interrelationship of Science, Technology and Human Rights"

In one line

A human right is a claim you have simply because you are a human being, which the law recognises rather than creates, and which somebody else has a duty to respect.

In the wording a student can write in an exam: a human right is a claim inherent in the human person by virtue of his or her humanity alone, independent of nationality, status, merit or the recognition of any particular State. It is universal, in that it belongs to everyone; inalienable, in that it cannot be given away or taken; indivisible, in that its various parts cannot be traded against one another; and interdependent, in that the enjoyment of one commonly depends on the enjoyment of others. Its distinguishing feature in law is that it imposes duties, chiefly on the State.

Why the law has this at all

Ordinary legal rights come from somewhere: a contract, a statute, a decree. They can be created and they can be repealed. That is convenient until the body doing the creating and repealing is the body you need protection from.

The twentieth century supplied the demonstration. What was done in Germany between 1933 and 1945 was in large part done under law, by a State using its own legal machinery against its own population. A conception of rights that depends on what the State has granted has nothing to say about that. So the framework built after 1945 rests on a different claim: that certain entitlements exist independently of any State's recognition, and that a State which denies them is in breach of an obligation it did not choose.

That is the claim behind the opening words of the Universal Declaration of Human Rights, which speaks of the recognition of the inherent dignity and of the equal and inalienable rights of all members of the human family. The verb is recognition. The Declaration does not purport to confer the rights; it purports to notice them.

The four characteristics, taken apart

Universal. The right belongs to everyone, everywhere. This is the characteristic most often contested, and the contest matters for this paper: a later chapter takes up the argument that the framework reflects one civilisation's assumptions and is applied unevenly.

Inalienable. You cannot validly surrender the right, and it is not forfeited by bad behaviour. A convicted prisoner retains the right not to be tortured. This characteristic does real work in Module III, because it is the reason a research participant's consent does not make everything permissible: some protections cannot be waived.

Indivisible. Civil and political rights on the one hand and economic, social and cultural rights on the other are not two grades of entitlement. This matters here because the right to enjoy the benefits of scientific progress sits in the second group, and the older habit of treating that group as aspirational is exactly what left the right to science undeveloped for fifty years.

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What a Human Right Is

Interdependent. Rights depend on each other. The right to health is worth little without access to information; privacy is worth little without an effective remedy.

The three generations

The classification is a teaching device, not a legal hierarchy, and it is commonly attributed to Karel Vasak, who borrowed the French revolutionary triad.

GenerationContentCharacterWhere it appears
FirstCivil and political: life, liberty, fair trial, expression, privacy, freedom from tortureChiefly negative: the State must abstainICCPR 1966; Part III of the Constitution of India
SecondEconomic, social and cultural: work, health, education, science, an adequate standard of livingChiefly positive: the State must provide, progressivelyICESCR 1966; Part IV of the Constitution
ThirdSolidarity rights: development, peace, a healthy environment, common heritageCollective; held by peoples as much as personsDeclarations rather than treaties

For this paper the classification is worth knowing for one reason above all. The right to science straddles the generations. Its freedom limb, the freedom indispensable for scientific research, behaves like a first generation right and asks the State to keep out. Its benefit limb asks the State to spend money and behaves like a second generation right. Its co-operation limb, and the idea that scientific knowledge is a common heritage, behave like third generation rights. A student who can say that has understood something that the printed topic label only implies.

Who owes the duty

A right without an identified duty bearer is a slogan. The modern formulation gives the State three duties, and the three recur throughout this book.

  1. Respect. The State must not itself violate the right. It must not conduct experiments on prisoners.
  2. Protect. The State must prevent third parties from violating it. It must regulate the private laboratory and the private hospital.
  3. Fulfil. The State must take positive steps to realise it. It must fund research, train scientists and make the results available.

The second duty is what makes this a legal subject rather than a moral one. Most technology today is developed and owned privately. If the framework reached only the State's own conduct, it would reach almost nothing that matters. It is the duty to protect that makes a State answerable for what a company does with a genetic database.

A worked example

A private fertility clinic in Mumbai advertises that it can select embryos by sex. A couple pays for the service.

Whose right is engaged? The unborn child has no legal personality, so the analysis does not start there. It starts with the equality rights of women as a class, which sex selection attacks at scale, and with the rights of the woman undergoing the procedure.

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What a Human Right Is

Which duty is engaged? Not respect, because the State is not doing it. Protect is the operative duty: the State must prevent the private actor from doing it. That is precisely what the PCPNDT Act of 1994 does, and Module II examines how.

Would consent answer the complaint? No, and this is where inalienability does its work. The couple's consent cannot cure a harm whose victim is not the couple.

What it does NOT mean

It does not mean rights are absolute. Almost every right may be limited. What the framework requires is that a limitation be prescribed by law, pursue a legitimate aim, and be proportionate. Module IV turns that requirement into a four-part test.

It does not mean a right is only what a court will enforce. Much of the material in this book is in declarations that no court applies directly. That makes them weak, not meaningless, and Module IV's closing chapters ask honestly how weak.

It does not mean the State is the only actor. It is the primary duty bearer, but the instruments in Module III address researchers, institutions and corporations directly.

Quick revision

  • A human right is inherent in the person, recognised rather than conferred, and imposes duties chiefly on the State.
  • Four characteristics: universal, inalienable, indivisible, interdependent.
  • Three generations: civil and political; economic, social and cultural; solidarity. The classification is a teaching device.
  • The right to science straddles all three, which is why it is hard to classify and easy to neglect.
  • Three duties: respect, protect, fulfil. The duty to protect is what reaches private technology.

Test yourself

1. Why does it matter that the Universal Declaration speaks of "recognition" rather than of grant? Because a right that the State grants is a right the State can withdraw, and the framework was built after a period in which a State used its own law against its own people. Recognition asserts that the entitlement exists independently of the State, so that denying it is a breach rather than a lawful policy choice.

2. Which of the three duties makes a State answerable for a private laboratory's conduct? The duty to protect. Respect governs the State's own conduct and fulfil requires positive provision; it is the duty to protect that requires the State to prevent third parties from violating rights, and it is the duty that makes regulation of private technology a human rights obligation rather than mere policy.

3. Explain why the classification into generations is awkward for the right to science. Because the right has limbs belonging to each generation at once. The freedom of research is a classic first generation liberty requiring abstention; the entitlement to the benefits of scientific progress is a second generation claim requiring expenditure; and international co-operation and the notion of a common heritage are third generation solidarity ideas. No single generation contains it.

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What a Human Right Is

4. A research participant signs a form agreeing to accept any risk whatever. Is that effective? Not entirely. Inalienability means some protections cannot be waived, and the instruments in Module III do not treat consent as making everything permissible. Consent is necessary, but the research must independently be ethically acceptable, which is what an ethics committee exists to decide.

Contents This chapter on its own page

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Chapter Three

The Right to Share in Scientific Advancement

Syllabus topic 1, "Interrelationship of Science, Technology and Human Rights"

In one line

The Universal Declaration says that everyone is entitled to a share in what science produces, and in the same breath protects the person who produced it.

In the wording a student can write in an exam: Article 27 of the Universal Declaration of Human Rights, 1948 contains the first statement in modern international law of a right relating to science. Article 27(1) provides that everyone has the right freely to participate in the cultural life of the community, to enjoy the arts and to share in scientific advancement and its benefits. Article 27(2) provides that everyone has the right to the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author. The article therefore states both a right of access to the fruits of science and a right of protection for those who create them.

Why the law has this at all

The drafters were writing in 1947 and 1948, with two things immediately behind them.

The first was the discovery that scientific knowledge could be turned into an instrument of mass destruction within a few years of the underlying physics being understood. The second was the discovery, through the Nuremberg trials then concluding, that medical science could be turned against the people it was supposed to serve.

Against that background it would have been easy to write an article about restraining science. The drafters did not. They wrote an article about entitlement to it. The claim they made was that the products of scientific advancement are not the private property of the nations or the classes that happen to fund the laboratories, and that ordinary people have a claim on them.

The provision itself

The text, in full, from the Declaration adopted by General Assembly resolution 217 A (III) on 10 December 1948:

Everyone has the right freely to participate in the cultural life of the community, to enjoy the arts and to share in scientific advancement and its benefits.

Everyone has the right to the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author.

Broken down

"Everyone." No qualification by nationality, residence, contribution or capacity to pay. The subject of the right is the human person, not the citizen and not the customer.

"Freely." The adverb governs participation and carries into the rest of the paragraph. It means without coercion and without arbitrary exclusion.

"To participate in the cultural life of the community, to enjoy the arts and to share in scientific advancement." Science is placed inside a cultural article, alongside art. That placement is not accidental and it has consequences. It treats science as part of what a community produces and holds in common, rather than as an economic commodity or a branch of industrial policy.

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The Right to Share in Scientific Advancement

"And its benefits." Two things are claimed, not one. A share in the advancement, which is the knowledge itself and the ability to take part in producing it, and a share in the benefits, which are its practical applications. A State that publishes research freely but prices the resulting medicine beyond reach has satisfied the first half and failed the second.

"The moral and material interests." Paragraph 2 is the intellectual property limb, and it is drawn deliberately narrowly. It protects the author, meaning the human creator. It speaks of moral as well as material interests, which is broader than a purely economic patent right and narrower in its beneficiary: a corporation holding a patent is not an author.

The tension inside the article

Paragraph 1 says everyone may share in the benefits. Paragraph 2 says the creator's interests are protected. Those two pull against each other, and the whole modern argument about patents and access to medicines lives in the gap.

The article does not resolve the tension, and it is important to say so rather than to pretend otherwise. What it does is refuse to let either side be forgotten. A student asked about access to medicines can therefore begin by observing that both the claim of the patient and the claim of the inventor are stated in the same article of the same instrument, which is why the question is genuinely hard.

A worked example

A laboratory in one country develops a vaccine using publicly funded research. Manufacturing capacity exists in a second country. A third country can afford neither the vaccine nor the licence.

Paragraph 1 gives the population of the third country a claim to share in the benefit. It is not charity that is being asked for; it is an entitlement stated in 1948.

Paragraph 2 protects the moral and material interests of the individual scientists who did the work. It does not, on its face, protect the balance sheet of the company that owns the patent, because that company is not an author. That is a genuine reading of the text and it is worth making, though it is not how the intellectual property system in fact operates.

The gap between the two is where later instruments do their work. The Covenant of 1966 turns the entitlement into a binding obligation with steps attached, General Comment 25 of 2020 spells out what those steps require, and the 1975 Declaration adds the duty of international co-operation.

Limits and what came after

The Declaration is a resolution of the General Assembly. It was not, when adopted, a treaty, and it created no directly enforceable obligation. Its authority has grown by other routes: through the argument that much of it now reflects customary international law, through its incorporation into national constitutions, and through the two Covenants of 1966 which turned its provisions into binding form.

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The Right to Share in Scientific Advancement

For this paper the sequence to remember is short. Article 27(1) of the Declaration in 1948 becomes article 15(1)(b) of the ICESCR in 1966, which becomes the subject of General Comment 25 in 2020. The wording changes at each step, and the changes are examinable.

Distinctions

Article 27(1) UDHRArticle 15(1)(b) ICESCR
FormDeclaration, not a treaty when adoptedTreaty, binding on parties
Wording"to share in scientific advancement and its benefits""to enjoy the benefits of scientific progress and its applications"
Duties attachedNone statedArticle 15(2), (3) and (4) state them
EnforcementNone directlyReporting to the Committee on Economic, Social and Cultural Rights

What beginners get wrong

Reading paragraph 2 as a patent clause. It protects authors, and it speaks of moral interests, which patent law does not recognise at all. Treating it as a straightforward endorsement of the patent system overstates it.

Forgetting that science sits in a cultural article. Students who quote article 27 for the science limb alone lose the argument that the drafters treated scientific knowledge as part of the common cultural inheritance.

Saying the Declaration is binding. It was not a treaty. Say instead that it has acquired authority through custom, constitutional reception and the Covenants.

Quick revision

  • Article 27(1): everyone has the right freely to participate in cultural life, enjoy the arts, and share in scientific advancement and its benefits.
  • Article 27(2): protection of the moral and material interests of the author of a scientific, literary or artistic production.
  • Two claims in paragraph 1: a share in the advancement and a share in the benefits.
  • Science sits in a cultural article, alongside art. That placement is doing work.
  • The two paragraphs pull against each other, and the access-to-medicines debate lives in that gap.
  • Declaration, 10 December 1948, General Assembly resolution 217 A (III). Not a treaty when adopted.

Test yourself

1. Set out article 27 and identify the two distinct rights it contains. Article 27(1) confers a right freely to participate in the cultural life of the community, to enjoy the arts and to share in scientific advancement and its benefits. Article 27(2) confers a right to the protection of the moral and material interests resulting from any scientific, literary or artistic production of which the person is the author. The first is a right of access to what science produces; the second is a right of protection for the person who produced it.

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The Right to Share in Scientific Advancement

2. Why does it matter that article 27(1) claims a share in both the advancement and its benefits? Because the two can be satisfied separately. A State that publishes research openly gives a share in the advancement, and a State that makes the resulting product available gives a share in the benefits. A State can do the first and fail the second entirely, which is what happens when knowledge is public but the medicine derived from it is unaffordable.

3. Does article 27(2) protect a pharmaceutical company's patent? Not on its own terms. The paragraph protects the moral and material interests of the author, meaning the human creator, and it protects moral interests that patent law does not recognise. A corporate patent holder is not an author, so the paragraph is a weaker foundation for corporate intellectual property than it is often assumed to be.

4. What is the significance of science being placed in an article about cultural life? It treats scientific knowledge as part of what a community produces and holds in common, rather than as a commodity or a matter of industrial policy. That framing supports the claim that the benefits of science are owed to everyone as members of a community, and it is the textual root of the later idea that scientific knowledge is a common heritage.

Contents This chapter on its own page

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Chapter Four

Privacy and Health in the Universal Declaration

Syllabus topic 1, "Interrelationship of Science, Technology and Human Rights"

In one line

Two more articles of the Declaration matter here, because the two fields this paper examines in depth are the two they protect: information and medicine.

In the wording a student can write in an exam: Article 12 of the Universal Declaration protects against arbitrary interference with privacy, family, home and correspondence, and against attacks on honour and reputation, and guarantees the protection of the law against such interference. Article 25 guarantees a standard of living adequate for health and well-being, including medical care and necessary social services, and gives special protection to motherhood and childhood. Together with article 27 they supply the three points at which the Declaration touches the subject matter of this paper.

The provisions themselves

Article 12:

No one shall be subjected to arbitrary interference with his privacy, family, home or correspondence, nor to attacks upon his honour and reputation. Everyone has the right to the protection of the law against such interference or attacks.

Article 25(1):

Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control.

Article 25(2):

Motherhood and childhood are entitled to special care and assistance. All children, whether born in or out of wedlock, shall enjoy the same social protection.

Article 12 broken down

"Arbitrary." The word is doing the central work, and it is the reason the article is usable seventy-five years later. It does not forbid all interference with privacy. It forbids interference that is arbitrary, which means without law, without a legitimate purpose, or disproportionate to that purpose. Module IV turns that single adjective into a four-part test.

"Privacy, family, home or correspondence." Four protected zones, listed because in 1948 those were the places a person could be intruded upon. The list is now the weakest part of the article, because the most valuable information about a person is no longer held at home or sent by post. It sits on a server owned by somebody else. The article's language survives only because "privacy" was stated first and separately, as a thing in itself rather than as a quality of the four places.

"Attacks upon his honour and reputation." A separate protection, and one that becomes newly important when a false statement can reach millions in an hour.

"The right to the protection of the law." Not merely a right to be left alone, but a right to a legal remedy. This is where the State's duty to protect enters: it must supply law that works against private intruders, not only refrain from intruding itself.

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Privacy and Health in the Universal Declaration

Article 25 broken down

"An adequate standard of living." Health is not framed as a right to be treated when ill. It is framed as a right to the conditions in which a person can be well: food, clothing, housing and medical care in one list. That framing matters for this paper, because it means a State cannot answer a right-to-health claim purely by building hospitals.

"Health and well-being." Two words, and the second is wider. Well-being takes in mental health, which is why the Mental Healthcare Act's rights chapter in Module II belongs to this tradition and not to a separate one.

"Medical care and necessary social services." Medical care is named expressly. It is one item in a list, not the whole of the right.

"Security in the event of ... sickness, disability ... or other lack of livelihood." The article contemplates that illness is an economic event as well as a medical one. Catastrophic medical expenditure is therefore a rights question and not merely a policy failure.

"Motherhood and childhood are entitled to special care." The clause that carries into Module II's chapters on pregnancy, termination, surrogacy and assisted reproduction, and into Module IV's chapter on children online.

How the two articles frame this paper

The structure of the Declaration explains the structure of the syllabus more neatly than the syllabus does.

Declaration articleWhat it protectsWhere this book takes it
12Privacy, correspondence, honour, and a legal remedyModule IV: data protection, surveillance, cyber offences
25Standard of living adequate for health, medical care, motherhood and childhoodModule II: the whole of Medicine and the Law
27A share in scientific advancement and its benefits, and protection of the authorModule I and Module IV: the right to science and the international response

A student who can draw that table has a way into almost any question on this paper, because it shows that the three fields the syllabus examines are not an arbitrary selection. They are the three places the 1948 text already touched.

A worked example

A State introduces a national health database. Every citizen's medical record is uploaded, and researchers may apply for access to anonymised extracts.

Article 25 supports it. Better data means better treatment and better epidemiology, and the State's duty to secure an adequate standard of health is served by knowing what is making people ill.

Article 12 constrains it. Medical information is the most sensitive category there is. The interference must not be arbitrary: it needs a law, a legitimate purpose and proportionality, and the citizen needs a remedy if the safeguards fail.

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Privacy and Health in the Universal Declaration

Article 27 complicates it. The research done on the database will produce benefits, and the population whose records made the research possible has a claim to share in them. If the outputs are licensed exclusively to a private firm, the article is engaged.

Notice that the three articles do not give one answer. They give three questions that a good answer must address. That is what the Declaration supplies to this subject: not a rule, but the agenda.

What beginners get wrong

Treating article 12 as absolute. It forbids arbitrary interference. A student who writes that surveillance always violates the Declaration has misread the operative word and will be unable to handle any realistic problem.

Reading article 25 as a right to free treatment. It is a right to an adequate standard of living for health, of which medical care is one named component. It says nothing directly about who pays.

Forgetting the second sentence of article 12. The right to the protection of the law is what makes the article bite against private actors, and private actors hold most of the data.

Quick revision

  • Article 12: no arbitrary interference with privacy, family, home or correspondence; no attacks on honour and reputation; and a right to the protection of the law against both.
  • Arbitrary is the operative word: interference must be lawful, legitimate in purpose and proportionate.
  • Article 25(1): a standard of living adequate for health and well-being, including food, clothing, housing, medical care and necessary social services, and security in sickness, disability and old age.
  • Article 25(2): special care for motherhood and childhood.
  • Articles 12, 25 and 27 map onto Modules IV, II and I respectively.

Test yourself

1. Why is the word "arbitrary" in article 12 more important than the list of four protected zones? Because the list reflects where a person could be intruded upon in 1948, and most sensitive information is no longer held at home or sent by post. The adjective, by contrast, states a test that survives any change of technology: interference must be lawful, must pursue a legitimate purpose, and must be proportionate. It is the part of the article that later law was able to build on.

2. What does the second sentence of article 12 add? A right to the protection of the law against interference and attacks. Without it the article would restrain only the State. With it, the State is obliged to provide legal machinery that works against private intruders too, which is what makes the article relevant to data held by companies.

3. How does article 25 frame the right to health, and why does the framing matter? It frames it as a right to a standard of living adequate for health and well-being, with food, clothing, housing, medical care and social services in a single list. The framing matters because it prevents a State from answering a right-to-health complaint solely by pointing to hospitals: the conditions of health are part of the right, not a separate policy area.

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Privacy and Health in the Universal Declaration

4. A national health database is challenged. Which Declaration articles are engaged and how do they pull? Article 25 supports the database, because better health information serves the State's duty to secure an adequate standard of health. Article 12 constrains it, because medical data is highly sensitive and the interference must not be arbitrary. Article 27 is engaged if research done on the data produces benefits, because the population whose records enabled it has a claim to share in those benefits.

Contents This chapter on its own page

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Chapter Five

The Right to Science in the Covenant

Syllabus topic 1, "Interrelationship of Science, Technology and Human Rights"

In one line

Eighteen years after the Declaration said everyone should share in scientific advancement, a treaty said States must actually do something about it.

In the wording a student can write in an exam: Article 15(1)(b) of the International Covenant on Economic, Social and Cultural Rights, 1966 provides that the States Parties recognise the right of everyone to enjoy the benefits of scientific progress and its applications. Unlike article 27 of the Universal Declaration, which was contained in a resolution of the General Assembly, article 15 is a treaty obligation binding on the States that have ratified it, and paragraphs (2), (3) and (4) of the article state the steps those States must take.

Why the law has this at all

The Declaration of 1948 was adopted as a common standard of achievement. It was deliberately not a treaty, because the drafters could not have obtained agreement on a binding text in 1948 and knew it.

The intention from the beginning was that the Declaration would be followed by a covenant. It took until 1966, and by then the Cold War had split the project in two. The civil and political rights went into one treaty and the economic, social and cultural rights into another, on the argument that the first kind could be granted immediately while the second required resources and could only be achieved progressively.

The right to science went into the second. That placement had a long and damaging consequence, and it is worth naming early: for decades the economic, social and cultural rights were treated as aspirations rather than obligations, and within that already-neglected treaty the right to science was the most neglected provision of all. General Comment 25, when it finally came in 2020, said as much.

The provision itself

Article 15, paragraph 1:

The States Parties to the present Covenant recognize the right of everyone:

(a) To take part in cultural life;

(b) To enjoy the benefits of scientific progress and its applications;

(c) To benefit from the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author.

Broken down

"The States Parties ... recognize." The verb is the same one the Declaration used, and it carries the same claim: the right is not being created here.

"The right of everyone." No limitation to nationals. A State's obligations under the Covenant are owed to everyone within its territory or jurisdiction.

"To enjoy the benefits." Compare the Declaration's "to share in scientific advancement and its benefits". The Covenant's wording is narrower in one respect and wider in another. It drops the express reference to sharing in the advancement, which is the participatory limb, and it adds applications, which is the practical limb. The participatory limb was not lost, but it had to be recovered by interpretation, and General Comment 25 is where that was done.

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The Right to Science in the Covenant

"Scientific progress and its applications." Both the knowledge and what is done with it. A State that produces excellent research which never reaches a clinic has not discharged the obligation.

"(a), (b) and (c) together." The three sub-paragraphs are one right with three faces: cultural participation, scientific benefit, and protection of the creator. Sub-paragraph (c) carries the same tension with (b) that paragraph 2 of article 27 carried with paragraph 1.

The wording changed, and the change is examinable

UDHR article 27(1)ICESCR article 15(1)(b)
Text"to share in scientific advancement and its benefits""to enjoy the benefits of scientific progress and its applications"
ParticipationExpressly included ("share in ... advancement")Not expressed; recovered by interpretation
ApplicationsImplied in "benefits"Expressly included
Legal characterDeclarationTreaty, binding on parties
MachineryNoneReporting to the Committee on Economic, Social and Cultural Rights

A worked example

A State ratifies the Covenant. It has a well-funded space programme and almost no rural primary healthcare.

Is it in breach of article 15(1)(b)? The question cannot be answered by pointing to the space programme, because the obligation is not to produce science. It is to secure everyone's enjoyment of the benefits of scientific progress and its applications.

What would a complaint look like? That the applications of well-established science, in the form of vaccines, antibiotics and clean water, are not reaching a large part of the population, while resources are directed to research whose benefits reach almost none of them. That is an argument about distribution, and article 15(1)(b) is where it lives.

What is the State's answer? Progressive realisation. The obligation under the Covenant is to take steps to the maximum of available resources with a view to achieving progressively the full realisation of the rights. A State is not obliged to achieve everything at once, but it is obliged to move, to move in the right direction, and not to go backwards.

Limits

Progressive realisation is a real limit and a real obligation. It permits a State to plead resources. It does not permit inaction, and the Committee has consistently held that a deliberately retrogressive measure requires strong justification.

There is no direct individual remedy for most States. An Optional Protocol allowing individual communications was adopted in 2008 and is in force, but only for the States that have accepted it. Most complaints therefore surface, if at all, through the reporting process, and this is one of the honest weaknesses Module IV returns to.

The right was underdeveloped for over fifty years. Article 15(1)(b) attracted almost no jurisprudence until the Committee issued General Comment 25 in 2020. A student should say so, because it explains why the answers to many questions on this topic are recent.

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The Right to Science in the Covenant

What beginners get wrong

Saying the Covenant "created" the right. It recognised it, and the Declaration had stated it eighteen years earlier. The Covenant made it binding and attached duties.

Treating "progressive realisation" as an excuse. It is a standard against which a State is measured, not a defence to any complaint whatever.

Quoting article 15(1)(b) alone. The obligation is unintelligible without paragraphs (2), (3) and (4), which state what the State has to do. Those are the next three chapters, and an exam answer that omits them is half an answer.

Quick revision

  • Article 15(1)(b) ICESCR, 1966: the right of everyone to enjoy the benefits of scientific progress and its applications.
  • Binding on States Parties, unlike the Declaration.
  • Wording changed from 1948: "advancement" became "progress", "share in" became "enjoy", and "applications" was added.
  • Read with (a) cultural life and (c) protection of the author. One right, three faces.
  • Subject to progressive realisation to the maximum of available resources; retrogression needs strong justification.
  • Almost no jurisprudence until General Comment 25 in 2020.

Test yourself

1. State article 15(1)(b) and explain how it differs in legal character from article 27 of the Universal Declaration. Article 15(1)(b) provides that States Parties recognise the right of everyone to enjoy the benefits of scientific progress and its applications. It differs in that the Covenant is a treaty binding on the States that ratify it, whereas the Universal Declaration was a resolution of the General Assembly creating no directly binding obligation. The Covenant also attaches machinery, in the form of reporting to the Committee on Economic, Social and Cultural Rights, and states the steps required in paragraphs (2), (3) and (4).

2. What was lost and what was gained when the 1948 wording became the 1966 wording? The express reference to sharing in scientific advancement was lost, which weakened the participatory limb until interpretation restored it. What was gained was the express reference to applications, which makes clear that the right extends beyond knowledge to what is done with it, and the binding character of a treaty obligation with steps attached.

3. Does progressive realisation mean a poor State owes nothing under article 15? No. It means the State must take steps to the maximum of its available resources with a view to achieving the full realisation of the right progressively. Inaction is not permitted, the direction of travel is measured, and a deliberately retrogressive measure requires strong justification. Poverty affects the pace, not the existence, of the obligation.

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The Right to Science in the Covenant

4. A State has a large research budget and poor basic healthcare. Is that a breach? Possibly, and the argument runs through distribution rather than through the size of the research budget. Article 15(1)(b) protects everyone's enjoyment of the benefits and applications of scientific progress, so a State in which well-established applications such as vaccines and clean water do not reach a large part of the population may be failing the obligation regardless of how much science it produces.

Contents This chapter on its own page

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Chapter Six

The Duty to Conserve, Develop and Diffuse Science

Syllabus topic 1, "Interrelationship of Science, Technology and Human Rights"

In one line

The Covenant does not merely say that everyone may enjoy what science produces. It tells States they must keep it, grow it and spread it.

In the wording a student can write in an exam: article 15(2) of the International Covenant on Economic, Social and Cultural Rights, 1966 provides that the steps to be taken by the States Parties to achieve the full realisation of the right recognised in article 15(1) shall include those necessary for the conservation, the development and the diffusion of science and culture. The paragraph turns the entitlement stated in article 15(1)(b) into positive obligations: to protect scientific knowledge and the means of producing it, to advance it, and to spread it and its applications through the population.

Why the law has this at all

A right to enjoy the benefits of scientific progress assumes that somebody is producing benefits, keeping them and passing them on. Article 27 of the Universal Declaration said nothing about who does that work or at whose cost. It stated an entitlement and stopped.

That gap is not academic. If the right required only that the State keep out of the way, a State could satisfy it completely by doing nothing at all: no research funding, no libraries, no science in its schools, no obstruction either. Nobody would be excluded from anything, because there would be nothing to be excluded from. Article 15(2) closes that escape. It is the reason the right to science is an expensive right and not merely a permissive one.

The paragraph is also the one students most often skip, because it reads like administration rather than like rights. It is not. Every practical failure this paper examines, a population that cannot get a medicine that exists, a school system that produces no scientists, a research archive allowed to rot, is a failure of one of these three words.

The provision itself

Article 15, paragraph 2:

The steps to be taken by the States Parties to the present Covenant to achieve the full realization of this right shall include those necessary for the conservation, the development and the diffusion of science and culture.

Broken down

"The steps to be taken." The Covenant's general obligation in article 2(1) is to take steps, individually and through international assistance and co-operation, especially economic and technical, to the maximum of available resources, with a view to achieving progressively the full realisation of the Covenant rights. Article 15(2) tells a State what some of those steps have to be aimed at.

"To achieve the full realization of this right." The expression looks back to the whole of paragraph 1, so the three duties serve cultural life under (a) and the protection of authors under (c) as well as the benefits of scientific progress under (b). A State cannot pick one sub-paragraph and say the steps were taken for that.

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The Duty to Conserve, Develop and Diffuse Science

"Shall include." A floor, not a ceiling. These three are compulsory, and a State that has done them is not thereby finished; other steps may still be necessary.

"Those necessary." The measure is what the object requires, not what is convenient or affordable in the abstract. Resources come in through article 2(1), not through a discount hidden in the word necessary.

"Conservation, development, diffusion." Three separate duties, and a State can be doing well at one and failing another. They are taken one at a time below.

"Of science and culture." Science is not separated out for weaker treatment. The same sentence governs both, which is the same structural point article 27 of the Declaration made by putting science in a cultural article.

What the three words mean

The Committee on Economic, Social and Cultural Rights, the treaty body that supervises the Covenant, put the distinction between abstaining and acting as plainly as it can be put:

States parties should not only abstain from interfering in the freedom of individuals and institutions to develop science and diffuse its results. States must take positive steps for the advancement of science (development) and for the protection and dissemination of scientific knowledge and its applications (conservation and diffusion).

Conservation is protection and preservation. It covers scientific knowledge already produced and the things that hold it: data sets, specimen and seed collections, archives, laboratories, instruments, and the trained people without whom none of it can be read. Knowledge that exists in a form nobody can any longer reach has not been conserved, and a State that lets that happen has failed this limb even though it never obstructed anybody.

Development is the advancement of science: research funding, research infrastructure, the training of scientists, and the institutional conditions in which inquiry can be carried on. The Committee treats this as a duty to promote actively, through education and investment in science and technology, through policies and regulations that foster research, and through the allocation of resources in budgets.

Diffusion is spreading science and its applications so that they reach people. The Committee names the instruments of diffusion in terms: libraries, museums and network access, a research infrastructure with adequate resources, and adequate financing of scientific education. It goes further and says that States should promote open science and open source publication of research, and that research findings and research data funded by States should be accessible to the public.

Which of the three duties this is

Every human right generates three duties on the State: to respect, to protect and to fulfil. Article 15(2) is the Covenant's own statement of the third. The Committee says so directly, that the duty to fulfil is reinforced and specified by article 15(2), which provides that States parties must take steps for the conservation, the development and the diffusion of science.

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The Duty to Conserve, Develop and Diffuse Science

That is worth holding on to, because it tells a student where to put the paragraph in an answer. A question about censorship of a researcher is answered under article 15(3) and the duty to respect. A question about a private laboratory discriminating is answered under the duty to protect. A question about a State that produces no science, teaches no science and shares no science is answered here.

What a State actually has to do

The Committee's general comment turns the three words into obligations concrete enough to be argued about. Six of them are worth knowing by name.

  1. Fund it. Allocate resources in budgets, and give priority in the allocation of public resources to research in the areas of greatest need in health, food and other basic needs, especially for vulnerable and marginalised groups.
  2. Legislate for it. Develop a participatory national framework law on the right that includes legal remedies for violations, and adopt a national strategy or action plan that includes a strategy for the conservation, the development and the diffusion of science.
  3. Teach it. Ensure that people have access to the basic education and skills necessary to understand and apply scientific knowledge, and that scientific education in public and private schools respects the best available scientific knowledge.
  4. Open it. Make every effort to ensure equitable and open access to scientific literature, data and content, including by removing barriers to publishing, sharing and archiving scientific outputs.
  5. Carry it to people. Make knowledge of scientific progress and its applications broadly available through schools, universities, technical colleges, libraries, museums, print and electronic media and other channels, with specific programmes to overcome problems of access related to age, language or cultural diversity.
  6. Defend it. Promote accurate scientific information, refrain from disinformation and disparagement intended to erode public understanding of and respect for science, and adopt mechanisms protecting people from false, misleading and pseudoscience based practices.

Two further points from the same source correct a common assumption about who owes this. Open science, the Committee says, cannot be achieved by the State alone: scientists, universities, publishers, scientific associations, funding agencies, libraries and the media all have a role, especially for research financed with public funds. And it warns that all States should contribute to the common task of developing science to the maximum of their available resources, because recommending that poor States focus exclusively on applied science actually increases the gap and the unfair distribution of knowledge and power between States.

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The Duty to Conserve, Develop and Diffuse Science

Going backwards

Because the obligation is to move forward, moving backward is itself a breach unless it is justified. The Committee holds that there is a strong presumption that retrogressive measures are not permissible, and it gives examples that map onto this paragraph precisely: removing programmes or policies necessary for the conservation, the development and the diffusion of science; imposing barriers to education and information on science; imposing barriers to citizen participation in scientific activities, including misinformation intended to erode public respect for science; and adopting legal and policy changes that reduce international collaboration on science.

Where such a measure is unavoidable, the State must show that it is necessary and proportionate, keep it in place only so long as it is necessary, ensure that disadvantaged groups are not disproportionately affected, and still guarantee the core obligations.

A worked example

The State of Ashwara ratified the Covenant. Three things happen in the same year.

The archive. Ashwara's National Crop Research Institute holds a seed collection assembled over sixty years, with the field records that make it usable. The Finance Ministry withdraws the maintenance grant, the cold storage fails, and part of the collection is lost. Nobody was obstructed and nobody was excluded. This is still a breach, of the conservation limb, because the State allowed knowledge and the material that carries it to be destroyed. It is also retrogressive: a functioning programme necessary to the conservation of science was removed.

The research budget. Ashwara funds a prestige robotics laboratory and nothing at all on a parasitic disease that affects two million of its poorest citizens and almost nobody elsewhere. That is a development question, and the answer is not that the robotics laboratory is forbidden. It is that public resources must give priority to research in the areas of greatest need in health and other basic needs, and a State that spends everything where the need is least has to justify that allocation.

The findings. Dr Meera Iyer, employed at a State university on public money, establishes a low cost diagnostic method for that same disease. Her results appear in a journal that charges a fee no district hospital in Ashwara can pay, and her data is not deposited anywhere. The State's science curriculum, meanwhile, has not been revised in twenty years. That is the diffusion limb twice over, once because research funded by the State is not accessible to the public and once because the population is not equipped to use it.

Ashwara's answer, and its limits. The State pleads progressive realisation and limited resources. That plea is available and is sometimes good: article 2(1) measures the obligation against the maximum of available resources. It does not answer the first item at all, because closing a working archive is a retrogressive act needing strong justification rather than a failure to expand. It answers the second only if Ashwara can show the allocation was reasoned, and it does the third no good whatever, because depositing publicly funded data and results costs almost nothing.

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The Duty to Conserve, Develop and Diffuse Science

Distinctions

Article 15(1)(b)Article 15(2)Article 15(3)
What it statesThe right of everyone to enjoy the benefits of scientific progress and its applicationsThe steps the State must take to realise that rightThe State's undertaking to respect the freedom indispensable for scientific research
Duty typeThe right, from which all three duties flowChiefly the duty to fulfilChiefly the duty to respect
Costs moneyIndirectlyYes, and that is its pointNo
Breached byExclusion from benefitsInaction, neglect, retrogressionInterference
ConservationDevelopmentDiffusion
ObjectKnowledge and the means of producing it that already existNew knowledgeReaching people with both
Typical breachArchives, collections and data allowed to decayNo funding, no training, no research basePaywalls, no science education, no libraries or network access
Typical measureMaintaining collections, data repositories, laboratoriesBudgets, grants, research institutions, scientific careersOpen access, public repositories, museums, curricula, translation

What beginners get wrong

Reading it as a paragraph about culture. The words are "science and culture" and the Committee's whole general comment is built on the science half. Nothing about the paragraph is confined to the arts.

Treating "shall include" as a complete list. It is a minimum. A State that has done these three things may still owe other steps under article 2(1).

Thinking a State discharges it by having universities. The duty is to conserve, develop and diffuse. A country with excellent universities whose findings never reach its own district hospitals has done the second and failed the third.

Assuming it is programmatic and unenforceable. The Committee states that this right, like every other right in the Covenant, is enforceable and therefore justiciable, and that States should establish mechanisms and remedies for violations by omission as well as by act. Whether courts in fact do this is a separate and much weaker story, which the closing chapters of Module IV take up.

Confusing diffusion with publication. Publishing a paper diffuses it to people who can already read papers. The Committee's examples run from libraries and museums to curricula and translation, and diffusion is measured by whether the knowledge arrives, not by whether it was released.

Quick revision

  • Article 15(2) ICESCR: the steps to be taken shall include those necessary for the conservation, the development and the diffusion of science and culture.
  • Conservation protects what exists; development advances it; diffusion spreads it and its applications.
  • It is the Covenant's own statement of the duty to fulfil, reinforced and specified.
  • Concrete duties: fund research where the need is greatest, legislate a framework and a plan, teach science, open access to publicly funded findings and data, carry knowledge through libraries, museums, media and curricula, and defend the public against pseudoscience and disinformation.
  • Retrogression is presumed impermissible: closing programmes, raising barriers to science education, or cutting international collaboration all count.
  • Resources are measured under article 2(1), to the maximum of what is available. Poverty affects the pace, not the existence, of the duty.
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The Duty to Conserve, Develop and Diffuse Science

Test yourself

1. Set out article 15(2) and explain what it adds to article 15(1)(b). Article 15(2) provides that the steps to be taken by States Parties to achieve the full realisation of the right shall include those necessary for the conservation, the development and the diffusion of science and culture. Article 15(1)(b) states an entitlement; standing alone it could be satisfied by a State that obstructs nobody and provides nothing. Article 15(2) adds the positive side, requiring the State to preserve existing scientific knowledge, to advance it and to spread it and its applications, and it is the Covenant's own specification of the duty to fulfil.

2. A State says it cannot afford a national research programme. Is that an answer? Partly, and only to the extent it is true. The obligation under article 2(1) is measured to the maximum of available resources, so a poor State is not required to match a rich one. But the plea does not excuse inaction, it does not excuse allowing existing scientific collections and data to be destroyed, which is retrogressive rather than merely slow, and it does not excuse the steps that cost almost nothing, such as making publicly funded research findings and data accessible.

3. Distinguish conservation from diffusion, with an example of a State that satisfies one and breaches the other. Conservation is the protection and preservation of scientific knowledge and the means of producing it; diffusion is spreading that knowledge and its applications so that people can reach and use them. A State that maintains a well kept national data archive which is closed to the public, taught in no school and reproduced in no library has conserved and has not diffused. The reverse also occurs: a State may publicise findings widely while allowing the collections that produced them to decay.

4. Give three examples of a retrogressive measure under this paragraph. Removing a programme or policy necessary for the conservation, the development or the diffusion of science, such as closing a functioning research archive; imposing barriers to education and information on science, including official misinformation intended to erode public respect for scientific research; and adopting legal or policy changes that reduce international collaboration on science. Each is presumed impermissible and requires the State to prove necessity and proportionality.

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The Duty to Conserve, Develop and Diffuse Science

5. Why is it wrong to say the diffusion duty is discharged by publishing research? Because diffusion is measured by arrival rather than by release. The Committee names libraries, museums, network access, scientific education and the media as instruments of diffusion, requires research findings and data funded by the State to be accessible to the public, and calls for specific programmes to overcome barriers of age, language and cultural diversity. Publication in a journal that a population cannot reach, in a language it does not read, and with no education equipping it to use the result, leaves the duty unperformed.

Contents This chapter on its own page

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Chapter Seven

Freedom Indispensable for Scientific Research

Syllabus topic 1, "Interrelationship of Science, Technology and Human Rights"

In one line

The person who does the research has a right of their own, and it is a right against the State that would rather they stopped.

In the wording a student can write in an exam: article 15(3) of the International Covenant on Economic, Social and Cultural Rights, 1966 provides that the States Parties undertake to respect the freedom indispensable for scientific research and creative activity. It is the freedom limb of the right to science. Where article 15(2) requires the State to act, article 15(3) requires it to abstain: to leave the researcher's judgment, methods, associations and publication alone, subject only to limitations that satisfy article 4 of the Covenant.

Why the law has this at all

Science is not a stock of results. It is a method, and the method consists of asking questions whose answers are not known in advance. A body that can decide which questions may be asked, or which answers may be announced, controls the results without ever having to falsify one.

The State is the body most likely to be in that position. It funds the laboratories, licenses the universities, appoints the vice-chancellors, issues the passports and regulates the journals. It also has strong reasons to prefer some findings to others: a finding may embarrass a policy, expose a licensed industry, or contradict something the State has told its people.

So a paragraph that only required the State to build and to spread science would be dangerous by itself. It would produce a well funded science whose conclusions were known before the work began. Article 15(3) is the counterweight, and it is the reason the right to science cannot be classified neatly as an economic and social right at all: this limb behaves exactly like a civil liberty.

The provision itself

Article 15, paragraph 3:

The States Parties to the present Covenant undertake to respect the freedom indispensable for scientific research and creative activity.

The limitation clause that governs it, article 4:

The States Parties to the present Covenant recognize that, in the enjoyment of those rights provided by the State in conformity with the present Covenant, the State may subject such rights only to such limitations as are determined by law only in so far as this may be compatible with the nature of these rights and solely for the purpose of promoting the general welfare in a democratic society.

Broken down

"Undertake to respect." Compare the verbs across the article. Paragraph 1 says the States Parties "recognize the right"; paragraph 2 says the steps "shall include"; paragraph 4 says they "recognize the benefits to be derived". Only paragraph 3 says "undertake to respect", and respect is the duty of non-interference. It is not subject to progressive realisation, because abstaining costs nothing and can therefore be done at once.

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Freedom Indispensable for Scientific Research

"The freedom." Singular, and undefined in the treaty. That is why the Committee on Economic, Social and Cultural Rights, the expert body to which States report under the Covenant, had to say what it contains. Its list is set out below.

"Indispensable." The adjective limits the protection and is often misread as weakening it. The Covenant does not protect every convenience a researcher would like. It protects what research cannot be carried on without. A denied promotion is not covered; a direction to reach a particular conclusion is.

"For scientific research and creative activity." The paragraph covers the artist as well as the scientist, which is again the Covenant treating science and culture as one subject. For this paper the scientific half is what matters.

What the freedom actually contains

The Committee's reading of article 15(3) lists the dimensions the freedom includes "at the least". They are worth learning as a list, because an examination answer that recites the bare words of the paragraph and stops has said almost nothing.

  1. Independent judgment. Researchers are protected from undue influence on their independent judgment.
  2. Autonomous institutions and self-chosen questions. Researchers may set up autonomous research institutions and define the aims and objectives of the research and the methods to be adopted.
  3. Conscience. Researchers may freely and openly question the ethical value of particular projects, and may withdraw from a project if their conscience so dictates.
  4. Collaboration. Researchers are free to co-operate with other researchers, nationally and internationally.
  5. Sharing. Scientific data and analysis may be shared with policymakers, and with the public wherever possible.

To those the Committee adds the right to publish. As a consequence of the freedom of research and of the State's duty to disseminate science, scientists have in principle the right to publish the results of their research, and any restriction must comply with article 4. The Committee goes further and reaches private contracts: a State should ensure that any contractual restriction on publication is consistent with the public interest, is reasonable and proportionate, and provides for the appropriate crediting of the researchers who did the work.

The same passage that defines the State's positive duty describes what scientific freedom includes in practice: protection and promotion of academic and scientific freedom, including freedom of expression and freedom to seek, receive and impart scientific information, freedom of association and freedom of movement.

Whose freedom it is

A student writing on this paragraph will usually treat it as the scientist's professional privilege. That is the commonest error on the topic and it inverts the structure of the right.

The Committee treats the right to participate in and to enjoy the benefits of scientific progress as containing both freedoms and entitlements, and it puts the freedom to enjoy the freedom indispensable for scientific research in the first group. The protection of freedom of scientific research is an element of everyone's right, not a benefit conferred on a profession.

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Freedom Indispensable for Scientific Research

The reasoning is not sentimental. If the State silences a researcher who has found that a river is poisoned, the researcher loses a job and the population loses the knowledge. The people injured by the interference are the people who would have used the finding, which is why the freedom sits inside a right held by everyone.

The ground it stands on: thought and expression

Article 15(3) did not invent scientific freedom. Research is thinking, and then saying what the thinking found, and both of those are protected in their own right by instruments this paper has already met.

Freedom of thought. Article 18 of the Universal Declaration provides that everyone has the right to freedom of thought, conscience and religion. Article 18(1) of the International Covenant on Civil and Political Rights repeats it in binding form, and article 18(2) adds that no one shall be subject to coercion which would impair his freedom to have or to adopt a belief of his choice. Inquiry is the exercise of that freedom in an organised way.

Freedom of expression. Article 19 of the Universal Declaration provides that everyone has the right to freedom of opinion and expression, and that the right includes freedom to hold opinions without interference and to seek, receive and impart information and ideas through any media and regardless of frontiers. Article 19 of the Civil and Political Covenant makes it binding: paragraph 1 protects the holding of opinions without interference, and paragraph 2 protects the freedom to seek, receive and impart information and ideas of all kinds, regardless of frontiers, in any medium.

Three consequences follow, and they are examinable.

The three phrases do different work. To seek protects the gathering of data. To receive protects reading the literature, which is why access to journals and to the internet is a free expression question and not only a budget question. To impart protects publication.

"Regardless of frontiers" is the textual root of scientific collaboration. The right to receive and impart information does not stop at a border, which is why an obstacle to working with foreign colleagues is an interference with expression before it is anything else. That phrase is the bridge into the next chapter.

Scientific freedom is more than expression, not less. Article 19 protects what a researcher says. Article 15(3) protects the conditions in which the saying becomes possible: institutional autonomy, the choice of question and method, and freedom from undue influence on judgment. A student who answers a question on article 15(3) purely with free speech material has covered about half of it.

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The limits, and how to test one

Freedom of scientific research is not absolute. The Committee says so in terms, and article 4 supplies the test. A limitation must satisfy every one of these:

  1. Determined by law. An executive instruction, an informal warning from a ministry, or a funder's pressure is not law.
  2. Compatible with the nature of the right. The Committee reads this as meaning that a limitation must respect the minimum core of the right.
  3. Solely for the purpose of promoting the general welfare in a democratic society. Protecting a policy, an industry or a reputation from an unwelcome finding is not that purpose.
  4. Proportionate. Where several means could achieve the legitimate aim, the least restrictive must be chosen, and the burden imposed on the right must not outweigh the benefit of the limitation.

The Committee then divides the field in a way worth memorising. Limits on the applications of science are relatively easy to justify: they can be used to guarantee the safety and quality of products, and human rights impact assessments may be needed to protect people against risky applications. Limits on the research process can also be necessary, particularly where research affects human beings, in order to protect their dignity, their integrity and their consent, and where research is conducted in countries or among populations other than the researchers' own, the State of origin must guarantee the rights and obligations of all parties involved. But any limitation on the content of scientific research implies a strict burden of justification by the State, in order to avoid infringing freedom of research.

The same division governs precaution. The Committee notes that limitations on the freedom of scientific research are compatible with the Covenant only in the circumstances set out in article 4, and that the precautionary principle applies more broadly to the use and application of scientific outcomes than to inquiry itself. The principle is taken on its own later in this module.

A worked example

Dr Farida Qureshi is a soil scientist at a public university. She begins a study of groundwater near a fertiliser plant. Five things happen. Each is tested the same way.

One. The funding contract. Part of her department's funding comes from the plant's owner, and the grant agreement says nothing may be published without the funder's written consent. This fails. A contractual restriction on publication must be consistent with the public interest and be reasonable and proportionate, and a private veto held by the party whose conduct is being measured is neither. The State's own duty here is the duty to protect: it must ensure that private investment in scientific institutions is not used to unduly influence the orientation of research or to restrict the scientific freedom of researchers.

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Two. The stop order. The Ministry writes to the university, and the governing council directs her to close the study. This is a limitation on the content of research, so the strict burden of justification applies, and the limitation fails at the first step of article 4 before anything else is considered: a letter is not a law. Had there been a statute, it would still have to promote the general welfare in a democratic society, and suppressing a finding about contaminated water does the opposite.

Three. The conference and the co-author. Her application to travel to an international meeting is refused, and a rule forbids her to share raw data with a colleague abroad. Both bite on the collaboration dimension of the freedom, and the Committee treats the removal of obstacles to international collaboration among scientists as an example of the duty to respect, unless the restriction can be justified under article 4. It also treats the reduction of international scientific collaboration as a retrogressive measure.

Four. The blood samples. She proposes to take blood from villagers to measure exposure. Here the answer changes. This is a limit on the research process where research affects human beings, and it is permissible: she needs the free and informed consent of every participant and clearance from an ethics committee, and those requirements protect dignity, integrity and consent rather than suppressing a finding. The instruments that govern this are the subject of Module III, and freedom of research has never been a licence over other people's bodies.

Five. The test kit. A company wants to sell a testing kit built on her method, and the regulator requires certification before it goes on sale. That is a limit on an application and not on the research, and the Committee treats regulation and certification as part of ensuring the quality and the responsible development of science.

The pattern. Items one, two and three are interferences with the freedom the Covenant protects. Items four and five are not interferences at all in the relevant sense; they are the ordinary conditions under which research on people and products on the market are allowed to proceed. Sorting a fact pattern into those two piles is the whole skill this topic tests.

Distinctions

Article 19 free expressionArticle 15(3) scientific freedom
ProtectsHolding opinions, and seeking, receiving and imparting informationIndependent judgment, autonomous institutions, choice of question and method, conscience, collaboration, data sharing, publication
Held byEveryone, as a civil and political rightEveryone, as part of the right to science; exercised chiefly by researchers
Limitation testProvided by law and necessary for the rights of others, national security, public order, public health or moralsDetermined by law, compatible with the nature of the right, solely for the general welfare in a democratic society, and proportionate
Reaches institutionsNot directlyYes: autonomy, funding independence, the conditions of inquiry
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Type of limitHow hard to justifyExample
On an applicationOrdinary regulationCertifying a diagnostic kit before sale
On the research processPermissible where it protects participantsConsent and ethics committee review for research on human beings
On the content of researchStrict burden of justification on the StateAn order not to study a subject, or not to publish a result

What it does NOT mean

It does not mean the researcher is above the law. The freedom is bounded by article 4 and by the rights of the people the research touches. Research on human beings without consent is not an exercise of scientific freedom; it is the wrong the Nuremberg Code was written to answer, and Module III sets that out.

It does not mean a right to be funded for anything. The claim to funding runs through article 15(2) and the duty to fulfil, and a State that declines to fund a particular project has not thereby interfered with anybody's freedom. What it may not do is fund on condition that the conclusion is agreed in advance.

It does not mean "respect" is a soft word. Respect is the strongest of the three duties in one specific way: it is immediate. A State may plead limited resources against a duty to fulfil. It cannot plead limited resources for a failure to leave a researcher alone.

It does not belong to scientists alone. The freedom is an element of everyone's right to participate in and enjoy the benefits of scientific progress. The public is the party that loses when it is denied.

Quick revision

  • Article 15(3) ICESCR: States Parties undertake to respect the freedom indispensable for scientific research and creative activity. Duty to respect, immediate, not progressive.
  • What it contains: independent judgment; autonomous institutions and self-chosen aims and methods; freedom of conscience to question and withdraw; national and international collaboration; sharing of data and analysis; and the right to publish.
  • Its ground: freedom of thought (UDHR article 18, ICCPR article 18) and freedom of opinion and expression (UDHR article 19, ICCPR article 19), which protect seeking, receiving and imparting information regardless of frontiers.
  • It is more than expression: it also protects institutional autonomy and the conditions of inquiry.
  • Limits run through article 4: determined by law, compatible with the nature of the right, solely for the general welfare in a democratic society, and proportionate.
  • Applications and the research process may be regulated. Limits on the content of research carry a strict burden of justification.
  • The freedom is an element of everyone's right, not a professional privilege.
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Test yourself

1. State article 15(3) and explain why its verb matters. Article 15(3) provides that the States Parties undertake to respect the freedom indispensable for scientific research and creative activity. The verb is "respect", which is the duty of non-interference, and it is the only limb of article 15 expressed that way: paragraph 1 recognises a right, paragraph 2 requires steps, paragraph 4 recognises benefits. Because abstention costs nothing, the duty is immediate rather than progressively realisable, so a State cannot plead lack of resources for interfering with research.

2. List the dimensions the freedom includes. Protection of researchers from undue influence on their independent judgment; the possibility of setting up autonomous research institutions and of defining the aims, objectives and methods of research; the freedom to question openly the ethical value of a project and to withdraw from it on grounds of conscience; the freedom to co-operate with other researchers nationally and internationally; and the sharing of scientific data and analysis with policymakers and, wherever possible, with the public. To these is added the right in principle to publish research results.

3. How does freedom of scientific research relate to freedom of expression? Freedom of expression is its ground. Article 19 of the Universal Declaration and article 19 of the Civil and Political Covenant protect the holding of opinions without interference and the freedom to seek, receive and impart information and ideas regardless of frontiers, which covers gathering data, reading the literature and publishing results, and the phrase "regardless of frontiers" is the textual basis for cross border collaboration. Article 15(3) adds what expression alone does not reach: institutional autonomy, freedom in the choice of question and method, and freedom from undue influence on judgment.

4. A State passes a law forbidding all research into a particular gene sequence, saying the subject is dangerous. How is that tested? Under article 4. The measure is determined by law, so it passes the first requirement. It must then be compatible with the nature of the right, which the Committee reads as respecting the minimum core; it must be solely for the purpose of promoting the general welfare in a democratic society; and it must be proportionate, meaning the least restrictive means capable of achieving the aim, with burdens that do not outweigh the benefit. Because it is a limitation on the content of research, the State carries a strict burden of justification, and a ban on inquiry will rarely be the least restrictive means when regulating the applications would meet the danger.

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5. Is a requirement of ethics committee approval an interference with scientific freedom? No. It is a limitation on the research process of the kind the Committee treats as permissible, because the research affects human beings and the requirement exists to protect their dignity, their integrity and their consent. The distinction to draw is between limits that protect the people research is done on, which are legitimate, and limits on the content of the inquiry or on the publication of its results, which carry a strict burden of justification.

6. Why is it wrong to call article 15(3) a privilege of scientists? Because the Committee treats the freedom indispensable for scientific research as an element of the right of everyone to participate in and to enjoy the benefits of scientific progress. The reason is practical as well as doctrinal: when a researcher is silenced, the knowledge that would have been produced is lost to the whole population, so the injury falls on the people who would have used it and not only on the person prevented from working.

Contents This chapter on its own page

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Chapter Eight

International Co-operation in Science

Syllabus topic 1, "Interrelationship of Science, Technology and Human Rights"

In one line

Science does not stop at a border, so the duties that go with it do not stop there either.

In the wording a student can write in an exam: article 15(4) of the International Covenant on Economic, Social and Cultural Rights 1966 requires States Parties to recognise the benefits to be derived from the encouragement and development of international contacts and co-operation in the scientific and cultural fields. Read with the general duty of international assistance and co-operation in article 2(1), it makes co-operation in science a component of the right to enjoy the benefits of scientific progress rather than an optional courtesy between governments.

Why the law has this at all

The other three limbs of article 15 look inward. They tell a State what to give its own people: a right to enjoy the benefits, a duty to conserve and diffuse, a freedom for its researchers. A State could comply with all three and still leave the world's scientific capacity where it found it, concentrated in a handful of rich countries.

That was the objection the newly independent States pressed at the drafting table and pressed again through the 1960s and 1970s. Knowledge was produced in a few places, and the places where it was not produced were the places that needed it most. A right to enjoy the benefits of scientific progress is worth very little to a country with no laboratories, no research budget and no way to buy the products of anybody else's laboratories.

Article 15(4) is the answer to that objection. It is short, and for many years it was the least discussed part of article 15, but it carries the whole international dimension of the right.

The provision itself

Article 15(4) of the Covenant:

The States Parties to the present Covenant recognize the benefits to be derived from the encouragement and development of international contacts and co-operation in the scientific and cultural fields.

Two things about that wording repay attention.

"Recognize the benefits to be derived from" is weaker than the language of the other limbs. Article 15(2) says the steps to be taken "shall include" those necessary for conservation, development and diffusion. Article 15(3) says States "undertake to respect". Article 15(4) says only that they recognise benefits. On its own it is close to a statement of policy.

It does not stand on its own. Article 2(1) of the same Covenant obliges each State Party to take steps, individually and through international assistance and co-operation, to achieve progressively the full realisation of the Covenant rights. Articles 55 and 56 of the Charter of the United Nations pledge Members to joint and separate action for economic and social progress. Article 15(4) is the specific application of a duty that already exists in general terms, and it is read that way.

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Broken down: what the Committee makes of it

General Comment 25 (2020) devotes its Part VI to international co-operation, and the argument runs in four steps. Each is a separate reason, and an answer that gives one of them has given a quarter of the material.

  1. Some science can only be done together. Certain fields require a universal endeavour, so co-operation among scientists has to be encouraged if science is to progress at all. States should enable researchers to take part in the international scientific community, which means practical things: facilitating travel in and out of the territory, and policies that let researchers share data and educational resources across borders.
  2. The disparities between countries are deep. Where financial or technological constraints require it, developing States should resort to international assistance and co-operation in order to comply with their Covenant obligations. Developed States should contribute to scientific development elsewhere by allocating aid and funding to scientific education, research and training, and by promoting collaboration between the scientific communities of developed and developing countries. Access to research results should be regulated so that developing countries and their citizens can reach them affordably, essential medicines being the example the Committee gives.
  3. The benefits should be shared. The applications resulting from scientific progress should be shared with the international community, particularly with developing countries, communities living in poverty, and groups with special needs and vulnerabilities, especially where the benefits are closely related to the enjoyment of economic, social and cultural rights.
  4. The worst risks are transnational. Climate change, rapid loss of biodiversity, dangerous technologies such as autonomous weapons based on artificial intelligence, and the threat of weapons of mass destruction cannot be addressed by any State alone. States should promote multilateral agreements to prevent those risks or mitigate them, and should act together against biopiracy and against illicit trafficking in organs, tissues, samples and genetic materials.

The Committee also names brain drain. While respecting a scientist's right to decide their own career, developed States should implement reasonable policies for identifying and countering, rather than fostering, its effects. That is a rare instance of a human rights body naming migration of skilled people as a distributive problem in science.

The 1975 Declaration says it in stronger words

The General Assembly's Declaration on the Use of Scientific and Technological Progress in the Interests of Peace and for the Benefit of Mankind, resolution 3384 (XXX) of 10 November 1975, is not a treaty and binds nobody. It is worth citing because its language is direct where the Covenant's is cautious, and because its preamble records the reasoning openly.

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Its paragraph 1 requires all States to promote international co-operation to ensure that the results of scientific and technological developments are used to strengthen international peace and security, freedom and independence, and for the economic and social development of peoples and the realisation of human rights.

Its paragraph 5 requires all States to co-operate in the establishment, strengthening and development of the scientific and technological capacity of developing countries, with a view to accelerating the realisation of the social and economic rights of the peoples of those countries.

Its preamble records why: that scientific and technological progress is of great importance in accelerating the social and economic development of developing countries, and that the transfer of science and technology is one of the principal ways of accelerating that development.

Note the difference in force. The Declaration says States "shall co-operate". The Covenant says States "recognize the benefits". The Declaration is the stronger sentence and the weaker instrument, and a good answer says so rather than quoting whichever is more convenient.

The right to development

The phrase that gathers this material in the wider literature is the right to development: the claim that every human person and all peoples are entitled to participate in, contribute to and enjoy economic, social, cultural and political development in which all human rights can be fully realised. It was proclaimed by the General Assembly in 1986 and has been contested ever since, principally over whether it is a right at all and, if it is, who owes the corresponding duty.

Handle this claim carefully. The instrument that proclaims the right to development is not in this book's authority base, and nothing here quotes it or gives it an article number. What can be said on the strength of the texts we do hold is narrower and is enough for this paper: article 15(4) recognises international scientific co-operation; article 2(1) makes international assistance and co-operation part of the means by which Covenant rights are realised; the 1975 Declaration requires co-operation to build scientific capacity in developing countries; and General Comment 25 spells out what that requires of developed States. A candidate who argues from those four is arguing from authority. A candidate who recites article numbers of the 1986 Declaration from memory is doing the thing this paper's own sources forbid.

Worked example

A vaccine against a mosquito-borne disease is developed in a European university laboratory using public research funding. The disease is endemic in eight countries in South Asia and sub-Saharan Africa and effectively absent in Europe. Trials were conducted in two of the affected countries because that is where the disease is. The manufacturer prices the vaccine at a level the health budgets of those countries cannot meet, and declines to license production locally.

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Step one, the right engaged. Article 15(1)(b): the people of the trial countries have a right to enjoy the benefits of scientific progress and its applications. A vaccine that exists and cannot be obtained is the paradigm case of a benefit withheld.

Step two, the co-operation limb. Article 15(4) with article 2(1) puts the developed State in the frame. General Comment 25 states that access to research results and their applications should be regulated so that developing countries and their citizens have adequate access in an affordable manner, and gives essential medicines as the example.

Step three, benefit sharing. The population that carried the risk of the trials is the population now unable to obtain the product. That is the point at which the general duty in paragraph 80 of the Comment, to share benefits particularly with developing countries and communities living in poverty, becomes concrete rather than aspirational.

Step four, what can actually be asked for. Not the abolition of the patent. The realistic asks are the ones the Comment names: public funding conditioned on affordable access, voluntary licensing for local manufacture, tiered pricing, and multilateral arrangements. The chapter on [Access to Medicines and Patents] takes the intellectual property side of this further.

What it does NOT mean

It is not a duty to give money. Article 15(4) creates no entitlement in one State to a payment from another. The Committee's language is about enabling environments, funding, collaboration and access regulation, not about a transfer that any court could quantify.

It is not only about money either. Half of what the Comment asks for costs very little: letting researchers travel, letting them share data, not obstructing collaboration. A State that funds nothing but obstructs nothing is in a better position under this limb than a State that writes a cheque and refuses visas.

Co-operation is not charity, and the Covenant does not frame it as such. The obligation is owed because the right exists, not because the giving State is generous. That is the whole point of putting it in a human rights treaty rather than in a development policy.

The developing State is not passive. Paragraph 79 puts an obligation on it too: where its own constraints require, it should resort to international assistance and co-operation. Failing to ask is itself a failure to take steps.

Limits and criticism

The limb is the weakest drafted in article 15 and has no enforcement machinery of its own. A State that does nothing under it faces the reporting procedure and nothing more.

It is also the limb where the gap between what the Committee says and what States do is widest. The Comment was adopted in April 2020, in the first weeks of a pandemic, and its paragraph 82 sets out at length what scientific co-operation against a pandemic should look like: sharing information about potential pathogens, early warning based on timely and transparent information, and sharing the best scientific knowledge and its applications once a pandemic develops. What followed is the strongest available illustration of the distance between the norm and the practice, and a good answer may say so, in measured terms, without turning into a political essay.

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Quick revision

  • ICESCR article 15(4): States Parties recognise the benefits to be derived from the encouragement and development of international contacts and co-operation in the scientific and cultural fields. The fourth and last limb of article 15.
  • It is read with article 2(1) (steps individually and through international assistance and co-operation) and articles 55 and 56 of the UN Charter.
  • General Comment 25, Part VI, gives four justifications: some science needs a universal endeavour; disparities between countries are deep; benefits should be shared, particularly with developing countries; the worst risks are transnational. It also names brain drain.
  • 1975 Declaration, paragraph 5: all States shall co-operate in building the scientific and technological capacity of developing countries. Paragraph 1 ties co-operation to peace, development and the realisation of human rights.
  • The Declaration is the stronger language in the weaker instrument.
  • The right to development is the wider frame; argue it from article 15(4), article 2(1), the 1975 Declaration and General Comment 25, which are in front of you, and do not quote the 1986 instrument's articles.

Test yourself

1. Set out article 15(4) and explain why it cannot be read on its own. It provides that States Parties recognise the benefits to be derived from the encouragement and development of international contacts and co-operation in the scientific and cultural fields. Standing alone its language is weaker than the other three limbs, since it requires only recognition of benefits rather than steps or respect. It is read with article 2(1) of the Covenant, which obliges States to take steps individually and through international assistance and co-operation, and with articles 55 and 56 of the UN Charter. So understood it is the specific application in the scientific field of a general duty that already binds.

2. Give the Committee's four reasons for a reinforced duty of co-operation in science. First, certain fields of science require a universal endeavour, so co-operation among scientists must be encouraged for science to progress; States should facilitate researchers' travel and the international sharing of data. Second, there are deep disparities between countries: developing States should resort to international assistance where their constraints require it, and developed States should fund scientific education, research and training elsewhere and regulate access to research results so they are affordable. Third, benefits should be shared with the international community, particularly developing countries, communities living in poverty and groups with special needs. Fourth, the most acute risks, climate change, biodiversity loss, autonomous weapons and weapons of mass destruction, are transnational and need multilateral agreements.

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3. A developed State funds no overseas research but freely admits foreign scientists, shares its published data and places no obstacle in the way of collaboration. A second State makes a large annual grant but refuses visas to researchers from the recipient countries. Which is closer to compliance with article 15(4)? The first. The Committee's account of the duty is not primarily financial: it asks States to enable participation in the international scientific community, specifically through facilitating travel and enabling the free sharing of data and educational resources. The second State has satisfied the funding dimension while defeating the participation dimension, and visas are named in the Comment where a grant is not. The better answer notes that neither is fully compliant, since the first does nothing about the disparity that paragraph 79 addresses.

4. Why should a candidate be cautious in writing about the right to development on this paper? Because the claim is easy to assert and hard to source. The right to development is contested both as to its existence as a right and as to who bears the duty, and the instrument proclaiming it is not among the texts this book works from, so any article number given for it would be recalled rather than read. The material that carries the same argument is available and binding or near-binding: article 15(4), article 2(1), paragraphs 1 and 5 of the 1975 Declaration, and Part VI of General Comment 25.

5. What does paragraph 82 of General Comment 25 say about pandemics, and why is its date significant? It states that pandemics are a crucial example of the need for scientific international co-operation, since pathogens do not respect borders and a local epidemic can rapidly become a pandemic. It calls for support for the World Health Organization, stronger commitment to scientific co-operation because national solutions are insufficient, sharing of scientific information about potential pathogens, improved early warning based on timely and transparent State information, and the sharing of scientific knowledge and its applications once a pandemic develops. The Comment was adopted on 30 April 2020, which makes the paragraph a statement of what the duty required at the moment it was being tested, and therefore a fair measure of the distance between the norm and State practice.

Contents This chapter on its own page

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Chapter Nine

The Right to Health in the Covenant

Syllabus topic 1, "Interrelationship of Science, Technology and Human Rights"

In one line

The right to health is not a right to be healthy. It is a right to the best that can presently be done for a person, and what can presently be done is settled by science.

In the wording a student can write in an exam: article 12 of the International Covenant on Economic, Social and Cultural Rights, 1966 provides that the States Parties recognise the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, and paragraph 2 lists four categories of step the States must take to achieve its full realisation. A State Party is a country that has agreed to be bound by the treaty. The article belongs in a paper on science because the standard that is attainable at any moment is fixed by what science has discovered and by how far its applications have been spread.

Why the law has this at all

The Universal Declaration of 1948 put health inside article 25, as one element of an adequate standard of living, in a single list with food, clothing, housing and medical care. That framing is worked out in [Privacy and Health in the Universal Declaration]. What the Declaration did not do was give health an article of its own, or say what a State actually had to do about it.

The Covenant did both. Article 11 keeps the adequate standard of living, and article 12 takes health out of it and gives it a provision of its own with a list of steps attached. The separation has a practical consequence. A State can no longer answer a complaint about health by pointing at rising general prosperity, because the Covenant now asks about health directly and asks what steps were taken.

The second drafting choice is the more interesting one. The article does not confer a right to be healthy, and it could not have done. Whether a particular person is healthy depends on inheritance, accident and conduct, none of which any government controls. So the entitlement was pegged instead to a standard: the highest attainable one. That phrase is what brings science into the article, because what is attainable is not a constant. It moves every time a vaccine, a test or a treatment is proved to work.

The provision itself

Article 12, in full:

1. The States Parties to the present Covenant recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

2. The steps to be taken by the States Parties to the present Covenant to achieve the full realization of this right shall include those necessary for:

(a) The provision for the reduction of the stillbirth-rate and of infant mortality and for the healthy development of the child;

(b) The improvement of all aspects of environmental and industrial hygiene;

(c) The prevention, treatment and control of epidemic, endemic, occupational and other diseases;

(d) The creation of conditions which would assure to all medical service and medical attention in the event of sickness.

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The Right to Health in the Covenant

The Covenant was adopted by General Assembly resolution 2200A (XXI) of 16 December 1966 and entered into force on 3 January 1976.

Broken down

"The enjoyment of." Not the provision of. A facility that exists but that a person cannot reach, afford or use has not produced enjoyment of anything, and the obligation is stated in terms of the outcome for the individual.

"The highest attainable standard." Two limits sit inside one phrase, pulling opposite ways. Highest stops a State settling for a standard that is merely adequate or merely customary. Attainable lets in both what medicine has actually achieved and what the particular State can actually deliver, which is why the same article means different things in different countries in the same year.

"Physical and mental." Mental health is in the treaty text itself. It was not read in later by an interpreter. That is why the rights chapter of the Mental Healthcare Act 2017, taken in [The Rights of a Person with Mental Illness], is part of this tradition and not a separate compartment.

"The steps ... shall include those necessary for." The four sub-paragraphs are a floor and not a ceiling. "Shall include" means a State that has done these four things has not thereby exhausted article 12; it means a State that has done none of them is certainly in breach.

(a) Stillbirth-rate, infant mortality, healthy development of the child. A stillbirth is the birth of a child that has died before delivery, and infant mortality is the rate at which children die in the first year of life. Both are named because both were, and remain, the plainest available measure of whether a health system works at all.

(b) Environmental and industrial hygiene. Hygiene here means the conditions that keep disease from arising: clean water, drainage, air, and safe conditions in workplaces. Nothing in this sub-paragraph is about doctors.

(c) Epidemic, endemic, occupational and other diseases. An epidemic disease is one that spreads rapidly through a population over a limited period. An endemic disease is one that is constantly present in a given population or area. An occupational disease is one caused by the work a person does. The verbs are three: prevention, treatment and control.

(d) Conditions assuring to all medical service and medical attention in the event of sickness. The only sub-paragraph about clinical care, and the operative words are to all. It requires the creation of conditions that assure the service; it does not say who pays for it.

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The Right to Health in the Covenant

Read the four together and the Covenant's picture of health is mostly not a picture of hospitals. Three of the four sub-paragraphs are about children, sanitation, workplaces and disease control, which are questions of engineering, epidemiology and public administration. That is a scientific picture of health, and it is the reason this article can be taught in this paper at all.

What article 12 borrows from the rest of the Covenant

Article 2(1). Each State Party undertakes to take steps to the maximum of its available resources, with a view to achieving progressively the full realisation of the rights. Progressive realisation is explained at [The Right to Science in the Covenant], and it governs article 12 in exactly the way it governs article 15.

Article 2(2). The States Parties undertake to guarantee that the rights will be exercised without discrimination of any kind as to race, colour, sex, language, religion, political or other opinion, national or social origin, property, birth or other status. This obligation is not progressive. It bites at once, and it is the limb on which most realistic article 12 arguments are actually built.

Article 4. Limitations are permitted only where they are determined by law, only so far as compatible with the nature of the rights, and solely for the purpose of promoting the general welfare in a democratic society. A quarantine order is the standard example, and [Public Health Powers and Epidemics] takes the Indian version of it.

Why an article on health sits in a paper on science

The Committee that supervises the Covenant set out the links expressly in 2020, in the general comment on science taken in the next chapter. It gives four, at paragraphs 67 to 71.

First, science is the instrument. Scientific progress creates the applications that prevent disease, such as vaccination, or that let it be treated more effectively. The Committee therefore says States should promote research through funding or other incentives and make the resulting applications accessible and affordable to everyone, and that they should prioritise progress in the prevention, control and treatment of epidemic, endemic, occupational and other diseases. That last phrase is article 12(2)(c) quoted back into the law of science.

Second, science mediates between health and property. Some applications are protected by patents. The Committee calls the right to science a significant mediator between a human right, health, and a property right, and says States should use the flexibilities of the TRIPS Agreement, the World Trade Organization's agreement on trade related aspects of intellectual property rights, to secure essential medicines. It names compulsory licences, meaning a licence granted by the State allowing somebody other than the patent holder to make a patented product without that holder's agreement. It adds that States should refrain from granting disproportionately lengthy terms of patent protection for new medicines. [Access to Medicines and Patents] takes this in full.

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The Right to Health in the Covenant

Third, there is a duty to deliver what already exists. States must make available and accessible to all without discrimination, and especially to the most vulnerable, the best available applications of scientific progress needed for the highest attainable standard of health, and should prioritise safe and effective generic medicines over brand-name ones in national health plans.

Fourth, research itself carries health risks. The Committee requires States to prevent or mitigate them by careful application of the precautionary principle and by protecting research participants, and to ensure that medicines and treatments are evidence based and that risks are evaluated and communicated clearly enough for a patient to give properly informed consent. Those are the subjects of [The Precautionary Principle] and of [Clinical Trials and Research on Patients].

A worked example

A State has ratified the Covenant. In its capital, a government hospital tests every tuberculosis patient for drug resistance and prescribes the newer regimen where the test is positive. Four hundred kilometres away, Savitri, a farm labourer, is diagnosed at a primary health centre that has no such test and stocks only the older drugs.

Is article 12 engaged? Yes, and the reason is the word attainable. The State cannot argue that the newer standard is beyond it, because the State itself is already delivering that standard somewhere within its own territory.

Which limbs? Article 12(2)(c), on the prevention, treatment and control of epidemic and endemic disease, and article 12(2)(d), on conditions assuring to all medical service and medical attention in the event of sickness. The two words "to all" are what Savitri actually relies on.

What is the State's defence? Resources, under article 2(1). Rolling out testing to every primary health centre costs money, and the obligation is to move progressively towards full realisation rather than to arrive at it at once.

Why does that not close the argument? For two reasons. Article 2(2) makes non-discrimination immediate, so if the gap between the capital and the district tracks a prohibited ground, scarcity does not explain it. And the general comment on science puts a duty on the State to make the best available applications accessible to all without discrimination and especially to the most vulnerable, which is a duty about distribution rather than about totals.

What does the right to science add? The test Savitri was not given is an application of scientific progress. The duty in article 15(2) to diffuse science, worked in [The Duty to Conserve, Develop and Diffuse Science], is engaged by the same facts. Her complaint is a right-to-science complaint and a right-to-health complaint at once, and an answer that notices only one of them is half an answer.

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The Right to Health in the Covenant

Distinctions

Universal Declaration article 25(1)Covenant article 12
Where health sitsInside a right to an adequate standard of livingIn a provision of its own
WordingA standard of living "adequate for the health and well-being""The highest attainable standard of physical and mental health"
Mental healthReached through the words "well-being"Named in the text itself
Steps requiredNone statedFour categories stated in paragraph 2
Legal characterA resolution of the General AssemblyA treaty, binding on the States that ratify it

What it does NOT mean

It does not mean a right to be healthy. No State can guarantee that outcome, and the article does not purport to. It guarantees a standard of provision and protection, measured against what is attainable.

It does not mean a right to free treatment. Sub-paragraph (d) requires the creation of conditions assuring medical service and attention to all. Who pays is left to the State, and a State that finances care through insurance rather than taxation is not thereby in breach.

It does not mean the four sub-paragraphs are the whole right. "Shall include" is inclusive language. Mental health, for instance, is named in paragraph 1 and appears in none of the four sub-paragraphs, and it is plainly inside the right.

It is not the same as the Indian right to health. India's enforceable right to health is read into article 21 of the Constitution, which is a different provision with a different history and a different remedy. That is [Science Under Article 21] and, in Module II, [The Right to Health Under Article 21].

Limits, and how the article reaches India

The weaknesses are the ones that attach to the whole Covenant. Realisation is progressive, article 4 permits limitations determined by law for the general welfare, and there is no general individual complaint procedure except for the States that have accepted the Optional Protocol, as [The Right to Science in the Covenant] records. Most supervision therefore happens through State reports rather than through anything resembling litigation.

India's Parliament has nonetheless written the Covenant into an Indian statute by name. Section 2(1)(f) of the Protection of Human Rights Act 1993 defines "International Covenants" to mean the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights adopted by the General Assembly of the United Nations on the 16th December, 1966, together with any other Covenant or Convention the Central Government may notify. Section 2(1)(d) then defines "Human Rights" as the rights relating to life, liberty, equality and dignity of the individual guaranteed by the Constitution or embodied in the International Covenants and enforceable by courts in India.

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The Right to Health in the Covenant

Read the closing words of that definition carefully, because they carry the whole weight. The Act does not make everything in the Covenant enforceable. It brings in Covenant rights that are enforceable by courts in India, and in practice the route by which a health claim becomes enforceable here runs through article 21 of the Constitution. That is the bridge this chapter was written to build, and Module II crosses it.

Quick revision

  • Article 12(1) ICESCR: the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. Not a right to be healthy.
  • Article 12(2): steps "shall include" those necessary for (a) stillbirth rate, infant mortality and the healthy development of the child; (b) environmental and industrial hygiene; (c) prevention, treatment and control of epidemic, endemic, occupational and other diseases; (d) conditions assuring to all medical service and medical attention in sickness.
  • Three of the four sub-paragraphs are not about clinical care at all. The Covenant's picture of health is preventive and environmental.
  • Article 2(1) progressive realisation, article 2(2) immediate non-discrimination, article 4 limitations by law for the general welfare.
  • The science link, at paragraphs 67 to 71 of the 2020 general comment: science is the instrument; it mediates between health and patent; there is a duty to deliver what already exists; and research itself carries risk.
  • Protection of Human Rights Act 1993, section 2(1)(d) and (f): the Covenants are named in Indian law, but only so far as the rights in them are enforceable by courts in India.

Test yourself

1. Why does article 12 speak of the "highest attainable standard" rather than of a right to health? Because health as an outcome cannot be guaranteed by any State. Whether a person is healthy depends on inheritance, accident and conduct. The article therefore fixes the obligation to a standard rather than to a result, and builds two limits into the phrase: highest, so that a State may not settle for the merely adequate, and attainable, which admits both the current state of scientific knowledge and the resources of the particular State.

2. What follows from the words "shall include" in article 12(2)? That the four sub-paragraphs are a floor and not an exhaustive statement of the right. A State that has taken all four categories of step may still be in breach in some other respect, and mental health, which appears in paragraph 1 and in none of the sub-paragraphs, is the clearest illustration.

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The Right to Health in the Covenant

3. A State says it cannot afford to extend a new diagnostic test beyond its capital. How would you answer? First, by article 2(2), which makes freedom from discrimination immediate rather than progressive, so that if the geographical gap tracks a prohibited ground the plea of scarcity does not explain it. Second, by the standard being demonstrably attainable, since the State is already delivering it internally. Third, by the duty stated in paragraphs 67 to 71 of the 2020 general comment on science to make the best available applications accessible to all without discrimination and especially to the most vulnerable, which is an obligation about distribution rather than about totals.

4. How does article 12 connect the right to health with the right to science? Through the word attainable, which makes the content of the health obligation depend on the state of scientific knowledge and on how far its applications have been diffused. The Committee's general comment on science states the connection in four ways: science supplies the applications that prevent and treat disease; it mediates between the right to health and patent rights; it generates a duty to deliver applications that already exist to everyone without discrimination; and research itself creates health risks that must be managed by precaution and informed consent.

5. Does the Protection of Human Rights Act 1993 make article 12 enforceable in India? Not by itself. Section 2(1)(f) names the Covenant, and section 2(1)(d) brings in rights embodied in the Covenants, but only those that are enforceable by courts in India. The Act supplies recognition and an institutional machinery rather than a new cause of action, and a health claim in India is in practice brought under article 21 of the Constitution.

Contents This chapter on its own page

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Chapter Ten

General Comment 25 and the Content of the Right

Syllabus topic 1, "Interrelationship of Science, Technology and Human Rights"

In one line

The Covenant gives the right to science one sentence. In 2020 the committee that supervises the Covenant published nineteen pages saying what that sentence means, and those nineteen pages are now the standard text on the subject.

In the wording a student can write in an exam: General comment No. 25 (2020) on science and economic, social and cultural rights, United Nations document E/C.12/GC/25, dated 30 April 2020, was adopted by the Committee on Economic, Social and Cultural Rights at its sixty-seventh session, held from 17 February to 6 March 2020. It interprets article 15(1)(b), (2), (3) and (4) of the Covenant. It states the normative content of the right, the elements against which a State's compliance is measured, the obligations the right generates, and the measures a State should adopt at home. Normative content means what the words of the provision actually require, as distinct from why the provision is thought to be a good idea.

What a General Comment is, and what it is worth

The Committee on Economic, Social and Cultural Rights is the expert body that supervises the Covenant, and it is not a court. The Covenant does not set it up; what the Covenant sets up is a reporting duty. Article 16(1) obliges each State Party to submit reports on the measures it has adopted and the progress it has made in achieving observance of the rights, and article 16(2)(a) sends those reports to the Secretary-General of the United Nations, who transmits them to the Economic and Social Council. The Committee is the body that examines them. Its ordinary work is to read the reports, question the State's representatives on them, and publish its observations.

A general comment is a different kind of output. Instead of addressing one State about one report, the Committee sets out, once and for all States at the same time, what a provision of the Covenant means. It is the considered reading of the treaty by the body the States themselves created to supervise it.

Two things follow, and a good answer states both. It is not a treaty and it binds nobody as a treaty does. No State signed it, no State ratified it, and it creates no obligation that the Covenant did not already contain. But its authority is of a different kind and is not weak. It is the settled interpretation of the supervisory body to which every State Party must answer, arrived at, in this instance, after what the Committee describes as a wide consultative process. A State whose conduct cannot be defended against it will lose the argument in the only forum where the argument is held.

The practical way to hold this is: the obligation is in the Covenant, the meaning is in the general comment. A pleading says the State breached article 15 of the Covenant, and then uses the general comment to say what article 15 required.

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General Comment 25 and the Content of the Right

Why it was written, and why so late

Two reasons appear in the opening paragraphs.

The first is that the subject matter had run away from the text. The Committee opens by observing that the intense and rapid development of science and technology has brought many benefits for economic, social and cultural rights, and that the risks, together with the unequal distribution of both the benefits and the risks, had produced a large and growing discussion.

The second is an admission. At paragraph 2 the Committee records that science is one of the areas of the Covenant to which States Parties give the least attention in their reports and in their dialogues with the Committee. The right had been in force since 1976 and had produced almost nothing, and the general comment exists to end that.

The Committee did not start from nothing. It names, among the material behind it, the Venice Statement on the Right to Enjoy the Benefits of Scientific Progress and its Applications of 2009, the UNESCO Universal Declaration on Bioethics and Human Rights of 2005, the UNESCO Recommendation on Science and Scientific Researchers of 2017, the report of the Special Rapporteur in the field of cultural rights on this right, and its own general comment No. 17 of 2005 on the protection of the moral and material interests of authors.

What the words mean

This is the part headed Normative content, paragraphs 4 to 14, and it is the part most likely to be examined directly.

Science. The Committee adopts the UNESCO definition, under which science is the organised attempt, by the objective study of observed phenomena and validation through the sharing of findings and data and through peer review, to discover and master the chain of causalities, relations or interactions. It then adds a test of its own at paragraph 5. Knowledge counts as science only if it is based on critical inquiry and is open to falsifiability and testability. Falsifiability means that the claim is of a kind that could in principle be shown to be false by evidence. Knowledge based solely on tradition, revelation or authority, which cannot be contrasted with reason and experience or checked by anybody else, is not science for the purposes of this right.

That paragraph does real work. It is what allows a State to refuse to treat an unfalsifiable claim as science without breaching anybody's right to science, and it is the foundation of the Committee's later insistence that States protect people from pseudoscience.

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General Comment 25 and the Content of the Right

Both kinds, and both senses. Science here covers the natural and the social sciences. It also means two things at once: a process carried on by a method, which the Committee calls doing science, and the results of that process, which are knowledge and applications.

Progress. The Universal Declaration says scientific advancement and the Covenant says scientific progress. At paragraph 6 the Committee reads both words as emphasising the capacity of science to contribute to the well-being of persons and of humankind, and draws a striking conclusion from it: the development of science in the service of peace and human rights should be prioritised by States over other uses.

Applications. The particular implementation of science to the specific concerns and needs of the population, including the technology derived from scientific knowledge, whether medical, industrial, agricultural or in information and communications.

Benefits, in three senses. First the material results, such as vaccinations, fertilisers and technological instruments. Second the scientific knowledge and information itself, because science delivers by the spread of knowledge and not only by the sale of products. Third, and least expected, the role of science in forming critical and responsible citizens who are able to participate fully in a democratic society. A student who can give all three has understood why this right is not simply a right to receive goods.

The right got a longer name, and that is the biggest thing in the document

At paragraphs 9 to 11 the Committee rejects any reading of article 15(1)(b) that draws a rigid line between the scientist who produces science and a general population entitled only to enjoy the products.

It reaches that conclusion by four routes. It applies article 31 of the Vienna Convention on the Law of Treaties, which requires a treaty to be read in its context and in the light of its object and purpose. It reads sub-paragraph (b) with sub-paragraph (a), the right to take part in cultural life, and holds that scientific activity is part of cultural life. It uses the preparatory work on the drafting of article 15, the negotiating record known as the travaux préparatoires, which shows the article was intended to develop article 27 of the Universal Declaration. And it points out in a footnote that where the English text of article 27 says "share", the equally official French, Spanish and Russian texts say "participate".

The result, stated at paragraph 11, is that the right is properly named the right to participate in and to enjoy the benefits of scientific progress and its applications. Participation was not added by the Committee; it was recovered. The consequence, that States must not merely refrain from blocking ordinary people from scientific activity but must actively facilitate it, including what the Committee calls citizen science, is worked out in [Participation in Scientific Progress].

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General Comment 25 and the Content of the Right

The other two limbs are read in the same section. Paragraph 13 lists what the freedom indispensable for scientific research contains, and paragraph 14 states that article 15(2) requires positive steps and not merely abstention. Those belong to [Freedom Indispensable for Scientific Research] and [The Duty to Conserve, Develop and Diffuse Science].

The structure it imposes on the right

PartParagraphsWhat it settles
I. Introduction and basic premises1 to 3Why a general comment on science was needed, and which limbs of article 15 it covers
II. Normative content4 to 14What science, progress, applications and benefits mean, and the longer name of the right
III. Elements of the right and limitations15 to 22The five essential elements, and when the right may lawfully be limited
IV. Obligations23 to 52General obligations, special protection for specific groups, respect and protect and fulfil, and the core obligations
V. Special topics of broad application53 to 76Participation and transparency, precaution, private research and intellectual property, interdependence with other rights, and emerging technologies
VI. International cooperation77 to 84Article 15(4), pandemics, and obligations reaching beyond a State's own territory
VII. National implementation85 to 89The four kinds of measure a State should put in place at home

Paragraph 15 is the hinge of that structure. The right contains freedoms and entitlements: the freedoms are the right to participate in scientific progress and the freedom indispensable for research, and the entitlement is to enjoy the benefits without discrimination. Both generate negative and positive obligations, and the right then has five interrelated and essential elements. Four of them are availability, accessibility, quality and acceptability, and they are the subject of the next chapter; the fifth, added at paragraph 20, is the protection of freedom of scientific research itself.

When the right may be limited

The Committee accepts at paragraph 21 that limitations may be necessary, because science and its applications can in some contexts damage economic, social and cultural rights. It then holds them to article 4 of the Covenant and adds a gloss.

The three requirements of article 4 are that the limitation is determined by law, that it promotes the general welfare in a democratic society, and that it is compatible with the nature of the right restricted. The Committee's gloss is that this implies two further things: the limitation must respect the minimum core obligations of the right, and it must be proportionate to the aim, which means that where several means could reasonably achieve the aim, the least restrictive must be chosen, and that the burdens imposed must not outweigh the benefits of the limitation.

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General Comment 25 and the Content of the Right

Paragraph 22 then divides limitations by what they restrict. Limits on applications are relatively easy to justify and are used for safety and product quality, with human rights impact assessments where an application is risky. Limits on the research process are permissible to protect the dignity, integrity and consent of human participants. But any limitation on the content of scientific research carries what the Committee calls a strict burden of justification on the State, precisely so that freedom of research is not eroded.

The floor: core obligations

Paragraphs 51 and 52 identify core obligations, meaning the part of the right a State must implement as a matter of priority. A State that fails to satisfy them must demonstrate that it made every reasonable effort, taking account of all the rights in the Covenant and of the maximum of its available resources.

Twelve are listed. Among them: eliminate laws, policies and practices that unjustifiably limit access to scientific facilities, services, goods and information; identify and remove anything that undermines the participation of women and girls in science; remove limitations on freedom of research that article 4 cannot justify; develop a participatory national framework law on the right, including legal remedies; ensure people have the basic education and skills needed to understand and apply scientific knowledge; ensure access to those applications of scientific progress that are critical to the right to health; give priority in public resources to research in areas of greatest need in health and food; ensure health professionals are properly trained in modern technologies and medicines; refrain from disinformation intended to erode public respect for science; and protect people from false, misleading and pseudoscience based practices.

Notice the sixth of those. The Committee makes access to health-critical applications a core obligation of the right to science, which is the connection [The Right to Health in the Covenant] approached from the other side.

What a State should do at home

Part VII, paragraphs 85 to 89, is short and is the most quotable passage in the document for an Indian answer, because it is a list of things a legislature and an executive can be asked to produce.

A State should put in place a normative framework protecting non-discriminatory access to the benefits of science, protecting freedom of research within article 4, requiring ethics and human rights in research including ethics committees, and harmonising intellectual property with this right. It should adopt a national plan of action to promote scientific progress and disseminate its results, with public funding, scientific education, mechanisms against pseudoscience and measures on the conditions of researchers. It should identify indicators and benchmarks, with disaggregated statistics and time frames, so that implementation can actually be measured. And it should establish effective mechanisms and remedies, because, in the Committee's words at paragraph 89, this right like every other is enforceable and therefore justiciable, meaning capable of being decided by a court. The Committee adds that the right can be violated by omission as well as by action, so the remedies must reach both.

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General Comment 25 and the Content of the Right

A worked example

Farida is an advocate. She acts for a group of patients challenging an executive order that bars the import of a class of diagnostic device, and she wants to run a right to science argument.

What the Covenant gives her. One sentence: the right of everyone to enjoy the benefits of scientific progress and its applications. On its own it does not tell a court what the State was obliged to do.

What the general comment gives her. A name for the right that includes participation; a definition of applications that plainly covers a diagnostic device; a limitation test, since the bar is a limitation and must therefore be determined by law, aimed at the general welfare, compatible with the nature of the right, proportionate, and the least restrictive means available; a core obligation about access to applications critical to health; and paragraph 89, which says the right is justiciable and that omissions count.

What she may not do with it. She may not plead that the State has violated General Comment 25. There is no such obligation. The breach is of the Covenant, and the general comment is the evidence of what the Covenant means. Nor is an Indian court bound to accept it, because it is not a treaty and India's courts apply Indian law; it is persuasive material about the content of an international obligation.

What it changes in practice. Before 2020 the argument would have been almost entirely her own construction. After 2020 every step of it can be attributed to the body that supervises the treaty, which is the difference between an argument and an authority.

What beginners get wrong

Treating it as binding law. Writing that "General Comment 25 provides that States must..." invites the reply that no State agreed to any such thing. Write instead that the Covenant obliges, and that the Committee has read the obligation as requiring the thing in question.

Thinking it created or renamed the right. Article 15(1)(b) reads today exactly as it read in 1966. The longer name is the Committee's description of what the article always contained, supported by the other language versions of the Universal Declaration and by the drafting record.

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General Comment 25 and the Content of the Right

Thinking it covers the whole of article 15. It covers sub-paragraph (1)(b) and paragraphs (2), (3) and (4). The right to take part in cultural life in (1)(a) is the subject of the Committee's general comment No. 21 of 2009, and the protection of authors in (1)(c) is the subject of its general comment No. 17 of 2005, to which paragraph 12 expressly refers the reader.

Assuming science means natural science. The Committee says in terms that it includes the social sciences. The test is method, not subject matter.

Quick revision

  • E/C.12/GC/25, 30 April 2020, Committee on Economic, Social and Cultural Rights, sixty-seventh session. Interprets article 15(1)(b), (2), (3) and (4).
  • A general comment is the supervisory body's authoritative reading. Not a treaty, binds nobody by itself, but it is the reference text: the obligation is in the Covenant, the meaning is in the general comment.
  • Written because science was the area of the Covenant States reported on least.
  • Science requires critical inquiry, falsifiability and testability. Tradition, revelation and authority alone are not science. Natural and social sciences both.
  • Benefits in three senses: material products, the knowledge itself, and the forming of critical citizens.
  • The right renamed: to participate in and to enjoy the benefits of scientific progress and its applications, recovered from article 27 of the Universal Declaration, the other language versions and the drafting record.
  • Five elements, four measurable ones plus freedom of research. Limitations under article 4 plus minimum core, proportionality and least restrictive means.
  • Core obligations are the floor, twelve of them, one being access to applications critical to health.
  • Part VII: normative framework, national plan of action, indicators and benchmarks, and remedies. The right is justiciable, and omissions violate it.

Test yourself

1. What is a general comment, and what authority does it have? It is a statement by a treaty's supervisory committee, addressed to all States Parties at once, of what a provision of the treaty means. It is not itself a treaty, no State ratifies it, and it creates no new obligation. Its authority is that it is the settled interpretation of the body to which every State Party must report and answer, so it is the reference text against which a State's conduct is measured in the only forum where that measurement happens.

2. What test does General Comment 25 apply to decide whether a body of knowledge is science? Whether it rests on critical inquiry and is open to falsifiability and testability, that is, whether it makes claims that could in principle be shown false by evidence and checked by others. Knowledge based solely on tradition, revelation or authority, which cannot be contrasted with reason and experience, is not science for the purposes of the right. Both natural and social sciences qualify, since the test is method rather than subject matter.

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General Comment 25 and the Content of the Right

3. Explain the change of name of the right and the reasoning behind it. The Committee calls it the right to participate in and to enjoy the benefits of scientific progress and its applications. It reached that by reading article 15(1)(b) with 15(1)(a) on cultural life, applying article 31 of the Vienna Convention on the Law of Treaties so that the provision is read in context and in the light of its object and purpose, consulting the drafting record which shows article 15 was meant to develop article 27 of the Universal Declaration, and noting that the equally official French, Spanish and Russian texts of article 27 use the verb to participate where the English uses to share. Participation was therefore recovered rather than invented.

4. On what conditions may a State limit this right? Under article 4 of the Covenant the limitation must be determined by law, must promote the general welfare in a democratic society, and must be compatible with the nature of the right. The Committee adds that it must respect the minimum core obligations and be proportionate, so that the least restrictive of the available means is chosen and the burdens do not outweigh the benefits. A limitation on the content of research attracts a strict burden of justification, whereas limitations on applications for safety and quality are more readily justified.

5. A student writes that "General Comment 25 makes it compulsory for India to fund scientific research." What is wrong with the sentence? It attributes binding force to the wrong instrument. The obligation, if any, arises under the Covenant, chiefly article 15(2) read with article 2(1), and the general comment is the Committee's reading of what that obligation involves. The accurate form is that the Covenant obliges the State to take steps for the development of science to the maximum of its available resources, and that the Committee has read that as requiring positive promotion, appropriate budget allocation and an enabling environment, not merely non-interference.

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Chapter Eleven

Availability, Accessibility, Acceptability and Quality

Syllabus topic 1, "Interrelationship of Science, Technology and Human Rights"

In one line

A right to science is empty unless you can say what has to exist, who must be able to reach it, whether it is any good, and whether it makes sense to the people it is for.

In the wording a student can write in an exam: the Committee on Economic, Social and Cultural Rights, in General Comment No. 25 (2020), gives the right to participate in and enjoy the benefits of scientific progress four essential elements, availability, accessibility, quality and acceptability, and adds the protection of the freedom of scientific research as a further element of the same right. The framework allows a State's compliance to be tested element by element instead of assessed as a whole.

Why the law has this at all

The problem with an economic and social right is that it is easy to state and hard to audit. "Everyone has the right to enjoy the benefits of scientific progress" tells a government nothing about what to build, and tells a committee nothing about what to look for in a State report.

The Committee had met this problem before. In General Comment No. 14 (2000) on the right to health it broke the right into availability, accessibility, acceptability and quality, and the framework proved usable: it turned a slogan into four questions each of which has a factual answer. That framework has since been applied to water, to food and to education.

General Comment 25 borrows it and applies it to science. This is worth saying plainly in an answer, because it shows where the test comes from and why it looks familiar to anyone who has studied the right to health.

The four elements

Availability

Availability is linked to the duty in article 15(2) to take steps for the conservation, the development and the diffusion of science. It means two things at once: that scientific progress is actually taking place, and that scientific knowledge and its applications are protected and widely disseminated.

The Committee is specific about what that requires. States should direct their own resources and coordinate the actions of others so that progress happens and its benefits are distributed, especially to vulnerable and marginalised groups. That needs instruments for the diffusion of science, and the Comment names libraries, museums and internet networks; a strong research infrastructure with adequate resources; and adequate financing of scientific education.

It also contains an instruction that sits oddly with much current practice: States should promote open science and open source publication of research, and research findings and research data funded by States should be accessible to the public.

Accessibility

Accessibility means that scientific progress and its applications should be accessible to all persons without discrimination. The Comment gives it three dimensions, and an answer that gives only the first has given a third of it.

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  1. Equal access to the applications of science, particularly where those applications are instrumental for the enjoyment of other economic, social and cultural rights.
  2. Access to information about the risks and benefits of science and technology, without discrimination.
  3. The open opportunity to participate in scientific progress, without discrimination. States should remove discriminatory barriers that stop people participating, for instance by facilitating access of marginalised populations to scientific education.

The third dimension is the one students most often miss. Accessibility is not only about receiving the products of science. It is about being allowed into the activity.

Quality

Quality refers to the most advanced, up to date and generally accepted and verifiable science available at the time, according to the standards generally accepted by the scientific community. It applies both to the process of scientific creation and to access to the applications and benefits.

Quality also includes regulation and certification, where necessary, to ensure the responsible and ethical development and application of science. States should rely on widely accepted scientific knowledge, in dialogue with the scientific community, to regulate and certify the circulation of new scientific applications that reach the public.

Two consequences follow that are worth stating. A State that gives its population access to something ineffective has not satisfied the right; access to a worthless remedy is not access to the benefits of scientific progress. And a State that certifies applications by a standard other than the accepted scientific one has failed this element even if the product is freely available.

Acceptability

Acceptability implies that efforts should be made to ensure that science is explained, and its applications disseminated in a way that facilitates their acceptance in different cultural and social contexts, provided this does not affect their integrity and quality. Scientific education and the products of science should be tailored to populations with special needs, and the Comment names persons with disabilities.

Acceptability also carries an ethical component. Scientific research has to incorporate ethical standards to ensure its integrity and the respect of human dignity, and the Comment points to the standards proposed in the Universal Declaration on Bioethics and Human Rights (2005). It lists some of them: benefits to research participants and other affected individuals should be maximised and possible harm minimised with reasonable protection and safeguards; the autonomy and free and informed consent of participants should be guaranteed; privacy and confidentiality respected; vulnerable groups or persons especially protected against discrimination; and cultural diversity and pluralism given due regard.

And a fifth: freedom of research

Paragraph 20 states that the protection of freedom of scientific research, dealt with at paragraph 13 and resting on article 15(3), is also an element of the right. It is treated in its own chapter, [Freedom Indispensable for Scientific Research], and is noted here so that the list is not given as four when the Comment gives five.

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The proviso inside acceptability

The words "provided that this does not affect their integrity and quality" carry more weight than their length suggests. They are the answer to an obvious objection: if science must be made acceptable in different cultural contexts, may a State dilute what it teaches to suit local opinion?

The answer is no. Acceptability governs how science is explained and delivered, not what is true. Adapting the presentation is required; adapting the content until it is no longer the accepted science defeats the quality element. A candidate who can state that relationship between the third and fourth elements has understood the framework rather than memorised it.

Worked example

A State runs a childhood immunisation programme. Vaccines are procured centrally and are free. Uptake in three districts is under thirty per cent. Testing the programme element by element:

Availability. The vaccine exists, is procured and is distributed, and there is a cold chain. This element is largely satisfied. If the State had no procurement at all, the analysis would stop here.

Accessibility. The vaccine is free, so there is no cost barrier, but the nearest centre in the three districts is a day's travel and opens on two mornings a week. Access is formally equal and practically unequal. The second dimension is also engaged: is information about the risks and benefits reaching these districts in a language people read?

Quality. Is the vaccine the current one, stored correctly and administered by trained staff? A vaccine that has lost potency in an unreliable cold chain fails this element while appearing to satisfy the first two.

Acceptability. Has the programme been explained in a way that makes sense in the local context? Where refusal is driven by a rumour, the failure is at this element, and no amount of additional supply will fix it. The remedy is explanation, engagement with those the community trusts, and materials suited to the population, including those with disabilities.

The lesson of the example is the utility of the framework. "Low uptake" is not a finding a lawyer can work with. "Adequate on availability, deficient on accessibility in three districts, and failing on acceptability" is a finding that names the obligation breached and the remedy required.

What it does NOT mean

These are not four separate rights. They are elements of one right, and a State does not comply by satisfying three of them. The immunisation example is designed to show that a programme can be strong on the first two and fail entirely because of the fourth.

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Availability is not the same as accessibility. A national library that exists in the capital is available. It is not accessible to a student six hundred kilometres away. The Committee treats the two separately because States routinely satisfy the first and report it as though it discharged the second.

Acceptability is not a veto. It does not entitle a community to demand that science be changed to match its beliefs. The proviso protects integrity and quality expressly.

Quality is not decided by the State alone. The standard is that generally accepted by the scientific community, and the Comment requires regulation to be undertaken in dialogue with it. A ministry that certifies a product against its own criteria has not met the element.

Distinctions

ElementThe question it asksThe typical failure
AvailabilityDoes it exist, and is it being produced and disseminated at all?No research infrastructure, no funding for scientific education, findings from publicly funded research locked away
AccessibilityCan everyone reach it, learn about it, and take part in it, without discrimination?Provision concentrated in cities; information only in the official language; barriers to entering scientific education
QualityIs it the accepted, current, verifiable science, and is it properly regulated and certified?Obsolete or ineffective applications; certification by a standard the scientific community does not accept
AcceptabilityIs it explained and delivered so that the people it is for can accept it, ethically and culturally?No explanation, no adaptation for persons with disabilities, research conducted without consent or safeguards

Quick revision

  • General Comment 25 (2020), paragraphs 16 to 19, gives the right to science four essential elements: availability, accessibility, quality and acceptability. Paragraph 20 adds freedom of research as a further element.
  • The framework is borrowed from General Comment 14 (2000) on the right to health.
  • Availability: progress actually happening, knowledge protected and widely disseminated; libraries, museums, internet networks, research infrastructure, financing of scientific education; open science and public access to publicly funded findings and data.
  • Accessibility: three dimensions, equal access to applications, access to information about risks and benefits, and the open opportunity to participate; remove discriminatory barriers, facilitate access of marginalised populations to scientific education.
  • Quality: the most advanced, up to date, generally accepted and verifiable science available at the time; includes regulation and certification in dialogue with the scientific community.
  • Acceptability: science explained and disseminated so as to be accepted in different cultural and social contexts, provided integrity and quality are not affected; tailored to persons with special needs; incorporates ethical standards, the Comment pointing to the Universal Declaration on Bioethics and Human Rights 2005.
  • The Comment's own order is availability, accessibility, quality, acceptability.
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Test yourself

1. Name the four elements and say where the framework comes from. Availability, accessibility, quality and acceptability, set out in paragraphs 16 to 19 of General Comment No. 25 (2020), with the protection of freedom of scientific research added at paragraph 20 as a further element of the same right. The framework is taken from General Comment No. 14 (2000) on the right to health, where the Committee first broke an economic and social right into these four elements so that compliance could be tested rather than merely asserted.

2. Give the three dimensions of accessibility. First, everyone should have equal access to the applications of science, particularly where those applications are instrumental for the enjoyment of other economic, social and cultural rights. Second, information about the risks and benefits of science and technology should be accessible without discrimination. Third, everyone should have the open opportunity to participate in scientific progress without discrimination, which requires States to remove discriminatory barriers, for example by facilitating access of marginalised populations to scientific education.

3. A government makes a traditional remedy freely available nationwide and promotes it energetically. Trials show it has no effect on the disease it is given for. Which element fails, and why does universal availability not save it? Quality fails. The element requires the most advanced, up to date, generally accepted and verifiable science available at the time, judged by standards generally accepted by the scientific community, and it applies to access to the applications and benefits of science as well as to the process of creation. An ineffective remedy is not a benefit of scientific progress, so distributing it universally satisfies availability and accessibility in form while defeating the right in substance. The element also covers regulation and certification, so a certification given against criteria the scientific community does not accept is itself part of the breach.

4. What work is done by the words "provided that this does not affect their integrity and quality" in the acceptability element? They prevent acceptability from becoming a licence to alter the content of science to suit local opinion. Acceptability governs how science is explained and how its applications are delivered, requiring adaptation of presentation to different cultural and social contexts and to populations with special needs. The proviso keeps that adaptation on the presentational side of the line, so that the quality element, which requires generally accepted and verifiable science, is not defeated by the element that follows it.

5. Which element does open access publishing belong to, and what exactly does the Comment ask for? Availability. The Comment states that States should promote open science and open source publication of research, and that research findings and research data funded by States should be accessible to the public. It sits under availability because that element concerns not only whether scientific progress is taking place but whether scientific knowledge is protected and widely disseminated, which is a question about diffusion rather than about individual access.

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Chapter Twelve

Participation in Scientific Progress

Syllabus topic 1, "Interrelationship of Science, Technology and Human Rights"

In one line

The right to science is not a right to be handed the products of somebody else's laboratory. It is a right to take part in the work, and in the decisions about what the work is for.

In the wording a student can write in an exam: participation in scientific progress is the limb of the right in article 15(1)(b) of the International Covenant on Economic, Social and Cultural Rights which entitles every person, and not only the professional scientist, to take part in scientific activity, to take part in the decisions that set the direction of scientific research, and to have the information needed to do both. The Committee on Economic, Social and Cultural Rights holds in General Comment No. 25 (2020) that article 15(1)(b) "encompasses not only a right to receive the benefits of the applications of scientific progress, but also a right to participate in scientific progress", and it accordingly names the right throughout that document as the right to participate in and to enjoy the benefits of scientific progress and its applications.

Why the law has this at all

Read on its own, the treaty wording sounds like the language of a recipient. Article 15(1)(b) speaks of the right "to enjoy the benefits of scientific progress and its applications", and enjoying a benefit is something done to you rather than something you do. On that reading the population waits, the scientists work, and the only legal question is whether what emerges is distributed fairly.

That reading has a practical defect, and it is the reason the participatory limb matters. A person who can only receive has no way of asking whether the right things are being researched at all. Distribution is a question about a product that already exists. Direction is a question about which products come into existence, and it is settled long before anybody has a benefit to distribute or to be excluded from.

The Committee refused the passive reading in terms. In paragraph 9 of General Comment 25 it says that the right "cannot be interpreted as establishing a rigid distinction between the scientist who produces science and the general population, entitled only to enjoy the benefits derived from research conducted by scientists", and that the restrictive interpretation is contrary to a reading of the provision that takes account of its context, object and purpose.

Where the participatory limb comes from

The Committee is interpreting a treaty text that does not use the word participation in sub-paragraph (b), so it has to show its working. Paragraph 10 gives four reasons, and an examiner who asks where the right to participate comes from is asking for these.

Article 15(1)(a) carries it. Sub-paragraph (a) recognises the right of everyone to take part in cultural life. Culture, the Committee says, is an inclusive concept, cultural life is larger than science, and it is reasonable to include scientific activity within it. So the right to take part in cultural life "includes the right of every person to take part in scientific progress and in decisions concerning its direction".

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The word "benefits" is wider than products. The benefits of scientific progress "are not restricted to the material benefits or products of scientific advancement, but include the development of the critical mind and faculties associated with doing science". A person who has never been allowed near the method has been denied a benefit even if the medicine reaches them.

The drafting record points the same way. The Committee relies on the preparatory work of article 15, which shows the article was written to develop article 27 of the Universal Declaration of Human Rights, and article 27 recognises a right to participate in scientific advancement and not only to benefit from its applications. That earlier article is worked in its own chapter.

The other official texts say participate. The Committee notes that the English text of the Universal Declaration uses the word "share", while the French, Spanish and Russian texts, which are equally official versions of the same instrument, use the verb to participate. The participatory limb was in the 1948 text and was obscured by one language's choice of word.

Broken down: the four things participation means

One, doing science. Paragraph 10 says that doing science does not concern only scientific professionals but also includes "citizen science", which the Committee glosses in the same sentence as ordinary people doing science, and the dissemination of scientific knowledge. The obligation has two halves: States "should not only refrain from preventing citizen participation in scientific activities, but should actively facilitate it".

Two, deciding what is researched. This is the limb with teeth. Paragraph 55 provides that, with due respect to scientific freedom, some decisions concerning the orientation of scientific research or the adoption of certain technical advancements should be subjected to public scrutiny and citizen participation, and that scientific and technological policies should as far as possible be established through participatory and transparent processes and implemented with accompanying transparency and accountability mechanisms.

Three, knowing enough to take part. Participation without information is theatre. Paragraph 53 requires States to create an environment in which actual or perceived conflicts of interest are adequately disclosed and regulated, particularly where researchers advise policymakers. Paragraph 54 requires States to promote a culture of active citizen engagement with science through informed democratic debate and dialogue between the scientific community and society. Paragraph 49 requires equitable and open access to scientific literature, data and content, including by removing barriers to publishing, sharing and archiving scientific outputs.

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Four, taking part in the control of risk. Paragraph 56 opens by saying that participation "also includes the right to information and participation in controlling the risks involved in particular scientific processes and its applications". Paragraph 57 completes the thought: in controversial cases the risks and potential of a technical advance should be made public so that society can decide, through informed and participatory public deliberation, whether the risks are acceptable. The principle that governs decisions under uncertainty is taken up in the chapter on the precautionary principle.

Participation is empty if whole groups cannot take part

Paragraph 28 identifies the groups that have experienced systemic discrimination in the enjoyment of this right, and names women, persons with disabilities, lesbian, gay, bisexual, transgender and intersex persons, indigenous peoples and persons living in poverty. It adds that temporary special measures might be necessary to achieve substantive equality.

Two of those are worked in a way this chapter needs. On women, paragraph 30 identifies a double discrimination: first, women have the right to participate in scientific research on an equal footing with men, so unequal access to scientific education or careers is discrimination in itself; second, because women are underrepresented in research, the research and the technologies that come out of it are commonly gender biased and insensitive to the needs of women. The exclusion damages the science as well as the excluded.

On indigenous peoples, paragraph 40 requires States to provide the educational and technological means to take part in the global scientific dialogue, and states that genuine consultation in order to obtain free, prior and informed consent is necessary whenever a State or a non-State actor conducts research, takes decisions or creates policies relating to science that have an impact on indigenous peoples, or uses their knowledge. Free, prior and informed consent here means agreement given without coercion, obtained before the activity begins, and with the facts disclosed.

The core obligations in paragraph 52 turn all of this into something a State must do first rather than eventually. Two of the listed bullets are participatory in terms: to identify and eliminate any law, policy, practice, prejudice or stereotype that undermines women's and girls' participation in scientific and technological areas, and to develop a participatory national framework law on this right which includes legal remedies for violations, together with a participatory national strategy or action plan.

A worked example

A State announces a national programme to sequence the genomes of ten thousand of its citizens, to build a database for medical research. Dr Iyer directs it. Kavita lives in a village selected for sampling, and her community has been asked to take part.

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Was the decision to fund this taken participatively? Paragraph 55 is the provision. The choice to spend a research budget on genomic sequencing rather than on, say, drinking water quality is a decision concerning the orientation of scientific research, and it should have been subjected to public scrutiny and citizen participation, through a transparent process, before the money moved.

Are the conflicts of interest on the table? If Dr Iyer also advises the ministry that approved the funding, or if the sequencing contract goes to a company in which the programme's advisers have an interest, paragraph 53 requires that the interest be disclosed and regulated. Note that this obligation attaches whether or not anybody has behaved badly: the requirement is disclosure of actual or perceived conflicts.

Does Kavita's community get a say, or only a form to sign? If the community is an indigenous one, paragraph 40 requires genuine consultation in order to obtain free, prior and informed consent before the research is conducted or its knowledge used. That is a decision about whether the research happens there at all, and it is not answered by Kavita individually signing a consent form at the sampling tent.

Can Kavita take part in the science? Paragraph 10 says the State must actively facilitate citizen participation, not merely permit it. A programme that treats the sampled population purely as a source of material, and never as people who might learn the method, read the results or question the design, has satisfied the delivery half of the right and failed this half.

Are the results published? Paragraph 49 requires equitable and open access to scientific literature and data, particularly for research financed with public funds. A publicly funded database whose findings are available only to the institutions that hold it fails that obligation.

Distinctions

Participation in scientific progressInformed consentAccess to the benefits
What it protectsA say in whether and how the science is doneControl over what is done to your own body or dataGetting the product once it exists
Who holds itEveryone, individually and as a publicThe individual patient or participantEveryone, without discrimination
When it bitesBefore the research, when direction and funding are set, and while it runsAt the moment of the interventionAfter there is something to distribute
Source used hereGeneral Comment 25, paragraphs 10, 11, 40, 49, 53 to 57Module II and Module IIIThe chapter on availability, accessibility, acceptability and quality

What it does not mean

It is not a vote on what is true. Paragraph 55 opens with the words "with due respect to scientific freedom". Participation governs decisions about the orientation of research and the adoption of technical advances. It does not put the content of a scientific finding to a show of hands, and paragraph 57 says in terms that the precautionary principle should not hinder and prevent scientific progress.

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It is not the scientist's own freedom. The freedom indispensable for scientific research is a separate limb of article 15, stated in paragraph 3 of that article and worked in its own chapter. Participation is a right of the public, including the public who are not scientists; scientific freedom is a protection for the researcher against interference. They can pull against each other, which is precisely why paragraph 55 begins by acknowledging the tension.

It is not consent. Consent is the individual's control over an intervention on their own person or data, and it is exercised at the moment of the intervention. Participation is exercised earlier, collectively, over the design and direction of the enterprise. A study in which every participant signed a valid consent form may still have been decided on without any participation at all.

It is not satisfied by an announcement. Paragraph 55 requires participatory and transparent processes that are implemented with accountability mechanisms attached. A consultation held after the decision is taken, or one whose outcome nothing depends on, does not meet a requirement expressed in those terms.

Limits

The interpretation is authoritative, not binding. General Comment No. 25 is a document of the Committee on Economic, Social and Cultural Rights, adopted at its sixty-seventh session and issued as E/C.12/GC/25 on 30 April 2020. It is the treaty body's own reading of article 15, and it is the best evidence of what the provision requires, but it is not itself a treaty and it creates no new obligation. What binds a State is article 15, read as the Committee reads it.

Participation can be limited. Limitations on this right must satisfy article 4 of the Covenant, which permits only limitations determined by law, compatible with the nature of the right, and solely for the purpose of promoting the general welfare in a democratic society. The Committee adds in paragraph 21 that a limitation must respect the minimum core of the right, must be proportionate, and where several means could achieve the aim, the least restrictive must be chosen.

There is no ready enforcement. The Covenant's ordinary machinery is State reporting to the Committee, and paragraph 2 of the General Comment records that science is one of the areas of the Covenant to which States parties give the least attention in their reports. A right that depends on being reported on, in the field States report on least, is weakly enforced, and an honest answer says so.

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Quick revision

  • The right in article 15(1)(b) is the right to participate in and to enjoy the benefits of scientific progress and its applications: General Comment 25, paragraph 11.
  • The passive reading is rejected in paragraph 9: no rigid distinction between the scientist who produces and a population entitled only to receive.
  • Four sources for the participatory limb, all in paragraph 10: article 15(1)(a) cultural life; benefits are wider than products; the drafting record and article 27 of the Universal Declaration; and the French, Spanish and Russian texts which say participate where the English says share.
  • Four contents: doing science (citizen science, actively facilitated); deciding the direction of research (paragraph 55); information and disclosure of conflicts of interest (paragraphs 53, 54, 49); and participation in controlling risk (paragraphs 56 and 57).
  • Excluded groups: paragraph 28. Women suffer a double discrimination, paragraph 30. Indigenous peoples require free, prior and informed consent, paragraph 40.
  • Core obligations, paragraph 52: eliminate what undermines women's and girls' participation, and adopt a participatory national framework law with remedies.
  • Limits: article 4 of the Covenant, proportionality and the least restrictive means; the General Comment interprets rather than binds.

Test yourself

1. Article 15(1)(b) says "to enjoy the benefits". Where does a right to participate come from? From four arguments in paragraph 10 of General Comment 25. Article 15(1)(a) recognises the right to take part in cultural life, scientific activity falls within cultural life, and taking part in cultural life therefore includes taking part in scientific progress and in decisions concerning its direction. The benefits of science are not only its material products but include the development of the critical mind associated with doing science. The drafting record shows article 15 was written to develop article 27 of the Universal Declaration, which includes participation. And the French, Spanish and Russian texts of that article, equally official, use the verb to participate where the English uses share.

2. Distinguish participation in scientific progress from informed consent. Consent is individual, is exercised at the moment of an intervention on a person or their data, and protects control over what is done to that person. Participation is collective as well as individual, is exercised before and during the enterprise, and protects a say in whether the research is done, in what direction and on what terms. A trial in which every participant gave valid consent may still have been designed and funded without any public participation, and the right in article 15(1)(b) would still be unsatisfied.

3. A State consults the public after it has signed the contract for a new technology. Is that participation? On the wording of paragraph 55, no. The paragraph requires that decisions concerning the orientation of research and the adoption of technical advances be subjected to public scrutiny and citizen participation, that policies be established through participatory and transparent processes, and that they be implemented with accompanying transparency and accountability mechanisms. A consultation after the decision has been taken is not a process by which the policy was established, and nothing turns on its outcome.

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4. Why does the Committee treat the exclusion of women from science as two wrongs rather than one? Paragraph 30. First, women have the right to participate in scientific research on an equal footing with men, so unequal access to scientific education and careers is itself discrimination. Second, because women are underrepresented in research, the research that gets done and the technologies that result are commonly gender biased and insensitive to women's particularities and needs. The first wrong is done to the excluded women; the second is done to everyone who then relies on science built without them.

5. Does participation mean the public can overrule a scientific finding? No. Paragraph 55 begins "with due respect to scientific freedom", and paragraph 57 states that the precautionary principle should not hinder and prevent scientific progress. What is opened to participation is the orientation of research, the adoption of particular technical advancements and the acceptability of the risks they carry, not the content of what the evidence shows. The public decides what shall be pursued and what risks are worth running; it does not decide what is true.

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Chapter Thirteen

Benefit Sharing

Syllabus topic 1, "Interrelationship of Science, Technology and Human Rights"

In one line

The people who carry the burden of research must not be the last people to receive what it produces.

In the wording a student can write in an exam: benefit sharing is the principle that the benefits resulting from scientific research and its applications are to be shared with society as a whole and with the international community, in particular with developing countries, with communities living in poverty and with the persons and groups who took part in the research itself. It is stated as Sharing of benefits in Article 15 of the UNESCO Universal Declaration on Bioethics and Human Rights, 2005, and in Article 19 of the UNESCO International Declaration on Human Genetic Data, 2003, it appears as a requirement that benefits be made available to all in Article 12(a) of the UNESCO Universal Declaration on the Human Genome and Human Rights, 1997, and it is stated as an obligation of international co-operation in paragraph 80 of General Comment No. 25 (2020) of the Committee on Economic, Social and Cultural Rights.

Why the law has this at all

Research draws three things out of a population: bodies, material and risk. Somebody has to take the experimental treatment first, supply the tissue or the data, and live in the place where the field trial is run. Those three contributions are real, they are borne by identifiable people, and they are the condition of the knowledge existing at all.

The product, however, moves. It is patented in one country, manufactured in another and priced for whoever can pay. There is nothing in the ordinary law of property or contract that connects the finished product back to the population that made it possible. A participant signs a consent form, receives whatever care the protocol provides, and the transaction is complete. That is a lawful arrangement and it can still be an unjust one.

Benefit sharing exists to close that gap. It says that the transaction is not complete when the consent form is signed, because the entitlement is not only the participant's. Society as a whole, the communities that hosted the work, and the countries that are poorest in scientific capacity all have a claim on what comes out. The claim is stated as a matter of right and not of generosity, which is what distinguishes it from charity.

The three places the principle is stated

The 1975 Declaration puts it as a duty on States. Paragraph 6 of the Declaration on the Use of Scientific and Technological Progress in the Interests of Peace and for the Benefit of Mankind, proclaimed by General Assembly resolution 3384 (XXX) of 10 November 1975, provides:

All States shall take measures to extend the benefits of science and technology to all strata of the population and to protect them, both socially and materially, from possible harmful effects of the misuse of scientific and technological developments, including their misuse to infringe upon the rights of the individual or of the group, particularly with regard to respect for privacy and the protection of the human personality and its physical and intellectual integrity.

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Two things are worth noticing in that sentence. The benefit and the protection are stated together, in one obligation, which is the structure of this whole paper. And the reach is "all strata of the population", which makes the distribution internal to a State as well as between States. Paragraph 3 of the same Declaration requires States to ensure that scientific and technological achievements satisfy the material and spiritual needs of all sectors of the population, and paragraph 5 requires co-operation in building the scientific capacity of developing countries. The nine paragraphs are taken one by one in Module IV.

The UNESCO declarations put it as a principle of bioethics. Article 15 of the 2005 Bioethics Declaration and Article 19 of the 2003 Genetic Data Declaration are both headed Sharing of benefits, and each sets out a list of the forms a benefit may take. Article 12(a) of the 1997 Genome Declaration says that benefits from advances in biology, genetics and medicine concerning the human genome shall be made available to all, with due regard for the dignity and human rights of each individual. Those three articles are worked in their own chapters in Module III; what this chapter takes from them is the principle they share.

General Comment 25 puts it inside the right to science. Paragraph 80 states the principle as one of the four justifications for the reinforced duty of international co-operation:

Third, the benefits and applications resulting from scientific progress should be shared, with due incentives and regulations, with the international community, particularly with developing countries, communities living in poverty and groups with special needs and vulnerabilities, especially when the benefits are closely related to the enjoyment of economic, social and cultural rights.

That placement matters for an examination answer. It means benefit sharing is not merely a rule of research ethics that happens to sit in some UNESCO texts. It is part of what article 15 of the Covenant requires, and article 15 is a treaty obligation.

Broken down: five questions the principle answers

One, shared with whom? With three groups, and a student who names only one has answered a third of the question. With society as a whole, because the knowledge is a common product. With the international community, particularly developing countries, because scientific capacity is unequally distributed between States. And with the persons and groups who took part in the research, because they carried the risk personally.

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Two, what counts as a benefit? Not money, principally. Both UNESCO articles list forms, and read together they run to much the same thing: continuing assistance to, and acknowledgement of, the people and groups who took part; access to health care; the provision of the new diagnostic methods, treatments or products that came out of the research; support for health services; access to scientific and technological knowledge; and facilities that build the capacity of the host country to do research of its own. The 2003 Declaration adds, in terms, the strengthening of developing countries' own capacity to collect and process genetic data.

Three, may the benefit be cash? The 2005 Declaration answers this with a warning rather than a prohibition: benefits must not become an improper inducement to take part in research. A payment large enough to make a poor person disregard a risk they would otherwise refuse has not shared a benefit, it has bought a consent. That is why the enumerated forms are weighted towards health care, knowledge and capacity rather than towards a cheque.

Four, when is the benefit owed? The principle is engaged before the research begins and not only after it succeeds. The 2005 Declaration requires that when a research agreement is negotiated, the terms of the collaboration and the agreement on the benefits be settled with equal participation by the parties to the negotiation. Benefit sharing agreed after the result is known is agreed by the party that now holds all the cards.

Five, who owes the duty? States, in the first place, under the 1975 Declaration and under article 15 of the Covenant. But the 2005 Declaration is addressed to States and also gives guidance to individuals, groups, communities, institutions and corporations, public and private, so the funder and the institution carry it too. General Comment 25 adds an extraterritorial obligation at paragraph 84: a State must regulate and monitor the conduct of multinational companies over which it can exercise control, so that they exercise due diligence to respect this right when acting abroad, and it must provide remedies, including judicial remedies, for their victims.

Research done somewhere else

The hardest form of the problem is research carried out among a population that is not the researchers' own, which is the ordinary case when a wealthy institution studies a disease that is common somewhere poor.

General Comment 25 addresses it at paragraph 22: when research is done in countries or among populations different from those of the researchers, the State of origin must guarantee the rights and obligations of all parties involved. The obligation follows the researchers home; it does not stop at the border of the country where the work was done.

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The 2005 Declaration adds two requirements of the same kind. Research funded from one State and carried out in another should be reviewed for ethics in both. And transnational health research should be responsive to the needs of the host countries, with the importance of research contributing to the alleviation of urgent global health problems recognised. A trial that recruits in a district for a condition common in that district, and produces a product that will never be sold there, fails that requirement squarely.

Who owns what science produces

Benefit sharing forces a prior question, and the instruments answer it in three places.

The human genome is not property. Article 4 of the 1997 Genome Declaration provides that the human genome in its natural state shall not give rise to financial gains, and Article 1 calls it, in a symbolic sense, the heritage of humanity. Something that is nobody's private property cannot generate a private entitlement to the profits of reading it. That is the strongest ownership statement in the whole authority base, and its own chapter in Module III works it out.

Traditional knowledge belongs to the communities that hold it. Paragraph 39 of General Comment 25 requires States to protect local, traditional and indigenous knowledge, including through special intellectual property regimes, and to secure the ownership and control of that knowledge by the communities and indigenous peoples concerned. The Indian examples of what happens when this fails are worked in the chapter on biopiracy and traditional knowledge.

Contribution must be credited. Paragraph 83 requires States, when negotiating international agreements or adopting a domestic intellectual property regime, to ensure that traditional knowledge is protected and that contributions to scientific knowledge are appropriately credited. Credit is itself a form of benefit, and it is the one most often withheld from the people at the collecting end of a study.

The intellectual property problem, at the level of principle

Benefit sharing and intellectual property are not natural enemies, and an answer that treats them as such is too simple. Paragraph 60 of General Comment 25 puts both sides: intellectual property enhances the development of science by giving inventors an economic incentive, and it can also work against the advancement of science and against access to its benefits in three specific ways.

The three, from paragraph 61, are worth learning as a set. It distorts what gets funded, because private money follows what is profitable and neglects what is not, which is what has happened with the diseases the Committee calls neglected. It restricts the sharing of research information for a period, through devices such as data exclusivity, and prices scientific publications beyond the reach of low-income researchers. And it can put the product itself out of reach, because a patent holder has a temporary exclusive right and can set the price, which is what has happened with new medicines essential to the life of persons with certain diseases.

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Paragraph 62 states the answer as a balance rather than an abolition. States should fund the research that the market neglects, if necessary through international co-operation; they should guarantee the social dimensions of intellectual property in their national law and in international agreements; and the Committee reiterates that intellectual property is a social product with a social function, so States have a duty to prevent unreasonably high costs for essential medicines, seeds and learning materials from undermining the rights of large parts of the population. How that plays out in Indian patent law is the subject of a later chapter of this module.

A worked example

A company incorporated abroad funds a trial of a new treatment for a parasitic disease. The trial runs at a district hospital in India. Sunanda, a farm labourer, enrols. Two hundred others in her district enrol with her. The treatment works, is patented, and is launched at a price no one in the district can pay.

Has anything unlawful happened? Possibly nothing, on the ordinary law. Sunanda consented, was treated according to the protocol, and suffered no injury. That is exactly why benefit sharing is stated separately: the wrong it addresses survives a lawful trial and a valid consent.

Which claim does Sunanda have? The claim of a person who took part in the research. The forms of benefit contemplated are continuing assistance and acknowledgement, access to health care, and provision of the treatment that came out of the research. A trial that ends the day the last data point is collected, leaving the participants with nothing, is the situation the enumerated forms are aimed at.

Which claim does the district have? The claim of the host population. The 2005 Declaration requires transnational health research to be responsive to the needs of host countries. A trial run in the district for a disease of the district, whose product is priced for another market, is not responsive to those needs.

Which claim does India have? The claim of a developing country under paragraph 80 of General Comment 25, that benefits and applications resulting from scientific progress be shared with the international community and particularly with developing countries, especially where the benefits are closely connected to economic, social and cultural rights. Treatment for a disease that disables labourers is such a benefit.

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When should this have been settled? At the negotiation, not now. The 2005 Declaration requires terms for collaboration and agreement on benefits to be established with equal participation by the parties to the negotiation, and the ethical review should have taken place in the funder's State as well as in India.

Who can be made to answer? India, as the State whose obligation under article 15 of the Covenant is engaged. And the funder's State, under paragraph 84, whose extraterritorial obligation is to regulate and monitor a company over which it can exercise control and to provide remedies for its victims.

Distinctions

Benefit sharingPayment to a participantCompensation for research injuryCharity
What it answersWho is owed a share of what the research producedWhat this person is paid for their time and troubleWhat is owed because this person was harmedWhat the holder chooses to give away
Who is owedParticipants, host communities, developing countries, societyThe individual participantThe injured individualNobody, as of right
TriggerThe research produced somethingEnrolmentInjury caused by the researchThe donor's decision
Risk it carriesMay be promised and never deliveredBecomes an improper inducement if too largeNone, but it is not a substitute for a shareSubstitutes goodwill for entitlement

What beginners get wrong

Treating benefit sharing as a money transfer. The enumerated forms in both UNESCO articles are mostly not money: access to care, provision of the resulting treatment, support for health services, access to knowledge, and capacity building. Cash is the form the instruments are most cautious about, because of the inducement problem.

Confusing it with consent. Consent decides whether this person may be included. Benefit sharing decides what is owed once the research has produced something, and it is owed to people who never signed anything, including the population of a country that hosted the work. Both can be satisfied and the other still breached.

Treating it as purely international. Paragraph 6 of the 1975 Declaration requires the benefits to be extended to all strata of the population, which is a duty a State owes internally. A country that acquires a technology and delivers it only to its richest cities has failed the principle without any foreign party being involved.

Saying intellectual property violates human rights. The Committee does not say that. It says intellectual property has positive and negative effects, identifies three specific negative ones, and calls for a balance in which access and the sharing of knowledge are guaranteed alongside the incentive. Stating the balance is the stronger answer.

Limits and criticism

The instruments say "should". Article 15 of the 2005 Declaration and Article 19 of the 2003 Declaration are drafted in the language of what ought to happen, and both instruments are declarations of the UNESCO General Conference rather than treaties. Article 19(b) of the 2003 Declaration expressly allows limitations to be provided by domestic law and international agreements, which leaves a wide door open.

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The forms are open ended. Each list ends with a residual item covering any other form of benefit consistent with the declaration's principles. That flexibility is useful, because what a community needs varies, and it also means that a token gesture can be presented as compliance. Nothing in either instrument measures adequacy.

There is no machinery. No body receives complaints about a breach of benefit sharing. The nearest thing to enforcement is that the principle now forms part of the Committee's reading of article 15 of the Covenant, so a State's failure can be raised in its periodic report, and paragraph 2 of General Comment 25 records that science is the area States report on least.

The duty falls on States and the benefit is held by private parties. International human rights obligations bind States. The patents, the data and the manufacturing capacity are mostly held by companies. General Comment 25 answers this with the duty to protect and the extraterritorial duty in paragraph 84, but a duty to regulate is a weaker instrument than a duty to deliver, and the gap is the standing criticism of this whole area.

Quick revision

  • Benefit sharing: the benefits of scientific research and its applications are to be shared with society as a whole, with the international community and particularly developing countries, and with the persons and groups who took part.
  • Stated as Sharing of benefits in Article 15 of the UNESCO Bioethics Declaration 2005 and Article 19 of the UNESCO Genetic Data Declaration 2003; as benefits "made available to all" in Article 12(a) of the Genome Declaration 1997; as a State duty in paragraph 6 of the 1975 Declaration; and inside the right to science at paragraph 80 of General Comment 25.
  • Forms of benefit: assistance and acknowledgement for participants, access to health care, provision of the resulting products, support for health services, access to knowledge, capacity building.
  • Benefits must not become an improper inducement to take part in research.
  • Terms must be settled at the negotiation, with equal participation, not after the result is known.
  • Ownership: the human genome in its natural state shall not give rise to financial gains (Genome Declaration, Article 4); traditional knowledge is owned and controlled by the communities that hold it (General Comment 25, paragraph 39); contributions must be credited (paragraph 83).
  • Intellectual property has three identified negative effects at paragraph 61: distorted funding, restricted sharing, and price. Paragraph 62 answers with balance, and calls intellectual property a social product with a social function.
  • Extraterritorial duty at paragraph 84: regulate and monitor multinational companies, and provide remedies.
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Test yourself

1. State the principle of benefit sharing and name the instruments in which it appears. Benefits resulting from scientific research and its applications should be shared with society as a whole and with the international community, particularly developing countries and communities living in poverty, and with the persons and groups who took part in the research. It appears as Article 15 of the UNESCO Universal Declaration on Bioethics and Human Rights 2005 and Article 19 of the UNESCO International Declaration on Human Genetic Data 2003, both headed Sharing of benefits; as Article 12(a) of the 1997 Genome Declaration; as paragraph 6 of the 1975 Declaration on the Use of Scientific and Technological Progress; and as paragraph 80 of General Comment No. 25 on article 15 of the Covenant.

2. A company pays each trial participant a large sum and provides nothing else. Has it shared the benefits? No, and it may have made the position worse. The 2005 Declaration warns that benefits must not constitute improper inducements to participate in research, and a payment large enough to lead a poor participant to accept a risk they would otherwise refuse is such an inducement. Benefit sharing is owed in addition to whatever a participant is paid for their time, is owed to people who were never enrolled, including the host community and the host country, and takes forms such as continuing access to the resulting treatment, support for health services and capacity building.

3. Why is it said that benefit sharing must be agreed before the research and not after it? Because the bargaining positions are not equal once the result is known. The 2005 Declaration requires that when a research agreement is negotiated, the terms of collaboration and the agreement on benefits be established with equal participation by the parties. After a successful trial the sponsor holds the data, the patent and the manufacturing capacity, and the host has nothing left to trade, so an agreement made then is not an agreement between equals.

4. How does General Comment 25 reconcile intellectual property with the right to science? Not by rejecting it. Paragraph 60 accepts that intellectual property gives incentives that drive research, and identifies three ways it can also work against the right: it distorts funding towards profitable subjects and away from neglected diseases; it restricts the sharing of research information, through devices such as data exclusivity and through the price of publications; and it can place the product beyond the reach of poor patients and poor countries. Paragraph 62 requires States to fund neglected research, to guarantee the social dimensions of intellectual property in domestic and international law, and to prevent unreasonably high costs for essential medicines, seeds and learning materials from undermining rights, because intellectual property is a social product with a social function.

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5. A State imports a new diagnostic technology and installs it only in private hospitals in its three largest cities. Has benefit sharing been breached, given that no foreign party is complaining? Yes, on the wording of paragraph 6 of the 1975 Declaration, which requires States to extend the benefits of science and technology to all strata of the population. The obligation is internal as well as international. Paragraph 47 of General Comment 25 points the same way, requiring States to use the maximum of their available resources to overcome the hurdles that any person faces in benefiting from new technologies, with particular relevance for disadvantaged and marginalised groups.

Contents This chapter on its own page

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Chapter Fourteen

Dual Use: the Same Technology Both Ways

Syllabus topic 1, "Interrelationship of Science, Technology and Human Rights"

In one line

The same discovery that saves a life can take one, and usually it is not two technologies but one, pointed in two directions.

In the wording a student can write in an exam: dual use describes the property of scientific knowledge and its applications by which a single body of knowledge, or a single technique or device derived from it, is capable both of advancing the enjoyment of human rights and of being employed to defeat them, so that the rights analysis cannot be performed on the technology in the abstract but only on a particular use of it by a particular actor in a particular setting.

Why the law has this at all

The natural way to think about a new technology is to ask whether it is good or bad, and the natural way to legislate is to permit the good ones and prohibit the bad. Neither survives contact with the subject.

Nuclear fission produces electricity and destroys cities. The chemistry of nitrogen fixation feeds a substantial part of the world's population and supplies explosives. A database that identifies a missing child by their face identifies a protester by theirs. Encryption protects a dissident's messages and a trafficker's. In each pair the underlying knowledge is identical, and often the equipment is too.

That is why a legal framework built on categorising technologies fails. It has to be built instead on uses, actors and safeguards, which is precisely what the human rights instruments do.

There is also a second reason, less obvious and more important for this paper. Because the same technology cuts both ways, a State can violate the right in either direction. It can allow a technology to be used against people, and it can withhold a technology people need. The two failures look nothing alike but they breach the same article, and the framework has to be able to catch both.

Where the idea sits in the texts

No instrument in this book's base uses the phrase "dual use". The idea is nevertheless written into the structure of the two central documents, which is a better answer than the phrase would be.

The 1975 Declaration is constructed on it. Its operative paragraphs alternate between the two directions:

  • Paragraph 1 requires States to promote co-operation so that the results of scientific and technological developments are used for peace, security, development and the realisation of human rights. That is the beneficial direction.
  • Paragraph 2 requires States to take appropriate measures to prevent the use of scientific and technological developments, particularly by State organs, to limit or interfere with the enjoyment of human rights. That is the harmful direction, and it names the State as the likely offender.
  • Paragraph 6 contains both in one sentence: States shall extend the benefits of science and technology to all strata of the population and protect them from possible harmful effects of misuse, particularly as regards privacy and the protection of the human personality and its physical and intellectual integrity.
  • Paragraph 7 requires that the utilisation of scientific achievements promote the fullest realisation of rights without discrimination, and paragraph 8 requires effective measures, including legislative measures, to prevent and preclude the utilisation of those achievements to the detriment of human rights and the dignity of the human person.
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Read paragraphs 6 to 8 together and the structure of the whole subject is visible: extend the benefits, prevent the harms, and do both by law.

The Covenant carries the same idea through its limitation clause rather than in terms. Article 15(1)(b) gives the right to enjoy the benefits. Article 4 permits limitations, and General Comment 25 applies it to science.

The limitation test

General Comment 25 is explicit that limits on this right may be necessary, because science and its applications can in certain contexts affect economic, social and cultural rights. Any limitation must satisfy article 4 of the Covenant:

  1. It must be determined by law.
  2. It must promote the general welfare in a democratic society.
  3. It must be compatible with the nature of the right restricted.

The Committee reads the third requirement as importing two further constraints: limitations must respect the minimum core obligations of the right, and they must be proportionate to the aim pursued. Where several means are reasonably capable of achieving the legitimate aim, the least restrictive must be selected, and the burdens imposed on enjoyment of the right should not outweigh the benefits of the limitation.

Paragraph 22 then distinguishes three kinds of limit, and the distinction is the most useful thing in the chapter:

What is limitedWhen it is justifiedHow heavy the burden of justification
The applications of scienceTo guarantee the safety and quality of products used by persons; human rights impact assessments may be necessary against risky applicationsOrdinary. This is routine regulation
The research processParticularly where research affects human beings, to protect their dignity, integrity and consent; where research is done among populations different from the researchers, the State of origin must guarantee the rights and obligations of all partiesOrdinary, and expected. This is research ethics
The content of scientific researchRarelyA strict burden of justification, to avoid infringing freedom of research

That last row is the point at which the framework refuses to let dual use become an excuse. A State may regulate what is done with knowledge far more readily than it may forbid the acquisition of knowledge.

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Worked example

A university group develops a method for reconstructing a person's approximate facial appearance from a DNA sample. Two applications follow at once. A police force wants it to generate a likeness of an unknown suspect from material at a scene. A humanitarian organisation wants it to help identify the dead after a disaster so families can be informed.

One technology, two uses. There is no separate humanitarian version. The same method, the same reference database, the same laboratory.

Which rights are engaged, on each side? For the humanitarian use: the families' interest in knowing the fate of a relative, and the dignity of the dead. For the police use: the presumption of innocence, privacy, and equality, since the method's error characteristics will not be uniform across populations and a likeness that is systematically wrong for one group produces investigations that fall unequally.

Apply the limitation test to a proposal to permit the police use. Is it determined by law, or is it an operational decision taken inside a police force? Does it pursue a legitimate aim? Is it proportionate: is there a less restrictive means reasonably capable of achieving the same aim, and does the burden on the persons wrongly implicated outweigh the investigative benefit?

Note which limb of paragraph 22 is engaged. A rule restricting the police use limits an application, which is ordinary regulation. A rule forbidding the university from publishing the method limits the content of research, which carries a strict burden of justification. A candidate who treats those two as the same restriction has missed the distinction the Comment draws.

And the other direction. If the technique is dependable for identifying the dead and the State declines to make it available after a disaster, the complaint is not about misuse at all. It is a failure to extend the benefit, contrary to paragraph 6 of the 1975 Declaration and article 15(1)(b).

What it does NOT mean

It does not mean that every technology is neutral. Neutrality is a claim about moral responsibility and it is usually made by people who would rather not accept any. Dual use is a claim about capability: the same capability can serve either end. Where a technology has a single realistic use and that use is the infliction of harm, calling it dual use is an evasion, and the treatment of weapons in [Weapons, Warfare and the Right to Life] proceeds on that footing.

It does not mean the two directions are equally likely. Which use predominates is a question of fact about incentives, cost and who owns the technology, and the answer is often not evenly balanced. Saying "it can be used well or badly" and stopping there is the weakest available answer.

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It is not a reason to refuse to regulate. The argument that a rule is pointless because the knowledge is already public confuses knowledge with application, and paragraph 22 keeps them apart precisely so that the first is not used as an excuse about the second.

It is not a reason to suppress research either. The strict burden of justification on limiting the content of research is there to stop dual use becoming a general licence for prohibition.

Limits and criticism

The framework tells you what questions to ask and not what answers to give. Whether a particular surveillance capability is proportionate is not settled by article 4; it is argued under it. That is a fair criticism of the whole limitation structure and it applies here.

The harder criticism is one of timing. Dual use is most easily managed early, when a technology is expensive and few people have it, and that is exactly when its harmful uses are hardest to foresee. By the time the harm is obvious the capability is cheap and widespread and the regulatory moment has passed. The 1975 Declaration's insistence in paragraphs 7 and 8 on legislative measures reads, in that light, as a demand that States act before they are certain, which is the same instinct as the precautionary principle discussed in [The Precautionary Principle].

Quick revision

  • Dual use: one body of knowledge or one technique both advances rights and defeats them, so the analysis must be of a use by an actor in a setting, never of the technology in the abstract.
  • A State can breach the right in either direction: by allowing harmful use, and by withholding a benefit.
  • 1975 Declaration: paragraph 1 the beneficial direction; paragraph 2 prevent use, particularly by State organs, to limit or interfere with rights; paragraph 6 both directions in one sentence, naming privacy and physical and intellectual integrity; paragraphs 7 and 8 require measures including legislative measures.
  • ICESCR article 4 governs limitations: determined by law; promoting the general welfare in a democratic society; compatible with the nature of the right. The Committee adds respect for the minimum core and proportionality, with the least restrictive means and a weighing of burdens against benefits.
  • General Comment 25, paragraph 22 distinguishes limits on applications (safety and quality, human rights impact assessments), on the research process (dignity, integrity, consent; the State of origin's duty where research is done among other populations), and on the content of research, which carries a strict burden of justification.

Test yourself

1. Define dual use and explain why it prevents a rights analysis being done on a technology in the abstract. Dual use is the property by which a single body of scientific knowledge, or a technique or device derived from it, is capable both of advancing the enjoyment of human rights and of being used to defeat them. It prevents analysis in the abstract because the same capability yields opposite conclusions depending on who exercises it, against whom, for what purpose and with what safeguards. A question framed as whether a technology is compatible with human rights therefore has no answer; the answerable question is whether a particular use by a particular actor, with the safeguards proposed, satisfies the limitation test.

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2. Show how the 1975 Declaration contains both directions, citing paragraphs. Paragraph 1 requires States to promote international co-operation so that the results of scientific and technological developments are used for peace and security, for economic and social development and for the realisation of human rights. Paragraph 2 requires appropriate measures to prevent the use of such developments, particularly by State organs, to limit or interfere with the enjoyment of human rights. Paragraph 6 states both together, requiring States to extend the benefits of science and technology to all strata of the population and to protect them from the harmful effects of misuse, with particular regard to privacy and the physical and intellectual integrity of the person. Paragraphs 7 and 8 then require measures, including legislative measures, to secure the beneficial use without discrimination and to prevent detrimental use.

3. Set out the three requirements of article 4 of the Covenant and the two constraints the Committee reads into the third. A limitation must be determined by law; it must promote the general welfare in a democratic society; and it must be compatible with the nature of the right restricted. The Committee reads the third as requiring, first, that limitations respect the minimum core obligations of the right, and second, that they be proportionate to the aim pursued, which means that where several means are reasonably capable of achieving the legitimate aim the least restrictive to economic, social and cultural rights must be chosen, and that the burdens imposed on enjoyment must not outweigh the benefits of the limitation.

4. A government proposes both to prohibit the sale of a genetic testing kit and to prohibit publication of the method by which it works. Are the two proposals assessed alike? No. The first limits an application of science, which paragraph 22 treats as ordinary regulation available to guarantee the safety and quality of products used by persons, and for which human rights impact assessments may be appropriate. The second limits the content of scientific research, which the same paragraph says implies a strict burden of justification by the State in order to avoid infringing freedom of research. Both must satisfy article 4, but the second faces a materially heavier justification, because the framework guards the acquisition of knowledge more jealously than its commercial application.

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5. Why is the claim that a technology is "neutral" not the same as the claim that it is dual use, and when does the neutrality claim fail? Dual use is a statement about capability, that the same means can serve opposite ends. Neutrality is a statement about responsibility, that the person who supplies the means bears none for what is done with them, and it does not follow from dual use. The neutrality claim fails wherever a technology has one realistic use and that use is the infliction of harm, since there is then no second direction to point to; it also fails wherever the supplier knows the use to which the capability will in fact be put, because the duty to protect under the 1975 Declaration's paragraphs 2 and 8 is engaged by foreseeable misuse and not only by intended misuse.

Contents This chapter on its own page

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Chapter Fifteen

Scientific Temper as a Fundamental Duty

Syllabus topic 1, "Interrelationship of Science, Technology and Human Rights"

In one line

The Constitution asks every citizen of India to develop a scientific cast of mind, and it says so in the Constitution itself rather than in a policy document.

In the wording a student can write in an exam: Article 51A(h) of the Constitution of India provides that it shall be the duty of every citizen of India to develop the scientific temper, humanism and the spirit of inquiry and reform. It is one of the eleven fundamental duties listed in Part IVA, which was inserted by the Constitution (Forty-second Amendment) Act, 1976, with effect from 3 January 1977. It is the provision in which the Constitution speaks directly about how a citizen should approach knowledge, and it is therefore the point at which the subject of this paper enters Indian constitutional text.

Why the Constitution has this at all

The Constitution as it stood until 1976 spoke in two voices and both of them spoke about the State. Part III confers rights that a person holds against the State. Part IV states principles the State is to be guided by. Neither Part says anything about what is expected of the person who holds the rights.

Part IVA was added to fill that silence. It states duties, and the duties are addressed to the citizen. Whether a constitution ought to do this at all is a real question, and it is one of the standing criticisms of the Part, taken up at the end of this chapter.

Why a scientific temper in particular? Because it is the one thing in this whole subject that a State cannot supply. A government can build laboratories, fund research, run schools and regulate medicines. It cannot make a person weigh evidence, and almost every harm this paper studies has a version in which the harm is not done by the State at all but chosen by the person who is harmed.

The provision itself

Article 51A opens with the words "It shall be the duty of every citizen of India", and then lists the duties. Clause (h) reads:

to develop the scientific temper, humanism and the spirit of inquiry and reform;

Two neighbouring clauses matter for this paper and are worth reading beside it. Clause (g) makes it the duty of every citizen to protect and improve the natural environment including forests, lakes, rivers and wild life, and to have compassion for living creatures. Clause (k), which was added later and which the next chapter but one takes up, makes it the duty of a parent or guardian to provide opportunities for education to a child between the ages of six and fourteen years.

Broken down

"It shall be the duty of every citizen of India." The duty is laid on the citizen. That single word settles most of the questions students ask about the article. It is not addressed to the State, so it is not a source of any obligation on the Government, and a person resident in India who is not a citizen is outside its terms.

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"To develop." Not "to have" and not "to possess". The verb contemplates something acquired over time and by effort, which is why the duty reads naturally as a duty about education and habit rather than about a state of mind a person either has or lacks.

"The scientific temper." This is the phrase the examiner will ask about, so it has to be pinned down. It does not mean scientific knowledge, and it is not a duty to study science. A temper is a disposition, a settled way of approaching a question. The scientific temper is the habit of asking what the evidence for a claim is, of preferring an explanation that has been tested to one that has not, and of holding a belief open to correction when the evidence changes.

"Humanism." The placing of human welfare and human dignity at the centre of judgement. Its presence in the same clause is what keeps the scientific temper from being read as a licence for anything that can be measured, which is precisely the failure Module III exists to answer.

"The spirit of inquiry and reform." Two dispositions again, and they are the practical end of the clause. Inquiry is the willingness to ask a question about a settled practice. Reform is the willingness to change the practice when the answer shows it to be wrong. Inquiry without reform produces nothing, and reform without inquiry is merely change.

Four words, one duty. Clause (h) is not four separate obligations. Reading them together is what stops "scientific temper" from collapsing into "technical training", and it is the reading a good answer states expressly.

Where it sits, and when it arrived

PartIVA, Fundamental Duties, which contains this one article
Article51A, with clauses (a) to (k)
Inserted byThe Constitution (Forty-second Amendment) Act, 1976, section 11
In force from3 January 1977
Clause (k) added byThe Constitution (Eighty-sixth Amendment) Act, 2002, section 4, with effect from 1 April 2010

The list therefore began with ten duties and has had eleven since 2010. The addition of clause (k) is the only change the Part has undergone, and it is a useful thing to know because it shows that Parliament treats the list as capable of growth.

Can it be enforced?

This is the question the article is really examined on, and the Constitution answers it by what it does not say.

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Part III carries its own remedy. Article 32 guarantees the right to move the Supreme Court by appropriate proceedings for the enforcement of the rights conferred by that Part, and empowers the Court to issue directions, orders and writs.

Part IV disclaims enforcement in terms. Article 37 provides that the provisions of that Part "shall not be enforceable by any court, but the principles therein laid down are nevertheless fundamental in the governance of the country and it shall be the duty of the State to apply these principles in making laws".

Part IVA does neither. It contains no machinery of its own, no sentence like article 37, and no penalty. Article 51A states duties and stops. Three consequences follow, and a student should state all three rather than only the first. No court can be moved to compel a citizen to develop a scientific temper. Breach of the clause is not by itself an offence, because the article creates none. And because the duty lies on the citizen, it is not a foundation for a claim against the Government either.

What is left is not nothing. The clause is part of the text of the Constitution, and a litigant may argue that another provision should be read in a way that is consistent with it, or that a law made to give it content is supported by it. That is an argument about how the Constitution should be construed. It is not a rule of enforcement, and it should not be written up as one.

The State-facing half of the same idea

The Constitution does not leave science entirely to the citizen. Article 48 directs the State to organise agriculture and animal husbandry "on modern and scientific lines", which is a directive principle and so falls under article 37.

International law puts the corresponding duty squarely on the State. General Comment No. 25 of the Committee on Economic, Social and Cultural Rights, adopted in 2020, states at paragraph 42 that the obligation to respect the right to science requires a State to refrain from disinformation, disparagement or deliberate misinformation intended to erode citizen understanding of and respect for science and scientific research. Paragraph 43 requires the State to ensure that private persons and entities do not disseminate false or misleading scientific information. Paragraph 44 requires protection against messages from pseudoscience, meaning claims presented as scientific that the scientific community does not accept, and it gives as its example parents who refuse vaccination for their children on grounds the scientific community considers false.

Put those beside clause (h) and the picture is complete. The Covenant obliges the State not to corrupt public understanding and to protect people from those who would. The Constitution asks the citizen to bring a disposition that makes the protection work. The general treatment of General Comment 25 belongs to [General Comment 25 and the Content of the Right]; what matters here is that the two instruments meet on this point.

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A worked example

Sunil Rane runs an unregistered clinic in a small town and advertises a mineral treatment that he says cures diabetes. He tells patients to stop taking insulin. Anjali Deshmukh's father is one of them, and after he is hospitalised she wants the practice stopped. She has read article 51A(h) and asks what it does for her.

Against Sunil Rane, directly, it does nothing. Clause (h) imposes a duty on him as a citizen. It confers no right on Anjali, states no sanction, and Part IVA supplies no machinery. A petition asking a court to enforce clause (h) against him has nowhere to go.

Against the State it does nothing either. The duty is addressed to citizens, so it is not a source of an obligation on the Government to act.

The enforceable law is elsewhere, and there is plenty of it. Article 21 and the obligation it casts on the State to preserve life are treated in [Science Under Article 21]. The regulation of drugs, of medical practitioners and of clinical establishments, and the liability of a person who holds himself out as competent to treat, are the subject matter of Module II.

What clause (h) contributes is the reason. It states, in the Constitution's own words, the interest that all of that machinery exists to protect, and it lets Anjali say that the Constitution itself treats the disposition Sunil Rane is exploiting as a matter of constitutional concern. General Comment 25 paragraph 43 points the same way, because it requires the State to ensure that private entities do not disseminate false or misleading scientific information.

The honest conclusion. Article 51A(h) explains why the problem is a constitutional problem. It is not the provision that solves it. An answer that says otherwise is overstating the article, and an answer that ignores the article altogether has missed why the Constitution mentions science at all.

Distinctions

Fundamental right, Part IIIDirective principle, Part IVFundamental duty, Part IVA
Who is boundThe StateThe StateEvery citizen of India
Enforceable by a courtYes, article 32 supplies the remedyNo, article 37 says so expresslyThe Part is silent: no machinery and no sanction
What it producesA claim against the StateA standard for governance and law makingA statement of what is expected of a citizen
The science exampleArticle 21: life, health, privacy, bodily integrityArticle 48: agriculture on modern and scientific linesArticle 51A(h): the scientific temper
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Scientific Temper as a Fundamental Duty

What beginners get wrong

Reading it as a duty to study science. It is a duty about how a claim is examined, not about what a person knows. A person with no formal education can satisfy it and a person with a science degree can fail it.

Saying that unscientific belief is unconstitutional. The article creates a duty, not an offence, and the Constitution's own guarantees of conscience, belief and expression sit in the same document. What the clause states is an expectation, and reading it as a prohibition contradicts both its wording and the rest of Part III.

Using it to demand that the Government fund research. That claim exists, but it comes from article 15(2) of the Covenant and is dealt with in [The Duty to Conserve, Develop and Diffuse Science]. Article 51A(h) is addressed to citizens and cannot carry it.

Treating "not enforceable" as "of no effect". The absence of machinery is a statement about remedies. It is not a statement that the words are not part of the Constitution, and the two should not be run together in an answer.

Limits and criticism

No definition. The Constitution does not say what a scientific temper is. The content has to be built from the words the phrase is joined to, which is why the clause has to be read whole.

No sanction and no machinery. A duty with neither is an unusual legal instrument, and the standing criticism of Part IVA is that it states aspirations in the register of obligation.

Citizens only. The duty binds citizens. A subject whose harms fall on everybody within the territory is oddly served by a provision limited by nationality.

The company it keeps. Clause (h) sits in a list that also asks citizens to respect the National Flag and to defend the country when called upon. The variety makes it easy to read the whole Part as exhortation and to skip past the one clause in it that has real work to do in this paper.

It binds the wrong party for the biggest problems. The decisions this subject is most worried about, whether to deploy a surveillance system, whether to license a drug, whether to fund a line of research, are taken by governments and companies, not by individual citizens. Clause (h) reaches none of them.

Quick revision

  • Article 51A(h): the duty of every citizen of India to develop the scientific temper, humanism and the spirit of inquiry and reform.
  • Part IVA, inserted by the Forty-second Amendment, 1976, in force from 3 January 1977. Clause (k) added by the Eighty-sixth Amendment, 2002, in force from 1 April 2010.
  • Addressed to the citizen, not the State. No machinery, no sanction, no equivalent of article 32 or article 37.
  • Scientific temper is a disposition, not knowledge: evidence, testing, and a belief open to correction.
  • Read all four words together: temper, humanism, inquiry, reform.
  • The State-facing counterparts: article 48 in Part IV, and General Comment 25 paragraphs 42, 43 and 44 in international law.
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Test yourself

1. State article 51A(h) and explain what "scientific temper" means in it. Article 51A(h) provides that it shall be the duty of every citizen of India to develop the scientific temper, humanism and the spirit of inquiry and reform. Scientific temper there means a disposition rather than a body of knowledge: the habit of asking what the evidence for a claim is, of preferring a tested explanation to an untested one, and of holding a belief open to correction. It is read together with humanism and with the spirit of inquiry and reform, which is what prevents it from being reduced to technical training.

2. Can a court enforce article 51A(h), and how do you know? No, and the answer comes from the structure of the Constitution rather than from any words in the article. Part III carries its own remedy in article 32. Part IV disclaims enforcement expressly in article 37. Part IVA does neither: it supplies no machinery, states no sanction and creates no offence. So no court can be moved to compel a citizen to develop a scientific temper, and because the duty lies on the citizen it founds no claim against the State either. It remains part of the constitutional text and may be used in argument about how another provision should be read.

3. A private hospital promotes an untested treatment. Is article 51A(h) breached, and what follows? The clause is addressed to citizens and speaks of developing a disposition, so calling this a breach of it adds nothing that can be acted on. The article supplies no remedy against the hospital and none against the State. What it supplies is the constitutional statement of the interest at stake, and the enforceable law has to be found in article 21 and in the statutes regulating medicine, drugs and clinical establishments. Internationally, General Comment 25 paragraph 43 requires the State to ensure that private entities do not disseminate false or misleading scientific information.

4. How does article 51A(h) fit the international framework on science? It is the citizen-facing half of a duty the international instruments place on the State. General Comment 25 requires a State to refrain from disinformation intended to erode public understanding of science, to stop private entities spreading false scientific information, and to protect people from pseudoscience. The Constitution asks the citizen to develop the disposition that makes those protections effective. Neither half works alone: a State that tells the truth to a population with no habit of testing claims achieves little, and a scientifically minded population cannot check a State that controls the information.

Contents This chapter on its own page

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Chapter Sixteen

Science Under Article 21

Syllabus topic 1, "Interrelationship of Science, Technology and Human Rights"

In one line

Almost everything this paper studies reaches Indian law through one sentence of the Constitution that never mentions science at all.

In the wording a student can write in an exam: Article 21 of the Constitution of India provides that no person shall be deprived of his life or personal liberty except according to procedure established by law. The Constitution contains no separate right to health, no separate right to privacy and no separate right to bodily integrity. Each of them has been held to be contained within the right to life and personal liberty, so article 21 is the provision through which a medical, informational or biological technology is tested against Indian constitutional law.

Why so much rests on one article

Look at what the Constitution does not say. There is no article guaranteeing medical treatment. There is no article about personal data. There is no article about what may be done to a person's body without their agreement. The document was settled in 1949, and none of those was then a question a constitution was expected to answer.

The rights therefore had to be found somewhere, and article 21 was the only place they could be found. Its two protected interests, life and personal liberty, are stated at the highest level of generality of any provision in Part III, and both are protected for every person, not only for a citizen. That is why the article, and not any other, became the route by which new technologies entered constitutional argument.

There is a second reason, and it is specific to this subject. A technology usually threatens a person before it threatens a class. The injury it does is to a body, to a mind, or to information about one person, and those are exactly the interests article 21 names. A right stated in terms of the individual is the right that a new capability collides with first.

The provision itself

No person shall be deprived of his life or personal liberty except according to procedure established by law.

Two features of that sentence carry the weight. It protects every person, so it is not limited by nationality. And it is written as a restraint on deprivation rather than as a grant, which is why the questions it generates are always about who may take something away, on what authority, and by what procedure.

How nineteen words came to carry more

The expansion did not happen by amendment. Article 21 has never been amended, and it reads today exactly as it reads above.

It happened by a change in how Part III is read. The Supreme Court in the nine judge decision worked below recorded the sequence. Two early decisions, one given by eight judges and one by six, had contained observations that the Constitution does not specifically protect privacy. Both rested on an approach that construed each provision of the fundamental rights chapter as embodying a distinct and self-contained protection. An eleven judge Bench later held that approach not to be good law, and a seven judge Bench approved the dissenting view in the second of the two early decisions and overruled its majority.

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Science Under Article 21

Once the guarantees of Part III are read together rather than in isolation, the content of "life" and "personal liberty" stops being fixed by a list. That is the whole mechanism, and a student who can state it in those terms can explain any of the extensions that follow without having to memorise them one by one.

The first limb: life, and therefore health

Pt. Parmanand Katara v. Union of India, AIR 1989 SC 2039, (1989) 4 SCC 286, decided on 28 August 1989.

Facts. The petitioner, describing himself as a human rights activist, filed a writ petition in the public interest on the basis of a newspaper report. A scooterist had been knocked down by a speeding car. He was taken to the nearest hospital, where the doctors refused to attend on him and said he should be taken to another hospital some twenty kilometres away that was authorised to handle medico-legal cases, meaning cases in which a criminal investigation is likely. He died before he could be taken there. The petitioner asked for directions that an injured person be given medical aid at once, with the procedural criminal law operating afterwards. The Union of India told the Court that no provision of the Indian Penal Code, the Code of Criminal Procedure or the Motor Vehicles Act prevented a doctor from attending a seriously injured person before the police arrived.

Held. Article 21 casts the obligation on the State to preserve life. Preservation of human life is of paramount importance, because once life is lost the position cannot be restored. Whether the patient is an innocent person or a criminal, those in charge of the health of the community are obliged to preserve life, since social laws do not treat death by negligence as a form of legal punishment. Every doctor, at a government hospital or otherwise, has the professional obligation to extend his services with due expertise for protecting life. No law or State action can be allowed to avoid or delay the discharge of that obligation, and laws of procedure that would interfere with it must give way.

Why it matters here. It is the step from a capability to a duty. Medical science had made it possible to save the scooterist; the hospital that could have saved him was standing in front of him; and article 21 is what turns "could" into "must". That step is the entire relationship between science and rights compressed into one case, and it is why a paper on science and human rights begins its Indian material here. The detail of the obligation to treat is taken up in [Emergency Treatment and the Duty to Treat], and the wider right to health under this article in [The Right to Health Under Article 21].

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Science Under Article 21

The second limb: privacy, and therefore data

Justice K.S. Puttaswamy (Retd.) v. Union of India, AIR 2017 SC 4161, (2017) 10 SCC 1, decided on 24 August 2017 by nine judges.

Facts. A Bench of three judges hearing the challenge to the Aadhaar scheme recorded, in its order of 11 August 2015, that the norms for and the compilation of demographic and biometric data by the Government were being questioned as a violation of the right to privacy. The Attorney General argued that the existence of a fundamental right of privacy was itself in doubt, relying on observations in the two early decisions described above. The petitioners answered that both rested on an approach later held not to be good law. Because the decisions that had since recognised privacy were given by smaller Benches, the question was referred upwards, and on 18 July 2017 a Constitution Bench directed that it be placed before nine judges.

Held. The Order of the Court disposed of the reference in four propositions. The decision holding that the right to privacy is not protected by the Constitution stands overruled. The second early decision stands overruled to the extent that it so holds. The right to privacy is protected as an intrinsic part of the right to life and personal liberty under article 21 and as a part of the freedoms guaranteed by Part III. The later decisions that had taken that position lay down the correct law. In the judgment delivered for four of the nine judges, Chandrachud J recorded that the Court had to be sensitive to the opportunities and dangers posed to liberty in a digital world; that information is nonrivalrous, invisible and recombinant, so that a person may never learn that their data has been taken; that a State intervening to protect a legitimate interest must nonetheless put in place a regime satisfying a threefold requirement of a law, a legitimate State aim and proportionality; and that a data protection regime must not permit collection that discriminates on grounds including genetic or health status.

Why it matters here. The case exists because of a technology. Nobody asked the Supreme Court an abstract question about privacy; a biometric identification programme was built, and the question could no longer be avoided. That is the pattern this whole paper describes, and here it is visible in the procedural history of a single case. The result matters twice over for what follows: it puts personal data inside article 21, and by naming genetic and health status it reaches the subject matter of Modules II and III as well as Module IV. The threefold requirement is worked out in [Informational Privacy and the Proportionality Test], and the right itself in [Privacy as a Fundamental Right].

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Science Under Article 21

The third limb: the body and the mind

Selvi v. State of Karnataka, AIR 2010 SC 1974, (2010) 7 SCC 263, decided on 5 May 2010.

Facts. A group of criminal appeals raised the legality of administering three scientific investigative techniques to a person who had not consented: narcoanalysis, in which a drug is used to reduce a subject's inhibition against speaking; polygraph examination, which measures physiological responses while a subject answers questions; and the Brain Electrical Activation Profile test, which measures electrical activity in the brain on exposure to stimuli associated with a crime. Accused persons, suspects and witnesses had been subjected to them without consent. The State defended the practice on the footing that the techniques help where evidence is hard to gather by ordinary means, cause no bodily harm, would be used only to guide the investigation rather than led in evidence, and are a gentler alternative to the third degree, meaning the physical ill treatment of suspects in custody.

Held. Compulsory administration of the techniques violates the right against self incrimination in article 20(3), whose protection extends to the investigative stage and covers accused persons, suspects and witnesses alike; the results are testimonial in character and are not material evidence. Forcing a person to undergo any of them also violates the substantive due process required before personal liberty is restrained, and does so whether the technique is administered in an investigation or for any other purpose, because the results can expose a person to adverse consequences that are not penal. Compulsory administration is an unjustified intrusion into the mental privacy of the individual, would amount to cruel, inhuman or degrading treatment in the language of evolving international human rights norms, and conflicts with the right to a fair trial. A compelling public interest cannot justify diluting those rights. No individual should be forcibly subjected to any of the techniques. Voluntary administration remains possible with safeguards, but even then the results by themselves are inadmissible, because the subject does not exercise conscious control over the responses.

Why it matters here. It is the clearest Indian case of a scientific technique meeting a constitutional right directly, and it settles two things this paper needs. Article 21 protects the mind as well as the body, so a technology that reads a person without touching them is still an intrusion. And the usefulness of a technique to the State is not an answer to the person's refusal, which is the proposition that every later argument about surveillance, genetic testing and compelled disclosure rests on. The forensic setting is taken further in [Forensic Science and the Rights of the Accused].

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Science Under Article 21

Why this is the hook for the rest of the paper

The technologyThe limb of article 21 it meetsWhere the book takes it
A treatment that exists but is withheldLife, and the State's duty to preserve itModule II, from [The Right to Health Under Article 21]
A procedure done to a patientBodily integrity and choiceModule II, from [Informed Consent: the Principle]
Research carried out on a personBodily and mental integrityModule III, from [The Nuremberg Code]
Data collected, stored or matchedPrivacy, including informational privacyModule IV, from [Privacy as a Fundamental Right]
A technique that reads a person's mind or body without consentMental privacy and fair trialModule I, [Forensic Science and the Rights of the Accused]

The table is worth learning, because a question on this paper about almost any technology can be opened by identifying which limb it touches. That is the practical value of putting article 21 in Module I rather than leaving it to the module where each application is discussed.

A worked example

A State government proposes to require every person receiving a food subsidy to submit to an iris scan at the ration shop, and to store the scans centrally so that duplicate claims can be detected.

Which limb is engaged? Privacy, on the authority of the nine judge decision above, because an iris pattern is personal data and its central storage is informational privacy. Bodily integrity is engaged more weakly, because the scan is taken from the person but nothing is done to them.

Is the scheme therefore unconstitutional? No, and a student who stops at "privacy is a fundamental right" has answered half the question. Article 21 permits deprivation according to procedure established by law, and the threefold requirement recorded in that case asks whether there is a law, whether the aim is legitimate, and whether the means are proportionate to it. Preventing the diversion of a subsidy is capable of being a legitimate aim.

Where the argument actually happens. On proportionality, and on the design of the scheme rather than on its purpose. Is central storage necessary, or would matching on a card achieve the same result? What happens to a person whose scan fails to read? Is there a remedy? Those are the questions [Informational Privacy and the Proportionality Test] works through.

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Science Under Article 21

What article 21 has done. It has converted a policy argument about administration into a constitutional argument with a burden on the State. That conversion is the whole function of the article in this paper.

Limits, and what article 21 does not do

It binds the State. Part III defines "the State" to include the Government and Parliament of India, the Government and Legislature of each State, and all local or other authorities within the territory of India or under the control of the Government of India. A private hospital, a private laboratory or a technology company is not, without more, bound by article 21. They are reached through statute, through the general law of wrongs, and through the State's own duty to make law that protects, which is why Module II is a module about Acts and not about the Constitution.

It permits deprivation. The article does not forbid interference with life or liberty. It requires a procedure established by law, and the case law above adds that the law must pursue a legitimate aim and be proportionate. An answer that treats article 21 as an absolute bar will be wrong on every realistic problem.

It is not a budget. A right that the State must not take away is easier to enforce than a claim that the State must provide. Article 21 works powerfully against action and less predictably against inaction, which is why the positive obligations in this subject are usually argued from the Covenant and from the directive principles alongside it. Those are taken up in [The Directive Principles on Health and Work].

What beginners get wrong

Saying article 21 was amended to include privacy or health. It was never amended. What changed was the reading of Part III as an integrated whole rather than as a set of watertight compartments.

Treating a Supreme Court decision as adding a new article. The decisions above did not create rights outside the text. They held what the words "life" and "personal liberty" already contain, which is why the reasoning matters more than the result.

Using article 21 against a private company. The Constitution restrains the State. The route to a private actor runs through legislation and through the general law, and confusing the two is the commonest structural error in answers on this paper.

Reading the nine judge decision as deciding the Aadhaar case. It decided the reference on whether privacy is a fundamental right. The validity of the scheme itself was a separate matter, decided later and by a different Bench.

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Science Under Article 21

Quick revision

  • Article 21: no person shall be deprived of his life or personal liberty except according to procedure established by law. Never amended. Protects every person.
  • The Constitution has no separate article on health, privacy or bodily integrity. All three sit inside article 21.
  • The mechanism: Part III is read as an integrated whole, not as separate compartments.
  • Life and health: article 21 casts the obligation on the State to preserve life, and every doctor has the professional obligation to protect it.
  • Privacy: protected as an intrinsic part of the right to life and personal liberty under article 21, held by nine judges in 2017, with a threefold requirement of law, legitimate aim and proportionality.
  • Body and mind: compulsory narcoanalysis, polygraph and brain profiling violate article 20(3) and intrude on mental privacy; a compelling public interest is no answer.
  • Limits: it binds the State, it permits lawful and proportionate deprivation, and it is stronger against action than against inaction.

Test yourself

1. Article 21 does not mention health, privacy or the body. How does it protect them? By interpretation, not amendment. The article protects life and personal liberty for every person, and Part III came to be read as an integrated whole rather than as a set of self-contained provisions, so the content of those two words is not fixed by any list. On that footing the Supreme Court held that article 21 casts an obligation on the State to preserve life, that privacy is intrinsic to the right to life and personal liberty, and that the article protects mental as well as physical integrity.

2. State the facts and holding of the nine judge privacy decision, and say why a science paper cares about it. A three judge Bench hearing the challenge to a biometric identification scheme referred the question upward after the Attorney General argued that no fundamental right of privacy existed, and a Constitution Bench placed it before nine judges. They held that the two early decisions denying constitutional protection to privacy stand overruled, and that the right to privacy is protected as an intrinsic part of the right to life and personal liberty under article 21 and as part of the freedoms in Part III. A science paper cares because the question was forced by a technology, and because the judgment brings personal data, including genetic and health data, inside the right to life.

3. Police wish to administer a lie detector test to a witness who refuses. Advise. The test may not be administered. Compulsory administration of a polygraph examination violates the right against self incrimination under article 20(3), whose protection extends to the investigative stage and covers witnesses as well as suspects and accused persons, and it violates the substantive due process required before personal liberty is restrained, because it is an unjustified intrusion into the mental privacy of the individual. That the results might be useful to the investigation is not an answer. If the witness later consents, the test may be conducted with safeguards, but the results by themselves would still be inadmissible, because the subject does not exercise conscious control over the responses.

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Science Under Article 21

4. Why is article 21 a weaker instrument against a private technology company than against a government department? Because Part III restrains the State, which is defined to include the Government and Parliament of India, the Government and Legislature of each State, and all local or other authorities in India or under the control of the Government of India. A private company is not within that definition, so a claim against it does not lie directly under article 21. It has to be brought under a statute, under the general law of wrongs, or by attacking the State's failure to make law that protects, which is why the regulation of medicine, data and technology in this book is statutory rather than constitutional.

Contents This chapter on its own page

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Chapter Seventeen

Education and the Diffusion of Knowledge

Syllabus topic 1, "Interrelationship of Science, Technology and Human Rights"

In one line

Knowledge that nobody is taught has not been diffused, so a right to share in scientific progress runs through the schoolroom before it reaches the laboratory.

In the wording a student can write in an exam: article 15(2) of the ICESCR requires that the steps taken by States Parties to achieve the full realisation of the right in article 15(1) shall include those necessary for the conservation, the development and the diffusion of science and culture, and the Committee treats scientific education as a principal instrument of diffusion. In India that duty meets article 21A of the Constitution, which makes free and compulsory education for children between six and fourteen a fundamental right, and the directive principles and fundamental duty that surround it.

Why the law has this at all

A person cannot enjoy the benefits of scientific progress if they cannot understand what is on offer, cannot evaluate a claim made to them, and cannot enter the activity that produces the knowledge. Every other part of the right depends on this one.

That dependence works in three directions, and a good answer names all three.

Education is how benefits reach people. A vaccine that a parent does not understand is refused. A soil test a farmer cannot read is not used. Diffusion that stops at publication has not reached anybody.

Education is how people enter science. The third dimension of accessibility, worked out in [Availability, Accessibility, Acceptability and Quality], is the open opportunity to participate in scientific progress. Nobody participates without being taught, so a barrier at school is a barrier to the right itself, years later and out of sight.

Education is how a population protects itself from misuse. A person who cannot distinguish a tested claim from an untested one is available to be deceived, which is the practical content of the fundamental duty to develop the scientific temper discussed in [Scientific Temper as a Fundamental Duty].

The provision itself

ICESCR article 15(2):

The steps to be taken by the States Parties to the present Covenant to achieve the full realization of this right shall include those necessary for the conservation, the development and the diffusion of science and culture.

Constitution of India, article 21A, inserted by the Constitution (Eighty-sixth Amendment) Act 2002:

The State shall provide free and compulsory education to all children of the age of six to fourteen years in such manner as the State may, by law, determine.

Three points of drafting matter here.

Article 15(2) is mandatory in form. The steps "shall include" those necessary for conservation, development and diffusion. Unlike article 15(4), which only asks States to recognise benefits, this limb tells them what their steps must contain.

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Education and the Diffusion of Knowledge

Article 21A is a fundamental right, not a directive principle. Before 2002 education appeared in Part IV, in article 45, as a direction to the State to endeavour to provide free and compulsory education for all children until the age of fourteen within ten years. The Eighty-sixth Amendment moved the entitlement for the six to fourteen group into Part III, where it is enforceable, and substituted a new article 45 directing the State to provide early childhood care and education for children below six.

The age band is narrow. Article 21A stops at fourteen. Scientific education in any serious sense begins around that age and continues well past it, so the fundamental right reaches the foundation of the diffusion duty and not its upper storeys, which remain in Part IV and in policy.

What the Committee asks for

General Comment 25 treats education as an element of availability. Availability requires instruments for the diffusion of science, and the Comment names libraries, museums and internet networks, a strong research infrastructure with adequate resources, and adequate financing of scientific education.

Under accessibility it requires States to remove discriminatory barriers that impede persons from participating in scientific progress, for instance by facilitating the access of marginalised populations to scientific education.

It is also specific about women. States must take steps to ensure women's substantive equality in access to scientific education and careers, for example by raising public awareness in order to eliminate stereotypes that exclude women from science, and by adopting policies allowing both men and women to balance domestic life with scientific careers. It states that temporary special measures, such as quotas for women in scientific education, might be necessary to speed up the attainment of substantive equality, and that the availability of kindergartens and other childcare institutions is key to the advancement of equality.

The Comment adds a proposition that is easy to pass over and useful in an answer: a gender-sensitive approach is not a luxury for scientific research but a crucial tool, because it ensures that scientific progress and new technologies adequately take account of the characteristics and needs of women and girls. It should be present from the choice of subject and the design of methodology onwards, and not relegated to the last stages.

The Indian frame around article 21A

Article 41 directs the State, within the limits of its economic capacity and development, to make effective provision for securing the right to work, to education and to public assistance in cases of unemployment, old age, sickness and disablement.

Article 45, as substituted in 2002, directs the State to endeavour to provide early childhood care and education for all children until they complete the age of six.

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Education and the Diffusion of Knowledge

Article 51A(k), the fundamental duty inserted by the same amendment, requires a parent or guardian to provide opportunities for education to his child or ward between the ages of six and fourteen. It is the mirror of article 21A: the State must provide, and the parent must not withhold.

Article 51A(h), the duty to develop the scientific temper, humanism and the spirit of inquiry and reform, supplies the content that distinguishes education in general from scientific education in particular.

Read together these make the Indian position on diffusion legible: an enforceable right for one age band, directive principles above and below it, and two fundamental duties that say what the education is for.

Worked example

A State government proposes to close the science stream in rural higher secondary schools where enrolment falls below a threshold, transferring those students to the arts stream locally or offering science at a residential school in the district town. The measure is defended as an efficient use of scarce laboratory equipment and qualified teachers.

Is article 21A engaged? Not directly. The students are above fourteen, so the fundamental right does not reach them, and this is the limit noted above.

Is the Covenant duty engaged? Yes. Article 15(2) requires steps necessary for the diffusion of science, and General Comment 25 names adequate financing of scientific education under availability and the removal of barriers to participation under accessibility. Withdrawing the subject from a rural area is a reduction in diffusion, and the Committee's general approach treats a deliberate backward step as requiring justification.

Who is affected, and does that matter? It does. The measure operates only on rural schools, and the residential alternative will in practice be taken up less by girls than by boys. The Comment's requirement of substantive equality in access to scientific education, and its acceptance that temporary special measures may be needed, are directly in point. Equality analysis of this kind is developed in [Equality and the Digital Divide].

What follows. The State is not obliged to run an under-enrolled laboratory in every village. It is obliged to show that it considered the effect on diffusion and on equality, and that the alternative genuinely preserves access rather than relocating it beyond reach. The distinction between a resource decision and an abdication is exactly what the four elements are for.

What it does NOT mean

Article 21A does not guarantee scientific education. It guarantees free and compulsory education for a defined age band and says nothing about content. The scientific character of that education comes from article 51A(h), from policy, and from the Covenant, not from article 21A itself.

Diffusion is not publication. Putting research findings on a public website satisfies part of availability. It does not by itself diffuse anything to a population that cannot read the language, reach the network or understand the material.

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The duty is not discharged by the school system alone. The Comment names libraries, museums and internet networks in the same breath as scientific education. Diffusion is a set of institutions, not a single one.

Free and compulsory does not mean free at the point of use only. The obligation runs to the conditions that make attendance possible, which is why the Comment's reference to childcare is not a digression.

Quick revision

  • ICESCR article 15(2): the steps taken shall include those necessary for the conservation, the development and the diffusion of science and culture. Mandatory in form, unlike article 15(4).
  • Article 21A: free and compulsory education for children of six to fourteen, inserted by the Eighty-sixth Amendment, 2002, which moved the entitlement from a directive principle into Part III.
  • The same amendment substituted article 45 (early childhood care and education below six) and inserted article 51A(k) (the parent's duty for six to fourteen). Article 41 covers the right to education within economic capacity; article 51A(h) supplies the scientific temper.
  • General Comment 25: adequate financing of scientific education under availability; removal of barriers and facilitating access of marginalised populations to scientific education under accessibility.
  • On women: awareness-raising against stereotypes, policies to balance domestic life with scientific careers, temporary special measures such as quotas may be necessary, childcare is key, and a gender-sensitive approach is not a luxury and belongs from the first stage of research.
  • Article 21A stops at fourteen, which is where serious scientific education begins.

Test yourself

1. State article 15(2) and explain how its language differs in force from article 15(4). Article 15(2) provides that the steps to be taken to achieve the full realisation of the right shall include those necessary for the conservation, the development and the diffusion of science and culture. It is mandatory in form: it prescribes what the State's steps must contain. Article 15(4) provides only that States Parties recognise the benefits to be derived from encouraging international contacts and co-operation, which on its own is close to a statement of policy and acquires its force from article 2(1) and the UN Charter.

2. What did the Eighty-sixth Amendment do, and why does it matter that education moved from Part IV to Part III? It inserted article 21A, guaranteeing free and compulsory education to children between six and fourteen; substituted article 45, directing the State to endeavour to provide early childhood care and education below six; and inserted article 51A(k), making it a fundamental duty of a parent or guardian to provide opportunities for education to a child between six and fourteen. The move matters because a directive principle under Part IV is not enforceable by a court, whereas a fundamental right under Part III is, so the entitlement changed from a direction to the State into a claim a child can assert.

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3. Why is article 21A an incomplete answer to the diffusion duty in article 15(2)? Because of its age band and its silence on content. It ends at fourteen, and scientific education in any developed sense begins around that age and continues into higher secondary and university study, none of which article 21A reaches. It also guarantees education without specifying its character, so nothing in the article requires that the education be scientific. The scientific content comes from article 51A(h), from policy and from the Covenant, and the stages above fourteen remain in Part IV and in executive policy rather than in Part III.

4. Set out what General Comment 25 requires of States in respect of women and scientific education. It requires steps to ensure women's substantive equality in access to scientific education and careers, giving as examples raising public awareness to eliminate stereotypes that exclude women from science, and policies enabling both men and women to balance domestic life with scientific careers. It states that temporary special measures such as quotas for women in scientific education might be necessary to speed up substantive equality, and that the availability of kindergartens and other childcare institutions is key. Separately it states that a gender-sensitive approach is not a luxury but a crucial tool, so that scientific progress takes account of the characteristics and needs of women and girls, and that it must be present from the choice of subject and the design of methodology onwards.

5. A State publishes all publicly funded research on a free website and argues that it has discharged the diffusion limb. Assess the argument. It has taken a step the Comment expressly asks for, since availability requires the promotion of open science and open source publication and public access to publicly funded findings and data. It has not discharged the limb. Diffusion under article 15(2) is a broader obligation, and the same paragraph names libraries, museums, internet networks, research infrastructure and adequate financing of scientific education as its instruments. Publication does not reach a person who cannot read the language of the paper, has no network access, or lacks the education to evaluate it, and the accessibility element separately requires removal of the barriers that prevent participation. Publication is one instrument of diffusion and the State has confused it with the whole duty.

Contents This chapter on its own page

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Chapter Eighteen

The Directive Principles on Health and Work

Syllabus topic 1, "Interrelationship of Science, Technology and Human Rights"

In one line

The Constitution does not only forbid the State from doing things. It also tells the State what to arrange, and three of those instructions are about the health of workers, the conditions they work in, and the public health of everybody else.

In the wording a student can write in an exam: articles 39(e), 42 and 47 of the Constitution of India are Directive Principles of State Policy contained in Part IV. Article 39(e) directs the State to secure that the health and strength of workers, men and women, and the tender age of children are not abused, and that citizens are not forced by economic necessity to enter avocations unsuited to their age or strength. Article 42 directs the State to make provision for securing just and humane conditions of work and for maternity relief. Article 47 requires the State to regard the raising of the level of nutrition and the standard of living of its people and the improvement of public health as among its primary duties.

What a directive principle is

Part IV of the Constitution is headed Directive Principles of State Policy. A directive principle is an instruction to the State about the ends its laws and policies should serve. It is not a right. Nobody can sue on it, and no court will strike a statute down because Parliament ignored one. Article 37 says exactly that, and then adds a second half which is the sentence that makes Part IV worth reading at all.

The provisions contained in this Part shall not be enforceable by any court, but the principles therein laid down are nevertheless fundamental in the governance of the country and it shall be the duty of the State to apply these principles in making laws.

Students remember the first half and forget the second. Unenforceable is one thing. Fundamental in the governance of the country, coupled with a duty of the State to apply these principles in making laws, is another. A directive principle cannot found a claim. It can explain what a statute was for, it can justify a law that restricts somebody's freedom to trade, and it is the constitutional answer to the question a technology case keeps producing: who was supposed to have done something about this?

Why this paper needs Part IV at all

Most of the harms this subject deals with are not inflicted by the State, and not on one identifiable person at one identifiable moment. A solvent used in a dyeing shed shortens the lives of the people who breathe it, over ten years, without any of them being able to say which day the injury happened. An automated line removes four hundred jobs across a district. Neither event looks like the classic violation in which an official does something to somebody.

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Part IV is built for that shape of problem. It is addressed to the State, it speaks of what the State must secure rather than what it must not do, and it does not need a named victim before it operates. That is why a science and technology paper reaches for it. The rights in Part III answer the question what may not be done. Part IV answers the question what must be arranged, and technological harm is nearly always a failure of arrangement.

The provisions themselves

Article 39 opens by directing the State to secure six things. The full clause list matters, because two of the six carry this chapter and a third carries the next one on automation.

The State shall, in particular, direct its policy towards securing:

(a) that the citizens, men and women equally, have the right to an adequate means of livelihood;

(b) that the ownership and control of the material resources of the community are so distributed as best to subserve the common good;

(c) that the operation of the economic system does not result in the concentration of wealth and means of production to the common detriment;

(d) that there is equal pay for equal work for both men and women;

(e) that the health and strength of workers, men and women, and the tender age of children are not abused and that citizens are not forced by economic necessity to enter avocations unsuited to their age or strength;

(f) that children are given opportunities and facilities to develop in a healthy manner and in conditions of freedom and dignity and that childhood and youth are protected against exploitation and against moral and material abandonment.

Article 42 is a single sentence.

The State shall make provision for securing just and humane conditions of work and for maternity relief.

Article 47 is two sentences joined into one, and the second half is the part everybody quotes.

The State shall regard the raising of the level of nutrition and the standard of living of its people and the improvement of public health as among its primary duties and, in particular, the State shall endeavour to bring about prohibition of the consumption except for medicinal purposes of intoxicating drinks and of drugs which are injurious to health.

Clause (f) of article 39 is in its present form because of the Constitution (Forty-second Amendment) Act 1976, which took effect on 3 January 1977. Articles 42 and 47 carry no amendment footnote in the official text at all, so both stand exactly as they were adopted.

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Broken down

Article 39(e), first limb: health and strength. The State must secure that the health and strength of workers are not abused. Two words are doing work. "Abused" is wider than injured: it covers wearing a person out by the conditions of the work, not only hurting them by an accident. And the clause protects strength as well as health, which is capacity to go on working, not merely the absence of disease. A process that leaves a worker able to do the job at thirty and unable at forty has abused their strength even if no doctor ever diagnoses anything.

Article 39(e), second limb: coerced choice. The State must secure that citizens are not forced by economic necessity to enter avocations unsuited to their age or strength. An avocation is an occupation or calling. The wrong this limb names is not that dangerous work exists. It is that poverty leaves a person no other option, so their consent to the danger is worth nothing. That is the exact shape of the argument about a technology which removes the safe jobs from a labour market and leaves only the unsafe ones.

Article 39(a): livelihood. Citizens, men and women equally, are to have the right to an adequate means of livelihood. This is the clause on which the whole automation argument rests, and it is worked out in [Work, Automation and Livelihood]. Note that it speaks of an adequate means of livelihood and not of a particular job, which is both its strength and its weakness: it survives the disappearance of an industry, and it promises nothing to the individual whose trade has gone.

Article 42: just and humane conditions of work. Two provisions in one line. "Just" is about the fairness of the terms, "humane" is about what the work does to the body and the mind of the person doing it, and maternity relief is a separate and specific instruction. Article 42 also uses a stronger verb than most of Part IV. It says the State shall make provision, where article 41 promises the right to work only "within the limits of its economic capacity and development" and article 47 falls back on "shall endeavour" for its prohibition limb.

Article 47: public health as a primary duty. Three objects are named: raising the level of nutrition, raising the standard of living, and improving public health. The article then calls these "among its primary duties", which is the strongest description Part IV gives to anything. The particular limb that follows requires the State to endeavour to prohibit the consumption of intoxicating drinks and of drugs which are injurious to health, except for medicinal purposes. That exception is a science and medicine carve-out written into the Constitution itself, and the statutory regime that draws the line between a medicine and a poison is taken in [Drugs, Standards and Control].

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The three routes from these articles into this paper

Occupational health. A new process brings a new exposure, and the people exposed are the people who need the wage. Articles 39(e) and 42 are the constitutional statement that arranging against this is the State's job. The international mirror is article 7(b) of the Covenant on Economic, Social and Cultural Rights, which recognises the right of everyone to "safe and healthy working conditions".

Public health. Technologies change what people eat, drink, breathe and are treated with, usually faster than the regulator moves. Article 47 is the general duty; article 12(2)(b) of the same Covenant requires States to take steps towards "the improvement of all aspects of environmental and industrial hygiene", and [The Right to Health in the Covenant] takes that article properly.

Livelihood. Article 39(a) and the second limb of 39(e) between them cover the case where a technology does not injure anybody but takes away the work. The Committee on Economic, Social and Cultural Rights has said what it thinks that requires, in paragraph 76 of General Comment No. 25 of 2020.

States parties should adopt policies to ensure that those vulnerable to temporary and long-term job loss as a result of scientific and technological advances are provided with and encouraged to pursue vocational training and other job placement opportunities.

That sentence is worth learning, because it is the only place in the material this paper works from where automation and the loss of a livelihood are named as a human rights obligation rather than as an economic misfortune.

A worked example

Anjali works in a small garment unit in Bhiwandi. The owner installs an automated cutting machine which does the work of six people and uses a bonding agent that gives off fumes in a room with two windows. Four of the six cutters are let go. Anjali keeps her job, and within a year she has a cough that does not clear.

Which articles of Part IV are engaged? For the fumes, article 39(e), because her health and strength are being abused by the conditions of the work, and article 42, because the conditions are neither just nor humane. For the four who lost their jobs, article 39(a), because their means of livelihood has gone. For the district as a whole, article 47, if the same agent is in use in thirty other sheds.

What does Part IV give Anjali? Not a case. She cannot file a petition asking the court to enforce article 42 against the State, and article 37 is the reason. The book takes the enforceable route separately: the right to life is in [Science Under Article 21], and the ways a person actually recovers something are in [Remedies When Technology Causes Harm].

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Then what is Part IV for, here? Two things, and both are examinable. First, it is the answer to who was supposed to act: not the machine, not the market, but the State, and its failure to have regulated the agent is a constitutional failure even though it is not an actionable one. Second, suppose the State does act, and the owner challenges the new rule as an unreasonable restriction on his freedom to carry on his business. Articles 39(e), 42 and 47 are the State's answer for why the restriction is a reasonable one. That is the work directive principles do most often and most usefully.

Distinctions

Part III, fundamental rightsPart IV, directive principlesPart IVA, fundamental duties
Addressed toThe State, in favour of the personThe StateEvery citizen
Enforceable in a courtYesNo, by article 37No
Typical form of wordsThe State shall notThe State shall secure, provide or endeavourIt shall be the duty of every citizen
What it does in an answerIt is the claimIt shows who had to act, and why a restricting law is reasonableIt puts the same aim on the individual
Where in this book[Science Under Article 21]This chapter and [The Environment in the Constitution][Scientific Temper as a Fundamental Duty]

What beginners get wrong

Treating unenforceable as unimportant. Article 37 makes Part IV unenforceable and in the same breath calls it fundamental in the governance of the country and a duty in making laws. An answer that quotes only the first half has quoted half a sentence.

Calling article 47 the prohibition article. Prohibition of intoxicating drinks and of injurious drugs is a particular application tacked on at the end. The general duty is nutrition, standard of living and public health, and article 47 is the only article in Part IV to describe what it demands as a primary duty.

Calling article 39(e) the child labour clause. It protects the health and strength of workers of both sexes first, and the tender age of children second. Its subject is abuse of health and strength, and its second limb is about economic coercion, not about the employment of children as such.

Reading article 42 as maternity leave. Maternity relief is the second of the two provisions in it. The first, just and humane conditions of work, is the wider one and is the one a technology answer needs.

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Limits and criticism

There is no remedy, and seventy years of breach produce nothing. A directive principle that has never been implemented leaves the person it was meant to help exactly where they were. That is the standing objection to Part IV and it should be stated in an answer rather than avoided.

The text is of 1950 and names the hazards of 1950. Neither automation nor data appears anywhere in Part IV. Article 39(a) reaches the loss of a livelihood only at one remove, by promising an adequate means rather than a job, and nothing in the Part speaks to a person displaced by a machine that works better than they do.

The verbs are inconsistent and nothing turns on it. Article 42 says the State shall make provision, article 41 confines the right to work to the limits of the State's economic capacity, and article 47 drops to shall endeavour for its prohibition limb. In an enforceable Part those differences would be litigated; here they are not, because none of them is enforceable.

The international framework has moved further than the Indian text. General Comment 25 names job loss caused by scientific and technological advance and attaches an obligation to it. An answer on this topic is stronger for running the constitutional and the international material together, rather than treating them as two separate questions.

Quick revision

  • Article 37: Part IV is not enforceable by any court, but is fundamental in the governance of the country and a duty of the State in making laws.
  • Article 39(e): health and strength of workers, and the tender age of children, not to be abused; citizens not to be forced by economic necessity into avocations unsuited to their age or strength.
  • Article 39(a): an adequate means of livelihood for citizens, men and women equally. The automation clause.
  • Article 42: just and humane conditions of work, and maternity relief.
  • Article 47: raising nutrition, the standard of living and public health, described as among the State's primary duties; prohibition of intoxicating drinks and injurious drugs except for medicinal purposes.
  • International mirrors: article 7(b) of the Covenant (safe and healthy working conditions) and article 12(2)(b) (environmental and industrial hygiene). General Comment 25, paragraph 76, on job loss from technological advance.
  • Part IV's practical use: it identifies who had to act, and it justifies a law that restricts a business.

Test yourself

1. Set out article 37 and explain why a directive principle is still worth citing. Article 37 provides that the provisions of Part IV shall not be enforceable by any court, but that the principles laid down in it are nevertheless fundamental in the governance of the country, and that it shall be the duty of the State to apply them in making laws. It is worth citing for three reasons: it identifies the State as the body that was required to act, it explains the purpose of a statute passed to give effect to it, and it supplies the justification when a law made in pursuance of it is attacked as an unreasonable restriction on somebody's freedom to trade.

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2. A chemical used in a new manufacturing process is found to damage the lungs of the workers who handle it. Which parts of article 39 and article 42 are engaged, and what do they give the workers? Article 39(e) is engaged in both its limbs: the health and strength of the workers are being abused, and if the local labour market offers nothing else, they have been forced by economic necessity into an avocation unsuited to their strength. Article 42 is engaged because the conditions of work are neither just nor humane. What the articles give the workers is not a cause of action, because article 37 excludes one. They give the constitutional statement that regulating the chemical was the State's duty, and they answer the employer who says the resulting regulation is an unreasonable interference with his business.

3. Why is article 47 unusual within Part IV? Because of the phrase "among its primary duties". Part IV elsewhere tells the State to secure, to provide, or to endeavour, and article 41 expressly limits its promise to the State's economic capacity. Article 47 alone characterises what it demands, namely the raising of nutrition and of the standard of living and the improvement of public health, as a primary duty of the State. It also contains an express medical exception, permitting the consumption of otherwise injurious drugs for medicinal purposes.

4. A factory replaces two hundred workers with machines. No one is injured. Is any part of Part IV engaged? Yes. Article 39(a) directs the State to secure that citizens have the right to an adequate means of livelihood, and the second limb of article 39(e) protects citizens from being forced by economic necessity into work unsuited to their age or strength, which is what an unemployed skilled worker is commonly pushed towards. Nothing in Part IV entitles anybody to keep a particular job. The international material goes one step further: paragraph 76 of General Comment 25 requires States to ensure that those vulnerable to job loss caused by scientific and technological advance are provided with vocational training and job placement opportunities.

5. Distinguish a directive principle from a fundamental duty. A directive principle is in Part IV, is addressed to the State, and instructs it about the ends its laws should serve. A fundamental duty is in Part IVA, is addressed to every citizen, and instructs the individual. Neither is enforceable by a court. They frequently state the two sides of one aim: the State is told to protect and improve the environment and the citizen is told to do the same, which is the pairing examined in [The Environment in the Constitution].

Contents This chapter on its own page

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Chapter Nineteen

The Environment in the Constitution

Syllabus topic 1, "Interrelationship of Science, Technology and Human Rights"

In one line

The Constitution tells the State to protect and improve the environment, and in the same amendment it told every citizen to do the same thing.

In the wording a student can write in an exam: article 48A of the Constitution of India provides that the State shall endeavour to protect and improve the environment and to safeguard the forests and wild life of the country. It is a Directive Principle of State Policy, so it is not enforceable by a court, and it was inserted by the Constitution (Forty-second Amendment) Act 1976 with effect from 3 January 1977. The same amendment inserted article 51A(g), which makes it the duty of every citizen of India to protect and improve the natural environment including forests, lakes, rivers and wild life, and to have compassion for living creatures.

Why the Constitution acquired an environmental article at all

The Constitution that came into force in 1950 said nothing about the environment. It is not an oversight so much as a date. The document was written for a country about to industrialise, and the directive that sits immediately before article 48A shows what the founders thought technology was for: article 48 tells the State to "endeavour to organise agriculture and animal husbandry on modern and scientific lines". Science appears in the original Part IV as a means of production, not as a source of risk.

By 1976 that had stopped being tenable, and the Forty-second Amendment added the missing half. What it added is worth stating precisely, because it is the shape of every environmental question in this paper. Environmental harm from technology is diffuse, so no one person can say the injury is theirs. It is cumulative, so no single act caused it. It is usually lawful, because the plant had its licences. And a large part of it falls on people who are not born yet. Ordinary rights language, which needs a victim, an actor and a moment, fails on all four counts.

The provisions themselves

Article 48A sits in Part IV, immediately after the directive on agriculture.

The State shall endeavour to protect and improve the environment and to safeguard the forests and wild life of the country.

Article 51A(g) is one of the fundamental duties in Part IVA.

to protect and improve the natural environment including forests, lakes, rivers and wild life, and to have compassion for living creatures;

Both were inserted by the same statute. The official print carries the footnote "Ins. by the Constitution (Forty-second Amendment) Act, 1976" against article 48A, at section 10 of that Act, and against the whole of Part IVA, at section 11, in each case with effect from 3 January 1977. The two provisions were therefore designed as a pair, and an answer that treats them as unrelated has missed the point of both.

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Broken down

"Shall endeavour." This is the weakest verb Part IV uses. Article 42 says the State shall make provision; article 47 calls its objects primary duties; article 48A only requires an attempt. Nothing turns on the difference in a court, because article 37 makes none of Part IV enforceable, but it matters in an answer: article 48A is a statement of direction, not of standard, and it fixes no level of environmental quality that the State must reach.

"Protect and improve." Two duties, not one. Protection is conservative: keep what is there from getting worse. Improvement is restorative: make it better than it is now. The second is the more demanding, and it is the one usually forgotten. A State that merely stopped further damage would have satisfied half of article 48A.

"The environment." The article does not define the word, and no other article of the Constitution defines it either. That is a real gap, and it is also why the provision has stayed useful: an undefined term of 1976 can absorb harms that nobody had heard of in 1976, which a defined term listing smoke, effluent and noise could not have done.

"The forests and wild life of the country." Two things are named specially, and only two. Neither pollution, nor water, nor air, nor soil, nor hazardous waste, nor any technology appears anywhere in the text of article 48A. Everything this paper is about therefore reaches article 48A through the general words, not through the specific ones.

Article 51A(g) is wider in its list and narrower in its subject. It speaks of the natural environment, and it names lakes and rivers, which article 48A does not. It then adds a duty that has no counterpart in Part IV at all: to have compassion for living creatures. But its subject is the individual citizen, and a duty on a citizen carries no sanction. What a fundamental duty is, and why India has them, is taken in [Scientific Temper as a Fundamental Duty].

What article 48A does not do

It confers no right on anybody. It is addressed to the State, and a person who wants a court to act cannot ask it to enforce article 48A, for the reason given in [The Directive Principles on Health and Work]. If there is an enforceable claim in an Indian environmental case, its textual home is elsewhere, and this book takes that route in [Science Under Article 21].

It does not bind the polluter. A factory is not the State, and article 48A says nothing to it. The route from a constitutional direction to a private defendant runs through legislation, which is why the answer to "what does article 48A do about a chemical plant?" is "it obliges the State to have passed and enforced a law about chemical plants". [The State's Duty to Regulate Technology] takes that step, and [Environment and Technological Harm] takes the industrial disaster that made the question urgent in India.

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It fixes no standard and provides no remedy. It tells nobody how clean the air must be, and it gives nobody anything when the air is dirty.

The international material that says the same thing

Three instruments in this paper's authority base carry the same idea, and each is stronger than article 48A in one respect.

The Covenant on Economic, Social and Cultural Rights, in article 12(2)(b), requires States to take steps towards "the improvement of all aspects of environmental and industrial hygiene" as part of the right to health. That is a treaty obligation rather than an unenforceable direction, and it is examined in [The Right to Health in the Covenant].

The Universal Declaration on Bioethics and Human Rights of 2005 devotes its article 17 to the protection of the environment, the biosphere and biodiversity, requiring due regard to "the interconnection between human beings and other forms of life" and to the role of human beings in protecting them. It is taken in [The Bioethics Declaration: Society and the Future].

General Comment No. 25 of 2020 supplies the standard article 48A lacks. In paragraph 56 the Committee describes the harm that must be guarded against in advance of full scientific certainty as harm to humans or to the environment that is "threatening to human life or health", "serious and effectively irreversible", "inequitable to present or future generations", or "imposed without adequate consideration of the human rights of those affected". Those four descriptions are the nearest thing this subject has to a definition of unacceptable environmental risk, and they belong to [The Precautionary Principle].

A worked example

An electroplating unit at Taloja discharges rinse water into a creek. The discharge is within the limits of the consent the unit holds. Over eleven years the creek silts up, the fish die, and the families in Sonavane village who fished it move to daily wage work. A resident, Suresh, wants to know what the Constitution gives him.

Can he sue on article 48A? No. It is in Part IV, it is addressed to the State, and article 37 forecloses enforcement. If his petition says nothing else, it fails.

Does article 51A(g) help him against the unit? No. It is a duty on citizens and it carries no sanction, and in any event the unit is a company rather than a citizen exercising a duty. Article 51A(g) is a reason, not a remedy.

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Where does article 48A actually bite? In three places. It tells him whom to complain about, namely the State that set the consent limits. It tells a court what the pollution statute was for, so that a doubtful provision in that statute is read in the way that protects the creek rather than the way that does not. And if the State tightens the consent limits and the unit challenges the tightening as ruinous, article 48A is the State's constitutional justification for having done it.

What must Suresh add to make a case? The right to life, and the statutory scheme, and a claim for compensation. All three are elsewhere in this book, and the point of this chapter is that article 48A never travels alone.

Distinctions

Article 48AArticle 51A(g)
Part of the ConstitutionPart IV, directive principlesPart IVA, fundamental duties
Addressed toThe StateEvery citizen of India
What it requiresTo endeavour to protect and improve the environment and safeguard forests and wild lifeTo protect and improve the natural environment including forests, lakes, rivers and wild life, and to have compassion for living creatures
EnforceableNo, by article 37No
Inserted byThe Constitution (Forty-second Amendment) Act 1976, section 10The same Act, section 11
Use in an answerWho had to act, and why a restricting law is reasonableThat the Constitution places the burden on the individual as well as the State

What beginners get wrong

Saying article 48A gives a right to a clean environment. It gives a direction to the State. Any right in this area has to be found in Part III, and locating it correctly is half of a good answer.

Swapping the two provisions. Article 48A binds the State and article 51A(g) binds the citizen. The mistake is easy because both use the words "protect and improve", and it is expensive because the whole point of quoting them together is that they are addressed to different people.

Thinking "shall endeavour" makes the article decorative. It weakens the language and it does not remove the direction. Part IV is unenforceable whatever verb it uses, so the softness of the verb changes far less than students assume.

Treating 1976 as the moment India acquired environmental law. The amendment put the subject into the Constitution. It did not create the statutory or common law machinery, and it did not by itself make anything actionable.

Limits and criticism

A direction without a standard. The article says protect and improve and stops. It does not say from what, to what level, or by when, and a duty with no measurable content cannot be failed in any way a court could recognise even if Part IV were enforceable.

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The named subjects are the wrong ones for this paper. Forests and wild life are named; industrial effluent, hazardous waste, emissions, radiation, chemicals and every technology that produces them are not. A student answering a technology question from article 48A is arguing from the general words of a provision whose specific words are about something else.

Nothing about future generations. The most distinctive feature of technological environmental harm is that it lands on people who cannot be consulted because they do not yet exist. Article 48A does not mention them. General Comment 25 does, in the phrase "inequitable to present or future generations", and the international instruments in Module III go further still.

Nothing about the causer. The article obliges the State and says nothing to the person who did the damage. That is a design feature of Part IV rather than a defect in article 48A, but it means the constitutional provision on the environment is silent about polluters, which surprises every student who reads it for the first time.

Quick revision

  • Article 48A: the State shall endeavour to protect and improve the environment and to safeguard the forests and wild life of the country. Part IV, unenforceable by article 37.
  • Article 51A(g): the duty of every citizen to protect and improve the natural environment including forests, lakes, rivers and wild life, and to have compassion for living creatures. Part IVA, also unenforceable.
  • Both inserted by the Constitution (Forty-second Amendment) Act 1976, sections 10 and 11, with effect from 3 January 1977. The original Constitution of 1950 said nothing about the environment.
  • Article 48A names only forests and wild life. Pollution, waste, water, air and technology appear nowhere in it.
  • Two duties in the words "protect and improve": one conservative, one restorative.
  • International mirrors: Covenant article 12(2)(b), environmental and industrial hygiene; Bioethics Declaration 2005 article 17; General Comment 25 paragraph 56 on serious, effectively irreversible harm inequitable to present or future generations.
  • Article 48A never travels alone. It identifies the duty bearer, colours the reading of a statute, and justifies a restriction.

Test yourself

1. State article 48A, say where it sits in the Constitution, and say how it got there. Article 48A provides that the State shall endeavour to protect and improve the environment and to safeguard the forests and wild life of the country. It is in Part IV, the Directive Principles of State Policy, so by article 37 it is not enforceable by any court although it is fundamental in the governance of the country. It was inserted by section 10 of the Constitution (Forty-second Amendment) Act 1976 and took effect on 3 January 1977; section 11 of the same Act inserted Part IVA, which contains the citizen's parallel duty in article 51A(g).

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2. A village downstream of a tannery petitions a court relying only on article 48A. What happens, and what should the petition have said? It fails, because article 48A is in Part IV and article 37 provides that Part IV is not enforceable by any court. The petition should have relied on a fundamental right in Part III, on the statutory pollution regime, and on a claim for compensation, using article 48A to show that the State was constitutionally directed to regulate, to argue for the reading of the statute that protects the watercourse, and to answer any complaint that the regulation is too strict.

3. Compare article 48A with article 51A(g). Why does it matter that they were inserted together? Article 48A directs the State; article 51A(g) imposes a duty on every citizen. Article 51A(g) is the wider list, adding lakes and rivers and a duty of compassion towards living creatures; article 48A is the one addressed to the body that can actually legislate. They were inserted by the same amendment, sections 10 and 11 of the Forty-second Amendment Act 1976, which shows that the framers of the amendment treated environmental protection as a shared burden rather than as a purely governmental one. Neither is enforceable.

4. What does article 48A fail to say that a technology question needs? It fails to define the environment, to name any source of harm, to fix any standard of quality, to say anything to the person or company that caused the damage, to provide a remedy, and to mention future generations. Every one of those gaps has to be filled from somewhere else: from a fundamental right, from a statute, or from the international material, where paragraph 56 of General Comment 25 supplies the account of harm that is serious, effectively irreversible or inequitable to present or future generations.

5. Why is it significant that article 48 speaks of organising agriculture on modern and scientific lines? Because it shows how the original Constitution understood science. In the text of 1950 science and technology appear in Part IV as instruments of development, something the State should apply more of. The idea that scientific and technological activity is itself a source of risk that the State must guard against enters the Constitution only in 1976, with article 48A and the fundamental duties. That change of posture, from science as a means to science as a hazard as well, is the whole of this paper in one amendment.

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Chapter Twenty

The Scientist: Rights and Responsibilities

Syllabus topic 1, "Interrelationship of Science, Technology and Human Rights"

In one line

The person who does the science has rights that the law protects, and duties that the law is only beginning to state.

In the wording a student can write in an exam: the scientific researcher occupies a double position under the human rights framework. As a rights holder the researcher enjoys the freedom indispensable for scientific research under article 15(3) of the ICESCR, together with the protection of the moral and material interests resulting from their production under article 15(1)(c), and the ordinary freedoms of expression, association and movement on which research depends. As a duty bearer the researcher is bound by the ethical constraints that attach to research on human beings, and participates in the State's obligation to ensure that scientific progress is not used to the detriment of human rights.

Why the law has this at all

Most of this paper is about what science does to people who are not scientists. This chapter is about the person in the laboratory, and it exists for two reasons that pull against each other.

The first is that research is fragile. It is easily suppressed, and the mechanisms are rarely dramatic. A refused visa, a withdrawn grant, an institutional ethics committee used as a censor, a law that makes a line of inquiry an offence, an employment contract that assigns the conclusions along with the copyright. A right to enjoy the benefits of scientific progress presupposes that somebody is free to produce them, which is why article 15(3) exists at all.

The second is that research is powerful, and the twentieth century supplied the evidence. The Nuremberg Code of 1947 was written because physicians who were among the best trained in the world conducted experiments on prisoners. The Declaration of Helsinki has been revised repeatedly because the problems did not stop in 1947. A framework that gave researchers freedom without duties would be a framework that had learnt nothing.

The chapter therefore has to hold both, and the order matters: the freedom is stated first because the duties are limits upon it, and a limit is unintelligible without the thing it limits.

The rights of the scientist

Freedom indispensable for scientific research

Article 15(3) provides that States Parties "undertake to respect the freedom indispensable for scientific research and creative activity". General Comment 25 states that in order to flourish and develop, science requires the robust protection of freedom of research, and gives the freedom at least five dimensions:

  1. Protection from undue influence on independent judgment. The researcher's conclusions must be the researcher's own.
  2. The possibility of setting up autonomous research institutions, and of defining the aims, objectives and methods of the research.
  3. The freedom to question the ethical value of a project openly, and the right to withdraw from a project if conscience so dictates.
  4. The freedom to co-operate with other researchers, nationally and internationally.
  5. The sharing of scientific data and analysis with policymakers, and with the public wherever possible.
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The third of these is the one that connects this chapter to the next section. The Comment protects the researcher who objects, which is a right that only makes sense on the assumption that a researcher has ethical duties in the first place.

Paragraph 20 adds that the protection of this freedom is itself an element of the right to participate in and enjoy the benefits of scientific progress, and not merely a separate guarantee sitting beside it. The full treatment is in [Freedom Indispensable for Scientific Research].

The moral and material interests of the author

Article 15(1)(c) recognises the right of everyone to benefit from the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author. It is the third limb of article 15(1) and the one most often confused with intellectual property.

The confusion is worth clearing up because it is a standard examination trap. The Covenant right is a human right of the author, a natural person, and it protects an interest connected to human dignity. A patent or a copyright is a legal entitlement, of limited duration, freely transferable, and commonly held by a company that is not the author at all. The two overlap and are not the same thing, and the point returns in [Access to Medicines and Patents].

The ordinary freedoms

Freedom of research is not self-executing. It operates through expression, association, movement and access to information, and it is usually attacked through those rather than directly. The Committee's insistence on facilitating researchers' travel in and out of the territory, discussed in [International Co-operation in Science], is an example of exactly this: the freedom is defeated at the visa counter rather than in the statute book.

The responsibilities of the scientist

The framework states these less systematically than it states the rights, and an honest answer says so. Three sources carry them.

The limitation clause. General Comment 25 at paragraph 22 accepts that limitations on the research process can be necessary, particularly where research affects human beings, in order to protect their dignity, integrity and consent. It adds a duty that is easy to miss and directly relevant to research conducted across borders: where the research is done in countries or among populations different from those of the researchers, the State of origin must guarantee the rights and obligations of all parties involved. That is aimed at the practice of conducting trials where regulation is weakest.

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The research ethics instruments. The Nuremberg Code 1947 and the Declaration of Helsinki state the duties owed to a research participant. Both are taken in Module III, where the ethics of scientific development is the syllabus topic. Neither is a treaty; both are the professional statement of what a researcher owes, and both are treated by the Comment as feeding the acceptability element of the right.

The acceptability element. Acceptability requires that scientific research incorporate ethical standards in order to ensure its integrity and the respect of human dignity, and General Comment 25 points to the standards proposed in the Universal Declaration on Bioethics and Human Rights 2005: maximising benefits and minimising harm with reasonable safeguards, guaranteeing autonomy and free and informed consent, respecting privacy and confidentiality, protecting vulnerable groups against discrimination, and giving due regard to cultural diversity and pluralism.

Taken together the responsibilities are: to obtain consent, to protect the participant, to be honest about method and result, to consider the foreseeable uses of the work, and to speak when a project is wrong.

UNESCO's Recommendation, named and placed

The instrument that states the scientist's position most fully is the Recommendation on Science and Scientific Researchers, adopted by UNESCO in 2017, revising an earlier Recommendation of 1974. General Comment 25 names it in its opening paragraph among the important documents on the relationship between science and economic, social and cultural rights, and cites it repeatedly: for the dimensions of freedom of research, for the definition of technology as knowledge relating directly to the production or improvement of goods or services, and in the sections on obligations and on international co-operation.

Two things follow, and the second is a caution.

What it is. A recommendation of the UNESCO General Conference. It is not a treaty and creates no binding obligation, but it is the most detailed international statement of the status, freedoms and responsibilities of the scientific researcher, and the Committee treats it as an authoritative reference in construing article 15.

What this book can say about it. The Recommendation is not among the texts held in this subject's authority base. Everything stated about it here is what General Comment 25 records, and no paragraph of the Recommendation is quoted or numbered from any other source. A candidate should do the same: name it, place it, say what the Committee draws from it, and resist the temptation to attribute to it provisions recalled from elsewhere.

Worked example

A pharmaceutical company funds a university team to trial a new drug. The contract provides that the company owns the data, that publication requires the company's written consent, and that the lead researcher will not comment publicly on the trial for three years after its conclusion. Midway through, the researcher forms the view that an adverse event pattern is emerging and that the trial should be stopped.

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Which of the researcher's rights are engaged? Independent judgment, first: a contract that makes publication conditional on the funder's consent is undue influence on the researcher's independent judgment in the sense of paragraph 13. The freedom to question the ethical value of the project and to withdraw is engaged directly by the researcher's own conclusion. The sharing of data and analysis with policymakers and, where possible, the public is engaged by the publication clause.

Which of the researcher's duties are engaged? The duty to the participants, who are being exposed to a risk the researcher now believes is materialising, and whose consent was given on a different footing. Consent that is not updated when the risk changes is not consent to the risk now being run.

Who else bears a duty? The State. The right in article 15(3) is a right against the State, and the Comment's account of obligations includes the duty to protect against the acts of private parties. A legal system in which such a clause is enforceable, and in which the researcher who speaks is liable in damages, is a system that has failed the duty to protect. The remedy is not to instruct the researcher to be brave; it is regulation of the terms on which publicly employed researchers may contract with funders.

Where does the analysis end up? The researcher's freedom and the participants' safety point the same way, which is the usual case. They are opposed less often than the drafting of this topic suggests, and an answer that assumes a standing conflict between the scientist's freedom and everyone else's rights has misread the framework.

Distinctions

Article 15(3) freedom of researchArticle 15(1)(c) moral and material interests
ProtectsThe activity of inquiryThe author's connection with what they produced
Held byResearchers, and institutions in respect of autonomyThe author, a natural person
AgainstThe State, and the State's failure to protect against private interferenceThe same
Confused withAcademic tenure and employment securityPatent and copyright
The differenceEmployment protection is a means to it, not the right itselfIntellectual property is transferable, time limited and often corporate; the Covenant right is neither

What it does NOT mean

Freedom of research is not absolute. General Comment 25 says so in terms at the end of paragraph 13, and paragraph 22 identifies where the limits fall.

It is not an entitlement to funding. The freedom to define aims, objectives and methods is a freedom from direction, not a claim on the public purse for a particular project.

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It is not a defence to harm. A researcher may not conduct an unethical experiment and plead article 15(3). The freedom is a freedom of inquiry, and the limits on the research process protecting dignity, integrity and consent are the very thing the Comment permits.

And the responsibilities are not merely professional. They appear in the acceptability element of a Covenant right, which means a State that permits research without them is in breach of the Covenant, not merely of good practice.

Quick revision

  • The scientist is both rights holder and duty bearer, and the freedom is stated first because the duties are limits on it.
  • Article 15(3): States undertake to respect the freedom indispensable for scientific research. General Comment 25, paragraph 13 gives five dimensions: independent judgment; autonomous institutions and the definition of aims and methods; freedom to question a project's ethics and to withdraw; freedom to co-operate nationally and internationally; sharing of data and analysis. Paragraph 20: the freedom is itself an element of the right.
  • Article 15(1)(c): the moral and material interests of the author. Not the same as intellectual property: the Covenant right is a human right of a natural person, IP is transferable, time limited and often corporate.
  • Responsibilities come from three places: paragraph 22 (limits on the research process to protect dignity, integrity and consent; the State of origin's duty where research is done among other populations), the ethics instruments (Nuremberg 1947, Helsinki), and the acceptability element, which points to the Universal Declaration on Bioethics and Human Rights 2005.
  • UNESCO Recommendation on Science and Scientific Researchers 2017: not a treaty, the fullest statement of the researcher's status, named and relied on throughout General Comment 25. Not in this book's base; do not quote paragraph numbers for it.

Test yourself

1. Give the five dimensions of freedom of research in General Comment 25 and say which of them presupposes that the researcher has duties. Protection of researchers from undue influence on their independent judgment; the possibility of setting up autonomous research institutions and of defining the aims, objectives and methods of research; the freedom to question openly the ethical value of certain projects and the right to withdraw if conscience so dictates; the freedom to co-operate with other researchers nationally and internationally; and the sharing of scientific data and analysis with policymakers and, wherever possible, the public. The third presupposes duties, since a right to object on ethical grounds and to withdraw is only intelligible if the researcher is understood to owe ethical obligations in respect of the work.

2. Distinguish article 15(1)(c) from a patent. Article 15(1)(c) recognises the right of everyone to benefit from the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author. It is a human right, held by a natural person, connected to human dignity and to the author's relationship with the work, and it is not transferable in the way property is. A patent is a legal entitlement created by statute, of limited duration, freely assignable, and frequently owned by a corporation that is not the author. The two overlap where an author holds intellectual property in their own production, but the Covenant right neither requires a particular intellectual property regime nor is satisfied merely because one exists.

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3. What does paragraph 22 of General Comment 25 require of the State of origin when research is conducted abroad, and what practice is it aimed at? It requires that, where research is done in countries or among populations different from those of the researchers, the State of origin must guarantee the rights and obligations of all parties involved. It is aimed at the practice of conducting research, particularly clinical trials, in jurisdictions where regulation, oversight and the practical ability of participants to obtain a remedy are weakest, so that the protections that would apply at home do not apply to the people actually exposed to the risk.

4. A university contract requires the funder's written consent before any publication. Assess it under article 15(3). It engages the first and fifth dimensions of the freedom in paragraph 13: protection from undue influence on independent judgment, and the sharing of scientific data and analysis with policymakers and with the public wherever possible. A power in the funder to withhold consent to publication places the researcher's conclusions under the control of a party with an interest in them. Because article 15(3) binds the State, the question is whether the State has discharged its duty to protect by regulating the terms on which researchers may contract; a legal system that enforces such a clause without qualification, and exposes a researcher who speaks to liability, has not.

5. What is the UNESCO Recommendation on Science and Scientific Researchers, and what is the correct way to use it in an answer on this paper? It is a recommendation adopted by the UNESCO General Conference in 2017, revising an instrument of 1974, and it is the fullest international statement of the status, freedoms and responsibilities of scientific researchers. It is not a treaty and binds no State, but General Comment 25 names it among the important documents in the field and relies on it repeatedly, including for the dimensions of freedom of research and for its definition of technology as knowledge relating directly to the production or improvement of goods or services. The correct use is to name it, place it as a non-binding but authoritative reference relied on by the Committee, and state what the Committee draws from it, without attributing to it particular numbered paragraphs unless its own text has been read.

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Chapter Twenty-One

The Precautionary Principle

Syllabus topic 1, "Interrelationship of Science, Technology and Human Rights"

In one line

When a technology may do serious harm and nobody yet knows whether it will, the law does not have to wait for proof before it acts.

In the wording a student can write in an exam: the precautionary principle requires that, in the absence of full scientific certainty, where an action or a policy may lead to unacceptable harm to the public or the environment, measures be taken to avoid or diminish that harm. In the formulation the Committee on Economic, Social and Cultural Rights adopted in General Comment No. 25 (2020), harm is unacceptable where it is threatening to human life or health, serious and effectively irreversible, inequitable to present or future generations, or imposed without adequate consideration of the human rights of those affected. Its practical effect is to move the cost of uncertainty from the person exposed to the risk on to the person creating it.

Why the law has this at all

The ordinary legal method runs backwards from an injury. Somebody is hurt, and the law asks who did it, whether they owed a duty, and whether the injury followed from the breach. That method works when the harmful thing is a falling wall, because the wall falls, the injury is visible, and the cause is not seriously in doubt.

It works badly on a new technology. The evidence that a substance or a process harms people commonly matures only after a large number of people have been exposed to it for a long time, because that exposure is what produces the data. A legal system that will not move until the evidence is complete is a system that has decided, in advance, to use the first generation of the exposed as the experiment.

There is a second difficulty, and it is structural rather than accidental. The body best placed to resolve the uncertainty is very often the body that profits from it remaining unresolved. Waiting for certainty therefore rewards whoever can slow the science down.

The precautionary principle is the answer to both difficulties. It gives a regulator a lawful basis for acting on a well founded suspicion, and it stops uncertainty from operating as a permanent defence.

Where the principle is stated for this paper

The most useful statement for an LL.M. student on this syllabus is not in an environmental treaty. It is in General Comment No. 25 (2020) on science and economic, social and cultural rights, E/C.12/GC/25, adopted by the Committee on Economic, Social and Cultural Rights on 30 April 2020. A General Comment is a treaty body's authoritative interpretation of the treaty it supervises, and the chapter that owns it explains what weight that carries.

The Committee puts precaution inside a section headed "Participation and the precautionary principle", and opens it this way:

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Participation also includes the right to information and participation in controlling the risks involved in particular scientific processes and its applications. In this context, the precautionary principle plays an important role. This principle demands that, in the absence of full scientific certainty, when an action or policy may lead to unacceptable harm to the public or the environment, actions will be taken to avoid or diminish that harm.

That placement is the single most examinable thing about the paragraph. On this syllabus precaution is not an idea borrowed from environmental law and attached to science. It is a limb of the right to science itself: if you have a right to take part in scientific progress, you have a right to a say in the risks that progress creates. The Committee's own footnote attributes the formulation to the World Commission on the Ethics of Scientific Knowledge and Technology, "The precautionary principle" (Paris, UNESCO, 2005).

Broken down

The principle has four elements, and an answer that states all four is worth far more than one that states the slogan.

  1. A threat of harm that can be identified in advance. Somebody must be able to say what the feared harm is and by what route it would occur. A vague unease is not a threat.
  2. Absence of full scientific certainty. This is the trigger, and it cuts both ways. There must be enough science to raise the concern and not enough to settle it. Where the harm is proved, the principle is not needed; where nothing but imagination supports the fear, the principle does not apply.
  3. The harm must be unacceptable. General Comment 25 gives four categories, and any one of them is enough: harm threatening to human life or health; harm that is serious and effectively irreversible; harm inequitable to present or future generations; and harm imposed without adequate consideration of the human rights of those affected. The fourth category is the one students miss, and it is the most useful, because it makes the manner of imposition a ground of objection by itself.
  4. Action to avoid or diminish the harm. The Committee says that actions "will be taken", not that the activity will be forbidden. The response is graduated.

The same paragraph names the working tools: "Technological and human rights impact assessments are tools that help to identify potential risks early in the process and the use of scientific applications." An impact assessment is a structured study, done before a project proceeds, of what it is likely to do to a defined interest.

What the principle does to the burden of proof

The burden of proof is the answer to the question "if nobody can tell, who loses?" Ordinarily it lies on the person complaining: a claimant who cannot show that the factory caused the illness fails, however sympathetic the claim.

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Precaution moves it. Once a credible threat of unacceptable harm is shown, the proponent of the activity is required to show that it can proceed safely, or on what conditions. The doubt no longer works in favour of the person creating the risk. That single shift is what the principle is for, and it is what its critics dislike about it.

Notice what it does not do. It does not reverse the burden in a criminal prosecution, where the accused is presumed innocent, and it does not make a regulator's opinion unchallengeable. It allocates the consequence of scientific uncertainty in a regulatory decision, and nothing more.

A worked example

Kaveri Agro Ltd applies to the licensing authority for permission to market a new seed coating in Maharashtra. Two published studies suggest that the compound persists in groundwater; a third finds no effect. Nobody has studied its effect on the children of the farming households that will handle it. Villagers in Warud object.

Element one, the threat. The objection is specific: persistence in groundwater, with a route of exposure through drinking water. That is a stated threat, not an unease.

Element two, the uncertainty. Two studies against one is exactly the state of knowledge the principle addresses. If the science were settled either way, the authority would simply apply it.

Element three, unacceptability. Harm through drinking water is threatening to health, which is the first category. Persistence makes it capable of being effectively irreversible, which is the second. And because nobody has studied the children who will handle the product, the harm would be imposed without adequate consideration of the human rights of those affected, which is the fourth.

Element four, the response, and it is graduated. The authority is not obliged to choose between a licence and a ban. It may require a human rights and technological impact assessment before deciding. It may licence on conditions: restricted quantities, mandatory protective equipment, monitoring of the village wells, and a reporting obligation. It may licence for a fixed period and review. It may suspend a decision until one study is repeated. Prohibition is the last of a series, not the first.

What the ordinary law would have done. A negligence claim would begin after the wells were contaminated, would require the villagers to prove that this compound caused their illness, and would probably fail on causation. The precautionary principle exists because that sequence arrives too late to be of use to anyone.

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Where the principle already operates in Indian law

India has no single enactment that states the principle in general terms, but the shape of it is visible in statutes a student on this paper is already reading, and quoting one of them is worth more than an assertion that Indian law accepts precaution.

Section 26A of the Drugs and Cosmetics Act, 1940. The Central Government may act if it "is satisfied, that the use of any drug or cosmetic is likely to involve any risk to human beings or animals", and may then "regulate, restrict or prohibit" its manufacture, sale or distribution. The trigger is likelihood of risk, not proof of injury, and the response is expressly graduated in the same three words the principle uses. The chapter on drugs control in Module II works the section in full.

Section 2(1) of the Epidemic Diseases Act, 1897. The State Government may take special measures when it is satisfied that the State or any part of it "is visited by, or threatened with, an outbreak of any dangerous epidemic disease". A threat is put on the same footing as a visitation. Module II examines the public health powers that follow.

The Constitution. Article 51A(g) makes it the duty of every citizen "to protect and improve the natural environment including forests, lakes, rivers and wild life, and to have compassion for living creatures", and article 48A places the corresponding endeavour on the State. The chapter on the environment in the Constitution takes article 48A; what matters here is that the constitutional text supplies a footing for anticipatory protection rather than only for compensation after the event.

Distinctions

IdeaWhat sets it offWhat it requires
PreventionA risk that is known and measurableControl the known risk: guards, limits, licences
PrecautionA credible threat that science cannot yet confirm or dismissAct anyway, proportionately, and put the burden on the proponent
ProhibitionA judgment that no acceptable safeguard existsStop the activity; the strongest of several precautionary responses
The ordinary civil claimAn injury that has already happenedProof by the injured person of duty, breach, causation and damage

What it does NOT mean

It does not demand zero risk. Nothing human is riskless, and a principle requiring proof of complete safety would forbid everything, including the technologies that save lives. The test is unacceptable harm, and the word doing the work is unacceptable.

It does not licence a State to shut down research. General Comment 25 says in terms that the principle "should not hinder and prevent scientific progress, which is beneficial for humanity", and that limitations on the freedom of scientific research are compatible with the Covenant only within article 4 of the ICESCR, which permits limitations determined by law, solely for the purpose of promoting the general welfare in a democratic society, and compatible with the nature of the right. Paragraph 22 adds that any limitation on the content of scientific research "implies a strict burden of justification by States". Precaution bites hardest on the use and application of scientific results and least on the asking of questions.

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It is not a substitute for evidence. It applies where there is a scientific basis for concern. Invoked against a fear with no scientific basis at all, it becomes a licence for whoever shouts loudest.

It is not a rule of criminal law. It governs what a regulator may do in advance. It does not lower the standard of proof for punishing anybody.

Limits and criticism

There is no single agreed formulation. Stated weakly, it says that uncertainty is not a reason to postpone cost effective measures against serious harm. Stated strongly, it says that no activity may proceed until its proponent proves it safe. The strong version is close to impossible to satisfy, because safety cannot be proved, only failed to be disproved, and a student who states only the strong version invites the obvious objection.

Inaction has victims too. Refusing or delaying a technology is itself a decision with a cost, measured in the harm the technology would have prevented. A delayed vaccine, a withheld diagnostic and an unapproved treatment all injure real people, and those people have the right to enjoy the benefits of scientific progress. The principle is a rule for deciding under uncertainty, not a presumption against novelty.

It can be captured. A rule that lets a State restrict a product without proving harm can be used for disguised protection of domestic industry, or by an established producer against a new competitor. The safeguard is procedural: reasons, evidence and review.

Somebody has to decide what is unacceptable, and that is a value judgment, not a scientific one. General Comment 25 accepts the difficulty and answers it with process. Because the application of the principle "is sometimes controversial", it says, participation and transparency become crucial: the risks and the potential of a technical advance should be made public so that society can decide, through informed, transparent and participatory public deliberation, whether the risks are acceptable. On this syllabus that is the answer to give. Precaution is legitimate when the people who will carry the risk have been told about it and heard.

Quick revision

  • Precautionary principle: in the absence of full scientific certainty, where an action or policy may lead to unacceptable harm to the public or the environment, action is taken to avoid or diminish that harm.
  • Stated for this paper in General Comment No. 25 (2020), E/C.12/GC/25, paragraph 56, under the heading "Participation and the precautionary principle". Precaution is a limb of the right to science, not an import.
  • Four categories of unacceptable harm: threatening to life or health; serious and effectively irreversible; inequitable to present or future generations; imposed without adequate consideration of the human rights of those affected.
  • Four elements: identified threat, scientific uncertainty, unacceptable harm, proportionate action. Tools: technological and human rights impact assessments.
  • Its real effect is on the burden of proof: the proponent must justify the activity, not the exposed person prove the injury.
  • Indian shape: section 26A of the Drugs and Cosmetics Act 1940 ("likely to involve any risk"), section 2(1) of the Epidemic Diseases Act 1897 ("visited by, or threatened with"), articles 48A and 51A(g) of the Constitution.
  • Limits: it must not hinder scientific progress; restrictions on research need strict justification under ICESCR article 4; inaction has victims; acceptability is decided by participation and transparency.
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Test yourself

1. State the precautionary principle and identify its four elements. In the absence of full scientific certainty, where an action or policy may lead to unacceptable harm to the public or the environment, measures must be taken to avoid or diminish that harm. Its elements are a threat of harm identified in advance; genuine scientific uncertainty, meaning enough evidence to raise the concern and not enough to settle it; harm that is unacceptable, which General Comment 25 defines as threatening to life or health, serious and effectively irreversible, inequitable across generations, or imposed without adequate consideration of the human rights of those affected; and a response proportionate to the threat.

2. Why does it matter that General Comment 25 places the principle under participation? Because it makes precaution part of the right to science rather than a borrowing from environmental law. If everyone has a right to participate in scientific progress, that participation includes a say in the risks the progress creates. It also supplies the answer to the principle's hardest question, which is who decides that a risk is unacceptable: the Committee's answer is informed, transparent and participatory public deliberation, not the unexplained opinion of a regulator.

3. A State bans all research on a new gene editing method because the public is anxious about it. Is that an application of the principle? Not as it stands. Precaution operates chiefly on the use and application of scientific results, and General Comment 25 says the principle should not hinder and prevent scientific progress. A limitation on the content of research must satisfy article 4 of the ICESCR, being determined by law, compatible with the nature of the right, and solely for the general welfare in a democratic society, and it carries a strict burden of justification. Public anxiety with no stated threat and no scientific basis does not discharge that burden.

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4. How does the principle change the burden of proof, and why is that its most important feature? Ordinarily the person alleging harm must prove it, so that scientific doubt defeats the claim and benefits whoever created the risk. Under the principle, once a credible threat of unacceptable harm is shown, the proponent of the activity must justify proceeding and on what conditions. It matters because the evidence about a new technology usually matures only after a population has been exposed, so leaving the burden where it ordinarily lies means the harm must occur before the law can respond.

5. Give two Indian statutory provisions that are precautionary in structure, and say what makes them so. Section 26A of the Drugs and Cosmetics Act 1940 lets the Central Government regulate, restrict or prohibit a drug or cosmetic where it is satisfied that its use "is likely to involve any risk" to human beings or animals: the trigger is likelihood, not proof, and the three verbs are a graduated response. Section 2(1) of the Epidemic Diseases Act 1897 lets a State Government take special measures where the State is "visited by, or threatened with" an outbreak, placing a threat on the same footing as an actual outbreak.

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Chapter Twenty-Two

How a Technology Becomes a Rights Question

Syllabus topic 2, "Implication of Development of Science and Technology on Human Rights"

In one line

A technology becomes a legal problem not because it is new, but because it changes what somebody is able to do to somebody else.

In the wording a student can write in an exam: a new technology becomes a human rights question when it alters the practical conditions on which an existing right depends, either by conferring on some person or body a capability that can be used against a protected interest, or by making available a means of realising a right that was previously unavailable. The analysis therefore proceeds not from the device but from the capability it creates, the right whose enjoyment that capability changes, the actor who bears the corresponding duty, and the justification, if any, for the interference.

Why a method is needed at all

Topic 2 asks about the implications of scientific and technological development for human rights. The list of relevant technologies is open and it grows every year. The syllabus was printed in 2016-17 and does not name the technologies a student will be asked about in the examination hall, because the University could not have known what they would be.

That makes memorising technologies a losing strategy. A candidate who has learnt facts about three named technologies is helpless when the question names a fourth. A candidate who has a method can take any technology, including one invented after the paper was set, and produce a legal answer about it.

The method below has six steps. It is not a formula to be recited; it is the order in which the questions have to be asked, because each step supplies the material the next one works on.

Step one: name the capability, not the device

The first mistake is to describe the machine. The law is not interested in how a device works. It is interested in what can now be done that could not be done before.

State the capability in a single sentence with four parts: what can now be done, by whom, to whom, and at what cost and scale. A camera that recognises faces is not the legal fact. The legal fact is that any body owning a camera and a database can now identify a stranger in a crowd, thousands of times an hour, without the stranger knowing and at almost no cost per identification.

That sentence is the whole of the analysis in miniature, and it usually contains its own answer. Everything that follows tests it.

Step two: ask what the capability changed

An activity that was always possible in principle can become a rights question when technology changes one of five things about it. Test each in turn.

  1. Scale. The act was possible for a few and is now possible for millions. Reading one person's letters was always possible; reading everyone's messages was not.
  2. Cost. The expense of doing it was itself the protection. When a thing that cost a week of an officer's time now costs nothing, the practical limit that stood in place of a legal limit has gone.
  3. Permanence. What used to be forgotten is now kept. A remark, a location, an illness or a debt that would have faded now stays retrievable for life.
  4. Invisibility. The person affected used to know it was happening. A search of a house is obvious; the same information taken from a handset is not, so the person cannot object, cannot correct an error, and cannot go to court.
  5. Delegation. A decision that a human being used to take is now taken by a machine, which means no one can be asked for reasons and the ordinary machinery of accountability finds nobody at home.
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A technology that changes none of the five is usually not a rights question. A technology that changes three or four of them is almost always one.

Step three: list the rights on both sides

Every serious technology advances some rights and threatens others, and an answer that gives only one side is incomplete on this paper. The chapter on dual use develops the point; here it is a discipline of the method.

Ask first which rights the technology serves: health, education, work, information, participation, the enjoyment of the benefits of scientific progress. Ask then which rights it threatens: life, privacy, equality, expression, fair trial, bodily integrity. Write both lists before choosing a side.

The examiner is not asking whether the technology is good. The examiner is asking whether the student can see both columns and then reason about the trade between them.

Step four: name the duty bearer and the duty

A right with no identified duty bearer is a complaint, not a legal claim. The chapter on what a human right is sets out the three duties of the State, to respect, to protect and to fulfil; the step here is to apply them.

Respect is engaged when the State itself deploys the technology: a police force running the facial recognition, a hospital run by the government holding the records.

Protect is engaged when a private actor deploys it, and this is the duty that does most of the work in this subject, because most technology is developed, owned and operated privately. The State's failure to regulate is itself the breach.

Fulfil is engaged when the complaint is that the technology is absent: no diagnostic equipment in the district hospital, no assistive technology in the school.

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The 1975 Declaration writes the first two duties into an instrument. Paragraph 2 requires States to take appropriate measures to prevent the use of scientific and technological developments, "particularly by the State organs", to limit or interfere with the enjoyment of human rights. Paragraph 8 requires States to take effective measures, "including legislative measures", to prevent and preclude the use of scientific and technological achievements to the detriment of human rights and of the dignity of the human person. The words "including legislative measures" are the treaty language of the duty to protect.

Step five: test the interference

Almost no right in this field is absolute, so identifying an interference does not end the argument. An interference must be justified, and the four questions are always the same: is it prescribed by law, does it pursue a legitimate aim, is it necessary for that aim, and is it proportionate, meaning that no less restrictive measure would do and that the harm imposed does not outweigh the benefit gained.

Module IV develops that test in the form Indian law now applies. At this stage what matters is the discipline of asking it. A student who writes that a technology "violates the right to privacy", and stops, has not answered the question, because every lawful search and every lawful interception also interferes with privacy.

Step six: ask about distribution and remedy

Two questions close the analysis, and both are frequently forgotten.

Distribution. Who receives the benefit and who carries the risk? The two are often different people, and where the population that bears the risk is not the population that gets the benefit, the objection is one of equality and of benefit sharing rather than of safety. The chapters on benefit sharing and on the digital divide take this further.

Remedy. What can the affected person actually do, and against whom? A right without a remedy fails at exactly the point where it matters. Ask whether the person can find out that the technology was used on them, whether they can obtain the evidence, whether there is a body with power to order the use stopped, and whether compensation is available. The chapter on remedies when technology causes harm follows those routes through.

What the instruments add

Two treaty provisions are worth carrying into any answer on this topic, because they show that the method is not merely an academic construction.

CEDAW, article 11(3). The Convention on the Elimination of All Forms of Discrimination against Women, adopted by General Assembly resolution 34/180 of 18 December 1979 and in force from 3 September 1981, provides that protective legislation relating to the matters covered by article 11 "shall be reviewed periodically in the light of scientific and technological knowledge and shall be revised, repealed or extended as necessary". That is a binding obligation to keep the law in step with what science now knows. It is the clearest treaty statement that a change in scientific knowledge can, by itself, make an existing law unlawful.

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CEDAW, article 14(2)(g). States must ensure to rural women the right "to have access to agricultural credit and loans, marketing facilities, appropriate technology and equal treatment in land and agrarian reform". Access to a technology is stated as a component of equality, which is the treaty form of step three's second column: the absence of a technology can breach a right just as its presence can.

The 1975 Declaration adds the general obligation in paragraph 7: States are to take the necessary measures, including legislative measures, to ensure that the utilization of scientific and technological achievements promotes the fullest realization of human rights "without any discrimination whatsoever on grounds of race, sex, language or religious beliefs".

A worked example

Godavari English School in Nashik installs a camera at its gate that records attendance by recognising each pupil's face. Mrs Kulkarni, the principal, buys the system from a private vendor, which stores the images on its own servers. Ayesha, aged fourteen, is marked absent three times because the system misreads her when she wears a headscarf.

Step one, the capability. The school, and in fact the vendor, can now identify and log the movement of every child at the gate, continuously, automatically, without any adult present, and at negligible cost per child.

Step two, what changed. Scale: every child, every day, instead of a register read by a teacher. Permanence: a biometric template of a minor is stored indefinitely. Invisibility: neither Ayesha nor her parents can see what is recorded or by whom. Delegation: the decision that Ayesha was absent is now taken by software. Four of the five changes are present.

Step three, both columns. Served: education administration, punctuality, the safety of children whose arrival can be confirmed. Threatened: privacy, the special protection owed to a child, equality, because the error rate is not evenly distributed, and the right to a remedy.

Step four, the duty. The school is private, so the primary duty engaged is the duty to protect: the State must regulate what a private school and a private vendor may do with a child's biometric data. That is the duty the 1975 Declaration puts in paragraph 8 as a duty to take effective measures, including legislative measures.

Step five, the justification. Is there a law permitting it? Is marking attendance a legitimate aim? Certainly. Is a facial biometric necessary for it, when a card, a register or a fingerprint-free roll call would do the same job? That is where the system probably fails, because a less restrictive means plainly exists. Proportionality asks whether a lifelong biometric record of a child is a fair price for saving a teacher five minutes a day.

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Step six, distribution and remedy. The benefit goes to the school in saved time, and the risk is carried by the children. Ayesha's remedy is the weakest part: she cannot see the data, cannot test the error, and has been marked absent by a decision with no author. The absence of a remedy is not a side issue in this problem. It is the strongest part of her case.

When a technology is NOT a rights question

The method has to be able to say no, or it says nothing. Three filters, and all three must be satisfied.

It must touch an interest that a right protects. A better gearbox on a bicycle affects convenience and nothing else. Convenience is not a protected interest.

The effect must be attributable to somebody who owes a duty. Harm caused by nobody in particular is a misfortune. Harm caused by a State organ, or by a private actor the State was obliged to regulate, is a rights question.

The effect must be more than trivial. Every technology has some effect on somebody. A right is engaged when the effect on the protected interest is real, not notional.

Applying those three keeps the answer honest. Many complaints about technology are complaints about a policy choice, a commercial practice or a personal taste, and calling them human rights violations weakens the phrase for the cases that deserve it.

The three ways a technology enters rights law

RouteWhat triggers itWhat the law does
As a threatThe capability can be used against a protected interestRestrain it: licence, condition, prohibit, punish
As a meansThe right cannot be enjoyed without itRequire its provision: assistive technology, diagnostics, access under CEDAW article 14(2)(g)
As a re-readingThe right's old wording no longer covers what it protectedInterpret the existing right afresh, as CEDAW article 11(3) obliges States to do with their own legislation

Most examination questions are about the first route. The best answers notice that the second and the third exist, because that is what distinguishes a student who has understood topic 2 from one who has learnt a list of dangers.

What beginners get wrong

Describing the technology instead of analysing it. Half a page on how a system works earns nothing. One sentence naming the capability earns everything, because it is the sentence the rest of the answer is built on.

Assuming a new technology needs a new right. It almost never does. The existing rights are re-applied to new facts. Claiming a new right is an exceptional move that has to be argued for, and the chapter on access to the internet shows what that argument looks like.

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Treating the State as the only actor. Most of the technology in this paper is private. The question is not only what the State did but what the State allowed, which is the duty to protect.

Stopping at "this violates a right". Interference is the beginning of the analysis. Justification is the rest of it, and an answer that skips step five has skipped the law.

Quick revision

  • A new technology becomes a human rights question when it changes the practical conditions on which an existing right depends, by creating a capability that can be used against a protected interest or by supplying a means of realising a right.
  • Six steps: name the capability; ask what it changed; list the rights on both sides; name the duty bearer and the duty; test the interference; ask about distribution and remedy.
  • Five changes to test for: scale, cost, permanence, invisibility, delegation.
  • The duty to protect does most of the work, because most technology is private. 1975 Declaration, paragraphs 2, 7 and 8.
  • CEDAW article 11(3): protective legislation must be reviewed periodically in the light of scientific and technological knowledge and revised, repealed or extended as necessary. Article 14(2)(g): access to appropriate technology as a component of equality for rural women.
  • Three filters before calling something a rights question: a protected interest, an attributable duty bearer, a more than trivial effect.
  • Three routes into rights law: threat, means, re-reading.

Test yourself

1. Set out the six steps of the analysis and say why the order matters. Name the capability rather than the device; ask what the capability changed, testing scale, cost, permanence, invisibility and delegation; list the rights the technology serves and the rights it threatens; identify the duty bearer and which of the duties to respect, protect or fulfil is engaged; test whether the interference is prescribed by law, pursues a legitimate aim, is necessary and is proportionate; and ask who gets the benefit, who carries the risk and what remedy the affected person has. The order matters because each step produces the material the next one uses: without the capability there is no right to identify, and without the right there is no duty to allocate.

2. Why is the duty to protect the most important of the three duties in this subject? Because the great majority of technology is developed, owned and deployed by private actors. If the framework reached only the conduct of State organs it would leave the hospital chain, the platform, the laboratory and the vendor untouched. The duty to protect makes the State answerable for failing to regulate them, which is why the 1975 Declaration speaks in paragraph 8 of effective measures including legislative measures.

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3. A district administration proposes to distribute tablets to schoolchildren. Is this a rights question, and if so which route? Yes, by the second route, technology as a means. The complaint in such cases is usually not that the tablet threatens a right but that its absence prevents the enjoyment of one, which engages the duty to fulfil. The equality analysis matters most: who is left out, and does the distribution widen an existing gap. CEDAW article 14(2)(g) is the treaty analogue, stating access to appropriate technology as part of equality rather than as a benefit.

4. Give an example of a technological change that is not a human rights question, and explain why. An improvement in the gearing of a bicycle. It fails the first filter, because the interest it affects is convenience, which no right protects. It also fails the second, since no duty bearer is responsible for anyone's ordinary preference between one gearbox and another. Keeping the filters strict matters: describing every commercial or policy complaint as a human rights violation devalues the term where it is genuinely needed.

5. What does article 11(3) of CEDAW add to this topic that no other provision in the base supplies? It states, in binding treaty form, that laws must be re-examined when scientific knowledge changes, and revised, repealed or extended accordingly. It is the textual foundation of the third route, in which a technology becomes a rights question not by creating a danger but by making an existing rule obsolete, and it shows that the obligation to keep law in step with science is a legal duty rather than good practice.

Contents This chapter on its own page

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Chapter Twenty-Three

Privacy and Surveillance

Syllabus topic 2, "Implication of Development of Science and Technology on Human Rights"

In one line

Privacy is the right that technology has changed most, because almost every new technology makes it cheaper to know something about a person.

In the wording a student can write in an exam: privacy is the interest of a person in controlling access to themselves, to information about themselves and to the space in which they make their own decisions; surveillance is the systematic observation of persons, and technological development has transformed it from an activity that was expensive, visible and necessarily selective into one that is cheap, invisible and capable of being applied to whole populations, which is why every modern statement of the right is concerned less with whether observation occurred than with whether it was authorised by law, pursued a legitimate aim and was proportionate.

Why the law has this at all

Privacy was protected long before there was any technology worth the name, and the older protections were mostly about physical space: the house, the letter, the body. They worked because the practical cost of intrusion did most of the enforcing. Following one person took an officer's whole day, so nobody followed everybody.

Technology dismantled that arrangement in the way described in [How a Technology Becomes a Rights Question]. Apply the five tests there:

  • Scale. Observation that could be applied to a few can now be applied to everyone at once.
  • Cost. The expense that limited surveillance in practice has gone, and with it the practical limit that stood in place of a legal one.
  • Permanence. What used to be forgotten is now retained and searchable years later.
  • Invisibility. The person observed no longer knows, so cannot object, cannot correct an error and cannot go to court.
  • Delegation. The decision to look, and the decision about what the looking means, is increasingly taken by a system rather than by a person who can be asked for reasons.

All five, which is why this is the largest single implication in topic 2 and why the Committee, in a general comment about science, found it necessary to talk about data at all.

The provisions

UDHR article 12 provides that no one shall be subjected to arbitrary interference with his privacy, family, home or correspondence, nor to attacks upon his honour and reputation, and that everyone has the right to the protection of the law against such interference or attacks. It is discussed with the other two Declaration articles in [Privacy and Health in the Universal Declaration].

ICCPR article 17 turns that into a binding obligation in almost the same words: no one shall be subjected to arbitrary or unlawful interference with his privacy, family, home or correspondence, nor to unlawful attacks on his honour and reputation, and everyone has the right to the protection of the law against such interference or attacks.

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The word to notice is "arbitrary or unlawful". Two conditions, not one. An interference must be lawful, meaning provided for by law, and it must not be arbitrary, which imports reasonableness and proportionality. A State that passes a statute permitting mass interception has satisfied the first and not the second.

The 1975 Declaration, paragraph 6, is the provision that ties privacy specifically to this paper. States are to extend the benefits of science and technology to all strata of the population and to protect them from possible harmful effects of the misuse of scientific and technological developments, including their misuse to infringe upon the rights of the individual or of the group, particularly with regard to respect for privacy and the protection of the human personality and its physical and intellectual integrity. That is a 1975 instrument naming privacy as the leading casualty of technological misuse, before most of the technology existed.

The Indian position

Justice K.S. Puttaswamy (Retd.) v. Union of India, AIR 2017 SC 4161, (2017) 10 SCC 1, decided on 24 August 2017 by nine judges.

Facts. A Bench of three judges hearing the challenge to the Aadhaar scheme recorded that the norms for and the compilation of demographic and biometric data by the Government were being questioned as a violation of the right to privacy. The Attorney General argued that the existence of a fundamental right of privacy was itself in doubt, relying on M P Sharma and Kharak Singh. The petitioners answered that both rested on an approach later held not to be good law. Because the decisions that had since recognised privacy were given by smaller Benches, the question was referred upwards, and on 18 July 2017 a Constitution Bench directed that it be placed before nine judges.

Held. The Order of the Court disposed of the reference in four terms. M P Sharma, which holds that the right to privacy is not protected by the Constitution, stands over-ruled. Kharak Singh stands over-ruled to the extent that it so holds. The right to privacy is protected as an intrinsic part of the right to life and personal liberty under article 21 and as a part of the freedoms guaranteed by Part III. Decisions subsequent to Kharak Singh which have enunciated that position lay down the correct position in law.

Why it matters here. The case exists because of a technology. Nobody asked the Supreme Court an abstract question about privacy; a biometric identification programme was built and the question could no longer be avoided. That is the pattern this whole paper describes, visible in the procedural history of one case. It also settles the Indian starting point for everything in Module IV: personal data is inside article 21.

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The three-part test

The instruments and the Indian cases converge on the same structure, and it is the structure an answer should use. An interference with privacy is permissible only if it satisfies three requirements.

  1. Legality. There must be a law. Not a policy, not an executive instruction, not an internal standard operating procedure. The law must be accessible and must be precise enough that a person can foresee when the power may be used against them.
  2. Legitimate aim. The purpose must be one the constitutional or treaty order recognises: national security, prevention of crime, public health, the protection of the rights of others.
  3. Proportionality. The measure must be rationally connected to the aim; there must be no less restrictive means reasonably capable of achieving it; and the benefit must outweigh the burden imposed on the right.

The same three-limbed structure governs limitations on the right to science under article 4 of the ICESCR, set out in [Dual Use: the Same Technology Both Ways]. That is not a coincidence: it is the general shape of limitation analysis in human rights law, and a candidate who has learnt it once can apply it to any right on this paper.

Worked example

A municipal corporation installs cameras with automated face recognition at every entrance to a public market. The stated purpose is the detection of pickpockets. Images are matched against a database of persons previously arrested, and all footage is retained for two years. The scheme is created by a resolution of the corporation.

Legality. It fails at the first step. A resolution of a municipal body is not a law that authorises interference with a fundamental right, and there is no statute defining who may be enrolled in the database, on what grounds, for how long, or with what remedy for a person wrongly included. The analysis could stop here, and a good answer says so before going on.

Legitimate aim. Prevention and detection of crime is a legitimate aim. This limb is usually satisfied and is rarely where a case is won.

Proportionality. Rational connection is arguable. The failure is at necessity and at balance. Retaining footage of every visitor for two years to catch pickpockets is not the least restrictive means; the burden falls on the entire population of shoppers, none of whom is suspected of anything; and matching against a database of persons previously arrested, rather than convicted, imports the error rate of past policing into every future identification.

The equality dimension. Recognition systems do not perform uniformly across populations, so a scheme of this kind distributes its errors unevenly. That converts a privacy problem into a discrimination problem, which is taken up in [Equality and the Digital Divide].

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What could survive. Cameras without automated matching, under a statute, with a defined retention period and an accessible complaints route, may well be proportionate. The point of the test is that it does not produce a yes or a no to "cameras"; it produces a yes or a no to a particular design.

What it does NOT mean

Privacy is not secrecy. A person who has told a doctor something has not made it public, and a person walking down a street has not consented to being tracked. The right protects control over access, not concealment.

"Nothing to hide" is not an argument the law recognises. It misstates the interest, which is not in hiding wrongdoing but in not being watched; and it misallocates the burden, since it is the State that must justify the interference, not the individual who must justify wanting to be left alone.

Consent does not cure everything. Consent obtained as the price of a service a person cannot do without is not a free choice, and the framework treats it accordingly.

Anonymised is not anonymous. Data stripped of names can frequently be re-identified by combining it with other data, which is precisely the property General Comment 25 notes when it observes that information is nonrivalrous and recombinant.

Surveillance is not only a State activity. Most of the capability is privately owned, which engages the duty to protect and makes regulation, rather than restraint, the primary obligation.

Limits and criticism

The three-part test is a method, not an answer, and its second limb is almost never contested. Cases are decided at legality and proportionality, and a candidate who spends an answer establishing that national security is a legitimate aim has spent it on the uncontested limb.

The deeper criticism is that the test is individual in shape and the harm is increasingly collective. It asks whether this person's rights were interfered with and whether that interference was justified. It is a poor instrument for a harm that consists in an entire population altering its behaviour because it knows it may be watched, since no individual can show that they in particular were observed. That is a real limitation of the framework and worth a sentence in an answer that has room for it.

Quick revision

  • UDHR article 12 and ICCPR article 17: no arbitrary or unlawful interference with privacy, family, home or correspondence; and a right to the protection of the law against it. Two conditions: lawful, and not arbitrary.
  • 1975 Declaration, paragraph 6: protect people from misuse of scientific and technological developments, particularly with regard to respect for privacy and the physical and intellectual integrity of the person.
  • Puttaswamy (2017), nine judges: privacy is protected as an intrinsic part of article 21 and as part of the Part III freedoms; M P Sharma over-ruled, Kharak Singh over-ruled to the extent it held otherwise.
  • The three-part test: legality (a law, accessible and foreseeable), legitimate aim, proportionality (rational connection, least restrictive means, benefit outweighing burden).
  • The five changes technology made: scale, cost, permanence, invisibility, delegation. Surveillance engages all five.
  • Not secrecy; "nothing to hide" is not an argument; consent as the price of a necessity is not free; anonymised is not anonymous; and most of the capability is private, so the duty to protect does the work.
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Test yourself

1. Set out article 17 of the ICCPR and explain the significance of the words "arbitrary or unlawful". Article 17 provides that no one shall be subjected to arbitrary or unlawful interference with his privacy, family, home or correspondence, nor to unlawful attacks on his honour and reputation, and that everyone has the right to the protection of the law against such interference or attacks. The two adjectives impose two distinct conditions. Unlawful means the interference must be provided for by law, so an executive practice with no legal basis fails immediately. Arbitrary imports a further standard of reasonableness and proportionality, so that a State which enacts a statute authorising an interference has satisfied the first condition and must still show the interference is not arbitrary. A test that collapsed the two would allow any interference a legislature chose to authorise.

2. What did Puttaswamy decide, and why is it a case about technology rather than about privacy in the abstract? Its Order disposed of the reference in four terms: M P Sharma is over-ruled in so far as it holds that privacy is not protected by the Constitution; Kharak Singh is over-ruled to the same extent; the right to privacy is protected as an intrinsic part of the right to life and personal liberty under article 21 and as part of the freedoms guaranteed by Part III; and the decisions after Kharak Singh which took that view state the law correctly. It is a case about technology because the question reached the Court only because a biometric identification programme had been built and challenged; the constitutional question was forced by the capability rather than raised for its own sake.

3. Apply the three-part test to a proposal to require every mobile telephone connection to be linked to a biometric identity. Legality asks whether a statute authorises it, whether that statute is accessible, and whether it is precise enough that a person can foresee when and how the power will be used, including who may access the resulting database and for what. Legitimate aim is likely satisfied, prevention of crime and national security both being recognised. Proportionality does the work: whether biometric linkage is rationally connected to the aim; whether a less restrictive means, such as documentary verification without biometrics or retention of the biometric only at the point of verification, would reasonably achieve it; and whether the benefit outweighs the burden of creating a database that links every person's communications to their body. The retention period, the access controls and the remedy available to a person wrongly matched are all part of proportionality rather than separate questions.

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4. Why is "nothing to hide" not an answer, and where does the burden of justification lie? Because it misdescribes the interest and misplaces the burden. The interest protected is control over access to oneself and one's information, not the concealment of wrongdoing, so a person with nothing to hide still loses something when they are watched. And under both article 17 and article 21 as construed in Puttaswamy, an interference must be justified by the State: it must point to a law, a legitimate aim and proportionality. The formulation reverses that, requiring the individual to explain why they should not be observed, which is the opposite of how a limitation clause operates.

5. What is the principal structural weakness of the three-part test as applied to population-scale surveillance? The test is individual in shape while the harm is collective. It asks whether a particular person's right was interfered with and whether that interference was justified, which suits a search of one house or the interception of one line. Where a capability is applied to a whole population, no individual can ordinarily show that they in particular were observed, and the characteristic injury, that people alter their behaviour because they know they may be watched, is not an injury to any identifiable claimant. The framework can address this through the requirement that a law be foreseeable and through proportionality at the level of the scheme rather than the instance, but it remains a poor fit for a diffuse harm.

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Chapter Twenty-Five

Equality and the Digital Divide

Syllabus topic 2, "Implication of Development of Science and Technology on Human Rights"

In one line

A new technology arrives unequally, and by arriving unequally it makes an existing inequality worse.

In the wording a student can write in an exam: the digital divide is the gap between those who have access to information and communication technologies, and the education and infrastructure required to use them, and those who do not; and it is the leading contemporary instance of a general proposition, that because scientific applications are distributed by wealth, geography, language, gender and disability, a technology that is neutral in design operates as a multiplier of pre-existing inequality unless the State takes positive steps, so that unequal access to science is not merely a misfortune but a question of discrimination under the equality guarantees.

Why the law has this at all

Every other chapter in this module asks what a technology does to a right. This one asks a prior question: to whose right?

The reason it comes first in importance and not first in the list is that its effects are cumulative and invisible. When a benefit arrives, it arrives where the roads, the electricity, the money and the schooling already are. Nobody decides that it should reach some people and not others; it simply does, and the gap it opens is then treated as the natural order rather than as a distribution somebody chose.

That is the moment at which the human rights framework has something to say. [What This Paper Is About] makes the point in its general form: once a treatment exists, the fact that a person cannot get it stops being misfortune and becomes a distribution. The law of equality is the instrument for saying so.

The provisions

ICESCR article 2(2) requires States Parties to guarantee that the rights in the Covenant will be exercised without discrimination of any kind as to race, colour, sex, language, religion, political or other opinion, national or social origin, property, birth or other status. Because the right to enjoy the benefits of scientific progress is a Covenant right, article 2(2) applies to it directly. That is the single most useful provision in this chapter and the one most often left out of answers.

UDHR article 2 states the same principle for the Declaration, and article 27(1) gives everyone the right freely to share in scientific advancement and its benefits. The word is everyone, and it is doing work.

The 1975 Declaration, paragraph 7, requires all States to take the necessary measures, including legislative measures, to ensure that the utilisation of scientific and technological achievements promotes the fullest realisation of human rights without any discrimination whatsoever on grounds of race, sex, language or religious beliefs.

CERD article 5 requires States Parties to guarantee the right of everyone, without distinction as to race, colour, or national or ethnic origin, to equality before the law in the enjoyment of a list of rights that includes the economic, social and cultural rights, among them the right to public health and medical care and the right to education and training.

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CEDAW supplies two provisions that are directly about technology and are worth citing by number because so few candidates do. Article 11(3) requires that protective legislation relating to matters covered by the employment article be reviewed periodically in the light of scientific and technological knowledge and revised, repealed or extended as necessary. Article 14(2)(g) requires States to ensure to rural women the right to have access to agricultural credit and loans, marketing facilities, appropriate technology and equal treatment in land and agrarian reform.

Constitution of India, articles 14 and 15, guarantee equality before the law and the equal protection of the laws, and prohibit discrimination on grounds of religion, race, caste, sex or place of birth. Article 15(3) and (4) permit special provision, which is the constitutional basis for the positive measures this chapter argues for.

What the Committee requires

General Comment 25 treats non-discrimination as running through the elements of the right rather than sitting beside them.

Under accessibility it requires that scientific progress and its applications be accessible to all without discrimination, in the three dimensions set out in [Availability, Accessibility, Acceptability and Quality]: access to applications, access to information about risks and benefits, and the open opportunity to participate. It requires States to remove discriminatory barriers, giving as its example the facilitation of access by marginalised populations to scientific education.

Under availability it requires that benefits be distributed especially to vulnerable and marginalised groups, which is a distributive instruction and not merely a prohibition on exclusion.

On women it goes further and permits temporary special measures, such as quotas for women in scientific education, to speed up substantive equality; and it states that a gender-sensitive approach is not a luxury but a crucial tool, because scientific progress and new technologies must take account of the characteristics and needs of women and girls from the first stage of research onwards.

Formal and substantive equality

This is where most of the marks are, and it is a distinction rather than a fact, so it can be learnt once and used everywhere.

Formal equality asks whether the rule treats people alike. A scheme that makes an online service available to every citizen on identical terms satisfies it completely.

Substantive equality asks whether people can actually enjoy the right on equal terms. The same scheme fails at once where a third of the population has no connection, a language barrier, no device, or no ability to read.

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The instruments are drafted for substantive equality, not formal. Article 2(2) requires that the rights be exercised without discrimination, not merely that they be granted alike; the Committee's requirement to remove barriers and to distribute benefits especially to marginalised groups is a positive duty; CEDAW article 4 and the Constitution's article 15(3) and (4) authorise differential treatment for that purpose; and General Comment 25 accepts quotas in terms.

The practical consequence is that a State cannot answer a complaint about the digital divide by showing that its scheme applies to everybody. That answer establishes formal equality and is the beginning of the problem, not the end of it.

Indirect discrimination and the digital divide

The divide rarely takes the form of a rule that excludes anyone. It takes the form of a facially neutral measure with unequal effect, which is the classic shape of indirect discrimination.

Four dimensions are worth naming separately, because an answer that names only the first is thin.

  1. Access. Whether a person has a connection, a device and reliable electricity. This is the dimension everyone writes about.
  2. Skills. Whether a person can use them. A connection given to somebody who cannot read the interface transfers the hardware and not the benefit.
  3. Quality of use. Whether what a person can do with the technology is comparable. A shared handset used for half an hour a day is not the same access as a private computer.
  4. Representation in the technology itself. Whether the technology was built for them at all. A system trained on data that under-represents a population performs worse for that population, which converts the divide from a question of access into a question of design. This is the point General Comment 25 makes about gender-sensitive research from the first stage.

Worked example

A State moves applications for a food subsidy entirely online, with biometric authentication at the point of collection. The stated purposes are the elimination of fraud and administrative saving. The rule applies to every applicant identically.

Formal equality. Satisfied. There is no classification on any prohibited ground.

Substantive equality. Test the four dimensions. Access: applicants without a connection or a device must rely on an intermediary, at a cost. Skills: applicants who cannot read cannot complete the form unaided, and the intermediary is now in a position of power over them. Quality of use: an applicant with intermittent connectivity may fail at the last step and lose the entitlement. Representation: biometric authentication fails more often for manual labourers, whose fingerprints are worn, and for the elderly, and those are disproportionately the people the subsidy exists for.

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Which right is engaged? Not only equality. The subsidy exists to secure an adequate standard of living, so a technological barrier to obtaining it is an interference with that right, effected through a means that bears unequally. Article 2(2) attaches the non-discrimination requirement to the exercise of the Covenant right itself.

What the State must show. That the measure pursues a legitimate aim, which it plainly does; and that the disparate effect is justified and mitigated. The mitigation is the whole of the practical answer: an offline route that is genuinely available rather than nominal, an exception procedure for authentication failure, and a rule that no entitlement is lost because a machine did not recognise a person.

The general lesson. The problem is not the technology. It is the removal of the alternative. A digital route added to a paper route enlarges access; a digital route that replaces a paper route redistributes it.

What it does NOT mean

It does not mean new technology should be withheld until everyone can have it. That would defeat the right in article 15(1)(b) rather than serve it. The duty is to extend the benefit and to attend to the distribution, which is what paragraph 6 of the 1975 Declaration says in one sentence.

It is not only about the internet. The divide in irrigation, in diagnostics, in cold chains and in laboratory access is older and in places more consequential. The digital case is the current instance of a permanent pattern.

Unequal outcome is not automatically discrimination. The framework asks whether the disadvantage is connected to a protected ground or to a group the Committee identifies as marginalised, and whether the State has taken the positive steps required of it. An answer that treats every inequality as a violation has stopped doing law.

And equality does not require identical treatment. CEDAW article 4, the Constitution's article 15(3) and (4), and the Committee's acceptance of temporary special measures all point the other way.

Quick revision

  • The digital divide: the gap in access to information and communication technologies and in the education and infrastructure to use them; the leading instance of technology as a multiplier of existing inequality.
  • ICESCR article 2(2): Covenant rights, including article 15(1)(b), to be exercised without discrimination on any of the listed grounds. The key provision.
  • 1975 Declaration, paragraph 7: measures, including legislative measures, so that utilisation of scientific achievements promotes the fullest realisation of rights without any discrimination whatsoever on grounds of race, sex, language or religious beliefs.
  • CERD article 5: equality before the law in the enjoyment of economic, social and cultural rights including public health, medical care, education and training.
  • CEDAW article 11(3): protective legislation to be reviewed in the light of scientific and technological knowledge. Article 14(2)(g): rural women's access to appropriate technology.
  • General Comment 25: remove discriminatory barriers; distribute benefits especially to vulnerable and marginalised groups; temporary special measures including quotas are permissible; a gender-sensitive approach from the first stage of research.
  • Four dimensions: access, skills, quality of use, and representation in the technology itself.
  • Formal equality asks if the rule treats alike; substantive equality asks if the right can be exercised alike. The instruments are drafted for the second.
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Test yourself

1. Which single provision most directly makes unequal access to science a question of discrimination, and why? Article 2(2) of the ICESCR, which requires States Parties to guarantee that the rights in the Covenant will be exercised without discrimination of any kind as to race, colour, sex, language, religion, political or other opinion, national or social origin, property, birth or other status. It is the most direct because the right to enjoy the benefits of scientific progress in article 15(1)(b) is itself a Covenant right, so the non-discrimination guarantee attaches to it without any further step of reasoning. Its wording also matters: it requires that the rights be exercised without discrimination, not merely conferred alike, which is the textual basis for a substantive rather than a formal reading.

2. Distinguish formal from substantive equality and say which the instruments adopt. Formal equality asks whether a rule treats people alike, and is satisfied by a measure that applies to everyone on identical terms. Substantive equality asks whether people are able in fact to enjoy the right on equal terms, and is not satisfied by identical treatment where the starting positions differ. The instruments adopt the substantive conception: article 2(2) speaks of rights being exercised without discrimination; General Comment 25 imposes positive duties to remove discriminatory barriers and to distribute benefits especially to vulnerable and marginalised groups, and accepts temporary special measures including quotas; CEDAW article 4 and articles 15(3) and 15(4) of the Constitution authorise differential treatment for that purpose.

3. Name the two CEDAW provisions that bear directly on technology and state what each requires. Article 11(3) requires that protective legislation relating to the matters covered by the employment article be reviewed periodically in the light of scientific and technological knowledge and be revised, repealed or extended as necessary. It is significant because it makes keeping the law in step with science a legal duty rather than good practice. Article 14(2)(g) requires States to ensure to rural women the right to have access to agricultural credit and loans, marketing facilities, appropriate technology and equal treatment in land and agrarian reform, which states access to technology as a component of equality rather than as a benefit conferred.

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4. A State replaces a paper application route with an online one that applies to all citizens identically. Identify the equality problem and the four dimensions along which you would test it. The problem is indirect discrimination: a facially neutral measure with unequal effect, which satisfies formal equality while redistributing practical access. The dimensions are access, whether the person has a connection, a device and reliable power; skills, whether they can use it unaided, since a person who cannot read the interface receives the hardware and not the benefit; quality of use, whether what they can do with it is comparable, a shared handset for a short period not being equivalent to private and reliable access; and representation in the technology itself, whether the system was designed and tested for them, since a system built on data under-representing a population performs worse for that population. The decisive fact is usually not the addition of the digital route but the removal of the alternative.

5. Why is it wrong to answer a digital divide complaint by saying that a new technology should not be introduced until everyone can have it? Because it treats the right as a right to equality alone, when article 15(1)(b) is a right to enjoy the benefits of scientific progress and article 15(2) imposes a duty to develop and diffuse science. Withholding a benefit from those who could have it does not confer it on those who cannot; it defeats the right for both groups while producing the appearance of equal treatment. Paragraph 6 of the 1975 Declaration states the correct obligation in a single sentence, requiring States both to extend the benefits of science and technology to all strata of the population and to protect them from harmful effects, so the duty is to extend and to attend to the distribution at the same time, not to choose between them.

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Chapter Twenty-Six

Health and Medical Technology

Syllabus topic 2, "Implication of Development of Science and Technology on Human Rights"

In one line

Medicine is where science reaches a person's body, so it is where the right to science and the right to health meet, and where each is measured against the other.

In the wording a student can write in an exam: medical technology is the application of scientific knowledge to the prevention, diagnosis and treatment of disease and to the sustaining of life, and it engages the human rights framework at three distinct points: as a benefit whose distribution is governed by the right to health and the right to enjoy the benefits of scientific progress; as an intervention on a person, governed by consent and bodily integrity; and as a capability that generates questions the older law never had to answer, such as when life ends and what may be done with a body's material.

Why the law has this at all

The right to health is old and its content used to be modest, because there was little medicine could do. What transformed it was capability. Once a disease can be prevented, the failure to prevent it becomes a decision. Once a life can be sustained, the withdrawal of the support becomes an act. Once a condition can be detected before birth, the detection itself becomes a question about what will be done with the knowledge.

This is why "Medicine and the Law" is a whole module of this paper and not a paragraph. Almost every hard case in the subject is medical, because medicine is where the technology is applied directly to a person, and where the person is at their least able to refuse.

The provisions

ICESCR article 12(1) recognises the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. Article 12(2) lists the steps to be taken, which include those necessary for the reduction of the stillbirth rate and of infant mortality and for the healthy development of the child; the improvement of all aspects of environmental and industrial hygiene; the prevention, treatment and control of epidemic, endemic, occupational and other diseases; and the creation of conditions which would assure to all medical service and medical attention in the event of sickness.

The words "highest attainable" do the work. The standard is not absolute health, which no State can confer, and it is not whatever the State currently provides. It is what is attainable, which is a function of the resources available and of what science has made possible. That is a right whose content rises when science advances, and it is the clearest illustration in the whole paper of the relationship between the two subjects.

UDHR article 25(1) states the older formulation: everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and necessary social services. It is discussed in [Privacy and Health in the Universal Declaration].

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Constitution of India, article 21, protects life and personal liberty and has been construed to include the right to health and to emergency medical treatment. Article 47, a directive principle, makes it a primary duty of the State to raise the level of nutrition and the standard of living and to improve public health. The Indian material is developed in [Science Under Article 21] and [The Directive Principles on Health and Work].

The three points of engagement

An answer is much stronger if it separates the three, because they have different tests, different duty bearers and different remedies.

As a benefit: distribution

The question is who gets it. The governing provisions are article 12, article 15(1)(b) and the non-discrimination guarantee in article 2(2). The four elements in [Availability, Accessibility, Acceptability and Quality] apply directly, and General Comment 25 makes the connection explicit when it says that everyone should have equal access to the applications of science particularly when they are instrumental for the enjoyment of other economic, social and cultural rights, health being the leading example.

The characteristic failures here are the ones in [Equality and the Digital Divide]: the technology exists and is concentrated where the money is. The characteristic remedy is distributive, not prohibitory.

As an intervention: consent

The question is whether it may be done to this person. The governing principles are in [Bodily Integrity and Intervention Without Consent], and the law is worked out in Module II through the doctrine of informed consent and the standard of care. Two Indian cases hold the ground and are taken there: Samira Kohli v. Dr. Prabha Manchanda on the consent a patient actually gave, and Jacob Mathew v. State of Punjab on when a failure becomes a crime rather than a tort.

The characteristic failure is the treatment given without a consent that was real. The characteristic remedy is compensatory, and sometimes criminal.

As a capability: the new questions

The question is what the law should be at all, because there was no rule before the capability existed. Life support made it necessary to decide when treatment may be withdrawn. Prenatal diagnosis made it necessary to decide what may be done with the result, which in India produced the Pre-conception and Pre-natal Diagnostic Techniques Act 1994. Assisted reproduction made it necessary to decide who a child's parents are, which produced the Surrogacy (Regulation) Act 2021 and the Assisted Reproductive Technology (Regulation) Act 2021. Transplantation made it necessary to define death, which the Transplantation of Human Organs and Tissues Act 1994 does.

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The characteristic failure here is delay: the capability arrives, the law does not, and the gap is filled by contract, by professional guidance or by nothing at all. All four statutes named above are Module II.

Worked example

A district hospital acquires a diagnostic device that detects a treatable cancer several years earlier than existing methods. It is expensive, and the hospital can screen roughly one tenth of the eligible population each year.

As a benefit. Article 12 requires steps towards the highest attainable standard, and the arrival of the device raises what is attainable. That does not oblige the State to screen everyone immediately; economic and social rights are subject to progressive realisation within available resources. It does oblige the State to have a defensible basis for the selection, because a scarce benefit distributed without criteria is distributed by proximity, influence and wealth, which is where article 2(2) bites. Clinical risk is a defensible criterion; ability to reach the hospital on a working day is not.

As an intervention. Screening is done to a person, so consent is required, and consent to a screening test is not merely consent to the procedure. It includes understanding what a positive result will mean, what the false positive rate is and what will follow. A signature obtained without that is not informed consent in the sense of UNESCO 2005 article 6.

As a capability. The device generates knowledge that did not previously exist, and the law has to decide who else may have it. May the result be shared with an insurer? With an employer? The question is not medical at all: it is the informational privacy question from [Privacy and Surveillance], arriving through a clinic.

What ties the three together. One machine, three legal analyses, three different bodies of law, three different remedies. A candidate who runs them together produces an answer that is about health policy. A candidate who separates them produces an answer that is about law.

What it does NOT mean

The highest attainable standard is not a guarantee of health. It is a right to the conditions and services necessary for health, judged against what is attainable, and no State guarantees any individual good health.

Progressive realisation is not an excuse. It permits a State to move towards full realisation over time within its resources. It does not permit inaction, does not permit retrogression without justification, and does not displace the minimum core or the immediate obligation of non-discrimination in article 2(2).

Access to a doctor is not access to medical technology. The four elements are the reason: availability of a service does not establish accessibility, quality or acceptability, and a scheme that supplies a clinic without supplying what the clinic needs has satisfied one element.

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And the arrival of a technology can reduce rights as well as expand them. A test that can be done can be demanded, by an employer, an insurer or a family, and the pressure falls hardest on those least able to resist it. That is the dual use proposition of [Dual Use: the Same Technology Both Ways] in its medical form.

Quick revision

  • Medical technology engages the framework at three points: as a benefit (distribution, article 12 with article 15(1)(b) and article 2(2)); as an intervention (consent and bodily integrity); as a capability (new questions the old law never answered).
  • ICESCR article 12(1): the highest attainable standard of physical and mental health. The content rises as science advances, which is the clearest link between the two halves of this paper. Article 12(2) lists steps: stillbirth and infant mortality, healthy development of the child, environmental and industrial hygiene, epidemic and occupational disease, and medical service and attention in sickness.
  • UDHR article 25(1): an adequate standard of living including medical care.
  • Constitution: article 21 (health and emergency treatment), article 47 (public health as a primary duty of the State).
  • General Comment 25: equal access to applications of science particularly where instrumental for other economic, social and cultural rights.
  • The three characteristic failures: maldistribution, treatment without real consent, and delay in legislating for a new capability.
  • The four Indian statutes generated by capability, all Module II: PCPNDT 1994, Surrogacy 2021, ART 2021, Transplantation of Human Organs and Tissues 1994.

Test yourself

1. Why is the phrase "highest attainable standard" the most important wording in article 12 for this paper? Because it makes the content of the right depend on what is attainable, and what is attainable is a function of scientific progress as well as of available resources. A standard fixed absolutely would be unachievable and a standard fixed at current provision would be meaningless, whereas a standard of the highest attainable rises whenever science makes a new prevention, diagnosis or treatment possible. That is the precise mechanism by which an advance in science enlarges a legal obligation, which is the relationship this paper exists to study.

2. Set out the three points at which medical technology engages the human rights framework, with the governing test for each. As a benefit, where the question is distribution: the governing provisions are article 12, article 15(1)(b) and the non-discrimination guarantee in article 2(2), applied through availability, accessibility, quality and acceptability, and the remedy is distributive. As an intervention, where the question is whether it may be done to this person: the governing principles are consent and bodily integrity, worked out through informed consent and the standard of care, and the remedy is compensatory and sometimes criminal. As a capability, where the question is what the rule should be at all because none existed before: the characteristic failure is legislative delay, and the response is a statute.

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3. A scarce diagnostic device can screen a tenth of the eligible population. Does article 12 require the State to screen everyone, and what does it require? No. The right is to the highest attainable standard and is subject to progressive realisation within available resources, so a State is not in breach merely because it cannot immediately extend a new technology to everyone. What it requires is that the State take deliberate steps towards fuller realisation, and that the selection among those who receive the scarce benefit rest on a defensible basis. That second requirement follows from article 2(2), which attaches non-discrimination to the exercise of Covenant rights immediately and not progressively: a scarce benefit distributed without criteria is in practice distributed by proximity, influence and wealth, and clinical need is a defensible criterion where ease of access to the hospital is not.

4. Explain the "delay" failure and give two Indian examples of statutes enacted to answer it. The delay failure occurs where a technological capability arrives and the law that should govern it does not, so that the gap is filled by contract, by professional guidance or by nothing, and the persons affected have no defined rights while it lasts. Prenatal diagnostic technology made it possible to determine the sex of a foetus and was answered by the Pre-conception and Pre-natal Diagnostic Techniques Act 1994. Assisted reproductive technology raised questions of parentage, of the position of the woman carrying the child and of commercial exploitation, and was answered by the Surrogacy (Regulation) Act 2021 and the Assisted Reproductive Technology (Regulation) Act 2021. Transplantation required a legal definition of death, supplied by the Transplantation of Human Organs and Tissues Act 1994.

5. In what sense can a medical technology reduce a person's rights rather than expand them? Because a test that can be performed can also be demanded. Once a condition can be detected, an employer, an insurer, a prospective spouse or a family may require the detection as a condition of something the person needs, and the resulting knowledge can be used to exclude them. The capability therefore creates a new pressure that did not exist before, and it falls hardest on those least able to refuse. The analysis is the dual use proposition in medical form: the same technology serves the right to health when used for the patient's benefit and defeats privacy, equality and sometimes livelihood when used at another party's demand, so the legal question is never whether the technology is good but who may require it and what may be done with the result.

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Chapter Twenty-Seven

Work, Automation and Livelihood

Syllabus topic 2, "Implication of Development of Science and Technology on Human Rights"

In one line

Every technology that replaces work replaces somebody's work, and the law has always been better at protecting the job than at protecting the person who loses it.

In the wording a student can write in an exam: automation is the substitution of mechanical or computational processes for human labour, and it engages the right to work in article 6 of the ICESCR, the right to just and favourable conditions of work in article 7, and in India the right to livelihood read into article 21, not by making the introduction of technology unlawful, but by imposing on the State duties of retraining, of social protection and of ensuring that the gains and the losses of a technological change are not borne by entirely different people.

Why the law has this at all

This is the oldest question in the subject. It is older than human rights law, and the pattern has repeated at least three times: the mechanisation of textile production, the mechanisation of agriculture, and the automation of clerical and now cognitive work. Each time three things were true together.

The technology increased total output. More cloth, more grain, more transactions. That is not in dispute and an answer that disputes it is answering a different question.

The gains and the losses fell on different people. The gain went to those who owned the technology and to consumers generally; the loss fell on a specific, identifiable and usually poorer group who had spent years acquiring a skill that stopped being worth anything.

The transition was where the suffering was. In the long run new work appeared. The people displaced were not the people who got it, and "in the long run" is a period measured in a working life.

Human rights law has nothing to say about the first proposition and everything to say about the second and third. That is the correct framing of the topic, and a candidate who states it in those terms has already distinguished the answer from an essay about robots.

The provisions

ICESCR article 6(1) recognises the right to work, which includes the right of everyone to the opportunity to gain his living by work which he freely chooses or accepts, and requires States to take appropriate steps to safeguard the right. Article 6(2) is the one that matters here: the steps to achieve full realisation shall include technical and vocational guidance and training programmes, policies and techniques to achieve steady economic, social and cultural development and full and productive employment under conditions safeguarding fundamental political and economic freedoms.

Read article 6(2) slowly. A treaty of 1966 places vocational training in the mandatory content of the right to work. That is the provision under which a displaced worker's claim is made, and almost nobody cites it.

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Article 7 recognises the right of everyone to the enjoyment of just and favourable conditions of work, which ensure in particular fair wages and equal remuneration for work of equal value without distinction of any kind, women being guaranteed conditions not inferior to those of men with equal pay for equal work; a decent living for the worker and their family; safe and healthy working conditions; equal opportunity for promotion subject to no considerations other than seniority and competence; and rest, leisure, reasonable limitation of working hours and periodic holidays with pay.

Two limbs of article 7 do work in this chapter that is easy to miss. Safe and healthy working conditions is the provision under which the introduction of a hazardous process is challenged, which links this chapter to [Environment and Technological Harm]. And equal opportunity for promotion subject to no considerations other than seniority and competence is engaged where the assessment is made by an automated system, which links it to [Artificial Intelligence and Decisions by Machines].

UDHR article 23 states the right to work, to free choice of employment, to just and favourable conditions and to protection against unemployment.

CEDAW article 11(3) requires that protective legislation relating to the matters covered by the employment article be reviewed periodically in the light of scientific and technological knowledge and revised, repealed or extended as necessary. It is the only provision in the base that expressly requires labour law to be kept in step with technological change, and it should be cited whenever the question is what the State ought to have done.

The Indian position

Article 21 has been construed to include the right to livelihood, on the reasoning that the right to life would be reduced to animal existence if it did not include the means by which a person lives. The doctrine matters here because it converts the loss of a means of living into a question about a fundamental right, though it does not follow that any particular job is protected.

Article 39(a), a directive principle, requires the State to direct its policy towards securing that the citizens, men and women equally, have the right to an adequate means of livelihood.

Article 41 requires the State, within the limits of its economic capacity and development, to make effective provision for securing the right to work, to education and to public assistance in cases of unemployment, old age, sickness and disablement, and in other cases of undeserved want.

Article 43 requires the State to endeavour to secure to all workers a living wage, conditions of work ensuring a decent standard of life and full enjoyment of leisure and social and cultural opportunities.

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Taken together the Indian frame is: a fundamental right to livelihood, with the machinery of protection sitting in Part IV. That asymmetry is the source of most of the difficulty, because the enforceable right is stated at a high level of generality and the specific obligations are in the unenforceable part.

What the right does and does not require

This is the heart of the chapter and the place to be precise.

It does not require that a technology be kept out. No provision in the base gives a worker a right that their employer continue using an obsolete process, and a right of that kind would defeat article 15(1)(b) and article 15(2), which require the development and diffusion of science. An answer that concludes that automation violates the right to work has reasoned from the wrong premise.

It does not guarantee any particular job. The right in article 6 is to the opportunity to gain a living by work freely chosen or accepted, which is a right to a functioning labour market and to the State's steps towards full and productive employment, not a right to remain in one post.

It does require the State to act on the transition. Article 6(2) puts technical and vocational guidance and training in the mandatory content. Article 41 requires provision for public assistance in unemployment. CEDAW article 11(3) requires the law itself to be reviewed as technology changes. The obligation is therefore concrete: retraining, income support during transition, and legislative review.

It does require attention to who bears the loss. Article 2(2) attaches non-discrimination to the exercise of Covenant rights. Where displacement falls disproportionately on women, on a caste or on a region, the equality analysis in [Equality and the Digital Divide] applies to the displacement itself and not only to access.

And it does require that the new work be work. Article 7's standards do not lapse because the work is mediated by a platform. Fair wages, safe conditions, rest and reasonable limitation of hours are stated as attributes of work, not of a contractual form, so an arrangement that reclassifies a worker without changing what they do engages article 7 directly.

Worked example

A State transport undertaking introduces automated fare collection and closes the conductor grade, which employs about four thousand people, most of whom joined between fifteen and twenty-five years ago and have no other qualification. It offers a redundancy payment calculated on years of service.

Is the introduction of the technology unlawful? No, and an answer should say so at once. Nothing in article 6, article 21 or the directive principles gives a worker the right to the continuation of a superseded process.

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What obligations are engaged? Article 6(2) directly: technical and vocational guidance and training programmes are part of the mandatory content of the right to work, so the question is whether retraining was offered, whether it was real, and whether it led anywhere. Article 41: public assistance in cases of unemployment is what the transition period requires. Article 39(a): adequate means of livelihood, which is the standard against which the redundancy payment is measured, since a payment that does not bridge the period to new employment has not secured a means of livelihood, only softened its loss.

Is there an equality question? Test it rather than assume it. If the conductor grade was one of the few open to a particular group, its closure removes that group's route into the undertaking, and a facially neutral decision has an unequal effect.

What about those redeployed? Article 7 applies to the new posts: equal opportunity for promotion on seniority and competence, and conditions not inferior. A redeployment to a grade with no progression satisfies the form of continued employment and not the substance of article 7.

The realistic conclusion. The undertaking may automate. It must retrain, support the transition, examine the distribution of the loss, and preserve conditions for those who remain. That is a lawyer's answer, and it is more useful to the four thousand than an argument that the machines should be banned.

What it does NOT mean

Technology does not simply destroy work. It changes its composition, and the historical record is that total employment has not fallen. That is not a reason for complacency, because the framework's concern is the distribution and the transition, and both can be severe while the aggregate is unchanged.

"New jobs will appear" is not an answer to a rights claim. It may be true and still irrelevant, because the person displaced is not the person who takes the new job, and article 6(2) addresses precisely that gap.

The right to work is not a right to be employed by anybody in particular. The duty bearer is the State, and its duty is to take steps towards full and productive employment, not to direct a private employer to retain a post.

And a productivity gain is not automatically a public benefit. Whether it is depends on where it goes, which is a distributive question and therefore a question the equality provisions reach.

Quick revision

  • ICESCR article 6(1): the right to work includes the opportunity to gain a living by work freely chosen or accepted. Article 6(2): steps shall include technical and vocational guidance and training programmes and policies for full and productive employment. Article 6(2) is the displaced worker's provision.
  • Article 7: just and favourable conditions, including fair wages and equal pay for work of equal value, a decent living, safe and healthy working conditions, equal opportunity for promotion on seniority and competence only, and rest and reasonable limitation of hours.
  • UDHR article 23; CEDAW article 11(3), labour law to be reviewed in the light of scientific and technological knowledge.
  • India: article 21 includes the right to livelihood; article 39(a) adequate means of livelihood; article 41 public assistance in unemployment; article 43 living wage and decent conditions. The enforceable right is general, the specific duties sit in Part IV.
  • The law does not forbid the technology and does not protect a particular job. It requires retraining, transitional support, legislative review, and attention to who bears the loss.
  • The three constants of every wave: output rises; gains and losses fall on different people; the harm is in the transition.
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Test yourself

1. Which provision of the Covenant is the displaced worker's provision, and why? Article 6(2), which provides that the steps to be taken to achieve the full realisation of the right to work shall include technical and vocational guidance and training programmes, and policies and techniques to achieve steady development and full and productive employment under conditions safeguarding fundamental political and economic freedoms. It is the displaced worker's provision because it places retraining inside the mandatory content of the right rather than leaving it to policy, so a State that permits a technological displacement without providing vocational guidance and training has failed a step the treaty says its steps shall include. It is also the provision that answers the objection that new work will appear, since it addresses the position of the person during the interval.

2. Does the right to work make the introduction of labour-replacing technology unlawful? Give reasons. No. Article 6(1) protects the opportunity to gain a living by work freely chosen or accepted, not the continuation of any particular post or process, and the duty bearer is the State rather than the individual employer. A right to the continuance of a superseded process would also conflict with article 15(1)(b) and article 15(2), which give everyone the right to enjoy the benefits of scientific progress and require States to take steps for the development and diffusion of science. What the framework requires is not prohibition but management of the transition: vocational training under article 6(2), public assistance in unemployment under article 41 in the Indian scheme, review of protective labour legislation in the light of technological knowledge under CEDAW article 11(3), and attention under article 2(2) to whether the loss falls disproportionately on a protected group.

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3. Identify two limbs of article 7 that bear on technological change and explain how. Safe and healthy working conditions is engaged whenever a new process introduces a hazard, so it is the provision under which the introduction of a dangerous technology is challenged by those who must work with it, and it connects this topic to industrial disaster and environmental harm. Equal opportunity for everyone to be promoted to an appropriate higher level, subject to no considerations other than seniority and competence, is engaged where selection or assessment is performed by an automated system, because a system that scores on correlates of past outcomes introduces considerations other than seniority and competence, which is what the limb forbids.

4. Set out the Indian constitutional position and explain why its structure creates difficulty. Article 21 has been construed to include the right to livelihood, on the footing that the right to life would be reduced to mere animal existence if it excluded the means by which a person lives. Article 39(a) directs the State to secure to citizens, men and women equally, the right to an adequate means of livelihood; article 41 requires effective provision, within the State's economic capacity, for the right to work and for public assistance in unemployment; and article 43 requires endeavour towards a living wage and decent conditions. The difficulty is structural: the enforceable guarantee in Part III is stated at a high level of generality, while the specific obligations that would answer a displacement, retraining and unemployment assistance, sit in Part IV and are not enforceable by a court, so the right that can be asserted is vague and the duties that are precise cannot be compelled.

5. A platform reclassifies its delivery riders as independent contractors while their work is unchanged. Which provision is engaged and why does the contractual form not settle the question? Article 7 is engaged, which recognises the right of everyone to the enjoyment of just and favourable conditions of work, including fair wages and equal remuneration for work of equal value, a decent living, safe and healthy working conditions, and rest, leisure and reasonable limitation of working hours with periodic holidays with pay. The contractual form does not settle the question because article 7 states these as attributes of work and of the person who performs it, not as incidents of a particular legal relationship, and article 6(1) speaks of the opportunity to gain a living by work rather than of employment in a technical sense. A reclassification that changes the label while leaving the direction, the hours and the economic dependence intact therefore alters who bears the cost of the standards without altering the standards themselves, and CEDAW article 11(3) supplies the further point that protective legislation is to be reviewed and extended as technological knowledge changes, which is exactly what a new mode of engaging labour calls for.

Contents This chapter on its own page

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Chapter Twenty-Eight

Expression and Information Technology

Syllabus topic 2, "Implication of Development of Science and Technology on Human Rights"

In one line

The same technology gave ordinary people the largest platform in history and gave the State the ability to switch it off.

In the wording a student can write in an exam: information technology has affected freedom of expression in both directions at once. It has enlarged the right in substance, by removing the intermediaries whose ownership of presses and broadcasting licences had confined mass speech to a few, and by making the right to seek and receive information practically exercisable for the first time. And it has supplied the State and private platforms with means of restriction that the older law never contemplated: blocking, filtering, removal at scale, shutdowns and criminal provisions drafted so widely that they reach protected speech.

Why the law has this at all

Article 19 has always protected three activities, and the older law was preoccupied with only one of them.

The neglected two matter here. When the means of publication were expensive, the right to impart information belonged in practice to those who owned the means, and the right to seek and receive was limited to what they chose to publish. The technology inverted that. It made imparting nearly costless and made seeking a genuine activity rather than a formality.

That is a substantial expansion of a right by technological means, and it is the best available example in this paper of a technology serving rights rather than threatening them. An answer that treats information technology only as a danger has missed half the topic and will not be able to explain the case law, which is largely about protecting the expansion.

The provisions

UDHR article 19: everyone has the right to freedom of opinion and expression; this right includes freedom to hold opinions without interference and to seek, receive and impart information and ideas through any media and regardless of frontiers.

The words "any media" and "regardless of frontiers" were written in 1948 and are the reason the right needed no amendment to cover a technology invented decades later.

ICCPR article 19 makes it binding and adds the limitation structure, which is where the law is actually argued:

  • Article 19(1): the right to hold opinions without interference. This one is absolute; no limitation clause touches it.
  • Article 19(2): the right to freedom of expression, including freedom to seek, receive and impart information and ideas of all kinds, regardless of frontiers, orally, in writing or in print, in the form of art, or through any other media of his choice.
  • Article 19(3): the exercise of the rights in paragraph 2 carries with it special duties and responsibilities, and may therefore be subject to certain restrictions, but these shall only be such as are provided by law and are necessary for respect of the rights or reputations of others, or for the protection of national security or of public order, or of public health or morals.
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Note the structure, because it is the same three-part test used in [Privacy and Surveillance]: a law, a listed aim, and necessity. Note also that the list of aims in article 19(3) is closed. A restriction serving an aim not on the list fails whatever its merits.

Constitution of India, article 19(1)(a), guarantees freedom of speech and expression, and article 19(2) permits reasonable restrictions on eight enumerated grounds. That list too is closed, which is the pivot of the Indian case.

The Indian case

Shreya Singhal v. Union of India, AIR 2015 SC 1523, (2015) 5 SCC 1, decided on 24 March 2015 by Chelameswar and Nariman JJ, judgment by Nariman J.

Facts. Writ petitions challenged section 66A of the Information Technology Act 2000, inserted by the 2008 amendment, which punished sending by a computer resource or communication device information that was grossly offensive or had menacing character, or that the sender knew to be false but sent for the purpose of causing annoyance, inconvenience, danger, obstruction, insult, injury, criminal intimidation, enmity, hatred or ill will. The petitions followed arrests for material posted online, and also challenged section 69A and the Blocking Rules 2009, section 79 and the Intermediary Guidelines Rules 2011, and section 118(d) of the Kerala Police Act.

Held, on section 66A. It is struck down in its entirety, being violative of article 19(1)(a) and not saved under article 19(2). The Court held it unconstitutional on the ground of overbreadth, because it takes within its sweep protected speech and speech that is innocent in nature, and is therefore liable to be used so as to have a chilling effect on free speech.

Held, on the rest of the scheme. Section 69A and the Blocking Rules 2009 are constitutionally valid. Section 79 is valid subject to section 79(3)(b) being read down to mean that an intermediary, on receiving actual knowledge from a court order or on being notified by the appropriate government or its agency that unlawful acts relatable to article 19(2) are going to be committed, then fails expeditiously to remove or disable access to the material; the Intermediary Guidelines Rules 2011 are valid subject to rule 3(4) being read down in the same way, the knowledge spoken of being only through the medium of a court order. Section 118(d) of the Kerala Police Act is struck down as violative of article 19(1)(a) and not saved by article 19(2).

Why it matters here. It is the clearest Indian instance of the sequence this paper describes: a technology creates a capability; Parliament legislates in wide terms because it cannot foresee the uses; a court cuts the legislation back on constitutional grounds. It also decides the practical question for every platform, by making a court order, rather than a private complaint, the trigger for an intermediary's duty to remove. A candidate should note both halves of the decision. Answers that say only that section 66A was struck down leave out the part that governs everyday practice.

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A warning about the text. The consolidated copy of the Information Technology Act served by India Code still prints section 66A. It is void, and a candidate who paraphrases it as live law has made an error that the judgment itself forecloses.

Restriction in the new forms

The older law of speech contemplated a prosecution after publication, or a licence before it. Technology produced four mechanisms that fit neither description, and they should be distinguished in an answer because their legal treatment differs.

  1. Blocking. The State orders access to specified material disabled. In India this is section 69A, upheld in Shreya Singhal, the Court noting the safeguards in the section and the Rules. It is prior restraint in substance and is treated as permissible where the statutory conditions are met.
  2. Intermediary liability. The State makes the carrier answerable for what the user says, which converts a private platform into a censor with an incentive to remove first and ask later. The Shreya Singhal reading down of section 79(3)(b) is the answer to that incentive.
  3. Shutdown. Access is suspended for a region or a population, restricting not one speaker but everybody's right to seek and receive. It is treated under proportionality, and the leading Indian authority is queued for Module IV.
  4. Private moderation. The largest volume of restriction is imposed by platforms under their own terms, where no State action is involved and the human rights framework operates, if at all, through the State's duty to protect rather than its duty to respect. This is the point developed in [The State's Duty to Regulate Technology].

Worked example

A State issues an order requiring platforms to remove, within six hours of a complaint from any government officer, content that is "likely to disturb public tranquillity", failing which the platform loses its protection from liability for all user content.

Which right, and whose? Article 19(1)(a) and article 19(2) of the Covenant, of the person whose content is removed; and the right to seek and receive of everybody who would have read it. The second is usually forgotten and is the stronger point where the removal is at scale.

Legality. Is "likely to disturb public tranquillity" precise enough that a person can foresee what is prohibited? Shreya Singhal struck down section 66A partly because terms such as "grossly offensive" and "annoyance" left a person of ordinary intelligence unable to know what was forbidden.

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Legitimate aim. Public order is on the list in both article 19(3) and article 19(2) of the Constitution, so the aim is available.

Necessity and proportionality. Six hours with liability for the whole platform on failure is an incentive to remove everything complained of without examining it, which is the structural objection to intermediary liability. The reading down in Shreya Singhal addresses exactly this by requiring a court order.

Overbreadth and chilling effect. The two doctrines the case turns on. The scheme reaches protected speech along with unprotected, and its effect is that speakers avoid lawful speech for fear of the consequence. Both are grounds of invalidity in themselves, independent of whether the power is in fact abused.

What it does NOT mean

It does not mean online speech has a special or lesser protection. The right applies through "any media"; the medium changes the analysis of proportionality, not the standard.

Striking down a provision is not deregulation. Shreya Singhal upheld the blocking power and preserved intermediary liability in a narrowed form. It replaced a bad rule with a workable one.

Private removal is not censorship in the constitutional sense, because the constitutional guarantee runs against the State. That is a reason to reach it through the duty to protect and through regulation, not a reason to treat it as unimportant, since it is quantitatively the largest restriction there is.

And the right to hold opinions is absolute. Article 19(1) has no limitation clause, which matters when a technology proposes to infer or influence what a person thinks rather than to restrict what they say.

Quick revision

  • UDHR article 19 and ICCPR article 19(2): freedom to seek, receive and impart information and ideas through any media and regardless of frontiers. The technology expanded the first two, which the older law neglected.
  • ICCPR article 19(1), the right to hold opinions without interference, is absolute. Article 19(3) permits restrictions only if provided by law and necessary for a closed list of aims: rights or reputations of others, national security, public order, public health or morals.
  • Constitution: article 19(1)(a) with the eight grounds in article 19(2), also a closed list.
  • Shreya Singhal (2015): section 66A struck down in its entirety, violative of article 19(1)(a), not saved by article 19(2), on the ground of overbreadth because it sweeps in protected and innocent speech and has a chilling effect. Section 69A and the Blocking Rules 2009 valid. Section 79 valid subject to section 79(3)(b) being read down to require actual knowledge by court order or government notification; rule 3(4) read down likewise. Section 118(d) of the Kerala Police Act struck down.
  • India Code's consolidated Act still prints section 66A. It is void.
  • Four new mechanisms of restriction: blocking, intermediary liability, shutdown, private moderation.
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Test yourself

1. Which two of the three activities protected by article 19 were transformed by information technology, and why does that matter? The freedom to impart information and the freedom to seek and receive it. When the means of mass publication were expensive, the freedom to impart belonged in practice to those who owned presses and broadcasting licences, and the freedom to seek and receive was confined to what those owners chose to publish. Technology made imparting nearly costless and made seeking a real activity. It matters because it establishes that the relationship between this technology and this right is not only one of threat: the same development that supplied new means of restriction also enlarged the substance of the right, which is the dual use proposition applied to expression.

2. Set out what was decided in Shreya Singhal, on all four matters before the Court. Section 66A of the Information Technology Act 2000 was struck down in its entirety as violative of article 19(1)(a) and not saved by article 19(2), on the ground of overbreadth, because it takes within its sweep protected and innocent speech and is liable to be used so as to have a chilling effect. Section 69A and the Blocking Rules 2009 were held constitutionally valid. Section 79 was held valid subject to section 79(3)(b) being read down, so that an intermediary's duty arises only on actual knowledge received through a court order or on notification by the appropriate government or its agency that unlawful acts relatable to article 19(2) are going to be committed; the Intermediary Guidelines Rules 2011 were held valid subject to rule 3(4) being read down in the same manner. Section 118(d) of the Kerala Police Act was struck down as violative of article 19(1)(a) and not saved by article 19(2).

3. Explain overbreadth and chilling effect, and why each is a ground of invalidity independent of actual abuse. A provision is overbroad when its terms reach beyond the speech that may legitimately be restricted and take in speech that is protected or innocent. A chilling effect is the consequence that speakers, uncertain where the line falls and unwilling to risk prosecution, refrain from lawful expression. Each is independent of actual abuse because the injury is done by the existence of the provision rather than by its enforcement: a person who does not speak because of a law that might reach them has lost the right without any prosecution occurring, and the loss cannot be repaired by an assurance that the power will be used sparingly, since the assurance does not restore the certainty the speaker lacked.

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4. Why is intermediary liability a structural threat to expression, and how did the Court answer it? Because it places the cost of a wrong decision entirely on one side. A platform that removes lawful content loses nothing, while a platform that leaves unlawful content in place risks liability for everything its users say, so any rule that makes liability turn on a private complaint gives the platform an overwhelming incentive to remove first and examine afterwards. The censor is then a private party with no duty to the speaker and no procedure the speaker can invoke. The Court answered it by reading down section 79(3)(b) so that the intermediary's obligation is triggered only by actual knowledge through a court order, or by notification from the appropriate government or its agency relating to acts covered by article 19(2), and by reading rule 3(4) of the Intermediary Guidelines Rules 2011 in the same way.

5. Why does it matter that the list of permissible aims in article 19(3) is closed? Because it removes from the State the argument that a restriction is justified by some purpose it considers valuable but that the instrument does not name. A restriction on expression must be provided by law and necessary for respect of the rights or reputations of others, or for the protection of national security, public order, public health or morals, and no other aim will do. A State that restricts speech to protect the dignity of an office, to prevent embarrassment, or to preserve an official account of events is therefore defeated at the second stage without any inquiry into proportionality. Article 19(2) of the Constitution works in the same way with its own eight enumerated grounds, which is why so much Indian argument is about whether a restriction can be fitted into one of them.

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Chapter Twenty-Nine

Environment and Technological Harm

Syllabus topic 2, "Implication of Development of Science and Technology on Human Rights"

In one line

Industrial technology concentrates a risk in one place and spreads the harm over everybody who lives near it, and the ordinary law of negligence cannot reach that.

In the wording a student can write in an exam: technological harm to the environment engages the right to life, the right to health in article 12 of the ICESCR, including the duty in article 12(2)(b) to improve all aspects of environmental and industrial hygiene, and the right to safe and healthy working conditions in article 7(b); and because the person harmed by an industrial escape can prove neither the internal process that caused it nor any want of care, the Indian courts have replaced fault with a rule of absolute liability resting on the proposition that an enterprise which profits from a hazardous activity must absorb the cost of its accidents.

Why the law has this at all

The ordinary law of tort was built for accidents between people who could see each other. It asks who was careless, and it requires the person harmed to prove it. Both requirements fail completely in the face of industrial technology, and they fail for reasons that are structural rather than evidential.

The victim cannot see inside the process. A person whose lungs are damaged by a gas that reached them in their sleep cannot say which valve failed, what the maintenance schedule was, or whether the shift supervisor was trained. The knowledge is entirely inside the enterprise.

Care may have been taken and the harm may still occur. A hazardous process is hazardous even when it is run properly. A rule that excuses the enterprise on proof of reasonable care leaves the loss with the people who happened to live nearby and had no say in the matter.

The harm is spread thin and wide. Thousands of small injuries, each too small to litigate alone, and many of them appearing years later.

The response of Indian law was to change the rule rather than to improve the evidence, and that response is the most important Indian contribution to this whole paper.

The provisions

ICESCR article 12(2)(b) requires that the steps taken towards the right to health include those necessary for the improvement of all aspects of environmental and industrial hygiene. It is the treaty hook for this topic and it is regularly overlooked in favour of article 12(1).

ICESCR article 7(b) guarantees safe and healthy working conditions, which reaches the people inside the plant, as against the people outside it.

The 1975 Declaration, paragraph 6, requires States to protect all strata of the population, socially and materially, from possible harmful effects of the misuse of scientific and technological developments. Paragraph 8 requires effective measures, including legislative measures, to prevent and preclude the utilisation of scientific and technological achievements to the detriment of human rights and the dignity of the human person.

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Constitution of India, article 21, protects life, and has been construed to include a right to a wholesome environment. Article 48A directs the State to protect and improve the environment and to safeguard the forests and wild life, and article 51A(g) makes it a fundamental duty of every citizen to protect and improve the natural environment and to have compassion for living creatures. These are worked in [The Environment in the Constitution].

The rule: absolute liability

M.C. Mehta v. Union of India, AIR 1987 SC 1086, (1987) 1 SCC 395, decided on 20 December 1986 by five judges, judgment by Bhagwati CJ.

Facts. The petitioners sought, by a writ petition under article 32, the closure of the units of Shriram Foods and Fertiliser Industries on the ground that they were hazardous to the community. While the petition was pending, oleum gas escaped from one of the units. The Delhi Legal Aid and Advice Board and the Delhi Bar Association applied for compensation for those harmed. A Bench of three judges, permitting Shriram to restart on conditions, referred the compensation applications to five judges because questions of great constitutional importance arose, including the scope of the Court's jurisdiction under article 32.

Held, the new rule. The Court refused to be confined to the rule in Rylands v. Fletcher as developed in England, saying that India no longer needed the crutches of a foreign legal order and could evolve a new principle to meet the situations thrown up by hazardous industry. It held that an enterprise engaged in a hazardous or inherently dangerous industry which poses a potential threat to the health and safety of those working in the factory and residing in the surrounding areas owes an absolute and non-delegable duty to the community to ensure that no harm results from the hazardous nature of the activity. The activity must be conducted with the highest standards of safety, and if harm results the enterprise is absolutely liable to compensate; it is no answer that it took all reasonable care and that the harm occurred without negligence.

Held, why the enterprise must bear it. Permission to carry on such an activity for private profit is to be treated as conditional on the enterprise absorbing the cost of accidents as an item of its overheads, and the activity can be tolerated only on condition that the enterprise indemnifies all who suffer, whether it is carried on carefully or not, since the enterprise alone has the resources to discover and guard against the hazard. The liability is not subject to the exceptions that qualify strict liability under Rylands v. Fletcher. The Court added that compensation must be correlated to the magnitude and capacity of the enterprise, so that it has a deterrent effect: the larger and more prosperous the enterprise, the greater the compensation payable.

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Why it matters here. It is the point at which Indian law accepted that a technology's characteristic harm cannot be handled by a rule designed for careless individuals. Three moves in it are worth learning separately: fault is removed; the exceptions are removed; and the measure of compensation is tied to the size of the defendant rather than only to the loss of the plaintiff, which converts a compensatory rule into a deterrent one.

The failure: Bhopal

Union Carbide Corporation v. Union of India, AIR 1992 SC 248, (1991) 4 SCC 584, decided on 3 October 1991 by five judges.

Facts. Proceedings arising out of the Bhopal gas leak of December 1984. The Union of India sued Union Carbide Corporation in the United States District Court for the Southern District of New York; those proceedings ended when the company's plea of forum non conveniens, that another court was the more appropriate forum, was upheld. The Union of India then sued in the District Court at Bhopal, and the claim was settled by orders of the Supreme Court of 14 and 15 February 1989. The settlement was challenged by review and by writ petitions, on grounds including that no fairness hearing had been afforded to the victims, that there was no re-opener clause if the fund proved inadequate, that the medical documentation and categorisation of injuries were unreliable, and that the quashing of pending criminal proceedings as part of the settlement was beyond the Court's power and opposed to public policy.

Held. The Court examined the absence of a fairness hearing and of a re-opener clause, the adequacy of the fund and the position should it prove insufficient, and whether the mere possibility that medical documentation and categorisation were faulty could justify setting the settlement aside. On its own powers it held that the inherent jurisdiction under articles 136 and 142 to withdraw, transfer and finally dispose of the suits and the pending criminal proceedings was not taken away by article 139A, and it construed the words "cause or matter" in article 142. It restored the criminal proceedings that the settlement had quashed. It also stated that an award of compensation is to be proportionate to the economic superiority of the offender.

Why it matters here. It is the case in which the system met the largest industrial disaster of the technological age and found its own machinery unequal to it. Note what the substantive rule could not do. M.C. Mehta had been decided two years before the settlement and states a rule of absolute liability with compensation geared to the size of the enterprise. What defeated the victims was not the absence of a rule. It was forum, which moved the claim between two legal systems and cost years; representation, since the persons whose claims were settled were not heard before the settlement; proof, since the categorisation of injury on which every individual award depended was contested; and time. A candidate who can say that the failure was procedural rather than doctrinal has understood the pair of cases.

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Worked example

A chemical plant on the edge of a town has an emission that damages crops on adjoining land over several years, and is later associated with a raised incidence of a respiratory illness among residents. The company shows that it operated within the limits of its consent to operate and that its equipment was maintained to the manufacturer's specification.

Does the compliance defence work? No, on M.C. Mehta. Absolute liability is not displaced by proof of reasonable care, and operating within a licence is a form of that proof. Compliance is relevant to prosecution and to the regulator; it does not answer a claim in absolute liability.

Who may sue and for what? The crop damage is a straightforward loss and is provable. The illness is where the difficulty lies: latency, multiple causes, and a population that is exposed rather than a claimant who is injured. This is the point at which the substantive rule is intact and the evidence is not, which is precisely the Bhopal problem in miniature.

What does the measure of compensation depend on? Under M.C. Mehta, on the magnitude and capacity of the enterprise as well as the harm, so that the award deters. That is a rule most students can state and few apply, and applying it is what makes an answer look like law rather than recitation.

Which rights are engaged beyond tort? Article 21 for the residents; article 7(b) for those working inside; article 12(2)(b) for the State's duty as to environmental and industrial hygiene; and paragraph 8 of the 1975 Declaration for the State's duty to take legislative measures rather than to wait for litigation. The precautionary principle in [The Precautionary Principle] governs what should have happened before the plant was permitted at all.

What it does NOT mean

Absolute liability is not strict liability. They are routinely confused and the difference is the whole point of M.C. Mehta: strict liability under Rylands v. Fletcher comes with exceptions, and the Court held that its rule is not subject to them.

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It does not apply to every industry. The rule is framed for an enterprise engaged in a hazardous or inherently dangerous activity, and that characterisation is the first thing an answer must establish rather than assume.

A liability rule is not a safety system. It operates after the harm. Article 12(2)(b) and paragraph 8 of the 1975 Declaration are about prevention, and the practical protection of a population comes from the consent conditions, the inspection and the siting decision, not from the prospect of a suit.

And compensation is not restoration. Bhopal is the standing demonstration. A fund, however calculated, does not undo an exposure, and the framework's preference for prevention follows from that.

Distinctions

Rylands v. Fletcher strict liabilityM.C. Mehta absolute liability
BasisEscape of a dangerous thing from a non-natural user of landEngagement in a hazardous or inherently dangerous activity
FaultNot requiredNot required
ExceptionsAct of God, act of a stranger, plaintiff's own default, statutory authority, consentNone
MeasureThe loss sufferedThe loss, correlated to the magnitude and capacity of the enterprise, so as to deter
DutyOwed as an incident of land useAbsolute and non-delegable duty to the community

Quick revision

  • ICESCR article 12(2)(b): steps for the improvement of all aspects of environmental and industrial hygiene. Article 7(b): safe and healthy working conditions. 1975 Declaration, paragraphs 6 and 8: protect from harmful effects of misuse; effective measures, including legislative measures.
  • Constitution: article 21, article 48A (State to protect and improve the environment), article 51A(g) (fundamental duty of the citizen).
  • M.C. Mehta (1986), five judges, Bhagwati CJ: a hazardous or inherently dangerous enterprise owes an absolute and non-delegable duty to the community; absolutely liable for resulting harm; no answer that all reasonable care was taken; not subject to the Rylands exceptions; compensation correlated to the magnitude and capacity of the enterprise to deter.
  • Union Carbide (1991): the Bhopal settlement reviewed; fairness hearing and re-opener clause considered; articles 136 and 142 not taken away by article 139A; criminal proceedings restored; compensation proportionate to the economic superiority of the offender.
  • The pair teaches the lesson: the substantive rule was strong and the outcome was still poor, because the failures were forum, representation, proof and time. Doctrine is worth what the procedure can deliver.

Test yourself

1. State the rule in M.C. Mehta and identify the three ways it departs from Rylands v. Fletcher. An enterprise engaged in a hazardous or inherently dangerous industry which poses a potential threat to the health and safety of those working in the factory and residing in the surrounding areas owes an absolute and non-delegable duty to the community to ensure that no harm results; it must conduct the activity with the highest standards of safety; and if harm results it is absolutely liable to compensate, it being no answer that all reasonable care was taken and that the harm occurred without negligence. It departs from Rylands v. Fletcher in that the liability is not subject to any of the exceptions that qualify strict liability; in that its basis is engagement in a hazardous activity rather than a non-natural user of land and the escape of a dangerous thing; and in that the measure of compensation is correlated to the magnitude and capacity of the enterprise so as to have a deterrent effect, rather than being confined to the loss suffered.

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2. Why does a fault-based rule fail the victim of an industrial escape? Because both of its requirements are unattainable for that victim. It requires proof of want of care, and the knowledge of the process, the maintenance and the training lies entirely inside the enterprise, so the person harmed cannot identify what failed. And it excuses the defendant where care was taken, which leaves the loss with people who live nearby and had no part in choosing the hazard, even though a hazardous process remains hazardous when properly run. The Court's answer in M.C. Mehta was to change the rule rather than to try to improve the plaintiff's evidence, reasoning that the enterprise alone has the resources to discover and guard against the hazard and that the cost of accidents should be an item of its overheads.

3. What was decided in Union Carbide, and why is it said that the failure there was procedural rather than doctrinal? The Court reviewed the settlement of the Bhopal claims recorded by its orders of 14 and 15 February 1989, considering the absence of a fairness hearing and of a re-opener clause, the adequacy of the fund, and whether the possibility of faulty medical documentation and categorisation could justify setting the settlement aside; it held that its inherent powers under articles 136 and 142 were not taken away by article 139A, construed 'cause or matter' in article 142, restored the criminal proceedings that had been quashed, and stated that compensation should be proportionate to the economic superiority of the offender. The failure is called procedural because the substantive rule was already available: M.C. Mehta had been decided in December 1986, two years before the settlement, and states absolute liability with a deterrent measure of compensation. What defeated the victims was the forum contest that moved the claim between two legal systems, the settlement of their claims without their being heard, the contested categorisation of injury on which each individual award depended, and the passage of time.

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4. A company shows it operated within the terms of its consent to operate and maintained its plant to specification. Is that a defence to a claim in absolute liability? No. Absolute liability is not displaced by proof that reasonable care was taken, and compliance with a licence and with a maintenance specification is a form of that proof. M.C. Mehta states in terms that it should be no answer to the enterprise to say that it had taken all reasonable care and that the harm occurred without any negligence on its part, and that the liability is not subject to the exceptions applicable under Rylands v. Fletcher, among which statutory authority is one. Compliance remains relevant to a prosecution and to the regulator's decisions, but it does not answer the civil claim.

5. Why does the framework prefer prevention to compensation in this area, and which provisions carry that preference? Because the characteristic harms of industrial technology cannot be undone: an exposure cannot be reversed, latency means the injury may appear years later, and the harm is spread across a population in increments too small to litigate individually, so that even a generous fund reaches some people late and others not at all. Bhopal is the standing demonstration. The preference is carried by article 12(2)(b) of the Covenant, which requires steps for the improvement of all aspects of environmental and industrial hygiene; by article 7(b), which requires safe and healthy working conditions; and by paragraph 8 of the 1975 Declaration, which requires effective measures including legislative measures to prevent and preclude the use of scientific and technological achievements to the detriment of human rights, prevention being the operative word in each.

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Chapter Thirty

Weapons, Warfare and the Right to Life

Syllabus topic 2, "Implication of Development of Science and Technology on Human Rights"

In one line

The clearest case of science defeating human rights is the one where that is what the science was for.

In the wording a student can write in an exam: weapons are the limiting case of the relationship between science and human rights, because they are the application in which the destructive capacity is the object rather than a side effect, and they engage the right to life in article 6 of the ICCPR, the prohibition on cruel, inhuman or degrading treatment in article 7, and the whole of the 1975 Declaration, whose preamble and operative paragraphs are addressed principally to the misuse of scientific and technological progress for purposes of war.

Why the law has this at all

The modern relationship between science and human rights begins here, and the dates make the point. The Universal Declaration was adopted in 1948, three years after the atomic bombings, by an organisation created to prevent a recurrence of the war that produced them. The Nuremberg Code was written in 1947 out of a trial about experiments conducted in a war. The 1975 Declaration was adopted in the middle of the Cold War, and its preamble is explicit about what worried its drafters.

Two features of weapons technology make it a distinct legal problem rather than merely a severe one.

Intention. In every other chapter the harm is a by-product, foreseeable or not, of an application meant to do something else. Here the capability to kill is the specification. That removes the argument, available everywhere else, that the technology is neutral between uses.

Irreversibility and scale. The harms of the most serious weapons cannot be undone, cannot be confined to the parties to a conflict, and in the case of the most powerful may be incompatible with the continued existence of a population. A framework built on remedies has little to offer after the event, which is why everything in this area is preventive.

What the 1975 Declaration says

This is the instrument to cite, and its paragraph 4 is the one most candidates never reach.

Paragraph 1 requires all States to promote international co-operation to ensure that the results of scientific and technological developments are used in the interests of strengthening international peace and security, freedom and independence, as well as for economic and social development and the realisation of human rights.

Paragraph 2 requires appropriate measures to prevent the use of scientific and technological developments, particularly by State organs, to limit or interfere with the enjoyment of human rights.

Paragraph 4 is the operative provision on warfare. All States shall refrain from any acts involving the use of scientific and technological achievements for the purposes of violating the sovereignty and territorial integrity of other States, interfering in their internal affairs, waging aggressive wars, suppressing national liberation movements or pursuing a policy of racial discrimination. Such acts are not only a flagrant violation of the Charter of the United Nations and of the principles of international law, but constitute an inadmissible distortion of the purposes that should guide scientific and technological developments for the benefit of mankind.

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That final phrase is the most useful sentence in the instrument for this topic. It does not merely prohibit the conduct; it characterises the use of science for those ends as a perversion of what science is for, which is a normative claim about the discipline itself and connects directly to the responsibilities discussed in [The Scientist: Rights and Responsibilities].

Paragraph 8 requires effective measures, including legislative measures, to prevent and preclude the utilisation of scientific and technological achievements to the detriment of human rights and the dignity of the human person.

The rights engaged

ICCPR article 6(1): every human being has the inherent right to life, this right shall be protected by law, and no one shall be arbitrarily deprived of his life. The word arbitrarily is what carries the analysis: the article does not prohibit every deprivation of life, and the question in any given case is whether the deprivation was arbitrary.

ICCPR article 7: no torture, and no cruel, inhuman or degrading treatment or punishment. Weapons that injure in particular ways, and weapons whose effects continue long after their use, are argued under this article as well as under article 6.

UDHR article 3: everyone has the right to life, liberty and security of person.

General Comment 25, paragraph 81, brings this within the right to science expressly. The Committee identifies among the most acute risks related to science and technology the development of dangerous technologies, such as autonomous weapons based on artificial intelligence, and the threat of weapons of mass destruction, especially nuclear weapons, notes that these risks are transnational and cannot be addressed without robust international co-operation, and requires States to promote multilateral agreements to prevent them or mitigate their effects.

That paragraph is worth citing precisely because it appears in a general comment about the right to enjoy the benefits of scientific progress. It establishes that the arms question is not outside this syllabus but inside the very right the syllabus is built on.

Where this paper stops

A boundary has to be stated, because the material invites an answer that belongs on a different paper.

International humanitarian law, the law of armed conflict, governs the conduct of hostilities and the lawfulness of particular weapons through the principles of distinction, proportionality in attack, precaution, and the prohibition of superfluous injury and unnecessary suffering. It is a distinct body of law with its own instruments and its own institutions, and in this LL.M. it is the subject of the separate paper on international humanitarian law and refugee law.

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Human rights law, which is this paper, addresses the same facts from the position of the individual and continues to apply, on the accepted view, in situations of armed conflict alongside humanitarian law. What this paper asks is narrower and quite specific: what does the development, possession and use of a technology whose purpose is destruction do to the rights of the person, and what does it do to the obligations of a State that is developing it?

A candidate who writes an answer about distinction and proportionality in attack has written a good answer to the wrong question. The right frame here is the 1975 Declaration, the right to life, and General Comment 25's treatment of transnational risk.

The four categories, and what distinguishes them

An answer is stronger for treating these separately rather than as a single category of frightening things.

CategoryThe rights problem it presentsThe characteristic legal response
NuclearEffects cannot be confined in space, in time or to combatants; consequences are irreversible and intergenerationalPrevention by treaty; non-proliferation and disarmament obligations; General Comment 25 names the threat expressly
Chemical and biologicalIndiscriminate by nature; biological agents are self-propagating, so the user cannot limit the harm even in principleProhibition by treaty of an entire class, coupled with control of the underlying research, which raises the dual use problem in its sharpest form
Autonomous weaponsThe decision to kill is delegated to a machine, so there is no person who decided and none who can be asked for reasons or held responsibleContested; General Comment 25 names them among the acute risks and calls for multilateral agreement
Surveillance and cyber capabilities used in conflictThe target is a population's information and infrastructure rather than its soldiers, and the effects fall on civilian lifeTreated under the ordinary human rights framework, since the harms are to privacy, health, expression and access to services

The third row is the one that belongs most naturally to this paper, because it is an instance of delegation, the fifth of the changes identified in [How a Technology Becomes a Rights Question], applied to the gravest decision there is. The argument against it is not that a machine will be less accurate than a person. It is that accountability requires an agent who chose, and there is none.

Worked example

A State's defence laboratory develops a system that identifies and engages targets without a human operator confirming each engagement. The system is more accurate in trials than a human crew. The State argues that fewer civilians will be harmed, so the technology serves the right to life rather than threatening it.

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Take the argument seriously. It is not frivolous, and the strongest answers engage with it. If the claim about accuracy is true, then a refusal to deploy costs lives, and that is a rights consequence too.

Then locate the flaw. The right to life is protected by article 6 in two ways: substantively, by prohibiting arbitrary deprivation, and procedurally, by requiring that a deprivation be capable of being investigated and accounted for. Accuracy answers the first and not the second. Where a machine selects and engages, there is no person who formed the judgment, so there is no judgment to review, no reasons to test, and nobody whose responsibility can be established. A right that cannot be vindicated after its breach is diminished however low the breach rate.

Add the distributional question. Systems trained on data perform unevenly across the populations represented in that data, so a claim of superior average accuracy is compatible with markedly worse performance for some group. That is the argument of [Equality and the Digital Divide] transposed to the use of force.

And the obligation on this State. Paragraph 8 of the 1975 Declaration requires effective measures including legislative ones; General Comment 25 requires the promotion of multilateral agreements against exactly this class of risk. The obligation is not satisfied by an internal review conducted by the department that built the system.

What it does NOT mean

It does not mean scientists may not work on defence. Neither the Declaration nor the Covenant prohibits it. Paragraph 4 prohibits the use of scientific achievements for specified purposes, principally aggressive war, and the responsibility of the individual researcher operates through the freedom to question the ethical value of a project and to withdraw, which is a freedom rather than a prohibition.

It does not mean the right to life is absolute in the sense of prohibiting all killing. Article 6 prohibits arbitrary deprivation, and that word does the work.

It does not mean this paper answers the lawfulness of a particular weapon. That is a humanitarian law question, and the honest answer here says so and then addresses the question this paper does ask.

And it does not mean a technology is exempt because it has civil uses. Almost all of them do, which is the dual use problem; the response is control of the use and of transfer, not a classification of the underlying knowledge as forbidden.

Quick revision

  • Weapons are the limiting case: destructive capacity is the object rather than a side effect, so the neutrality argument is unavailable. Harms are irreversible and cannot be confined, so the framework is preventive.
  • 1975 Declaration, paragraph 4: States shall refrain from using scientific and technological achievements to violate sovereignty and territorial integrity, interfere in internal affairs, wage aggressive wars, suppress national liberation movements or pursue racial discrimination; such acts are a flagrant violation of the Charter and an inadmissible distortion of the purposes that should guide scientific development. Paragraphs 1, 2 and 8 supply peace and security, prevention of State misuse, and legislative measures.
  • ICCPR article 6(1): inherent right to life, protected by law, no arbitrary deprivation. Article 7: cruel, inhuman or degrading treatment. UDHR article 3.
  • General Comment 25, paragraph 81: names autonomous weapons based on artificial intelligence and weapons of mass destruction, especially nuclear weapons, as acute transnational risks, and requires States to promote multilateral agreements.
  • Four categories: nuclear, chemical and biological, autonomous, and cyber or surveillance capabilities in conflict.
  • The autonomous weapons objection is about accountability, not accuracy: no agent decided, so nothing can be reviewed and nobody can be held responsible.
  • The boundary: distinction, proportionality in attack and superfluous injury belong to international humanitarian law, which is a different paper in this LL.M.
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Test yourself

1. Set out paragraph 4 of the 1975 Declaration and explain why its closing words matter. It requires all States to refrain from any acts involving the use of scientific and technological achievements for the purposes of violating the sovereignty and territorial integrity of other States, interfering in their internal affairs, waging aggressive wars, suppressing national liberation movements, or pursuing a policy of racial discrimination, and states that such acts are not only a flagrant violation of the Charter of the United Nations and of the principles of international law but constitute an inadmissible distortion of the purposes that should guide scientific and technological developments for the benefit of mankind. The closing words matter because they go beyond prohibition to characterisation: they assert that science has purposes, that those purposes are the benefit of mankind, and that the military use in question is a perversion of the enterprise itself, which is the normative foundation for the responsibilities of the individual researcher.

2. Why are weapons described as the limiting case of this subject? Because the feature that makes every other topic difficult is absent. Elsewhere the harm is a by-product of an application intended to do something else, which is what makes the dual use analysis necessary and what supports the argument that a technology is neutral between uses. In a weapon the destructive capacity is the specification rather than a side effect, so there is no second direction to point to and the neutrality argument is unavailable. The other distinguishing features are irreversibility and scale: the harms of the most serious weapons cannot be undone and cannot be confined in space, in time or to the parties to a conflict, which is why the legal response is preventive rather than remedial.

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3. What does General Comment 25 say about weapons, and why is it significant that it says it? Paragraph 81 identifies among the most acute risks to the world related to science and technology the development of dangerous technologies such as autonomous weapons based on artificial intelligence, and the threat of weapons of mass destruction, especially nuclear weapons; states that such risks are transnational and cannot be adequately addressed without robust international co-operation; and requires States to promote multilateral agreements to prevent them from materialising or to mitigate their effects. It is significant because the Comment is an authoritative interpretation of the right to participate in and enjoy the benefits of scientific progress under article 15 of the ICESCR. Its treatment of weapons therefore places the arms question inside the right this syllabus is built on, rather than leaving it to the law of armed conflict, and supplies a candidate with a Covenant-based route into the topic.

4. State the objection to autonomous weapons in its strongest form, and explain why a claim of superior accuracy does not answer it. The objection is that the decision to take a life is delegated to a system, so no person formed the judgment. Article 6 protects life both substantively, by prohibiting arbitrary deprivation, and procedurally, by requiring that a deprivation be capable of investigation and accounting. A claim of superior accuracy addresses only the substantive limb, by asserting a lower rate of wrongful killing. It leaves the procedural limb untouched, because where a machine selected and engaged there is no judgment to review, no reasons that can be tested, and no agent whose responsibility can be established, so a person wrongly killed has no remedy and the State has no answerable official. A further point is distributional: a system's accuracy is an average across the populations represented in its training data, so superior overall performance is consistent with markedly worse performance for a particular group.

5. Where does this paper stop and international humanitarian law begin, and how should a candidate handle the boundary? International humanitarian law governs the conduct of hostilities and the lawfulness of particular weapons, through the principles of distinction, proportionality in attack, precaution, and the prohibition of weapons causing superfluous injury or unnecessary suffering, and in this LL.M. it is the subject of a separate paper. This paper approaches the same facts from the position of the individual and asks what the development, possession and use of a destructive technology does to the rights of the person and to the obligations of the State that develops it, using the 1975 Declaration, the right to life in article 6, and General Comment 25's treatment of transnational risk. A candidate should state the boundary expressly, note that human rights law continues to apply in armed conflict alongside humanitarian law, and then answer the question this paper asks, because an answer written entirely in the vocabulary of distinction and proportionality in attack answers a question that was not set.

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Chapter Thirty-One

Biotechnology, Genetics and Human Dignity

Syllabus topic 2, "Implication of Development of Science and Technology on Human Rights"

In one line

Genetic technology is the first technology whose object is the instructions for making a person, which is why the law reaches for the one concept it usually keeps in the preamble.

In the wording a student can write in an exam: biotechnology applied to the human genome raises questions that the ordinary rights of privacy, health and equality do not fully answer, because the information at stake is shared with a person's relatives and descendants, is predictive rather than merely descriptive, and is constitutive of the person rather than merely about them; and the concept the instruments use to bear that weight is human dignity, which appears in the UNESCO Declaration of 1997 not as rhetoric but as an operative standard against which practices are measured.

Why the law has this at all

Human dignity is usually the thing a human rights instrument says in its preamble before getting to the enforceable part. The UDHR opens by recognising the inherent dignity of all members of the human family, and article 1 says all human beings are born free and equal in dignity and rights. In most fields nothing turns on it.

In this field things turn on it, because genetic information has four properties that defeat the ordinary analysis.

It is shared. A person's genome is substantially the genome of their parents, siblings and children. A disclosure by one person discloses about others who never consented and may not know. No other category of personal information has this property to the same degree.

It is predictive. It speaks about a future that has not happened, which is exactly what an insurer or an employer wants and exactly what the person cannot disprove.

It is immutable. A person can change an address or a password. Nobody can change a genome, so a harm caused by its disclosure is permanent.

It is constitutive. It is not merely information about a person; it is, in one sense, the specification of the person. That is why a framework built on autonomy and privacy feels inadequate here, and why the instruments reach for a different concept.

The 1997 Declaration

The Universal Declaration on the Human Genome and Human Rights was adopted by the General Conference of UNESCO on 11 November 1997 and endorsed by the General Assembly by resolution 53/152 of 9 December 1998. It is not a treaty. Its authority comes from adoption and endorsement, and from the absence of any competing instrument.

Its first four articles do the conceptual work.

Article 1: the human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity. In a symbolic sense, it is the heritage of humanity. The qualification "in a symbolic sense" is deliberate and should be noticed: the genome is not property held in common, and the phrase does not create rights of ownership.

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Article 2(a): everyone has a right to respect for their dignity and for their rights regardless of their genetic characteristics. Article 2(b): that dignity makes it imperative not to reduce individuals to their genetic characteristics and to respect their uniqueness and diversity.

Article 2(b) is the operative core of the whole instrument and the sentence to learn. The wrong it names is reduction: treating a person as their genotype. That is precisely what an insurer does in pricing a policy on a marker, what an employer does in screening, and what a State does in classifying a population.

Article 3: the genome evolves and is subject to mutations, and contains potentialities expressed differently according to each individual's natural and social environment, including health, living conditions, nutrition and education. This is a scientific proposition placed in a legal instrument in order to defeat determinism: the genome is not destiny, and a legal consequence attached to a marker rests on a claim the science does not support.

Article 4: the human genome in its natural state shall not give rise to financial gains. Note the qualification. It does not prohibit patents on inventions derived from genetic knowledge; it addresses the genome in its natural state, and the line between the two is the whole of the argument in [Access to Medicines and Patents].

The rights of the person

Article 5 governs intervention. Research, treatment or diagnosis affecting an individual's genome may be undertaken only after rigorous and prior assessment of the potential risks and benefits and in accordance with national law; in all cases the prior, free and informed consent of the person must be obtained, and where they cannot consent, consent or authorisation is obtained as prescribed by law, guided by their best interest; research protocols must be submitted for prior review; and where a person lacks capacity, research affecting their genome may be carried out only for their direct health benefit, research without expected direct benefit being permissible only by way of exception, with the utmost restraint, at minimal risk and burden, where it is intended to benefit others of the same age category or with the same genetic condition.

Article 5(c) states a right that has no real counterpart elsewhere in human rights law: the right of each individual to decide whether or not to be informed of the results of a genetic examination and of the consequences. It is a right not to know, and it exists because the information is predictive and unalterable, so that receiving it can injure a person who can do nothing with it.

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Article 6: no one shall be subjected to discrimination based on genetic characteristics that is intended to infringe or has the effect of infringing human rights, fundamental freedoms and human dignity. Note "or has the effect of", which reaches indirect discrimination.

Article 7: genetic data associated with an identifiable person and stored or processed for research or any other purpose must be held confidential in the conditions set by law.

Article 8: every individual has the right to just reparation for damage sustained as a direct and determining result of an intervention affecting their genome.

Article 9: limitations on the principles of consent and confidentiality may be prescribed only by law, for compelling reasons, within the bounds of public international law and international human rights law. It is the limitation clause, and it is narrow.

Research and its limits

Article 10: no research or research application concerning the human genome, in particular in biology, genetics and medicine, should prevail over respect for the human rights, fundamental freedoms and human dignity of individuals or of groups.

Article 11: practices contrary to human dignity, such as reproductive cloning of human beings, shall not be permitted, and States and competent international organisations are invited to co-operate in identifying such practices and taking the necessary measures.

Article 11 is the clearest instance in the whole of this paper of dignity operating as an operative legal standard rather than as an aspiration. It does not say cloning is unsafe, or that it is unpopular. It says the class of prohibited practices is defined by contrariety to dignity, and gives reproductive cloning as an example of the class rather than as its whole content. That drafting is deliberate: it leaves the category open, so that practices not yet invented can fall within it.

Worked example

An insurer proposes to require applicants for life cover to disclose the results of any genetic test they have taken, and to price the policy accordingly. It argues that it does not require anyone to take a test, that it asks only for information the applicant already has, and that non-disclosure of known risk is a familiar ground for avoiding a contract.

Article 6 is engaged directly. Discrimination based on genetic characteristics that has the effect of infringing rights and dignity is prohibited, and the words "has the effect of" defeat the answer that no discrimination was intended.

Article 2(b) names the wrong precisely. Pricing on a marker reduces the individual to their genetic characteristics, which is what article 2(b) says dignity makes it imperative not to do.

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Article 3 answers the actuarial argument. The genome contains potentialities expressed differently according to the individual's environment, health, living conditions, nutrition and education. A marker is a probability across a population, not a fact about this applicant, so the insurer's inference is weaker than it presents itself as being.

Article 5(c) shows the second harm. A rule of this kind destroys the right not to know, because a person who wishes to remain uninformed must now choose between the knowledge and the insurance. The pressure operates without anyone compelling a test, which is why the insurer's first argument does not answer the objection.

And the harm is not confined to the applicant. A test result discloses about siblings and children who are not parties to the contract. That is the shared property of genetic information doing legal work, and it is the reason this cannot be handled as an ordinary question of contractual disclosure.

What it does NOT mean

The genome is not the common property of humanity. Article 1 says heritage "in a symbolic sense", and the qualification is there precisely to prevent the property reading.

Article 4 is not a prohibition on biotechnology patents. It addresses the genome in its natural state. What may be patented, and on what conditions, is a question for patent law, and in India for section 3(d) of the Patents Act, taken up in [Access to Medicines and Patents].

Genetic non-discrimination is not a bar on all use of genetic information. Article 9 permits limitations on consent and confidentiality by law, for compelling reasons, within the bounds of international human rights law. Clinical use with consent is the ordinary case and is not touched.

And dignity is not a trump card. It is doing specific work here, identified in article 2(b) as the prohibition on reducing a person to their genetic characteristics. An answer that invokes dignity without saying what it forbids in the case at hand has used the word rather than the concept.

Quick revision

  • Genetic information is shared, predictive, immutable and constitutive, which is why privacy and equality alone do not answer it and why the instruments use dignity.
  • UNESCO 1997, adopted 11 November 1997, endorsed by GA resolution 53/152 of 9 December 1998. Not a treaty.
  • Article 1: the genome underlies the unity of the human family; in a symbolic sense the heritage of humanity. Article 2(a): dignity and rights regardless of genetic characteristics. Article 2(b): imperative not to reduce individuals to their genetic characteristics. Article 3: potentialities expressed differently according to environment, so the genome is not destiny. Article 4: the genome in its natural state shall not give rise to financial gains.
  • Article 5: prior risk assessment, prior free and informed consent, prior review of protocols, and for a person without capacity, direct health benefit save by exception. Article 5(c): the right not to know.
  • Article 6: no discrimination on genetic characteristics intended to or having the effect of infringing rights and dignity. Article 7: confidentiality. Article 8: just reparation. Article 9: limitations on consent and confidentiality only by law, for compelling reasons.
  • Article 10: no research application shall prevail over rights, freedoms and dignity. Article 11: practices contrary to human dignity, such as reproductive cloning, shall not be permitted, the class being left open.
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Test yourself

1. What four properties of genetic information make it a distinct legal problem? It is shared, because a person's genome is substantially that of their parents, siblings and children, so a disclosure by one person discloses about others who have not consented. It is predictive, speaking to a future that has not occurred and which the person cannot disprove. It is immutable, so a harm caused by disclosure cannot be undone by changing anything. And it is constitutive, being in one sense the specification of the person rather than merely information about them. Together these defeat an analysis built only on privacy and consent, since consent by one person cannot cover the others implicated and no remedy can restore the position.

2. Set out article 2(b) of the 1997 Declaration and explain why it is the operative core of the instrument. It provides that the dignity of everyone, regardless of their genetic characteristics, makes it imperative not to reduce individuals to their genetic characteristics and to respect their uniqueness and diversity. It is the operative core because it names the specific wrong that genetic technology makes possible: reduction, that is, the treatment of a person as their genotype. That is what an insurer does in pricing on a marker, an employer in screening, and a State in classifying a population, so the article converts dignity from a preambular sentiment into a test that can be applied to a practice.

3. What is the right not to know, where is it found, and why does it exist? It is the right of each individual to decide whether or not to be informed of the results of a genetic examination and of the resulting consequences, stated in article 5(c) of the 1997 Declaration. It exists because genetic information is predictive and unalterable: a person may learn that they will probably develop a condition they can do nothing to prevent, and the knowledge injures without enabling any action. It has no close counterpart elsewhere in human rights law, where the usual concern is to secure access to information rather than to protect a person from receiving it.

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4. Why is article 11 significant for the argument that dignity is an operative standard rather than rhetoric? Because it defines a prohibited class by reference to dignity alone. It provides that practices contrary to human dignity, such as reproductive cloning of human beings, shall not be permitted, and invites States and competent international organisations to co-operate in identifying such practices and in taking the measures necessary. It does not rest the prohibition on safety, on efficacy or on public opinion, and it gives reproductive cloning as an example of the class rather than as its whole content, which leaves the category open so that practices not yet invented may fall within it. Dignity is therefore performing the function of a legal standard, supplying the criterion by which a practice is judged.

5. An employer requires applicants to disclose existing genetic test results but requires nobody to be tested. Which provisions answer it? Article 6 is engaged directly, since it prohibits discrimination based on genetic characteristics that is intended to infringe or has the effect of infringing human rights, fundamental freedoms and human dignity, and the words "has the effect of" defeat the argument that no discrimination was intended. Article 2(b) identifies the wrong as reduction of the individual to their genetic characteristics. Article 3 answers the argument from actuarial or occupational rationality, because the genome contains potentialities expressed differently according to the individual's environment, health, living conditions, nutrition and education, so a marker is a probability across a population rather than a fact about the applicant. Article 5(c) shows the second harm, since a requirement of this kind destroys the right not to know by forcing a person who wishes to remain uninformed to choose between the knowledge and the employment. And article 7 is engaged because genetic data associated with an identifiable person must be held confidential in the conditions set by law, which a general disclosure requirement circumvents.

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Chapter Thirty-Two

Artificial Intelligence and Decisions by Machines

Syllabus topic 2, "Implication of Development of Science and Technology on Human Rights"

In one line

When a machine makes the decision, there is no one who decided, and almost every protection a person has depends on there being someone who decided.

In the wording a student can write in an exam: automated and algorithmic decision-making engages human rights not primarily through the accuracy of the systems but through accountability, because the guarantees on which a person relies, that a decision be reasoned, that it be capable of challenge, that a duty bearer be identifiable and that the decision-maker be answerable, all presuppose an agent who formed a judgment; and because systems built by learning from records of past decisions reproduce the distribution of those decisions, so that a facially neutral system can operate as an instrument of indirect discrimination contrary to article 2(2) of the ICESCR and article 26 of the ICCPR.

Why the law has this at all

The syllabus was printed in 2016-17 and does not name this technology. It is nonetheless squarely within topic 2, for the reason given in [How a Technology Becomes a Rights Question]: the topic asks about the implications of scientific and technological development, and the University could not have listed the technologies a candidate would face years later.

The Committee took the same view. General Comment 25 (2020) refers to artificial intelligence twice: once in naming autonomous weapons based on artificial intelligence among the most acute transnational risks, and once in its treatment of the risks accompanying scientific progress. That is enough to place the subject inside the right this paper is built on, without inventing any instrument that does not exist.

Apply the five tests from the method chapter and the reason this technology matters becomes visible. It changes scale, because a decision procedure can be applied to millions of cases; cost, because assessment that required a trained person is now nearly free; permanence, because the record and the model persist; invisibility, because the person affected often does not know a system was used; and above all delegation, because the judgment itself has moved. It is the only technology in this module that engages the fifth test as its principal effect rather than as a side effect.

What the framework already provides

There is no treaty on artificial intelligence in this book's authority base, and a candidate should not pretend otherwise. What exists is a set of general provisions that apply to a decision however it is made, and the strength of an answer lies in showing that they apply rather than in lamenting that a special instrument is absent.

ICCPR article 14 guarantees equality before courts and tribunals and a fair hearing. Where an automated system informs a decision about bail, sentence or entitlement, the guarantee requires that the person be able to know and contest the case against them, which is defeated if the reasoning is unavailable.

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ICCPR article 26 guarantees equality before the law and the equal protection of the law without discrimination, and prohibits discrimination on any ground including "other status". ICESCR article 2(2) does the same for Covenant rights. Both reach measures that are neutral in form and unequal in effect.

ICCPR article 17 protects against arbitrary or unlawful interference with privacy, which is engaged by the collection and combination of the data such systems require, as set out in [Privacy and Surveillance].

ICESCR article 7(c) guarantees equal opportunity for promotion in employment subject to no considerations other than seniority and competence. It is an unexpectedly exact provision for automated assessment: a system that ranks on proxies correlated with past outcomes introduces considerations other than seniority and competence, which is what the limb forbids.

Constitution of India, article 14, guarantees equality before the law and the equal protection of the laws, and the settled doctrine that State action must not be arbitrary is directly engaged by a decision for which no reason can be given. Article 21 supplies the requirement of a fair procedure where life or personal liberty is affected.

General Comment 25, paragraph 22, supplies the regulatory route: limitations on the applications of science may be used to guarantee the safety and quality of products used by persons, and human rights impact assessments might be necessary to protect persons against risky applications. That sentence is the treaty-body basis for requiring an assessment before deployment, and it is the most directly useful citation available on this topic.

The four problems

Keeping these separate is what distinguishes a legal answer from a general essay.

  1. Opacity. Where a system's output cannot be explained, the person affected cannot identify the error, and the reviewing body cannot test the reasoning. The right injured is procedural: not the right to a favourable decision, but the right to know why.
  2. Bias. A system trained on records of past decisions learns the distribution in those records, including the effects of past discrimination. It then applies that distribution to new cases with the appearance of objectivity. The wrong is indirect discrimination, and the appearance of neutrality makes it harder to detect than the practice it automates.
  3. Accountability. Where the decision is delegated, responsibility disperses among the body that deployed the system, the vendor that built it, and the people who assembled the data. Each can point to another, and a rights framework that cannot identify a duty bearer cannot deliver a remedy.
  4. Scale. A human decision-maker who is wrong is wrong in a limited number of cases and inconsistently. A system that is wrong is wrong in every case of that kind, identically, until somebody notices. The consistency that is presented as the technology's virtue is what converts an individual error into a population-level harm.
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Worked example

A State uses an automated system to decide which applications for a disability pension are examined by an officer and which are refused on the papers. The system was trained on the outcomes of previous applications. It is more consistent than the officers it replaced, and processing times have fallen.

State what is good about it. Faster decisions and consistency are real benefits to applicants, and article 15(1)(b) means the applicants have an interest in the State using what science has made available. An answer that treats the system as self-evidently objectionable has not applied the framework.

Opacity. Can a refused applicant be told why? If the answer is that the system scored the application below a threshold, no reason has been given, and the requirement of a fair procedure under article 21 and of non-arbitrariness under article 14 of the Constitution is not met.

Bias. The training data are past outcomes, so if a category of applicant was historically refused for reasons unconnected with entitlement, the system will reproduce that refusal rate and present it as a finding. Testing for this requires the outcomes to be examined by group, which requires that the data be collected and published; a State that does not measure cannot claim compliance with article 2(2).

Accountability. Who decided? If the department says the system did, and the vendor says it only supplied a tool, then no one is answerable, and the applicant's remedy is against a body that disclaims the decision.

Scale. An officer with a mistaken view of a condition affects the applications they see. A system with the same mistaken view affects every application of that kind in the State, immediately.

What the framework requires. Not prohibition. A human rights impact assessment before deployment, in the terms of paragraph 22; reasons capable of being given to the applicant; outcomes monitored by group; a real route to human reconsideration; and an identified body that owns the decision. Those five are the answer, and they are all available from provisions that already exist.

What it does NOT mean

It does not mean automated decisions are unlawful. No provision in the base prohibits them, and consistency and speed are genuine benefits. The framework regulates the conditions of use.

It does not mean accuracy is the test. A system that is more accurate on average may still fail, because the guarantees are procedural and distributive as well as substantive. This is the same point made about autonomous weapons in [Weapons, Warfare and the Right to Life].

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A human in the loop is not automatically an answer. Where the person is presented with a score and has neither the time nor the information to go behind it, the human is a formality and the decision remains the machine's. The question is whether the human can and does exercise judgment.

And there is no treaty here. A candidate should not attribute to the ICCPR, the ICESCR or the UNESCO declarations any provision about artificial intelligence. What those instruments contain are general guarantees that apply, and General Comment 25's two references. Saying so accurately is worth more than a confident citation to something that does not exist.

Quick revision

  • Later than the 2016-17 syllabus, and inside topic 2 because that topic is drafted openly; General Comment 25 (2020) refers to artificial intelligence, naming autonomous weapons based on artificial intelligence among acute transnational risks at paragraph 81.
  • The principal effect is delegation, the fifth of the five changes; the others, scale, cost, permanence and invisibility, are all present too.
  • No treaty on the subject. The provisions that apply: ICCPR article 14 (fair hearing), article 26 and ICESCR article 2(2) (equality, reaching indirect discrimination), ICCPR article 17 (privacy), ICESCR article 7(c) (promotion on no considerations other than seniority and competence), Constitution articles 14 and 21.
  • General Comment 25, paragraph 22: limitations on applications to guarantee safety and quality, and human rights impact assessments might be necessary against risky applications. The most useful citation on this topic.
  • Four problems: opacity, bias, accountability, scale.
  • Five requirements: impact assessment before deployment, reasons that can be given, outcomes monitored by group, a real route to human reconsideration, and an identified body that owns the decision.

Test yourself

1. On what basis is a technology later than the syllabus properly examinable on this paper? Because topic 2 asks about the implications of the development of science and technology on human rights without naming any technology, and was printed in 2016-17 when the University could not have known which technologies a candidate would face. The topic is therefore drafted openly by design. The point is confirmed by General Comment 25, adopted in 2020, which is the authoritative interpretation of the right on which the paper rests and which itself refers to artificial intelligence, including autonomous weapons based on artificial intelligence among the most acute transnational risks at paragraph 81.

2. State the accountability problem and explain why it is distinct from the problem of bias. The accountability problem is that where a decision is delegated to a system, responsibility disperses among the body that deployed it, the vendor that built it and those who assembled the training data, so that each can point to another and no duty bearer can be identified. It is distinct from bias because it would remain even if the system were perfectly unbiased: a correct decision for which no one is answerable still deprives the affected person of reasons, of a route of challenge and of a respondent. Bias concerns the content of the decisions, accountability concerns the structure within which they are made, and a remedy for one does not supply a remedy for the other.

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3. Why is ICESCR article 7(c) an unexpectedly precise provision for automated assessment in employment? Because it guarantees equal opportunity for everyone to be promoted in his employment to an appropriate higher level, subject to no considerations other than those of seniority and competence. An automated ranking system does not assess competence directly; it scores on features correlated with the outcomes recorded in its training data, which may include the length of a gap in employment, the institution attended or patterns associated with a group. Each such feature is a consideration other than seniority and competence, so the provision is breached by the method of assessment itself, independently of whether the outcome can be shown to be discriminatory on a prohibited ground.

4. A department says a refused applicant was scored below the threshold by its system. Has a reason been given? No. A score is a restatement of the outcome, not a reason for it: it tells the applicant what the system concluded and nothing about why, so it identifies no fact that might be wrong, no criterion that might be misapplied and nothing that can be contested. That defeats the guarantee of a fair hearing under article 14 of the ICCPR where the decision is one to which the article applies, and in India it engages both the requirement of a fair procedure under article 21 and the doctrine under article 14 that State action must not be arbitrary, a decision for which no reason can be given being the paradigm of arbitrariness. The practical requirement is that the department be able to state the factors that determined the outcome in this case in terms the applicant can address.

5. Is a human in the loop a sufficient safeguard? Give reasons. Not by itself. The safeguard is meant to preserve an agent who forms a judgment, and it does so only if that person has the information, the time and the authority to reach a different conclusion. Where an officer is presented with a score and a queue, lacks access to the factors behind the score, and is measured on throughput, the human presence is a formality and the effective decision remains the system's, so opacity and accountability are untouched while the appearance of human decision-making defeats scrutiny. The question is therefore not whether a person is nominally in the loop but whether they can and do exercise independent judgment, which requires that reasons be available to them, that departure from the recommendation be permitted and recorded, and that rates of departure be monitored.

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Chapter Thirty-Three

Reproductive Technology and Autonomy

Syllabus topic 2, "Implication of Development of Science and Technology on Human Rights"

In one line

Reproductive technology gives people choices they never had, and gives everybody around them a new opportunity to make the choice for them.

In the wording a student can write in an exam: reproductive technology has separated conception from intercourse, gestation from parenthood, and the detection of a foetus's characteristics from its birth, and each separation creates a decision that did not previously exist; the human rights question is therefore who decides, and Indian law answers it by locating reproductive choice within personal liberty under article 21, while permitting reasonable restrictions of which the governing statutes are examples.

Why the law has this at all

Before the technology, reproduction was largely a matter of fact rather than of decision, and the law's involvement was correspondingly thin. Every advance converted a fact into a choice.

Contraception and safe termination made continuation a decision rather than an inevitability. Prenatal diagnosis made the characteristics of a foetus knowable before birth, which in India produced a specific and severe harm, the elimination of female foetuses, and a statute directed at it. Assisted reproduction made conception possible without intercourse, and gestation possible in a body other than that of the intended mother, which raised questions of parentage, payment and exploitation that no earlier law had needed to answer.

Each new choice attracted claimants. Once a decision exists, a husband, a family, a clinic, an employer or a State may all wish to make it, and the person whose body is involved may be the one with the least power in the room. That is why this topic is about autonomy rather than about technology.

The Indian case

Suchita Srivastava v. Chandigarh Administration, AIR 2010 SC 235, (2009) 9 SCC 1, decided on 28 August 2009.

Facts. A woman described in the proceedings as mentally retarded, an orphan in the care of a government institution in Chandigarh, was found to be pregnant after an assault. The Administration approached the High Court for permission to terminate the pregnancy. An Expert Body constituted to examine her reported in favour of continuing the pregnancy, and she had herself expressed a willingness to bear the child. The High Court nevertheless directed termination by its order of 17 July 2009.

Held, on consent. The termination could not be permitted without her consent. Her reproductive choice was to be respected notwithstanding her lack of understanding of the sexual act, apprehensions about her capacity to carry the pregnancy to term and about her assumption of maternal responsibilities, since the Medical Termination of Pregnancy Act 1971 itself contemplates that the consent of a woman found to be mentally retarded is required.

Held, on the right. A woman's right to make reproductive choices is a dimension of personal liberty under article 21. Reproductive choices may be exercised to procreate as well as to abstain from procreating, the crucial consideration being that a woman's right to privacy, dignity and bodily integrity should be respected. Taken to their logical conclusion, reproductive rights include a woman's entitlement to carry a pregnancy to full term, to give birth and to raise children.

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Held, on limits. In the case of pregnant women there is a compelling State interest in protecting the life of the prospective child, so termination is permitted only where the conditions of the applicable statute are fulfilled, and the provisions of the MTP Act 1971 may be viewed as reasonable restrictions on the exercise of reproductive choices.

Why it matters here. It establishes the right in the harder direction. The choice the Court protected was the choice to continue a pregnancy, asserted by a woman whose capacity was in question, against a decision that others believed was in her interests, and supported by the Expert Body rather than opposed by it. That is the clearest Indian statement of the proposition running through this whole module: a technology or procedure may not be applied to a person because somebody else considers it good for them. It is also the case that answers the misreading, common in student work, that reproductive rights mean a right to terminate: the Court says expressly that the right runs both ways.

CEDAW

Article 16(1)(e) requires States Parties to ensure, on a basis of equality of men and women, the same rights to decide freely and responsibly on the number and spacing of their children and to have access to the information, education and means to enable them to exercise these rights.

Two features are worth noting. The right is to decide, which locates it in autonomy rather than in health provision. And it expressly includes access to the means, so a State that recognises the choice while making the means unavailable has not complied.

The four statutes, and what each answers

Each is a legislative response to a capability, and each is taken in full in Module II. What matters here is the pattern.

StatuteThe capability it answersThe autonomy question it decides
Medical Termination of Pregnancy Act 1971Safe terminationWhen a pregnancy may be terminated, and on whose consent
Pre-conception and Pre-natal Diagnostic Techniques Act 1994Determination of foetal sex and characteristics before birthProhibits the use of a diagnostic capability for selection, so a technology lawful for one purpose is forbidden for another
Assisted Reproductive Technology (Regulation) Act 2021Conception without intercourse; donation of gametesWho may access the technology, and the position of donors
Surrogacy (Regulation) Act 2021Gestation by a woman other than the intended motherWhether and on what terms another woman's body may be used, and whether payment is permitted
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The PCPNDT Act repays attention because it is the clearest instance in Indian law of the dual use analysis from [Dual Use: the Same Technology Both Ways] being resolved by statute. The same ultrasound serves the health of the pregnancy and enables sex selection. Parliament did not ban the machine; it regulated the use, the communication of the result and the registration of the clinic. That is the model response to a dual use technology, and a candidate who can say so has understood both chapters.

Worked example

A married woman attends a fertility clinic. The consent form for the procedure requires the signature of her husband. She wishes to proceed; he refuses. Separately, the clinic offers to disclose the sex of the foetus once a pregnancy is established, describing it as information the family is entitled to.

The consent requirement. Suchita Srivastava locates reproductive choice in the woman's personal liberty under article 21, with privacy, dignity and bodily integrity as the crucial considerations, and CEDAW article 16(1)(e) states the right to decide on a basis of equality between men and women. A requirement that transfers the decision about her body to another person defeats both. Whether a particular statute or rule imposes such a requirement is a question for Module II; the constitutional analysis is the one above.

The offer to disclose. This is an offence, not a service. The PCPNDT Act prohibits the communication of the sex of the foetus, and the offer is the precise conduct the Act exists to prevent. Note the structure of the wrong: the diagnostic technology is lawful and valuable, and it is the use and the communication that are prohibited.

Whose autonomy is at stake in the second point? Not only the woman's. The harm the Act addresses is committed against the foetus and, at scale, against the sex ratio of a population, and the pressure to seek the information usually comes from the family. This is a case where a restriction on information protects rather than diminishes the woman's position, which is worth saying because it cuts against the assumption that autonomy always favours disclosure.

What it does NOT mean

Reproductive rights are not a right to terminate. Suchita Srivastava says in terms that the choices may be exercised to procreate as well as to abstain from procreating, and the case itself protected the choice to continue.

The right is not absolute. The Court recognised a compelling State interest in protecting the life of the prospective child and treated the MTP Act's conditions as reasonable restrictions.

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Incapacity does not transfer the choice. The woman in the case was found to lack capacity in a general sense and her expressed willingness still governed, because the statute required her consent. Capacity is question-specific, and a finding of incapacity for some purposes does not licence a decision for her on this one.

And regulating a technology is not the same as prohibiting it. The PCPNDT Act is the model: the machine remains lawful, and the use, the disclosure and the premises are controlled.

Quick revision

  • Reproductive technology separates conception from intercourse, gestation from parenthood, and diagnosis from birth; each separation creates a decision, and the legal question is who decides.
  • Suchita Srivastava (2009): a woman's right to make reproductive choices is a dimension of personal liberty under article 21; exercisable to procreate as well as to abstain; privacy, dignity and bodily integrity are the crucial considerations; the right includes carrying to term, giving birth and raising children. Termination could not be ordered without her consent even though she was found to be mentally retarded, because the MTP Act itself requires it. There is a compelling State interest in the prospective child, and the MTP Act's conditions are reasonable restrictions.
  • CEDAW article 16(1)(e): the same rights to decide freely and responsibly on the number and spacing of children and to have access to the information, education and means to exercise them.
  • Four statutes, all Module II: MTP 1971, PCPNDT 1994, ART (Regulation) 2021, Surrogacy (Regulation) 2021.
  • PCPNDT is the model dual-use response: the machine is lawful; the use, the communication of the result and the registration of the clinic are regulated.

Test yourself

1. What did Suchita Srivastava decide about reproductive choice, and why is the direction of the choice significant? It held that a woman's right to make reproductive choices is a dimension of personal liberty under article 21, that such choices may be exercised to procreate as well as to abstain from procreating, and that the crucial consideration is respect for her privacy, dignity and bodily integrity, reproductive rights including her entitlement to carry a pregnancy to full term, to give birth and to raise children. The direction matters because the choice protected was the choice to continue the pregnancy, asserted by a woman whose capacity was in question, against a High Court order for termination that others considered to be in her interests. It therefore establishes that the right is not a right to terminate but a right to decide, and it does so in the situation where the argument for overriding the person was at its strongest.

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2. On what basis did the Court hold that her consent was required, given the finding about her capacity? On the basis of the statute. The Medical Termination of Pregnancy Act 1971 itself contemplates that a woman found to be mentally retarded should give her consent, so the requirement did not have to be constructed from the constitutional right alone. The Court accordingly respected her expressed willingness to bear the child notwithstanding her lack of understanding of the sexual act and the apprehensions about her capacity to carry the pregnancy to term and to assume maternal responsibilities, and it declined to use the parens patriae jurisdiction to reach a different result, the Expert Body having in any event reported in favour of continuation.

3. Explain why the PCPNDT Act is the model response to a dual use technology. Because it separates the technology from its use. Prenatal diagnostic technology is valuable for the health of the pregnancy and is the same technology that enables selection by sex. Parliament did not prohibit the equipment, which would have defeated the beneficial use and with it the right to enjoy the benefits of scientific progress. It regulated instead the conduct: the use of the technique for the prohibited purpose, the communication of the sex of the foetus, and the registration and conduct of the premises where the technique is performed. That is the structure a dual use analysis calls for, since the object of regulation is a use by an actor in a setting rather than a body of knowledge or a machine.

4. State CEDAW article 16(1)(e) and identify the two features that give it force. It requires States Parties to ensure, on a basis of equality of men and women, the same rights to decide freely and responsibly on the number and spacing of their children and to have access to the information, education and means to enable them to exercise these rights. Its first feature is that the right is a right to decide, which places it in autonomy rather than in health provision, so a State does not comply merely by providing services if the decision is made by someone else. Its second is that it expressly extends to the information, education and means, so a State that recognises the choice in principle while leaving the means unavailable, unaffordable or unreachable has not discharged the obligation.

5. A clinic requires a husband's signature before a woman may undergo a fertility procedure. Analyse the requirement. It transfers to another person a decision that Suchita Srivastava locates within the woman's own personal liberty under article 21, the crucial considerations being her privacy, dignity and bodily integrity, and it does so in respect of a procedure performed on her body. It also conflicts with CEDAW article 16(1)(e), which requires the same rights to decide on the number and spacing of children on a basis of equality of men and women, since a veto held by one spouse and not the other is the denial of that equality. The general principle from bodily integrity applies as well: an intervention on a person requires that person's consent, and a third party's consent is not a substitute for it but at most an additional formality. Whether a particular statute or clinic rule imposes such a requirement, and what follows if it does, is a question of the statutory scheme taken in Module II; the constitutional objection stands independently of it.

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Chapter Thirty-Four

Forensic Science and the Rights of the Accused

Syllabus topic 2, "Implication of Development of Science and Technology on Human Rights"

In one line

Science entered the criminal process offering to answer the question a trial exists to answer, and the law had to decide how much of the accused it may use to do so.

In the wording a student can write in an exam: forensic techniques engage the right against self-incrimination in article 20(3) of the Constitution and article 14(3)(g) of the ICCPR, the right to a fair trial, and personal liberty under article 21; and the governing distinction in Indian law is between material taken from the body of an accused, which may be compelled, and material that is testimonial in character, being the product of the accused's own mental process, which may not.

Why the law has this at all

The criminal process is built on a settled allocation. The prosecution must prove its case, and the accused need not assist. Every technique that reads a person more deeply puts pressure on that allocation, because each one offers a shortcut to the fact in issue.

The pressure is not theoretical. The argument advanced for these techniques is always the same, and it is always sincere: the crime is serious, the evidence is scarce, the technique is not painful, and the alternative to using it is worse treatment of the suspect. That argument was made to the Supreme Court in the leading case, and it is the argument a candidate must be able to answer.

The Indian case

Selvi v. State of Karnataka, AIR 2010 SC 1974, (2010) 7 SCC 263, decided on 5 May 2010 by Balakrishnan CJI, Raveendran and Panchal JJ.

Facts. Criminal appeals raised the legality of administering three techniques without consent: narcoanalysis, in which a drug is used to reduce a subject's inhibition against speaking; the polygraph, which measures physiological responses while the subject answers questions; and the Brain Electrical Activation Profile test, which measures electrical activity in the brain on exposure to stimuli associated with a crime. Accused persons, suspects and witnesses had been subjected to them without consent. The State defended the practice as assisting where evidence is hard to gather, causing no bodily harm, being used to guide the investigation rather than led in evidence, and being a gentler alternative to the third degree.

Held, on article 20(3). Compulsory administration violates the right against self-incrimination. The protective scope of article 20(3) extends to the investigative stage and, read with section 161(2) of the Code of Criminal Procedure 1973, protects accused persons, suspects and witnesses alike. The article protects the choice between speaking and remaining silent whether the resulting testimony is inculpatory or exculpatory, and the results of each technique bear a testimonial character and cannot be categorised as material evidence.

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Held, on article 21 and beyond. Compulsion also violates the substantive due process required for restraining personal liberty, and does so whether the technique is administered during an investigation or for any other purpose, since the results could expose a person to adverse consequences of a non-penal nature. The techniques cannot be read into the Explanation to sections 53, 53-A and 54 of the Code by an expansive interpretation. Compulsory administration is an unjustified intrusion into mental privacy, would amount to cruel, inhuman or degrading treatment in the language of evolving international human rights norms, and conflicts with the right to a fair trial. Invocations of a compelling public interest cannot justify diluting such rights.

The order. No individual should be forcibly subjected to any of the techniques, whether in a criminal investigation or otherwise. Room is left for voluntary administration with safeguards, but even where the subject has consented the results by themselves are not admissible, because the subject does not exercise conscious control over the responses.

The distinction that decides these cases

The reason DNA and fingerprints are treated differently from narcoanalysis is not that one is more modern or more reliable. It is the testimonial line.

Material evidenceTestimonial evidence
What it isA physical thing taken from the body or the scene: blood, hair, a fingerprint, a footprint impressionThe product of the accused's own mental process: a statement, an answer, a recognition
Why it is differentIt exists independently of the accused's mind and would exist if they were unconsciousIt requires the accused to furnish something from their own knowledge
Article 20(3)Not engaged, on the settled viewEngaged
Statutory route in IndiaThe Code's provisions on medical examination, sections 53, 53-A and 54None, and Selvi holds these cannot be stretched to supply one

The Court's reasoning on the three techniques is that each produces a result that is testimonial in character even though nothing is spoken in the ordinary way. The polygraph and the BEAP test read a bodily response, but the response is a proxy for the content of the mind, so the result conveys personal knowledge. That step is the intellectual heart of the case and is what a good answer must reproduce.

The second holding, which is often missed

Even a consenting subject's test results are not admissible by themselves. The reason given is that the subject does not exercise conscious control over the responses. That is a statement about the reliability of the technique rather than about the rights of the accused, and it matters for two reasons.

It means consent does not convert the technique into ordinary evidence, so a practice of obtaining consent from persons in custody cannot be used to get the results before a court.

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And it shows the Court doing something courts are often reluctant to do: assessing the scientific claim rather than accepting it. The techniques were not excluded only because using them would be unfair; they were also found not to be what they were said to be.

DNA, and where the line now sits

DNA identification is material evidence on the distinction above, so article 20(3) is not the obstacle. The questions it raises fall elsewhere and are the questions worked in [Bodily Integrity and Intervention Without Consent] and [Privacy and Surveillance]:

  • Taking the sample is an interference with bodily integrity, so it needs statutory authority and proportionality.
  • Retention of the profile after acquittal is an interference with informational privacy that is not justified by the aim of solving the offence charged.
  • Familial searching, partial matching to identify relatives, extends the burden to persons against whom nothing is alleged and who have not consented.
  • Error and interpretation: a match is a probability, and its weight depends on the size and composition of the reference database, which is a matter about which the accused must be able to cross-examine.

Worked example

An investigating officer proposes to put a suspect through a polygraph examination and, on the strength of the result, to search a location. The suspect signs a consent form at the police station in the presence of the officer.

Was the consent free? A consent given in custody to a technique proposed by the custodian raises the freedom question directly. This is the point where the consent requirements set out in [Bodily Integrity and Intervention Without Consent] do their work, and Selvi contemplates voluntary administration only with safeguards.

If the consent was valid, may the result be used? Not by itself. Selvi is express: even where the subject has consented, the results by themselves are inadmissible, because the subject does not exercise conscious control over the responses.

May the search proceed on the result? This is the practical question and it is distinct. The prohibition on compulsory administration is absolute in the sense the Court described, and the inadmissibility of the result is a rule about evidence. Whether information derived from a lawful voluntary test may direct an investigation is a separate question from whether the test itself may be led, and an answer should keep the two apart.

And what if there had been no consent? Then nothing in it is available. Compulsory administration violates article 20(3) and substantive due process under article 21, and a compelling public interest is not an answer.

What it does NOT mean

It is not a prohibition on forensic science. DNA, fingerprints and medical examination under the Code are untouched. The case is about techniques that read the mind.

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Article 20(3) is not confined to the trial. Selvi holds that its protective scope extends to the investigative stage, and that read with section 161(2) it covers suspects and witnesses as well as the accused.

"It only guides the investigation" is not an answer. The Court rejected it, holding the violation complete whether the technique is administered in an investigation or for any other purpose, since the results can expose a person to non-penal adverse consequences.

And the absence of pain is not the test. The State argued that the techniques cause no bodily harm, and the Court held that the intrusion is into mental privacy, which the absence of physical harm does not answer.

Quick revision

  • The line is material versus testimonial. Material evidence exists independently of the mind and may be compelled; testimonial evidence is the product of the accused's mental process and may not.
  • Selvi (2010): compulsory narcoanalysis, polygraph and BEAP violate article 20(3), whose scope reaches the investigative stage and, with section 161(2), covers accused, suspects and witnesses; the results are testimonial, not material. They also violate substantive due process under article 21, are an unjustified intrusion into mental privacy, would amount to cruel, inhuman or degrading treatment, and conflict with the right to a fair trial. A compelling public interest cannot justify dilution.
  • The techniques cannot be read into the Explanation to sections 53, 53-A and 54 of the Code.
  • Voluntary administration is possible with safeguards, but the results by themselves are inadmissible, because the subject does not exercise conscious control over the responses.
  • ICCPR article 14(3)(g): not to be compelled to testify against oneself or to confess guilt.
  • DNA is material evidence, so the issues are taking, retention, familial searching and the weight of a match, not article 20(3).

Test yourself

1. State the distinction between material and testimonial evidence and explain how the Court applied it to the polygraph. Material evidence is a physical thing obtained from the body or the scene, such as blood, hair or a fingerprint; it exists independently of the accused's mind and would exist if they were unconscious, so compelling its production does not require the accused to furnish anything from their own knowledge and article 20(3) is not engaged. Testimonial evidence is the product of the accused's own mental process and conveys personal knowledge, and it is protected. The Court applied the distinction to the polygraph by looking past the fact that what is measured is a bodily response: the response is a proxy for the content of the mind, so the result conveys personal knowledge and bears a testimonial character, which is why it cannot be categorised as material evidence.

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2. How far does the protection of article 20(3) extend, on the reasoning in Selvi? Its protective scope extends to the investigative stage of criminal cases, and not merely to the trial; read with section 161(2) of the Code of Criminal Procedure 1973 it protects accused persons, suspects and witnesses examined during an investigation alike; and it protects the choice between speaking and remaining silent irrespective of whether the testimony that would result proves inculpatory or exculpatory, since the aim is to prevent the forcible conveyance of personal knowledge relevant to the facts in issue.

3. Why are the results of a voluntarily administered test still inadmissible by themselves, and what is significant about that holding? Because the subject does not exercise conscious control over the responses, so the material produced is not the product of a deliberate act of communication even where the subject agreed to undergo the procedure. It is significant for two reasons. It prevents the prohibition being circumvented by obtaining consent from persons in custody, since consent secures the lawfulness of administering the test but not the admissibility of its product. And it shows the Court evaluating the scientific claim rather than accepting it: the exclusion rests not only on the unfairness of compelling the technique but on a finding about what the technique can actually establish.

4. The State argued that the techniques cause no bodily harm and are gentler than the third degree. Why did these arguments fail? The absence of bodily harm failed because the intrusion the Court identified was into mental privacy, and the integrity protected under article 21 extends to the mind as well as the body, so a technique that touches nobody may still be an intrusion. The comparison with the third degree failed because the alternative offered is itself unlawful, and the lawfulness of a practice is not established by showing that it is preferable to torture. The Court also rejected the related submission that the techniques would merely guide the investigation, holding that the violation is complete whether they are administered during an investigation or for any other purpose, because the results can expose a person to adverse consequences of a non-penal nature.

5. Since DNA identification is material evidence, what questions does it raise and where are they answered? Article 20(3) is not the obstacle, so the questions arise elsewhere. The taking of a sample is an interference with bodily integrity and requires statutory authority and proportionality. The retention of a profile after an acquittal is an interference with informational privacy that the aim of investigating the offence charged does not justify, since that aim has been exhausted. Familial searching extends the burden to relatives against whom nothing is alleged and who have given no consent, so the interference reaches persons entirely outside the process. And the weight of a match is a probability that depends on the size and composition of the reference database, which the accused must be able to test in cross-examination if the right to a fair trial is to be real. These are questions of bodily integrity, of privacy and of fair trial rather than of self-incrimination.

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Chapter Thirty-Five

Technology and the Rights of the Child

Syllabus topic 2, "Implication of Development of Science and Technology on Human Rights"

In one line

A child cannot consent, cannot assess a risk that will mature in twenty years, and cannot leave, which is why every technology reaches them on different terms.

In the wording a student can write in an exam: children are treated separately in this subject not because the rights are different but because the conditions on which rights are exercised are absent: a child lacks the legal capacity to consent, lacks the information and experience to assess a risk, is dependent on adults whose interests may not coincide with theirs, and is exposed for a longer remaining lifetime to any harm that materialises; so the framework supplements the ordinary rights with a standard of the best interests of the child, with special protection where the child cannot choose, and with obligations owed by the State against the family as well as against strangers.

Why the law has this at all

Every protection in this paper assumes a person who can do something. Consent assumes capacity. Privacy assumes an ability to withhold. A remedy assumes someone who can complain. Children satisfy none of these assumptions fully, and the youngest satisfy none at all.

There is a second reason, less obvious and more important. A child's exposure is long. Data collected about a nine-year-old will still exist when they apply for work; a decision recorded now shapes what is available later; a harm from an intervention may appear in a decade. The framework's ordinary tools are built around a present interference with a present interest, and here the interest is largely in the future.

And there is a third. The adult who decides for the child is usually the parent, and the framework normally treats the family as the child's protection rather than as a source of risk. In this subject it cannot always do so, and General Comment 25 says as much in terms.

What the Committee requires

Paragraph 38 requires States to adopt measures to ensure that children living in poverty, particularly those with disabilities, have full access to the enjoyment of the right to participate in and enjoy the benefits of scientific progress, as they are entitled to special care and assistance, especially through pedagogical tools and quality scientific education that allow the development of the child's personality, talents and mental and physical abilities to their fullest potential. The Committee cites the Convention on the Rights of the Child, particularly its articles 24 and 29, for that proposition.

Paragraph 44 is the important one, because it addresses the family. The Committee states that States parties may have to protect people within their own familial, social or cultural context where their right to enjoy the benefits of scientific progress is affected, and that persons who, owing to their age or capacity, cannot choose for themselves must receive special protection.

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Its example is worth setting out because it is the clearest case in the whole Comment. Where parents decide not to have their children vaccinated on grounds the scientific community considers false, the parents' decision entails risks for the child and sometimes for society, from the possible resurgence of infectious diseases previously under control. In these cases the best interests of the child must be a primary consideration.

Paragraph 44 continues with two propositions that bear on children and on others: that people may be subject to great pressure from their social environment to undergo traditional treatment rather than benefit from the best available medical attention, and that States must guarantee everyone the right to choose or refuse treatment with full knowledge of the risks and benefits, subject to limitations meeting the criteria of article 4; and that States must establish protective measures in relation to messages from pseudoscience, which create ignorance and false expectations among the most vulnerable sectors of the population.

The Convention, named and placed

The Convention on the Rights of the Child of 1989 is the instrument that governs this area, and it is the most widely ratified human rights treaty there is. General Comment 25 relies on it, citing at footnote 12 particularly its articles 24 and 29, in support of the proposition in paragraph 38 about children in poverty, scientific education and the development of the child's abilities to their fullest potential.

Two things follow.

What can be said. The Convention is the governing instrument; the Committee treats it as directly relevant to the enjoyment of the right to science by children; and the standard of the best interests of the child, which paragraph 44 applies, is the Convention's central principle.

What this book will not do. The Convention is not in this subject's authority base, so no article of it is quoted here and none is paraphrased. A candidate should do the same: name it, state what the Committee draws from it, and avoid reciting article numbers that have not been read. That is a stronger answer than a confident but unsourced list, and it is the discipline this book applies to every instrument it does not hold.

The Indian provisions

Article 21A: free and compulsory education for children of six to fourteen, discussed in [Education and the Diffusion of Knowledge].

Article 24: no child below the age of fourteen years shall be employed to work in any factory or mine or engaged in any other hazardous employment. It is a fundamental right and it is directly a technology provision, since the hazard it addresses is industrial.

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Article 39(e): the State shall direct its policy towards securing that the tender age of children is not abused and that citizens are not forced by economic necessity to enter avocations unsuited to their age or strength. Article 39(f): that children are given opportunities and facilities to develop in a healthy manner and in conditions of freedom and dignity, and that childhood and youth are protected against exploitation and against moral and material abandonment.

ICESCR article 10(3) requires special measures of protection and assistance on behalf of all children and young persons, and requires States to set age limits below which the paid employment of child labour is prohibited and punishable. Article 12(2)(a) requires steps for the reduction of the stillbirth rate and of infant mortality and for the healthy development of the child.

Worked example

A State proposes that every school pupil be issued a tablet preloaded with an application that records attendance, monitors reading progress and reports both to a central education database, retained until the pupil turns twenty-five. Parents consent on enrolment by signing a general form.

The benefit is real and should be stated. Article 15(1)(b) gives the child an interest in what science has made available, and paragraph 38 requires pedagogical tools and quality scientific education, particularly for children in poverty. An answer that treats the scheme as simply objectionable has ignored half the framework.

Consent. The child has not consented and cannot. The parent has consented, in general terms, at a moment when refusal would have meant not enrolling in school. Consent given as the price of a compulsory service is not free, and paragraph 44 is the provision that lets a State's obligation be asserted against the family's decision rather than through it.

Whose interests. The best interests of the child are a primary consideration. The interests served by retention until twenty-five are administrative, and the child's interest in not carrying a school record into adult life points the other way.

Duration. Retention for a decade after the child leaves school is the point at which the scheme fails proportionality most clearly, because the purpose that justifies collection expires long before the retention does.

Equality. Paragraph 38 requires attention to children living in poverty, particularly those with disabilities. A device-based scheme distributes by household, so a child without power at home is monitored as absent rather than assisted, and the tool that was meant to include them records their exclusion.

What survives. The tablets, the teaching application, and progress data held by the school for the school year. What does not survive is central retention to twenty-five on a consent the child never gave.

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What it does NOT mean

It does not mean children should be kept away from technology. The Committee's demand is for access: pedagogical tools and quality scientific education, especially for children in poverty and children with disabilities. Exclusion is the harm paragraph 38 is directed against.

It does not mean parental consent is worthless. It is ordinarily the mechanism by which a child's rights are exercised. Paragraph 44 identifies the exception, where the decision made for the child is contrary to the child's interests on grounds the scientific community considers false.

Best interests is not the same as the child's wishes, and it is a primary consideration rather than the only one. The Committee's own example, vaccination, is a case where the standard operates against a decision made within the family and in favour of the child and of others.

And a child's inability to consent does not license intervention. The rule in [Bodily Integrity and Intervention Without Consent] applies: where a person cannot consent, the intervention needs authority, a best-interests basis and, in research, direct health benefit save by narrow exception.

Quick revision

  • Children are treated separately because the conditions of exercising rights are absent: no capacity to consent, no ability to assess risk, dependence on adults, and a longer remaining exposure.
  • General Comment 25, paragraph 38: measures so that children living in poverty, particularly those with disabilities, have full access; they are entitled to special care and assistance, through pedagogical tools and quality scientific education developing the child's personality, talents and mental and physical abilities to their fullest potential. Footnote 12 cites the Convention on the Rights of the Child, particularly articles 24 and 29.
  • Paragraph 44: States may have to protect people within their familial, social or cultural context; those who cannot choose for themselves by reason of age or capacity need special protection; where parents refuse vaccination on grounds the scientific community considers false, the best interests of the child must be a primary consideration. Also: the right to choose or refuse treatment with full knowledge of risks and benefits, and protective measures against messages from pseudoscience.
  • Constitution: article 21A (education six to fourteen), article 24 (no child under fourteen in a factory, mine or hazardous employment), article 39(e) and (f).
  • ICESCR article 10(3) (special measures, age limits for paid employment), article 12(2)(a) (infant mortality and the healthy development of the child).
  • The Convention on the Rights of the Child is not in this book's base: name it, say what the Committee draws from it, quote nothing.

Test yourself

1. Why does the framework treat children separately, given that they hold the same rights? Because the conditions on which rights are exercised are absent or impaired. A child lacks the legal capacity to consent, so the ordinary licence for intervention is unavailable; lacks the information and experience to assess a risk, particularly one that will mature years later; is dependent on adults whose interests may diverge from theirs; and has a longer remaining lifetime over which a harm can operate, so that data collected or a decision recorded now continues to affect them into adult life. The rights are the same; what differs is the person's ability to invoke them, which is why the framework supplements them with special protection and with the standard of the best interests of the child.

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2. Set out paragraph 44 of General Comment 25 and explain why it is significant that it addresses the family. It states that States parties may sometimes have to protect people within their own familial, social or cultural context where their right to participate in and enjoy the benefits of scientific progress is affected, and that persons who cannot choose for themselves by reason of age or capacity must receive special protection. Its example is that where parents decide not to have their children vaccinated on grounds the scientific community considers false, the decision entails risks for the child and sometimes for society through the resurgence of infectious diseases previously under control, and that in such cases the best interests of the child must be a primary consideration. It is significant because human rights law ordinarily treats the family as the child's protection and the State as the potential threat. Here the Committee accepts that the decision made within the family can itself be the interference, which supplies the basis for a State obligation asserted against the parent's decision rather than exercised through it.

3. What does paragraph 38 require, and which treaty does the Committee rely on for it? It requires States to adopt measures ensuring that children living in poverty, particularly those with disabilities, have full access to the enjoyment of the right to participate in and enjoy the benefits of scientific progress and its applications, on the footing that they are entitled to special care and assistance, especially through pedagogical tools and quality scientific education that allow the development of the child's personality, talents and mental and physical abilities to their fullest potential. The Committee cites the Convention on the Rights of the Child, particularly its articles 24 and 29, at footnote 12.

4. How should a candidate handle the Convention on the Rights of the Child on this paper, if they have not read its text? By naming it and placing it rather than reciting it. The correct statement is that the Convention of 1989 is the governing instrument for children's rights and the most widely ratified human rights treaty, that General Comment 25 relies on it for the proposition in paragraph 38 and cites particularly its articles 24 and 29, and that its central principle, the best interests of the child, is the standard the Committee applies in paragraph 44. What should not be done is to attribute numbered provisions to it from memory, since an article number recalled rather than read is the commonest way an otherwise sound answer becomes inaccurate, and the argument can be made in full from the Comment, which is available.

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5. A school scheme monitors pupils through issued devices and retains the data until they are twenty-five, with a general parental consent given on enrolment. Identify the three strongest objections. First, consent: the child has not consented and cannot, and the parent's consent was given in general terms at a moment when refusal meant forgoing schooling, so it is not free in the sense the framework requires, and paragraph 44 permits the State's obligation to be asserted against a decision made within the family. Second, duration and purpose: the justification for collection is educational and expires when the pupil leaves school, whereas the retention continues for years afterwards, so the measure fails proportionality at the point where purpose and retention diverge. Third, equality: paragraph 38 requires particular attention to children living in poverty and to those with disabilities, and a device-based scheme distributes by household, so a child without reliable power or connectivity is recorded as absent rather than assisted, and a tool intended to include them documents their exclusion instead.

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Chapter Thirty-Six

Technology and Persons with Disabilities

Syllabus topic 2, "Implication of Development of Science and Technology on Human Rights"

In one line

For most people technology is a convenience; for a person with a disability it is frequently the difference between being able to do a thing and not, which turns a question of access into a question of rights.

In the wording a student can write in an exam: assistive and accessible technology is the clearest instance in this paper of science operating as a means of realising human rights rather than as a threat to them, and the legal problem is correspondingly different: it is not restraint but distribution and design, so the obligations are to include persons with disabilities in decisions about science, to implement universal design, to provide reasonable accommodation, and to secure their free, prior and informed consent where they are subjects of research.

Why the law has this at all

Two propositions, both from General Comment 25 paragraph 34, set the frame.

Persons with disabilities have suffered deep discrimination in the enjoyment of this right. The Committee gives two reasons, and they are of different kinds. Either because of severe physical, communication and information obstacles to accessing basic and higher scientific education and careers; or because the products of scientific progress do not take into account their specificities and particular needs.

The second reason is the more interesting and the one an answer should dwell on. The exclusion is not always a barrier placed in the way. Often it is an absence at the design stage: a product built without a class of users in mind excludes them as effectively as a locked door, and nobody involved intended it. That is why the remedy the Committee reaches for is design rather than accommodation alone.

Persons with disabilities bring their unique perspectives and experiences into the scientific landscape, thus specifically contributing to the promotion of the right. The Committee puts this positively and deliberately. The claim is not merely that they should receive the products of science; it is that their participation improves science, which is the third dimension of accessibility, the open opportunity to participate, from [Availability, Accessibility, Acceptability and Quality].

What the Committee requires

Paragraph 35 sets out seven measures States parties should adopt at the least to overcome discrimination against persons with disabilities in the enjoyment of this right. They are worth learning as a list, because a question on this topic is answered by them.

  1. Promote participation and contribution of persons with disabilities, including women with disabilities who face multiple discrimination, in decision-making procedures concerning science.
  2. Develop statistics on access to science and its benefits disaggregated by disability.
  3. Implement universal design.
  4. Promote technologies that facilitate access to scientific education and employment for persons with disabilities.
  5. Ensure that reasonable accommodation is provided, to enable access to scientific education and employment and to ensure that they benefit from the products of scientific development, including its diffusion and dissemination in adapted formats.
  6. Adopt appropriate measures to raise awareness of the capabilities and contributions of persons with disabilities and to combat stereotypes and harmful practices. The Committee cites the Convention on the Rights of Persons with Disabilities, particularly articles 1 to 9, for this.
  7. Ensure that persons with disabilities have given their free, prior and informed consent when they are subjects of research.
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Paragraph 19 adds the acceptability element: scientific education and the products of science should be tailored to the particularities of populations with special needs, such as persons with disabilities. So the requirement of adapted formats is not only in paragraph 35 but is built into one of the four elements of the right itself.

Two ideas that carry marks

Universal design means designing a product, environment or service so that it is usable by the widest range of people without adaptation. It operates before the person arrives. A building with a step and a later ramp has been accommodated; a building designed level was universally designed. In technology the difference is stark and cheap: software written so that a screen reader can interpret it costs almost nothing at the design stage and cannot be retrofitted without rewriting.

Reasonable accommodation is the modification made for a particular person in a particular case, where the general design does not serve them. It operates after the person arrives, and is limited by reasonableness.

The two are complements, not alternatives, and the Committee requires both, at paragraph 35(c) and (e) respectively. The distinction matters legally because they allocate cost and initiative differently: universal design is a standing obligation owed to everybody in advance, while reasonable accommodation is triggered by an individual and can be resisted on grounds of disproportionate burden. A State that relies on accommodation alone has left the excluded person to ask, every time.

The Convention, named and placed

The Convention on the Rights of Persons with Disabilities of 2006 is the governing instrument. General Comment 25 relies on it, citing at footnote 11 particularly its articles 1 to 9, in support of the requirement to raise awareness of capabilities and contributions and to combat stereotypes and harmful practices.

As with the Convention on the Rights of the Child in [Technology and the Rights of the Child], the Convention is not in this book's authority base. It is named, placed, and relied on through what the Committee records of it, and no article of it is quoted here. A candidate should do likewise, and should note that the Convention is the source of the two concepts above, which the Committee uses without defining them.

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The Indian frame

Article 14 guarantees equality before the law and the equal protection of the laws, and equal protection has long been understood to permit and sometimes require differential treatment where circumstances differ. Article 15 prohibits discrimination on the enumerated grounds and permits special provision. Article 41 requires the State, within the limits of its economic capacity and development, to make effective provision for securing the right to work, to education and to public assistance in cases of unemployment, old age, sickness and disablement, and in other cases of undeserved want. Article 41 is the directive principle that names disablement expressly and is the natural citation for the distributive obligation.

Worked example

A State digitises its public services: applications, payments, certificates and grievances all move to a single portal. The portal is built to a modern visual design and is not compatible with screen readers. The State's answer is that any person unable to use it may attend a facilitation centre where an operator will complete the transaction for them.

Which right, and how is it engaged? Article 15(1)(b) read with article 2(2). The applications of science must be accessible without discrimination, particularly where they are instrumental for the enjoyment of other rights, and here they are instrumental for almost every dealing with the State.

Universal design. Paragraph 35(c) requires it, and this is the paradigm failure: compatibility with assistive software is a design property that costs little in advance and a great deal to retrofit. The exclusion was not intended and is complete.

Is the facilitation centre reasonable accommodation? It is an accommodation, and it is worse than it looks. It requires the person to travel; it makes them dependent on an operator; and it destroys the privacy of every transaction, since the operator sees the medical, financial and family information the portal handles. A blind applicant conducts their affairs in front of a stranger while a sighted applicant does so alone. That is not equal access; it is access on inferior terms, and the inequality is in dignity and privacy rather than in outcome.

Adapted formats. Paragraph 35(e) requires that the products of scientific development be disseminated in adapted formats, and paragraph 19 puts the same requirement inside acceptability. The obligation is to make the portal usable, not to supply a human substitute for it.

Participation. Paragraph 35(a) asks who was in the room. A portal that fails this way is almost always one designed without any user who needed a screen reader, which is the design-stage exclusion of paragraph 34 producing the access-stage exclusion.

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Measurement. Paragraph 35(b) requires statistics disaggregated by disability. A State that does not measure who is failing to complete a transaction cannot know it has this problem, and cannot demonstrate compliance.

What it does NOT mean

It does not mean technology is uniformly good here. The same automation discussed in [Artificial Intelligence and Decisions by Machines] can exclude: a system trained on data that does not represent disabled users performs worse for them, and a verification step that assumes a particular physical capability locks them out entirely. The point is that the balance in this area is unusually favourable, not that the risks are absent.

Assistive technology is not charity. It is the means by which a right is exercised, which is why the Committee places it under an obligation rather than under welfare.

Reasonable accommodation does not discharge the design obligation. They are separate requirements in paragraph 35, and an accommodation that requires the person to ask, to travel, or to surrender privacy is unequal access even when it works.

And participation is not consultation after the fact. Paragraph 35(a) speaks of participation and contribution in decision-making procedures concerning science, which is a place at the table rather than a comment on a finished design.

Quick revision

  • The area where technology is chiefly an enabler, so the legal problem is distribution and design, not restraint.
  • Paragraph 34: deep discrimination, for two reasons, physical, communication and information obstacles, and products that do not take account of their specificities and particular needs; and persons with disabilities contribute to the promotion of the right.
  • Paragraph 35, seven measures at the least: (a) participation in decision-making, including women with disabilities facing multiple discrimination; (b) statistics disaggregated by disability; (c) universal design; (d) promote technologies facilitating access to scientific education and employment; (e) reasonable accommodation, including dissemination in adapted formats; (f) raise awareness and combat stereotypes, citing the CRPD, particularly articles 1 to 9; (g) free, prior and informed consent where they are research subjects.
  • Paragraph 19: acceptability requires science and its products to be tailored to populations with special needs, such as persons with disabilities.
  • Universal design operates before the person arrives and is owed to everyone; reasonable accommodation operates after, for an individual, and is limited by reasonableness. Both are required.
  • India: articles 14 and 15; article 41, which names disablement expressly.
  • The CRPD is not in this book's base: name it, say what the Committee draws from it, quote nothing.

Test yourself

1. Give the Committee's two reasons why persons with disabilities have suffered deep discrimination in the enjoyment of this right, and say why the second is the more significant. Either because of severe physical, communication and information obstacles to accessing basic and higher scientific education and careers, or because the products of scientific progress do not take into account their specificities and particular needs. The second is more significant because it locates the exclusion at the design stage rather than at the point of access: nothing is placed in the person's way and nobody intends to exclude them, but a product built without them in mind is unusable by them, and the effect is as complete as a barrier. It follows that the remedy cannot be limited to removing obstacles after the fact and must reach the design itself, which is why the Committee requires universal design and participation in decision-making.

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2. Distinguish universal design from reasonable accommodation and explain why both are required. Universal design is the design of a product, environment or service so that it is usable by the widest possible range of people without adaptation; it operates before any particular person arrives, is owed generally, and in technology is usually cheap in advance and expensive to retrofit. Reasonable accommodation is a modification for a particular person in a particular case where the general design does not serve them; it operates after the person arrives, is triggered by them, and is limited by reasonableness so that it can be resisted as a disproportionate burden. Both are required, at paragraph 35(c) and (e) respectively, because each fails where the other is absent: design cannot anticipate every individual need, and accommodation alone leaves the excluded person to ask every time, on terms that are often less private and less convenient than those enjoyed by everybody else.

3. List the measures paragraph 35 requires States to adopt at the least. To promote the participation and contributions of persons with disabilities, including women with disabilities who face multiple discrimination, in decision-making procedures concerning science; to develop statistics on access to science and its benefits disaggregated by disability; to implement universal design; to promote technologies that facilitate access to scientific education and employment; to ensure that reasonable accommodation is provided so that they can access scientific education and employment and benefit from the products of scientific development, including diffusion and dissemination in adapted formats; to adopt appropriate measures to raise awareness of their capabilities and contributions and to combat stereotypes and harmful practices; and to ensure that they have given their free, prior and informed consent when they are subjects of research.

4. A State offers a facilitation centre where an operator completes online transactions for anyone unable to use its portal. Is that equal access? No. It is an accommodation rather than access, and it is unequal in three respects that the framework recognises. It requires the person to travel, so the transaction costs them time and money a sighted user does not spend. It makes them dependent on another person's assistance, removing the independence the service gives everybody else. And it destroys privacy, since the operator sees whatever the transaction contains, including medical, financial and family information, so the person conducts their affairs before a stranger while others conduct theirs alone. The inequality is therefore in dignity and privacy rather than in outcome, and paragraph 35(c) and (e) require the portal itself to be usable and disseminated in adapted formats rather than a human substitute to be provided for it.

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5. Why does the Committee say that persons with disabilities contribute to the promotion of this right, and which element of the right does that statement belong to? Because it treats them as participants in science and not merely as recipients of its products, stating in paragraph 34 that they bring unique perspectives and experiences into the scientific landscape and thereby specifically contribute to the promotion of the right. The statement belongs to the third dimension of accessibility, the open opportunity for everyone to participate in scientific progress without discrimination, under which States must remove discriminatory barriers that impede participation. Its practical importance is that it supports the obligation in paragraph 35(a) to include them in decision-making procedures concerning science, which is a claim to a place in the process rather than a claim to the output of it, and it supplies the answer to the design-stage exclusion identified in paragraph 34.

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Chapter Thirty-Seven

Access to Medicines and Patents

Syllabus topic 2, "Implication of Development of Science and Technology on Human Rights"

In one line

A medicine that exists and cannot be afforded is the sharpest form of the question this paper asks, because nothing is missing except permission and price.

In the wording a student can write in an exam: the patent system is defended as the mechanism by which research is financed, and criticised as the mechanism by which the products of research are withheld from those who cannot pay; the human rights framework does not resolve that argument in the abstract but supplies the terms of it, since article 15(1)(b) gives everyone the right to enjoy the benefits of scientific progress, article 12 the right to the highest attainable standard of health, and article 15(1)(c) the author's own moral and material interests, so that the question is not whether intellectual property is legitimate but what limits the enjoyment of the other rights places upon it.

Why the law has this at all

The difficulty is genuine and an answer that pretends otherwise is weak. Both propositions below are true.

Research is expensive and somebody must pay for it. A pharmaceutical company that cannot recover the cost of developing a medicine will not develop the next one, and the loss falls on future patients who will never know what they did not get. A framework that treats every patent as a violation would defeat article 15(1)(b) in the long run by destroying the supply of benefits to enjoy.

A monopoly on a medicine is a monopoly on a life. Where the product is a treatment for a fatal condition, the price is not a commercial term but a condition of survival, and the people excluded are excluded by a legal instrument rather than by any scarcity of the substance.

The framework's response is neither to abolish patents nor to defer to them. It is to treat intellectual property as a policy instrument subject to the rights, and to insist that the domestic law be designed with the other rights in view.

The three Covenant provisions

Article 15(1)(b): the right of everyone to enjoy the benefits of scientific progress and its applications. A medicine is the paradigm application.

Article 12: the right to the highest attainable standard of physical and mental health. As explained in [Health and Medical Technology], "highest attainable" rises when science advances, so the existence of an effective medicine enlarges the obligation.

Article 15(1)(c): the right of everyone to benefit from the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author.

Article 15(1)(c) is the provision most often misused in answers. It is a human right of a natural person, the author, connected to dignity. A patent is a statutory entitlement, of limited duration, freely assignable, and in the pharmaceutical field almost always held by a company that is not an author at all. The two overlap and are not the same, and the point is made in [The Scientist: Rights and Responsibilities]. It follows that a corporation cannot answer a claim under article 12 by invoking article 15(1)(c); the Covenant right it would be invoking is not its own.

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What the Committee says

Paragraph 17, under accessibility, requires that everyone have equal access to the applications of science, particularly when they are instrumental for the enjoyment of other economic, social and cultural rights. Medicines are the clearest case of such an application.

Paragraph 79 requires that access to research results and their applications be regulated in a form that allows developing countries and their citizens adequate access to these products in an affordable manner, such as access to essential medicines. The Committee names essential medicines expressly as its example.

Paragraph 80 requires that the benefits and applications resulting from scientific progress be shared, with due incentives and regulations, with the international community, particularly developing countries, communities living in poverty and groups with special needs, especially where the benefits are closely related to the enjoyment of economic, social and cultural rights.

The words "with due incentives and regulations" are the Committee accepting, in its own text, that the financing problem is real. That is the balanced position, and a candidate who quotes the phrase demonstrates it.

UNESCO 1997, article 4, adds a rule at the boundary: the human genome in its natural state shall not give rise to financial gains. It does not prohibit patents on inventions derived from genetic knowledge, and the qualification is where the argument lies.

The Indian answer: section 3(d)

India's legislative response is the most studied in the world, and this is the case.

Novartis AG v. Union of India, AIR 2013 SC 1311, (2013) 6 SCC 1, decided on 1 April 2013 by Aftab Alam and Ranjana Prakash Desai JJ.

Facts. Novartis applied for an Indian patent for the beta crystalline form of Imatinib Mesylate, marketed as Gleevec, used in the treatment of chronic myeloid leukaemia. The application had lain in the mailbox awaiting the amendments by which India introduced product patents for pharmaceuticals. It was refused, and the refusal upheld by the Intellectual Property Appellate Board, on the ground among others that the claimed product was a new form of a known substance which did not satisfy section 3(d) of the Patents Act 1970.

Held. Where a patent is claimed for a new form of a known substance with known efficacy, the product must satisfy, in addition to clauses (j) and (ja) of section 2(1), the test of enhanced efficacy in section 3(d) read with its Explanation. In the case of a medicine, efficacy means therapeutic efficacy. Increased bioavailability alone may not necessarily amount to an enhancement of therapeutic efficacy; whether it does in a given case must be specifically claimed and established by research data, and no material had been offered to show that the beta crystalline form would produce enhanced or superior therapeutic efficacy over the Imatinib free base. In whichever way section 3(d) is viewed, whether as setting up standards of patentability or as an extension of the definition of invention, the product failed its test.

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Held, the caution. The Court added expressly that this does not mean section 3(d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances, and that it would be a grave mistake to read the judgment as meaning that section 3(d) was amended so as to undo the change made by the deletion of section 5 of the parent Act.

Why it matters here. Section 3(d) is a domestic device that keeps a known medicine in the public domain unless a genuine therapeutic gain is proved, which is the practice sometimes called evergreening: extending a monopoly by patenting minor variations of an existing product. The case is important for this paper in two ways. It shows a legislature designing patent law with access in view, which is what the Committee asks for at paragraph 79. And the caution in the judgment shows a court refusing to convert a targeted rule into a general hostility to innovation, which is the balance paragraph 80 states in the words "with due incentives and regulations".

TRIPS and Doha, named and placed

The international framework is the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of 1994, which requires members of the World Trade Organization to make patents available for inventions in all fields of technology including pharmaceuticals, and the Doha Declaration on the TRIPS Agreement and Public Health of 2001, adopted after the controversy over access to antiretroviral medicines, which affirmed that the Agreement should be interpreted and implemented in a manner supportive of members' right to protect public health and to promote access to medicines for all, and addressed the flexibilities available to that end, including compulsory licensing.

Neither instrument is in this book's authority base. They are named here because an answer on this topic that did not mention them would be incomplete, and nothing is quoted from either. A candidate should do the same: name them, state their effect in general terms, and avoid attributing numbered articles to a text they have not read. The compulsory licence, by which a State authorises manufacture without the patent holder's consent on stated conditions, is the mechanism most often discussed, and it is a creature of the domestic patent statute operating within that international framework.

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Worked example

A company holds an Indian patent on an antiviral medicine. The annual course costs more than a district's entire drug budget. A domestic manufacturer can produce it at a fraction of the price. The company argues that a compulsory licence would destroy the incentive to develop the next antiviral.

Which rights, on each side? For the patients, article 12 and article 15(1)(b), reinforced by paragraphs 17 and 79 of the Comment, which name affordable access to essential medicines. For the company, no Covenant right of its own: article 15(1)(c) protects the author, and the corporate patent holder is not one. Its argument is a policy argument about incentives, and paragraph 80's reference to due incentives is where that argument properly belongs.

Is the patent valid at all? The first question, not the last. If the product is a new form of a known substance, section 3(d) applies and enhanced therapeutic efficacy must be established by research data, on Novartis. A patent that should not have been granted needs no licence to defeat it.

If the patent is valid. The question becomes the statutory conditions for a compulsory licence, which is domestic patent law, applied within the TRIPS framework as addressed at Doha. The human rights framework does not itself grant the licence; it supplies the reason the statutory power exists and the standard against which its exercise is judged.

And what else is available. The framework's own preferences are broader than litigation: public funding conditioned on affordable access, tiered pricing, voluntary licensing for local manufacture, and the international measures in [International Co-operation in Science]. An answer confined to compulsory licensing has taken the narrowest of the available routes.

What it does NOT mean

It does not mean patents violate human rights. The Covenant protects the author's interests in article 15(1)(c) and the Committee accepts the need for incentives in terms. The claim is about the design and the limits of the system.

Section 3(d) is not a bar on incremental innovation. Novartis says so expressly, and calls the contrary reading a grave mistake.

Efficacy is not any advantage. For a medicine it is therapeutic efficacy, and increased bioavailability does not by itself establish it; it must be claimed and proved by research data.

And a corporation is not an author. The most common error in answers on this topic is to give a company the benefit of article 15(1)(c).

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Quick revision

  • Three provisions: article 15(1)(b) (benefits of scientific progress), article 12 (highest attainable standard of health), article 15(1)(c) (the author's moral and material interests, a human right of a natural person, not a patent).
  • General Comment 25: paragraph 17, equal access to applications particularly where instrumental for other economic, social and cultural rights; paragraph 79, access regulated so that developing countries and their citizens have affordable access, such as essential medicines; paragraph 80, benefits shared with due incentives and regulations.
  • UNESCO 1997, article 4: the genome in its natural state shall not give rise to financial gains. Not a bar on biotechnology patents.
  • Novartis (2013): a new form of a known substance must satisfy section 3(d) enhanced efficacy in addition to section 2(1)(j) and (ja); for a medicine, efficacy means therapeutic efficacy; increased bioavailability alone is not enough and must be specifically claimed and established by research data. Express caution: section 3(d) does not bar all incremental inventions, and reading it so would be a grave mistake.
  • TRIPS 1994 and the Doha Declaration 2001, not in the base: name them, state their effect, quote nothing. Compulsory licensing is a creature of the domestic statute within that framework.

Test yourself

1. Why can a corporate patent holder not rely on article 15(1)(c) of the Covenant? Because article 15(1)(c) recognises the right of everyone to benefit from the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author. It is a human right, held by a natural person, connected to that person's relationship with what they created and to their dignity. A patent is a statutory entitlement of limited duration, freely assignable, and in the pharmaceutical field usually held by a company that did not author anything and could not be an author. A corporation invoking the article is therefore invoking a right that is not its own, and its true argument, that monopoly rents finance future research, is a policy argument about incentives rather than a rights claim, which is where paragraph 80's reference to due incentives places it.

2. State the holding in Novartis on section 3(d), including the caution. Where a patent is claimed for a new form of a known substance with known efficacy, the product must satisfy, in addition to clauses (j) and (ja) of section 2(1) of the Patents Act 1970, the test of enhanced efficacy in section 3(d) read with its Explanation; in the case of a medicine, efficacy means therapeutic efficacy; and increased bioavailability alone may not necessarily amount to an enhancement of therapeutic efficacy, whether it does in a given case having to be specifically claimed and established by research data. No such material having been offered for the beta crystalline form of Imatinib Mesylate, the product failed the test however section 3(d) is characterised. The Court cautioned expressly that this does not mean section 3(d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances, and that it would be a grave mistake to read the judgment as undoing the change made by the deletion of section 5 of the parent Act.

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3. What does paragraph 79 of General Comment 25 require, and why is its example significant? It requires that access to research results and their applications be regulated in a form that allows developing countries and their citizens adequate access to these products in an affordable manner, and gives access to essential medicines as its example. The example is significant because it moves the Committee's requirement from a general statement about the diffusion of science to the specific field where the conflict with intellectual property is sharpest, and because it identifies affordability rather than mere availability as the standard. A State or an international arrangement under which a medicine exists but cannot be bought therefore fails the paragraph even though nothing is physically scarce.

4. Set out the two true propositions that make this topic genuinely difficult. The first is that research is expensive and must be financed, so that a system which allowed no return would reduce the supply of new medicines, and the loss would fall on future patients who would never learn what they did not receive; a framework treating every patent as a violation would therefore defeat article 15(1)(b) over time. The second is that a monopoly over a medicine for a fatal condition is in practical terms a monopoly over survival, and those excluded by the price are excluded by a legal instrument rather than by any scarcity of the substance itself. The framework does not choose between them: it treats intellectual property as a policy instrument subject to the rights, requires the domestic law to be designed with access in view, and accepts in paragraph 80 that benefits are to be shared with due incentives and regulations.

5. How should a candidate handle TRIPS and the Doha Declaration if they have not read the texts? By naming and placing them without quoting them. The accurate statement is that TRIPS, concluded in 1994, requires members of the World Trade Organization to make patents available for inventions in all fields of technology including pharmaceuticals, and that the Doha Declaration on the TRIPS Agreement and Public Health of 2001, adopted after the controversy over access to antiretroviral medicines, affirmed that the Agreement should be interpreted and implemented in a manner supportive of members' right to protect public health and to promote access to medicines for all, and addressed the flexibilities available for that purpose including compulsory licensing. What should be avoided is attributing numbered articles to either text from memory. An answer that names them accurately and argues the substance from the Covenant, General Comment 25 and Novartis is stronger than one that cites article numbers it cannot vouch for.

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Chapter Thirty-Eight

The State's Duty to Regulate Technology

Syllabus topic 2, "Implication of Development of Science and Technology on Human Rights"

In one line

Almost all the technology in this paper is built and owned by people the human rights framework does not bind, which is why the State's duty to regulate is where the whole subject ends up.

In the wording a student can write in an exam: human rights obligations bind States, while research, development, manufacture and deployment are overwhelmingly in private hands, so the framework reaches technology principally through the tripartite obligation to respect, protect and fulfil, of which the duty to protect, requiring the State to prevent interference by private persons and entities, carries most of the weight in this subject.

Why the law has this at all

A student's first instinct is to ask whether a company has violated somebody's human rights. On the orthodox view it has not, because the company is not bound by the Covenant. That answer is correct and useless on its own, and the framework's response is to redirect the question: what was the State required to do about it?

This is not a technicality. It changes what an answer looks like. Instead of asking whether a platform, a laboratory or a manufacturer behaved badly, the analysis asks whether the State licensed, inspected, required, prohibited, funded or failed to legislate. The wrong is a regulatory failure, and it is attributable to a party that can be brought before a body.

The 1975 Declaration understood this in 1975. Its paragraph 8 requires effective measures, including legislative measures, to prevent and preclude the utilisation of scientific and technological achievements to the detriment of human rights, and its paragraph 9 requires States, whenever necessary, to take action to ensure compliance with legislation guaranteeing human rights in the conditions of scientific and technological development. Paragraph 9 is about enforcement rather than enactment, and it is regularly forgotten.

The three obligations

General Comment 25, paragraph 41, states that States parties have an obligation to respect, protect and fulfil the right to participate in and enjoy the benefits of scientific progress. The Comment then works each out with examples, and the examples are what make an answer concrete.

To respect

Paragraph 42. The obligation requires States to refrain from interfering directly or indirectly in the enjoyment of the right. The examples are:

  • eliminating barriers to accessing quality science education and to the pursuit of scientific careers;
  • refraining from disinformation, disparagement or deliberate misinformation intended to erode citizen understanding of and respect for science and scientific research;
  • eliminating censorship or arbitrary limitations on access to the Internet, which undermines access to and dissemination of scientific knowledge; and
  • refraining from imposing, or eliminating, obstacles to international collaboration among scientists, unless the restrictions can be justified under article 4 of the Covenant.
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The second is unusual and worth noticing. A duty on the State not to spread false scientific information is a duty about the State's own speech, and it is stated as an element of the duty to respect a Covenant right.

To protect

Paragraph 43. The obligation requires States to adopt measures to prevent any person or entity from interfering with the right, for example by preventing access to knowledge or by discriminating on grounds of gender, sexual orientation or gender identity or other circumstances. The Comment names the entities it has in mind: universities, schools, laboratories, cultural or scientific associations, patients in hospitals and volunteers participating in scientific experiments. Its examples of the duty are:

  • ensuring that scientific associations, universities, laboratories and other non-State actors do not apply discriminatory criteria;
  • protecting people from participating in research or tests that contravene the applicable ethical standards for responsible research, and guaranteeing their free, prior and informed consent;
  • ensuring that private persons and entities do not disseminate false or misleading scientific information; and
  • ensuring that private investment in scientific institutions is not used to unduly influence the orientation of research or to restrict the scientific freedom of researchers.

The last example is the one that answers the funding contract in [The Scientist: Rights and Responsibilities]. A State that permits such a contract to be enforced without qualification has not protected the researcher's freedom, and the Comment says so in terms.

Paragraph 44 extends the duty into the family and the community, and is worked in [Technology and the Rights of the Child].

To fulfil

Paragraph 45. The duty requires States to adopt legislative, administrative, budgetary and other measures and to establish effective remedies aimed at the full enjoyment of the right. The measures include education policies, grants, participation tools, dissemination, providing access to the Internet and other sources of knowledge, participation in international co-operation programmes, and ensuring appropriate financing.

Paragraph 46 states that the duty to fulfil is reinforced and specified by article 15(2), the duty to take steps for the conservation, the development and the diffusion of science, discussed in [The Duty to Conserve, Develop and Diffuse Science].

Where regulation actually bites

The obligations above are stated at the level of principle. In practice a State regulates technology through a small number of instruments, and an answer is stronger for naming them.

InstrumentWhat it controlsExample in this paper
Prohibition of a useA specific application, the technology remaining lawfulPCPNDT 1994, prohibiting communication of foetal sex
Licensing and registrationWho may operate, and on what conditionsClinics under the ART and Surrogacy Acts; hazardous industry consents
Standards and certificationWhether a product may reach the publicThe quality element in General Comment 25, requiring regulation in dialogue with the scientific community
Mandatory assessmentWhether a deployment may proceed at allHuman rights impact assessments, paragraph 22
Liability rulesWho bears the cost when harm occursAbsolute liability in M.C. Mehta
Procurement and funding conditionsWhat is built, and on what terms it is made availablePublic funding conditioned on affordable access, paragraph 79
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The last row is the one most often overlooked, and it is frequently the most effective. A State that funds research can set the terms of access at the outset, which avoids the far harder problem of extracting concessions from a monopolist afterwards.

Worked example

A private company operates a network of diagnostic laboratories. It offers a discounted genetic screening panel, sells anonymised aggregate results to insurers, and requires customers to accept those terms as a condition of the discount. There is no statute governing genetic data as such.

Is the company bound by the Covenant? No. That is the starting point, not the conclusion.

What was the State required to do? Under the duty to protect, to adopt measures preventing any person or entity from interfering with the right, including by ensuring that non-State actors do not apply discriminatory criteria and that consent is free, prior and informed. Consent obtained as the price of a discount, from customers who are not told what re-identification is possible, is not consent of that quality.

Is "there is no statute" an answer for the State? It is the opposite of an answer. Paragraph 45 requires legislative measures, and paragraph 8 of the 1975 Declaration requires effective measures including legislative measures. The absence of a statute is the breach, not the excuse for it.

And if a statute exists but nothing is done? Then paragraph 9 of the Declaration is engaged, which requires action to ensure compliance with legislation guaranteeing human rights in the conditions of scientific development. Enactment without enforcement is a distinct failure and should be identified as such.

What would compliance look like? A statutory rule on genetic data and consent; a prohibition on use for insurance underwriting or a rule of non-discrimination equivalent to article 6 of the UNESCO Declaration of 1997; a regulator with inspection powers; and a remedy for the individual, which is [Remedies When Technology Causes Harm].

What it does NOT mean

It does not mean private actors have no responsibilities. They have them in domestic law, in professional regulation and in the ethics instruments. What they do not have is direct obligations under the Covenant, which is why the analysis is routed through the State.

The duty to protect is not a duty to prohibit. The Comment's examples are about ensuring, requiring and guaranteeing. Prohibition is one instrument among several and usually the crudest.

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It is not satisfied by enactment alone. Paragraph 9 of the 1975 Declaration and the reference to effective remedies in paragraph 45 both point to enforcement.

And the duty to respect is not merely passive. Paragraph 42 requires the State to refrain from interfering indirectly as well as directly, and lists eliminating barriers, eliminating censorship and eliminating obstacles, all of which require action rather than abstention.

Quick revision

  • Human rights bind States; technology is mostly private; so the framework reaches it through respect, protect and fulfil, paragraph 41.
  • Respect, paragraph 42: refrain from interfering directly or indirectly; eliminate barriers to science education and careers; refrain from disinformation, disparagement or deliberate misinformation; eliminate censorship or arbitrary limitations on internet access; remove obstacles to international collaboration, unless justified under article 4.
  • Protect, paragraph 43: prevent any person or entity from interfering; non-State actors must not apply discriminatory criteria; protect people from research contravening ethical standards and guarantee free, prior and informed consent; prevent private dissemination of false or misleading scientific information; ensure private investment does not unduly influence the orientation of research or restrict scientific freedom.
  • Fulfil, paragraph 45: legislative, administrative, budgetary and other measures and effective remedies; education policies, grants, participation tools, dissemination, access to the Internet, international co-operation, appropriate financing. Paragraph 46: reinforced by article 15(2).
  • 1975 Declaration: paragraph 8, effective measures including legislative measures; paragraph 9, action to ensure compliance with legislation. Enactment without enforcement is a separate failure.
  • Six instruments: prohibition of a use, licensing, standards and certification, mandatory assessment, liability rules, and procurement and funding conditions.

Test yourself

1. Why does the analysis of a private company's conduct proceed through the State, and why is that not merely a technicality? Because the Covenant and the other instruments impose obligations on States parties, and a company is not a party to them, so a claim that the company has violated the Covenant is misconceived. It is not a technicality because it changes the question asked and the party answerable. Instead of asking whether the company behaved badly, which no international body can determine and no individual can enforce against it under the treaty, the analysis asks what the State licensed, required, prohibited, inspected, funded or failed to legislate. The wrong is identified as a regulatory failure attributable to a party that is bound and that can be brought before a treaty body or a domestic court.

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2. Set out the four examples the Committee gives of the duty to respect. Eliminating barriers to accessing quality science education and to the pursuit of scientific careers; refraining from disinformation, disparagement or deliberate misinformation intended to erode citizen understanding of and respect for science and scientific research; eliminating censorship or arbitrary limitations on access to the Internet, which undermines access to and dissemination of scientific knowledge; and refraining from imposing, or eliminating, obstacles to international collaboration among scientists, unless such restrictions can be justified in accordance with article 4 of the Covenant. Three of the four require the State to eliminate something, so the duty to respect is not purely one of abstention.

3. Which example under the duty to protect answers the problem of a funder controlling a researcher's conclusions? The requirement that States ensure that private investment in scientific institutions is not used unduly to influence the orientation of research or to restrict the scientific freedom of researchers. It matters because the researcher's freedom under article 15(3) is a right against the State, so a contractual restriction imposed by a private funder cannot itself breach the Covenant. The duty to protect supplies the missing link: a State whose law enforces such a clause without qualification, and which exposes a researcher who publishes contrary to it to liability, has failed to adopt the measures the Comment requires.

4. A State says it cannot act against a harmful commercial use of a technology because no statute covers it. Assess that answer. It is not a defence but a statement of the breach. The duty to fulfil in paragraph 45 requires States to adopt legislative, administrative, budgetary and other measures and to establish effective remedies aimed at the full enjoyment of the right, and paragraph 8 of the 1975 Declaration requires effective measures including legislative measures to prevent and preclude the use of scientific achievements to the detriment of human rights. The absence of a statute in an area where private conduct is interfering with the right is therefore the failure alleged. A separate failure arises where a statute exists and nothing is done, since paragraph 9 of the Declaration requires action to ensure compliance with legislation guaranteeing human rights in the conditions of scientific and technological development.

5. Name the six instruments through which a State regulates technology and identify the one most often overlooked. Prohibition of a particular use while the technology itself remains lawful; licensing and registration of those who may operate and on what conditions; standards and certification governing whether a product may reach the public; mandatory assessment before deployment, such as the human rights impact assessments contemplated by paragraph 22; liability rules allocating the cost when harm occurs, such as absolute liability; and procurement and funding conditions. The last is the one most often overlooked and frequently the most effective, because a State that funds research can fix the terms of access at the outset, which is far easier than extracting concessions afterwards from a party that has since acquired a monopoly, and paragraph 79's requirement that access be regulated so as to be affordable is naturally implemented in that way.

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Chapter Thirty-Nine

Remedies When Technology Causes Harm

Syllabus topic 2, "Implication of Development of Science and Technology on Human Rights"

In one line

A right without a remedy is a sentence in a book, and technological harm is unusually good at defeating remedies.

In the wording a student can write in an exam: article 2(3) of the ICCPR requires States Parties to ensure an effective remedy to any person whose rights are violated, notwithstanding that the violation was committed by persons acting in an official capacity, to ensure determination by a competent authority, and to ensure that the remedy is enforced; and the practical difficulty in this subject is that technological harm characteristically defeats each of the ordinary routes, being latent, diffuse, technically opaque and produced by a party far larger than the person harmed.

Why the law has this at all

Everything before this chapter states an obligation. This chapter asks the question the person actually harmed asks, which is what they can do on Monday morning.

The four features that make it hard are worth stating at the outset, because each defeats a different element of a claim.

Latency. The harm appears years after the exposure, by which time limitation periods have run, records have gone and the enterprise may no longer exist.

Diffusion. Thousands of people are injured a little. Each claim is too small to be worth bringing alone, and the aggregate is enormous.

Opacity. The evidence of what happened is inside the defendant: the process, the maintenance records, the training data, the model. The claimant must plead a case about facts they cannot see.

Asymmetry. The defendant is a company or a State with counsel; the claimant is a person with a disability, a village, or a family. Union Carbide is the standing illustration of what that asymmetry does over time.

The provisions

ICCPR article 2(3) requires each State Party to undertake three things: to ensure that any person whose rights are violated shall have an effective remedy, notwithstanding that the violation has been committed by persons acting in an official capacity; to ensure that any person claiming such a remedy shall have their right determined by competent judicial, administrative or legislative authorities, or by any other competent authority provided for by the legal system, and to develop the possibilities of judicial remedy; and to ensure that the competent authorities enforce such remedies when granted.

The third limb is the one that matters most in this subject. A remedy that is granted and not enforced satisfies nothing, and the Covenant says so expressly.

UDHR article 8: everyone has the right to an effective remedy by the competent national tribunals for acts violating the fundamental rights granted him by the constitution or by law.

UNESCO 1997, article 8: every individual shall have the right, according to international and national law, to just reparation for any damage sustained as a direct and determining result of an intervention affecting his or her genome. Note the causal standard: direct and determining, which is a demanding test in exactly the field where causation is hardest.

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General Comment 25, paragraph 45, includes the establishment of effective remedies within the duty to fulfil.

The Indian routes, and where each fails

An answer that lists remedies is adequate. An answer that says where each one breaks is good.

Constitutional

Article 32 gives the right to move the Supreme Court for the enforcement of fundamental rights, and is itself a fundamental right; article 226 gives the High Courts a wider jurisdiction. Public interest litigation has made these the principal route for diffuse harms, and M.C. Mehta was itself a petition under article 32.

Where it fails. It reaches State action and public functions most comfortably; it delivers directions better than it delivers money to individuals; and it depends on a petitioner willing to litigate for years. In M.C. Mehta the Court declined to set up a special machinery for the compensation claims and instead directed the Delhi Legal Aid and Advice Board to file actions in the appropriate court, with the Delhi Administration funding them, which shows the constitutional court routing individual compensation back to ordinary litigation.

Civil

The action in tort, and in this field principally the rule of absolute liability established in M.C. Mehta, which removes fault and the Rylands v. Fletcher exceptions, and measures compensation with reference to the magnitude and capacity of the enterprise so that it deters.

Where it fails. Not on doctrine but on proof, delay and cost. This is the lesson of Union Carbide, where the substantive rule already existed and the victims were defeated by forum, by not being heard before their claims were settled, by the contested categorisation of injury on which every individual award depended, and by time.

Criminal

Prosecution of those responsible. In Union Carbide the Court restored the criminal proceedings that the settlement had quashed, holding that its powers under articles 136 and 142 were not taken away by article 139A.

Where it fails. The standard of proof is the highest; identifying an individual within a corporate structure is difficult; and a conviction compensates nobody. Jacob Mathew, taken in Module II, sets a deliberately high threshold before professional error becomes crime.

Statutory

Consumer protection, industrial and factory legislation, environmental statutes, and sector regulators. The Consumer Protection Act 2019 supplies a forum designed for exactly the small-value, high-volume claim that ordinary litigation cannot absorb.

Where it fails. Jurisdictional limits, the need to fit the claimant into a defined status such as consumer, and the absence of any statute at all in new fields, which is the gap identified in [The State's Duty to Regulate Technology].

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The human rights commissions

The Protection of Human Rights Act 1993 constitutes the National Human Rights Commission and State Commissions, with functions of inquiry, intervention in proceedings and recommendation.

Where it fails. The Commission's principal outputs are recommendations, so this route supplies inquiry and publicity rather than an enforceable award, which is a real contribution where the difficulty is opacity and a limited one where the need is money.

Worked example

An industrial process contaminates groundwater in three villages over a decade. Illness appears in a proportion of residents at rates above the district average. The company denies causation, points to other sources of contamination, and its consent to operate was never revoked.

Constitutional. A petition under article 32 or 226 can obtain the things individuals cannot: an order for testing, disclosure of the company's records, an expert committee, and remediation. It is the right route for the facts and for the structural relief.

Civil. M.C. Mehta removes fault, so the claimants do not have to prove negligence, and compliance with the consent to operate is no defence. What remains is causation for the individual, which the absolute liability rule does not touch, and this is where the claims will actually be contested.

Criminal. Available in principle, and it will identify no individual within the company without the documents that the constitutional proceeding is best placed to extract. Note the ordering: the routes are complementary and are usually run together.

Statutory. Whether the residents can bring themselves within a statutory forum depends on their status, and people injured by contamination of a common resource frequently fit none of the definitions.

The Commission. An inquiry can establish and publish the facts, which is disproportionately valuable where the central problem is that nobody outside the company knows what happened.

The realistic assessment. The strongest position is the constitutional proceeding used to establish the facts and to obtain remediation, with compensation pursued behind it. Anyone who says the villagers have a good claim in tort and stops there has not understood what the last forty years of this litigation demonstrate.

What it does NOT mean

Absolute liability does not remove causation. It removes fault. The claimant must still show that this harm came from this activity, and in latent, multi-cause illness that is the whole battle.

A constitutional remedy is not a substitute for compensation. M.C. Mehta itself sent the compensation claims to the ordinary courts.

A settlement is not necessarily a remedy. Union Carbide is the demonstration: a settlement reached without the persons affected being heard, and without a re-opener clause if the fund proved inadequate, was the subject of the review.

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And a remedy that is not enforced is not a remedy. Article 2(3)(c) makes enforcement a separate obligation, and it is the limb most often omitted from an answer.

Quick revision

  • ICCPR article 2(3): three limbs, an effective remedy notwithstanding official capacity; determination by a competent authority and development of judicial remedies; and enforcement of remedies when granted.
  • UDHR article 8: effective remedy by competent national tribunals. UNESCO 1997, article 8: just reparation for damage that is a direct and determining result of an intervention affecting the genome. General Comment 25, paragraph 45: effective remedies are part of the duty to fulfil.
  • Five Indian routes and where each fails: constitutional (articles 32 and 226; strong on structural relief, weak on individual money, and M.C. Mehta sent compensation to the ordinary courts); civil (absolute liability; defeated by proof, delay and cost, as Union Carbide shows); criminal (highest standard, hard to attribute within a company, compensates nobody; Union Carbide restored the quashed proceedings); statutory (needs a defined status and an existing statute); Protection of Human Rights Act 1993 (inquiry and recommendation, not an enforceable award).
  • Four features that defeat remedies: latency, diffusion, opacity, asymmetry.
  • Absolute liability removes fault, not causation.

Test yourself

1. Set out the three limbs of article 2(3) of the ICCPR and say which is most often overlooked. First, to ensure that any person whose rights are violated shall have an effective remedy, notwithstanding that the violation has been committed by persons acting in an official capacity. Second, to ensure that any person claiming such a remedy shall have their right determined by competent judicial, administrative or legislative authorities, or by any other competent authority provided for by the legal system, and to develop the possibilities of judicial remedy. Third, to ensure that the competent authorities enforce such remedies when granted. The third is most often overlooked and is the most important in this subject, because a remedy that is pronounced and not enforced leaves the person exactly where they were, and the Covenant treats enforcement as a distinct obligation rather than an incident of the first.

2. Name the four features of technological harm that defeat remedies, and say which element of a claim each defeats. Latency, which defeats limitation and the availability of evidence, since the harm appears long after the exposure and records and defendants may be gone. Diffusion, which defeats the economics of litigation, since each individual injury is too small to justify a claim while the aggregate is very large. Opacity, which defeats pleading and proof, since the material facts about the process, the maintenance or the model lie inside the defendant. And asymmetry, which defeats endurance, since the claimant faces a party with far greater resources over a period measured in years.

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3. Explain why absolute liability, though a strong rule, did not deliver in Bhopal. Because the obstacle was never the standard of liability. M.C. Mehta had been decided in December 1986, two years before the settlement, and it removes fault, removes the exceptions applicable under Rylands v. Fletcher, and measures compensation by reference to the magnitude and capacity of the enterprise so as to deter. What defeated the victims in Union Carbide was procedural: the forum contest that moved the claim between two legal systems and consumed years, the settlement of their claims without their being heard, the absence of a re-opener clause if the fund proved inadequate, the contested medical documentation and categorisation on which each individual award depended, and the passage of time. The case therefore demonstrates that a substantive rule is worth only as much as the procedure available to enforce it.

4. What is the significance of the causal standard in article 8 of the UNESCO Declaration of 1997? Article 8 provides that every individual has the right, according to international and national law, to just reparation for any damage sustained as a direct and determining result of an intervention affecting his or her genome. The standard is significant because it is demanding in precisely the field where causation is at its most difficult. Genetic harm is characteristically latent, probabilistic and multi-causal, so a requirement that the intervention be both the direct and the determining cause will exclude many claims that the rest of the Declaration's protections appear to contemplate. It illustrates the general point of the chapter, that the substantive protection and the remedial standard are drafted separately and can be pitched at different levels.

5. What did the Court do in M.C. Mehta about the compensation claims, and what does that show? Having declined to decide whether Shriram was an authority within the meaning of article 12, the Court did not set up a special machinery to investigate the claims of those affected by the oleum gas escape. It directed the Delhi Legal Aid and Advice Board to take up their cases and to file actions on their behalf in the appropriate court within two months, directed the Delhi Administration to provide the necessary funds for filing and prosecuting them, and asked the High Court to nominate judges so that they could be disposed of expeditiously. It shows that even a constitutional court laying down a far-reaching rule of liability routed the individual compensation claims back into ordinary civil litigation, which is why the constitutional route is strong for structural relief and for extracting facts, and weaker as a means of putting money into the hands of a particular injured person.

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Module II

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Chapter Forty

What Medical Law Is

Syllabus topic 3, "Medicine and the Law"

In one line

There is no Medicine Act, and that is the first thing to understand about medical law.

In the wording a student can write in an exam: medical law is not a single code but the body of rules governing the practice of medicine, the relationship between the health professional and the patient, and the use of medical technology on the human body, assembled from four sources that developed separately: constitutional law, which supplies the right to health and to life; the law of obligations, principally tort and contract, which supplies the remedy of the injured patient; the criminal law, which sets the point at which professional failure becomes an offence; and a shelf of specific statutes, each enacted to answer a particular capability that medicine acquired.

Why the law has this at all

A student who expects a code is looking for something that does not exist, and the reason it does not exist is historical rather than accidental.

For most of its history medicine had few interventions that could seriously harm a patient and fewer that could seriously help one, so the law that governed it was the ordinary law that governed everybody: if a practitioner injured a patient, that was a trespass or a negligence like any other. There was nothing about medicine that called for a separate body of rules.

What changed was capability, and it changed in a particular pattern. Each new capability produced a decision nobody had needed to make before, and each such decision was eventually answered by a specific statute rather than by a general one. That is why the field looks like a shelf and not a code, and it is why the four branches sit at such different levels of generality: the constitutional material is very broad, and the statutory material is very narrow, and they meet in the middle at the ordinary law of obligations.

The four bodies of law

Constitutional

Article 21 supplies the right to life and personal liberty, from which the right to health, the right to emergency treatment and the right to make reproductive choices have all been drawn. Article 47 makes the improvement of public health a primary duty of the State. Articles 14 and 15 govern the distribution of what the health system provides.

What it does. It creates obligations owed by the State and by public functionaries, and it supplies the writ jurisdiction under articles 32 and 226 through which systemic failures are litigated.

What it does not do. It rarely puts money in the hands of an individual injured patient, for the reasons in [Remedies When Technology Causes Harm].

Taken in [The Right to Health Under Article 21] and [Emergency Treatment and the Duty to Treat].

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Chapter Forty-One

The Doctor and the Patient

Syllabus topic 3, "Medicine and the Law"

In one line

The relationship between a doctor and a patient is several legal relationships at once, and which one a claimant relies on decides what they must prove.

In the wording a student can write in an exam: the doctor and patient stand in a relationship that is simultaneously contractual, where the patient or someone on their behalf pays for the service; tortious, since a duty of care arises from the undertaking of treatment whether or not anything is paid; fiduciary, in that the patient submits their body and their confidences to a person whose knowledge they cannot match; and statutory, in that the practitioner's competence, conduct and registration are governed by legislation. A claimant chooses among these, and the choice determines the elements to be proved, the limitation period, the forum and the measure of recovery.

Why the law has this at all

Two features of the relationship make it unlike the ordinary dealings the law of obligations was built for, and every rule in this module is a response to one of them.

The inequality of knowledge is total and irreducible. In an ordinary contract the parties can each assess what they are getting. A patient cannot. They cannot evaluate the diagnosis, cannot judge whether the procedure proposed is the right one, and frequently cannot tell afterwards whether what went wrong was avoidable. Every consumer protection doctrine assumes a party who could in principle inform themselves; here that assumption fails, which is why consent must be informed by the other side rather than merely obtained.

The patient's body is the subject matter. In an ordinary contract for services the thing worked on is separable from the person. Here it is the person, so a failure is not merely a loss of value but an injury, and an unauthorised act is not merely a breach but a trespass.

Those two features explain why the law adds a fiduciary layer to what would otherwise be an ordinary service relationship, and why consent occupies the place in this module that offer and acceptance occupy in the law of contract.

When the relationship begins

This matters more than students expect, because duties do not exist before it.

The relationship arises when a practitioner undertakes the care of a person, and the undertaking may be express or implied from conduct. Payment is not necessary: a doctor treating without charge owes the same duty of care, which is why the tortious analysis is the general one and the contractual analysis the special case.

Three situations at the edges are worth naming.

The emergency. A doctor confronted with an injured stranger is not in a pre-existing relationship, and the obligation to treat arises from a different source. That is the subject of [Emergency Treatment and the Duty to Treat], where Pt. Parmanand Katara holds that every doctor, at a government hospital or otherwise, has the professional obligation to extend services with due expertise for protecting life.

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Chapter Forty-Two

The Right to Health Under Article 21

Syllabus topic 3, "Medicine and the Law"

In one line

The Constitution does not contain a right to health, and India has one anyway.

In the wording a student can write in an exam: the right to health is not enumerated in Part III; it has been read into the right to life in article 21 by construing life as something more than mere animal existence, and by reading article 21 in the light of the directive principles in Part IV, principally articles 38, 41, 42 and 47, which are not themselves enforceable. The resulting right is enforceable against the State, is strongest at the point of emergency treatment, and weakens as the claim moves from a denial of treatment to a demand for the provision of services.

Why the law has this at all

The framers put health in Part IV. Article 47 makes the improvement of public health a primary duty of the State, and articles 39(e), 41 and 42 deal with health at work, public assistance in sickness and maternity relief. Article 37 states that the directive principles are not enforceable by any court while being fundamental in the governance of the country.

That allocation was deliberate, and it reflected a judgment about resources: a right that cannot be delivered should not be justiciable, because a court cannot build a hospital.

Two developments unsettled it. The first was the reading of article 21 as protecting more than physical survival, which made it possible to ask what a life requires. The second was the recognition that the directive principles, although unenforceable in themselves, could be used to interpret the fundamental rights, so that Part IV informs the content of Part III without becoming enforceable in its own right.

The result is a right whose strength varies with what is asked of it, and a candidate who can explain that gradient has understood the topic.

The provisions

Article 21: no person shall be deprived of his life or personal liberty except according to procedure established by law.

Article 47: the State shall regard the raising of the level of nutrition and the standard of living of its people and the improvement of public health as among its primary duties.

Article 41: the State shall, within the limits of its economic capacity and development, make effective provision for securing the right to work, to education and to public assistance in cases of unemployment, old age, sickness and disablement.

Article 42: the State shall make provision for securing just and humane conditions of work and for maternity relief.

Article 39(e): the State shall direct its policy towards securing that the health and strength of workers, men and women, and the tender age of children are not abused.

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Chapter Forty-Three

Emergency Treatment and the Duty to Treat

Syllabus topic 3, "Medicine and the Law"

In one line

When a person will die without treatment, everything else waits.

In the wording a student can write in an exam: Indian law recognises a duty to treat in an emergency that operates on two levels: a professional obligation binding every registered medical practitioner, whether in government or private practice, to extend services with due expertise for the protection of life, which no rule of procedure may delay; and a constitutional obligation on the State, arising from article 21, to provide timely medical treatment through the hospitals it runs, breach of which sounds in compensation in the writ jurisdiction.

Why the law has this at all

The problem was specific and it was procedural. A person injured in circumstances suggesting a crime became a medico-legal case, and the practice that grew up around such cases was that a doctor waited: for the police to arrive, for the formalities to be completed, or for the patient to be moved to a hospital authorised to handle them. The waiting was not cruelty. It was caution by practitioners who believed that treating first would expose them to being summoned, questioned and harassed.

The result was that the availability of the science was irrelevant to the person dying in front of it. That is the pattern of this entire paper in its most concentrated form: a capability existed, a rule of procedure stood between the capability and the person, and the law had to decide which gave way.

The professional duty

Pt. Parmanand Katara v. Union of India, AIR 1989 SC 2039, (1989) 4 SCC 286, decided on 28 August 1989 by Rangnath Misra and G.L. Oza JJ.

Facts. The petitioner, describing himself as a human rights activist, filed a writ petition in the public interest on the basis of a newspaper report. A scooterist was knocked down by a speeding car and taken to the nearest hospital, where the doctors refused to attend on him and said he should be taken to another hospital some twenty kilometres away that was authorised to handle medico-legal cases. He died before he could be taken there. The petitioner asked for directions that every injured citizen be given medical aid at once, with the procedural criminal law operating afterwards. The Union of India stated that no provision of the Indian Penal Code, the Code of Criminal Procedure or the Motor Vehicles Act prevented a doctor from promptly attending a seriously injured person before the arrival of the police.

Held. Article 21 casts the obligation on the State to preserve life. Preservation of human life is of paramount importance, because once life is lost the status quo ante cannot be restored, resurrection being beyond the capacity of man. Whether the patient is an innocent person or a criminal liable to punishment, it is the obligation of those in charge of the health of the community to preserve life, so that the innocent may be protected and the guilty punished; social laws do not contemplate death by negligence as a form of legal punishment. Every doctor, whether at a government hospital or otherwise, has the professional obligation to extend his services with due expertise for protecting life. No law or State action can intervene to avoid or delay the discharge of that paramount obligation, and laws of procedure, whether in statute or otherwise, that would interfere with it cannot be sustained and must give way. The Court directed that the decision be given adequate publicity through the national media, Doordarshan and All India Radio, and through the High Courts and Sessions Judges.

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Chapter Forty-Seven

Medical Confidentiality and Its Limits

Syllabus topic 3, "Medicine and the Law"

In one line

A patient tells a doctor things they would tell nobody else, and they do it because the law promises the doctor will not repeat them.

In the wording a student can write in an exam: the duty of confidence obliges a medical practitioner not to disclose information obtained in the course of the professional relationship; it originates in the Hippocratic Oath, is expressed in the International Code of Medical Ethics and in the Code of Medical Ethics made under Indian medical council legislation, and is reinforced by the constitutional right to privacy under article 21; and its principal exception in Indian law is disclosure where there is a serious and identifiable risk to a specific person who, if not informed, would be exposed to infection.

Why the law has this at all

The justification is instrumental as much as it is about dignity, and an answer that gives only the dignity reason has given the weaker half.

The dignity reason. Medical information is among the most intimate a person has, and its disclosure exposes them to stigma, exclusion and loss of employment. The facts of the leading case are the illustration: the appellant was ostracised by his community and left his home State.

The instrumental reason. Medicine cannot work without candour. A patient who fears disclosure conceals symptoms, avoids testing and does not seek treatment. The confidentiality rule therefore protects public health as well as the individual, which is why an exception justified by public health must be drawn narrowly: an exception wide enough to deter people from testing at all defeats the interest it invokes.

That tension is the whole of this chapter.

The sources of the duty

Professional. The Hippocratic Oath, the International Code of Medical Ethics, and the Code of Medical Ethics framed by the Indian medical council authority, which the Court in the leading case set out at length. The professional codes are not merely ethical: they are made under statutory authority and are enforced by the regulator, discussed in [Regulating the Profession].

Constitutional. The right to privacy under article 21, now on the footing established in Justice K.S. Puttaswamy (Retd.) v. Union of India, AIR 2017 SC 4161, (2017) 10 SCC 1, which held that the right to privacy is protected as an intrinsic part of the right to life and personal liberty under article 21 and as part of the freedoms guaranteed by Part III.

Contractual and fiduciary. The relationship itself, as set out in [The Doctor and the Patient]: the fiduciary character of the relationship is what makes confidence a legal obligation and not merely an expectation.

International. UNESCO 2005, article 9, requires that the privacy of the persons concerned and the confidentiality of their personal information be respected, and that to the greatest extent possible such information should not be used or disclosed for purposes other than those for which it was collected or consented to, consistent with international law and national law. ICCPR article 17 protects against arbitrary or unlawful interference with privacy.

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Chapter Forty-Eight

Health Data and Privacy

Syllabus topic 3, "Medicine and the Law"

In one line

Confidentiality was a rule about what a doctor says; data protection is a rule about what a system holds, and the difference is that the system never forgets and is not a person.

In the wording a student can write in an exam: health data engages the same interest as medical confidentiality but under conditions the older duty was not designed for, since information that was once held in a single practitioner's record is now collected at scale, retained indefinitely, combined with other data, and processed by entities with no relationship to the patient; and the legal response accordingly shifts from a duty owed by an individual professional to a framework of purpose limitation, consent, security and accountability applied to whoever holds the data, resting constitutionally on informational privacy under article 21 as recognised in Puttaswamy.

Why the law has this at all

Apply the five changes from [How a Technology Becomes a Rights Question] to a medical record and the case for a separate body of rules makes itself.

Scale. A practitioner's confidence covered the patients they saw. A hospital system covers everyone who ever attended, and a national health identifier covers everyone.

Cost. Copying and searching a paper record cost something and that cost limited what was done with it. Neither costs anything now.

Permanence. A paper record decayed and was eventually destroyed. A digital record persists, so a diagnosis at nineteen is retrievable at fifty.

Invisibility. A patient knew when their doctor was consulted about them. They do not know when a record is accessed, transferred, analysed or sold.

Delegation. Decisions about care, eligibility and pricing are increasingly taken by systems reading the record, which is the problem of [Artificial Intelligence and Decisions by Machines].

The last three are what the duty of confidence cannot reach. It is a duty owed by a person who can be identified and sued, and it addresses disclosure; the harms above arise from retention, combination and processing, often without any disclosure in the ordinary sense.

The constitutional foundation

Justice K.S. Puttaswamy (Retd.) v. Union of India, AIR 2017 SC 4161, (2017) 10 SCC 1, decided on 24 August 2017 by nine judges, held that the right to privacy is protected as an intrinsic part of the right to life and personal liberty under article 21 and as a part of the freedoms guaranteed by Part III, over-ruling M P Sharma and over-ruling Kharak Singh to the extent that it held otherwise.

Two features of the reasoning bear directly on health data, and both were recorded in the judgment delivered for four of the nine judges. Information is nonrivalrous, invisible and recombinant, so that a person may never learn that their data has been taken. And a data protection regime must not permit collection that discriminates on grounds including genetic or health status, which names this subject matter expressly.

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Chapter Forty-Nine

Medical Negligence: the Civil Action

Syllabus topic 3, "Medicine and the Law"

In one line

A doctor is liable for failing to bring reasonable skill to the case, not for failing to cure the patient.

In the wording a student can write in an exam: medical negligence in its civil form requires the three ordinary components, a duty owed to the patient, a breach of that duty judged against the standard of the ordinarily competent practitioner professing that skill, and resulting damage caused by the breach; and the standard is a professional one, so that a practitioner who acts in accordance with a practice accepted as proper by a responsible body of skilled medical opinion is not negligent merely because another body of opinion, or a more skilled practitioner, would have acted differently.

Why the law has this at all

Medicine is practised under three conditions that ordinary negligence law does not contemplate, and the special features of the medical standard are responses to them.

Outcomes are uncertain even when the treatment is right. A patient may die under impeccable care. If a bad outcome were evidence of a breach, every unsuccessful treatment would be a claim, and the practitioners most willing to take difficult cases would be the most exposed.

Reasonable practitioners genuinely differ. There are competing schools of established practice in most fields. A standard that required the single best course would require a court to choose between medical schools of thought, which it is not equipped to do.

Hindsight is unavoidable. By the time a case is tried, the outcome is known and the risk has materialised, which makes the decision look worse than it was when it was taken.

The rules below answer each in turn, and an answer that presents them as protections for doctors has only half the point: they are the conditions under which a workable standard can exist at all.

The elements

Duty. It arises from the undertaking of the care of the person, and does not depend on payment, as set out in [The Doctor and the Patient]. Jacob Mathew v. State of Punjab, AIR 2005 SC 3180, (2005) 6 SCC 1, records that negligence has three essential components, duty, breach and resulting damage.

Breach. The standard is that of the ordinarily competent practitioner exercising and professing that particular skill. Samira Kohli v. Dr. Prabha Manchanda records it in the familiar form: a doctor is not negligent if he has acted with normal care in accordance with a recognised practice accepted as proper by a responsible body of medical men skilled in that particular field, even though there may be a body of opinion that takes a contrary view; and where there is more than one recognised school of established medical practice, it is not negligence to follow one in preference to the others.

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Chapter Fifty

Medical Negligence: the Criminal Standard

Syllabus topic 3, "Medicine and the Law"

In one line

The same conduct is not both a tort and a crime; the criminal law starts much further along.

In the wording a student can write in an exam: criminal liability for medical negligence requires more than the civil standard: the negligence must be gross or of a very high degree, and mens rea must be shown; the expression "rash or negligent act" in the provision punishing causing death by negligence is to be read as qualified by the word "grossly", even though that word does not appear in it; and the test for prosecuting a medical professional is whether the accused did or omitted to do something which no medical professional in his ordinary senses and prudence would have done or omitted.

Why the law has this at all

The argument for prosecuting doctors is easy to state and it is not frivolous: a person is dead, a professional failure caused it, and the criminal law exists for exactly that. The argument against is what the Supreme Court accepted, and it has three parts.

The civil and criminal concepts of negligence are different in kind, not merely in degree of proof. Jacob Mathew holds that the jurisprudential concept of negligence differs in civil and criminal law, and that for negligence to amount to an offence mens rea must be shown.

Medicine involves calculated risk in every case. A practitioner who takes on a difficult case accepts a probability of a bad outcome. If the ordinary standard sufficed for prosecution, the surgeon who operates on the sickest patients would be the most exposed, and the rational response would be to refuse those patients.

A prosecution is itself the punishment. Arrest, suspension and years of proceedings fall on the practitioner long before any verdict, so a low threshold operates as a sanction regardless of outcome.

None of this is an argument that doctors should be immune, and an answer should say so. It is an argument about where the line falls.

The case

Jacob Mathew v. State of Punjab, AIR 2005 SC 3180, (2005) 6 SCC 1, decided on 5 August 2005 by R.C. Lahoti CJI, G.P. Mathur and P.K. Balasubramanyan JJ.

Facts. Jiwan Lal Sharma was a patient in a private ward of a hospital in Ludhiana. On the night of 22 February 1995 he had difficulty breathing. His son called the duty nurse; doctors came after some delay; an oxygen cylinder was connected to the patient's mouth but the cylinder was found to be empty; and by the time another cylinder was arranged the patient had died. His son filed a First Information Report and an offence of causing death by a rash or negligent act, read with the provision on common intention, was registered against the doctors.

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Chapter Fifty-One

Medical Services Under Consumer Law

Syllabus topic 3, "Medicine and the Law"

In one line

The consumer forum is where medical claims are actually brought, and the case that put them there turned on who pays.

In the wording a student can write in an exam: medical services rendered by a practitioner or a hospital constitute a service for the purposes of consumer protection legislation, so that a patient is a consumer and may proceed before the consumer fora rather than by ordinary civil suit, except where the service is rendered free of charge to every patient, or under a contract of personal service; and the decisive question in the exceptions is who bears the cost, not where the treatment was given or whether the practitioner is a member of a regulated profession.

Why the law has this at all

The civil action described in [Medical Negligence: the Civil Action] is sound in doctrine and unusable in practice for most patients. A suit takes years, requires court fees on the amount claimed, and demands expert evidence the claimant must fund in advance. A patient with a claim worth a modest sum has a right and no way to enforce it, which is the asymmetry problem in [Remedies When Technology Causes Harm].

Consumer legislation was designed for exactly that gap: a cheaper forum, a simpler procedure, a three-tier structure, and no requirement to pay court fees proportionate to the claim. Whether it reached medicine was contested, and the profession's argument was not absurd: a doctor is not a shopkeeper, treatment is not a product, and a bad outcome is not a defective good.

The case

Indian Medical Association v. V.P. Shantha, AIR 1996 SC 550, (1995) 6 SCC 651, decided on 13 November 1995 by Kuldip Singh, S.C. Agrawal and B.L. Hansaria JJ.

Facts. A group of matters raising whether, and when, a medical practitioner or a hospital renders a service within section 2(1)(o) of the Consumer Protection Act 1986. The Indian Medical Association argued that practitioners, being members of a profession subject to the disciplinary control of the medical councils, fell outside the Act, and that in any event their services were rendered under a contract of personal service, which the definition excludes.

Held. The Court set out twelve conclusions. The essential ones are these.

The general rule. Service rendered to a patient by a medical practitioner by way of consultation, diagnosis and treatment, both medicinal and surgical, falls within "service" as defined, except where the doctor renders service free of charge to every patient or under a contract of personal service.

Professional regulation is no answer. That practitioners belong to the medical profession and are subject to the disciplinary control of the medical councils does not exclude their services from the Act. Discipline and consumer liability run in parallel, which is the fifth column identified in [What Medical Law Is].

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Chapter Fifty-Two

Compensation and How It Is Measured

Syllabus topic 3, "Medicine and the Law"

In one line

Damages in a medical case are an attempt to express in money a loss that is not financial, and the law is candid that it cannot be done properly.

In the wording a student can write in an exam: compensation for medical injury is assessed on the ordinary principle of restitutio in integrum, that the claimant is so far as money can do it to be placed in the position they would have occupied but for the wrong; it is divided into pecuniary loss, which is calculated, and non-pecuniary loss, which is estimated by convention; and in the constitutional jurisdiction it is awarded on a different footing again, as a public law remedy for the violation of a fundamental right rather than as damages in tort.

Why the law has this at all

A patient who has lost a limb, a faculty, a livelihood or a relative is not made whole by money and everybody involved knows it. The law persists because the alternative is worse: leaving the loss where it fell, on the person who did not cause it.

Two consequences follow and they shape the whole subject.

The calculation is a proxy, not a valuation. Nothing in the exercise claims that a life is worth the figure produced. The figure is what the legal system can administer consistently.

Consistency matters as much as accuracy. Two claimants with the same injury should receive comparable sums, and a system that produced wildly different awards for the same loss would be unjust however generous any individual award.

The two heads

Pecuniary loss

What can be counted. Four components, and an answer should list them because they are what a claim actually contains.

  1. Expenses already incurred. Treatment, medicines, travel, and the cost of remedying the injury. In Paschim Banga the claimant had spent about Rs 17,000 at a private hospital after being refused by six State hospitals, and that expenditure is the paradigm of this head.
  2. Future expenses. Continuing treatment, prosthetics, attendant care, and modifications to a home.
  3. Loss of earnings to date.
  4. Loss of future earning capacity. The largest item in a serious case, and the one requiring a method: earnings at the time, an allowance for future prospects, a multiplier reflecting the remaining working life, and a deduction for the claimant's own living expenses in a fatal case.

Non-pecuniary loss

What cannot be counted, and is nonetheless real.

Pain and suffering, past and future. Loss of amenities, the inability to do things the claimant could do before. Loss of expectation of life. Loss of consortium in a fatal case, and the loss of a parent's care to a child.

These are assessed by convention rather than calculation, which is not a defect to be apologised for but the only available method: a court fixes a figure that is consistent with what has been awarded for comparable injuries.

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Chapter Fifty-Three

Regulating the Profession

Syllabus topic 3, "Medicine and the Law"

In one line

A court can order a doctor to pay; only the regulator can stop them practising.

In the wording a student can write in an exam: the medical profession in India is regulated by the National Medical Commission Act 2019, which replaced the earlier council-based structure with a Commission and four Autonomous Boards, maintains the National Register of licensed practitioners, makes registration the condition of lawful practice through the bar to practice, and vests the regulation of professional conduct and medical ethics in the Ethics and Medical Registration Board, which exercises appellate jurisdiction over the actions of State Medical Councils.

Why the law has this at all

The court remedies in the preceding chapters share a limitation: they operate after an injury, at the suit of the person injured, and they produce money. None of them addresses the practitioner who is unfit to practise, and none of them protects the next patient.

Professional regulation answers three problems the ordinary law cannot.

Entry. Somebody must decide who may hold themselves out as a doctor, and the criterion has to be qualification rather than the market's willingness to pay.

Continuing fitness. A practitioner may become unfit through conduct, incapacity or dishonesty without any patient having yet been harmed, and a system that waited for harm would be waiting for the very thing it exists to prevent.

Standards. The negligence standard in [Medical Negligence: the Civil Action] is defined by reference to what a responsible body of practitioners accepts as proper. Somebody has to state what that is, and the profession's own code is where it is stated.

That last point is the connection between this chapter and the rest of the module: professional regulation does not merely run alongside the law of negligence, it supplies the content of the standard the law applies.

The structure of the 2019 Act

Section 3 constitutes the National Medical Commission, and section 4 provides for its composition. Section 10 sets out its powers and functions.

Section 16 constitutes four Autonomous Boards, and the division of labour between them is the thing to learn:

BoardFunctionSection
Under-Graduate Medical Education BoardUndergraduate education24
Post-Graduate Medical Education BoardPostgraduate education25
Medical Assessment and Rating BoardAssessment and rating of institutions26
Ethics and Medical Registration BoardRegistration and professional conduct27

Section 11 constitutes the Medical Advisory Council, whose functions are in section 12.

Sections 14 and 15 provide for the National Eligibility cum Entrance Test and the National Exit Test, which are the entry gates to and from medical education.

Section 28 requires the prior permission of the Medical Assessment and Rating Board before any person establishes a new medical college, starts a postgraduate course or increases the number of seats, and section 29 sets the criteria for approving or disapproving a scheme.

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Chapter Fifty-Four

Regulating the Hospital

Syllabus topic 3, "Medicine and the Law"

In one line

Most medicine happens inside an institution, and the patient's dealings are with the institution rather than with any one doctor.

In the wording a student can write in an exam: the Clinical Establishments (Registration and Regulation) Act 2010 regulates the institution rather than the practitioner, by prohibiting the running of a clinical establishment unless it is registered, by making registration conditional on prescribed minimum standards of facilities, personnel and records, and by imposing on every registered establishment an undertaking to provide, within the staff and facilities available, such medical examination and treatment as may be required to stabilise the emergency medical condition of any individual who comes or is brought to it.

Why the law has this at all

The regulation of practitioners, described in [Regulating the Profession], leaves a gap that grows every year: it addresses persons, and medicine is increasingly delivered by organisations.

Three failures belong to the institution and to nobody in particular.

The empty cylinder. The facts of Jacob Mathew are an institutional failure described as a personal one. Somebody should have checked; the system should have made checking unnecessary; and the criminal law reached neither, for the reasons in [Medical Negligence: the Criminal Standard].

The absent capacity. In Paschim Banga six State hospitals turned a man away for want of a bed or a department. No practitioner refused to treat him. The failure was of provision.

The unqualified operator. A nursing home with no registered practitioner, no sterile facility and no records injures patients without any identifiable professional to discipline.

A patient cannot regulate an institution by suing it, and a professional council cannot discipline a building. Hence a statute directed at the establishment itself.

The scheme

Section 11 is the operative prohibition: no person shall run a clinical establishment unless it has been duly registered in accordance with the Act.

Section 12(1) sets the conditions for registration and continuation, and every one of them is left to be prescribed:

  • (i) the minimum standards of facilities and services;
  • (ii) the minimum requirement of personnel;
  • (iii) provisions for maintenance of records and reporting; and
  • (iv) such other conditions as may be prescribed.

Note the phrase "for registration and continuation": the conditions are not a hurdle cleared once but a standing requirement, which is what makes inspection meaningful.

Section 13 provides for the classification of clinical establishments of different systems into categories, which is how a single Act accommodates a district hospital and a single-doctor clinic.

The institutions. Section 3 establishes the National Council, whose functions are in section 5; section 8 provides for the State Council of clinical establishments; section 10 designates the authority for registration.

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Chapter Fifty-Five

Drugs, Standards and Control

Syllabus topic 3, "Medicine and the Law"

In one line

The third thing medicine can get wrong is not the doctor or the hospital but the substance itself.

In the wording a student can write in an exam: the Drugs and Cosmetics Act 1940 regulates the product, by prescribing standards of quality, by defining and prohibiting the misbranded, adulterated and spurious drug, by requiring licensing of manufacture and sale, and by providing an apparatus of Government Analysts, Inspectors, sampling and prosecution; and it operates on the supply chain rather than on the clinical encounter, so it protects a population rather than compensating a patient.

Why the law has this at all

The patient is in the worst possible position to judge a medicine. They cannot see what is in it, cannot test it, cannot evaluate the claim on the label, and are frequently taking it because a person they trust told them to. Every assumption on which ordinary consumer law rests fails, for the same reason it fails in the clinical encounter, described in [The Doctor and the Patient].

Two consequences follow, and they explain the shape of the Act.

Regulation must be anticipatory. A defective drug cannot be identified by the person harmed, so control operates before the product reaches anyone: at manufacture, at import, at sale, and by sampling.

The wrong is committed against a population. One contaminated batch injures everyone who takes it, and each individual injury may be small, latent or indistinguishable from the disease. This is the diffusion problem from [Remedies When Technology Causes Harm], and it is why the Act is penal rather than compensatory.

The scheme

Section 3 contains the definitions, and three of them do most of the work: drug, cosmetic, and the categories that make a drug unlawful.

Standards of quality are dealt with by section 16, and the following sections define the three categories of unlawful drug that recur through the Act and through any answer on it:

CategorySectionThe essence of it
Misbranded17The drug is not what its label represents; the wrong is in the description
Adulterated17AThe substance has been contaminated or interfered with
Spurious17BThe drug purports to be a product it is not; the wrong is in the identity

The distinction matters because it locates the fault. A misbranded drug may be perfectly good medicine wrongly described; a spurious drug is an imitation of another product; an adulterated drug is corrupted in substance. An answer that treats them as three words for "bad drug" has missed the scheme.

Section 18 is the central prohibition. From such date as the State Government may fix by notification, no person shall himself or by another on his behalf manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale, or distribute:

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Chapter Fifty-Six

Clinical Trials and Research on Patients

Syllabus topic 3, "Medicine and the Law"

In one line

A trial asks a patient to accept a risk for the benefit of people who are not yet ill, and everything in the law of research follows from that asymmetry.

In the wording a student can write in an exam: research on human subjects is distinguished from treatment by its purpose, since treatment is directed to the benefit of the patient before the practitioner while research is directed to the production of generalisable knowledge; and because that purpose does not align with the participant's own interest, the law imposes requirements that ordinary treatment does not, principally free, prior, express and informed consent, independent ethical review, a favourable risk-benefit assessment, and a continuing right to withdraw without disadvantage.

Why the law has this at all

The distinction between treatment and research is the whole foundation and it is worth stating precisely, because it is where students go wrong.

In treatment, the practitioner does what they believe is best for this patient. If it does not work, they try something else. Nothing is being tested and no one else's interest is in the room.

In research, the object is to find out whether something works, which requires that the answer not be known in advance, that the intervention be applied according to a protocol rather than to the patient's evolving needs, and frequently that some participants receive a comparator rather than the intervention. The participant is therefore accepting a risk partly for others.

That asymmetry is not wrong and research is indispensable. What it means is that consent, which in treatment is a licence for something intended to help this person, becomes in research the only thing standing between the participant and the use of their body for another purpose. Hence the requirements are stricter, and hence the historical record.

The historical foundation

The Nuremberg Code 1947 was written because physicians conducted experiments on prisoners. Its first point, of ten, is that the voluntary consent of the human subject is absolutely essential, and it stands before the points on the design of the experiment, the avoidance of unnecessary suffering, the qualifications of the investigator and the termination of the experiment. Point 9 provides that during the experiment the subject should be at liberty to bring it to an end, and point 10 that the scientist in charge must be prepared to terminate it at any stage if continuation is likely to result in injury, disability or death.

ICCPR article 7 makes the position binding: no torture or cruel, inhuman or degrading treatment, and in particular no one shall be subjected without his free consent to medical or scientific experimentation. There is no limitation clause, so this is one of the interferences that cannot be justified at all, as explained in [Bodily Integrity and Intervention Without Consent].

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Chapter Fifty-Seven

Access to Medicines: Price and Patent

Syllabus topic 3, "Medicine and the Law"

In one line

A prescription the patient cannot fill is a diagnosis and nothing more.

In the wording a student can write in an exam: access to medicines is the point at which the right to the highest attainable standard of health under article 12 of the ICESCR and article 21 of the Constitution meets the law of patents, and it is a question of medical law and not only of intellectual property, because the practical obstacle to treatment is frequently neither the absence of a doctor nor the absence of a diagnosis but the price of the product; the Indian legislative response is section 3(d) of the Patents Act 1970, construed in Novartis, which keeps a known medicine in the public domain unless a genuine therapeutic gain is proved.

Why the law has this at all

Consider where the failures in this module actually leave a patient. [Emergency Treatment and the Duty to Treat] gets them through the door. [The Right to Health Under Article 21] establishes what the State owes. [Regulating the Profession] and [Regulating the Hospital] ensure the practitioner and the institution are fit. [Drugs, Standards and Control] ensures the medicine is what it claims to be.

Every one of those can be satisfied, and the patient still goes untreated because the medicine costs more than they have. That is not a failure of medicine, of the doctor or of the hospital. It is a distribution, and the point made in [What This Paper Is About] applies exactly: once a treatment exists, the fact that a person cannot get it stops being misfortune and becomes a distribution that somebody chose.

The right, on the health side

ICESCR article 12(1): the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. As explained in [Health and Medical Technology], the content rises as science advances, so the existence of an effective medicine enlarges the obligation.

General Comment 25, paragraph 17, requires equal access to the applications of science particularly when they are instrumental for the enjoyment of other economic, social and cultural rights, and a medicine is the clearest such application.

Paragraph 79 requires that access to research results and their applications be regulated so that developing countries and their citizens have adequate access to these products in an affordable manner, such as access to essential medicines. The Committee names essential medicines as its own example.

Paragraph 80 requires that benefits be shared, with due incentives and regulations, particularly with developing countries and communities living in poverty, especially where they are closely related to the enjoyment of economic, social and cultural rights.

Article 21 and article 47 supply the domestic footing, worked in [The Right to Health Under Article 21].

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Chapter Fifty-Eight

Organ Transplantation: the Scheme of the Act

Syllabus topic 3, "Medicine and the Law"

In one line

A transplant takes something irreplaceable out of one person and puts it into another, and the law's whole task is to be sure the first person agreed and was not paid.

In the wording a student can write in an exam: the Transplantation of Human Organs and Tissues Act 1994 regulates the removal, storage and transplantation of human organs and tissues for therapeutic purposes; it is built on three pillars, an authority for removal that must exist in every case, a restriction confining living donation to near relatives except where the Authorisation Committee approves, and a prohibition on commercial dealing enforced by the offences in the later sections; and it required, as a precondition of the whole scheme, that Indian law adopt a definition of brain-stem death.

Why the law has this at all

Transplantation created three problems simultaneously, and no earlier law answered any of them.

When is a person dead? A heart that stops can now be restarted, and a body whose brain has irreversibly ceased to function can be maintained. Organs for transplant must be taken while they are perfused, which means the moment of death has to be defined by law rather than left to observation. Section 2(d) does it, and it is taken in [Brain Stem Death and the Law].

Who may agree, and to what? The donor may be dead and unable to agree, alive and under pressure from a family, or a person who cannot consent at all. The Act answers each situation separately in sections 3 to 9.

What stops a market? An organ is scarce, valuable and located in poor people. Left to contract, transplantation becomes a trade in the bodies of those with no other asset, which is why the Act's most severe provisions are its prohibitions on commercial dealing.

Sections 1 and 2: application and definitions

Section 1 gives the short title, application and commencement. Section 25 repeals the earlier law and saves what was done under it.

Section 2 contains the definitions, and four matter.

  • Section 2(d), brain-stem death: the stage at which all functions of the brain-stem have permanently and irreversibly ceased, and is so certified under section 3(6).
  • Section 2(e), deceased person: a person in whom permanent disappearance of all evidence of life occurs, by reason of brain-stem death or in a cardio-pulmonary sense, at any time after live birth has taken place.
  • Near relative, which is the category that controls living donation under section 9.
  • Therapeutic purposes, which is the only permitted purpose of removal.

Section 2(e) is worth pausing on: Indian law recognises two deaths, the cardio-pulmonary and the brain-stem, and the second exists because transplantation required it.

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Chapter Fifty-Nine

Brain Stem Death and the Law

Syllabus topic 3, "Medicine and the Law"

In one line

A technology forced the law to answer a question it had never had to ask, which is when a person has died.

In the wording a student can write in an exam: brain-stem death is defined by section 2(d) of the Transplantation of Human Organs and Tissues Act 1994 as the stage at which all functions of the brain-stem have permanently and irreversibly ceased, certified under section 3(6); section 2(e) then defines a deceased person as one in whom permanent disappearance of all evidence of life occurs by reason of brain-stem death or in a cardio-pulmonary sense, so that Indian law recognises two deaths; and the certification is entrusted to a Board of medical experts whose composition the section prescribes.

Why the law has this at all

For all of history before mechanical ventilation, death needed no legal definition because it was self-evident: breathing stopped, the heart stopped, and shortly afterwards everything else did. The cardio-pulmonary criterion was not a rule of law but a description of the only sequence that occurred.

Two technologies broke it apart.

Ventilation made it possible for a body's circulation and respiration to be maintained after the brain had irreversibly ceased to function. Something is happening in the bed, and it is not clear whether it is a person.

Transplantation made the answer urgent and consequential. Organs deteriorate rapidly once circulation stops, so viable organs come from a body that is still perfused. If death occurs only when the heart stops, most transplantation is impossible; if death can be declared while the heart beats, then the moment of declaration determines when a person may lawfully be opened.

That combination is why the definition sits in a transplantation statute rather than in a general law, and it is worth saying so in an answer: the definition of death in Indian law was written for the purposes of a particular technology, which is an unusual and slightly uncomfortable fact.

The provisions

Section 2(d): "brain-stem death" means the stage at which all functions of the brain-stem have permanently and irreversibly ceased and is so certified under sub-section (6) of section 3.

Read the definition carefully, because it has two limbs and students give only the first. Brain-stem death is a clinical state and a certified state: a body in which brain-stem function has irreversibly ceased is not, for the purposes of the Act, in a state of brain-stem death until it has been certified under section 3(6). The definition builds the procedure into the fact.

Section 2(e): a "deceased person" means a person in whom permanent disappearance of all evidence of life occurs, by reason of brain-stem death or in a cardio-pulmonary sense, at any time after live birth has taken place.

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Chapter Sixty

Transplantation: Regulation and Registration

Syllabus topic 3, "Medicine and the Law"

In one line

An organ cannot be removed just anywhere by just anyone, and the machinery that decides where and by whom is what makes the rest of the Act enforceable.

In the wording a student can write in an exam: the Act controls transplantation institutionally as well as substantively, by prohibiting under section 10 the conduct of removal, storage or transplantation except by a registered hospital and at a registered place, by constituting Appropriate Authorities under section 13 with the powers in section 13B, by providing for registration of hospitals under section 14 and of Tissue Banks under section 14A, for the certificate under section 15 and its suspension or cancellation under section 16, and for appeals under section 17.

Why the law has this at all

A prohibition that operates only on individuals is unenforceable in medicine, for the reason given in [Regulating the Hospital]: the acts are done inside institutions, by teams, with records the outsider cannot see.

Registration solves three problems at once. It creates a list, so the Authority knows where transplantation happens and can inspect. It creates a licence that can be withdrawn, which is a sanction that operates without proving a crime. And it creates a condition attached to a valuable permission, so that compliance is in the institution's own interest rather than only in the patient's.

Section 10: where and by whom

Section 10(1), from the commencement of the Act:

  • (a) no hospital, unless registered under the Act, shall conduct, or associate with, or help in, the removal, storage or transplantation of any human organ or tissue;
  • (b) no medical practitioner or any other person shall conduct, or cause to be conducted, or aid in conducting, by himself or through another, any activity relating to removal, storage or transplantation at a place other than a place registered under the Act;
  • (c) no place, including a hospital registered under section 15(1), shall be used or caused to be used for any purpose other than therapeutic purposes; and
  • (d) no Tissue Bank, unless registered under the Act, shall carry out any activity relating to the recovery, screening, testing, processing, storage and distribution of tissues.

Section 10(2) contains the single exception, and it is worth knowing precisely: notwithstanding sub-section (1), the eyes or the ears may be removed at any place from the dead body of any donor, for therapeutic purposes, by a registered medical practitioner. The Explanation provides that "ears" includes ear drums and ear bones.

That exception exists because corneal and similar donation must happen very quickly after death and usually not in a transplant centre, and it should be read with the proviso to section 3(4) permitting a prescribed technician to enucleate a cornea.

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Chapter Sixty-One

Trade in Organs and Its Punishment

Syllabus topic 3, "Medicine and the Law"

In one line

Every other rule in this Act is a way of stopping one thing, and this is what happens to the people who do it anyway.

In the wording a student can write in an exam: the Act punishes three distinct wrongs, removal without authority under section 18, commercial dealings in human organs under section 19 and in human tissues under section 19A, and contravention of any other provision under section 20; the penalty for commercial dealing is the severest in the Act and carries a statutory minimum; and prosecution is controlled by section 22, which permits cognizance only on a complaint by the Appropriate Authority or by a person who has given it sixty days' notice.

Why the law has this at all

A prohibition without a sanction is advice. The near-relative rule in section 9, the Authorisation Committee, the registration of hospitals and the requirement of therapeutic purpose in section 11 all exist to prevent a market, and none of them would survive contact with the incentives if breaching them were merely irregular.

The incentives are worth stating plainly, because they explain the severity. An organ is scarce and lifesaving; the recipient is often wealthy and dying; the donor is often poor and healthy; and the transaction can be concealed inside a lawful-looking clinical process. Every element of a market is present, and the only thing standing against it is the criminal law.

Section 18: removal without authority

Section 18(1): any person who renders his services to or at any hospital and who, for purposes of transplantation, conducts, associates with, or helps in any manner in, the removal of any human organ without authority, is punishable with imprisonment which may extend to ten years and fine which may extend to twenty lakh rupees.

Section 18(2) adds the professional consequence, and it is the provision that connects this Act to [Regulating the Profession]. Where a person convicted under sub-section (1) is a registered medical practitioner, his name shall be reported by the Appropriate Authority to the respective State Medical Council for necessary action including removal of his name from the register for three years for the first offence and permanently for the subsequent offence.

Section 18(3), inserted in 2011, punishes the same conduct in relation to human tissue with imprisonment up to three years and fine up to five lakh rupees.

Two features are worth an answer. The offence reaches anyone who "renders his services to or at any hospital", so it is not confined to the surgeon; and it catches those who associate with or help in any manner, so the theatre staff and the coordinator are within it.

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Chapter Sixty-Two

Termination of Pregnancy: the Act

Syllabus topic 3, "Medicine and the Law"

In one line

The Act does not create a right to terminate a pregnancy; it creates an exemption from the criminal law for a doctor who terminates one on stated grounds.

In the wording a student can write in an exam: the Medical Termination of Pregnancy Act 1971 operates by providing in section 3(1) that, notwithstanding anything in the Penal Code, a registered medical practitioner shall not be guilty of any offence under that Code or any other law if a pregnancy is terminated in accordance with the Act; it then states in section 3(2) the gestational limits, the number of practitioners whose opinion is required, and the two grounds; it requires consent under section 3(4); it confines the place under section 4; and it punishes termination outside the scheme under section 5.

Why the law has this at all

Two features of the structure decide almost every question, and both should be stated at the outset of an answer.

The Act is an exemption, not an entitlement. Its operative provision protects the practitioner from prosecution. It does not confer on a woman a right to obtain a termination, and it does not oblige any practitioner to perform one. The right that does exist is constitutional, and it comes from Suchita Srivastava, taken in the next chapter.

The gatekeeper is the doctor's opinion. The grounds in section 3(2) are satisfied by the opinion, formed in good faith, of the practitioner or practitioners. The statute therefore places the decision with the profession, and the pregnant woman's own view is relevant to consent but is not, on the face of the Act, one of the grounds.

Those two features are the source of every criticism of this legislation, and a candidate who identifies them has the framework for the next chapter.

Sections 1 and 2

Section 1 gives the short title, extent and commencement. Section 2 contains the definitions, of which "registered medical practitioner" matters most: it requires, among other things, experience or training in gynaecology and obstetrics as prescribed.

Section 3: when a pregnancy may be terminated

Section 3(1), the exemption: notwithstanding anything contained in the Indian Penal Code, a registered medical practitioner shall not be guilty of any offence under that Code or under any other law for the time being in force, if a pregnancy is terminated by him in accordance with the provisions of this Act.

Section 3(2), as substituted in 2021, subject to sub-section (4), a pregnancy may be terminated by a registered medical practitioner:

  • (a) where the length of the pregnancy does not exceed twenty weeks, if one such practitioner is of the opinion; or
  • (b) where the length exceeds twenty weeks but does not exceed twenty-four weeks, in the case of such category of woman as may be prescribed by rules, if not less than two registered medical practitioners are of the opinion,

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Chapter Sixty-Three

Abortion, Autonomy and the 2021 Amendment

Syllabus topic 3, "Medicine and the Law"

In one line

The Constitution gives the decision to the woman and the statute gives it to her doctor, and the whole of this topic is the distance between those two sentences.

In the wording a student can write in an exam: the constitutional position is that a woman's right to make reproductive choices is a dimension of personal liberty under article 21, exercisable to procreate as well as to abstain, the crucial consideration being respect for her privacy, dignity and bodily integrity; the statutory position is that a termination is lawful only where a registered medical practitioner is of the opinion, formed in good faith, that a listed ground exists; and the Medical Termination of Pregnancy (Amendment) Act 2021 widened the statute considerably without altering that basic allocation of the decision.

The constitutional right

Suchita Srivastava v. Chandigarh Administration, AIR 2010 SC 235, (2009) 9 SCC 1, decided on 28 August 2009.

Facts. A woman described in the proceedings as mentally retarded, an orphan in the care of a government institution in Chandigarh, was found to be pregnant following an assault. The Administration sought the High Court's permission to terminate. An Expert Body reported in favour of continuing the pregnancy, and she had herself expressed a willingness to bear the child. The High Court nevertheless directed termination, by its order of 17 July 2009.

Held, on consent. The termination could not be permitted without her consent. Her reproductive choice was to be respected notwithstanding her lack of understanding of the sexual act, apprehensions about her capacity to carry the pregnancy to term and about her assumption of maternal responsibilities, since the Act itself contemplates that the consent of a woman found to be mentally retarded is required.

Held, on the right. A woman's right to make reproductive choices is a dimension of personal liberty under article 21. Reproductive choices may be exercised to procreate as well as to abstain from procreating, the crucial consideration being that her right to privacy, dignity and bodily integrity should be respected. Taken to their logical conclusion, reproductive rights include a woman's entitlement to carry a pregnancy to full term, to give birth and to raise children.

Held, on limits. In the case of pregnant women there is a compelling State interest in protecting the life of the prospective child, so termination is permitted only where the conditions of the applicable statute are fulfilled, and the provisions of the Act may be viewed as reasonable restrictions on the exercise of reproductive choices.

Why it matters here. Three things follow, and an answer should take them in order. The right exists and is constitutional. It runs in both directions, so it is not a right to terminate but a right to decide. And the statute is a reasonable restriction on it, which means the statute is measured against the right rather than being the source of it.

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Chapter Sixty-Four

Sex Selection: the PCPNDT Scheme

Syllabus topic 3, "Medicine and the Law"

In one line

The clearest case in Indian law of a statute passed because a technology threatened a right, and it does not ban the machine.

In the wording a student can write in an exam: the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act 1994 answers a capability rather than a substance: ultrasonography and related techniques made the sex of a foetus knowable before birth, and the response was not to prohibit the technique, which has genuine diagnostic value, but to confine its purposes under section 4, to prohibit the communication of the sex of the foetus under section 5(2), to prohibit sex determination and sex selection under section 6, and to prohibit advertisement under section 22.

Why the law has this at all

This is the paradigm dual use problem from [Dual Use: the Same Technology Both Ways], and it is worth setting out because the Act's structure follows directly from it.

The same ultrasound scan that detects a chromosomal abnormality, a congenital anomaly or a sex-linked genetic disease also reveals the sex of the foetus. There is no separate machine and no separate procedure. A prohibition on the technology would remove a diagnostic capability of real value to pregnant women, and would defeat the right to enjoy the benefits of scientific progress. A permission unaccompanied by control produced, on the evidence that prompted the legislation, the elimination of female foetuses on a scale visible in the sex ratio of a population.

Parliament therefore regulated the use, the communication of the result, and the premises, leaving the technique lawful. That is the model response to a dual use technology, and a candidate who says so has connected this chapter to Module I.

Note also what the harm is, because it is unusual in this module. The wrong is not done to the person on the table. It is done to the foetus and, cumulatively, to the sex ratio of a population, and the pressure to seek the information usually comes from the woman's family. The Act therefore restricts information in order to protect the woman, which cuts against the assumption running through the rest of this module that autonomy favours disclosure.

Sections 1 to 3B: application, definitions and who may act

Section 1 gives the short title, extent and commencement. The long title and the short title were both substituted in 2003, when the Act was extended from pre-natal diagnostic techniques to pre-conception sex selection.

Section 2 contains the definitions, including Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic, pre-natal diagnostic procedures, pre-natal diagnostic techniques and sex selection.

Section 3 regulates Genetic Counselling Centres, Genetic Laboratories and Genetic Clinics: no such Centre, Laboratory or Clinic shall conduct or associate with, or help in, the conduct of activities relating to pre-natal diagnostic techniques unless registered under the Act, and no person shall conduct such activities except at a registered place and unless qualified as prescribed.

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Chapter Sixty-Five

PCPNDT: Registration and Authorities

Syllabus topic 3, "Medicine and the Law"

In one line

A prohibition on communicating the sex of a foetus is unprovable unless somebody knows which machines exist, where they are, and what was written down each time one was used.

In the wording a student can write in an exam: the Act is enforced through a three-tier structure: a Central Supervisory Board under sections 7 to 16 with the functions in section 16, State and Union territory Supervisory Boards under section 16A, and Appropriate Authorities under section 17 with the powers in section 17A; and it operates on the ground through compulsory registration of Genetic Counselling Centres, Genetic Laboratories and Genetic Clinics under sections 18 and 19, with cancellation or suspension under section 20 and an appeal under section 21.

Why the law has this at all

The substantive prohibitions in the previous chapter share a difficulty: none of them can be proved from outside.

Section 5(2) forbids communicating the sex of a foetus "by words, signs, or in any other manner". A nod across a room leaves no trace. Section 6 forbids conducting a technique for the purpose of determining sex, and purpose is a state of mind. Section 4 permits a scan only on a recorded indication, and a record can be written to fit.

The Act's answer is not a better prohibition but an apparatus: a register of who may act, a requirement to record, a power to inspect and seize, and a sanction that operates without proving a crime. That is the same reasoning as [Regulating the Hospital], and here it does more work, because the offence is invisible and the registration is not.

Sections 7 to 16: the Central Supervisory Board

Section 7 constitutes the Central Supervisory Board, and prescribes its composition, which includes the Minister in charge of the Ministry of Health and Family Welfare as Chairperson, the Secretary in charge as Vice-Chairperson, officers of named Ministries, members of Parliament, medical experts, and representatives of women's organisations.

Section 8 fixes the term of office of members. Section 9 provides for meetings of the Board, requiring it to meet at least once in six months. Section 10 provides that vacancies shall not invalidate its proceedings. Section 11 permits the temporary association of persons with the Board for particular purposes. Section 12 provides for the appointment of officers and other employees. Section 13 deals with the authentication of orders and instruments. Section 14 sets out disqualifications for appointment as a member, and section 15 the eligibility of a member for reappointment.

Section 16 states the functions of the Board, and these are the ones to know:

  • (i) to advise the Central Government on policy matters relating to the use of pre-natal diagnostic techniques and sex selection techniques and against their misuse;
  • (ii) to review and monitor implementation of the Act and rules and to recommend changes;
  • (iii) to create public awareness against the practice of pre-conception sex selection and pre-natal determination of the sex of a foetus leading to female foeticide;

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Chapter Sixty-Six

PCPNDT: Offences and Enforcement

Syllabus topic 3, "Medicine and the Law"

In one line

The Act punishes the clinic, punishes the family that asks, and expressly refuses to punish the woman who was made to go.

In the wording a student can write in an exam: the enforcement scheme punishes practitioners and clinic personnel under section 23(1), reports the convicted practitioner to the State Medical Council under section 23(2), punishes any person who seeks the aid of a clinic for sex selection under section 23(3), and then makes two decisive provisions: section 23(4), which provides that sub-section (3) shall not apply to the woman who was compelled; and section 24, which requires the court to presume, unless the contrary is proved, that she was compelled by her husband or another relative, who is thereby liable for abetment.

Why the law has this at all

The enforcement problem here is the one identified at the end of [Trade in Organs and Its Punishment], and this Act solves it where the transplantation statute does not.

In an organ sale, the poorest participant, the paid donor, is exposed to the same offence as the broker, so the person best placed to give evidence has the strongest reason to stay silent. The same structure would have been fatal here. A statute that punished everyone who obtained a sex determination would punish the pregnant woman, who is ordinarily the person under pressure rather than the person applying it, and would guarantee that no prosecution ever had a witness.

Sections 23(4) and 24 reverse that. The woman is removed from the offence, and the presumption places the liability on the relative who sent her. A candidate who can compare the two statutes on this point has understood something about enforcement design that neither Act states in terms.

Section 23: the offences

Section 23(1) applies to a medical geneticist, gynaecologist, registered medical practitioner, or any person who owns a Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic, or is employed in such a place and renders professional or technical services to or at it, whether on an honorary basis or otherwise, and who contravenes any provision of the Act or the rules. Punishment: imprisonment up to three years and fine up to ten thousand rupees; on subsequent conviction, imprisonment up to five years and fine up to fifty thousand rupees.

Two features matter. The offence is committed by contravening any provision, so it does not require proof that a sex determination occurred: a failure of the recording requirement under section 4(3) or of consent under section 5(1) is enough. And it reaches those working on an honorary basis, closing the obvious avoidance.

Section 23(2): the name of the registered medical practitioner shall be reported by the Appropriate Authority to the State Medical Council for necessary action, including suspension of registration if the charges are framed by the court and till the case is disposed of, and on conviction removal of his name from the register for five years for the first offence and permanently for the subsequent offence.

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Chapter Sixty-Seven

Assisted Reproductive Technology: the Scheme

Syllabus topic 3, "Medicine and the Law"

In one line

Conception outside the body separated the people who supply the material, the person who carries the child, and the people who will raise it, and the law had to decide what each of them is.

In the wording a student can write in an exam: the Assisted Reproductive Technology (Regulation) Act 2021 regulates clinics and banks that provide assisted reproductive technology, defined as all techniques that seek to obtain a pregnancy by handling the sperm or the oocyte outside the human body and transferring the gamete or embryo into the reproductive system of a woman; it establishes a National Board and State Boards shared with the Surrogacy Act, a National Registry, and appropriate authorities; it imposes duties as to consent, records, sourcing of gametes, storage and research; and it settles the status of the child and the position of the donor.

Why the law has this at all

The capability created three legal questions that had no answers, and the Act is organised around them.

What is the child, and whose? Where gametes come from donors and an embryo is transferred to a woman who may or may not be the intended mother, the ordinary presumptions of parentage fail. Section 31 answers it.

What is a donor? A person who supplies gametes is neither a parent nor a patient nor a seller, and each of those characterisations would produce a different set of consequences. Sections 27 and 31(2) answer it.

What stops a market? Gametes and embryos are transferable and valuable, and the same reasoning applies as in [Trade in Organs and Its Punishment]. Section 29 answers it.

Before the Act, all three were governed by contract and by professional guidance, which is the delay failure described in [Health and Medical Technology]: the capability arrived and the law did not.

Sections 1 and 2: application and definitions

Section 1 gives the short title, extent and commencement. Section 2 contains the definitions, and the ones that decide questions are:

  • assisted reproductive technology, which covers all techniques that seek to obtain a pregnancy by handling the sperm or the oocyte outside the human body and transferring the gamete or embryo into the reproductive system of a woman;
  • assisted reproductive technology bank, an organisation registered under the Act for supplying gametes;
  • assisted reproductive technology clinic, a premises equipped with requisite facilities for the procedures;
  • commissioning couple, an infertile married couple who approach a clinic or bank for the services;
  • donor, a person who provides sperm or oocyte; and
  • infertility, the inability to conceive after a year of unprotected coitus or such other proven medical condition preventing conception.

Section 45 provides that the application of other laws is not barred, so the Act sits alongside the PCPNDT Act, the Surrogacy Act and the general law rather than displacing them. Section 46 is the power to remove difficulties.

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Chapter Sixty-Nine

ART: Authorities and the National Registry

Syllabus topic 3, "Medicine and the Law"

In one line

The Act's substantive rules are about donors and embryos, and none of them can be checked unless somebody knows every clinic in the country and what it did.

In the wording a student can write in an exam: the Act is enforced through a National Assisted Reproductive Technology and Surrogacy Registry under sections 9 to 11, acting as a central database of all clinics and banks; appropriate authorities under sections 12 to 14 with the powers of a civil court; compulsory registration of clinics and banks under sections 15 to 17, with suspension or cancellation under section 18 and an appeal under section 19; and a power to inspect premises under section 20.

Why the law has this at all

The rules in the previous chapter are almost all numerical, and numbers are only enforceable against a record.

Section 27(4) says an oocyte donor may donate once in her life. Nothing in a single clinic's file can establish that she has not donated elsewhere. Section 27(3) says a single donor's gametes may not go to more than one commissioning couple, which is a statement about the whole country rather than about one bank. Section 28(2) limits storage to ten years, which requires a record that outlasts the storage.

Each of those is a rule that only a national database can police, which is why section 11 exists and why it is drafted as a database provision rather than as a reporting duty.

Sections 9 to 11: the National Registry

Section 9: the Central Government may, within ninety days from the commencement of the Act, by notification, establish for the purposes of this Act and the Surrogacy Act a Registry called the National Assisted Reproductive Technology and Surrogacy Registry.

Two things to note. The Registry serves both statutes, which is the second welding point between them. And the power is expressed as "may", with a ninety-day period, which is a weaker formulation than a duty.

Section 10: the Registry shall consist of such scientific, technical, administrative and supportive staff as may be prescribed, on prescribed terms.

Section 11 sets out its functions:

  • (a) it shall act as a central database in the country through which the details of all the clinics and banks of the country, including the nature and types of services provided, the outcome of the services and other relevant information, shall be obtained on a regular basis;
  • (b) it shall assist the National Board by providing the data generated from that database; and
  • (c) the data shall be utilised by the National Board for making policies and guidelines and shall help in identifying new research areas and in conducting research.

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Chapter Seventy

ART: Offences and Penalties

Syllabus topic 3, "Medicine and the Law"

In one line

The Act's severest punishment is not for anything done to an embryo but for advertising that you will choose its sex.

In the wording a student can write in an exam: the offences fall into three groups: sex selective advertising under section 32, punished most severely of all; the seven prohibited acts in section 33(1), which include abandoning or exploiting the child, trading in embryos or gametes, importing them, exploiting the commissioning couple or donor, transferring an embryo into a male person or an animal, selling for research, and using intermediates to obtain donors; and the residual offence in section 34; with cognizance under section 35 confined to a complaint by the National Board or a State Board.

Section 32: sex selective advertising

Section 32(1): the clinic, or bank, or agent thereof, shall not issue, publish, distribute, communicate or cause to be issued, published, distributed or communicated any advertisement in any manner including internet, regarding facilities of sex selective assisted reproductive technology.

Section 32(2): contravention is punishable with imprisonment not less than five years, extending to ten, or with fine not less than ten lakh rupees, extending to twenty-five lakh, or with both.

That is the heaviest penalty in the Act, and it is worth pausing on why. The section punishes an advertisement, not a procedure. Nothing need have been done to any embryo, and no woman need have been treated. The legislature has ranked the creation of a market for sex selection above the individual acts in section 33, which is the same judgment reflected in section 22 of the PCPNDT Act and in section 19(f) of the Transplantation Act: a demand cultivated by advertising produces the practice, so the advertisement is attacked first.

Section 33: the seven prohibitions

Section 33(1): any medical geneticist, gynaecologist, registered medical practitioner or any person shall not:

  • (a) abandon, disown or exploit, or cause to be abandoned, disowned or exploited in any form, the child or children born through assisted reproductive technology;
  • (b) sell human embryos or gametes, or run an agency, a racket or an organisation for selling, purchasing or trading in human embryos or gametes;
  • (c) import or help in getting imported in whatsoever manner human embryos or human gametes;
  • (d) exploit the commissioning couple, woman or the gamete donor in any form;
  • (e) transfer a human embryo into a male person or an animal;
  • (f) sell any human embryo or gamete for the purpose of research; or
  • (g) use any intermediates to obtain gamete donors or purchase gamete donors.

Section 33(2): contravention of clauses (a) to (g) is punishable with a fine not less than five lakh rupees, extending to ten lakh, for the first contravention; and for a subsequent contravention, imprisonment not less than three years, extending to eight, and fine not less than ten lakh rupees, extending to twenty lakh.

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Chapter Seventy-One

Surrogacy: the Scheme of the Act

Syllabus topic 3, "Medicine and the Law"

In one line

A woman carries a child she will not keep, for people who cannot carry one, and the Act's whole design is to make sure she is not paid and not abandoned.

In the wording a student can write in an exam: the Surrogacy (Regulation) Act 2021 permits only altruistic gestational surrogacy, by prohibiting under section 4 any surrogacy except for a medical indication necessitating gestational surrogacy, only for altruistic purposes, and not for commercial purposes or for producing children for sale, prostitution or exploitation; it requires three certificates and a court order on parentage and custody before a procedure may begin; it protects the surrogate mother by consent, insurance and a once-in-a-lifetime limit; and it deems the child a biological child of the intending couple.

Why the law has this at all

Surrogacy separates gestation from parenthood, and in doing so it creates a relationship the law had no category for. The woman carrying the child is not the mother in the intended sense, is not a patient being treated for her own condition, and is not an employee. Before the Act she was, in practice, a party to a contract.

That produced three problems the Act is built around.

The child's status. Who the parents are, and from the moment of birth rather than after a later proceeding, since a child whose parentage is unsettled has no one owing it anything.

The surrogate's position. A woman undergoing pregnancy and childbirth with no therapeutic benefit to herself, frequently poorer than the people commissioning, and exposed to pressure at every stage including on whether to continue the pregnancy.

Commercialisation. The same reasoning as [Trade in Organs and Its Punishment]: where a scarce and valuable capacity is located in poor people, an unregulated market extracts it from them.

The Act answers all three, and the answers are strict enough that the criticism of it is the opposite of the criticism of the ART Act: not that it under-protects, but that its eligibility conditions exclude a great many people who might otherwise have used it.

Sections 1 to 3: application and definitions

Section 1 gives the short title, extent and commencement. Section 2 contains the definitions, of which these decide questions:

  • altruistic surrogacy, a surrogacy in which no charges, expenses, fees, remuneration or monetary incentive of whatever nature, except the medical expenses and such other prescribed expenses incurred on the surrogate mother and the insurance coverage for her, are given to the surrogate mother or her dependents or representative;
  • commercial surrogacy, commercialisation of surrogacy services or procedures or their component services, including selling or buying human embryos or trading in gametes, or a surrogacy where a monetary benefit or reward in cash or kind exceeding the basic medical expenses and insurance coverage is given;
  • intending couple, a couple who have a medical indication necessitating gestational surrogacy and who intend to become parents through surrogacy;
  • surrogate mother, a woman bearing a child who is genetically related to the intending couple, through surrogacy from the implantation of an embryo in her womb.

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Chapter Seventy-Two

Surrogacy: Clinics, Registration and Procedure

Syllabus topic 3, "Medicine and the Law"

In one line

A surrogacy leaves a child who will one day be an adult, and the Act keeps the paperwork for twenty-five years because of that.

In the wording a student can write in an exam: no surrogacy clinic may operate unless registered under sections 11 and 12, registration may be suspended or cancelled under section 13 with an appeal under section 14 available to the clinic and to the intending couple or woman, and every clinic must maintain records for twenty-five years under section 46, with a power of search and seizure in the appropriate authority under section 47.

Section 3: the prohibition on clinics

Section 3 prohibits and regulates surrogacy clinics from the commencement of the Act:

  • no surrogacy clinic, laboratory or clinical establishment of any kind shall conduct, offer, undertake, promote or associate with or avail of surrogacy or its procedures unless registered under the Act;
  • no surrogacy clinic shall employ or cause to be employed or take services of any person, whether on honorary basis or on payment, who does not possess the prescribed qualifications;
  • no medical practitioner, gynaecologist, paediatrician, embryologist or any other person shall conduct, offer, undertake, promote or associate with surrogacy or its procedures at a place other than a place registered under the Act; and
  • no surrogacy clinic, paediatrician, gynaecologist, embryologist or any person shall promote, publish, canvass, propagate or advertise, in any manner including by internet, anything that is intended to lead to surrogacy or its procedures otherwise than in accordance with the Act, or that relates to commercial surrogacy.

The advertising prohibition sits alongside section 22 of the PCPNDT Act and section 32 of the ART Act, and the reasoning is the same: a market advertised into existence produces the practice.

Sections 11 to 14: registration

Section 11(1): no person shall establish any surrogacy clinic for undertaking surrogacy or rendering surrogacy procedures in any form unless duly registered under the Act. Section 11(2): every application shall be made to the appropriate authority in the prescribed form and manner with the prescribed fee, and the section provides for the period within which existing clinics must apply.

Section 12(1): the appropriate authority shall, after holding an inquiry and after satisfying itself that the applicant has complied with all the requirements of the Act and the rules, grant a certificate of registration in the prescribed form and manner, subject to prescribed conditions. Section 12 further provides for the period of validity and for rejection after an opportunity of being heard, with reasons recorded in writing.

Section 13(1): the appropriate authority may, suo motu or on complaint, issue a show cause notice to a surrogacy clinic to show cause why its registration should not be suspended or cancelled, for the reasons mentioned. Section 13(2): if, after giving a reasonable opportunity of being heard, the authority is satisfied that there has been a breach of the Act or the rules, it may, without prejudice to any criminal action it may take, suspend the registration for such period as it thinks fit or cancel it. Section 13(3): notwithstanding those sub-sections, if the authority is of opinion that it is necessary or expedient in the public interest, it may, for reasons to be recorded in writing, suspend the registration without issuing a notice.

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Chapter Seventy-Three

Surrogacy: Boards and Appropriate Authorities

Syllabus topic 3, "Medicine and the Law"

In one line

Two statutes, one Board, one Registry, and this is the Act that builds them.

In the wording a student can write in an exam: the National Assisted Reproductive Technology and Surrogacy Board is constituted by section 17 of this Act, with its term, meetings, disqualifications and functions in sections 18 to 25; State Boards are constituted by section 26 with corresponding provisions in sections 27 to 34; the National Registry is established by section 15; and appropriate authorities are appointed under section 35 with functions in section 36 and powers in section 37. The Assisted Reproductive Technology (Regulation) Act 2021 does not duplicate any of this: its sections 4 and 7 apply these provisions to its own Boards.

Why the two Acts share machinery

Assisted reproduction and surrogacy overlap almost entirely in practice. A gestational surrogacy requires an embryo created outside the body, so it is an assisted reproductive technology procedure as well as a surrogacy; the same clinics perform both; the same donors and the same laboratories are involved.

Parliament enacted the two statutes together and gave them a single Board and a single Registry rather than two of each. That is why:

  • section 3 of the ART Act provides for the National Board and section 4 applies this Act's provisions to it;
  • section 6 of the ART Act provides for the State Board and section 7 applies this Act's provisions to it; and
  • section 9 of the ART Act and section 15 of this Act both establish the National Assisted Reproductive Technology and Surrogacy Registry, for the purposes of both statutes.

A candidate asked about the composition of the Board under the ART Act must therefore answer from this statute, and saying so is itself worth a mark.

Section 15 and 16: the Registry

Section 15 establishes the National Assisted Reproductive Technology and Surrogacy Registry for the purposes of this Act and the Assisted Reproductive Technology Act.

Section 16 applies the provisions of the Assisted Reproductive Technology Act with respect to the National Registry, so the Registry's composition and functions are found in sections 10 and 11 of that Act, worked in [ART: Authorities and the National Registry].

Note the symmetry. The Boards are built here and borrowed by the ART Act; the Registry is built there and borrowed here. Neither statute is complete on its own, which is the single most important structural fact about both.

Sections 17 to 25: the National Board

Section 17 constitutes the National Assisted Reproductive Technology and Surrogacy Board, and prescribes its composition, which includes the Minister in charge of the Ministry of Health and Family Welfare as Chairperson, the Secretary to the Government of India in charge of the Department dealing with the Act as Vice-Chairperson, three women Members of Parliament, three members of the Ministries concerned, an eminent woman representing a women's organisation, an officer of the Indian Council of Medical Research, and eminent medical practitioners in the relevant specialities as expert members.

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Chapter Seventy-Four

Surrogacy: Offences, and the Rights Question

Syllabus topic 3, "Medicine and the Law"

In one line

The Act punishes the trade severely, presumes the surrogate was compelled, and is criticised for protecting her by taking away her choice.

In the wording a student can write in an exam: the offences are graded in three tiers, commercial surrogacy and exploitation under section 38, punishable with up to ten years and ten lakh rupees; contravention by clinics and practitioners under section 39, up to five years and ten lakh rupees; and failure to follow altruistic surrogacy by the intending couple or woman under section 40; section 42 requires the court to presume compulsion of the surrogate; and section 43 makes every offence cognizable, non-bailable and non-compoundable.

Section 38: the central prohibition

Section 38(1): no person, organisation, surrogacy clinic, laboratory or clinical establishment of any kind shall:

  • (a) undertake commercial surrogacy, provide it or its related component procedures or services in any form, or run a racket or an organised group to empanel or select surrogate mothers, or use individual brokers or intermediaries to arrange for surrogate mothers and surrogacy procedures, at such clinics, laboratories or at any other place;
  • (b) issue, publish, distribute, communicate or cause to be issued, published, distributed or communicated any advertisement in any manner regarding commercial surrogacy by any means whatsoever, scientific or otherwise;
  • (c) abandon or disown or exploit, or cause to be abandoned, disowned or exploited in any form, the child or children born through surrogacy;
  • (d) exploit or cause to be exploited the surrogate mother or the child born through surrogacy in any manner whatsoever;
  • (e) sell human embryo or gametes for the purpose of surrogacy, and run an agency, racket or organisation for selling, purchasing or trading in them for that purpose;
  • (f) import or help in getting imported, in whatsoever manner, human embryos or gametes for surrogacy; and
  • (g) conduct sex selection in any form for surrogacy.

Section 38(2): notwithstanding the Indian Penal Code, contravention of clauses (a) to (g) by any person is punishable with imprisonment which may extend to ten years and fine which may extend to ten lakh rupees.

Section 38(3) defines advertisement for this section as including any notice, circular, label, wrapper or other document, including advertisement through internet or any other media, in electronic or print form, and any visible representation made by means of any hoarding, wall-painting, signal light, sound, smoke or gas.

That definition is worth quoting in an answer. "Signal light, sound, smoke or gas" is drafting of a deliberately exhaustive kind, and it tells you what the legislature expected the practice to do when the obvious channels were closed.

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Chapter Seventy-Five

Mental Health: Capacity and the Advance Directive

Syllabus topic 3, "Medicine and the Law"

In one line

The Act reverses the assumption that a person with mental illness cannot decide, and then lets a person decide in advance for a time when they cannot.

In the wording a student can write in an exam: the Mental Healthcare Act 2017 provides in section 4 that every person, including a person with mental illness, shall be deemed to have capacity to make decisions about their mental healthcare or treatment if they can understand relevant information, appreciate the reasonably foreseeable consequences, and communicate the decision; it confines in section 3 the determination of mental illness to accepted medical standards and excludes determination on grounds of social non-conformity; and it creates in sections 5 to 13 the advance directive, by which a person may state in writing how they wish, and do not wish, to be treated when capacity is lost.

Why the law has this at all

Mental illness has been the standing exception to everything else in this module. Consent, autonomy and the right to refuse were treated as suspended by a diagnosis, and the older law proceeded by asking who could decide for the person rather than whether the person could decide.

Two propositions drove the change and both appear on the face of the Act.

A diagnosis is not an incapacity. A person may have a mental illness and be entirely able to decide about their treatment, may be able to decide some things and not others, and may lose and regain the ability. The older approach, which treated the diagnosis as the answer, was wrong as a matter of fact.

Incapacity is episodic, and a person knows their own illness. Someone who has experienced an episode knows what happened, what helped, and what they do not want done again. The advance directive is the mechanism by which that knowledge is given legal effect at the moment they can no longer state it.

Section 3: determining mental illness

Section 3(1): mental illness shall be determined in accordance with such nationally or internationally accepted medical standards, including the latest edition of the International Classification of Disease of the World Health Organisation, as may be notified by the Central Government.

Section 3(2): no person or authority shall classify a person as a person with mental illness except for purposes directly relating to the treatment of the mental illness, or in other matters covered under the Act or any other law.

Section 3(3): mental illness shall not be determined on the basis of:

  • (a) political, economic or social status, or membership of a cultural, racial or religious group, or any other reason not directly relevant to the person's mental health status;
  • (b) non-conformity with moral, social, cultural, work or political values or religious beliefs prevailing in the person's community.

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Chapter Seventy-Six

The Nominated Representative

Syllabus topic 3, "Medicine and the Law"

In one line

Somebody has to speak for a person who cannot, and the Act lets the person choose who that will be, and tells them how to speak.

In the wording a student can write in an exam: the nominated representative is the person appointed under section 14 to act for a person with mental illness in the matters the Act assigns; the appointment may be made by the person themselves in writing on plain paper, or in an advance directive, and failing that the Act supplies a statutory order of precedence; section 15 provides for a minor; section 16 allows the Board to revoke or alter the appointment; and section 17 states the duties, which are not to decide for the person but to give particular credence to the views of the person so far as they understand the decision.

Why the law has this at all

The problem is the one in [Consent for a Person Who Cannot Consent], with two features that make it harder in this setting.

Incapacity here is episodic and recurrent. A person may need someone to act for them this month and not next year, and again the year after. A once-and-for-all guardianship is the wrong instrument.

The family is not always the ally. The person most likely to be appointed by default is the person who may have committed the individual, may be managing their property, or may be the source of the difficulty. The older law assumed the family's interests and the patient's coincided; this Act does not.

The response is characteristic of the whole statute: let the person choose in advance, supply a default only where they have not, and constrain how the appointed person exercises the role.

Section 14: appointment

Section 14(1): notwithstanding section 5(1)(c), every person who is not a minor shall have a right to appoint a nominated representative.

Section 14(2): the nomination shall be made in writing on plain paper with the person's signature or thumb impression.

That is a deliberately low formality. No stamp, no attestation, no lawyer, and a thumb impression suffices. The Act is drafted for people who may be poor, may be unable to write, and may be making the appointment in a hospital.

Section 14(3): the person appointed shall not be a minor, shall be competent to discharge the duties or perform the functions assigned under the Act, and shall give his consent in writing to the mental health professional to discharge them. So the representative must accept the role, and the acceptance is given to the professional rather than to the appointer.

Section 14(4): where no nominated representative is appointed, the following are deemed to be the nominated representative, in the order of precedence:

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Chapter Seventy-Seven

The Rights of a Person with Mental Illness

Syllabus topic 3, "Medicine and the Law"

In one line

Chapter V of the Act is a list of rights written by people who knew exactly what happens inside institutions.

In the wording a student can write in an exam: sections 18 to 28 confer on a person with mental illness the right to access mental healthcare, to community living, to protection from cruel, inhuman and degrading treatment, to equality and non-discrimination, to information, to confidentiality, to access their medical records, to personal contacts and communication, to legal aid, and to make complaints about deficiencies in the provision of services; and the rights are stated with a specificity unusual in Indian legislation because each of them answers a documented practice.

Why the law has this at all

A right stated generally is unenforceable inside a closed institution. Nobody outside can see what happens, the person inside may be unable to complain, and a general prohibition on cruel or degrading treatment gives an inspector nothing to check.

The Act's answer is enumeration. Instead of a general guarantee, section 20(2) lists eleven specific entitlements, each of which can be verified by walking into a ward and looking. That converts a right into a checklist, and it is why the section reads as it does.

The second reason is that this Act, unlike most in this module, was written after a period of documented institutional abuse and with the Convention on the Rights of Persons with Disabilities in view. Its drafters knew what they were legislating against.

Sections 18 and 19: access and community living

Section 18(1): every person shall have a right to access mental healthcare and treatment from mental health services run or funded by the appropriate Government.

The section requires those services to be of affordable cost, of good quality, available in sufficient quantity, accessible geographically, without discrimination, and provided in a manner that is acceptable to persons with mental illness and their families and care-givers.

Those five criteria are the availability, accessibility, acceptability and quality framework from [Availability, Accessibility, Acceptability and Quality], written into an Indian statute. A candidate who notices that has connected Module I to Module II, and it is worth a sentence.

The section also requires provision of mental health services in every district, and the range of services specified, and provides that persons with mental illness living below the poverty line or who are destitute or homeless shall be entitled to treatment free of any charge and without any expense at establishments run or funded by Government.

Section 19: the right to community living. Every person with mental illness shall have a right to live in, be part of and not be segregated from society, and shall not continue to remain in a mental health establishment merely because he does not have a family or is not accepted by his family or is homeless or for any other reason.

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Chapter Seventy-Nine

HIV: Confidentiality and Disclosure

Syllabus topic 3, "Medicine and the Law"

In one line

The Supreme Court said a doctor may tell the fiancée; Parliament said yes, but only after four conditions, and never where telling her will get a woman beaten.

In the wording a student can write in an exam: section 8 prohibits compelled disclosure of HIV status except by order of a court, and prohibits any person from disclosing another's HIV status imparted in confidence or in a fiduciary relationship except with informed consent recorded in writing, subject to six exceptions; and section 9 permits a physician or counsellor, and no other healthcare provider, to disclose a person's HIV-positive status to their partner, but only on four cumulative conditions and subject to three provisos, of which the third forbids disclosure to the partner of a woman where there is a reasonable apprehension of violence, abandonment or severe harm to her or those close to her.

Why the law has this at all

This is the chapter where the case law and the statute meet directly, and the comparison is the whole point.

Mr 'X' v. Hospital 'Z', AIR 1999 SC 495, (1998) 8 SCC 296, held that the Code of Medical Ethics carves out an exception to confidentiality where there is a serious and identifiable risk to a specific person who, if not informed, would be exposed to infection, and that a doctor may consider it a duty to ensure that a sexual partner is informed regardless of the patient's own wishes. On the facts, the appellant's right to confidentiality was not enforceable, because the proposed marriage carried a health risk to an identifiable person.

The order of 10 December 2002 then held that everything in the 1998 judgment beyond that narrow holding was uncalled for.

What the case left was a permission with no procedure. A doctor could tell the partner, and nothing said who could tell, when, after what steps, or what happened where telling the partner would expose the patient to violence. Section 9 supplies all of that, and reading the two together is the best available illustration in this book of the difference between a judicial permission and a legislative scheme.

Section 8: the general rule

Section 8(1), notwithstanding anything in any other law:

  • (i) no person shall be compelled to disclose his HIV status except by an order of the court that the disclosure is necessary in the interest of justice for the determination of issues in the matter before it; and
  • (ii) no person shall disclose or be compelled to disclose the HIV status or any other private information of another person imparted in confidence or in a relationship of a fiduciary nature, except with the informed consent of that person or their representative obtained in the manner specified in section 5, and the fact of such consent has been recorded in writing by the person making the disclosure.

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Chapter Eighty

HIV: Ombudsman, Courts and Remedies

Syllabus topic 3, "Medicine and the Law"

In one line

The Act gives a person who has been discriminated against an official to complain to, a thirty-day deadline for an answer, and protection against being punished for having complained.

In the wording a student can write in an exam: enforcement runs through a Complaints Officer in the establishment under section 21 and then an Ombudsman appointed by every State Government under section 23, who inquires into violations relating to discrimination under section 3 and the provision of healthcare services, may compel information on pain of the Penal Code, and must pass a reasoned order within thirty days; the penalties are in sections 37 to 39; section 40 prohibits victimisation of a complainant; and section 43 gives the Act overriding effect.

Why the law has this at all

Every statute in Module II has a prohibition. Almost none has a remedy the affected person can actually use, which is the difficulty set out in [Remedies When Technology Causes Harm].

The person this Act protects faces every one of the four obstacles named there in an acute form. The harm is diffuse, a refusal of a job, a school place, a tenancy; the loss in any one instance is too small to litigate. The evidence is opaque, since an employer does not write down the real reason. The asymmetry is total. And the act of complaining reveals the very fact whose revelation caused the harm.

The Act answers each. It supplies a cheap and local forum, a power to compel information, a deadline, protection against retaliation, and, in section 34, suppression of identity in proceedings.

Sections 23 to 28: the Ombudsman

Section 23(1): every State Government shall appoint one or more Ombudsman, either (a) a person possessing prescribed qualification and experience, or (b) by designating any of its officers not below a prescribed rank, to exercise the powers and discharge the functions conferred under the Act.

Section 23(3): the Ombudsman shall have jurisdiction over such area or areas as the State Government may by notification specify.

Clause (b) matters practically. A State need not create a new office; it may designate an existing officer, which removes the usual excuse for non-appointment and is why this remedy is more likely to exist on the ground than a specialist tribunal would be.

Section 24(1): the Ombudsman shall, upon a complaint made by any person, inquire into violations of the Act in relation to acts of discrimination mentioned in section 3 and the providing of healthcare services by any person, in the prescribed manner.

Two limits are worth noting. The complaint may be made by any person, not only the person affected, which matters where the affected person cannot safely complain. But the jurisdiction is confined to section 3 discrimination and healthcare services, so it does not extend to every provision of the Act.

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Chapter Eighty-One

Euthanasia, the Living Will and Dying with Dignity

Syllabus topic 3, "Medicine and the Law"

In one line

A person may refuse in advance the treatment that would keep them alive, and a doctor who honours that refusal commits no crime.

In the wording a student can write in an exam: active euthanasia, the intentional taking of life, remains unlawful; passive euthanasia, the withholding or withdrawal of medical intervention from a patient in the terminal stage of illness or in a persistently vegetative state where artificial intervention will merely prolong suffering, is lawful; and a person of sound and competent mind may, by an advance directive in writing, specify the medical intervention which is not to be adopted should they lose the ability to decide, such a directive being entitled to deference by the treating doctor, who is protected against criminal liability for abiding by it in a good faith exercise of professional judgment.

Why this is the hardest question in the module

Every other chapter concerns what may be done to a person. This one concerns what may be stopped, and the difficulty is that the two look identical from outside the bed and are opposite in law.

Three propositions have to be held together, and they pull against each other.

Life is protected. Article 21 protects life, and the Penal Code makes the intentional taking of another's life culpable. No framework that treats a life as disposable can be right.

Treatment is an intervention, and interventions need consent. Everything in [Informed Consent: the Principle] applies. A competent adult may refuse treatment, including treatment without which they will die, and a doctor who treats over that refusal commits a trespass.

A person who has lost capacity cannot refuse now. So the question becomes whether their earlier refusal governs, which is the question the advance directive answers.

The case

Common Cause (A Regd. Society) v. Union of India, AIR 2018 SC 1665, (2018) 5 SCC 1, decided on 9 March 2018 by a Constitution Bench of five judges.

Facts. A writ petition by a registered society seeking a declaration that the right to die with dignity is a fundamental right within article 21, and directions permitting a person to execute a document giving instructions to withhold or withdraw medical treatment should they reach a stage where recovery is impossible. The matter went to a Constitution Bench because the two-judge decision in Aruna Shanbaug had permitted passive euthanasia on a reading of the Constitution Bench decision in Gian Kaur.

Held, on active euthanasia. The intentional taking away of the life of another is made culpable by the Penal Code. Active euthanasia falls within the express prohibitions of the law and is unlawful.

Held, on the advance directive. An individual who is in a sound and competent state of mind is entitled, by means of an advance directive in writing, to specify the nature of medical intervention which may not be adopted in future, should he or she cease to possess the mental ability to decide. Such a directive is entitled to deference by the treating doctor. The treating doctor who, in a good faith exercise of professional medical judgment, abides by an advance directive is protected against the burden of criminal liability.

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Chapter Eighty-Two

Public Health Powers and Epidemics

Syllabus topic 3, "Medicine and the Law"

In one line

The whole of India's epidemic law is four sections written in 1897, and they confer a power without stating a single limit on it.

In the wording a student can write in an exam: the Epidemic Diseases Act 1897 empowers a State Government, when satisfied that the State or any part of it is visited by, or threatened with, an outbreak of any dangerous epidemic disease, and if it thinks the ordinary provisions of the law are insufficient, to take or empower any person to take such measures, and by public notice to prescribe such temporary regulations as it deems necessary to prevent the outbreak or its spread; section 2A confers corresponding powers on the Central Government; section 3 penalises disobedience; and section 4 protects persons acting under the Act.

Why this chapter is short and important

The Act is four sections long. That is not a summary; it is the statute. And the brevity is the point of the chapter, because it means that every question about the limits of an epidemic power in India is a constitutional question rather than a statutory one.

Consider what the ordinary framework requires before a right may be interfered with, from [Privacy and Surveillance]: legality, a legitimate aim, and proportionality. An epidemic measure will always satisfy the second. The first is where the difficulty lies, because a statute that authorises "such measures as it shall deem necessary" is a law in form and supplies almost no foreseeability. And the third is left entirely to the courts, because the Act itself imposes no requirement of necessity, no time limit, no review and no compensation as of right.

Section 2: the power

Section 2(1): when at any time the State Government is satisfied that the State or any part of it is visited by, or threatened with, an outbreak of any dangerous epidemic disease, the State Government, if it thinks that the ordinary provisions of the law for the time being in force are insufficient for the purpose, may:

  • take, or require or empower any person to take, such measures; and
  • by public notice, prescribe such temporary regulations to be observed by the public or by any person or class of persons,

as it shall deem necessary to prevent the outbreak of such disease or the spread thereof; and may determine in what manner and by whom any expenses incurred, including compensation if any, shall be defrayed.

Read the sub-section for what it does not contain. There is no definition of "dangerous epidemic disease". There is no requirement that the measures be proportionate, or the least restrictive available, or limited in duration beyond the word "temporary". There is no procedure, no appeal and no review. Compensation is not a right but a matter the Government "may determine".

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Chapter Eighty-Three

Medical Examination, Medical Evidence and the Accused

Syllabus topic 3, "Medicine and the Law"

In one line

A doctor asked by the police to examine a person is doing two things at once, and the law has to say which of them he is doing.

In the wording a student can write in an exam: a medical examination of a person in custody engages the right against self-incrimination in article 20(3), personal liberty under article 21, and the professional obligations of the examining practitioner; the Code of Criminal Procedure authorises examination in defined circumstances under sections 53, 53-A and 54; and Selvi v. State of Karnataka holds that those provisions cannot be read expansively to authorise techniques that produce testimonial material, and that compulsory administration of such techniques is unconstitutional.

Why the law has this at all

The examining doctor is in a position that occurs nowhere else in this module. The person on the table is not their patient in the ordinary sense; the person who requested the examination is not the person examined; and the product of the examination will be used against the person examined.

Everything in [The Doctor and the Patient] is therefore displaced. There is no undertaking of care in the usual sense, the fiduciary element is compromised because the doctor owes something to the investigating agency, and the ordinary rule that a person may refuse to be touched runs into a statute that says otherwise.

The law's answer proceeds in two steps: identify what kind of material the examination produces, and then ask whose authority licenses it.

The statutory authority

Section 53 of the Code permits the examination of an accused person by a medical practitioner at the request of a police officer, where there are reasonable grounds for believing that an examination will afford evidence as to the commission of an offence, and permits the use of such force as is reasonably necessary. Its Explanation defines examination to include the examination of blood, blood stains, semen, swabs, sputum and sweat, hair samples and finger nail clippings, by the use of modern and scientific techniques including DNA profiling and such other tests which the practitioner thinks necessary in a particular case.

Section 53-A provides specifically for the examination of a person accused of rape.

Section 54 provides for the examination of an arrested person at his own request, which is the provision that protects a person in custody by allowing them to obtain evidence of ill-treatment.

Section 161(2) provides that a person examined by the police is bound to answer truly all questions relating to the case other than questions the answers to which would have a tendency to expose him to a criminal charge or to a penalty or forfeiture. It is the statutory counterpart of article 20(3) and, as Selvi holds, extends the protection to witnesses and suspects and not only to the accused.

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Chapter Eighty-Four

The Unborn, the Newborn and the Law

Syllabus topic 3, "Medicine and the Law"

In one line

Indian law has never said what a foetus is, and it has said a great deal about what may and may not be done to one.

In the wording a student can write in an exam: the legal status of the unborn is not determined in the abstract by Indian law; instead a series of statutes each answers a particular question about what may be done, and the protection afforded varies with the question rather than following from any single view of what a foetus is; so the correct method is to identify the statute that governs the act in issue rather than to reason from a general premise about when life begins.

Why the question is answered this way

The abstract question, whether a foetus is a person, is one that legal systems answer badly when they answer it at all, because any answer determines too much. If the foetus is a person from conception, termination is homicide and much assisted reproduction is unlawful. If it is nothing until birth, the Pre-conception and Pre-natal Diagnostic Techniques Act has no subject matter and an embryo may be dealt with as property.

Indian law has taken neither course. It has legislated act by act, and the result is a set of answers that are individually coherent and collectively resist reduction to a single principle. That is not a defect to be apologised for in an answer; it is the structure, and describing it accurately is the task.

What the statutes actually decide

Termination: the Medical Termination of Pregnancy Act 1971

The Act does not confer a right to terminate; it exempts a registered medical practitioner from criminal liability where a pregnancy is terminated in accordance with it. Termination is permitted on the practitioner's opinion formed in good faith on two grounds, one of which, in section 3(2)(ii), is that there is a substantial risk that if the child were born it would suffer from any serious physical or mental abnormality.

What that settles. The foetus is protected to the extent that terminating a pregnancy is unlawful outside the Act, and the protection is defeasible on grounds that include its own probable condition. Suchita Srivastava records the position exactly: there is a compelling State interest in protecting the life of the prospective child, and the Act's provisions may be viewed as reasonable restrictions on the woman's reproductive choices.

What it does not settle. Whether the foetus is a person. The Act works by exempting the doctor, not by weighing two persons' rights.

Selection: the PCPNDT Act 1994

Section 6 prohibits conducting any pre-natal diagnostic technique for the purpose of determining the sex of a foetus, and prohibits any person from causing or allowing selection of sex before or after conception. Section 4(2) confines the permitted purposes of the techniques to the detection of listed abnormalities.

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Module III

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Chapter Eighty-Five

What Ethics Adds to Law

Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."

In one line

Most of what has gone badly wrong in science was lawful when it happened, which is why the instruments in this module exist.

In the wording a student can write in an exam: ethics and law diverge in scientific research more sharply than in almost any other field, because the law regulates what is known to be dangerous and research is by definition the pursuit of what is not yet known; the instruments in this module, the Nuremberg Code, the Declaration of Helsinki and the three UNESCO declarations, are the international community's attempt to close that gap by stating standards that bind before any legislature has acted, and they matter to a lawyer because they supply the content of the acceptability element of the right to science, are relied on by treaty bodies, and are increasingly written into domestic statutes.

Why a law paper spends a module on this

Three reasons, and a candidate should be able to give all three.

Because what happened was lawful. This is the point that makes the module necessary rather than decorative. The experiments that produced the Nuremberg Code were conducted by qualified physicians, in accredited institutions, under a legal order that permitted them. Nothing unlawful was done in the sense that a domestic lawyer would recognise, which is precisely why a purely legal framework was inadequate to the problem and why a statement of principle that did not depend on any State's law had to be made.

Because law arrives late. The pattern in [How a Technology Becomes a Rights Question] is that a capability exists before the rule that governs it. In the interval, the only available standard is an ethical one, and the interval is where the harm occurs. Research ethics is therefore not a soft alternative to regulation but the only operative constraint at the moment when constraint matters most.

Because the law now incorporates it. This is the reason the module belongs on a law paper rather than a philosophy one. General Comment 25 makes the incorporation express: the acceptability element of the right to science requires that scientific research incorporate ethical standards in order to ensure its integrity and the respect of human dignity, and it names the standards proposed in the Universal Declaration on Bioethics and Human Rights as the reference. Ethics is thus a component of a Covenant right, and a State that permits research without those standards is in breach of the Covenant.

Where ethics and law diverge

Four situations, and naming them is what turns a general observation into an answer.

Conduct that is not unlawful and is wrong. A trial conducted where regulation is weakest, on participants who have no alternative source of treatment, with a design that would not be approved at home. Every step may comply with the host State's law.

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Chapter Eighty-Six

Human Experimentation Before Nuremberg

Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."

In one line

The rules of research ethics are not deductions from a theory; each one is the correction of something that was actually done.

In the wording a student can write in an exam: the framework of research ethics was constructed retrospectively, in response to a documented practice of experimentation on human beings who had not agreed and could not refuse; the participants were characteristically persons already under the control of the institution conducting the research, so that the feature which made them available was the same feature that made their consent impossible; and the resulting instruments are best read as a list of corrections rather than as a body of derived principle.

Why this chapter is here

Because the alternative is a list of rules a student cannot evaluate.

Told as abstract propositions, the ten points of the Nuremberg Code sound obvious to the point of banality. Voluntary consent is essential. The experiment should avoid unnecessary suffering. The subject should be free to end it. A reader who meets them without context assumes they state what any decent person would do anyway, and consequently does not understand why they had to be written, why the first point is the longest, or why they take the form they do.

Told against what happened, every point has an author and an occasion.

The pattern

Four features recur, and they explain the shape of every instrument that followed.

The participants were people under control. Prisoners, detainees, institutionalised patients, orphaned children, conscripted soldiers, and the inmates of asylums. The reason is administrative rather than ideological: research on human beings requires a supply of human beings who will be available, will not withdraw, and will not complain. Every institution that holds people provides that supply.

Consent was absent, and its absence was not concealed. In most of the documented cases nobody asked, because nobody thought it necessary. That is what makes the first point of the Nuremberg Code a correction rather than a restatement.

The researchers were competent and often eminent. The experiments were not conducted by charlatans. They were designed by qualified investigators, some of them distinguished, and published in the ordinary way. That is why the framework does not rely on professional standing as a safeguard.

It was lawful. As set out in [What Ethics Adds to Law], the legal order permitted it. No prosecution was available under the law as it stood.

Three settings, and what each produced

Detention. Where a State holds people, it holds a research population. The consequence, recorded in every subsequent instrument, is the rule that vulnerability arises from circumstance rather than from any characteristic of the person, which is the subject of [Vulnerable Participants and Exploitation]. A prisoner is not less able to understand than anyone else; they are less able to refuse.

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Chapter Eighty-Seven

The Nuremberg Code

Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."

In one line

Ten sentences, written by judges rather than scientists, that every subsequent instrument in this field is a commentary on.

In the wording a student can write in an exam: the Nuremberg Code 1947 consists of ten points formulated in the judgment of a military tribunal trying physicians for experimentation on human beings; the first, that the voluntary consent of the human subject is absolutely essential, is stated as an absolute and placed before every other requirement; and the remaining nine govern the justification, design, conduct and termination of an experiment, so that consent is a necessary and not a sufficient condition of permissible research.

The ten points

The Code is short enough to be learnt entire, and an answer that reproduces its structure accurately is worth more than one that paraphrases it loosely.

1. The voluntary consent of the human subject is absolutely essential.

2. The experiment should be such as to yield fruitful results for the good of society.

3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease.

4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur.

6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

8. The experiment should be conducted only by scientifically qualified persons.

9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end.

10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him, that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

The structure

The ten points are not a list of equals, and reading their arrangement is what turns recitation into understanding.

PointsWhat they governThe question each answers
1ConsentMay this be done to this person at all?
2, 3JustificationIs the research worth doing, and is it properly founded?
4, 5, 6, 7RiskWhat may the participant be exposed to?
8CompetenceWho may conduct it?
9, 10TerminationWho may stop it, and when?

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Chapter Eighty-Eight

The Declaration of Helsinki

Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."

In one line

The profession's own answer to Nuremberg, written by doctors rather than judges, revised nine times in sixty years, and enforced by journals rather than by courts.

In the wording a student can write in an exam: the Declaration of Helsinki is a statement of ethical principles for medical research involving human participants, adopted by the World Medical Association in 1964 and amended repeatedly, most recently in 2024; it differs from the Nuremberg Code in authorship, being the profession's own statement rather than a tribunal's; in reach, since it addresses the research enterprise as a whole including committees, protocols, registration and publication; and in method, since it permits research on those who cannot consent, subject to conditions, where the Code did not address them at all.

Why a second instrument was needed

The Nuremberg Code answered the question the trial raised and left four gaps, identified in [The Nuremberg Code]: it did not define consent, made no provision for those who cannot consent, required no independent review, and provided no enforcement.

Those gaps were not oversights. They were the consequence of the Code's origin: a tribunal states the rule the case requires, and the case before it concerned competent adults experimented upon without any consent at all.

But medicine needed to conduct research on children, on the unconscious and on the incapable, and needed to know on what terms. A rule of absolute voluntary consent, read literally, forbids all of it and therefore forbids paediatric medicine from advancing at all. Helsinki is the profession's attempt to state terms rather than to abandon the principle.

The structure

The current text is organised under headings, and knowing them is the quickest way to answer a question on its scope.

HeadingWhat it covers
PreamblePurpose, addressees, and the primacy of the participant
General PrinciplesThe duty to protect participants, the primacy of their interests over all other interests
Risks, Burdens, and BenefitsAssessment and management of risk
Individual, Group, and Community VulnerabilityWho requires additional protection and on what terms
Scientific Requirements and Research ProtocolsThe design and the protocol
Research Ethics CommitteesIndependent review
Privacy and ConfidentialityProtection of participants' information
Free and Informed ConsentThe consent requirements in detail
Use of PlaceboComparison against the best proven intervention
Post-Trial ProvisionsWhat participants are owed when the trial ends
Research Registration, Publication, and Dissemination of ResultsRegistration before recruitment; publication of results
Unproven Interventions in Clinical PracticeUse outside a trial

Compare that with the Code's ten points and the difference in reach states itself. The Code governs an experiment; Helsinki governs a research system, including the committee that approves it, the register it is entered in, and the journal that publishes it.

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Chapter Eighty-Nine

Research Ethics Committees

Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."

In one line

The one safeguard in this module that operates before anything happens, and the only one that does not depend on the judgment of the person who wants the research to proceed.

In the wording a student can write in an exam: a research ethics committee reviews a research protocol before the research begins and has authority to approve, require changes to, withdraw approval for and suspend it; article 19 of the UNESCO Declaration of 2005 requires that independent, multidisciplinary and pluralist ethics committees be established, promoted and supported at the appropriate level; and the Declaration of Helsinki requires prior submission of the protocol, independence and authority to resist undue influence from the researcher, the sponsor or others, and, in international collaborative research, approval by committees in both the sponsoring and the host countries.

Why prior review is the decisive safeguard

Everything else in this module operates on the participant or on the investigator. Consent operates on the participant, who cannot assess the science. The other Nuremberg points operate on the investigator, who is the person with the strongest interest in proceeding.

A committee is the only mechanism that is prior, external and empowered. It sees the protocol before a participant is approached; it is not the person who wants the answer; and it can refuse.

The history in [Human Experimentation Before Nuremberg] explains why that combination is needed. The investigators there were competent and eminent, so competence is not a safeguard. The participants were unable to refuse, so consent is not a safeguard in the settings where research is easiest to conduct. What was missing was somebody with the power to say no who did not want the research to happen.

Article 19: what a committee must be

Independent, multidisciplinary and pluralist ethics committees should be established, promoted and supported at the appropriate level in order to:

  • (a) assess the relevant ethical, legal, scientific and social issues related to research projects involving human beings;
  • (b) provide advice on ethical problems in clinical settings;
  • (c) assess scientific and technological developments, formulate recommendations and contribute to the preparation of guidelines on issues within the scope of the Declaration; and
  • (d) foster debate, education and public awareness of, and engagement in, bioethics.

The three adjectives in the opening line are the examinable part.

Independent means independent of the researcher, the institution and the sponsor. A committee constituted by the body whose funding depends on the trial is not one, and this is the requirement most often defeated in practice.

Multidisciplinary because the issues are simultaneously scientific, legal, ethical and social, as clause (a) states, and no single discipline can assess all four. A committee of clinicians will not see the legal problem; a committee of lawyers will not see the design problem.

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Chapter Ninety-One

Vulnerable Participants and Exploitation

Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."

In one line

Some people are easy to recruit and hard to protect, and the reason is almost never that they do not understand.

In the wording a student can write in an exam: vulnerability in research describes a situation in which a person, group or community is at greater risk of being wronged or harmed, arising from factors that may be fixed or contextual and dynamic; it is distinct from incapacity, since a vulnerable person may understand perfectly and be unable to refuse; article 8 of the UNESCO Declaration of 2005 requires that human vulnerability be taken into account and that individuals and groups of special vulnerability be protected and their personal integrity respected; and the Declaration of Helsinki requires that the harms of exclusion be weighed against the harms of inclusion, permitting research with such persons only where it is responsive to their health needs and priorities and they stand to benefit.

The distinction that governs the topic

Two conditions are constantly confused, and separating them decides most problems.

Incapacity is an inability to make the decision: to understand the information, to appreciate the consequences, or to communicate a choice. It is the subject of article 7 of the UNESCO Declaration and of section 4 of the Mental Healthcare Act, and the response is a substituted decision on the standard of best interest with the person's involvement.

Vulnerability is an impaired ability to refuse, or an increased exposure to harm if things go wrong. The person may understand the protocol better than the investigator. What they lack is a real alternative, or the standing to say no, or the resources to absorb an injury.

The prisoner in [Human Experimentation Before Nuremberg] is the clearest illustration: not less able to understand than anyone else, and less able to decline. So is the patient asked by their own treating consultant, addressed by the dependent-relationship rule in [Free and Informed Consent in Research].

Why the distinction matters practically. The remedy for incapacity is a substituted decision. The remedy for vulnerability is not substitution, because the person can decide; it is to alter the circumstances in which the decision is asked for, by changing who asks, removing the consequence of refusal, or declining to conduct the research in that population at all.

Article 8, and the two-sided obligation

Article 8 of the UNESCO Declaration provides that, in applying and advancing scientific knowledge, medical practice and associated technologies, human vulnerability should be taken into account, and that individuals and groups of special vulnerability should be protected and the personal integrity of such individuals respected.

Two limbs, and both matter. Taking vulnerability into account is a design obligation running through the whole of research, not a rule about a category of person. Protection and respect for personal integrity is the specific obligation owed where special vulnerability exists.

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Chapter Ninety-Two

Research Carried Out in Developing Countries

Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."

In one line

A trial is cheapest where oversight is lightest and participants have fewest alternatives, and the population that carries the risk is usually not the population that will be able to buy the result.

In the wording a student can write in an exam: transnational research raises the problem of double standards, in which a study is conducted in a host country under conditions that would not be approved in the sponsoring country; the instruments answer it by requiring ethical review in both the host State and the State where the funder is located under article 21(2), by requiring research to be responsive to the needs of host countries under article 21(3), by requiring agreement on the benefits of research with equal participation under article 21(4), and, most usefully for a lawyer, by placing on the State of origin the duty to guarantee the rights and obligations of all parties under paragraph 22 of General Comment 25.

Why the incentives point one way

The structure of the problem should be stated plainly, because every rule in this chapter is a response to it.

Cost. A trial is cheaper where wages, facilities and regulatory compliance cost less.

Speed. Recruitment is faster where the condition is prevalent and where potential participants have no alternative source of treatment, so enrolment is quick and withdrawal rare.

Oversight. Where the regulator is under-resourced, review is lighter and the study proceeds sooner.

Liability. Where the practical ability of a participant to obtain a remedy is limited, the expected cost of an injury is lower.

Each of those makes the host country attractive for a reason that is simultaneously a reason for concern. That is the same inverse relation identified in [Human Experimentation Before Nuremberg]: the features that make a population available are the features that make its consent and its protection problematic.

And the benefit runs the other way. The product is priced for markets that can pay, so the population that bore the risk is frequently not the population that will obtain the result. That is the benefit-sharing failure taken in [Access to Medicines and Patents].

The double standard

The specific ethical objection has a name and a precise content. A double standard exists where research is conducted in a host country to a standard lower than would be required of the same sponsor at home: a placebo control where the standard treatment would be required in the sponsoring country, a consent process that would not be accepted there, an ethics review that would not pass there, or no provision for the participant after the trial.

The Declaration of Helsinki forecloses the argument directly through two provisions taken elsewhere in this module. The comparator is the best proven intervention, not the intervention locally available, which is the point in [The Declaration of Helsinki]. And an ethics committee must take national and international norms into account but these must not be allowed to reduce or eliminate any of the protections for research participants set out in the Declaration, which is the point in [Research Ethics Committees].

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Chapter Ninety-Three

Placebo, Standard of Care and After the Trial

Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."

In one line

To find out whether a treatment works you must withhold it from somebody, and the question is from whom, compared with what, and what they get afterwards.

In the wording a student can write in an exam: the standard of care in a controlled trial is the best proven intervention, against which a new intervention must be tested; placebo or no intervention is permissible only where no proven intervention exists, or where for compelling and scientifically sound methodological reasons it is necessary to determine efficacy or safety and the participants will not be subject to additional risks of serious or irreversible harm; and post-trial provisions must be arranged in advance for all participants who still need an intervention identified as beneficial and reasonably safe in the trial.

Why the question is hard

An answer should begin by conceding that the objection to placebo controls is not obvious, because a candidate who treats them as self-evidently wrong will misstate the science.

The methodological case is real. A controlled trial establishes that an intervention works by comparing it against something. Comparing against an existing treatment answers a different question, whether the new intervention is better than the old, and requires far more participants to answer it. A placebo answers whether the intervention works at all, faster and with fewer people exposed.

Withholding is unavoidable in some form. Every trial withholds the intervention from somebody; that is what a control is. The question is never whether to withhold but what the person who does not receive the intervention receives instead.

And the participants have agreed. They have been told, they have consented, and they may withdraw.

The framework nonetheless restricts placebo use, and the reason is the one running through the whole module: consent does not answer everything. A participant may agree to a design that no committee should have approved, which is the Nuremberg proposition that points 2 to 8 apply to a consented experiment.

The rule

The Declaration requires that the benefits, risks, burdens and effectiveness of a new intervention be tested against those of the best proven intervention, except in two situations.

The first exception. Where no proven intervention exists, the use of placebo, or no intervention, is acceptable. This is the uncontroversial case: nothing is being withheld, because there is nothing to withhold.

The second exception, and it is cumulative. Where:

  • for compelling and scientifically sound methodological reasons, the use of any intervention other than the best proven one, or of placebo, or of no intervention, is necessary to determine the efficacy or safety of an intervention; and
  • the participants who receive any intervention other than the best proven one, or placebo, or no intervention, will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.

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Chapter Ninety-Four

Registration, Publication and Research Integrity

Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."

In one line

A trial that goes unregistered can be buried if the result is unwelcome, and a participant who took a risk for a result nobody sees took it for nothing.

In the wording a student can write in an exam: the Declaration of Helsinki requires that medical research involving human participants be registered in a publicly accessible database before recruitment of the first participant, and that researchers make publicly available the results of their research, being accountable for the timeliness, completeness and accuracy of their reports, with negative and inconclusive as well as positive results published or otherwise made publicly available, sources of funding, institutional affiliations and conflicts of interest declared, and reports of research not in accordance with the Declaration not accepted for publication.

Why this is a rights question and not housekeeping

Three arguments, and a candidate should give all three because the topic looks administrative until they are made.

The participant's risk is wasted. A person who enrols accepts a burden so that a question may be answered for others. If the answer is never published, the burden produced nothing, and the justification for asking them to bear it fails retrospectively. That is why publication is an ethical obligation of the researcher and not merely a professional convention.

Suppression distorts the evidence base. Where unfavourable results are not published, the published literature over-represents success, so clinicians and regulators make decisions on a body of evidence that is systematically wrong. The harm falls on patients who were never in any trial.

False science interferes with rights directly. General Comment 25 makes this express. Under the quality element at paragraph 18, the right to science requires the most advanced, up-to-date and generally accepted and verifiable science available at the time, according to the standards generally accepted by the scientific community. And under the duty to protect at paragraph 43, States must ensure that private persons and entities do not disseminate false or misleading scientific information, and that private investment in scientific institutions is not used to unduly influence the orientation of research or to restrict the scientific freedom of researchers.

So research integrity is not adjacent to the right to science; it is a component of it.

Registration

The requirement is short and its precision is the point: medical research involving human participants must be registered in a publicly accessible database before recruitment of the first participant.

Three features.

Before the first participant. Not before publication, not before the results are known, and not at the sponsor's convenience. Registration precedes recruitment, which means the existence of the trial is on the record before anyone can know how it will turn out.

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Chapter Ninety-Five

The Genome and Human Dignity

Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."

In one line

The first four articles decide what the genome is, and everything else in the Declaration follows from those answers.

In the wording a student can write in an exam: article 1 provides that the human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity, and that in a symbolic sense it is the heritage of humanity; article 2 provides that everyone has a right to respect for their dignity and rights regardless of their genetic characteristics, and that that dignity makes it imperative not to reduce individuals to their genetic characteristics and to respect their uniqueness and diversity; article 3 provides that the genome evolves and is subject to mutations, containing potentialities expressed differently according to each individual's natural and social environment; and article 4 provides that the human genome in its natural state shall not give rise to financial gains.

The Declaration, and what it is

Adopted by the General Conference of UNESCO at its twenty-ninth session on 11 November 1997, and endorsed by the United Nations General Assembly by resolution 53/152 of 9 December 1998.

That endorsement matters and should be stated in any answer on this instrument. It is not a treaty and creates no obligation binding in international law, but no other instrument in this module carries the General Assembly's endorsement, and it is the reason this Declaration is treated as the authoritative statement in its field.

Its structure is worth learning as a map, because a question will normally concern one part of it:

PartArticlesSubject
A1 to 4Human dignity and the human genome
B5 to 9Rights of the persons concerned
C10 to 12Research on the human genome
D13 to 16Conditions for the exercise of scientific activity
E17 to 19Solidarity and international co-operation
F20 and 21Promotion of the principles
G22 to 25Implementation

Article 1: what the genome is

The human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity. In a symbolic sense, it is the heritage of humanity.

Three propositions in two sentences, and each does work.

Unity. The genome is the ground of what all human beings have in common, which supplies the answer to any claim that genetic difference marks a difference in status.

Diversity. In the same breath, the genome is the ground of recognising diversity. That pairing is deliberate: the instrument refuses to treat unity and difference as opposed, so genetic variation is a fact about the human family rather than a departure from a type.

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Chapter Ninety-Six

The Genome: Rights of the Person Concerned

Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."

In one line

Five articles that between them govern who may touch a genome, who may be told what it says, and what happens when it goes wrong.

In the wording a student can write in an exam: article 5 governs intervention, requiring prior risk-benefit assessment, the prior, free and informed consent of the person concerned, prior review of research protocols, and, for a person without capacity, research only for their direct health benefit save by narrow exception, and stating in article 5(c) the right of each individual to decide whether or not to be informed of the results of a genetic examination; article 6 prohibits discrimination based on genetic characteristics; article 7 requires confidentiality of genetic data associated with an identifiable person; article 8 provides for just reparation; and article 9 permits limitations on consent and confidentiality only by law, for compelling reasons, within the bounds of international human rights law.

Article 5: intervention

The article has five lettered paragraphs and each answers a distinct question.

5(a). Research, treatment or diagnosis affecting an individual's genome shall be undertaken only after rigorous and prior assessment of the potential risks and benefits pertaining to it, and in accordance with any other requirement of national law.

5(b). In all cases, the prior, free and informed consent of the person concerned shall be obtained. If the person is not in a position to consent, consent or authorisation shall be obtained in the manner prescribed by law, guided by the person's best interest.

5(c). The right of each individual to decide whether or not to be informed of the results of genetic examination and the resulting consequences should be respected.

5(d). In the case of research, protocols shall in addition be submitted for prior review in accordance with relevant national and international research standards or guidelines.

5(e). Where a person does not have the capacity to consent, research affecting their genome may only be carried out for his or her direct health benefit, subject to the authorisation and protective conditions prescribed by law. Research without an expected direct health benefit may be undertaken only by way of exception, with the utmost restraint, exposing the person only to a minimal risk and minimal burden, and if the research is intended to contribute to the health benefit of other persons in the same age category or with the same genetic condition, subject to conditions prescribed by law and compatible with the protection of the individual's human rights.

Two observations tie this article to the rest of the book. Paragraph (e) is the same regime as article 7(b) of the 2005 Declaration, worked in [Consent for a Person Who Cannot Consent], and the parallel is close enough that a candidate may treat them together. And paragraph (d)'s requirement of prior review is the ethics committee obligation of [Research Ethics Committees] applied to genetic research.

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Chapter Ninety-Seven

Research on the Genome and Its Limits

Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."

In one line

The Declaration permits research on the genome, subordinates it to rights, prohibits a class of practice by reference to dignity alone, and then tells States what conditions to create so that the research can be done well.

In the wording a student can write in an exam: article 10 provides that no research or research application concerning the human genome should prevail over respect for the human rights, fundamental freedoms and human dignity of individuals or groups; article 11 provides that practices which are contrary to human dignity, such as reproductive cloning of human beings, shall not be permitted; article 12 requires that benefits from advances concerning the genome be made available to all and states that freedom of research is part of freedom of thought; and articles 13 to 16 set the conditions for scientific activity, being the responsibilities of researchers, the State's duty to foster the conditions for free research, the requirement that results not be used for non-peaceful purposes, and the promotion of independent, multidisciplinary and pluralist ethics committees.

Article 10: the ordering principle

No research or research applications concerning the human genome, in particular in the fields of biology, genetics and medicine, should prevail over respect for the human rights, fundamental freedoms and human dignity of individuals or, where applicable, of groups of people.

The article establishes an order of priority rather than a prohibition, and that is its importance. It does not say research is subordinate to convenience, or to opinion, or to regulation; it says that where research or its application collides with human rights, fundamental freedoms and human dignity, the latter prevail.

Two features are worth noting. The reference to groups of people is unusual, and it matters for genetic research because a finding about a population, an ethnic group or a community can injure every member of it without identifying any of them. And the phrase "or research applications" extends the ordering to what is done with the knowledge, not merely to the conduct of the study.

Article 11: dignity as an operative standard

Practices which are contrary to human dignity, such as reproductive cloning of human beings, shall not be permitted. States and competent international organizations are invited to co-operate in identifying such practices and in taking, at national or international level, the measures necessary to ensure that the principles set out in this Declaration are respected.

This is the most important sentence in the module for the purposes of a question about what dignity does, and three things should be said about it.

The prohibited class is defined by dignity alone. Not by safety, not by efficacy, not by public opinion. The article does not say reproductive cloning is dangerous or unproven; it says the class of prohibited practices is the class of practices contrary to human dignity, and reproductive cloning is given as an instance of the class.

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Chapter Ninety-Eight

The Genome: Solidarity and Implementation

Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."

In one line

The last nine articles are about what States must do so that the first sixteen are not merely stated.

In the wording a student can write in an exam: article 17 requires States to respect and promote the practice of solidarity towards individuals, families and population groups particularly vulnerable to or affected by disease or disability of a genetic character, and to foster research on rare as well as endemic diseases; article 18 requires the fostering of international dissemination of scientific knowledge and of co-operation particularly between industrialized and developing countries; articles 20 and 21 require promotion of the principles through education and the facilitation of open international discussion; and articles 22 to 25 provide for implementation, including the role of the International Bioethics Committee under article 24 and the saving clause in article 25.

Article 17: solidarity

States should respect and promote the practice of solidarity towards individuals, families and population groups who are particularly vulnerable to or affected by disease or disability of a genetic character. They should foster, inter alia, research on the identification, prevention and treatment of genetically based and genetically influenced diseases, in particular rare as well as endemic diseases which affect large numbers of the world's population.

Three things in one article, and each is worth separating.

Solidarity is named as a practice. The word is unusual in a rights instrument, which ordinarily speaks of obligations and entitlements. Solidarity denotes something States are to respect and promote rather than a duty owed to an identified claimant, and it is directed at how a society treats those affected by genetic disease rather than at any particular transaction.

The protected class is drawn widely. Individuals, families and population groups, and those particularly vulnerable to as well as affected by disease or disability of a genetic character. Including families is a recognition of the shared property of genetic information developed in [Biotechnology, Genetics and Human Dignity]; including those merely vulnerable extends protection to people who are not ill.

Rare and endemic diseases are named together. This is the most practically significant part of the article. Rare diseases attract no commercial research because the market is too small; endemic diseases which affect large numbers of the world's population attract none because the affected population cannot pay. The two failures are opposite in cause and identical in effect, and the article requires States to foster research on both, which is the neglected-disease problem stated in a 1997 instrument.

Articles 18 and 19: international co-operation

Article 18. States should make every effort to continue fostering the international dissemination of scientific knowledge concerning the human genome, human diversity and genetic research, and to foster scientific and cultural co-operation, particularly between industrialized and developing countries.

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Chapter Ninety-Nine

Genetic Data: What It Is and Why It Is Special

Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."

In one line

Four reasons why a genetic record is unlike every other record a person has, stated in one article of one instrument.

In the wording a student can write in an exam: the International Declaration on Human Genetic Data 2003 governs the collection, processing, use and storage of human genetic data, human proteomic data and the biological samples from which they are derived; article 4 states that such data have a special status because they can be predictive of genetic predispositions, may have a significant impact on the family including offspring, extending over generations, and in some instances on the whole group to which the person belongs, may contain information whose significance is not necessarily known at the time of collection, and may have cultural significance; and article 5 confines the purposes for which they may be dealt with to four.

Why a separate instrument was needed

The 1997 Declaration is about the genome; this one is about the data. The distinction is not pedantic, and stating it is the first move in any answer.

A genome is a biological fact about a person. Genetic data is a record, held by somebody, in a system, capable of being copied, combined, transferred and searched. Everything that makes data protection a separate discipline from bodily integrity applies, and it applies with the additional features that article 4 identifies.

The structure follows the life of the data, and knowing it is the quickest way into a question:

PartArticlesStage
A1 to 7General provisions
B8 to 12Collection
C13 to 15Processing
D16 to 19Use
E20 to 22Storage
F23 to 27Promotion and implementation

Articles 1 and 2: aims and terms

Article 1 states the aims and scope: to ensure respect for human dignity and protection of human rights and fundamental freedoms in the collection, processing, use and storage of human genetic data, human proteomic data and the biological samples from which they are derived, in accordance with the requirements of equality, justice and solidarity, while giving due consideration to freedom of thought and expression, including freedom of research.

Article 2 defines the terms, and three matter for an answer: human genetic data, information about heritable characteristics of individuals obtained by analysis of nucleic acids or by other scientific analysis; human proteomic data, information pertaining to an individual's proteins; and biological sample, any sample of biological material from which genetic data can be derived.

The inclusion of proteomic data and of biological samples is deliberate. Protecting the data alone would leave the sample from which it can be re-derived unprotected, so the instrument reaches the material as well as the record.

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Chapter One Hundred

Genetic Data: Collection and Consent

Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."

In one line

Consent to give a sample, the right to take that consent back, and the right to decide whether you want to be told what the sample said.

In the wording a student can write in an exam: article 8 requires prior, free, informed and express consent, without inducement by financial or other personal gain, for the collection of genetic data, proteomic data or biological samples and for their subsequent processing, use and storage, whether by public or private institutions; article 9 governs withdrawal, which is available unless the data are irretrievably unlinked to an identifiable person; article 10 extends the right to decide whether or not to be informed of research results, and where appropriate to identified relatives who may be affected; article 11 requires non-directive genetic counselling; and article 12 governs collection for forensic and legal proceedings.

Article 8: consent

8(a). Prior, free, informed and express consent, without inducement by financial or other personal gain, should be obtained for the collection of human genetic data, human proteomic data or biological samples, whether through invasive or non-invasive procedures, and for their subsequent processing, use and storage, whether carried out by public or private institutions. Limitations on this principle should be prescribed only for compelling reasons by domestic law consistent with the international law of human rights.

Four features of that sentence are examinable.

"Without inducement by financial or other personal gain." No other consent provision in this book contains this. It excludes payment for a sample outright, which is the genetic counterpart of the prohibitions on payment for organs and gametes, and it extends beyond money to other personal gain, so an offer of preferential treatment or of access to a service is equally excluded.

"Whether through invasive or non-invasive procedures." A cheek swab requires the same consent as a blood draw. The consent is to the taking of genetic information, not to a physical intrusion, which is why the manner of collection does not lower the standard.

"And for their subsequent processing, use and storage." The consent covers the whole life of the sample, not the moment of collection, which is what makes the change-of-purpose rule in article 16 necessary rather than optional.

"Public or private institutions." A private sequencing company is bound as a State laboratory is.

8(b) to (d) deal with those who cannot consent. Where a person is incapable of giving informed consent, authorization should be obtained from the legal representative, who should have regard to the best interest of the person concerned. An adult not able to consent should as far as possible take part in the authorization procedure, and the opinion of a minor should be taken into consideration as an increasingly determining factor in proportion to age and degree of maturity. And in diagnosis and health care, genetic screening and testing of minors and adults not able to consent will normally only be ethically acceptable when they have important implications for the health of the person and have regard to their best interest.

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Chapter One Hundred One

Genetic Data: Access, Privacy and Quality

Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."

In one line

Three articles: the person may see their own data, four named parties may not, and whoever holds it must keep it accurate and secure.

In the wording a student can write in an exam: article 13 provides that no one should be denied access to his or her own genetic data or proteomic data unless irretrievably unlinked or unless domestic law limits access in the interest of public health, public order or national security; article 14 requires States to protect the privacy and confidentiality of data linked to an identifiable person, family or, where appropriate, group, and provides that such data should not be disclosed or made accessible to third parties, in particular employers, insurance companies, educational institutions and the family, except for an important public interest reason restrictively provided by law or with prior, free, informed and express consent; and article 15 requires accuracy, reliability, quality and security, and rigour, caution, honesty and integrity in processing and interpretation.

Article 13: access to one's own data

No one should be denied access to his or her own genetic data or proteomic data unless such data are irretrievably unlinked to that person as the identifiable source or unless domestic law limits such access in the interest of public health, public order or national security.

The right and its two exceptions.

The right is to one's own data. It does not extend to a relative's, which is why the brother in the preceding chapter has no claim, and it complements rather than contradicts the right not to be informed in article 10: a person may decline to be told and may later ask, and both are exercises of the same control over information about themselves.

The first exception is factual. Where the data are irretrievably unlinked, there is nothing that can be identified as this person's, so access is impossible rather than refused.

The second exception is legal, and it is narrow: domestic law may limit access in the interest of public health, public order or national security. Note what is absent from that list. Commercial confidentiality is not there; institutional convenience is not there; and the interests of the holder are not there.

Compare section 25 of the Mental Healthcare Act in [The Rights of a Person with Mental Illness], which permits specific information to be withheld from a patient's records where release would cause serious mental harm or harm to others, subject to an application to the Board. The two provisions solve the same problem differently: the Indian statute allows withholding on a clinical ground with a right of appeal, the Declaration allows it only on three stated public grounds and only by law.

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Chapter One Hundred Two

Genetic Data: Use, Storage and Benefit Sharing

Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."

In one line

What may be done with the data afterwards, how long it may be kept, when two databases may be joined, and what the people who gave it are owed.

In the wording a student can write in an exam: article 16 prohibits use for a different purpose incompatible with the original consent unless fresh consent is obtained or domestic law provides for an important public interest reason; article 19 requires that benefits from the use of the data be shared with society as a whole and the international community, listing seven forms; article 21 requires destruction when no longer necessary, including of samples taken from a suspect in a criminal investigation; and article 22 makes consent essential for cross-matching data stored for different purposes.

Article 16: change of purpose

16(a). Data and samples collected for one of the purposes in article 5 should not be used for a different purpose that is incompatible with the original consent, unless:

  • the prior, free, informed and express consent of the person is obtained under article 8(a); or
  • the proposed use, decided by domestic law, corresponds to an important public interest reason and is consistent with international human rights law.

Where the person lacks capacity, article 8(b) and (c) apply mutatis mutandis.

16(b). Where such consent cannot be obtained, or in the case of data irretrievably unlinked, the data may be used in accordance with domestic law or following the consultation procedures set out in article 6(b), that is, consultation of an independent, multidisciplinary and pluralist ethics committee.

This article is the answer to the problem article 4(a)(iii) identifies: the significance of genetic data is not necessarily known at the time of collection, so a consent given for one purpose cannot be informed about a use that becomes possible later. The Declaration does not solve that by making consent perpetual, which would be fiction, nor by prohibiting further use, which would sterilise every archive. It requires fresh consent, or a law serving an important public interest, or, where neither is available, a committee.

Note the drafting of the prohibition: not any different purpose, but a different purpose incompatible with the original consent. A purpose that is different but compatible does not require the machinery, which leaves room for research that develops naturally from what was agreed.

Article 17: stored samples collected for other purposes

17(a). Stored biological samples collected for purposes other than those in article 5 may be used to produce genetic or proteomic data with the prior, free, informed and express consent of the person. However, domestic law may provide that where such data have significance for medical and scientific research purposes, for example epidemiological studies, or public health purposes, they may be used for those purposes following the consultation procedures in article 6(b).

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Chapter One Hundred Three

The Bioethics Declaration: Scope and Aims

Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."

In one line

The broadest of the three UNESCO instruments, addressed to States but reaching corporations, and the one a treaty body has adopted as its reference.

In the wording a student can write in an exam: the Universal Declaration on Bioethics and Human Rights 2005 addresses ethical issues related to medicine, life sciences and associated technologies as applied to human beings, taking into account their social, legal and environmental dimensions; it is addressed to States and, as appropriate, provides guidance to individuals, groups, communities, institutions and corporations, public and private; its aims include providing a universal framework of principles and procedures to guide legislation; and its principles open with article 3(2), that the interests and welfare of the individual should have priority over the sole interest of science or society.

Why this instrument matters most

Three reasons, and they should be given before the content.

Its scope is the widest. The 1997 Declaration concerns the genome; the 2003 Declaration concerns genetic data. This one concerns medicine, life sciences and associated technologies as applied to human beings, which covers everything in Module II and most of Module I.

It is addressed to States and reaches corporations. Article 1(2) is unusual and should be quoted: the Declaration is addressed to States, and as appropriate and relevant it also provides guidance to decisions or practices of individuals, groups, communities, institutions and corporations, public and private. Most instruments in this field address either States or professionals; this one names corporations expressly, which matters because, as [The State's Duty to Regulate Technology] explains, most of the technology is privately owned.

A treaty body has adopted it. General Comment 25's acceptability element requires that scientific research incorporate ethical standards to ensure its integrity and the respect of human dignity, and names the standards proposed in the Universal Declaration on Bioethics and Human Rights. That is the route by which this instrument enters article 15 of the ICESCR, described in [What Ethics Adds to Law], and no other instrument in this module has it.

Article 1: scope

1(1). The Declaration addresses ethical issues related to medicine, life sciences and associated technologies as applied to human beings, taking into account their social, legal and environmental dimensions.

Two phrases carry it. "As applied to human beings" confines the instrument: it is not a declaration about science generally but about science applied to people. And the naming of the social, legal and environmental dimensions makes plain that the ethical issue is not confined to the clinical encounter, which is why articles 16 and 17 reach future generations and the biosphere.

1(2). Addressed to States; and as appropriate and relevant, guidance for individuals, groups, communities, institutions and corporations, public and private.

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Chapter One Hundred Four

The Bioethics Declaration: the Core Principles

Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."

In one line

Eight articles that move outward from the individual decision to the community, and one of them says that culture may not be used to defeat the rest.

In the wording a student can write in an exam: articles 6 to 13 state the principles governing the person: consent in article 6, persons without the capacity to consent in article 7, human vulnerability and personal integrity in article 8, privacy and confidentiality in article 9, equality, justice and equity in article 10, non-discrimination and non-stigmatization in article 11, respect for cultural diversity and pluralism in article 12, and solidarity and cooperation in article 13; and article 12 contains the Declaration's most important qualification, that cultural considerations are not to be invoked to infringe dignity, human rights and fundamental freedoms, nor the Declaration's principles, nor to limit their scope.

Articles 6 to 8: recapitulated in order

These three are taken in full elsewhere and are placed here so that the Declaration's own structure is visible.

Article 6, consent. Preventive, diagnostic and therapeutic intervention only with the prior, free and informed consent of the person, based on adequate information, express where appropriate and withdrawable at any time and for any reason without disadvantage or prejudice; research requiring consent that is additionally express, on information in a comprehensible form including the modalities for withdrawal; and a collective community agreement or the consent of a community leader or other authority never substituting for an individual's informed consent.

Article 7, persons without the capacity to consent. Authorisation in accordance with best interest and domestic law, with the person involved to the greatest extent possible in consenting and withdrawing; research only for direct health benefit, save by way of exception, with the utmost restraint, at minimal risk and minimal burden, to benefit others in the same category; and refusal to be respected.

Article 8, vulnerability. Human vulnerability should be taken into account, and individuals and groups of special vulnerability should be protected and the personal integrity of such individuals respected.

Note the progression the Declaration builds: the competent person decides (6); the person who cannot decide is decided for, on a standard that keeps them involved (7); and the person who can decide but cannot decide freely is protected (8). Those are the three positions a person can occupy, and the instrument addresses each.

Article 9: privacy and confidentiality

The privacy of the persons concerned and the confidentiality of their personal information should be respected. To the greatest extent possible, such information should not be used or disclosed for purposes other than those for which it was collected or consented to, consistent with international law, in particular international human rights law.

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Chapter One Hundred Five

The Bioethics Declaration: Society and the Future

Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."

In one line

Four articles that widen the frame from the individual to society, to the generations after this one, and to the living world they will need.

In the wording a student can write in an exam: article 14 makes the promotion of health and social development a central purpose of governments shared by all sectors of society, and lists five things that progress in science and technology should advance; article 15 requires that benefits be shared with society as a whole and the international community, in particular with developing countries, and that benefits not constitute improper inducements to participate in research; article 16 requires that the impact of life sciences on future generations, including on their genetic constitution, be given due regard; and article 17 requires due regard for the interconnection between human beings and other forms of life and for the protection of the biosphere and biodiversity.

Article 14: social responsibility and health

14(1). The promotion of health and social development for their people is a central purpose of governments that all sectors of society share.

Note the two halves. It is a central purpose of governments, so the obligation is placed on the State; and it is one that all sectors of society share, which reaches the private sector without pretending to bind it.

14(2). Taking into account that the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition, progress in science and technology should advance:

  • (a) access to quality health care and essential medicines, especially for the health of women and children, because health is essential to life itself and must be considered to be a social and human good;
  • (b) access to adequate nutrition and water;
  • (c) improvement of living conditions and the environment;
  • (d) elimination of the marginalization and the exclusion of persons on the basis of any grounds;
  • (e) reduction of poverty and illiteracy.

This is the most striking provision in the Declaration and it should be read carefully, because it is not the provision a reader expects in a bioethics instrument.

It states a direction for science itself. Not what science may not do, but what progress in science and technology should advance. That is a purposive obligation of the kind stated in article 12(b) of the 1997 Declaration, that applications shall seek to offer relief from suffering.

Three of the five items are not medical at all. Nutrition and water, living conditions and the environment, and poverty and illiteracy. The article treats those as the proper objects of scientific progress, which is the recognition that health is produced by conditions rather than by clinics, the same reasoning that underlies article 3 of the 1997 Declaration and section 3(3) of the MTP Act's reference to the woman's actual or reasonably foreseeable environment.

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Chapter One Hundred Six

The Bioethics Declaration: Applying the Principles

Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."

In one line

Four articles on how the principles are to be worked: how decisions are made, who reviews them, how risk is handled, and what happens when the activity crosses a border.

Their heading in the Declaration is APPLICATION OF THE PRINCIPLES, and that heading matters. Articles 3 to 17 say what is owed. Articles 18 to 21 say through what process the saying is made real, which is why an examiner asking "how is the Declaration applied?" is asking about exactly these four.

Article 18: decision-making and addressing bioethical issues

18(1). Professionalism, honesty, integrity and transparency in decision-making should be promoted, in particular declarations of all conflicts of interest and appropriate sharing of knowledge. Every endeavour should be made to use the best available scientific knowledge and methodology in addressing and periodically reviewing bioethical issues.

18(2). Persons and professionals concerned and society as a whole should be engaged in dialogue on a regular basis.

18(3). Opportunities for informed pluralistic public debate, seeking the expression of all relevant opinions, should be promoted.

Four things are worth pulling out.

Conflicts of interest are named. The article does not merely commend integrity; it specifies declarations of all conflicts of interest as the particular way integrity is shown, which is the point made in [Registration, Publication and Research Integrity].

The best available scientific knowledge is a requirement of ethics, not only of science. An ethical decision taken on out-of-date evidence is not merely a scientific failure; the article makes it an ethical one, and paragraph 4 of the Declaration of Helsinki takes the same view when it makes medical research subject to standards that promote and ensure respect.

Bioethical issues are to be reviewed periodically. The obligation does not close when a decision is taken, because the state of knowledge moves.

And paragraphs (2) and (3) make the public a participant. Not merely informed, and not merely consulted at the end: engaged in dialogue on a regular basis, with informed pluralistic public debate seeking the expression of all relevant opinions. That is a demanding standard, and it is the ground of the point in [What Ethics Adds to Law] that an ethical framework which is decided entirely by experts has no answer to the objection that it is a professional convenience.

Article 19: ethics committees

Independent, multidisciplinary and pluralist ethics committees should be established, promoted and supported at the appropriate level in order to:

  • (a) assess the relevant ethical, legal, scientific and social issues related to research projects involving human beings;
  • (b) provide advice on ethical problems in clinical settings;
  • (c) assess scientific and technological developments, formulate recommendations and contribute to the preparation of guidelines on issues within the scope of the Declaration;
  • (d) foster debate, education and public awareness of, and engagement in, bioethics.

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Chapter One Hundred Seven

The Bioethics Declaration: Promotion and Final Provisions

Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."

In one line

Four articles on how the Declaration is to be promoted, and three on how it is to be read.

Articles 22 to 25 are printed under PROMOTION OF THE DECLARATION and are addressed to States and to UNESCO. Articles 26 to 28 are printed under FINAL PROVISIONS and are addressed to whoever is applying the instrument: read it as a whole, limit it only by law and only on stated grounds, and never read it as authorising an act contrary to human rights.

Article 22: role of States

22(1). States should take all appropriate measures, whether of a legislative, administrative or other character, to give effect to the principles set out in the Declaration in accordance with international human rights law. Such measures should be supported by action in the spheres of education, training and public information.

22(2). States should encourage the establishment of independent, multidisciplinary and pluralist ethics committees, as set out in Article 19.

The formula in 22(1) is the standard implementation clause of human rights instruments, and it is worth recognising as such: legislative, administrative or other character is the same triad used in article 2(1) of the International Covenant on Economic, Social and Cultural Rights, which requires each State party to take steps by all appropriate means, including particularly the adoption of legislative measures.

Two things about it here.

"In accordance with international human rights law" subordinates the Declaration to the treaties. This is not an independent regime; the measures are to give effect to the principles within the existing human rights framework, which is the same move article 26 of the 1997 genome Declaration makes and the reason [The Bioethics Declaration: Scope and Aims] treats aim (a) as the key to the whole instrument.

Paragraph (2) converts article 19 into a State obligation. Article 19 says committees should be established, promoted and supported, without saying by whom. Article 22(2) supplies the answer for the ordinary case, and it repeats all three adjectives rather than referring back loosely, which means a State that encourages committees composed only of scientists has not done what 22(2) asks.

Article 23: bioethics education, training and information

23(1). In order to promote the principles and to achieve a better understanding of the ethical implications of scientific and technological developments, in particular for young people, States should endeavour to foster bioethics education and training at all levels and to encourage information and knowledge dissemination programmes about bioethics.

23(2). States should encourage the participation of international and regional intergovernmental organizations and of international, regional and national non governmental organizations in this endeavour.

The phrase in particular for young people is worth noticing, because it is not decoration. The instruments in this module all address a technology that will be applied over a lifetime longer than the lifetime of the people who wrote them, and article 16 has already required regard for future generations. Education of the young is the only mechanism in the Declaration that acts on those generations directly rather than on their inheritance.

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Chapter One Hundred Eight

Benefit Sharing, Biopiracy and Traditional Knowledge

Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."

In one line

When a community has known for centuries that a plant heals, and somebody else patents the healing, the law has to decide whether anything was taken and, if it was, from whom.

In the wording a student can write in an exam: benefit sharing is the principle that those from whom a scientific advance was derived, whether as research participants, as a source population or as the holders of the knowledge that made the advance possible, are entitled to share in what results from it; traditional knowledge is knowledge of nature, species and their properties held and transmitted by a local, traditional or indigenous community; and biopiracy is the appropriation of a biological resource or of traditional knowledge, commonly by the grant of an intellectual property right over it, without the consent of the community that holds it and without sharing the benefit.

Why the law has this at all

Benefit sharing as it appears in [Benefit Sharing] and in [Research Carried Out in Developing Countries] answers a question about contribution: a population bore the burden of the research, so a population should share in the result. This chapter is about a harder case.

Here the community did not take part in the research. It did something earlier and larger: it produced the knowledge that made the research possible. The relationship is not that of a participant to a trial but of an author to a work, and the difficulty is that the intellectual property system was not built to recognise an author of that kind.

Three features of the system produce the mismatch.

A patent requires novelty, and the system decides what counts as known. Knowledge that has been written in a Sanskrit text or spoken in a village for four hundred years is, in fact, old. Whether it is prior art depends on whether the patent office can find it, and a patent office searching journals in European languages will not.

A patent requires an inventor, and traditional knowledge has none. It is held collectively and transmitted across generations, so there is nobody to name on the application and nobody whose twenty-year monopoly is about to expire.

And the system is territorial while the knowledge is not. A patent granted in one country over knowledge held in another is granted by an office that owes the holders nothing and may never hear of them.

The consequence is that the ordinary operation of a neutral system transfers value in one direction. That is why the subject appears in a human rights paper at all: not because a patent office acts in bad faith, but because a rule of general application produces a systematically unequal result, which is the same structure identified in [Equality and the Digital Divide].

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Chapter One Hundred Nine

Precaution, Risk and Dual-Use Research

Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."

In one line

Some research produces knowledge that is useful and dangerous in the same sentence, and the ethical question is not only whether to do it but whether to say what was found.

In the wording a student can write in an exam: dual-use research is research whose knowledge, methods or products can reasonably be anticipated to be applied both beneficially and harmfully; risk assessment and management under article 20 of the 2005 Declaration is the discipline that applies where the risk can be estimated; and the precautionary principle applies where it cannot, requiring that measures be taken to avoid or diminish unacceptable harm notwithstanding the absence of full scientific certainty. The three ideas are commonly run together in an answer, and they should not be.

Why the law has this at all

[Dual Use: the Same Technology Both Ways] establishes the general point: the same knowledge cuts both ways, so a legal framework built on classifying technologies as good or bad fails, and the analysis must be of uses, actors and safeguards.

This chapter is about what that means at the point where research is done and written up, and it is harder, for a reason worth stating precisely.

Every earlier control in this module operates on an application. A drug is tested before it is sold; a technique is regulated before it is used on a patient; a device is licensed before it is deployed. In each case the knowledge already exists and the question is what may be done with it.

Dual-use research raises the question one stage earlier. The harm is not in an application yet to be authorised but in the knowledge itself, which once published cannot be recalled. A control that operates on the application is therefore useless: by the time an application appears, the method that produced it is in the literature and in every laboratory that reads it.

That is why the subject reaches the ethics of publication, which nothing else in the module does, and why it sits uncomfortably in a human rights framework whose default is that knowledge should be shared as widely as possible.

Three ideas that must be kept apart

An answer that distinguishes these three is worth far more than one that treats them as a single principle.

When it appliesWhat it asksWhere it is stated
Risk assessment and managementThe harm can be identified and its likelihood estimatedAssess it, then manage it; residual risk may be acceptedArticle 20 of the 2005 Declaration
The precautionary principleThere is a credible threat of unacceptable harm and the science is not settledAct anyway; the cost of uncertainty falls on the proponentGeneral Comment 25, in the section on participation and the precautionary principle
Dual-use concernThe harm depends on who uses the knowledge and how, not on whether it is well understoodConsider the misuse before doing the work, and again before publishingArticle 21(5) of the 2005 Declaration; paragraph 81 of General Comment 25

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Chapter One Hundred Ten

The Ethics of Emerging Technology

Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."

In one line

The instruments in this module were written between 1947 and 2005, and the technologies that now raise the hardest questions did not exist when they were drafted, so the examinable skill is applying an old framework to a new thing rather than reciting either.

In the wording a student can write in an exam: an emerging technology raises three difficulties for the framework in this module. It may act on people who cannot consent because they do not yet exist; it may reach an interest the instruments never named, such as the contents of a mind; and it may make decisions without a decision-maker, so that no duty-bearer is identifiable. The method for handling all three is in [How a Technology Becomes a Rights Question], and this chapter applies it.

Why the law has this at all

A framework of principles has one advantage over a framework of rules, and it is exactly the advantage this subject needs: a principle applies to a thing its drafters never saw.

Article 6 of the 2005 Declaration requires prior, free, express and informed consent to any preventive, diagnostic and therapeutic medical intervention. Nothing in it depends on knowing what interventions are possible, so it governs a technique invented next year as readily as one invented in 1960. That is why article 26 requires the Declaration to be read as a whole, and why article 11 of the 1997 Declaration prohibits practices which are contrary to human dignity, such as reproductive cloning of human beings: the class is stated, the example is illustrative, and the class can take in members nobody had thought of.

But the advantage has a limit, and the limit is the subject of this chapter. A principle reaches a new technology only if the new technology's harm falls within an interest the framework already recognises. Where it does not, the framework is silent, and the honest answer to an examination question is to say where the silence begins.

Gene editing

What is new. Techniques that make precise, cheap and reliable changes to a genome. Editing a somatic cell changes the person treated. Editing the germ line, an embryo or a gamete, changes every descendant.

What the framework already says. More than students expect, and it is a mistake to say the instruments are silent.

  • Article 16 of the 2005 Declaration: the impact of the life sciences on future generations, including on their genetic constitution, is to be given due regard. This is the textual anchor, and it is worked in [The Bioethics Declaration: Society and the Future].
  • Article 24 of the 1997 Declaration: the International Bioethics Committee is to give advice on the identification of practices that could be contrary to human dignity, such as germ-line interventions. The example is named.
  • Article 11 of the 1997 Declaration: practices contrary to human dignity shall not be permitted, the class being open.
  • Article 5 of the 1997 Declaration: research, treatment or diagnosis affecting the genome is to be undertaken only after rigorous prior assessment of the risks and benefits, with prior, free and informed consent, and where a person is unable to consent, only for direct health benefit subject to authorisation and protections. [Research on the Genome and Its Limits] works this.

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Module IV

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Chapter One Hundred Eleven

The Information Society and Human Rights

Syllabus topic 5, "Development in information and Human Rights Cyber Terrorism."

In one line

When information became the thing that is produced, stored, moved and sold, every right that depends on what other people know about you changed its shape.

In the wording a student can write in an exam: the information society is a society in which the generation, processing and transmission of information become the principal source of productivity and power, so that the ordinary conditions of life, work, government and association are mediated by information systems. Its arrival is a human rights event because rights that were previously limited by the cost of knowing are no longer limited at all: the practical protection a person once had from being watched, recorded, identified, ranked or silenced came from the expense and difficulty of doing those things, and that protection has gone.

Why the law has this at all

The whole of this book is built on the proposition stated in [What This Paper Is About]: a technology changes what is possible, and the law then has to decide a question it did not have to decide before. Module II showed it in medicine, one statute at a time. Module IV shows it in information, and the difference is one of scale.

Consider what protected privacy before the information society, and notice that none of it was law.

Records were on paper, so finding one was work. A file existed in one place, and consulting it meant going there. The cost of retrieval was itself a limit on how often anybody was looked up.

Records did not combine. A hospital knew what a hospital knew, an employer what an employer knew. Bringing two files together required somebody to decide to do it and then do it by hand.

Records decayed. Paper was lost, misfiled and destroyed, and a thing forgotten was, in practice, gone.

And speech reached as far as the speaker could be heard. A defamatory remark in a village stayed in the village; a pamphlet reached those who were handed one.

Every one of those limits was practical, not legal, and every one of them has been removed. Retrieval is instant, records combine by default, storage is cheaper than deletion, and a sentence typed by anyone can reach everyone. The law of privacy, of reputation, of speech and of equality was written against the background of those limits, and it now has to do without them.

That is the proposition Module IV works out, and it has two directions, exactly as [Dual Use: the Same Technology Both Ways] would predict. The same removal of cost that lets a State watch a population lets a citizen demand the State's records; the same reach that spreads a lie spreads the correction; the same identification system that excludes people from a ration shop is the thing that got them onto the list.

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Chapter One Hundred Twelve

Access to the Internet

Syllabus topic 5, "Development in information and Human Rights Cyber Terrorism."

In one line

Indian law protects what you do on the internet, not the internet itself, and the difference decides every problem on this topic.

In the wording a student can write in an exam: the Supreme Court has declared that the freedom of speech and expression and the freedom to practise any profession or carry on any trade, business or occupation over the medium of the internet enjoy constitutional protection under articles 19(1)(a) and 19(1)(g), restriction on which must conform to articles 19(2) and 19(6) including the test of proportionality; the Kerala High Court has held that the right to have access to the internet becomes part of the right to education as well as of the right to privacy under article 21. Neither declares a free-standing fundamental right to the internet, and the accurate proposition is that the internet is a medium through which existing rights are exercised, so a restriction on the medium is a restriction on those rights and must be justified as such.

Why the law has this at all

Two reasons, and they are different.

The first is doctrinal. A right of expression is worth what its medium is worth. If the State may close the medium at will, the right survives in form and disappears in fact, which is why article 19(1)(a) was held from early on to protect the means of circulation and not merely the act of speaking. The internet is now the medium through which a very large part of expression, work, education and commerce is conducted, so a power to switch it off is a power over all of them at once.

The second is practical, and it is the digital divide. [Equality and the Digital Divide] establishes that technology multiplies existing inequality. Access is where that happens first: when banking, welfare, admission, employment and the courts are reached through a network, a person without access is not merely inconvenienced but excluded from ordinary participation, and the WSIS Declaration's paragraph 10 commitment to turn the digital divide into a digital opportunity for all is the international statement of the same point.

The Indian position, stated exactly

Anuradha Bhasin v. Union of India

Facts. On and after 4 August 2019 the Government of Jammu and Kashmir restricted movement under section 144 of the Code of Criminal Procedure and suspended mobile, internet and landline services across the territory. The editor of a newspaper published from Srinagar petitioned that the suspension prevented the press from working, and a Member of Parliament petitioned on the restrictions generally. The suspension orders had been made under the Temporary Suspension of Telecom Services (Public Emergency or Public Safety) Rules 2017, framed under the Indian Telegraph Act 1885, and most of them had not been published.

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Chapter One Hundred Thirteen

The Right to Information

Syllabus topic 5, "Development in information and Human Rights Cyber Terrorism."

In one line

Every citizen may ask a public authority for any record it holds, need give no reason for asking, and must be answered in thirty days.

In the wording a student can write in an exam: the Right to Information Act 2005 creates a practical regime by which all citizens have the right to information held by or under the control of a public authority, exercisable by a written or electronic request that need state no reason, answerable within thirty days and within forty-eight hours where the information concerns the life or liberty of a person, subject to the exemptions in sections 8 and 9, which are themselves subject to a public interest override in section 8(2) that operates notwithstanding the Official Secrets Act 1923.

Why the law has this at all

The preamble states it better than a paraphrase can. The Constitution has established a democratic Republic, and democracy requires an informed citizenry and transparency of information which are vital to its functioning and also to contain corruption and to hold Governments and their instrumentalities accountable to the governed.

Three things follow, and they organise the whole Act.

Information is held on behalf of the people, not owned by the office holding it. That is why section 6(2) forbids asking the applicant why they want it: an owner may ask a borrower's purpose, a custodian may not.

The default is disclosure and the exemption is the exception. Sections 8 and 9 are drafted as departures from a right stated first in section 3, which is the opposite of the Official Secrets Act structure the Act displaced, and section 22 gives the Act overriding effect over that Act and over any other law.

And accountability is the object, so the machinery has teeth. Section 20 imposes a personal penalty on the officer, not on the department, and puts the burden of justification on the officer.

For this paper the Act matters because it is the counter-current identified in [The Information Society and Human Rights]: the same collapse in the cost of storing and retrieving information that lets a State watch a population is what makes it feasible for a citizen to demand a record and be given it in thirty days. A book that treats information technology only as a threat to rights has missed the statute that turns it into a remedy.

The scheme of the Act

Who may ask, and for what

Section 3. Subject to the provisions of the Act, all citizens shall have the right to information. Note citizens: the Act does not extend the right to non-citizens, which is unusual among the rights in this book.

Section 2(f). Information means any material in any form, including records, documents, memos, e-mails, opinions, advices, press releases, circulars, orders, logbooks, contracts, reports, papers, samples, models, data material held in any electronic form and information relating to a private body which can be accessed by a public authority under any other law. The list is deliberately long and expressly reaches opinions and advices, which is what makes file notings arguable, and it reaches private bodies indirectly.

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Chapter One Hundred Fourteen

Privacy as a Fundamental Right

Syllabus topic 5, "Development in information and Human Rights Cyber Terrorism."

In one line

Nine judges held in 2017 that privacy is protected by the Constitution, and they did so because a technology had made the question impossible to avoid.

In the wording a student can write in an exam: in Justice K.S. Puttaswamy (Retd.) v. Union of India the Supreme Court, sitting in nine judges, over-ruled M P Sharma and, to the extent that it so held, Kharak Singh, and declared that the right to privacy is protected as an intrinsic part of the right to life and personal liberty under Article 21 and as a part of the freedoms guaranteed by Part III of the Constitution.

Why the question arose when it did

Privacy had been argued in India for sixty years without being settled, and it was settled in 2017 for the reason this whole book is about: a technology was built, and the question could no longer be postponed.

Facts. A Bench of three judges hearing the challenge to the Aadhaar scheme recorded, by its order of 11 August 2015, that the norms for and the compilation of demographic and biometric data by the Government were being questioned as a violation of the right to privacy. The Attorney General argued that the existence of a fundamental right of privacy was itself in doubt, relying on observations in M P Sharma and Kharak Singh, decisions of eight and six judges. The petitioners answered that both rested on an approach later held not to be good law. Because the decisions that had since recognised privacy were given by smaller Benches, the question was referred upwards, and on 18 July 2017 a Constitution Bench directed that it be placed before nine judges.

Notice the shape of that. Nobody asked the Court an abstract question about privacy. A biometric identification programme was built, and the argument that there was no right for it to infringe made the anterior question unavoidable. That is the proposition of [How a Technology Becomes a Rights Question] happening in a courtroom.

What the Court decided

Held. Justice K.S. Puttaswamy (Retd.) v. Union of India, AIR 2017 SC 4161, decided on 24 August 2017 by nine judges, disposed of the reference in four terms. The decision in M P Sharma, which holds that the right to privacy is not protected by the Constitution, stands over-ruled. The decision in Kharak Singh stands over-ruled to the extent that it so holds. The right to privacy is protected as an intrinsic part of the right to life and personal liberty under Article 21 and as a part of the freedoms guaranteed by Part III of the Constitution. Decisions subsequent to Kharak Singh which have enunciated that position lay down the correct position in law.

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Chapter One Hundred Fifteen

Informational Privacy and the Proportionality Test

Syllabus topic 5, "Development in information and Human Rights Cyber Terrorism."

In one line

Any State interference with privacy has to be authorised by law, aimed at something legitimate, and no heavier than the aim requires; and it is the last of those three that decides real cases.

In the wording a student can write in an exam: informational privacy is the interest a person has in controlling the dissemination of information about themselves, which the 2017 judgment identifies as one of the three zones of privacy alongside spatial privacy and privacy of choice; and the proportionality test by which an interference with it is judged has, in the form the 2018 Bench applied, four parts: the measure must be designated for a proper purpose; the measures undertaken must be rationally connected to the fulfilment of the purpose; there must be no alternative less invasive measures; and there must be a proper relation between the importance of achieving the aim and the importance of limiting the right.

Why the test exists

A right that cannot be limited is a right nobody will apply, and a right that can be limited for any reason is not a right. Every constitutional system therefore needs a way of deciding when a limitation is acceptable, and there are only two candidates.

A categorical rule says what may never be done. It is predictable and it is brittle: it either forbids things that ought to be permitted in an emergency, or it is drafted so loosely that it forbids nothing.

A structured balancing test asks a series of questions in a fixed order. It is less predictable and much more useful, because it can take in a technology nobody had thought of, and because it forces the State to say what it is doing and why, which is itself a discipline.

India took the second, and the reason it matters for this paper is that informational privacy is exactly the interest a categorical rule cannot protect. There is no class of data that must never be collected and no purpose for which data may never be used; the wrong is always in the relation between how much was taken, from whom, for what, and for how long. Only a proportionality test can express that.

The three-fold requirement and the four-part test

Students routinely confuse these two, and the confusion is easy to remove: they are the same test at different levels of detail.

The three-fold requirement, from the 2017 judgment, is the frame: an invasion of life or personal liberty must meet (i) legality, which postulates the existence of law; (ii) need, defined in terms of a legitimate state aim; and (iii) proportionality which ensures a rational nexus between the objects and the means adopted to achieve them.

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Chapter One Hundred Seventeen

Data Protection: Duties of the Data Fiduciary

Syllabus topic 5, "Development in information and Human Rights Cyber Terrorism."

In one line

Whoever decides what is done with your data is answerable for it, cannot contract out of that, and must delete it when the reason for holding it has gone.

In the wording a student can write in an exam: a Data Fiduciary, defined in section 2(i) as any person who alone or in conjunction with other persons determines the purpose and means of processing of personal data, is by section 8(1) responsible for complying with the Act in respect of any processing undertaken by it or on its behalf by a Data Processor, irrespective of any agreement to the contrary or failure of a Data Principal to carry out the duties provided under this Act; must take reasonable security safeguards to prevent personal data breach; must intimate the Board and each affected Data Principal of a breach; and must erase personal data when consent is withdrawn or the specified purpose is no longer served, whichever is earlier.

Why the word "fiduciary"

The choice of word is deliberate and it is worth a paragraph in any answer.

A controller, which is the term used in comparable statutes elsewhere, describes a fact: this person decides what happens to the data. A fiduciary describes a relationship: this person holds something for another and must act in that other's interest. The word carries into the statute the idea that [The Doctor and the Patient] develops in Module II, where the relationship is unequal because one side knows and the other does not, and where the answer of the law is to impose duties that do not depend on what the weaker party agreed to.

Section 8(1) is where the choice of word becomes operative, because it makes the duty independent of two things a contractual model would treat as decisive: agreement to the contrary, and the other party's own default.

Section 8: the general obligations

8(1). Responsible for compliance irrespective of any agreement to the contrary or failure of a Data Principal to carry out the duties provided under this Act, in respect of processing undertaken by it or on its behalf by a Data Processor.

Two limbs, and both matter. The duty cannot be contracted away, which answers the terms of service that purport to disclaim liability. And it survives the Data Principal's own default, which is a striking provision because section 15 imposes duties on the Data Principal and the Schedule fines her up to ten thousand rupees for breaching them: she may be penalised for her breach, and the fiduciary is still liable for its own.

8(2). A Data Processor may be engaged to process on the fiduciary's behalf, for any activity related to offering goods or services, only under a valid contract.

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Chapter One Hundred Eighteen

Data Protection: Rights and Duties of the Data Principal

Syllabus topic 5, "Development in information and Human Rights Cyber Terrorism."

In one line

Four rights, all of them exercisable only against a fiduciary you have dealt with, and a section of duties that makes the individual the only person in the Act who can be fined for what she says about herself.

In the wording a student can write in an exam: Chapter III gives the Data Principal a right to access information about her personal data (section 11), a right to correction, completion, updating and erasure (section 12), a right to grievance redressal, which she must exhaust before approaching the Board (section 13), and a right to nominate another individual to exercise her rights on her death or incapacity (section 14); and section 15 imposes duties on her, breach of which the Schedule penalises up to ten thousand rupees.

Section 11: access

11(1). The Data Principal has the right to obtain, from a fiduciary to whom she has previously given consent, including consent as referred to in section 7(a), upon a request in the prescribed manner:

  • (a) a summary of personal data which is being processed by that fiduciary and the processing activities undertaken with respect to it;
  • (b) the identities of all other Data Fiduciaries and Data Processors with whom the personal data has been shared, along with a description of the personal data so shared; and
  • (c) any other information related to her personal data and its processing, as prescribed.

11(2). Clauses (b) and (c) do not apply to sharing with another Data Fiduciary authorised by law to obtain such personal data, where the sharing is pursuant to a request made in writing by that other fiduciary for the purpose of prevention or detection or investigation of offences or cyber incidents, or for prosecution or punishment of offences.

Three things are worth pulling out.

The right is a right to a summary, not to a copy. Comparable statutes give a right of access to the data itself. This gives a summary of the data and of the processing activities, which is less, and the difference is the sort of thing an examiner asks about.

Clause (b) is the strongest provision in the chapter, because it makes the onward chain visible. Knowing who else has your data is the precondition of doing anything about it, and without clause (b) a person cannot even identify the fiduciaries against whom to exercise the other rights.

And 11(2) removes exactly that visibility for law enforcement sharing. The exception is drawn on the recipient (authorised by law to obtain), the form (a request in writing) and the purpose (prevention, detection, investigation, prosecution or punishment of offences or cyber incidents), so it is narrower than a blanket exemption. But its effect is that a person cannot learn that her data was given to the police, which is the point at which the interest in knowing is highest. Read it with [Surveillance, Interception and Monitoring].

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Chapter One Hundred Nineteen

Data Protection: Exemptions and the Board

Syllabus topic 5, "Development in information and Human Rights Cyber Terrorism."

In one line

The Act says who does not have to obey it, and then creates the body that decides whether everybody else has.

In the wording a student can write in an exam: section 16 permits the Central Government to restrict the transfer of personal data to a notified country or territory; section 17(1) exempts six kinds of processing from most of the Act; section 17(2)(a) permits the Central Government to notify an instrumentality of the State in respect of which the provisions of this Act shall not apply at all, on grounds of sovereignty and integrity of India, security of the State, friendly relations with foreign States, maintenance of public order or preventing incitement to any cognizable offence relating to any of these; and sections 18 to 28 establish the Data Protection Board of India, a body corporate whose Chairperson and Members are appointed by the Central Government for a term of two years and are eligible for re-appointment.

Section 16: transfer outside India

16(1). The Central Government may, by notification, restrict the transfer of personal data by a Data Fiduciary for processing to such country or territory outside India as may be so notified.

16(2). Nothing in the section restricts the application of any other law providing a higher degree of protection for or restriction on transfer.

The drafting is a blacklist, and that is the point to make. Comparable regimes work by whitelist: transfer is prohibited unless the destination has been assessed as adequate. Here transfer is permitted unless the destination has been notified as restricted, so the default is free flow and the burden of acting falls on the Government. Sector regulators may still impose stricter rules, which section 16(2) preserves, and the localisation requirements imposed by the financial and telecom regulators are the practical example.

Section 17(1): the six exemptions from Chapters II and III

Where any of these applies, the provisions of Chapter II except sections 8(1) and 8(5), the whole of Chapter III, and section 16 do not apply:

  • (a) processing necessary for enforcing any legal right or claim;
  • (b) processing by any court or tribunal or any other body in India entrusted by law with a judicial, quasi-judicial, regulatory or supervisory function, where necessary for that function;
  • (c) processing in the interest of prevention, detection, investigation or prosecution of any offence or contravention of any law;
  • (d) processing of the data of Data Principals not within the territory of India pursuant to a contract with a person outside India by a person based in India;
  • (e) processing necessary for a scheme of compromise, arrangement, merger, amalgamation, reconstruction, demerger, transfer of undertaking or division approved by a court, tribunal or competent authority;
  • (f) processing to ascertain the financial information, assets and liabilities of a person who has defaulted on a loan or advance from a financial institution, subject to the disclosure provisions of other law.

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Chapter One Hundred Twenty

Data Protection: Penalties, Appeals and the Rest of the Act

Syllabus topic 5, "Development in information and Human Rights Cyber Terrorism."

In one line

The Act has no offences and no compensation: everything is a money penalty imposed by an administrative body, appealable to a telecom tribunal, and the money goes to the Consolidated Fund.

In the wording a student can write in an exam: sections 31 to 34 provide for mediation, voluntary undertaking, monetary penalties determined by the Board on seven listed considerations and specified in the Schedule, and the crediting of penalties to the Consolidated Fund of India; sections 29 and 30 give an appeal to the Appellate Tribunal, which is the Telecom Disputes Settlement and Appellate Tribunal, whose orders are executable as a decree of a civil court; and sections 35 to 44 contain the miscellaneous provisions, of which section 39 bars the jurisdiction of civil courts and section 44 amends three other Acts.

Appeal: sections 29 and 30

Who hears it. Section 2(a) defines the Appellate Tribunal as the Telecom Disputes Settlement and Appellate Tribunal established under section 14 of the Telecom Regulatory Authority of India Act 1997, and section 44(1) amends that section so that the Tribunal's appellate jurisdiction expressly includes appeals under this Act.

29(1) to (3). Any person aggrieved by an order or direction made by the Board may appeal, within sixty days of receipt, in the prescribed form with the prescribed fee; the Tribunal may admit a late appeal on sufficient cause.

29(4) and (5). After hearing the parties the Tribunal may pass such orders as it thinks fit, confirming, modifying or setting aside the order appealed against, and shall send a copy to the Board and the parties.

29(6) and (7). Appeals to be dealt with as expeditiously as possible, with an endeavour to dispose of them within six months; where that is not done, the Tribunal shall record its reasons in writing.

29(8) to (10). Procedure as prescribed, without prejudice to sections 14A and 16 of the 1997 Act; a further appeal against the Tribunal's orders is governed by section 18 of that Act, which takes it to the Supreme Court; and the Tribunal shall, as far as practicable, function as a digital office, digital by design.

30. An order of the Tribunal is executable by it as a decree of a civil court, for which purpose it has all the powers of a civil court, and it may instead transmit the order to a civil court having local jurisdiction, which shall execute it as if it were its own decree.

The choice of forum is worth a comment. A data protection appeal goes to a tribunal constituted for telecom disputes, chosen because it exists rather than because of any subject-matter fit. It is the same economy that made the Consumer Protection Act's machinery available for medical services in [Medical Services Under Consumer Law]: an existing tribunal is cheaper than a new one, and the price is that the body hearing the appeal was designed for something else.

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Chapter One Hundred Twenty-One

Surveillance, Interception and Monitoring

Syllabus topic 5, "Development in information and Human Rights Cyber Terrorism."

In one line

Three powers in one Act: to read what is being sent, to stop the public seeing what was sent, and to watch the traffic without reading anything, and the safeguards for all three are in rules rather than in the statute.

In the wording a student can write in an exam: section 69 of the Information Technology Act 2000 permits the Central or a State Government, or an officer specially authorised, to direct any agency of the appropriate Government to intercept, monitor or decrypt any information transmitted, received or stored through any computer resource, if satisfied that it is necessary or expedient on one of seven listed grounds, for reasons to be recorded in writing, and subject to the procedure and safeguards prescribed under sub-section (2); section 69A permits the Central Government to direct any agency or intermediary to block for access by the public any information, on six grounds, again for recorded reasons and subject to prescribed procedure; and section 69B permits the Central Government by notification to authorise an agency to monitor and collect traffic data or information to enhance cyber security.

Section 69: interception, monitoring and decryption

69(1). Where the Central Government or a State Government, or any officer specially authorised by either, is satisfied that it is necessary or expedient to do so in the interest of:

  • the sovereignty or integrity of India,
  • defence of India,
  • security of the State,
  • friendly relations with foreign States,
  • public order,
  • preventing incitement to the commission of any cognizable offence relating to the above, or
  • investigation of any offence,

it may, subject to sub-section (2) and for reasons to be recorded in writing, by order, direct any agency of the appropriate Government to intercept, monitor or decrypt any information transmitted, received or stored through any computer resource.

69(2). The procedure and safeguards subject to which interception, monitoring or decryption may be carried out shall be such as may be prescribed.

69(3). The subscriber or intermediary or any person in charge of the computer resource shall, when called upon, extend all facilities and technical assistance to (a) provide or secure access to the computer resource, (b) intercept, monitor or decrypt, or (c) provide information stored in the computer resource.

69(4). Failure to assist is punishable with imprisonment up to seven years and fine.

Four features deserve separate notice, because each is a point in an answer.

The seventh ground is the wide one. Six of the seven grounds are the article 19(2) grounds, which is deliberate: they are the grounds on which speech may be restricted. The seventh, investigation of any offence, is not in article 19(2) at all, and it is not confined to serious offences, to cognizable offences or to offences of any particular class. So the same power that is available for the security of the State is available for the investigation of any offence whatever.

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Chapter One Hundred Twenty-Two

Speech Online and Its Limits

Syllabus topic 5, "Development in information and Human Rights Cyber Terrorism."

In one line

The Supreme Court struck down the provision that made it an offence to send a grossly offensive or annoying message, and the reasons it gave are the test for every speech restriction online.

In the wording a student can write in an exam: in Shreya Singhal v. Union of India the Supreme Court held that section 66A of the Information Technology Act 2000 is struck down in its entirety being violative of Article 19(1)(a) and not saved under Article 19(2); that section 69A and the Blocking Rules 2009 are constitutionally valid; and that section 79 is valid subject to section 79(3)(b) being read down so that an intermediary loses its immunity only on actual knowledge from a court order or on being notified by the appropriate government or its agency that unlawful acts relatable to Article 19(2) are going to be committed and then fails to act.

What section 66A said, and the fact that it is void

Facts. Section 66A was inserted by the amendment of 2008. It punished a person who sent, by means of a computer resource or a communication device, (a) any information that is grossly offensive or has menacing character; (b) any information which he knows to be false, but for the purpose of causing annoyance, inconvenience, danger, obstruction, insult, injury, criminal intimidation, enmity, hatred or ill will, persistently makes by making use of such computer resource or a communication device; or (c) any electronic mail or electronic mail message for the purpose of causing annoyance or inconvenience or to deceive or to mislead the addressee or recipient about the origin of such messages. The punishment was imprisonment which may extend to three years and fine. Arrests followed for posts and messages of a kind that would not have been actionable in any other medium, and the constitutional validity of the section was challenged in a batch of writ petitions.

Held. Shreya Singhal v. Union of India, AIR 2015 SC 1523, decided on 24 March 2015 by Chelameswar and Nariman JJ, summarised its own conclusions in four propositions. Section 66A of the Information Technology Act, 2000 is struck down in its entirety being violative of Article 19(1)(a) and not saved under Article 19(2). Section 69A and the Information Technology (Procedure and Safeguards for Blocking for Access of Information by Public) Rules 2009 are constitutionally valid. Section 79 is valid subject to Section 79(3)(b) being read down to mean that an intermediary upon receiving actual knowledge from a court order or on being notified by the appropriate government or its agency that unlawful acts relatable to Article 19(2) are going to be committed then fails to expeditiously remove or disable access to such material, and the Intermediary Guidelines Rules 2011 are valid subject to rule 3(4) being read down in the same manner. Section 118(d) of the Kerala Police Act is struck down as violative of article 19(1)(a) and not saved by article 19(2).

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Chapter One Hundred Twenty-Three

Intermediaries, Safe Harbour and Takedown

Syllabus topic 5, "Development in information and Human Rights Cyber Terrorism."

In one line

A platform is not liable for what its users post, so long as it stays passive, does what it is told by a court or the Government, and follows the rules; and the question the whole subject turns on is who decides what comes down.

In the wording a student can write in an exam: section 79(1) of the Information Technology Act 2000 provides that an intermediary shall not be liable for any third party information, data, or communication link hosted by him; section 79(2) makes that immunity conditional on the intermediary's function being limited to providing access, or on its not initiating the transmission, selecting the receiver or selecting or modifying the information, and on its observing due diligence and such guidelines as the Central Government may prescribe; and section 79(3) withdraws the immunity where the intermediary conspired, abetted, aided or induced the unlawful act, or where, upon receiving actual knowledge, it fails to expeditiously remove or disable access to the material, that second limb being read down in Shreya Singhal v. Union of India to a court order or a notification by the appropriate government or its agency confined to unlawful acts relatable to Article 19(2).

Why safe harbour exists

An intermediary carries other people's speech. If it were liable for everything it carried, it would face an impossible choice: read everything, which is not possible at scale, or remove everything complained of, which is censorship performed by a private company with no interest in the speaker's rights and every interest in avoiding liability.

Safe harbour solves that by making liability conditional on behaviour rather than on content. The platform is immune while it stays passive; it becomes liable when it participates in the wrong or when it defies a lawful order. That structure is what keeps the decision about lawfulness with a court or the State rather than with a company.

Which is exactly why the read-down in Shreya Singhal matters so much. Section 79(3)(b) as enacted removed the immunity upon receiving actual knowledge, and if a complaint were actual knowledge, then every complaint would force the platform to decide lawfulness on pain of liability, and the rational response would be to remove first and ask nothing. The Court's reading down puts the decision back where it belongs.

Section 79 in terms

79(1). Notwithstanding anything contained in any law for the time being in force but subject to sub-sections (2) and (3), an intermediary shall not be liable for any third party information, data, or communication link hosted by him. The Explanation defines third party information as any information dealt with by an intermediary in his capacity as an intermediary.

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Chapter One Hundred Twenty-Four

Internet Shutdowns

Syllabus topic 5, "Development in information and Human Rights Cyber Terrorism."

In one line

A government may switch the network off, but only by a published order, on stated reasons, for a defined area, for no more than fifteen days, and only if the object cannot be achieved by any other reasonable means.

In the wording a student can write in an exam: in Anuradha Bhasin v. Union of India the Supreme Court held that an order suspending internet services indefinitely is impermissible, that suspension can be utilized for temporary duration only, that any such order must adhere to the principle of proportionality and must not extend beyond necessary duration, that it is subject to judicial review, and that all orders in force must be published so as to enable the affected persons to challenge it; and the Telecommunications (Temporary Suspension of Services) Rules 2024, made under section 20(2)(b) of the Telecommunications Act 2023 and in supersession of the Temporary Suspension of Telecom Services (Public Emergency or Public Safety) Rules 2017, now require a suspension order to be published, to clearly state the reasons, to be limited to a clearly defined geographical area, a specified type of telecommunication service and a specified duration, not exceeding fifteen days, and to be made only where the authority has considered that the objectives cannot be achieved by any other reasonable means.

The case

Facts. On and after 4 August 2019 the Government of Jammu and Kashmir restricted movement under section 144 of the Code of Criminal Procedure and suspended mobile, internet and landline services across the territory. The editor of a newspaper published from Srinagar petitioned that the suspension prevented the press from working, and a Member of Parliament petitioned against the restrictions generally. The suspension orders had been made under the Temporary Suspension of Telecom Services (Public Emergency or Public Safety) Rules 2017, framed under the Indian Telegraph Act 1885, and most of them had not been published.

Held. Anuradha Bhasin v. Union of India, AIR 2020 SC 1308, decided on 10 January 2020 by Ramana, Subhash Reddy and Gavai JJ, issued fifteen directions. Those on the internet are:

  • the State is directed to publish all orders in force and any future orders under section 144 and for the suspension of telecom services, including internet, to enable the affected persons to challenge it before the High Court or appropriate forum;
  • the Court declares that the freedom of speech and expression and the freedom to practice any profession or carry on any trade, business or occupation over the medium of internet enjoys constitutional protection under Article 19(1)(a) and Article 19(1)(g), restriction being subject to Article 19(2) and (6), inclusive of the test of proportionality;
  • an order suspending internet services indefinitely is impermissible under the Suspension Rules and suspension can be utilized for temporary duration only;
  • any such order must adhere to the principle of proportionality and must not extend beyond necessary duration;
  • any such order is subject to judicial review;
  • because the Rules then provided neither a periodic review nor a time limitation, the Review Committee constituted under Rule 2(5) must conduct a periodic review within seven working days of the previous review;
  • the State is directed to review all orders suspending internet services forthwith, and orders not in accordance with the law laid down must be revoked; and
  • the State is to consider forthwith allowing government websites, localized or limited e-banking facilities, hospitals services and other essential services in regions where services are not likely to be restored immediately.

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Chapter One Hundred Twenty-Five

Cybercrime: the Scheme of the IT Act

Syllabus topic 5, "Development in information and Human Rights Cyber Terrorism."

In one line

The Act has two enforcement systems running side by side: an administrative one that compensates, and a criminal one that punishes, and the 2008 amendment built almost the whole of the second.

In the wording a student can write in an exam: Chapter IX of the Information Technology Act 2000 provides for penalties, compensation and adjudication, under which a contravention is adjudged by an adjudicating officer not below the rank of a Director to the Government of India or an equivalent State officer, who may award compensation or impose a penalty where the claim for injury or damage does not exceed rupees five crore, jurisdiction above that vesting with the competent court; Chapter XI creates the offences, which are tried by criminal courts, investigated by a police officer not below the rank of Inspector, and, where punishable with imprisonment of three years and above, are cognizable, the offence punishable with three years being bailable.

Why the Act looks the way it does

The Act as enacted in 2000 was a commerce statute. Its long title speaks of legal recognition for transactions carried out by electronic data interchange, and the bulk of it is about electronic records, digital signatures, certifying authorities and the Controller. Its penal provisions were few: section 43 on damage to a computer, section 65 on tampering with source documents, section 66 on hacking, and the obscenity provision in section 67.

The amendment of 2008 changed the character of the statute. It inserted 43A, 66A to 66F, 67A, 67B, 67C, 69A, 69B, 72A, 77A, 77B, 79A, 84A, 84B and 84C, substituted 66, 69 and 79, and turned an electronic commerce law into the principal criminal statute for conduct done through computers. Everything the syllabus asks about, from identity theft to cyber terrorism, is a product of that amendment.

Two consequences follow, and both are examinable.

The Act is not a code. Section 77 provides that no compensation awarded, penalty imposed or confiscation made under this Act shall prevent the award of compensation or imposition of any other penalty or punishment under any other law for the time being in force. So the general criminal law applies alongside it, and a single act may be an offence under both.

And the provisions inserted in 2008 were drafted quickly. Section 66A, inserted then, was struck down in Shreya Singhal v. Union of India for vagueness and overbreadth, and the consolidated statute still prints it. [Speech Online and Its Limits] deals with that.

Contravention and offence: the distinction to hold

This is the structural point of the chapter.

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Chapter One Hundred Twenty-Six

Identity Theft and Cheating by Personation

Syllabus topic 5, "Development in information and Human Rights Cyber Terrorism."

In one line

Two short offences: using someone else's identifier, and using a computer to cheat by pretending to be someone.

In the wording a student can write in an exam: section 66C punishes whoever fraudulently or dishonestly makes use of the electronic signature, password or any other unique identification feature of any other person, with imprisonment which may extend to three years and fine up to one lakh rupees; and section 66D punishes whoever, by means of any communication device or computer resource, cheats by personation, with the same punishment.

The two offences

Section 66C: identity theft.

  • Actus reus: makes use of the electronic signature, password or any other unique identification feature of any other person.
  • Mens rea: fraudulently or dishonestly, which are the terms defined in the general penal law, dishonesty importing an intention to cause wrongful gain or wrongful loss and fraud importing an intent to deceive.
  • Punishment: imprisonment of either description up to three years and fine up to one lakh rupees.

Section 66D: cheating by personation.

  • Actus reus: cheats by personation, by means of any communication device or computer resource.
  • Punishment: identical, up to three years and fine up to one lakh rupees.

The relationship between them. Section 66C is complete on the use of the identifier; no victim need be deceived and no loss need follow. Section 66D requires a cheat, which imports the general law of cheating: deception, inducement, and delivery of property or damage. So 66C is the earlier offence in the sequence and the easier to prove, and 66D is the one that reaches the person who actually obtained something.

Both carry three years, which matters because of [Cybercrime: the Scheme of the IT Act]: by section 77B an offence punishable with three years and above is cognizable, and the offence punishable with three years is bailable. So both are cognizable and bailable, and by section 78 both must be investigated by an officer not below the rank of Inspector.

What "unique identification feature" reaches

The phrase in section 66C is electronic signature, password or any other unique identification feature of any other person, and its width is the interesting part.

Named: the electronic signature and the password.

"Any other unique identification feature" is not defined, and on ordinary construction it reaches anything that uniquely identifies a person: a biometric, a one-time passcode, a unique identity number, an account identifier, and a device identifier tied to a person. That reading matters for [Digital Identity and Biometrics], because the misuse of an authentication credential is exactly what the 2018 Bench had in mind when it struck down the part of section 57 of the Aadhaar Act that let a body corporate or an individual seek authentication under a contract.

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Chapter One Hundred Twenty-Seven

Violation of Privacy and Obscene Material Online

Syllabus topic 5, "Development in information and Human Rights Cyber Terrorism."

In one line

Four offences, and they are not the same offence at different strengths: one protects a person from being seen, and three regulate what may be published.

In the wording a student can write in an exam: section 66E punishes whoever intentionally or knowingly captures, publishes or transmits the image of a private area of any person without his or her consent, under circumstances violating the privacy of that person, with imprisonment up to three years or fine not exceeding two lakh rupees, or both; section 67 punishes publishing or transmitting obscene material in electronic form; section 67A punishes publishing or transmitting material containing a sexually explicit act or conduct; and section 67B punishes a range of conduct involving material depicting children in sexually explicit act or in an obscene or indecent manner, and the grooming and facilitation of online abuse.

Section 66E: violation of privacy

This is the provision to know, because it is the only offence in the Act built on the concept the constitutional law uses.

The offence. Whoever intentionally or knowingly captures, publishes or transmits the image of a private area of any person without his or her consent, under circumstances violating the privacy of that person. Punishment: imprisonment which may extend to three years or fine not exceeding two lakh rupees, or both.

The definitions, which are the whole of the section.

  • "Transmit" means to electronically send a visual image with the intent that it be viewed by a person or persons.
  • "Capture", with respect to an image, means to videotape, photograph, film or record by any means.
  • "Private area" means the naked or undergarment clad genitals, pubic area, buttocks or female breast.
  • "Publishes" means reproduction in the printed or electronic form and making it available for public.
  • "Under circumstances violating privacy" means circumstances in which a person can have a reasonable expectation that (i) he or she could disrobe in privacy, without being concerned that an image of his private area was being captured; or (ii) any part of his or her private area would not be visible to the public, regardless of whether that person is in a public or private place.

Four things follow, and each is examinable.

Three verbs, three offences. Capture, publish and transmit are separate, so the photographer, the person who puts the image on a site, and the person who forwards it each commit the offence independently. Forwarding is transmitting.

Consent is an ingredient, not a defence. The words are without his or her consent, so the prosecution must establish absence of consent, and consent to capture is not consent to publish.

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Chapter One Hundred Twenty-Eight

Cyber Terrorism: Section 66F

Syllabus topic 5, "Development in information and Human Rights Cyber Terrorism."

In one line

The only offence in the Act punishable with imprisonment for life, and it has two limbs that have almost nothing in common: one is about causing harm, and the other is about obtaining information.

In the wording a student can write in an exam: section 66F of the Information Technology Act 2000 defines the offence of cyber terrorism in two limbs. Under limb (A) a person commits it who, with intent to threaten the unity, integrity, security or sovereignty of India or to strike terror in the people or any section of the people, denies access, penetrates or exceeds authorised access, or introduces a computer contaminant, and by means of such conduct causes or is likely to cause death or injuries to persons or damage to or destruction of property or disrupts or knowing that it is likely to cause damage or disruption of supplies or services essential to the life of the community or adversely affect the critical information infrastructure specified under section 70. Under limb (B) a person commits it who knowingly or intentionally penetrates or accesses a computer resource without authorisation or exceeding authorized access and thereby obtains access to information, data or computer database that is restricted for reasons of the security of the State or foreign relations, or any restricted information with reasons to believe that it may be used to cause or likely to cause injury to specified interests. Whoever commits or conspires to commit cyber terrorism shall be punishable with imprisonment which may extend to imprisonment for life.

Limb (A): the harm limb

Break it into its three requirements, because the section is unreadable until it is broken up.

First, the intent. With intent to threaten the unity, integrity, security or sovereignty of India or to strike terror in the people or any section of the people. This is a specific intent, and it is the element that separates this offence from ordinary hacking. Note that the second alternative, striking terror in any section of the people, does not require any threat to the State.

Second, the conduct. One of three:

  • (i) denying or cause the denial of access to any person authorized to access computer resource;
  • (ii) attempting to penetrate or access a computer resource without authorisation or exceeding authorized access;
  • (iii) introducing or causing to introduce any Computer Contaminant.

Note that (ii) is satisfied by an attempt, so the conduct element does not require success.

Third, the consequence. By means of such conduct, the person:

  • causes or is likely to cause death or injuries to persons; or
  • causes or is likely to cause damage to or destruction of property; or
  • disrupts, or knowing that it is likely to cause damage or disruption of, supplies or services essential to the life of the community; or
  • adversely affects the critical information infrastructure specified under section 70.

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Chapter One Hundred Twenty-Nine

Investigation, Jurisdiction and the Transnational Problem

Syllabus topic 5, "Development in information and Human Rights Cyber Terrorism."

In one line

Indian law claims jurisdiction over an offence committed anywhere in the world if it touched a computer in India, and then has almost no way of getting the evidence.

In the wording a student can write in an exam: section 75 of the Information Technology Act 2000 provides that the Act shall apply also to any offence or contravention committed outside India by any person irrespective of his nationality, if the act or conduct constituting the offence or contravention involves a computer, computer system or computer network located in India; section 78 requires investigation by a police officer not below the rank of Inspector; section 80 permits such an officer to enter any public place and search and arrest without warrant a person reasonably suspected of an offence under the Act; and section 81 gives the Act overriding effect, subject to a proviso preserving rights under the Copyright Act 1957 and the Patents Act 1970.

Why jurisdiction is the hard problem

Every other chapter in this module assumes that when a right is infringed there is somebody within reach to answer for it. Information technology defeats that assumption in three ways at once.

The actor may be anywhere. The person who impersonates, defrauds or attacks need never enter the country whose resident is harmed.

The evidence is somewhere else again. The account, the log, the message and the payment may each sit on a server in a different State, held by a company that owes India nothing.

And the harm is in a third place. The victim is in India, the platform in one country, the server farm in another, the offender in a fourth.

A legal system can respond by extending its own claim, by cooperating with others, or by both. India has done the first generously and the second hardly at all, and the gap between the two is this chapter.

The Indian claim: section 75

75(1). Subject to sub-section (2), the provisions of the Act shall apply also to any offence or contravention committed outside India by any person irrespective of his nationality.

75(2). The Act applies to such an offence or contravention if the act or conduct constituting the offence or contravention involves a computer, computer system or computer network located in India.

This is a very wide claim, and it is worth seeing how wide. It does not require the offender to be Indian, or to have been in India, or to have intended any effect in India. The single connecting factor is that the conduct involves a computer, computer system or network located in India, and involves is not defined. A message routed through an Indian server, a copy cached in India, or an account held on a machine in India would each arguably satisfy it.

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Chapter One Hundred Thirty

Digital Identity and Biometrics

Syllabus topic 5, "Development in information and Human Rights Cyber Terrorism."

In one line

The Court upheld a national biometric identity because it delivers welfare, and cut out every part of it that did anything else.

In the wording a student can write in an exam: in Justice K.S. Puttaswamy (Retd.) v. Union of India (2018) a Bench of five judges upheld the Aadhaar (Targeted Delivery of Financial and Other Subsidies, Benefits and Services) Act 2016 as satisfying the triple test of a law, a legitimate State aim and proportionality, holding that only matters over which there is a reasonable expectation of privacy are protected by article 21; but it declared unconstitutional the part of section 57 enabling a body corporate or individual to seek authentication, struck down section 33(2), read down section 33(1) to require a hearing, struck down the regulation permitting authentication records to be archived for five years, held retention beyond six months impermissible, held the metadata regulation impermissible in its present form, held rule 9 of the Prevention of Money-Laundering (Maintenance of Records) Rules 2005 on the linking of bank accounts disproportionate, and held the Department of Telecommunications circular of 23 March 2017 on the linking of mobile numbers illegal and unconstitutional as it is not backed by any law.

What a biometric identity does to privacy

Before the case, the analysis. A biometric identity system has four features that no earlier identity document had, and each is a distinct rights problem.

It is not revocable. A password can be changed after a breach; a fingerprint cannot. The consequence is that a compromise is permanent.

It is the same key everywhere. A single identifier used across welfare, banking, telecom and employment allows records held for different purposes by different holders to be joined, which is the combination problem of [Informational Privacy and the Proportionality Test]. Purpose limitation is the answer, and it is only as strong as the rule that enforces it.

It generates a record every time it is used. Authentication is not merely identification; each use leaves a log of where the person was and what they were doing, so the system produces a running account of a person's life as a by-product.

And it becomes a condition of participation. Where a benefit is available only on authentication, a person who cannot authenticate is excluded from it, so a technical failure becomes a denial of a right. That is the exclusion problem of [Equality and the Digital Divide].

The case

Facts. The Aadhaar scheme enrols residents and issues a unique number against demographic and biometric information held in a central repository. Section 7 of the Aadhaar Act 2016 makes authentication a condition of receiving a subsidy, benefit or service the expenditure for which is met from the Consolidated Fund of India. The Act was certified by the Speaker as a Money Bill and passed accordingly. It was challenged as violating the right to privacy the same Court had recognised in 2017, and on the ground that a Bill containing provisions outside article 110(1) could not be a Money Bill.

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Chapter One Hundred Thirty-One

Children Online

Syllabus topic 5, "Development in information and Human Rights Cyber Terrorism."

In one line

Indian law now says that a child is anyone under eighteen, that nothing may be done with their data without a parent's verified consent, and that they may not be tracked or advertised to at all.

In the wording a student can write in an exam: section 2(f) of the Digital Personal Data Protection Act 2023 defines a child as an individual who has not completed the age of eighteen years; section 9(1) requires a Data Fiduciary, before processing any personal data of a child or a person with disability who has a lawful guardian, to obtain verifiable consent of the parent or the lawful guardian; section 9(2) forbids processing likely to cause any detrimental effect on the well-being of a child; and section 9(3) forbids tracking or behavioural monitoring of children or targeted advertising directed at children.

The three regimes that apply

A child online is protected by three different bodies of law, and an answer that gives only one is incomplete.

Data protection, in section 9 of the 2023 Act, which governs what may be done with a child's information.

The criminal law, principally section 67B of the Information Technology Act 2000, which punishes material depicting children and the conduct that produces and spreads it, and which reaches grooming.

And the intermediary obligations, in the 2021 Rules, under which every intermediary must make reasonable efforts to cause its users not to host information that is harmful to child, and must remove specified content on complaint.

Section 9 of the 2023 Act

9(1). Before processing any personal data of a child, or of a person with disability who has a lawful guardian, the Data Fiduciary shall obtain verifiable consent of the parent or the lawful guardian, in the prescribed manner. The Explanation provides that consent of the parent includes the consent of lawful guardian, wherever applicable.

9(2). A Data Fiduciary shall not undertake such processing of personal data that is likely to cause any detrimental effect on the well-being of a child.

9(3). A Data Fiduciary shall not undertake tracking or behavioural monitoring of children or targeted advertising directed at children.

9(4). Sub-sections (1) and (3) may be made inapplicable to prescribed classes of Data Fiduciaries, for prescribed purposes, subject to prescribed conditions.

9(5). The Central Government may, if satisfied that a Data Fiduciary's processing of children's data is done in a manner that is verifiably safe, notify the age above which that fiduciary is exempt from all or any of the obligations in sub-sections (1) and (3).

The penalty. Item 3 of the Schedule fixes a penalty for breach of the additional obligations in relation to children extending to two hundred crore rupees, the second heaviest in the Act.

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Chapter One Hundred Thirty-Two

Disinformation, Elections and the Public Sphere

Syllabus topic 5, "Development in information and Human Rights Cyber Terrorism."

In one line

Regulating lies means appointing somebody to identify them, and the person appointed is usually the person with the most to gain from the identification.

In the wording a student can write in an exam: disinformation is false information disseminated with intent to deceive, and misinformation is false information disseminated without that intent; the difficulty in regulating either is that a restriction on falsehood requires an authority to determine falsity, so the question is who decides, and in Kunal Kamra v. Union of India the Bombay High Court struck down the 2023 amendment to rule 3(1)(b)(v) of the Intermediary Rules, which made a fact check unit of the Central Government the identifier of what is fake or false or misleading about any business of the Central Government, holding it violative of Articles 14, 19(1)(a) and 19(1)(g), ultra vires the parent Act, vague and overbroad, incapable of being saved by reading down, failing the test of proportionality, and producing a chilling effect qua an intermediary.

Why this is the hardest speech problem

Every other restriction in [Speech Online and Its Limits] is defined by a quality of the speech that a court can assess: whether it incites, whether it defames, whether it is obscene. Falsity is different in three ways.

Truth is not among the article 19(2) grounds. The eight grounds are sovereignty and integrity, security of the State, friendly relations with foreign States, public order, decency or morality, contempt of court, defamation, and incitement to an offence. Falsity as such is not one of them, so a restriction on speech merely because it is untrue has to be brought within another ground, usually public order.

Determining falsity requires a determiner. A court can decide whether particular words defame a particular person, but a rule addressed to the whole of public discourse cannot wait for a trial in every case, so it needs a body that decides quickly. That body then holds the power the rule creates.

And the speech that matters most is contested. The statements that do political damage are usually not simple falsehoods but characterisations, predictions, selective truths and disputed claims, on which the determination of falsity is itself a political act.

Add the technology and the problem changes scale. [The Information Society and Human Rights] records that speech once reached as far as the speaker could be heard, and that the limit has gone. Recommendation systems select what each person sees, so a falsehood is not merely available but delivered; synthetic media makes fabrication cheap; and the same profiling that section 9(3) of the Digital Personal Data Protection Act 2023 forbids for children is what allows a message to be aimed at the people most likely to act on it.

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Chapter One Hundred Thirty-Three

What a Normative Response Is

Syllabus topic 6, "Impact of Scientific and Technological Progress on Human Rights : Normative Response of the International Community."

In one line

The international community answers a problem with an instrument, and the kind of instrument it chooses decides in advance how much the answer can achieve.

In the wording a student can write in an exam: a normative response is the creation by the international community of a standard of conduct addressed to States and, sometimes, to others, in response to a development that existing law does not adequately govern. Such responses take several forms, of which the important distinction is between a treaty, which binds those States that consent to it, and soft law, which does not bind but which states an agreed standard, guides interpretation, and may in time contribute to binding law.

Why the classification matters before anything else

Every question on topic 6 is really a question about force. A candidate who can recite the contents of the 1975 Declaration and cannot say whether a State is obliged to comply with it has answered the smaller half.

Three consequences follow from the classification of an instrument, and they are the three things to establish first about any text.

Who is bound. A treaty binds only its parties. A General Assembly declaration binds nobody, though it is addressed to all States.

What happens on breach. A treaty may carry a reporting mechanism, a complaints procedure, or none. A declaration carries none.

And how it is used in argument. A binding instrument is cited as the source of the obligation. A non-binding instrument is cited as the agreed meaning of an obligation that exists elsewhere, which is exactly how [Access to the Internet] shows the Kerala High Court using international material: read into the fundamental rights where there is no inconsistent domestic law occupying the field.

The forms, with the book's own examples

Treaty, convention, covenant

What it is. An agreement between States, in written form, governed by international law, binding on those that become parties by ratification or accession.

What it can do. Create obligations, establish institutions, and provide for supervision.

What it cannot do. Bind a State that has not consented. So the number of parties is part of the answer to any question about its reach.

In this book. The International Covenant on Economic, Social and Cultural Rights 1966, whose article 15 is the binding form of the right to science and is worked in [Article 15 of the Covenant Read Whole]; the International Covenant on Civil and Political Rights 1966; the Convention on the Elimination of All Forms of Racial Discrimination 1965; the Convention on the Elimination of All Forms of Discrimination against Women 1979; and, outside India's participation, the Convention on Cybercrime (ETS No. 185) and the UN Convention against Cybercrime.

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Chapter One Hundred Thirty-Four

The 1975 Declaration: How It Came About

Syllabus topic 6, "Impact of Scientific and Technological Progress on Human Rights : Normative Response of the International Community."

In one line

The General Assembly proclaimed in 1975 that science must serve peace and human rights, and it did so because of the arms race, decolonisation and the demand of newly independent States for technology.

In the wording a student can write in an exam: the Declaration on the Use of Scientific and Technological Progress in the Interests of Peace and for the Benefit of Mankind was proclaimed by General Assembly resolution 3384 (XXX) of 10 November 1975; its title states its purpose, and its preamble records that scientific and technological progress has become one of the most important factors in the development of human society, that developments can give rise to social problems, as well as threaten the human rights and fundamental freedoms of the individual, that achievements can be used to intensify the arms race, suppress national liberation movements and deprive individuals and peoples of their human rights, and that the transfer of science and technology is one of the principal ways of accelerating the economic development of developing countries.

Reading the title

The title is unusually informative and should be quoted in an answer: Declaration on the Use of Scientific and Technological Progress in the Interests of Peace and for the Benefit of Mankind.

"Use", not development, discovery or regulation. The instrument is not about whether science should proceed but about the purposes to which its results are put, which is the dual-use structure of [Dual Use: the Same Technology Both Ways] stated in a title.

"In the interests of peace" is the first purpose named, and it comes before human rights. That order tells the reader what the drafters were most worried about.

And "for the benefit of mankind" is the distributive purpose, which the operative paragraphs turn into obligations about developing countries and about all strata of the population.

The setting, as the preamble records it

An answer on how the Declaration came about should be built from its own recitals rather than from general history, and the recitals name four things.

The arms race

The preamble notes with concern that scientific and technological achievements can be used to intensify the arms race. In 1975 the arms race was nuclear, and the concern is a concern about the direction of scientific effort itself: that the most capable science of the age was being applied to weapons.

This is why paragraph 1 leads with peace and security, and why paragraph 4 forbids the use of scientific achievements for the purposes of violating the sovereignty and territorial integrity of other States, interfering in their internal affairs, waging aggressive wars. [Weapons, Warfare and the Right to Life] takes the substance.

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Chapter One Hundred Thirty-Five

The 1975 Declaration: What It Obliges States To Do

Syllabus topic 6, "Impact of Scientific and Technological Progress on Human Rights : Normative Response of the International Community."

In one line

Nine paragraphs, each beginning with the words "All States shall", and they divide into three that promote, three that prevent, and three that require law.

In the wording a student can write in an exam: the Declaration proclaimed by General Assembly resolution 3384 (XXX) of 10 November 1975 contains nine operative paragraphs, each opening All States shall.

They require States to promote international co-operation for peace and for the realisation of rights (1); to prevent the use of developments, particularly by the State organs, to limit rights (2); to ensure that achievements satisfy the material and spiritual needs for all sectors of the population (3); to refrain from using achievements to violate sovereignty, interfere in internal affairs, wage aggressive wars, suppress national liberation movements or pursue racial discrimination (4); and to co-operate in developing the scientific and technological capacity of developing countries (5).

They further require States to extend the benefits to all strata of the population and protect them from possible harmful effects of misuse, particularly as to privacy and the protection of the human personality and its physical and intellectual integrity (6); to take necessary measures, including legislative measures, so that utilisation promotes the fullest realization of human rights without any discrimination whatsoever on grounds of race, sex, language or religious beliefs (7); to take effective measures, including legislative measures, to prevent and preclude utilisation to the detriment of human rights and fundamental freedoms and the dignity of the human person (8); and to take action to ensure compliance with legislation guaranteeing human rights and freedoms in the conditions of scientific and technological developments (9).

The nine, one by one

Paragraph 1: co-operation for peace and rights

All States shall promote international co-operation to ensure that the results of scientific and technological developments are used in the interests of strengthening international peace and security, freedom and independence, and also for the purpose of the economic and social development of peoples and the realization of human rights and freedoms in accordance with the Charter of the United Nations.

Five objects are named: peace and security, freedom and independence, economic and social development of peoples, and the realization of human rights and freedoms. The obligation is to promote international co-operation, so it is directed outward and not at a State's own conduct, which is what paragraph 2 does.

Paragraph 2: prevent use by State organs

All States shall take appropriate measures to prevent the use of scientific and technological developments, particularly by the State organs, to limit or interfere with the enjoyment of the human rights and fundamental freedoms of the individual as enshrined in the Universal Declaration of Human Rights, the International Covenants on Human Rights and other relevant international instruments.

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Chapter One Hundred Thirty-Six

Article 15 of the Covenant Read Whole

Syllabus topic 6, "Impact of Scientific and Technological Progress on Human Rights : Normative Response of the International Community."

In one line

One article, four limbs, and it is the whole of the binding law on the right to science.

In the wording a student can write in an exam: article 15 of the International Covenant on Economic, Social and Cultural Rights 1966 provides that States Parties recognize the right of everyone (a) to take part in cultural life; (b) to enjoy the benefits of scientific progress and its applications; (c) to benefit from the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author; that the steps to be taken to achieve the full realization of this right shall include those necessary for the conservation, the development and the diffusion of science and culture; that States Parties undertake to respect the freedom indispensable for scientific research and creative activity; and that they recognize the benefits to be derived from the encouragement and development of international contacts and co-operation in the scientific and cultural fields.

Why the article has to be read whole

Module I took each limb separately because each has its own content, and [The Right to Science in the Covenant], [Participation in Scientific Progress], [The Duty to Conserve, Develop and Diffuse Science], [Freedom Indispensable for Scientific Research] and [International Co-operation in Science] do that work. Assembling them shows three things that no single limb shows.

The four limbs are a system, not a list. Paragraph 1(b) gives the individual a right to enjoy the benefits. Paragraph 2 obliges the State to produce and spread the science that generates them. Paragraph 3 protects the freedom without which there is nothing to spread. And paragraph 4 supplies the co-operation without which a State that cannot do its own science has nothing to give its people. Remove any one and the others fail: a right to benefits with no science, science with no diffusion, diffusion with no freedom, or freedom in a State with no capacity.

The article balances the author against the public. Paragraph 1(c) protects the moral and material interests resulting from any scientific, literary or artistic production of which he is the author, and paragraph 1(b) gives everyone the enjoyment of the benefits. Those pull against each other, and the tension is the whole of the access-to-medicines argument in [Access to Medicines and Patents] and of the traditional knowledge argument in [Benefit Sharing, Biopiracy and Traditional Knowledge].

And it is drafted as a right, not as a programme. The words are recognize the right of everyone, so the beneficiary is a person and not a State's science policy. That is the difference between article 15 and the whole of the 1975 Declaration.

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Chapter One Hundred Thirty-Seven

General Comment 25 as the Authoritative Reading

Syllabus topic 6, "Impact of Scientific and Technological Progress on Human Rights : Normative Response of the International Community."

In one line

The body that supervises the Covenant said in 2020 what article 15 means, and it turned four limbs of a sentence into a code.

In the wording a student can write in an exam: General Comment No. 25 (2020) on science and economic, social and cultural rights, E/C.12/GC/25, was adopted by the Committee on Economic, Social and Cultural Rights on 30 April 2020; it is the treaty body's authoritative interpretation of article 15(1)(b), (2), (3) and (4) of the Covenant, and it supplies what the article does not: the meaning of benefits, the rejection of a division between scientists and the public, the three obligations to respect, protect and fulfil, the limitation test under article 4, the precautionary principle, the duties on traditional knowledge and indigenous peoples, and the obligations of international cooperation, including in a pandemic.

Why a general comment carries weight

[What a Normative Response Is] classifies it: an interpretation issued by the treaty body established to supervise the treaty. Three consequences follow, and stating them is the first move in any answer that relies on the document.

It is not binding. No State consented to it, and no court is obliged to follow it.

It is authoritative because of who wrote it. The Committee is the body the Covenant's supervisory system makes responsible for examining State reports and assessing compliance, so its reading of article 15 is the reading the States will be measured against when they report.

And it is the only detailed reading there is. Article 15 is four limbs of one sentence, adopted in 1966. Between 1966 and 2020 the Committee said very little about the science limb; paragraph 2 of the General Comment itself records that science is one of the areas of the Covenant to which the least attention has been given. The document therefore does not compete with an existing interpretation; it supplies the first one.

What it adds to article 15

The meaning of "benefits"

Paragraph 8 gives three, and they are cumulative rather than alternative.

First, the material results of the applications of scientific research, such as vaccinations, fertilizers, technological instruments and the like.

Secondly, the scientific knowledge and information directly deriving from scientific activity, as science provides benefits through the development and dissemination of the knowledge itself.

Lastly, the role of science in forming critical and responsible citizens who are able to participate fully in a democratic society.

The third is the surprising one and it is the one to use. It makes scientific literacy a benefit of scientific progress in its own right, so a State that supplies vaccines and suppresses science education has delivered one benefit and withheld another. It also links this right to democratic participation, which is why [Disinformation, Elections and the Public Sphere] belongs in the same paper.

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Chapter One Hundred Thirty-Eight

The UNESCO Trilogy of 1997, 2003 and 2005

Syllabus topic 6, "Impact of Scientific and Technological Progress on Human Rights : Normative Response of the International Community."

In one line

Three declarations in eight years, each answering a question the last one had not been asked, and the shortest of them is the strictest.

In the wording a student can write in an exam: UNESCO's General Conference adopted the Universal Declaration on the Human Genome and Human Rights in 1997, the International Declaration on Human Genetic Data in 2003, and the Universal Declaration on Bioethics and Human Rights in 2005; all three are declarations and not treaties, so none binds; they protect different objects, being respectively the genome, the data, and the person in the whole field of medicine and the life sciences; and their limitation clauses differ, article 9 of the 1997 Declaration being the stricter in requiring compelling reasons where article 27 of the 2005 Declaration requires only that a limitation be by law.

The three, and what each was for

1997: the genome

The occasion. The Human Genome Project was under way and the mapping of the human genome was in prospect. The question nobody had had to answer was what the genome is in law: a substance, an inheritance, a person's property, or something else.

The answer. Article 1 declares that the human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity, and that in a symbolic sense, it is the heritage of humanity. [The Genome and Human Dignity] works it.

What it produced. Twenty-five articles on dignity, non-discrimination, consent, confidentiality, the right not to know, research and its limits, solidarity and implementation. Its article 11 prohibits practices which are contrary to human dignity, such as reproductive cloning of human beings, and its article 24 charges the International Bioethics Committee with identifying such practices, such as germ-line interventions.

2003: the data

The occasion. Sequencing became cheap and biobanks became large, so the question shifted from what the genome is to what may be done with the information derived from it.

The answer. The 2003 Declaration is about a thing that can be copied, linked, moved and stored, which the genome cannot. Its structure follows the life cycle of data: collection, processing, use, storage and destruction.

What it produced. Twenty-seven articles, of which the ones the book uses most are article 8 on prior, free, informed and express consent, article 9 on withdrawal, article 14 on privacy and confidentiality, article 16 on change of purpose, article 18 on circulation across borders, and article 19 on benefit sharing. [Genetic Data: What It Is and Why It Is Special] and the three chapters after it work them.

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Chapter One Hundred Thirty-Nine

Professional Self-Regulation as a Normative Response

Syllabus topic 6, "Impact of Scientific and Technological Progress on Human Rights : Normative Response of the International Community."

In one line

Doctors and researchers wrote the rules of research ethics before any State did, and the rules worked everywhere the profession worked and nowhere else.

In the wording a student can write in an exam: professional self-regulation is the adoption by a profession of binding standards for its own members, enforced by professional consequence rather than by law; the Nuremberg Code 1947 and the Declaration of Helsinki, first adopted by the World Medical Association in 1964 and revised many times since, are its two great instances in this field; their advantages are speed, specificity and reach across borders; and their limits are that they bind only the profession, provide the injured person no remedy, and are made by the people they regulate.

Why the professions got there first

Three reasons, and each is a general feature of the technique rather than an accident of history.

The profession knows before the legislature does. A capability appears in a laboratory or a clinic years before it appears in a Bill, and the people who can see what it will do are the people using it. [The Ethics of Emerging Technology] shows the same pattern with the 2011 influenza episode: the restraint was agreed among researchers because there was nothing else available in the time.

The profession's rules cross borders and a State's do not. A researcher who moves to another country carries the profession with them. That is why the Declaration of Helsinki matters in jurisdictions that have never legislated on research ethics, and why [Research Carried Out in Developing Countries] can treat it as the governing standard even where the host State has none.

And the profession has a sanction that operates without a court. The refusal of a journal to publish, the refusal of an ethics committee to approve, and the loss of a licence are all consequences that do not require proof beyond reasonable doubt, a complainant, or a limitation period. [Registration, Publication and Research Integrity] shows the publication sanction doing most of the practical work.

The Nuremberg Code

What it is. Ten points on permissible medical experiments, set out in the judgment of the tribunal in the trial of physicians at Nuremberg in 1947. [The Nuremberg Code] works all ten.

Its peculiar origin. It was not adopted by a profession or by States. It was written by judges, in a criminal judgment, as the standard by which the defendants' conduct was to be measured, and it was afterwards taken up by the professions as their own. So its authority is the authority of a judgment that nobody enforces, transmitted by adoption.

Its first point is the one everything else rests on. The voluntary consent of the human subject is absolutely essential. [Free and Informed Consent in Research] traces the line from there to article 6 of the 2005 Declaration.

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Chapter One Hundred Forty

The Regional Response: the Council of Europe

Syllabus topic 6, "Impact of Scientific and Technological Progress on Human Rights : Normative Response of the International Community."

In one line

Europe did what the world would not: it made the ethics of biomedicine and the law of cybercrime into binding treaties, and it opened both to States outside Europe.

In the wording a student can write in an exam: the Council of Europe produced the two binding instruments this subject otherwise lacks. The Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (ETS No. 164), the Oviedo Convention, was opened at Oviedo on 4 April 1997 and entered into force on 1 December 1999; the Treaty Office describes it as the first legally-binding international text designed to preserve human dignity, rights and freedoms, through a series of principles and prohibitions against the misuse of biological and medical advances. The Convention on Cybercrime (ETS No. 185), the Budapest Convention, was opened at Budapest on 23 November 2001 and entered into force on 1 July 2004; the Treaty Office describes it as the first international treaty on crimes committed via the Internet and other computer networks.

What a regional response is, and why it can go further

A regional instrument is made by a group of States within an organisation of limited membership, rather than by the whole international community.

Three consequences, and they are the answer to why Europe has treaties and the United Nations has declarations.

Agreement is easier among fewer and more similar States. A convention needs a text every party can ratify. Among the members of the Council of Europe, whose legal systems and constitutional traditions overlap, that text can say more than one acceptable to the whole General Assembly.

A binding form becomes possible. The 1997, 2003 and 2005 UNESCO instruments are declarations for the reasons [The UNESCO Trilogy of 1997, 2003 and 2005] gives. Oviedo, on substantially the same subject and adopted in the same year as the first of them, is a convention.

And enforcement machinery becomes possible, because a regional organisation already has courts and committees.

The cost is reach. A regional instrument binds its parties, and most of the world is not among them.

The Oviedo Convention, ETS No. 164

The record. Opened at Oviedo on 4 April 1997. Open for signature by the member States, the non-member States which have participated in its elaboration and by the European Union, and for accession by other non-member States. Entry into force 1 December 1999, on five ratifications including four member States.

What the Treaty Office says it does, and this is the level at which the chapter may state its content:

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Chapter One Hundred Forty-One

Special Procedures and the Special Rapporteur

Syllabus topic 6, "Impact of Scientific and Technological Progress on Human Rights : Normative Response of the International Community."

In one line

The Human Rights Council appoints independent experts to examine a problem, and their reports are how the system moves between treaties.

In the wording a student can write in an exam: the special procedures of the Human Rights Council are independent human rights experts with mandates to report and advise on human rights from a thematic or country-specific perspective; they serve in their personal capacity and are unpaid; the system covers civil, cultural, economic, political and social rights; and, as at 1 January 2025, the Office of the High Commissioner recorded sixty special procedures, being forty-six thematic mandates and fourteen mandates relating to countries or territories, with eighty-seven mandate holders. Two mandates matter directly to this paper: the Special Rapporteur in the field of cultural rights, whose thematic work includes the right to enjoy the benefits of scientific progress and its applications, and the Special Rapporteur on the right to privacy, whose mandate was created by the Council in 2015.

What a special procedure is

Who. An independent expert, or a working group of them, appointed by the Human Rights Council. They are not United Nations staff, they are not paid for the work, and they serve in a personal capacity, which is what independence means here: the mandate holder is not answerable to any State, including their own.

What they do. Four things.

Report. An annual thematic report to the Council, and often a report to the General Assembly, on a subject the mandate holder selects within the mandate. This is the output most often cited, and it is how an expert reading of a right reaches the public record.

Visit. Country visits, by invitation, followed by a report on the situation in that country.

Communicate. Communications to States about individual cases or about legislation, alleging that conduct is inconsistent with international standards, to which the State is invited to reply. The communications and the replies are published.

And advise. Contributions to standard-setting, and the sort of expert input that later appears in a general comment or a declaration.

What they cannot do. Decide anything. There is no binding finding, no order, and no remedy; the sanction is publication and the pressure it creates.

Why this mechanism suits this subject

Three reasons, and they belong in any answer on how the international community actually responds to a new technology.

It is fast. A mandate holder can report on a technology two years after it appears. A treaty on the same subject would take a decade, and a general comment requires a treaty body to reach agreement.

It is expert and independent at once. The problem with technology in a rights framework is that the people who understand it are usually employed by those who deploy it. A mandate holder is appointed for expertise and serves unpaid in a personal capacity, which is the only combination the system has.

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Chapter One Hundred Forty-Two

Reporting, Treaty Bodies and Enforcement

Syllabus topic 6, "Impact of Scientific and Technological Progress on Human Rights : Normative Response of the International Community."

In one line

The Covenant obliges States to write reports about themselves, a committee reads them and comments, and that is the whole of the machinery.

In the wording a student can write in an exam: article 16(1) of the International Covenant on Economic, Social and Cultural Rights provides that States Parties undertake to submit reports on the measures which they have adopted and the progress made in achieving the observance of the rights recognized herein; article 16(2)(a) requires them to be submitted to the Secretary-General, who transmits copies to the Economic and Social Council, and 16(2)(b) requires transmission of relevant parts to the specialized agencies; article 17(1) requires reports in stages; and the reports are in practice examined by the Committee on Economic, Social and Cultural Rights, which issues concluding observations. There is no court, no judgment and no sanction.

What the Covenant actually provides

Article 16(1). The undertaking is to submit reports on the measures which they have adopted and the progress made in achieving the observance of the rights recognized herein. Two things are reported: what was done, and what progress resulted. So the obligation matches the standard in article 2(1), which is to take steps with a view to achieving progressively the full realization of the rights.

Article 16(2). Reports go to the Secretary-General, who transmits copies to the Economic and Social Council for consideration, and transmits relevant parts to the specialized agencies where the State is also a member of them and the parts relate to matters within their responsibilities. That second limb is how a report on article 15 reaches UNESCO and how a report on health reaches the World Health Organization.

Article 17(1). Reports are furnished in stages, in accordance with a programme, so a State does not report on everything at once.

And the Committee. The Covenant itself creates no committee; the examination function was given to a body established by the Economic and Social Council, which is why the Committee on Economic, Social and Cultural Rights sits differently from the treaty-created committees. Its outputs are concluding observations on a State's report and general comments interpreting the Covenant, the latter taken in [General Comment 25 as the Authoritative Reading].

The reporting cycle, and its four weaknesses

How it works. The State prepares a report, submits it, the Committee poses written questions, a delegation appears, the Committee issues concluding observations identifying positive aspects, concerns and recommendations, and the next report is due after a period.

And here is what is wrong with it, stated fairly because each weakness has an answer.

The State reports on itself. The primary evidence is the account given by the party whose compliance is in question. The answer is that civil society submits parallel reports, and the Committee's questions are informed by them, so the State's account is tested rather than accepted.

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Chapter One Hundred Forty-Three

India and the International Response

Syllabus topic 6, "Impact of Scientific and Technological Progress on Human Rights : Normative Response of the International Community."

In one line

India is bound by the treaties and answerable to nobody under them, and the way the international standards reach an Indian person is through a constitutional court.

In the wording a student can write in an exam: India acceded to both International Covenants on 10 April 1979, ratified the Convention on the Elimination of All Forms of Racial Discrimination in 1968, ratified the Convention on the Elimination of All Forms of Discrimination against Women on 9 July 1993, acceded to the Convention on the Rights of the Child on 11 December 1992 and ratified the Convention on the Rights of Persons with Disabilities on 1 October 2007; it signed the Convention against Torture in 1997 and has not ratified it; it has not accepted the individual complaints procedures under the Covenants; and it is not a party to the Budapest Convention and did not sign the UN Convention against Cybercrime at Hanoi in October 2025. The international standards nevertheless operate in Indian law, because article 51(c) of the Constitution directs the State to foster respect for international law and treaty obligations, article 253 empowers Parliament to legislate for implementing any treaty, agreement or convention, and the courts read international conventions and norms into the fundamental rights where there is no inconsistent domestic law occupying the field.

What India has and has not accepted

The Covenants. India acceded to the International Covenant on Economic, Social and Cultural Rights and to the International Covenant on Civil and Political Rights on 10 April 1979. So article 15, the whole of the right to science, binds India, and so does article 17 of the civil and political Covenant on privacy.

The other core treaties in this book's frame. The Racial Discrimination Convention, signed 1967 and ratified in 1968. The Women's Convention, signed 30 July 1980 and ratified on 9 July 1993. The Convention on the Rights of the Child, acceded to on 11 December 1992, which supplies the international standard behind [Children Online] and [Technology and the Rights of the Child]. The Convention on the Rights of Persons with Disabilities, ratified on 1 October 2007, which lies behind [Technology and Persons with Disabilities] and behind the guardianship provisions of section 9 of the Digital Personal Data Protection Act 2023.

What India has not done, and each omission matters here.

The Convention against Torture was signed in 1997 and has not been ratified, so the obligations of that treaty do not bind India. It is relevant to this paper because [Forensic Science and the Rights of the Accused] and [Bodily Integrity and Intervention Without Consent] concern compelled procedures, and the domestic protection there is article 20(3) and article 21 as applied in Selvi v. State of Karnataka rather than any treaty obligation.

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Chapter One Hundred Forty-Four

The Gaps in the International Response

Syllabus topic 6, "Impact of Scientific and Technological Progress on Human Rights : Normative Response of the International Community."

In one line

The international response to science and technology is broad, detailed, agreed and almost entirely unenforceable, and the reasons for that are structural rather than accidental.

In the wording a student can write in an exam: the international normative response to the impact of scientific and technological progress on human rights suffers from five gaps: it is overwhelmingly soft law, so the detailed instruments do not bind; the binding instrument is thin, article 15 of the Covenant being four limbs of one sentence; there is no complaints mechanism available to most people, so no violation is ever adjudicated; the response is reactive and slow, each instrument answering the technology of a decade earlier; and the right to science is almost never litigated, so a right that has existed since 1966 has produced almost no case law.

Gap 1: the detail is in the instruments that do not bind

The count. The instruments that say the most bind the least. The 2005 Bioethics Declaration has 28 articles; the 2003 genetic data Declaration has 27; the 1997 genome Declaration has 25; the 1975 Declaration has 9 operative paragraphs. None of them binds anybody. The instrument that binds, article 15 of the Covenant, is four limbs of a single sentence.

Why it is so. [What a Normative Response Is] gives the reason: agreement is available at the level of principle and not at the level of obligation, and a treaty must be drafted so that every prospective party can ratify it. So detail and force are traded against each other, and the international community has consistently chosen detail.

The answer to the criticism. Soft law hardens. It is read into domestic rights, as [India and the International Response] shows; it supplies the content that general comments and courts use; and it records a consensus that would not otherwise exist. A standard that binds nobody and is followed is worth more than an obligation that binds few.

But the answer has a limit. Reading in requires a domestic court willing to do it and a field not already occupied by statute, so the force of the international material depends entirely on the constitutional culture of the State in question. In a State whose courts do not read in, the detailed instruments do nothing at all.

Gap 2: the binding instrument is thin, and was unread for fifty years

The count. Article 15 gives the right to enjoy the benefits of scientific progress and its applications in eleven words. Between the Covenant's adoption in 1966 and General Comment 25 in 2020 there was no authoritative interpretation of that limb, and the General Comment itself records at its paragraph 2 that science is among the areas of the Covenant to which the least attention has been given.

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Chapter One Hundred Forty-Five

Technologies That Did Not Exist in 1975

Syllabus topic 6, "Impact of Scientific and Technological Progress on Human Rights : Normative Response of the International Community."

In one line

The framework was finished before the technologies that now matter most existed, and the useful question is not whether it is out of date but at which joint each new technology breaks it.

In the wording a student can write in an exam: the normative framework of this paper was built between the Universal Declaration of Human Rights 1948 and the UNESCO Bioethics Declaration 2005, with the 1975 Declaration and article 15 of the Covenant at its centre; the technologies that now raise the hardest questions, mass data processing, artificial intelligence, gene editing and neurotechnology, either did not exist or were not foreseen when it was written; and the framework nevertheless reaches most of them, because it is stated in terms of interests protected rather than things regulated, failing only where a new technology's harm falls outside every interest it recognises.

Why the framework has lasted

Because it names interests, not objects. Article 6 of the 2005 Declaration requires prior, free, express and informed consent to any preventive, diagnostic and therapeutic medical intervention. Nothing in it depends on knowing which interventions exist. Article 15(1)(b) of the Covenant gives the right to enjoy the benefits of scientific progress and its applications, which covers applications not yet made. Paragraph 6 of the 1975 Declaration protects privacy and the protection of the human personality and its physical and intellectual integrity, which was written about the technologies of 1975 and reads as though written about neurotechnology.

Because it says so. The 1975 preamble speaks of neutralising present and possible future harmful consequences. The nine judges in [Privacy as a Fundamental Right] said that the Constitution must evolve with the felt necessities of time, that its meaning cannot be frozen on the perspectives present when it was adopted, and that the rapid growth of technology may render obsolescent many notions of the present. Both instruments were written by people who knew they were writing for a future they could not see.

And because the classes are open. Article 11 of the 1997 Declaration prohibits practices which are contrary to human dignity, such as reproductive cloning of human beings. The example is illustrative and the class is open, so the prohibition can take in members nobody had thought of, which is exactly what article 24's reference to the International Bioethics Committee identifying such practices contemplates.

Where it breaks, and the four joints

[The Ethics of Emerging Technology] identified three; the fourth belongs to this chapter because it is about the instruments rather than about the technologies.

The consent joint: a subject who does not yet exist

The technology. Germ-line gene editing changes every descendant.

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The rest of this subject

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