Bridges Weekly Trade News DigestVolume 16Number 42 • 5th December 2012

WHO Adopts Strategic Work Plan on Health R&D

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Member states at the World Health Organization (WHO) last week approved a strategic work plan on the issue of research and development (R&D) for diseases that disproportionally affect developing countries, following up on a report by a WHO expert group earlier this year.  However, they stopped short of moving forward on a binding convention in this area, which had also been recommended in the report.

The Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG)- established two years ago in the context of the implementation of the WHO’s global strategy and plan of action on public health, innovation, and intellectual property (GSPA-PHI)  -  was tasked with examining current and proposed financing of R&D for diseases that disproportionately impact poor countries, along with diseases that occur in both developed and developing countries.

The CEWG’s report, released in May, suggests that all countries should aim to achieve specified levels of public funding for health R&D relevant to the needs of developing countries, and that a financing system be established under a convention based on contributions by governments. The proposal received support, among others, from Economics Nobel Laureate Joseph Stiglitz at its launch in Geneva. (See Bridges Weekly, 9 May 2012)

The exclusive protection afforded by patents to pharmaceutical products is an important market mechanism that allows for the channelling of resources for future R&D on innovative products, according to the CEWG report. However, it also recalls the 2001 Doha Declaration on TRIPS and Public Health, which says that, while intellectual property protection is key for the development of new medicines, it can also make products less affordable for poor countries.

Therefore, according to the CEWG report, an R&D convention should not serve as “a replacement for the existing intellectual property rights system,” but should instead act as a supplementary instrument in areas “where the current system does not function.”

Such a convention, the CEWG argues, should focus on the development of health technologies for diseases that occur almost exclusively in poor countries - such as malaria and African sleeping sickness - as well as the specific needs of developing countries regarding more globally widespread illnesses, such as cancer and diabetes.

At the meeting in Geneva last week, countries were tasked with reviewing the CEWG report and advancing options for research coordination, financing, and monitoring of R&D expenditures for developing country health needs. In the final outcome, members agreed to establish a Global Health R&D Observatory at the WHO “to monitor and analyse relevant information on health R&D… with a view to contributing to the identification of gaps and opportunities… as well as… to support coordinated actions.”

The decision also calls upon the WHO Director General to explore funding and coordination mechanisms in this area. It makes no mention of a framework or convention, which was a sticking point for many delegations.

Members at odds over convention

During the meeting, the United States reportedly opposed any inclusion of treaty language or even a mention of the “CEWG” in the final outcome. According to IP Watch, a specialised news publication focusing on intellectual property issues, the US expressed concerns that the proposed treaty was more about access to medicines and other development issues, rather than the problem of medical R&D gaps.

Many EU countries reportedly also voiced their apprehension regarding a convention, citing a lack of political will for financial commitments.

Thailand, who chaired the meeting, supported the recommendation for a binding convention because “experiences on global special programs by using voluntary contributions had proved not sustainable and [given the] unpredictable level of funding size.”

Civil society, industry reactions

Earlier in the week, a handful of civil society groups circulated an open letter which called the establishment of a global health R&D observatory a “positive step,” while noting that more still needs to be done, given the extent of the challenge.

Médecins Sans Frontières was among those to argue that more action is needed, noting that the current outcome is insufficient. “Instead of pushing forward with a real plan to address the continued lack of suitable and affordable vaccines, drugs and diagnostics that our teams in the field face, all countries have really pledged to do is to continue observing the situation,” the NGO said.

For its part, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) welcomed the outcome, saying that it “focuses the international health community on concrete and pragmatic steps to address short- and medium-term needs, including understanding what the gaps and the priorities are.”

Next steps

The final decision asks that the report and resolution be forwarded to the WHO’s Executive Board and World Health Assembly next year for adoption “without re-opening it.” Countries will reconvene before the World Health Assembly in 2016 to “assess progress and continue discussions on the remaining issues in relation to monitoring, coordination and financing for health R&D taking into account all relevant analyses and reports, including the analysis of the CEWG Report.”

ICTSD reporting; “WHO Members Agree On ‘Strategic Work Plan’ On Health R&D - But No Convention,” IP WATCH, 29 November 2012.

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