WHO sets path for model R&D projects for developing countries

Members of the World Health Organization Executive Board this week moved forward on the long path to new ways to spur research and development for diseases that mainly afflict poor populations. A process has been set for considering – and potentially choosing among – eight projects in the coming months. But bigger questions of alternative systems were left for further discussion.

The WHO Executive Board (EB) met from 20-25 January. The meeting documents are here.

Demonstration Projects

The Board on 24 January considered a WHO secretariat report on the issue, and, after discussion, board members adopted a draft decision, EB134/CONF./13 [pdf], on the way forward on eight projects. The draft decision was sponsored by France, South Africa and Switzerland.

The draft decision stated that further meetings be held in order to judge the eight proposals on the basis of previously agreed criteria (the proposals were called 7+1 because one of the projects did not meet the minimum standard but was next in line in the rating system).

The eight “demonstration projects” are listed in the WHO secretariat report, EB134/27 [pdf].

The eight were selected from among 22 overall proposals by a panel of experts in December (IPW, WHO, 6 December 2013). The 22 proposals came from the regional level, and are provided in full detail here.

Also listed in the secretariat report are the criteria by which the projects are being judged, including whether it addresses a priority public need in developing countries and a market failure. Projects were also assessed based such things as: potential impact and contribution to strengthening research capacity in developing countries; prospects for partnerships; proposed approaches for de-linkage of the cost of R&D from product price; and use of innovative financing mechanisms.

The next meetings, to be held in March and April, will be convened by the chair and vice-chair of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG), and will include stakeholders for the projects. The issue will then likely go to the annual World Health Assembly in May.

For transparency purposes, it was decided by member states today (25 January) that the meetings would include, as observers only, one member state from each of the six WHO regions. These regional representatives were to be drawn randomly by the WHO regional director (or the DG in their absence) from a basket of all the names from the region, and if they decline, another name will be drawn, WHO said. WHO will post the names on the website and will assist the participating member states with participation, it said.

Separately, the secretariat report identifies conflicts of interest for 7 out of the 19 experts who chose the shortlisted eight projects in December, meaning they were recused from decision-making, according to the secretariat report. These included the chair of the December expert meeting, Marcel Tanner, who is chairman of the board of the Drugs for Neglected Diseases initiative (DNDi), which had two proposals on the list, and Maged Al-Sherbiny, a member of a committee of the African Network for Drugs and Diagnostics Innovation (ANDI), which also had two proposals on the list.

R&D Financing Alternatives Drifting?

Meanwhile, a second aspect of the process related to finding alternative funding mechanisms was not substantively discussed by the Board this week. This track is described in a parallel document, EB134/26 [pdf], a report from the director general.

The director general is mandated by members to establish a “global health research and development observatory,” which is discussed in the report and was referenced by several members this week. The observatory will enable users to analyse data on financing for global health R&D, identify priorities, and compare between countries and regions.

The report reviews possible options for mechanisms to coordinate health R&D, including to establish a new global advisory body, as recommended by the CEWG. It also discusses ways in which a funding mechanism might be set up from a legal standpoint. But no decision was taken by members on this component.

The WHO official responsible for the funding mechanism component is Peter Beyer, who came from the Swiss government.

Summing up the CEWG discussion, Marie-Paule Kieny, WHO assistant director-general for health systems and innovation (from France), who oversees the full process, said she was “encouraged to see member state support for this agenda item not faltering after all these years.”

Member State Views

Argentina affirmed the importance of the observatory as a way to help with harmonisation, but it said that all functions must be coordinated, and that an “umbrella” structure is needed. “We’re making headway on these proposals,” the delegate said, and they want to make headway on the other components as well, and then have a joint resolution.

Qatar, on behalf of the Eastern Mediterranean region, said the process so far lacked advertisement and consultation in some regions, and so in order to avoid “further mishaps,” it recommended that one member state from each region be included in the meetings.

This proposal was supported by a variety of delegations after Panama suggested modifying it to say the member states would participate “as observers.” Panama said they saw the importance of having states involved, but said it is not necessary to have “micromanagement.” Qatar agreed with observers.

The amendment to the draft decision was accepted and will appear in EB134/CONF./13 operative paragraph 1, after the word “CEWG.”

Bolivia started to discuss the financing mechanism, and said any mechanism created should be under the WHO umbrella, and called for member states to have a meeting on these issues before the May Health Assembly.

France said the launching of the projects is “valuable” as it will allow a test, and praised the global observatory.

The United States supported the draft decision and opposed any suggestions that would slow down the process.

Monaco also wanted to work within the “existing structure” and supported the draft decision.

Advocates Wonder Where Ambition Went, Call for Bigger Efforts

As a UN agency striving to assert its role as the premier intergovernmental body for global public health policymaking, the issue has been a sore spot for years. Committee after committee has been unable to come up with ideas that member states will agree on. They do agree on the need to address a known market failure that it is unprofitable for the private sector to conduct R&D on diseases for poor populations that will not be able to pay for the resulting medicines.

A number of ideas have been put forward in recent years that reach outside the existing model in which R&D is funded by high prices on drugs, but the more far-reaching ideas usually do not survive governmental and private sector opposition.

Nongovernmental organisations that spoke at the Board meeting raised questions about the ability of the chosen demonstration projects to have a significant effect on the process that they were designed to address.

The People’s Health Movement/Medicus Mundi renewed a call for a proposed international treaty on medical R&D. It said it is “unlikely” the demonstration projects will be very helpful in changing the system that privileges profits over patients.

Health Action International (HAI) said the chosen projects do not test a more transformative process to the benefit of access to medicines for all, and said they may end up little more than a “forgettable footnote.”

James Love, the executive director of Knowledge Ecology International, who delivered the remarks on behalf of HAI, said new incentive mechanisms were proposed, such as de-linking pricing from R&D, but none of these were selected by the experts. The current incentive mechanism leads to high prices and many people dying from lack of access, he said.

HAI asked that the Board recommend the Health Assembly consider all of the proposals and reach a decision there.

The Medicus Mundi and HAI statements are available here.

Médecins Sans Frontières (MSF, Doctors without Borders) said in its statement it remains concerned about the lack of financing for R&D as it is being postponed until 2016, and the demonstration projects may not provide the models of alternatives needed.

Many of chosen eight projects are “straightforward funding proposals” for projects in countries, MSF said, saying that instead, only projects that represent alternative mechanisms should go forward.

DG: Don’t Delay and Have No Doubt

WHO Director General Margaret Chan closed the topic by urging participants, “Please don’t cast any doubt on the process.” She acknowledged that the effort has been “dragging on for a long time” and said she hoped that there were no efforts to delay the process. The random selection of member state observers is a way to prevent anyone from delaying the process, she said.

Source: Intellectual Property Watch

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By William New

Published: Jan. 27, 2014, 8:11 p.m.

Last updated: Jan. 28, 2014, 1:13 a.m.

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