WHO Experts To Analyse R&D Financing, Focus On Poor Country Diseases

The World Health Organization expert working group tasked with studying proposals on financing and coordinating research and development for diseases that disproportionately affect developing countries will meet next week. The working group’s path is not easy as it follows a predecessor group that sustained allegations of conflict of interest and lack of transparency.

The WHO is showing a resolve to demonstrate that a new era of transparency will now be the norm in the discussions with an unusual move to open part of the consultations to stakeholders, who may bring new proposals for discussion. Nevertheless, stakeholders may have a difficult finding existing proposals under discussion in the group on the WHO website, as they are not clearly posted and apparently some may have changed since last year.

The Consultative Expert Working Group on Research and Development: financing and coordination (CEWG) is meeting from 5-7 April (IPW, IP Live, 29 March 2011). It takes forward the work of the Expert Working Group (EWG). The group will give a progress report at the May 2011 World Health Assembly and a final report to the May 2012 assembly.

The CEWG is part of a larger WHO initiative, the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA). The Global Strategy is a medium term strategic plan (2008-2015), formulated in 2009, which aims to “foster innovation and improve access for people in developing countries.”

The Global Strategy has eight elements. CEWG is part of the 7th element “promoting sustainable financing mechanisms.” Asked about progress in the implementation of this plan of action by WHO Executive Board members in January, Marie-Paule Kieny, WHO assistant director general for innovation, information, evidence and research, gave a presentation highlighting that progress was being made.

According to Zafar Mirza, coordinator of the WHO Department of Public Health, Innovation and Intellectual Property, the first meeting of the CEWG shows the commitment of the WHO leadership to be as transparent as possible. That’s because the meeting has been opened up to full stakeholder participation.

“We thought opening this meeting would be an opportunity also to respond to member states’ desire for more transparency on the CEWG,” he told Intellectual Property Watch.

The tentative agenda shows an open session on conflict of interest and transparency during the first day of the CEWG. In January, during the WHO Executive Board meeting, the panel of 21 experts to sit in the CEWG was presented by the WHO secretariat. This list led to controversy as it included a representative from the pharmaceutical industry who is author of one of the proposals that the CEWG has to take into consideration. Some countries and civil society complained about a possible conflict of interest (IPW, WHO, 22 January 2011). The list of experts was ultimately approved by the Board.

The CEWG mandate will be presented in an open session on 5 April. Then on 6 April, there will be an open forum to enable the CEWG “to understand better the perspective of different stakeholders on the issues before it and any additional submissions and proposals,” according to the WHO website.

On 7 April, CEWG members will work in closed session before a summary is made by the chair in an open session at the end of the day.

“For stakeholders, this meeting is an early opportunity to give suggestions, new developments, and new ideas,” Mirza said. WHA Resolution 63.28 asks to bring transparency and provide regular updates to member states. “This is a new way of working, more transparent, more open, more interactive, and hopefully more productive,” he said.

Three sets of proposals will be examined by the working group, Mirza said. This includes a set of proposals short-listed by the EWG, a set that was not short listed by the EWG, and a set composed of any new proposals that might be put forward. The first two categories include “improvement” on previous proposals, he said. Some countries had criticised the EWG for not including some of their proposals in the process, like Bolivia [pdf] (IPW, WHO, 18 May 2010).

The working group was also criticised for not paying enough attention to proposals to de-link costs of research and development from the price of health products, and for not sufficiently taking into account intellectual property rights in the criteria used to evaluate proposals. All countries’ comments are here.

According to the CEWG’s term of reference, the working group will “deepen the analysis of the EWG, in particular by examining the practical details of four innovative financing sources proposed by the EWG, reviewing five promising proposals identified by the EWG, and exploring further six proposals that did not meet the EWG criteria.” The WHA resolution setting up the CEWG “is silent about whether the CEWG should deal with five proposals” in section 5.4 of the EWG report [pdf], about approaches to funding allocation, and two proposals in section 5.5 of the report on proposals to improve efficiency. “The CEWG will need to decide how to deal with these proposals,” the document says.

The four innovative financing sources (section 5.3 of the EWG report) are: a new indirect tax, voluntary contributions from businesses and consumers, the taxation of repatriated pharmaceutical industry profits, and new donor funds for health research and development. The five “promising” proposals (section 5.6 of the EWG report) are: open source, patent pools, the Health Impact Fund, a priority review voucher, and orphan drug legislation. The six further proposals (annex 2 of the EWG report) are: transferable intellectual property rights, green intellectual property, the removal of data exclusivity, a biomedical research and development treaty, large end-stage prizes, and neglected disease tax breaks for companies.

Asked if an analysis of those different proposals had been made by the WHO secretariat, Mirza said this is not the secretariat’s mandate, but the mandate of CEWG. In this first meeting, “the working group members will decide how they want to look at these proposals, and what will be their method of work. They might, if they wish, ask for technical assistance from the secretariat to analyse the proposals,” he said.

The EWG was in charge of examining “current financing and coordination of research and development, as well as proposals for new innovative sources of financing to stimulate research and development related to Type II and Type III diseases, and the specific research and development needs of developing countries in relation to Type I diseases,” according to the CEWG background paper.

Type I diseases are incident in both rich and poor countries, with large numbers of vulnerable populations in each, Type II diseases are incident on both rich and poor countries, but with a substantial proportion of the cases in poor countries, and Type III diseases are those that are overwhelmingly or exclusively occurring in developing countries, according to the WHO.