WHO Expert Group To Recommend Binding R&D Treaty Negotiation

A World Health Organization expert group has narrowed proposals under consideration for ways to finance research and development for diseases predominately affecting poor populations. Among the remaining recommendations is that WHO members launch negotiations for a binding treaty.

“This group is going to recommend to member states to consider initiating negotiations” of an R&D convention, Zafar Mirza, coordinator in the WHO Department of Public Health, Innovation and Intellectual Property, said recently. “The group thinks its time has come.”

The preliminary recommendation of the Consultative Expert Working Group on Research and Development: financing and coordination (CEWG) was announced on 18 November, at the end of its third meeting.

A progress report will be given to the annual January WHO Executive Board meeting, and the group hopes to finalise the report by February, making it public in March in the six UN languages.

The first draft of the CEWG report is to be presented to the annual World Health Assembly in May 2012. At the November meeting, the group discussed ways to improve the report, according to Mirza. The discussion will be incorporated into the report.

The group decided that six out of 15 proposals under consideration best fit the agreed criteria of the group, according to slides of 18 November presentation. The six are: a globally binding instrument for R&D and innovation for health; direct grants to companies in developing countries; equitable licensing; patent pools; pooled funds; precompetitive R&D platforms / open source and access; and prizes. Few details are available on the latest versions of the proposals.

The remainder found to fit the criteria less well or to be not directly related to R&D were: green intellectual property; the Health Impact Fund; orphan drug legislation; priority review voucher; purchase or procurement agreements; tax breaks for companies; transferable IP rights; regulatory harmonisation; and removal of data exclusivity.

The chair of the 21-member CEWG is John Arne Røttingen, director general of the Norwegian Knowledge Centre for Health Services, and vice chair is Claudia Inês Chamas of Brazil. The group’s work arose from the 2008 WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property.

Binding Convention

The CEWG reaffirmed its commitment to further develop thinking on a global binding instrument on R&D funding, he said. In July, the group made a preliminary recommendation to start negotiations for a possible R&D treaty (IPW, WHO, 5 July 2011).

Since then, their thinking has evolved to call for a “global binding instrument,” sources said. Loosely, the concept is to create a new binding global instrument, negotiated under the WHO. A government signing the instrument would commit to rules that regulate which – and how much – health R&D is undertaken in order to ensure adequate financing is available for “needs-driven” health R&D.

The convention, which the WHO general counsel said falls under Article 19 of the WHO constitution, would address R&D related to Type II and Type III diseases (predominately affecting poor populations), and the specific R&D needs of developing countries in relation to Type I diseases (also occurring in developed countries), according to the 18 November presentation.

The binding instrument is seen as necessary because “current funding is insufficient and global coordination is necessary to find solutions to the global disease burden,” it said.

At the November meeting there was discussion of possible principles and objectives for a global binding instrument, Mirza said.

The principles behind the binding instrument include: open knowledge innovation, de-linkage, competition, access and strengthening innovative capacity in developing countries; a global coordination mechanism; a call for increased public investment; a mechanism for redistributing resources; and the pooling of funds to meet these aims, according to the presentation.

Among the option and principles the group discussed in November, according to sources, was that governments should consider different forms of revenue generation to match the proposed funding commitments, and that taxes on activities harmful to populations health, such as tobacco or alcohol, might be appropriate and would be earmarked for health R&D. Other possibilities were that if member states introduce any international indirect tax increase such as the financial transaction tax, a portion of the revenues would be dedicated to global health R&D; and that there could be more encouragement of voluntary private funding toward a pooled funding mechanism.

It is unclear how the treaty proposal will be received by developed countries such as the United
States, according to sources.

No Threat to IP System

A key point made by meeting chair was that the instrument is not aimed at replacing the existing IP-based system, Mirza said.

“CEWG thinks it works when it works,” he said. But when it doesn’t work, the alternative is to develop a system in which governments make binding financial commitments to provide funding for R&D for diseases disproportionately affecting developing countries.

Other Favoured Proposals

Among the “best-fit” group, equitable licensing, patent pools, precompetitive R&D platforms / open source and access, and prizes (in particular milestone prizes) were clustered under “open knowledge innovation” in draft recommendations. The other recommendations are the direct grants, pooled funding, the R&D convention, coordination mechanisms, and strengthening capacity in and technology transfer to developing countries, the presentation said.

Equitable licensing is aimed at ensuring that intellectual property-protected technology and medicines that arose from public funding or in public sector institutions such as universities should be licensed in a way that makes affordable versions available in resource-limited countries.

Under patent pools, patent holders to license their patents to a pool based on negotiated terms. This allows generic manufacturers to use licenses from the pool under special restrictions.

Pooled funds, meanwhile, provide funding to research organisations, including product development partnerships, on a long-term, secure basis. Pooled funds are managed by a board or facility, and can be generated from new sources such as taxes or bonds, or improved management of existing funds. There are a variety of proposals to the CEWG on pooled funds.

Prizes are typically in the form of rewards for developing a product (an end prize) or for completing a step in the R&D process (a milestone prize).

With direct grants to companies in developing countries, the funds are given to small and medium-sized companies to develop a product to the stage where they can more easily find other funders to take it to later stages of development.

A report [pdf] on the CEWG to an October European Congress on Tropical Diseases and International Health gave an indication of the kinds of questions raised and answers provided about the CEWG process and proposals.

The full CEWG membership is as follows:

Prof John-Arne Røttingen, Norway, Chair, EURO region
Prof Claudia Chamas, Brasil, Vice-Chair, PAHO region

Mr L.C. Goyal, India, Rapporteur, SEARO region
Ms Hilda Harb, Lebanon, Rapporteur, EMRO region
Dr Leizel Lagrada, Philippines, Rapporteur, WPRO region
Prof Bongani Mayosi, South Africa, Rapporteur, AFRO region

Dr Kovana Loua, Guinea
Prof Jean de Dieu Rakotomanga, Madagascar
Dr Samuel Okware, Uganda
Prof Carlos Correa, Argentina
Prof Steven Morgan, Canada
Prof Laksono Trisnantoro, Indonesia
Dr Pichet Durongkaveroj, Thailand
Dr Meri Koivusalo, Finland
Prof Paul Herrling, Switzerland
Prof Albrecht Jahn, European Union
Prof Hossein Malekafzali, Islamic Republic of Iran
Dr Rajae El Aouad Berrada, Morocco
Mr Peilong Liu, China
Mr Shozo Uemura, Japan