Saturday, 28 May 2016
WHA69: Resolution WHA69.23 on CEWG follow-up charts course for WHO’s work on R&D
At this year’s World Health Assembly (WHA69), the future of WHO’s engagement on an agreement on global norms for R&D funding was the subject of intense negotiations. These WHO discussions on R&D norms took place in Room XXIII of the Palais des Nations on Thursday, 26 May 2016 and Friday, 27 May 2016, chaired by Mr Anshu Prakash, Joint Secretary, Ministry of Health and Family Welfare, India. Informed sources told KEI that consensus was reached at around 7 PM on Friday evening. The results were better than we expected.
The result of these deliberations is contained in document WHA69.23 – Follow-up of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination. WHO has published this here: http://apps.who.int/gb/ebwha/pdf_files/WHA69/A69_R23-en.pdf
The WHO has chartered a course which leaves the Organization and its member states policy space to consider an agreement on global norms for R&D funding after Dr. Margaret Chan steps down from the helm of the WHO.
Here are some selected passages from the resolution:
Follow-up of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination
The Sixty-ninth World Health Assembly,
PP2 Acknowledging that the 2030 Agenda for Sustainable Development includes the commitment to support the research and development of vaccines and medicines for the communicable and non-communicable diseases that primarily affect developing countries, provide access to affordable medicines and vaccines, in accordance with the Doha Declaration on the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the Agreement on Trade-Related Aspects of Intellectual Property Rights regarding flexibilities to protect public health, and, in particular, provide access to medicines for all;
PP 4 Noting with particular concern that for millions of people the right to the enjoyment of the highest attainable standard of physical and mental health, including access to medicines, remains a distant goal, that especially for children and those living in poverty, the likelihood of achieving this goal is becoming increasingly remote;
PP 5 Noting the establishment of the High-Level Panel on Access to Medicines convened by the UN Secretary-General;
PP 6 Underscoring that health research and development should be needs-driven and evidence-based and be guided by the following core principles: affordability, effectiveness, efficiency, and equity; and it should be considered as a shared responsibility;
PP7 Acknowledging the central role of the Global Observatory on Health Research and Development to consolidate, monitor and analyze relevant information on health research and development activities related to type II and III diseases and the specific research and development needs of developing countries in relation to type I diseases, as well as for potential areas where market failures exist, and also antimicrobial resistance and emerging infectious diseases likely to cause major epidemics, building on national and regional observatories (or equivalent functions) and existing data collection mechanisms, with a view to contributing to the identification and the definition of gaps and opportunities for health research and development priorities and supporting coordinated actions on health research and development;
(OP2) REQUESTS the Director-General:
(4) to expedite, as part of the development of the Global Observatory on Health research and development, the development of norms and standards for classification of health research and development, including common reporting formats, building on existing sources, in consultation with Member State experts and relevant stakeholders in order to collect and collate information systematically;
(5) to promote the Global Observatory on Health Research and Development among all stakeholders, including through regular open-access publications and outreach activities and encourage all stakeholders to regularly share relevant information on health research and development with the Global Observatory on Health Research and Development;
(7) to establish a WHO Expert Committee on Health R&D to provide technical advice on prioritization of health research and development for Type II and III diseases and specific research and development needs of developing countries in relation to Type I diseases as well as for potential areas where market failure exists based, inter alia, on the analyses provided by the Global Observatory on Health Research and Development. The Expert Committee will, as needed, consult with all relevant stakeholders in carrying out its work as specified in its terms of reference, which will be formulated and submitted to the 140th session of the Executive Board for its consideration;
(8) to take into account the study conducted by the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases, and on the basis of the report of the CEWG, present a proposal with goals and an operational plan for a voluntary pooled fund to support research and development for Type III and Type II diseases and specific research and development needs of developing countries in relation to Type I diseases, to be submitted to the Seventieth World Health Assembly through the 140th session of the Executive Board;
The plan shall describe how the WHO Global Observatory on Health Research and Development, the WHO Expert Committee on Health Research and Development and the Scientific Working Group of a pooled fund will work together, with specific disease examples, and in line with the core principles of affordability, effectiveness, efficiency, equity and the principle of delinkage. The plan shall also provide options for sustainable funding;
(10) to promote policy coherence within WHO on its research and development related activities such as those in relation to the Research and Development Blueprint for Emerging Pathogens and the Global Action Plan on Antimicrobial Resistance in terms of application of the core principles of affordability, effectiveness, efficiency and equity and the objective of delinkage identified in WHA66.22;
(11) to report to the Seventieth World Health Assembly, through the 140th session of the Executive Board, on the implementation of this resolution, and request the Seventieth World Health Assembly to consider convening another open-ended meeting of Member States in order to assess progress and continue discussions on the remaining issues in relation to monitoring, coordination and financing for health research and development, taking into account relevant analyses and reports.
Statement by James Love, Director, Knowledge Ecology International
“Delinkage is moving forward, one step at a time, at the WHO. The resolution on sustainable R&D funding does more than we expected, and sets the stage for a renewed debate in 2017, after the U.S. elections, and during the campaign for a new WHO DG. The fact that the Secretariat is asked to look at ‘options for sustainable funding’ for a pooled R&D funding model is important, since at the end of the day, this negotiation should focus on ‘sustainable funding’ mechanisms. Without money, and lots of it, it will not be important. All delinkage efforts depend upon governments finding ways to fund R&D outside of the framework of high drug prices. We have asked countries to focus on the incentives that will be needed to induce counties to collaborate on funding R&D as a public good. We also favor a system of multiple pooled funding mechanisms competing against each other for government funding. Neither of these proposals have moved forward, but when you look at what it takes to get sustainable funding, you have to ask why a country would want to be a donor, and then the questions of incentives, benefits to donors and the ability to choose managers of R&D funds, becomes more relevant.”