Taking a Rights-Based Approach to AIDS Research

An Interview with David Patterson


At the last two International AIDS Conferences, the Canadian HIV/AIDS Legal Network has co-sponsored workshops (“Putting Third First”) that have been widely recognized for bringing together AIDS advocates from diverse fields, including microbicides, vaccines and treatment. The common ground is a human rights-based approach, which argues that international statutes are important tools for advancing treatment and prevention agendas. Australian-born David Patterson was a founding member of the Network in 1992 and is now its director of International Programs and Capacity Building. Trained in law and public policy, Patterson has helped the Network develop its comprehensive approach, to promoting AIDS vaccine research and access to treatment in Canada and around the world. Recently, he spoke with IAVI Report Senior Writer Emily Bass about why scientific research on AIDS vaccines and other interventions is a human right.

How can a human rights-based approach be used to further HIV vaccine research—or any scientific research?

The rights-based approach draws on a strong, developing body of international law that proclaims and secures the rights of individuals with respect to their governments. In the area of HIV/AIDS, we’re looking particularly at the right to health. Governments have to assure the conditions under which people can be healthy.

We argue that if there’s research which needs to be done—for example, on new treatments or prevention technologies, like vaccines and microbicides—then governments have the obligation either to do that research or to make sure it gets done.

What are some of the international agreements you invoke in making these arguments?

The source document for all our work is the Universal Declaration of Human Rights, which proclaims that every human being should be guaranteed the right to education, freedom from persecution, and a standard of living adequate for their health and well-being. Most governments have entered into legally-binding treaties whereby they promise to assure the rights set out in the Universal Declaration. For civil and political rights, governments have committed to immediate action; for other areas, like health, they have committed to acting to the best of their ability according to their national resources.

The right to health and other obligations are also set out clearly in the International Covenant on Economic, Social, and Cultural Rights (ICESCR), which has been ratified by over 140 countries. The ICESCR is one of the treaties which guarantees the rights set out in the Universal Declaration.

How effective are these treaties, especially when countries like the US do not sign them? [The US has never ratified the ICESCR, although it signed in 1977.]

International law is being tested at the moment, and in some areas it’s been strengthened and extended. For example, we’re seeing the introduction of an international criminal court, and the further development of mechanisms for handling individual complaints under human rights treaties.

Even countries that are uncomfortable with the idea of a universal human rights framework are beginning to acknowledge that these laws exist. When North Korea tried to withdraw from the nuclear nonproliferation treaty, the fact that they announced they were going to withdraw, in the way that the treaty proclaims, actually meant that they saw themselves as being bound by it.

Human rights lawyers also argue that these declarations are customary international law, meaning that countries can be held to their principles even if they have not signed a specific treaty.

Where are examples of international covenants being applied in the field of HIV/AIDS?

One example is the case that South African activists brought against the government to gain national access to antiretrovirals which reduce mother-to-child transmission. The arguments put before the court addressed not only South Africa’s constitutional obligations, but also its obligations under international law.

There was also a case of a foreign national in the UK who was facing deportation to his home country, but was so sick with AIDS that he surely would have died if he had been deported. The European Court of Human Rights held that it would have been a breach of his human rights to send him back, given his condition. It’s a rather limited decision because it applied to someone who was very ill. But at the same time, it was a decision that put access to treatment in a human rights framework.

It doesn’t take much to go a bit further and argue that if you have an epidemic but no cure or affordable treatment, then governments are obliged to explore vaccines as an option.

How have can these covenants be linked to AIDS research?

Vaccines are starting to be included in a growing body of work on the right to health. For example, in August 2002, the UN Commission on Human Rights appointed Paul Hunt, a law professor from New Zealand, to serve a three-year term as a special rapporteur on the right to health, focusing on neglected diseases and HIV/AIDS in developing countries. We’re going to provide him with the materials that have been developed on obligations of governments around AIDS vaccines and research, so they can be factored into his work.

AIDS vaccines were also being incorporated into the latest version of the UN guidelines on how international law applies to AIDS. The original version was prepared in 1996, a time when vaccines and treatments weren’t high on the agenda in the context of the developing world. Last year the guidelines were revised, and they now make direct reference to legal and other measures to assure access to treatments and vaccines.

The UN General Assembly Declaration of Commitment on HIV/AIDS is not binding on states, but it’s another advocacy tool we can use.

How can governments start to get involved in vaccine research?

National vaccine plans are a great entry point. They are evidence of governments taking up their responsibilities to address the right to health in the domain of epidemic diseases, which are specifically mentioned in the ICESCR.

A national vaccine plan can lay out the ways that governments will fulfill some of the obligations related to assuring this right, including investing in the research directly, or assuring private sector conditions such as tax incentives, that encourage investment. A plan can also lay out commitment to investment in basic science; support for public-private research partnerships; creation of laws to limit liability claims; and government-backed compensation funds for vaccine manufacturers. National vaccine plans can also be explicit about the ways that governments will ensure the right of access to the benefits of scientific research, which is also proclaimed in the ICESCR.

So far, Canada is the only industrialized country which is developing a national plan. How did this happen?

Community advocacy around HIV vaccines actually started in Canada in 1999 on legal and ethical issues. Together with the Center for Bioethics of the Clinical Research Institute in Montreal, we developed a background paper. The next step was a national workshop, funded by the government agency Health Canada, that brought together many groups—including men who have sex with men, injection drug users, and aboriginal peoples and AIDS researchers. Out of that came recognition of the need for a much more coherent strategy in Canada.

We released a set of recommendations in a report  (www.aidslaw.ca/Maincontent/issues/vaccines.htm) and at the Network’s satellite meeting in Barcelona, (www.aidslaw.ca/barcelona 2002/e-barcelona2002.htm). And in Barcelona, the Canadian government representative announced that Canada would actually develop a vaccine plan.

What will the plan include?

As it stands now, the plan will involve a research strategy and an access strategy, which will look at complicated issues around a vaccine’s degree of efficacy, costs, and the use of partially protective vaccines. We’re also committed to including a component on Canada’s international response around the development of HIV vaccines.

Another suggested element is a communications plan. Before release of the VaxGen data, the Network worked closely with the Canadian AIDS Society to distribute materials and brief the press. Once the data came out, David Thompson, who works on national vaccine issues at the Network, did extensive media interviews. So the NGO community was prepared in a way that showed coordination and leadership. We hope the national vaccine plan in Canada will include government planning for similar activities.

As other countries go through this process of making national plans, differences will surely emerge. Is there a point where we get some consensus?

I would be delighted if five or six countries came up with vaccine plans within the next year or so. Especially if they addressed research obligations and so on, because this would give advocates another tool for holding governments to their commitments.

But we’re a long way from the situation where we’ve got a problem with too many conflicting vaccine plans. The first few may be quite different from one another. But the more they’re shared, the more people will draw on the experience of the groundbreakers, and the plans will become more homogeneous over time. The challenge is to recognize that there is commonality. My sense is that countries often think their situation is so specific that they have little to learn from other countries. Yet from a global and historical perspective, we can see this is not true.

Getting back to the topic of treaties and agreements, does international law also apply to corporations?

We’re not seeking to apply international human rights law directly to corporations at this stage. I think it could undermine the credibility of the tools we have. If we say that international law assures everyone the right to everything, and that everyone has a commitment to assure this right, then it just becomes meaningless.

So we have to recognize the limitations of international law, while at the same time asserting the responsibility of governments to regulate corporations within their respective and collective jurisdictions.

Are there other ways to apply some of these principles to companies?

There is a whole area of exploration into this—it’s very cutting edge. The United Nations has created a Global Compact with businesses to assure human rights and environmental awareness in the context of globalization (see www.unglobalcompact.org/Portal ). There have been other efforts, too. The International Labor Organization (Geneva) worked with businesses, government and labor to develop a code of practice on HIV/AIDS in the workplace, addressing stigma and discrimination, treatment and care for workers. There’s an expectation that once a process like this has taken place, then the three sectors will move it forward, and the ILO made a call for that in February, 2002.

But these initiatives are not legally binding. As advocates, we call this area “soft law.” The hard law is the treaties—the ink on the paper. Soft law is this expanding area of a sense of obligation that other actors should respect international law, even when they are not directly bound by it.

In the AIDS vaccine field, we can develop memoranda of understanding with transnational corporations involved in research and, eventually, distribution of vaccines—similar to the commitments which have been made to reduce the prices of antiretroviral medications in the developing world.

Is there a tension between the kinds of intellectual property [IP] issues in developing vaccines—where companies need assurances that IP will be protected—and treatment, where the move is towards generic manufacturing?

We have to acknowledge that the private sector isn’t going to invest unless there is a predictable international IP environment. At the same time, we recognize the overwhelming imperative to provide affordable treatment as soon as possible to people living with HIV in developing countries.

I think the answer lies in recognizing that intellectual property must be respected in order for research to continue, and, simultaneously, that the poorest countries should be allowed to utilize existing protections and mechanisms to assure access to treatments. This means that we in the West will continue to pay high prices for our medications, and that we will carry the burden of the research agenda so that people in developing countries can benefit from this research.

Governments also have an obligation here, which is to guarantee purchase in both developed and developing world contexts. If we can do this—for example, through long-term commitments of governments and institutions like UNICEF and the World Bank to purchase vaccines—then it will also strengthen companies’ willingness to develop vaccines based on the most common clades in developing countries, if clade turns out to be important for vaccine efficacy.

Can the research community draw on international law to protect or improve the rights of people in certain potential trial populations, like commercial sex workers and IV drug users?

Governments want this research, and they don’t want to be seen to be obstructing it. So trials are another advocacy opportunity. We can say to governments, “Look, we have a concern here.” We need to ask for a clear statement from host and partner countries on issues such as confidentiality [around serostatus or trial participation] and protection of human rights, so the research can proceed.

So it’s an incremental process.

Absolutely. I think when people look at laws, they see things in black-and-white. But people who work in the law know that there are many factors which influence a decision to prosecute, and that a lot can be done without actually achieving law reform. In fact, law reform may be the last thing to come about, once communities and authorities realize what is necessary.

The Durban and Barcelona “Putting Third First” satellite meetings brought together treatment, vaccine and microbicide advocates. Based on that experience, where are the opportunities for collaboration among these fields?

There are many areas. Treatment access is a key issue for vaccine research because of the need to assure the best treatment for participants who become infected during the course of trials.

Increasing the health care budget at country level is another area for joint collaboration. So is assuring mechanisms for distributing health commodities, whether they’re treatments, HIV vaccines or other vaccines. Medical literacy amongst practitioners and the communities is another common agenda point.

How do you respond to cost-benefit analyses which pit treatment against prevention, or funding for existing interventions against research into new ones?

The difficult decisions about budget allocations can best be made by the countries that are directly affected. We hope they will do that with full community consultation. I don’t think that we can easily say from the outside that a different proportion should be going in one direction or the other. The way we can assist is by advocating for full community consultation, sharing information and models, and by assuring governments the best possible deal on the medications they want to purchase—for example, through bulk purchase agreements, regional purchase strategies, generics.

What are your goals for the next year?

Our short-term plan is to have a follow-up meeting between vaccine, microbicide and treatment activists to advance our common agendas.

With IAVI, we’re also looking at national legislative frameworks that can advance vaccine research and access, and at what experience has been gathered so far. For example, India’s Lawyers Collective HIV/AIDS Unit, which co-hosted the Barcelona satellite along with the Legal Network and South Africa’s AIDS Law Project, has been invited to submit proposals for an HIV/AIDS bill that we expect will contain some vaccine-related proposals. So we are very interested in the Indian experience, particularly because it is being done in a consultative fashion.

We are also developing a community action kit, which will take many of the issues we’ve discussed here and set them out in ways that advocates can easily use. We’d like to pilot test it in different languages and countries.

How has the field changed over the past few years?

Jonathan Mann used to talk about the legal and ethical imperative to undertake vaccine research. At the first satellite meeting we had in Durban—I think there were about three vaccines in the pipeline at that time—we were saying, listen, governments actually have legal obligations to invest much more heavily in this area.

Since then the climate has changed a lot, and we’ve seen a much greater interest and investment in HIV vaccines from both our private sector foundations and from governments—although I wish we had more Phase III trials.

But I think the principle is there: That governments are not only obliged to assure the right to health for HIV-positive people, but also to assure the best possible prevention technologies for people who are HIV-negative. Besides being a moral and ethical obligation, we also have to look at this as an international legal obligation.