Debate Erupts At WHO Over “Consensus” On Financing R&D For The Poor

World Health Organization members on Friday held a tense discussion over legal and political aspects of a consensus reached by a small number of member states in November on implementing a plan to address the global lack of research and development for neglected diseases predominantly afflicting poor populations. The discussion may continue today, with the linkage of an agenda item on neglected tropical diseases and the report of an expert working group offering numerous ideas for addressing the problem.

[Update: the expert working group reference has been removed from the resolution on neglected tropical diseases by agreement of member states.]

The 132nd WHO Executive Board meeting is taking place from 21-29 January. Executive Board documents are here.

A top issue for the week is the longstanding public health policy problem of finding ways to stimulate R&D on treatments for diseases for which there is little incentive for the private sector to invest, since they traditionally recoup their R&D costs through high prices on the resulting medicines. The issue broke open on 25 January in the context of taking forward a report from an expert working group.

The issue also is proceeding at the Executive Board under a separate agenda item on neglected tropical diseases (NTDs), which is expected to continue today. On that item, a new draft document was circulated over the weekend, showing a proposal to link this item with the report of the expert working group. The draft text from 26 January, EB132/CONF./5, is available here [pdf].

WHO members had put significant effort into addressing this market failure in recent years, and at the 2012 annual World Health Assembly set up (IPW, WHO, 25 May 2012) an open-ended meeting (attendable by all) of member states. That meeting took place in late November (IPW, WHO, 29 November 2012).

The November meeting, which took up the report of the predecessor Consultative Expert Working Group (CEWG) was instructed by the May 2012 Assembly to:

analyse thoroughly the report and the feasibility of the recommendations proposed by the CEWG, taking into account, as appropriate, related studies. This meeting will also take into account the results from national consultations and regional committee discussions and develop proposals or options relating to (1) research coordination, (2) financing and (3) monitoring of R&D expenditures, to be presented under a substantive item dedicated to the follow up of the CEWG report in the Sixty-sixth World Health Assembly through the 132nd session of the Executive Board.” The 66th Assembly will take place in May.

The November meeting went into the wee hours on its final night, and came out with an agreement among those in the room on a draft resolution (EB132/21) that contained a fairly strongly worded preamble, and a relatively vague set of actions, with the exception of information gathering, including through the setting up of an “observatory”. This compromise outcome disappointed a number of member states and public health advocates who have been working on this issue at WHO for many years leading up to this point and hoped for a more ambitious plan.

In addition to the observatory, the action plan calls on WHO to develop norms and standards for classification of health R&D, “in order to systematically collect and collate information.” Other concrete actions are for WHO to facilitate “the implementation of a few R&D demonstration projects,” review existing mechanisms, and explore and evaluate existing mechanisms. It says that if no suitable mechanism is found, WHO should “develop a proposal for effective mechanisms, including pooling resources and voluntary contributions,” with a plan for monitoring. Finally, the plan calls for another open-ended meeting prior to the May 2016 Health Assembly – in order to continue discussions.

Broadly speaking, the neglected disease R&D issue is seen as a mandate on the existing global system for medicines R&D, which is primarily driven by companies in developed countries. Perhaps not surprisingly, developed country governments at WHO have sought to keep the discussion from including anything representing a dramatic change to that system, though they readily acknowledge its shortcomings in addressing the problem of medicines for diseases of the poor.

Developed countries point to the “difficulty” of the issue, presumably as they must negotiate for an outcome that does not threaten the viability of their successful research-based pharmaceutical industries. Meanwhile, those industries have stepped up their voluntary activities in this area, and are present to tell member states about their efforts.

Developing countries are concerned that donations are not sustainable nor enough, and say finding sustainable financing was the objective of this WHO effort. For instance, Bolivia this week called again for “promoting innovation in an open way so results can be used for the public good,” and so that “R&D does not hinge only on the price.” It is important, the delegate said, that new alternatives be explored and not just continue to focus on market-based approaches. Indonesia also said this agreement is not sufficient and that it is important to de-link R&D from prices and have a legally binding instrument for R&D.

The consensus action plan is a derivative of a bigger process that contained numerous options for financing R&D for neglected diseases, including a treaty. This was stripped out during the November meeting, which has led to efforts to keep more of the proposals of the Consultative Expert Working Group (CEWG) – such as the treaty idea – on the table for future discussion.

Among others, The Lancet journal published an editorial urging WHO to make more concrete actions, asserting that “the future elimination and eradication of neglected tropical diseases depends on it.”

A WHO-led major donor meeting in London last year helped to shift the effort to solve this problem, but some argue did not replace the need for a new financial mechanism for R&D.

Non-governmental organisations at the Executive Board were particularly sharp in their criticism of the November outcome, and seven groups sent a joint letter expressing “deep concern at the lack of ambition and apparent inaction of the WHO and the Member States.” They pointed in particular to the absence of any suggestion of alternatives to the existing price-based R&D system. They also raised concern that when the agreement was reached in the deep of night in November, there were about 25 members of the WHO membership of 194, and interpreters had long since gone home. This point was also raised in the meeting by a representative speaking on behalf of Health Action International (HAI).

Médecins Sans Frontières (MSF, Doctors without Borders ) at the Board meeting this week said it was “deeply disappointed” with the November meeting outcome, and that members were “being asked to pass – unopened – an extremely weak Resolution which threatens to change nothing.” Furthermore , clarifications are needed for the few elements of the resolution that could possibly deliver results, MSF said. The group suggested the observatory identify what R&D is being undertaken and is missing, and work to determine R&D priorities.

“Without significantly strengthened public leadership and public funding for neglected areas of R&D, we will be left with a piecemeal response,” MSF said. “We need a more sustainable solution – a global R&D framework – driven by Member States themselves.”

The International Federation of Pharmaceutical Manufactures and Associations (IFPMA), meanwhile, said that outcomes from the November meeting “show member states’ long-term commitment to address this endeavor comprehensively and to deliver tangible outputs.” The industry group also said, “Colleagues, we need a mix of vision and pragmatism in this debate,” and referred to the action plan as a “concrete path.”

“These are difficult challenges, but we believe that understanding key research gaps is a precondition to addressing them,” IFPMA said. The representative said its member companies’ R&D programmes have increased, and that industry “stand[s] ready to provide expertise and assist further in this process.” Financing their participation may be a key question.

The Gates Foundation was listed among the NGO participants at the November meeting. The foundation takes a positive approach toward the use of the patent system and licensing for public health objectives.

Legal Question

Meanwhile, a number of developing countries are seeking to strengthen the language in the November action plan, which urges members to take actions but does not commit them to it. But this was seen by developed countries as an attempt to reopen the consensus document from November, and that document states that it cannot be reopened.

The report of the open-ended November meeting strongly recommended that the Board approve the report and recommend the May Assembly not reopen it. A legal question arose as to whether the Assembly could be told not to reopen a document, and WHO legal counsel said that from a strictly legal perspective, the Assembly can reopen. But politically, it may be a different question.

It was decided after heated debate to send it on to the May Assembly to be decided there whether to open it. The developing countries say they are not intending to go against the consensus but to enhance it. China was particularly outspoken on the “supreme right” of governments to discuss topics at the Assembly if they choose. Argentina, and Ecuador on behalf of the region, were among the others concerned about the inability to reopen it.

Developed countries such as the United States and Australia said the consensus was the “best outcome possible,” and warned developing countries not to reopen discussions, as opening any part could reopen the whole. Many called the consensus text a “good first step,” and saw this as the start of a long-term effort.

The chair of the November meeting, Viroj Tangcharoensathien of the Thailand Ministry of Public Health, told the Board that it could not reopen the document and that it “will have to mind its business.” He also repeated the phrase that it is a “solid first step.”

The Executive Board chair discouraged countries from reopening it, saying, “I have no intention of being the chair who reopened a consensus.”

WHO Director General Margaret Chan was driven to break into song. She sang, “Getting to know you, getting to know all of you, getting to like you, getting to work better with you.” And was met with mirth, and some alleviation of tensions – at least for the moment. She concluded the agenda item by declaring that members would “fight it out” at the Assembly.

The November package will be sent on to the Assembly, along with the comments made by members during the Board meeting. And apparently, if they choose, they will reopen it.

Meanwhile, new ideas may still emerge in the Executive Board under the agenda item on neglected tropical diseases.