Benefit Sharing

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.

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.

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.

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.

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

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.

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.

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.

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.