On Thursday, 5 April 2012, the World Health Organization released the report of the Report of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) entitled “Research and Development to Meet Health Needs in Developing Countries: Strengthening Global Financing and Coordination”.
The main recommendation of the CEWG calls upon WHO member states to commence formal intergovernmental negotiations on a binding convention on R&D. The antecedents of the CEWG which include the WHO Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) and the WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) both considered the idea of an R&D treaty. Element 2.3(c) of the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property specifically addresses the biomedical R&D treaty by calling 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”.
The CEWG report has built upon the foundations of the CIPIH report and the WHO Global Strategy and Plan of Action has provided a comprehensive evaluation of the R&D convention (in chapters 3,6 and annexes 2 and 3); the CEWG recommendation on the R&D convention states:
On balance we consider that the time has come for 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. This would also be in order to put on a secure footing the implementation of the GSPA-PHI which Member States agreed in 2008, and in particular the sustainable financing of R&D.
[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.
As mentioned before, the original mandate of the WHO IGWG was to secure “an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries”. It would appear that CEWG experts concluded that establishing a biomedical R&D convention would fulfill the original mandate of the WHO IGWG.
As the CEWG report notes, the basic concepts that undergird the R&D convention include the “delinking of the prices of medicines from the costs of R&D and the involvement of all governments in setting priorities and coordinating and funding R&D efforts.”
In terms of a pathway to establish an R&D convention, the CEWG report suggests the following next steps:
As is evident from our report, the issues that will need to be addressed in a negotiation of a binding agreement are many and complex. One of the reasons why the negotiations on the GSPA-PHI took so long was that there was very little preparatory work done to generate a draft text for consideration by the Intergovernmental Working Group that was established to draft the GSPA-PHI. We suggest therefore a process on the following lines:
- When dealing with our report the World Health Assembly should consider, first, establishing a working group or technical committee composed of two Member States from each WHO region to undertake preparatory work on the elements of a draft agreement, soliciting inputs as necessary from other Member States, relevant intergovernmental organizations, funders, researchers, the private sector, civil society and academics as necessary. Alternatively, as was done with the FCTC, an open-ended intergovernmental working group could be established with appropriate technical support.
- It should also provide for the establishment of an intergovernmental negotiating body open to all Member States, to be established under Rule 40 of the World Health Assembly?s Rules and Procedure, to draft and negotiate the proposed R&D agreement following on from the report of the proposed working group.
- WHO would need to provide appropriate resources to support the working group or technical committee.
KEI has collected quotes from various organizations in relation to the publication of the CEWG report.
Thiru Balasubramaniam, Knowledge Ecology International (KEI)
The CEWG report has provided the WHO the road map to reassert its primacy in public health and fulfill the promise of the WHO Global Strategy on Public Health, Innovation and Intellectual Property (WHA61.21) in providing a transformative architecture for enhancing sustainable, needs-driven medical innovation.
Sophie Bloemen, HAI Europe
The CEWG report is a powerful affirmation of the need to move beyond the status quo and traditional models of medical innovation. Moreover, it provides a clear vision of how to proceed, with an emphasis on ‘open knowledge innovation’ and a recommendation for a binding intergovernmental Convention on R&D. The report rightly sees these instruments as essential if the problems of limited access and lack of innovation for diseases that disproportionately affect developing countries, are to be adequately addressed. It is now up to the WHO & Member States to make things happen, and the WHA in May will show whether they are up to the challenge.
Michelle Childs, Médecins Sans Frontières – Access Campaign
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. 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. If the vision of a transformation of the approach to securing innovation and access for the majority of the world’s population is to be delivered, governments must act. At the World Health Assembly in May, governments must seize this opportunity and commit to a establishing a binding convention for essential health research and development for the needs of developing countries .
Patrick Durisch, Berne Declaration
On the eve of the 65th World health Assembly, the CEWG report sends a strong political signal to the WHO Member States. The current model of medical innovation revolving around intellectual property rights has clearly shown its limits, in particular for diseases that disproportionately affect Southern countries. An international binding R&D instrument, such as the one suggested by the CEWG, can simultaneously promote needs-driven innovation and access to medicines, and address the public health needs of both developing and developed countries. It is high time for all WHO Member States to take on their duty and guarantee the right to health for all in this interdependent world.
K. Gopakumar, Third World Network (TWN)
The CEWG report provides a clear way forward to address the longstanding problem of underfunding of R&D to meet the health technology needs of developing countries. We strongly urge the WHO Member States to set a clear road map in the upcoming WHA for the negotiation with an objective to conclude a convention under Article 19 of the WHO Constitution as recommended by CEWG.
David Hammerstein, Transatlantic Consumer Dialogue
The world desperately needs new models of medical innovation that respond to the real health needs of the majority as opposed to the insatiable demands of a few lucrative markets. The WHO Expert Working Group has created a roadmap for a needed fundamental change in how biomedical research and development can be liberated from the stranglehold of the Big Pharma monopolies and progressively oriented toward fruitful sharing of scientific knowledge in the endeavour of delivering affordable, essential medicines for all.
James Love, Knowledge Ecology International (KEI)
The World Health Organization’s Consultative Expert Working Group on R&D has issued a report that covers a wide range of topics. It is clear that the CEWG focused the most on making a case for a new WHO treaty to increase global public sector spending on medical R&D. Many of the other topics addressed in the CEWG report received less attention, in part due to the wide range of proposals under consideration, and the limited time available to the CEWG. With regard to the R&D treaty, the CEWG has proposed a set of objectives for the agreement, which are both impressive and responsive to the core calls for reforms, including such topics as boosting R&D spending to address health needs of developing countries, improving innovative capacity in developing countries, expanding access to knowledge, and de-linking R&D costs from prices of products. In May, the World Health Assembly (WHA) will be asked to act on the proposal to begin negotiations on such a treaty, and we hope countries can begin to move the proposal forward.
The CEWG proposed objectives for a binding agreement:
- Implementing states’ obligations and commitments arising under applicable international human rights instruments with provisions relevant to health.
- Promoting R&D for developing new health technologies addressing the global challenges constituted by the health needs of developing countries by means which secure access and affordability through delinking R&D costs and the prices of the products.
- Securing sustainable funding to address identified R&D priorities in developing countries.
- Improving the coordination of public and private R&D
- Enhancing the innovative capacity in developing countries and technology transfer to these countries.
- Generating R&D outcomes as public goods, freely available for further research and production.
- Improving priority-setting based on the public health needs of developing countries and decision-making relying on governance structures which are transparent and give developing countries a strong voice.
- Core elements under the convention should focus on development of health technologies for Type II and Type III diseases as well as the specific needs of developing countries related to Type I diseases.
Oxfam welcomes the CEWG as another critical step towards a global system of research and development that truly meets the urgent health needs and priorities of people living in poverty in low and middle income countries. Member States must now ensure that WHO has the predictable financial and human resources to work with Member States to implement the recommendations, including development of a research and development treaty.
Dr Mira Shiva, Initiative for Health & Equity in Society, Health Action International Asia Pacific
It has been really long since the CIPIH report came out , the WHO ‘s CEWG report has come out now and is welcome. We strongly hope that the 65th WHA of 2012 will see the issue of public health needs of developing countries met through financial and policy support of need based R&D, where medicines, medical & health technologies are concerned. We are hoping to see a constructive role being played by the member states from the technologically advanced countries, appropriate assertiveness by the member states from Developing countries & a proactive role by the WHO to see the recommendations implemented.
Xavier Seuba, Farmamundi / Alianza LAC-GLobal por el acceso a medicamentos
The WHO has traditionally been reluctant to use its hard-law powers, which remained almost forgotten. The global public health community has been pushing forward a needs-driven research and development treaty for the last decade. Now, the CEWG has endorsed that view. It is, therefore, time for health diplomats at the World Health Assembly to realize that international health law is also a constitutional responsibility of the WHO. It is also the moment for all relevant stakeholders to give body to such a framework.
The WHO Consultative Expert Working Group (CEWG) recommended in its Report of 5 April 2012 to start negotiations on a binding international instrument on health R&D under article 19 of the Constitution of the WHO. 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. And, if successful, this could be the most important achievement of WHO in the area of medicines since its creation.