WHO Agrees Plan For Sustainable R&D For Developing Countries; TDR May Host Pooled Fund

World Health Organization members in committee today agreed on a plan taking forward efforts to find alternative financing for diseases predominantly afflicting poor populations. The draft decision was modified overnight to address concerns that the agreed path assess projects on their success in finding alternatives, allow coverage of all types of disease, and not exclude other possibilities in the future.

The adopted decision, A67/B/CONF./2 Rev.1, is available here [pdf].

The 67^th World Health Assembly is taking place from 19-24 May. The committee decision is expected to go to the full WHO membership for approval at the closing plenary of the Assembly later today.

The issue comes in the context of the “Follow-up of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination” (CEWG).

The decision includes the possibility of establishing “a pooled fund for voluntary contributions towards research and development.” There was an interest of some delegations to make it mandatory but this was not successful, sources said.

The adopted version of the decision expands on an earlier version on indicators for measuring success of “demonstration” projects, and the decision’s effect on future discussions.

There are four demonstration projects currently underway, and another four expected to follow, aimed at testing out alternative approaches to financing R&D for diseases for which there is little economic incentive to innovate.

On the indicators, the decision calls for “analysis of the extent of innovative components being implemented by the projects including financing, the use of open access models, multisectoral research platforms, and delinkage, among other criteria.” Delinkage refers to separating drug prices from the cost of the R&D.

On future discussions, language was added to clarify that the work is “without prejudice to future discussions in the context of CEWG recommendations and actions on other sustainable mechanisms for financing health research and development.”

Another addition clarified that the pooled fund could cover “type III and Type II and the specific development needs of developing countries, in relation to type I diseases.” The types of diseases are defined by WHO as such:

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

The concern around disease types arose after the first draft decision mentioned the WHO Special Programme for Research and Training in Tropical Diseases (TDR). TDR is seen as being limited to type I diseases.

The decision requests the secretariat to further explore the pooled fund with TDR, but now includes several additional conditions. These include “recognizing that the scope of the diseases should not be limited to type III diseases but should be in line with the GSPA-PHI mandate.”

GSPA-PHI refers to the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property agreed at the 63rd WHA.

The adopted decision also adds: “recognizing the need for a sustainable financial mechanism for health R&D,” and “recognizing the role of Member States in the governance of the coordination mechanism.”

The secretariat is requested to report to the next Assembly, through the January Executive Board meeting.

The adopted version of the decision was proposed by France. The original version of the draft decision was sponsored by France, Switzerland and India. It met with some confusion after being read out on 22 May (IPW, WHO, 23 May 2014).

[Update] First-Ever Fund based on Delinkage?

“What was important is that the World Health Organization is creating a pooled fund for research and development that is based upon delinkage, that includes not only type III but also type II and some aspects of Type I diseases,” James Love, president of Knowledge Ecology International (KEI), told Intellectual Property Watch. “Delinkage is being mainstreamed.”

“Delinkage means getting the drugs at generic prices all the time,” so the cost of the drug has nothing to do with the cost of the R&D, Love said. “That’s radical.”

This has been the “endgame” of the “innovation and access” movement, he said. “There’s no other solution that will get you there,” Love said of delinkage. “It’s not the best solution, it’s the only solution. Until you stop linking R&D with price you are going to have these problems.”

“It’s the first time a fund has been set up committed to the principle of delinkage,” said Love.

It also “makes sense” to build on the existing secretariat structure, he said, referring to TDR.