WHO Expert Group Sifts Ideas For A New Global Drug R&D Mechanism

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A diverse team of global experts on public health research and development will meet this week behind closed doors to analyse proposals for ways to fund R&D on diseases afflicting poor populations – and for who should coordinate such global efforts.

On 7-8 July, the second meeting will be held of the 21-member Consultative Expert Working Group on Research and Development: financing and coordination (CEWG). The group has been mandated by WHO members to look for answers to the lack of monetary incentives for private sector investment in R&D for diseases occurring mainly among populations that cannot pay high prices for the resulting drugs and technologies.

This second meeting is “very critical” and will focus on “substance,” said Zafar Mirza, coordinator of the WHO Department of Public Health, Innovation and Intellectual Property. But it is not considered a negotiation, he told Intellectual Property Watch.

This meeting is about the different proposals on the table that the secretariat has helped organise so that group members can make decisions about “what kind of importance they want to assign to each one of the proposals,” he said. Criteria have been established for weighing the proposals (IPW, WHO, 23 May 2011).

Global Impact?

The effort of this group has the potential to make a significant difference in global policy on R&D. The related issue of developing affordable medicines for developing countries has caused global tensions (for instance, see here), some of which could be helped by this group’s work.

“This report will be based on a very thorough analysis of all the new thinking,” some captured by the previous working group, said Mirza. “We are hoping this report will make some clear, simple recommendations on the state of affairs on financing and coordination mechanisms in R&D health technologies, and what steps can be taken” as looked upon by the CEWG.

“This report will provide an ‘action agenda’ about the new ideas, he added.

At its first meeting, the CEWG decided (see the meeting “inception” report here [pdf]) that its focus should be on:

“the financing and coordination of research and development for health products and technologies (including, for example, medicines, vaccines, diagnostics, devices and delivery technologies) related to Type II and Type III diseases [affecting predominantly developing countries] and the specific research and development needs of developing countries in relation to Type I diseases. However, it acknowledged the importance of other relevant areas of research and development which may require additional financing and/or improved coordination such as:
• better policies for research and development and innovation
• improved public health, clinical and preventive interventions including, for example,
diagnostic algorithms
• health policy and health systems, to improve delivery and access to new and existing
products.”

Openness among Members

The first meeting of the CEWG was more open; this one will be closed except for a public session on 8 July at 5:30 at which there will be an open briefing with the chair taking questions.

The agenda is not public, but the meeting is expected to focus on the 22 proposals from the preceding group that worked on these issues, plus any new ideas that have come up.

“It is clear CEWG members need to discuss between themselves the different proposals,” Mirza said. So far, there is no indication of which proposals could be considered the most promising.

There were 21 submissions to a public submission period that ended on 15 June, and the expert group will consider these, but it appeared the submissions included few significantly new ideas from the previous discussions, he said.

Despite members’ decision to close the expert group process to non-governmental representatives at times, the WHO stressed that its work is transparent, free of conflict of interest. The group is taking a “very broad and open approach,” said Mirza. The first expert working group met with concerns from some members and stakeholders of conflict of interest.

As to measures of success of the group, it is up to the group members, and is so far “anybody’s guess” what they will look like, he said.

Coordinating the Coordinators

While the work at the WHO on R&D financing has long been highlighted, the expert group’s work might provide a step toward a new structure of global coordination of these issues.

“If you were to ask me today what is the global coordinating mechanism for R&D, I would say there is none through which all of the efforts of stakeholders are being coordinated,” said Mirza.

“All of the major stakeholders invested heavily in this area are doing this in an isolated way,” said Mirza. But he noted that this is not a new issue in public health, as it was pointed out by economist Jeffrey Sachs and others in the past. “But with the inherent difficulties, no such coordinating mechanism has been put in place,” he said.

Mechanisms for financing and coordinating are “quite intertwined with each other,” he noted.

Timeline for CEWG

Under the expert group’s timeline (IPW, WHO, 23 May 2011), a first draft of the report is expected in October, prior to the third meeting on 17-18 November. This will include a draft assessment of proposals and draft recommendations, according to

A second draft would be finalised after the November meeting, and a progress report will be given to the 130th session of the WHO Executive Board meeting in January 2012. It is not clear yet whether a draft of the actual CEWG report will be provided to the Executive Board, or just a progress report.

This will be preceded by side events during sessions of the WHO regional committees from August to October. A regional consultation on the CEWG for African countries has been scheduled on 27 August in Abidjan, Côte d’Ivoire, the day before the WHO regional committee meeting, Mirza said.

The first meeting of the CEWG was held on 5-7 April (IPW, WHO, 8 April 2011), and built upon a previous group called the Expert Working Group (EWG), whose work was criticised by some member states and stakeholders as lacking transparency and being tainted with conflict of interest.

The CEWG chair is John Arne Røttingen of Norway and vice chair is Claudia Inês Chamas of Brazil. Rapporteurs for the meetings represent regions and come from India, Lebanon, the Philippines and South Africa.

The WHO secretariat has a small team, including Mirza, within the Public Health, Innovation and Intellectual Property department supporting the CEWG, and a part-time consultant, Charles Clift of the United Kingdom, who headed the WHO secretariat work on the Commission on Intellectual Property Rights, Innovation and Public Health (IPW, WHO, 3 April 2006).

The group’s work arose from the 2008 WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property.

The WHO, which announced a serious budget shortfall at its recent annual assembly in May, has found funds for its work with this year’s expert group both from within the director general’s budget and from a few member governments, Mirza said.

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

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