International Instrument On Medical R&D Still On Negotiating Table At WHO 28/11/2012 by Rachel Marusak Hermann for Intellectual Property Watch 1 Comment Print This Post World Health Organization member states gathering this week at the WHO headquarters in a meeting to address global gaps in the drug development system said that there is still much work to be done before consensus can be reached on a resolution. For now, the latest draft resolution keeps a wide range of monitoring, coordinating, and financing options on the table, not yet setting a clear direction. By the end of day two of the open-ended meeting on the follow-up of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG), at least two versions of a draft proposal on elements of a draft resolution have circulated, the latest of which is available here [pdf]. As agreed during the 65th World Health Assembly last May, WHO member states are meeting from 26-28 November to examine the CEWG report, the feasibility of its recommendations, and to develop proposals or options related to research coordination, financing, and the monitoring of R&D expenditures. The meeting public documents are available here. In the latest draft resolution, the possibility of a binding convention on medical research and development, which was the CEWG report’s main recommendation and an area of debate during these negotiations, remains open. “[OP1 proposed by Iran – Decides to establish a Global Health R&D Monitoring, Coordination and Financing Action Framework, as an initial step towards the development of effective, safe, quality, suitable and affordable health technologies that existing market mechanisms and public policies fail to deliver]” “OP2 URGES Member States: … [to work further with the objective of elaborating an international instrument on R&D related to Type II and Type III diseases and the specific R&D needs of developing countries in relation to Type I diseases that incorporates actions on monitoring, coordination and financing without prejudice of the legal nature of the resulting instrument]” “OP3 REQUESTS the Director-General: … [To convene an intergovernmental working group open to all Member States to identify the objectives and components of an instrument without prejudice to its legal nature, on monitoring, coordination and financing of health R&D related to Type II and III diseases and the special R&D needs of developing countries in relation to Type I diseases]” These passages were not included in an earlier version of the draft resolution, available here [pdf]. In reaction to this earlier version, a delegate from a middle-income country commented, “this draft does not accurately reflect the conversation over the past two days.” The delegate said that there was a clear divide between countries in favour of a binding convention and those in support of a voluntary commitment approach. During opening statements, Thailand and Colombia expressed strong backing of an R&D treaty, according to sources. Some high-income countries, including the United States and those in the European Union, called for a more incremental approach. For example, in terms of research coordination, the EU suggested a pilot process [pdf], which would focus on “2-3 distinct diseases or health conditions” as a starting point. It also called for the creation of a “virtual multi stakeholder platform (including funders and implementers for sharing and harmonisation and alignment of research challenges and financing.” Non-governmental organisations (NGOs), including Médecins Sans Frontières (MSF, Doctors Without Borders), the Third World Network, and Knowledge Ecology International (KEI), present in the halls outside of the closed-door WHO meeting, called for member states to take decisive action. Michelle Childs, director of policy and advocacy at MSF’s Access Campaign, told Intellectual Property Watch, “The question is whether tomorrow is the dawn of a new day, or a familiar one, where there are stop-gap measures. What we are most concerned about is that they will miss the opportunity to fix this problem rather than put a band-aid on it.” [Updated] James Love, director of KEI, underscored the opportunity to advance innovative R&D incentive schemes by, for example, delinking associated costs from the price of medicines. According to sources, delinkage may be included in the preamble which should be added in the next draft. Over 60 NGOs submitted an open letter [pdf] on the follow-up of the CEWG report, which was delivered by Health Action International (HAI) and KEI during the first morning session. WHO observers, additional NGOs, and at least one group from the private sector, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), were permitted to attend the first morning session. IFPMA’s statement is available here. [pdf] Viroj Tangcharoensathien of Thailand is chairing the meeting and will hold an open briefing session on the outcomes on 29 November. 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