WHO Members To Address Proposals For Financing Developing Country R&D

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Members of the World Health Organization at their annual meeting tomorrow will address proposals for ways to finance research and development for diseases which afflict mainly developing countries but for which there are not lucrative markets.

The World Health Assembly (WHA) is meeting from 21-26 May. Tomorrow morning (23 May), members are scheduled to address the issue of financing R&D for neglected diseases.

At issue is a report from the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG), which was established at the last WHA to come up with ideas.

The group issued its report last month, available here.

There are now four proposals related to the CEWG report for the WHA to consider tomorrow, according to sources. Broadly speaking, two of them – Kenya and Paraguay for the UNASUR (Union of South American Nations) group – are in favour of agreeing to move toward a binding convention. The other two – from Switzerland and the United States – would undertake a process but not clearly pre-judging the outcome as a binding convention.

Committee A of the WHA is expected to take up the proposals immediately after a brief plenary session starting the day tomorrow. Countries may take the floor to signal support for one proposal or another. It is possible that a drafting group will be created to address the various proposals, with the aim of getting agreement on one proposal by week’s end, sources said.

At a WHA side event today, WHO Director General Margaret Chan appeared to be lukewarm to the idea of a binding convention. She praised the group for setting a high standard for managing divisive views and transparency, and noted that the WHO secretariat is there to implement whatever policies are decided by the member states.

But Chan mentioned the failure of the WHO Framework Convention on Tobacco Control to get all countries to fulfil their binding obligations by June of this year. She further said that sometimes there is an agreement that is not binding but still does very well in getting compliance. The question is whether or not countries are committed to the health of their populations. If they are, she said, then “there are many ways to skin a cat.”

This fit with a view taken at another side event in the evening by a member of the US delegation, who said that he has been “sceptical” about the idea of a binding treaty since it assumes that all countries will sign it and live up to it once negotiated. He also cited the Tobacco Convention as an example, since there is no enforcement for those who do not comply.

But James Love, executive director of Knowledge Ecology International, countered at the event by saying that there are examples of agreements where the norms get ratified at the national level even if not signed by a government, and that there can be a “no shirking” effect pushing countries to live up to obligations.

At the earlier WHA side event today, the CEWG chair and vice chair, John Arne Røttingen, presented the report again, saying the group was made up of professionals with a “mixed set of experiences,” and that the process took place transparently and with a positive outcome. The group narrowed over a 100 proposals down to a small set of recommendations, including to negotiate a convention on financing of R&D for neglected diseases.

The basic underlying ideas that emerged from the group discussions, Røttingen said, were that: affordable products can best be achieved through open competition in production where intellectual property rights are not a sufficient incentive; that it requires the de-linking of cost and price; it requires upfront public financing of R&D; and R&D is re-established as a global public good with a need for public financing.

He showed a graph that explained how de-linking of R&D from price would move development from a private to a public activity.

CEWG Vice-Chair Claudia Inês Chamas of Brazil said the group considered proposals on the basis of a range of criteria, including: public impact, efficiency/cost effectiveness, technical feasibility, financial, management of IPRs, de-linking, access/potential to lower prices, governance/accountability, and capacity building.

Six proposals met the criteria well. They include a global framework on R&D; direct grants to companies; patent pools; pooled funds; open approaches to R&D; and milestone prizes.

“It is not realistic to expect voluntary contributions to raise large amounts of funding,” she said. Proponents pointed to the successful model employed by UNITAID, in which airline taxes represent some 70 per cent of its financial base.

She said some governments are not meeting their goals on spending on health research. The proposal would ask governments to commit to goals, preferably using a target of R&D spending as a set portion of 0.01 per cent of annual GDP on R&D aimed at developing countries. Using 2009 figures, this could bring about $6 billion per year, they said. Funds would be pooled for maximum impact. Røttingen called the amount sought “miniscule” compared with spending by governments to fix the financial system in recent years.

There are also recommendations for coordination, such as to create a “global health R&D observatory, and establish an advisory mechanism, with WHO playing a central role in coordination.

But the conclusion of the working group was that a global binding instrument is needed, in the form of a convention like the WHO Framework Convention on Tobacco Control. Principles for the instrument are that it included de-linking, all governments are involved, it provides a sustainable funding mechanism, and it is supplementary to the existing IP system, she said.

The next steps are for the WHA to consider establishing a working group or technical committee of two members from each region to undertake preliminary work for drafting an agreement. It would also establish an intergovernmental negotiating body.

The aim would be to create a single coordinated place to address these issues, including to prepare data on R&D.

What is needed are “sustainable and pragmatic solutions,” Røttingen said. “We don’t need more patchwork.”

But the proposal is not for a separate system, rather it could be “fully integrated,” he said.

Amb. Tom Mboya Okeyo of Kenya also addressed the evening side event. He called the discussions around neglected disease R&D financing a “marathon” as it has been going on for over four years. In a marathon, he said, “you have to know when to step up the pace,” and said now is the time to act on the CEWG proposal.

Mboya said normally diplomats will shelve a report if they don’t like it, or if it contains something in it, will set up another working group. “But here it is different,” he said. “We have 2.7 billion people out there who are suffering, so we have to do something different.”

“What is needed is not setting up another working group or another expert group,” he said. “What is needed is for the 65th World Health Assembly to agree on a [strategy] for an R&D convention,” building on the earlier WHA-agreed global strategy and plan of action for neglected diseases.

Other participants at the evening side event were: Michelle Childs, director of policy and advocacy, Médecins Sans Frontières (MSF) Access Campaign; Tido von Schoen-Angerer, executive director, MSF Access Campaign; Jon Pender, vice president of government affairs for GlaxoSmithKline and chair of the IFPMA Global Health Committee; and Pascale Boulet, advisor, Drugs for Neglected Diseases initiative (DNDi); Tessel Mellema, advisor, Health Action International, and Love of KEI.

MSF, DNDi and Health Action International were strongly in support of the R&D convention approach.

Love said he has been coming to Geneva for years and that report after report has shown the need for addressing R&D for neglected diseases. “The core of this proposal is how to mobilize resources for neglected disease R&D,” he said, adding that it should not be a large obligation for countries that are already investing in this type of R&D.

Pender of GSK said he is not certain that a binding instrument is needed to address the problem, and gave several examples of initiatives the private sector is undertaking, such as for a malaria vaccine where, he said, there is no commercial market, and “there will be no attempt to recover the costs of R&D or my trips to Geneva.”

William New may be reached at wnew@ip-watch.ch.

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