WHO Experts To Narrow Health R&D Projects For Developing Countries At December Meeting

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Years-old efforts by members of the World Health Organization to come up with viable ways to boost research and development of medical products for diseases primarily affecting poor populations are coming to head, with a key meeting in December. That meeting of experts will be an opportunity to narrow down proposals being developed by the six WHO regional offices.

The annual World Health Assembly last May adopted a “decision” directing the WHO to consult with regions – with engagement of stakeholders – to identify “demonstration projects” showing details of how proposed ideas might work.

The WHO has been implementing that decision, according to Zafar Mirza, coordinator of the WHO Department of Public Health, Innovation and Intellectual Property, and all six regional offices have held or are holding consultations.

More information on the demonstration project process is available on the WHO PHI website here.

The WHO headquarters will not receive any proposals except from the regional offices, Mirza said. The deadline to do so is this week, and information about the proposed projects will be available on the PHI website after 15 November, he said.

The effort to set up demonstration projects follows an earlier agreed resolution containing three areas of action. The other two actions were to establish a global health R&D observatory, and to develop norms and standards to better collect data on health R&D. A progress report has been prepared on these other two areas and is part of the overall discussion.

Decision by Experts

On the demonstration projects, WHO has instructed regional offices not to send more than four projects for each region. These 24 total proposals will be assessed and reduced down by a group of experts in December.

The meeting will be held at WHO on 3-5 December to “help us select a ‘few’ projects,” Mirza said, referring to the language of the May decision. Mirza said this is understood to mean between two and 10 projects, with a target of maybe six.

The December meeting will consist of experts invited by the WHO director general in consultation with regional offices. In choosing the experts, the secretariat is trying to strike a balance based on regions, expertise and other criteria. Some regions have recommended names, he said. The experts will adopt a methodology for deciding which proposals to choose.

The first two days of the meeting will be open to member states as observers, Mirza said. The final day will likely involve a meeting of member states with experts sitting in and invited to brief member states on the proposals. It was not clear how other stakeholders will participate in the meeting.

On to EB, WHA

A report will be prepared on the December meeting outcome and sent to the WHO Executive Board meeting in January. The Board could adopt, reject or suggest changes to the report.

Then the report goes to the World Health Assembly (WHA) in May. If the Board suggests changes, the work would be done before the Assembly.

If the WHA approves, those projects will be agreed and implemented by the WHO.

Background

The R&D financing issue has a long history at WHO, where it has been the subject of tough negotiations. Members generally agree that there is a market failure in which the financial incentive for companies to invest in research on neglected diseases is lacking. But they have spent years in disagreement over how to solve it.

The 2012 WHA welcomed a report from the Consultative Expert Working Group (CEWG) and said consultations were needed. A November 2012 meeting led to key recommendations of the group, such as for an R&D treaty, being stripped from the list of possible approaches. Members in the deep of night in the November meeting agreed to a draft resolution that included a strategic workplan for taking forward the CEWG recommendations.

The CEWG resolution contains three areas of action: establishing a global health R&D observatory; setting up demonstration projects; and developing norms and standards to better collect data on health R&D. The May decision point focusses on advancing the demonstration projects.

The resolution requires reporting to the 2014 Executive Board in January. A core element of the process is to identify ways to finance R&D into neglected diseases, those predominantly affecting poor populations, for which there is little commercial market.

“We are trying to understand what others have done in this area,” said Mirza, adding that a meeting with stakeholders was held earlier this year.

WHO is looking at what different international organisations, agencies and others have been doing on issues such as tracking of financial flows and pipelines for R&D.

“We are trying to develop a vision,” he said.

Regional Group Meetings

The six regions have been holding their meetings, many in the past week or so. The results of the meetings will be posted by WHO on 15 November.

The Pan-American Health Organization already reported the results of its 22-23 October meeting at its headquarters in Washington, DC. The negotiations led to agreement on four proposals, with several alternatives included. As reported, they are:

“1. Chagas R & D Accelerator Initiative: a coordination mechanism for accelerating the development of new health tools for Chagas diseases
2. Development of a vaccine against schistosomiasis based on the recombinant SM14 a member of the fatty acid binding protein: controlling transmission of a disease of poverty
3. Ecosystem for Financing Development of an Open Source Multiplex Point of Care (POC) Diagnostic Test for the Differential Diagnosis of Fever or Sepsis, Henceforward, this will be referred to as the Open Source Fever Diagnostic Project)
4. Development of a Class D CPG ODN (D35 as an adjunct to chemotherapy for cutaneous leishmaniasis and post Kala-Azar Dermal Leishmaniasis (PKDL)

*Alternative projects (in order of priority)*

5. Affordable Diagnostic Tests for Cancer
6. Accelerating Innovation and Access to Medicines for Tuberculosis Through Open Collaboration: A Push, Pull, Pool Approach (“The 3 p Project”)
7. Establishment of Public-Private Partnership for the Development of a Diagnostic Kit for Prenatal and Postpartum)”

 

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

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