Info Service on Health Issues (Jun16/01)
Geneva, 2 June (K M Gopakumar) – World Health Organization Member States have agreed to postpone discussions on a research and development treaty tasked to the Consultative Expert Working Group (CEWG).
However, the resolution adopted at the 69th World Health Assembly (WHA) does not set out any process to discuss the remaining issues of the implementation of the recommendations of the CEWG recommendations.
[In 2013 the CEWG developed a legally binding instrument to address the health research and development (R&D) needs of developing countries. This proposed instrument consists of three pillars viz. a global R&D observatory to capture information, an advisory committee for prioritisation and coordination, and a sustainable financing mechanism based on a mandatory contribution from Member States.
[In 2013 Member States adopted resolution WHA 66.22 that opted for a fragmented implementation of the recommendations and decided to establish a Global R&D Observatory. Thus the discussion on the main recommendation was pushed to the margin under the title “remaining issues”. Further, the resolution decided to convene an open-ended meeting of Member States prior to the recently concluded 2016 WHA. This was held on 2 to 4 May but could not reach any consensus on the future course of action. The 69th WHA resolution is the result of the negotiations at the open-ended meeting and a drafting group during the WHA that met on 23 to 28 May in Geneva.]
Contrary to expectations, the WHA resolution fails to agree to hold another open- ended meeting to discuss the remaining issues in the light of other developments. However, the resolution states: “… to report to the 70th World Health Assembly, through the 140th session of the Executive Board, on the implementation of this resolution, and request the 70th 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”.
Thus the next WHA in 2017 is not to discuss whether to launch negotiations on an R&D treaty but to discuss whether to consider “convening another open-ended meeting of Member States in order to assess progress and continue discussions on the remaining issues”. These remaining issues are related to monitoring, coordination and financing for health R&D while taking into account relevant analyses and reports.
The “relevant analyses and reports” is an indirect to reference to the UN Secretary- General’s High Level Panel on Access to Medicines. The Panel is expected to make certain recommendations on the need for new approaches to biomedical R&D.
[The High Level Panel has invited proposals and is to “review and assess proposals for their potential to improve health technologies innovation and access, and make recommendations that: a. Remedy the policy incoherence between international human rights law and trade rules in the context of access to health technologies; and b. Achieve a better balance of the justifiable rights of inventors, the right to health and sustainable development”.]
During the open-ended meeting in May, Brazil made a proposal for the draft resolution to hold another meeting prior to the 2017 WHA to discuss the R&D treaty. That text read: “… to convene an open-ended meeting after the publication of the report of the UN Secretary-General’s High-Level Panel on Access to Medicines, and the UN High Level Meeting on Antimicrobial Resistance in order to seek policy coherence on health innovation and access and inform further governmental discussions on the follow-up to the Consultative Expert Working Group on Research and Development: Financing and Coordination”.
A developing country delegate disclosed to Third World Network (TWN) that all Member States, except for the United States and Switzerland, had agreed to the proposal. The US opposed not only to the proposal but also to any reference to the High-Level Panel on Access to Medicines. It also demanded removal of references to the Panel from the resolution citing the reason that it was not constituted by UN Member States. However, the resolution did make a reference to the Panel in the preamble: “Noting the establishment of the High-Level Panel on Access to Medicines convened by the UN Secretary-General”.
The new approaches to R&D had come up in view of the lack of health products to address the unmet health needs of developing countries, such as neglected tropical diseases. Over the years it expanded to cover market failures in R&D in areas such as antimicrobial resistance and medicines in emergencies.
The means of implementation of Sustainable Development Goal 3 of the 2030 Agenda for Sustainable Development, which deals with health states: “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 essential 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”.
[The current dominate patent-driven R&D model attracts financial resources to those diseases where the pharmaceutical industry can earn high levels of profit through high prices using patent monopoly. Therefore, pharmaceutical companies are not investing resources in those areas where the profitability is less such as diseases predominantly affecting developing country populations, where people or governments cannot afford to pay high prices. As a result, there is a non-availability of effective health products to address the health needs of developing countries. The patent system has inherent limitations in addressing the twin objectives of innovation and access. The CEWG recommends the use of new R&D approaches to achieve these twin objectives by using the principle of de-linking the cost of R&D from the price of final products.]
The non-commitment to hold another open-ended meeting shows that some developed countries are blocking any effective discussion to move towards an R&D treaty, as had happened with another resolution, WHA 66.22 in 2013.
The latest resolution agreed to streamline the establishment of the Global R&D Observatory, an instruction given to the WHO Director-General through WHA 66.22 that has not been fulfilled even after 3 years, citing lack of funding. Further, the resolution requests the Director-General “… 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”. The resolution also requests the Director-General to submit terms of reference and a work plan to the Executive Board (EB) meeting in January 2017.
In order to mobilise the resources for the implementation of the agreed work plan under WHA 66.22 the resolution requests the Director-General to mobilise financial resources through WHO’s financing dialogues, a mechanism to mobilise resources from donors including philanthropic foundations.
On the second pillar of the CEWG recommendation, i.e. the prioritisation and coordination of R&D, the resolution requests the Director-General to “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 EB for its consideration”.
Regarding the financing of R&D the resolution asks the Director-General to present a business plan based on a report prepared by the consultancy firm McKinsey for the Tropical Drug Research (TDR) programme. The resolution states: “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 70th World Health Assembly through the 140th session of the Executive Board”.
According to many observers, the idea of a pooled voluntary fund would effectively undermine a sustainable financing mechanism and R&D treaty as recommended by the CEWG.
According to the resolution, “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 de-linkage. The plan shall also provide options for sustainable funding.”
Observers point to the poor performance of past experiences of the failure of voluntary funds to generate sufficient resources, including the underfunding of WHO’s demonstration projects, which was initiated to implement R&D. The demonstration projects are facing an acute resource crunch and attracted only USD 7.65 million against the required USD 85 million.
The resolution also softly requests the Director-General “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 de-linkage identified in WHA 66.22.”
According to many observers, the Global Observatory and prioritisation and coordination of R&D are important issues. However, this development pushes the real systemic issue to the margins i.e. the reform of the current biomedical R&D model, with sustainable financing for non-patent driven R&D approaches through an R&D treaty. The situation was summarised by a senior diplomat from a developing country as gaspillage (waste) during the open-ended meeting in May. The final resolution adopted by WHA 66 further reinforces this.