WHO Wrestles With Plan To Pursue R&D For Neglected Diseases

World Health Organization members today are expected to address a proposal on future efforts to find a solution to the longstanding problem of sustainable funding for research into diseases predominantly afflicting poor populations. An effort to close the topic yesterday was delayed when a proposal was put forward that named a WHO department as the potential host of the future activities on this issue. 

The work is taking place in committee at the annual World Health Assembly, which is meeting from 19-24 May.

The Assembly is asked to consider a report on the WHO Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG). This group is an outgrowth of years of negotiations at WHO.

A draft decision circulated to a few member states and read out to the committee addressing the issue was not accepted yesterday, as other members requested to see the document in writing before giving their approval. The draft decision was being worked on in a side room today, according to a source, and is expected to come up again later.

The initial draft decision is reprinted below, and was circulated this morning as document A67/B/CONF./2 [pdf].

Report on CEWG

The report on CEWG is in WHA document A67/27 [pdf], which includes a report on work mandated by the past Assembly. This includes setting up a Global Health Research and Development Observatory for collecting and sharing information, on which the secretariat said work has begun. This includes some mapping of stakeholders, work on databases, and holding of consultations.

The document includes a reference to pooled funding, and states that the next step in the search for alternative R&D financing, if member states decide to pursue the possibility of a pooled fund, would be to determine whether any of the most-qualified organisations would be willing to take on such a task. The draft decision takes that step forward.

A second related document A67/28 [pdf], describes four health R&D demonstration projects that were chosen from a much longer list of possibilities. Four other projects were listed as possible and will be further examined in a future meeting. The document provides the indicators used to select the projects, and for future measurement of success. The draft decision endorses the indicators.

Pooled Fund and Draft Decision

Yesterday, many countries stated support for the CEWG documents, and several countries, including Switzerland, Brazil and Kenya, announced they would donate to the pooled fund.

But the draft decision caught some members by surprise. India was named as a cosponsor of the draft decision document, but today the paper names France and Switzerland as the sponsors. Several other countries asked for a paper copy and more time.

Item four of the draft decision proposes an assessment of a “pooled fund for voluntary contributions,” and requests the secretariat to “further explore the option with TDR, take appropriate action, and submit a report” to next year’s Assembly.

TDR is the WHO Special Programme for Research and Training in Tropical Diseases. TDR published an article this month on “New R&D models in neglected diseases under review.” The article, which describes the new proposals set out by TDR, is available here.

Concerns raised included a lack of transparency in the process, and that involving TDR might limit the scope of diseases addressed by the WHO efforts on R&D for uneconomical diseases to only those considered “tropical,” a smaller group than previously referenced. There was also concern that this way forward might narrow the larger vision of finding a truly sustainable new way to finance R&D. And some members questioned whether the pooled fund should be voluntary.

Some of these concerns were addressed yesterday by the WHO secretariat, which said for instance that it would not be limited to TDR’s current scope. But members still requested more time to consider the draft decision.

The Drugs for Neglected Diseases initiative (DNDi), which will carry out one of the four approved demonstration projects (on leishmaniasis) has shown support for the idea of TDR hosting the efforts.

“Through this project, we really want to demonstrate some innovative mechanism to finance and coordinate R&D, Alexandra Heumber, head of policy affairs at DNDi, told Intellectual Property Watch.

DNDi says TDR could be the potential host of the pooled fund upon conditions, appropriate governance, geographic scope should be low and MICs, and not just NTDs, and transparency.

“We also agree that nothing should be locked into this pooled fund,” Heumber said, and that the other discussions are ongoing.

Demonstration Projects

There were eight accepted demonstration projects put forward by the CEWG, after some of the more ambitious ones were cut [clarified]. Four projects are already underway, and many members yesterday raised their interest in the next four demonstration projects proceeding quickly to acceptance.

The first four approved demonstration projects are:

1) The Visceral Leishmaniasis (VL) Global R&D & Access Initiative (proponent: Drugs for Neglected Diseases initiative)

2) Exploiting the pathogen box: an international open-source collaboration to accelerate drug development in addressing diseases of poverty (proponent: Medicines for Malaria Venture)

3) Development of Class D CpG oligodeoxynucleotides (D35) as an adjunct to chemotherapy for cutaneous leishmaniasis and post kala-azar dermal leishmaniasis (proponents: United States Food and Drug Administration et al.)

4) Development for easy to use and affordable biomarkers as diagnostics for types II and III diseases (proponents: African Network for Drugs and Diagnostics Innovation et al.)

Below is the Initial Text of Draft Decision on CEWG:

“WHA 67(xx) Follow-up of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination

The Sixty-seventh World Health Assembly, having considered the reports on the follow-up on the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination – Health research and development demonstration projects[2]

(1) welcomes the progress made in implementation of resolution WHA66.22;

(2) notes the outcome of the review of the 7+1 short-listed demonstration projects that took place in Geneva on 10 March 2014;

(3) welcomes the support provided by the Secretariat to the proponents of the four selected demonstration projects.

(4) endorses the indicators to measure success in implementing the health research and development demonstration projects; and

(5) notes the assessment of the possibility of using an existing mechanism to host a pooled fund for voluntary contributions towards research and development that disproportionately affect developing countries, and requests the Director-General to further explore this option with TDR, take appropriate action and submit a report to the sixty-eighth World Health Assembly.”