WHO Tackles Intellectual Property, R&D Treaty

27 May 2009

Members of the World Health Organization gathered for their 62nd annual assembly at WHO headquarters in Geneva last week. The meeting was held from 18-22 May, but did not extend into a second week as originally planned, due to the recent outbreak of the H1N1 flu virus. But members still found time for intense discussions on intellectual property, innovation and public health, particularly with respect to the fine-tuning of the 2008 Global Strategy on Public Health, innovation and Intellectual Property. A proposal for a treaty on biomedical research and development emerged as a particularly controversial issue.

Members Reach Resolution on IP, Innovation and Public Health

After intense debate, Member States adopted a final plan of action on public health, innovation and intellectual property that includes an agreed list of stakeholders who will be involved in the process of implementation, as well as a time frame and progress indicators by which to monitor progress in this respect. Member states approved the final plan following three years of work by the WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG). Established by the World Health Assembly, or WHA, the IGWG was asked to draw up a global strategy and plan of action on ways to bring new thinking on innovation and access to medicines and to provide a framework for essential health research and development relevant to diseases which disproportionately affect developing countries. 

But the final approval was not without contention. Several member states expressed concern over the process by which negotiating text, “Open paragraphs on Stakeholders,” was presented to the Assembly. The document contains proposals for the remaining stakeholders of the Global Strategy and Plan of Action. Several developing countries argued that the process of consultation was not sufficiently inclusive. In a joint intervention, Barbados, Bangladesh, Bolivia, and Suriname noted that “only a limited number of countries were invited to negotiate on the remaining bracketed text of the WHO plan of Action leaving the majority of states with no real recourse or fora to engage in meaningful negotiations prior to the convening of the 62nd Assembly.”

Faiyaz Murshid Kazi, the Bangladesh representative, told ICTSD that his delegation was unsatisfied with the process by which the consensus text was reached, adding that such a process should have been more participatory.

Mixed Reactions to possible treaty on Research and Development

Discussions focused extensively on a possible treaty in biomedical research and development (R&D). This treaty, which has been strongly supported by groups from civil society and countries such as Bangladesh, Barbados, Bolivia and Suriname, stems from a recommendation included in the Global Strategy that calls for “further exploratory discussions on the utility of possible instruments or mechanisms for essential health and biomedical R&D, including inter alia, an essential health and biomedical R&D treaty.”
Although the sponsors believe that such a treaty would considerably “transform the landscape of biomedical innovation to incorporate needs driven health R&D,” several developed country members, primarily the US and the EU, said that the WHO was not an appropriate forum for the discussions on the treaty.

The issue of WHO acting as a main stakeholder was controversial. However, after informal negotiations, the WHO’s status as a stakeholder was dropped. This changetriggered concerns among several non-governmental organisations and developing country members. Barbados stated that such an omission could leave the proposal without a forum for discussion or advancement once the Expert Group on R&D Financing concludes its time limited mandate.  Bolivia also added that “much time, effort, and hope may be lost if WHO, which is in a position to support the needs of developing countries, is not allowed to participate in bringing it to fruition.”

Several NGOs, including Essential Action, Health Action International, Knowledge Ecology International, and Medecins Sans Frontieres, also expressed concern on the matter.  In an open letter to WHO member states, the NGOs noted their surprise that the WHO had been removed as a stakeholder.
“WHO is the UN agency with the mandate for global health [and] it is unacceptable that there would be any opposition the WHO having a role in taking forward discussions on what global norms should be contained in a proposal for a biomedical treaty,” the groups wrote.

For its part, the WHO secretariat assured Members that the organisation could consider the proposal, even though it would not be a formal stakeholder in the process.  The WHO’s legal counsel reaffirmed that position. The “[d]ecision undertaken on agenda item 12.8 shall not prejudice the future consideration of a biomedical R&D treaty by the WHO Executive Board and the World Health Assembly,” the counsel said. Agreement was subsequently reached following the assurance from the WHO legal counsel that the proposal for an R&D treaty could be legitimately considered by the Executive Board.

Counterfeit Issues Still Surfaced Despite being cut from WHA Agenda

During discussions on WHO’s Mid-term Strategy Plan 2008-2019, some member states objected to the use of the term ‘counterfeit’ in the organisation’s work.  Many countries are opposed to the use of this term since it is associated with the definition provided in the WTO’s Agreement on Trade-Related Aspects of Intellectual Property. Such countries worry that the use of the term in the context of the WHO’s work could cause the organisation to consider public health issues through the lens of IP enforcement.
Specifically, the medium term plan allows the WHO to assist countries in implementing the International Medical Products Anti-counterfeiting Taskforce (IMPACT) strategy. The composition of this taskforce was met with much apprehension during the January meeting of the WHO Executive Board meeting, as many developing countries raised concerns over the legitimacy of the body, arguing that it was not representative of all relevant stakeholders and perspectives on this issue. In light of these concerns by member states, the WHO’s Director General, Dr. Margaret Chan, agreed to replace the term ‘counterfeit’ in favour of other terms such as ‘sub-standard’.

Although initially on the agenda for this year’s Assembly, the controversial issue was subsequently dropped as the WHA was curtailed due to the recent H1N1 influenza outbreak.

ICTSD reporting; IP-Watch reporting; “WHO members near deal on IP, Innovation and Public Health, with Key Question,” 21 May 2009.; IP-Watch reporting; “Off the Agenda, Counterfeits Still Draw attention at the health Assembly:, 23 May 2009; IP-Watch reporting, “Broad Plan on IP, Innovation in Developing Countries Approved at the WHO, 22 May 2009; Indian Express reporting, “WHO gets what role?”, May 22 2009.

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