The WHO’s Final Sprint Toward An International Convention On R&D

An international convention on research and development for neglected diseases has never been so closely within reach. A World Health Organization expert group is recommending the implementation of a legally binding instrument to secure new sources of funding to spur health research in areas where the current system has failed.

In the run-up to the 65th annual World Health Assembly (WHA), scheduled to take place on 21-26 May, the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) presented its recommendations in a recently released report, “Research and development to meet health needs in developing countries: strengthening global financing and coordination.” The report is available here.

Released on 5 April, the publication was made available well ahead of the WHA in order to allow delegates enough time to digest the more than 200-page document. In addition, the WHO will hold a briefing session on 27 April for Geneva-based permanent missions. CEWG Chair Prof. John-Arne Røttingen, and Vice Chair Prof. Claudia Inês Chamas, will present the group’s recommendations and field any questions. Due to high demand, this briefing will exceptionally be open to all official WHO observers.

The report’s main recommendation is to initiate the process of implementing an international convention on R&D. The report states, “[T]he time has now come for WHO Member States to begin a process leading to the negotiation of a binding agreement on R&D relevant to the health needs of developing countries, and this would be under Article 19 of the WHO Constitution.”

In the history of the WHO, Article 19, which provides the WHA with the authority to adopt conventions, has only been implemented once with the Framework Convention on Tobacco Control. Zafar Mirza, coordinator of the department of WHO Public Health, Innovation and Intellectual Property, who coordinated the secretariat’s support of the CEWG, said the group’s recommendation is significant.

“Indeed there is a mandate and there is a precedence,” he told Intellectual Property Watch. “But one also has to appreciate that this mandate has only been used once in the past 60 years, which speaks to the importance of this issue.”

Debate to Come

Some of the other recommendations include making research that addresses the health needs of developing countries more available in the public domain or by appropriate open licensing approaches through, for example, patent pools. Additionally, the report recommends that countries and philanthropic organisations increase their funding and specifically suggests that all countries should commit at least 0.01 percent of gross domestic product to research to develop health technologies for use in developing countries.

Røttingen said that it was important to define the contribution rate. He told Intellectual Property Watch, “Helping to develop knowledge, by financing it, is a contribution toward a global public good. We decided to propose a specific number both to avoid the problem of free riders and to set clear expectations in terms of commitment from the start. This rate of contribution would mean a doubling of existing resources.”

The group’s outcome is yet another key milestone in a 10-year history of work within the WHO on this issue. Prior to the CEWG, established by the WHA in 2010, there were other working groups, commissions and reports seeking sustainable financing for needed R&D. As noted in the publication’s introduction, the process may be reaching a final phase: “The report from this Consultative Expert Working Group seeks to bring this longrunning debate, if not to closure, to a head.”

The CEWG is made up of 21 regionally representative experts from a wide range of backgrounds, including research, government and industry. In developing their recommendations, the expert group assessed about 100 proposals (IPW, WHO, 5 July 2011). The CEWG was established by the 63rd WHA in 2010, under Resolution 63.28 [pdf] with the objective of submitting a final report this 65th WHA.

Røttingen said: “Ideally, I hope that member states will see that what we have been doing has been rigorous analysis and that this diverse group has agreed on key recommendations based on the proposals and ideas put to us. And hopefully they will see that the best way to get countries to implement the recommendations and commit to contributing to this urgent issue is through a formal agreement.”

Ultimately, the way forward will be decided by the WHA, the WHO members’ decision-making body. In light of the CEWG’s report, member states will discuss the recommendations and decide on a resolution on how to advance the issue following the Assembly.

“One major challenge in a process like this is that if you are not able to achieve consensus on recommendations or at least the process to achieve such consensus, what will be the way forward?” Røttingen said. “I hope that if constituencies do not agree, they will suggest clear alternatives. We do not want to end with the status quo, because all stakeholders agree the current situation is just not viable.”

Positive Reactions

Most public health experts agree that intellectual property rights and sales do not provide the incentive needed for investment to develop medicines, vaccines, and other technologies needed to treat the diseases affecting the world’s poorest populations. The Médecins Sans Frontières (MSF, Doctors Without Borders) Access Campaign website provides a long list of examples of “how the current model of R&D is failing patients in the developing world.” To name a few, there have been almost no new drugs developed to treat tuberculosis in decades; there is no test widely available to diagnose infants that have HIV/AIDS in poor countries; and there is no simple test that can detect Chagas disease.

MSF is one of several non-governmental organisations to support the CEWG’s recommendations. Knowledge Ecology International (KEI) compiled a list of views on the report with statements from several public health stakeholders. Michelle Childs, head of policy and advocacy at MSF’s Access Campaign, calls on governments to commit to the convention.

“The needs are clear: our medical teams in the field need better drugs, diagnostics and vaccines that are developed for use in resource-limited settings,” Childs said. “The expert report makes a clear and compelling case that we need to move away from a piecemeal approach, and towards a cohesive approach to funding, coordination and priority-setting to address the gaps in research and development through a convention.”

The intergovernmental South Centre issued a statement that “the negotiation and adoption of an international instrument that promotes pharmaceutical R&D that addresses the needs of developing countries would be a key element for the implementation of the GSPA-PHI,” referring to the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property agreed at the 63rd WHA.

“If successful,” the South Centre said, “this could be the most important achievement of WHO in the area of medicines since its creation.”

Although the International Federation of Pharmaceutical Manufacturers & Association (IFPMA) did not yet wish to comment specifically on the report, Mario Ottiglio, associate director of Public Affairs & Global Health Policy at IFPMA, said, “Discussions of new approaches and mechanisms for stimulating R&D into diseases that disproportionately affect developing countries should account for the complexity and ongoing evolution of the current pharmaceutical innovation paradigm.”

“There is not a ‘one-size-fits-all’ approach to stimulating R&D for these diseases,” Ottiglio added. “To continue meeting patient needs worldwide, several mechanisms yielding concrete health technology outputs should be integrated to drive a complete cycle of research, development and access to new medicines.”

KEI will continue advancing the conversation with a panel entitled, “An Essential Health and Biomedical Research and Development Treaty” on 25 April during the Global Forum for Health Research 2012 in Cape Town, South Africa.

Another briefing will be held for member states and official WHO observers on 22 May, the second day of the WHA, where the CEWG chair and vice chair will again present report recommendations and respond to questions.

Related Intellectual Property Watch articles are here, here, and here.