WHO Board To Address R&D Financing, Influenza

Finding financing to develop medicines for under-researched diseases, regulatory harmonisation, and pandemic influenza preparedness will top the agenda at next week’s World Health Organization Executive Board meeting.

The Executive Board will meet from 18-23 January. Its recommendations are sent to the annual WHO member decision-making World Health Assembly, which meets in May.

Discussion on implementing key aspects of the ongoing WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property will likely focus on a report by an expert working group charged with finding innovative financing mechanisms for research on diseases disproportionately affecting developing countries.

The report of the expert working group, an executive summary [pdf] of which was released in late December and will be presented to the Executive Board, outlines key recommendations on financing for research and development at several different stages of drug development, including raising new funds, improving allocation of existing funds, and improving efficiency in the R&D system. [Update: the full text of the report is now available here].

The Executive Board is invited to make recommendations on the basis of this report, so what happens with the group’s work depends on discussions next week. Background work on the report is available from the working group’s website here.

Regulatory harmonisation, such as streamlining processes for ensuring drug safety, is one of the major recommendations of the expert working group in the area of increasing efficiency in the R&D system, according to the executive summary of its report.

Strengthening regulation is also one of the activities the WHO secretariat has said it is undertaking as part of its implementation of the global strategy [pdf], which requires a “strengthening of the WHO prequalification programme.” Drug regulation may become a key discussion point on public health and intellectual property this year, according to sources.

The prequalification programme is a tool for organisations (often, though not exclusively, UN agencies), and evaluates and lists medicines that meet standards of quality, safety and efficacy. It currently lists products related to HIV/AIDS, malaria, tuberculosis and reproductive health, but work under the global strategy has called for it to expand its scope to include other neglected tropical diseases, as well as pandemic influenza.

The WHO is under pressure following the recent leak of several documents related to the expert working group report, some of which seemed to indicate that there was undue access by the pharmaceutical industry to the process (IPW, WHO, 9 December 2009).

Influenza also is likely to be a big point of discussion next week. There are still critical outstanding issues in the WHO’s plans for dealing with a potential pandemic outbreak: all intellectual property issues as well as the language and scope of a legally binding Standard Material Transfer Agreement (SMTA) for virus and benefit sharing.

And there is recent concern from several members of the Parliamentary Assembly of the Council of Europe that the threat of pandemics may have been exaggerated “in order to promote … patented drugs and vaccines.” A motion to investigate [pdf] the consequences of the alleged exaggeration will be discussed at the winter session from 25-29 January.

“Criticism is part of an outbreak cycle,” WHO press officer Fadéla Chaib said to UN press in response to the motion. “We expect and indeed welcome criticism and the chance to discuss it… we take this work seriously and guard against the influence of any vested interests. We welcome any legitimate review process that can improve our work. At a later date, WHO will undoubtedly work with outside experts to examine its response and their findings will be made public.”

Another issue that might arise next week is counterfeit medicines, though it is not on the agenda.

A new report on counterfeit medicine is expected to be delivered by the secretariat to the May World Health Assembly. At the 2009 Executive Board meeting, a report by the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) sparked concern in several developing countries and civil society groups that intellectual property violations were being conflated with public health concerns.

There is a new fact sheet now available on the WHO website on counterfeit medicines.