Global Health Law and Communicable Diseases

A third device was tried and has largely failed: making the Organization's declaration the trigger for assistance, so that the reporting State gains something. Where the assistance does not arrive, the incentive to report is not restored, and that is the criticism levelled after the outbreaks of the last two decades.

The Framework Convention on Tobacco Control, 2003

Adopted by resolution WHA56.1 of the Fifty-sixth World Health Assembly, expressly under article 19 of the Constitution, and the first convention ever adopted under that article.

Why tobacco. The resolution records the Assembly as determined to protect present and future generations from tobacco consumption and exposure to tobacco smoke, noting with profound concern the escalation in smoking and other forms of tobacco use worldwide, and convinced that this convention is a groundbreaking step, with special consideration to be given to the particular situation of developing countries and countries with economies in transition.

Article 3, the objective. To protect present and future generations from the devastating health, social, environmental and economic consequences of tobacco consumption and exposure to tobacco smoke, by providing a framework for tobacco control measures to be implemented by the Parties at the national, regional and international levels, in order to reduce continually and substantially the prevalence of tobacco use and exposure to tobacco smoke.

It is a framework convention, which is a form worth understanding. A framework convention states objectives, principles and general obligations, and leaves the detail to protocols and to national implementation. Compare a codifying convention such as the Vienna Convention on the Law of Treaties, which states the rules themselves.

Article 4, guiding principles. Every person should be informed of the health consequences, addictive nature and mortal threat posed by tobacco consumption and exposure to tobacco smoke, and effective legislative, executive, administrative or other measures should be contemplated to protect all persons from exposure; and strong political commitment is necessary to develop comprehensive multisectoral measures at every level.

Article 5(3), the provision that has been most used. In setting and implementing their public health policies with respect to tobacco control, Parties shall act to protect these policies from commercial and other vested interests of the tobacco industry in accordance with national law. That is unusual in a treaty: an obligation to insulate the making of policy from a named industry.

Article 8, protection from exposure. Parties recognize that scientific evidence has unequivocally established that exposure to tobacco smoke causes death, disease and disability, and each Party shall adopt and implement in areas of existing national jurisdiction as determined by national law, and actively promote at other jurisdictional levels, effective measures providing for protection from exposure to tobacco smoke in indoor workplaces, public transport, indoor public places and, as appropriate, other public places.

The other substantive articles, which need naming and not working: article 6, price and tax measures; article 9, regulation of the contents of tobacco products; article 11, packaging and labelling, including health warnings; article 12, education and public awareness; article 13, a comprehensive ban on tobacco advertising, promotion and sponsorship, subject to a Party's constitution; article 14, cessation and treatment; article 15, illicit trade; article 16, sales to and by minors.

Institutions. A Conference of the Parties under article 23, reporting by Parties under article 21, and by article 24 a permanent secretariat designated by the Conference, secretariat functions being provided by the World Health Organization until one is established.

Entry into force. By article 36, on the ninetieth day following the deposit of the fortieth instrument of ratification, acceptance, approval, formal confirmation or accession, and for each later State on the ninetieth day after its own deposit. India is a Party, and its Cigarettes and Other Tobacco Products Act 2003 is its principal implementing legislation.

Note how the Convention operates as a treaty and not as a regulation. It binds only Parties, under article 19 of the Constitution, and article 20 of the Constitution obliged every Member, within eighteen months of adoption, to act on acceptance and to give reasons if it declined. Contrast article 22 in [The International Health Regulations], where silence binds.

The WHO Pandemic Agreement, 2025

Adopted by resolution WHA78.1 of the Seventy-eighth World Health Assembly on 20 May 2025, and this is the second article 19 instrument.

How it came about. The resolution recalls decisions SSA2(5) of 2021 and WHA77(20) of 2024, which, acknowledging the need to address gaps in preventing, preparing for and responding to health emergencies, established the Intergovernmental Negotiating Body to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response, with a view to adoption under article 19, or under other provisions of the WHO Constitution. The Assembly then adopts, pursuant to article 19 of the Constitution, the Agreement annexed to the resolution.

The Preamble records what drove it. The Assembly was deeply concerned by the inequities at national and international levels that hindered timely and equitable access to health products to address coronavirus disease (COVID-19), and recognised the need to address serious shortcomings at the national, regional and global levels in prevention, preparedness, response and health system recovery for public health emergencies of international concern, including pandemic emergencies. And it reaffirmed, in the same recital that calls for the widest possible international collaboration, the principle of the sovereignty of States in addressing public health matters.

Article 2, the objective. Guided by equity and the principles further set forth, to prevent, prepare for and respond to pandemics, and the provisions apply both during and between pandemics unless otherwise specified.

Applying between pandemics is the design point. Preparedness cannot be assembled during an emergency, so an instrument that operated only in a pandemic would be useless.

Article 3, principles and approaches. The Parties shall be guided, among others, by:

the sovereign right of States, in accordance with the Charter of the United Nations and the principles of international law, to legislate and to implement legislation within their jurisdiction;

full respect for the dignity, human rights and fundamental freedoms of all persons, including the enjoyment of the highest attainable standard of health of every human being, as well as the right to development and full respect for non-discrimination, gender equality, and the protection of persons in vulnerable situations;

full respect for international humanitarian law as relevant;

equity as a goal, principle and outcome, striving for the absence of unfair, avoidable or remediable differences among and between individuals, communities and countries;

solidarity, with inclusivity, transparency and accountability, recognising different capacities and the special circumstances of landlocked developing countries, small island developing States and least developed countries;

the best available science and evidence as the basis for public health decisions.

Article 3(1) is the answer to the objection that was made against the Agreement while it was negotiated, that it would let the Organization dictate national health policy. The first principle in the instrument is the sovereign right of States to legislate within their jurisdiction.

The substantive chapters, which a candidate should be able to list: article 4 pandemic prevention and surveillance; article 5 the One Health approach, treating human, animal and environmental health as one field; article 6 preparedness, readiness and health system resilience; article 7 the health and care workforce; article 8 regulatory systems strengthening; article 9 research and development; article 10 sustainable and geographically diversified local production; article 11 transfer of technology and cooperation on related know-how; article 12 the Pathogen Access and Benefit-Sharing System; article 13 supply chain and logistics; article 14 procurement and distribution; article 15 whole-of-government and whole-of-society approaches; article 17 international cooperation and support; article 18 sustainable financing.

Article 12 is the heart of the bargain and the reason the negotiation took four years. The problem it addresses is old and is the same problem the Convention on Biological Diversity addressed for genetic resources: a State that shares a pathogen sample sees vaccines developed from it and sold back to it at a price it cannot pay, or not sold to it at all. Access and benefit-sharing is the attempt to link the two, so that sharing the sample carries a claim on what is made from it.

Institutions. Article 19, a Conference of the Parties; article 20, the right to vote; article 21, reports; article 22, a Secretariat; article 23, settlement of disputes.

Article 24, relationship with other agreements. Interpretation and application shall be guided by the Charter of the United Nations and the Constitution of the World Health Organization; the Parties recognise that the Agreement, the International Health Regulations and other relevant agreements should be interpreted so as to be compatible; and the Agreement shall not affect the rights and obligations of any Party deriving from other international agreements.

Article 25, reservations. Reservations may be made unless incompatible with the object and purpose of the Agreement. That is article 19(c) of the Vienna Convention written into the treaty itself, and [Reservations to Treaties] explains why the test is put that way.

Article 33, entry into force. On the thirtieth day following the deposit of the sixtieth instrument of ratification, acceptance, approval, formal confirmation or accession, and for each later State or organisation on the thirtieth day after its own deposit. Article 34 makes the Secretary-General of the United Nations the Depositary.

Signature was not immediate, and the resolution says why: the Agreement shall be open for signature after adoption of the Annex described in article 12 by the Health Assembly, at WHO headquarters in Geneva and thereafter at United Nations Headquarters in New York, on dates the Assembly determines. So the pathogen access and benefit-sharing Annex had to be finished before States could sign, and until it was, the Agreement was adopted but not open.

The Assembly's holding position, meanwhile. The resolution urges all States, pending entry into force, to take all appropriate measures to further the Agreement's objective, guided by equity and solidarity; and urges that if a pandemic emergency is determined before entry into force, States take measures promptly, on a voluntary basis, in line with the Agreement's provisions, without prejudice to any State's position on the Agreement itself.

That paragraph is a small lesson in the law of treaties. An adopted but unratified treaty binds nobody, so the Assembly could only urge. What it produces is close to the interim obligation in article 18 of the Vienna Convention, arrived at by recommendation rather than by law.

A worked example

State AA is a Member of the Organization. It votes against the Pandemic Agreement, does not sign it, and says nothing to the Director-General for two years. An outbreak then begins in its territory. State BB is a Party to the Framework Convention on Tobacco Control and permits tobacco companies to sit on the committee drafting its tobacco policy. State CC ratifies the Pandemic Agreement with a reservation excluding article 12.

State AA and the Pandemic Agreement. Adoption under article 19 does not bind it. But article 20 of the Constitution obliged State AA, within eighteen months of adoption, to take action relative to acceptance, to notify the Director-General of the action taken, and, not having accepted, to furnish a statement of the reasons for non-acceptance. Two years of silence breaches article 20.

Is State AA free of obligation in the outbreak? No. The International Health Regulations bind it under article 22 of the Constitution unless it rejected or reserved in time, and [The International Health Regulations] sets out the notification duty. The Agreement and the Regulations are separate instruments, which is what article 24(2) of the Agreement recognises when it requires them to be interpreted so as to be compatible.

State BB's committee. Article 5(3) of the Framework Convention requires Parties, in setting and implementing public health policies with respect to tobacco control, to act to protect these policies from commercial and other vested interests of the tobacco industry in accordance with national law. Seating the industry on the drafting committee is the paradigm of what that provision forbids.

State CC's reservation. Article 25 permits reservations unless incompatible with the object and purpose. Article 12 is the pathogen access and benefit-sharing system, the central bargain of the instrument, so a reservation excluding it is a strong candidate for incompatibility, and under [Reservations to Treaties] each other Party judges that for itself under article 20(4) of the Vienna Convention.

Change one fact: State AA accepts the Agreement but a pandemic begins before the sixtieth instrument is deposited. The Agreement is not in force, so it binds nobody, and resolution WHA78.1 only urges States to take measures promptly, on a voluntary basis, in line with its provisions.

Distinctions table

What it does NOT mean

Global health law is not one instrument. It is assembled from the WHO Constitution, human rights treaties, trade law and environmental law.

Adopting a convention under article 19 does not bind Members. Acceptance does.

The Pandemic Agreement does not give the Organization power over national health policy. Article 3(1) makes the sovereign right of States to legislate the first guiding principle, and the Preamble reaffirms the principle of sovereignty in addressing public health matters.

The Agreement was not in force on adoption. Article 33 requires sixty instruments, and signature awaited the article 12 Annex.

A framework convention is not a weak treaty. It binds; it states objectives and general obligations and leaves detail to protocols and national law.

Reservations to the Agreement are not free. Article 25 permits them only where not incompatible with the object and purpose.

Limits and criticism

Two conventions in nearly eighty years is a thin record for an organisation whose Assembly may adopt them on any matter within its competence, and it reflects how much easier it is to obtain a recommendation than a treaty.

The incentive problem is not solved. A State still loses trade and travel by reporting an outbreak, and the Agreement's answer, that equity in access to products will follow, depends on machinery that had not been completed when the Agreement was adopted.

Article 12 was the hardest article to write and is the easiest to reserve against. A system of access and benefit-sharing whose Annex is separately negotiated, and to which reservations may be entered subject only to the object and purpose test, may deliver samples without delivering benefits, which is the outcome the sharing States most fear.

The tobacco convention shows what implementation depends on. Its substantive obligations are almost all qualified by national law and national jurisdiction, so the Convention's real force has come through domestic legislation and litigation, and Parties whose legislation is weak are not visibly in breach.

Quick revision

Global health law = the WHO Constitution and what the Health Assembly makes under articles 19, 21 and 23; the right to health in the human rights treaties; trade law on medicines and on restrictions; environmental law on prevention and due diligence.

Why communicable disease is a legal problem: reporting an outbreak costs the reporting State trade and travel, so the incentive is to conceal; the law answers with a duty to notify and a discipline on other States' responses.

FCTC 2003, resolution WHA56.1, the first article 19 convention. Article 3: protect present and future generations from the devastating health, social, environmental and economic consequences of tobacco. Article 4: every person should be informed of the health consequences, addictive nature and mortal threat. Article 5(3): protect tobacco control policy from commercial and other vested interests of the tobacco industry. Article 8: protection from exposure in indoor workplaces, public transport, indoor public places. Article 36: in force on the ninetieth day after the fortieth instrument. Secretariat functions by WHO until a permanent one is designated.

WHO Pandemic Agreement, resolution WHA78.1 of 20 May 2025, adopted pursuant to article 19, from the Intergovernmental Negotiating Body set up by SSA2(5) 2021 and WHA77(20) 2024. Article 2: prevent, prepare for and respond to pandemics, applying both during and between pandemics. Article 3: the sovereign right of States to legislate; human rights including the highest attainable standard of health; international humanitarian law; equity; solidarity; best available science. Article 5 the One Health approach; article 12 the Pathogen Access and Benefit-Sharing System; article 19 a Conference of the Parties; article 24 compatibility with the International Health Regulations; article 25 reservations unless incompatible with the object and purpose; article 33 in force on the thirtieth day after the sixtieth instrument; article 34 the Secretary-General is Depositary.

Test yourself

1. What is global health law?

It is the body of international law bearing on the health of populations, assembled from instruments that were not drafted as a single system. It comprises the WHO Constitution and what the Health Assembly makes under it, namely conventions under article 19, regulations under article 21 and recommendations under article 23; the human rights treaties, principally the right to the enjoyment of the highest attainable standard of health, stated in the WHO Preamble in 1946 and made a treaty obligation by the International Covenant on Economic, Social and Cultural Rights; trade law, since access to medicines turns on the intellectual property rules in TRIPS and health restrictions on trade engage the general exceptions of GATT; and environmental law, whose obligation of prevention as a matter of due diligence applies to health harms crossing frontiers. The law of treaties and of State responsibility apply throughout.

2. Why is communicable disease a problem international law must address?

Because the incentives facing a State that discovers an outbreak run the wrong way. Reporting brings closed borders, halted trade, cancelled travel and lost tourism; concealment postpones all of that. The WHO Preamble states the consequence for other States: unequal development in different countries in the promotion of health and control of disease, especially communicable disease, is a common danger, and the health of all peoples is fundamental to the attainment of peace and security. The law's answer has two parts: an obligation to notify within a fixed time, and a discipline on the measures other States may take in response, so that the reporting State does not lose more by reporting than by concealing. A third device, making assistance follow the report, works only so far as the assistance actually arrives.

3. Give an account of the Framework Convention on Tobacco Control.

It was adopted by resolution WHA56.1 of the Fifty-sixth World Health Assembly under article 19 of the WHO Constitution, and was the first convention ever adopted under that article. Its objective, in article 3, is to protect present and future generations from the devastating health, social, environmental and economic consequences of tobacco consumption and exposure to tobacco smoke, by providing a framework for tobacco control measures to be implemented at the national, regional and international levels in order to reduce continually and substantially the prevalence of tobacco use. It is a framework convention, stating objectives, principles and general obligations and leaving detail to protocols and national law. Its most used provision is article 5(3), which requires Parties to act to protect their tobacco control policies from the commercial and other vested interests of the tobacco industry. Article 8 requires protection from exposure to tobacco smoke in indoor workplaces, public transport and indoor public places, and other articles cover taxation, product contents, packaging and labelling, advertising bans, cessation, illicit trade and sales to minors. It entered into force on the ninetieth day after the fortieth instrument was deposited, and India is a Party.

4. What is the WHO Pandemic Agreement and how was it adopted?

It was adopted by resolution WHA78.1 of the Seventy-eighth World Health Assembly on 20 May 2025, pursuant to article 19 of the WHO Constitution, following negotiation by the Intergovernmental Negotiating Body established by decisions SSA2(5) of 2021 and WHA77(20) of 2024 to draft an instrument on pandemic prevention, preparedness and response. Its objective under article 2, guided by equity, is to prevent, prepare for and respond to pandemics, and its provisions apply both during and between pandemics unless otherwise specified. Article 3 states its guiding principles, beginning with the sovereign right of States to legislate and implement legislation within their jurisdiction, and continuing with human rights including the highest attainable standard of health, international humanitarian law, equity, solidarity and the best available science. Article 33 provides that it enters into force on the thirtieth day following the deposit of the sixtieth instrument, and the Secretary-General of the United Nations is the Depositary under article 34.

5. Explain article 12 of the Pandemic Agreement and why it was contentious.

Article 12 establishes the Pathogen Access and Benefit-Sharing System. The problem it addresses is that a State which shares samples of a pathogen found in its territory enables the development of vaccines, diagnostics and treatments from which it may then be excluded, either by price or by supply, and the experience of the COVID-19 pandemic is recorded in the Agreement's Preamble as deep concern at the inequities that hindered timely and equitable access to health products. Article 12 links access to samples with a share of what is produced from them. It was contentious because it is the central bargain between the States that supply the pathogens and those that possess the manufacturing capacity, and its detail was left to an Annex to be adopted separately by the Health Assembly, so that under resolution WHA78.1 the Agreement was not even opened for signature until that Annex had been adopted.

6. Compare a convention under article 19 with regulations under article 21.

A convention under article 19 requires a two-thirds vote of the Health Assembly and comes into force for each Member only when accepted by it in accordance with its constitutional processes, so it is an ordinary treaty in its binding effect; article 20 then obliges every Member, within eighteen months of adoption, to take action relative to acceptance, to notify the Director-General, and to give reasons if it does not accept. Regulations under article 21, confined to the five subjects that article lists, come into force under article 22 for all Members after due notice, except for those which notify the Director-General of rejection or reservations within the period stated in the notice, so silence binds. The Framework Convention on Tobacco Control of 2003 and the Pandemic Agreement of 2025 are the only instruments adopted under article 19; the International Health Regulations and the Nomenclature Regulations are the instruments adopted under article 21.