WHO R&D Financing Committee Approved With Controversial Industry Expert

World Health Organization members yesterday struck a compromise allowing a Swiss industry representative to sit on a committee selecting proposals for research and developing financing for neglected diseases, disregarding the fact that he is author of one of the proposals. Special safeguards were added to prevent undue influence, but questions remain for some about a conflict of interest.

The compromise was reached in the margins of the WHO Executive Board meeting after developed countries threatened to subject other committee appointees to scrutiny. Critics say the Swiss private sector proposal could be worth billions of dollars to developed country brand-name pharmaceutical companies. Developing countries, including those with burgeoning generics industries also have favourable and polarising candidates on the 21-member expert committee, though none considered as directly positioned to benefit from the outcome.

The rotating, 34-member WHO Executive Board is meeting from 17-25 January.

The Consultative Expert Working Group on Research and Development: Financing and Coordination is part of the WHO global strategy and plan of action on public health, innovation and intellectual property [pdf], which covers the years 2008-2013.

The working group’s mandate is to explore new and innovative sources of funding to stimulate research and development needs, with a particular focus on developing countries.

A predecessor working group fell prey to allegations of conflict of interest and lack of transparency. The last World Health Assembly in May 2010 approved the establishment of a new working group, and a list of experts drawn from a roster of names provided by regional directors was provided to the Executive Board members (IPW, WHO, 17 January 2010).

On the first day of this week’s Board meeting, several governments including Bangladesh, Brazil and Thailand raised concerns about the expert proposed by Switzerland, Paul Herrling, head of Novartis Institutes for Developing World Medical Research. Brazil also asked for the CVs of the short-listed candidates. The CVs of the list of experts are now available on the WHO website.

Marie-Paule Kieny, WHO assistant director general for innovation, information, evidence and research, yesterday defended the expert choices, saying they were based on the requirement from the WHA for regional representativeness, gender balance and diversity of expertise. She said if members agreed on the group composition, the WHO would ask all the experts to sign a declaration of interest which would be reviewed, and before each and every meeting, each member of the group would have to sign a declaration of interest, made public by the group.

Declaration of Interest, Video Link as Safeguards

Brazil, which opposed Herrling in the list, said yesterday that the stakes include equity in global health. It called for a briefing on the mechanism for conflict of interest before the World Health Assembly in May. Ecuador supported the Brazilian position. A Brazilian delegate told Intellectual Property Watch that with the safeguards of the declaration of interest it seemed a better approach to leave Herrling on the working group than either delay the constitution of the group or maybe see other valuable other experts challenged.

Thailand said it had no intention of removing any names from the list but that a focus should be placed on the declaration of interest and members with a conflict of interest during the working group meetings should retract from the session and “leave the room”. The country also proposed to have a video link of the working sessions for member states.

No other countries asked the floor on the subject. Kieny said WHO would conduct transparent management of conflict of interest and proposed to have a video link for public portions of the working group meeting.

Zafar Mirza, coordinator of public health, intellectual property and innovation at WHO, told Intellectual Property Watch that time was very short and the secretariat would try to be as efficient as possible. According to Mirza, the first meeting of the working group should happen as soon as March. The nomination of the working group chair is left to the working group itself in its first meeting, which will be held in Geneva.

In-Depth Debate Focused On an Individual

Gaudenz Silberschmidt, vice director of the Swiss Federal Office of Public Health, told Intellectual Property Watch that the Swiss delegation “agrees with other delegations and expects a conflict of interest management in the working group in a totally transparent way.”

“While the expert that Switzerland submitted comes from industry, he is an independent mind and one of the world experts on how research is conducted,” Silberschmidt said. “We knew that for some people an expert coming from industry could create concerns but we never tried to conceal the fact.”

Silberschmidt said Herrling “proposed one of the innovative financing project that the working group is going to discuss and it is expected that he will not take part of the decision making when this particular project is analysed but many other experts on this working groups have links to other projects to be studied by the working group.”

Herrling, interviewed by Intellectual Property Watch, said, “I know most of the people who criticized my inclusion and they are good friends. We have worked on aspects of the access to medicines for poor patients for several years. They are people who are proposing other types of models and they see the fact that I am elected as a problem since I wrote one of the proposals that will be submitted to the working group. This was clear from the start.”

“Critical reactions to my nomination are part of an open society and ultimately we all want to solve the same issue, disagreement exists only on the best way to achieve it,” he said.

For the International Federation of Pharmaceutical Manufacturers and Associations, “industry participation in multi-stakeholder fora where its scientific, technical or management expertise are relevant is appropriate and in the public interest. With regard to the work of the CEWG, industry is a particularly relevant stakeholder, as a leading practitioner and funder of R&D into diseases of the developing world. It is important that all CEWG members’ interests are transparent, so they can be balanced by inclusion of a range of different stakeholder views – something that the WHO has visibly striven to achieve in this body.”

Civil Society Outraged

Nine public health and development groups sent a letter on 20 January to the Board Chairman Mihaly Kökény and Vice-Chairman Paulo Buss to oppose the nomination of Herrling.

After the Board decision to accept the nomination of the list of experts, James Love, director of Knowledge Ecology International said “I am quite disappointed the Obama administration was among those insisting that obvious and highly inappropriate conflicts of interest be ignored.”

For Patrick Durisch, Health Programme coordinator for the Berne Declaration, “both the nomination of Paul Herrling to the CEWG by Switzerland and its subsequent shortlisting by WHO are serious mistakes. This casts doubts about the real capacity of WHO to address the issue of conflicts of interests among its expert working groups, and to remain independent from corporate interests.”