WHO Members Agree On “Strategic Work Plan” On Health R&D – But No Convention

After three days and two nights of tough negotiations to address the global gap in research and development for neglected diseases at the World Health Organization, member states agreed to endorse a strategic work plan that includes proposals on the coordination, financing, and monitoring of R&D expenditures separately, but not to advance the idea of an overarching framework. The recommendation for a global R&D convention proved divisive to the very end of the negotiations.

The open-ended meeting of member states on the follow-up of the report of the Consultative Expert Working Group (CEWG) on Research and Development: Financing and Coordination stretched late into the night last night, and saw the participation of WHO Director General Margaret Chan in the negotiations, which closed early on 29 November.

Member states agreed on a draft report and resolution [pdf], recommending it to be adopted by the next World Health Assembly “without re-opening it.”

Meeting to consider the expert CEWG report and develop proposals on research coordination, financing, and monitoring of R&D expenditures, member states agreed to establish a Global Health R&D Observatory, explore existing funding and coordinating mechanisms, and to review progress again at the World Health Assembly in May 2016.

It’s an outcome that has left many member states and public health experts, who were hoping for a more ambitious strategy, disappointed.

The meeting chair, Viroj Tangcharoensathien of Thailand, held an open briefing on the meeting outcomes, and said that the recommendation to move forward on a medical R&D treaty was the most contentious issue during the three-day meeting.

“Some member states are in favour of a treaty or a legally binding convention, but most – I have measured carefully – most member states are not favourable at this juncture. Therefore, there is no attribute to the term convention in the draft resolution,” said Tangcharoensathien.

Treaty Resistance

During the closed-door negotiations, delegations from the United States and European Union were reported to be the most resistant to the idea of a global health R&D convention.

Led by Nils Doulaire, the US delegation refused to comment on the negotiations or its position on the treaty proposal. However, according to sources, the US expressed concerns that the initiative was more about technology transfer, medicines availability, and development issues, rather than solving the problem of medical R&D gaps.

Several member states said the US delegation stood as a major blocker to any inclusion of treaty language. According to some, the US wanted any mention of “CEWG” removed from the resolution during the last day of negotiations.

As the expert group’s report strongly recommended the establishment of a binding convention on medical R&D, “CEWG” had apparently become inextricably linked to “medical R&D treaty.”

In terms of EU opposition, several European countries expressed a lack of political will to make any binding financial commitments given the difficult economic climate and called for a more incremental approach. It should be noted that a convention would not necessarily provide for obligatory financial contributions.

On the second day of negotiations, the EU proposed a pilot process for R&D coordination, 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.”

The suggestion seems to have been translated into the final draft resolution under OP4.4, which requests the director general 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.”

Treaty Language Attempts

Member states who strongly spoke out in favour of a binding convention included Colombia, Bolivia, and Thailand.

During the opening session, Thailand’s delegation made its position clear in an oral intervention [pdf]: “[E]xperiences on global special programs by using voluntary contributions had proved not sustainable and unpredictable level of funding size. Having proved by these failure cases, my delegations propose that a binding Convention should be developed in a time-limited manner.”

While member states in favour of a binding convention did not expect this open-ended meeting to result in treaty negotiations, they were largely hoping for language in the resolution that would keep the topic on the negotiating table this year.

In the draft resolution [pdf] released in the morning of the last day of negotiations, Iran had added language calling for the elaboration of “an international instrument on R&D … without prejudice of the legal nature of the resulting instrument.”

Brazil led a drafting group that led the development of the next version of the draft resolution [pdf], released at the start of the afternoon session. All references to an international instrument had been removed.

Attempts were made to insert framework language into the final resolution during the last stretch of negotiations but did not succeed.

However, the meeting chair emphasised where agreement was achieved, including on the creation of a Global Health R&D Observatory. “Rome is not constructed overnight. There is a step of building blocks of construction to achieve the goal of better access to suitable, affordable, quality medical products for the poor of developing countries,” Tangcharoensathien said during the meeting briefing.

Reactions

The mobilisation around these negotiations has been significant. Several non-governmental organisations (NGOs) were quick to issue pointed reactions to the meeting outcomes.

A statement from Médecins Sans Frontières (MSF, Doctors Without Borders) asserts: “Instead of pushing forward with a real plan to address the continued lack of suitable and affordable vaccines, drugs and diagnostics that our teams in the field face, all countries have really pledged to do is to continue observing the situation. Countries have substituted process for progress.”

“After ten years of intergovernmental negotiations and several landmark expert reports with concrete proposals on how to fix a R&D system that fails to deliver, this is a triumph of political foot-dragging and lack of leadership,” MSF said.

A statement from Knowledge Ecology International (KEI) said, “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,” according to KEI.

The statement from the Council on Health Research for Development (COHRED) said, “While COHRED welcomed the strong support of WHO Member States at the CEWG meeting this week to strengthen health R&D capacities and national capabilities for monitoring of health R&D information, it is clear that Member States also need to ensure that committed financing is available for these recommendations to become a workable reality rather than more rhetoric. We look forward to working with WHO Member States to support low and middle-income countries build greater health R&D capacity, and support the monitoring and co-ordination of it.”

From the biopharmaceutical industry side, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said, “This outcome focuses the international health community on concrete and pragmatic steps to address the short- and medium-term needs, including understanding what the gaps and the priorities are. In this spirit, the proposed Observatory could, with the help of all relevant partners and adequate resources, play a key role.”