Around 2 am the open ended consultations on the CEWG recommendations finished their work on a report and proposed resolution, which is attached below. [See also interviews during the negotiations here: http://www.youtube.com/user/KEIWashDC/videos.]
In the afternoon of the third day, WHO Director General Margaret Chan stepped in and took charge of the negotiations, insisting the negotiators arrive at a consensus text, which emerged long after translation was available and after many negotiators had left the room. The final text is 4 pages long with no substantive brackets. The last recommendation of the report was as follows:
The open-ended meeting of Member States strongly recommends that the EB considers this report and its attached resolution with a view to recommending the adoption of the resolution by the WHA without re-opening it.
The three page resolution that was attached to the report requires the Director General:
- to develop norms and standards for classification of health R&D
- to establish a Global Health R&D Observatory within WHO’s Secretariat
- to develop a proposal for effective mechanisms, including pooling resources and voluntary contributions, as well as a plan to independently monitor their effectiveness
- the implementation of a few health R&D demonstration projects to address identified gaps which disproportionately affect developing countries, particularly the poor and for which immediate action can be taken;
- To make a number of reports on coordination and funding mechanisms and demonstration projects in 2014 and 2015
- to convene another Open-ended meeting of Member States prior to the 69th WHA in May 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; consensus
A number of negotiators from developing countries pressed for a much more ambitious outcome, building upon the bold report of the WHO Consultative Expert Working Group on R&D Financing, but the United States and the European Union, both dealing with large financial crises, were dead set against any action of the R&D Treaty proposal until 2016. Unless WHO member states are willing to open the resolution to amendment, attention will now shift the the creation of the R&D observatory and the “demonstration projects,” and evaluating new strategies to persuade the United States and the European Union that investments in medical research and development are inadequate, and that the current system has flaws, including but not limited to those associated with high prices for products, inadequate R&D for diseases that predominately concern poor persons living in developing countries, under-funding of other priority health R&D needs, and well documented (but not referenced) inefficiencies and market failures.
The CEWG report proposed the creation of a new binding agreement to provide billions of dollars annually for R&D to address the special health care needs of poor persons living in developing countries, and to introduce new approaches to funding R&D that included open innovation models, the delinkage of R&D costs from product prices and technology transfer and capacity building in developing countries.
What emerged from the negotiation was a much weaker watered down resolution that basically called for the creation of the R&D Observatory, mentioned some good principles and values without openly acknowledged the failures of the current system, and put off discussions of the CEWG more transformative reforms until 2016.
The issue of delinkage was mentioned, but only the preamble of the document and only in connection with incentives, and not other funding mechanisms such as grants or other “push” funding.
The report and proposed resolution are a huge disappointment for KEI and others who expected the WHO to begin work on an international agreement to provide sustainable funding for medical R&D in areas of priority, and to implement delinkage and open innovation models. KEI recognizes that this is a difficult time to create new financial obligations to fund R&D. But it is appalling that the negotiators settled on a three and half year delay in the discussions. If the US and the EU don’t think medical R&D is that important, they should stop making demands in trade agreements for expanded intellectual property protection for pharmaceutical drugs.
The Obama Administration has resisted the R&D treaty and more general reforms of medical R&D financing for the past four years, and now has blocked the treaty until the end of his second term in office, leaving the issue of funding for global health priorities to the next President. A treaty on R&D financing would have not have cost the United States any money, while creating obligations on other countries to pay more for global health R&D projects. The only reason for blocking this initiative to was to protect the existing drug development business model. The existing model benefits big pharma the most, and exploits consumers and marginalizes the poor.
Selected elements of the preamble, from the proposed resolution
PP5 Acknowledging the need for improving monitoring of health R&D resource flows, and identification of gaps in health R&D, better coordination of health R&D and priority-setting based on the public health needs of developing countries; consensus
PP6 Acknowledging also that the provision of additional information on disease burden, research opportunities, the potential health impact, and estimations of the resources needed to develop new health products and make them accessible to the poor in developing countries can provide an important basis for advocacy for additional financing; consensus
PP7 Recognizing the importance of securing sustainable financing mechanisms for health R&D to develop and deliver health products1 to address the health needs of developing countries; consensus
PP8 Recalling the Global strategy and plan of action which refers to a range of incentive schemes for health R&D with one objective being the de-linkage of the costs of R&D from the price of health products; consensus
PP9 Recognizing the interlinkage of monitoring, coordination and financing of health R&D as well as the importance of predictability and sustainability of resources required to enhance health R&D; consensus
PP10 Reaffirming the importance of facilitation of technology transfer on mutually agreed terms between developed and developing countries as well as among developing countries as appropriate; consensus
PP11 Underscoring that health R&D should be needs-driven and evidence-based, and be guided by the following core principles: affordability, effectiveness, efficiency, equity, and it should be considered as a shared responsibility; consensus
PP12 Realizing the need for improving priority-setting and transparent decision-making processes based on the public health needs of developing countries; consensus
PP13 Noting the important role of the public and private sectors in promoting innovation and developing new health products; consensus
OP1 Endorses the following strategic work plan to improve monitoring, coordination and ensure sustainable funding for health R&D, in line with the GSPA, as a step to achieve the goal of development and delivery of affordable, effective, safe and quality health products in which existing market mechanisms fail to provide incentives for health R&D; also agrees to further develop the strategic work plan through broad engagement of public and private entities, academia and civil society; consensus
From the operational sections for the Director General:
OP4 REQUESTS the Director-General: consensus
OP4.1 to develop norms and standards for classification of health R&D, building on existing sources, in consultation with Member States and relevant stakeholders, in order to systematically collect and collate information; consensus
OP4.2 to support Member States in their endeavor to establish or strengthen health R&D capacities and monitor relevant information on health R&D; consensus
OP4.3 to establish a Global Health R&D Observatory within WHO’s Secretariat to monitor and analyse relevant information on health R&D, building on national and regional observatories (or equivalent functions) and existing data collection mechanisms with a view to contributing to the identification of gaps and opportunities for health R&D and defining priorities in consultation with Member States, as well as, in collaboration with other relevant stakeholders, as appropriate, in order to support coordinated actions; consensus
OP4.4 To facilitate through regional consultations and broad engagement of relevant stakeholders the implementation of a few health R&D demonstration projects to address identified gaps which disproportionately affect developing countries, particularly the poor and for which immediate action can be taken; consensus
OP4.5 To review existing mechanisms to assess their suitability to perform the coordination function of health R&D; consensus
OP4.6 to explore and evaluate existing mechanisms for contributions to health R&D, and if there is no suitable mechanism, to develop a proposal for effective mechanisms, including pooling resources and voluntary contributions, as well as a plan to independently monitor their effectiveness; consensus
OP4.7 to convene another Open-ended meeting of Member States1 prior to the 69th WHA in May 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; consensus
OP4.8 to report on the review of existing coordination mechanisms (OP4.5), as well as on the evaluation of existing mechanisms for contributions to health R&D (OP4.6) to the sixty-seventh World Health Assembly, through the Executive Board at its […] session and to report on the implementation of health R&D demonstration projects (OP4.4) to the sixty-eight World Health Assembly, through the Executive Board at its […] session, and transmit the report of the open-ended Member States meeting to the sixty-ninth WHA. consensus
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