WHO still finding its way on financing R&D for diseases affecting poor countries
In search of sustainable innovation models for cures for diseases affecting primarily developing countries, with the Ebola epidemic as a new reminder of the necessity and urgency of the matter, the World Health Organization had tasked an expert working group with the search for solutions. Last week, the WHO Executive Board took note of the progress made so far.
WHO members have been working for years to come up with ideas for a new sustainable research and development (R&D) model for such diseases, for which there is little market incentive to invest in the R&D. In the meantime, this week Switzerland, Norway and Brazil pledged funds to advance ongoing R&D projects.
The WHO 136th WHO Executive Board (EB) meeting from 26 January to 3 February took note of the progress made by the secretariat on R&D financing for diseases affecting primarily developing countries.
The EB was asked to note the follow-up of the report [pdf] of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG).
In particular, the report details the possibility of establishing a pooled fund for voluntary contributions towards research and development for type III diseases (affecting overwhelmingly developing countries) and type II diseases (affecting both rich and poor countries, but with a substantial proportion of the cases in poor countries). The fund would also be used for specific research and development needs of developing countries in relation to type 1 diseases (affecting vulnerable populations).
Also to be noted by the EB was the follow-up report [pdf] of the CEWG on demonstration projects, which are sample R&D funding projects currently being tested.
Switzerland, Norway, Brazil Pledge Funds
Switzerland pledged approximately US$ 4.2 million as a voluntary contribution to finance demonstration projects, US$ 2.1 million for the potential pooled fund, and US$ 40,000 to start the global health R&D Observatory. The R&D Observatory is meant to provide a centralised, comprehensive and reliable data source for information on neglected disease R&D, according to the WHO.
In addition, Switzerland also foresees a matching fund mechanism, which would add another 50 percent to each financial contribution from a low and middle-income country, up to a maximum of US$2 million.
Norway also announced its intention to finance the demonstration projects combining a direct contribution of Norwegian krone 5 million (about US$ 758,000), with a matching fund used to increase contributions from low and middle-income countries by 50 percent, up to another Norwegian krone 5 million.
EB members agreed that the pooled fund would be hosted by the WHO Special Programme for Research and Training in Tropical Diseases (TDR). For the management of the money itself, Marie-Paule Kieny, WHO assistant director-general, said the WHO report proposes two options. Either the money could be managed by TDR or by a third party such as the World Bank could administer the funds. The WHO deems that the management within TDR would be preferable, she said, for accountability reasons.
Norway remarked on the need to avoid double counting of matching funds, so that a contribution from a low or middle-income country can only be matched once.
Brazil, for its part, pledged US$ 1 million.
The demonstration projects “aim at developing health technologies (medicines, diagnostics, medical devices, vaccines, etc.) for diseases disproportionately affect developing countries and for which identified R&D gaps remain unaddressed due to market failures,” according to WHO.
Eight projects were initially approved. Three projects are ongoing:
– The Visceral Leishmaniasis (Vl) Global R&D & Access Initiative (Drugs for Neglected Diseases initiative (DNDi));
– Exploiting The Pathogen Box: An International Open Source Collaboration To Accelerate Drug Development In Addressing Diseases Of Poverty (Medicines for Malaria Venture (MMV));
– The Development Of Class D Cpg Odn (D35) As An Adjunct To Chemotherapy For Cutaneous Leishmaniasis And Post Kala-Azar Dermal Leishmaniasis (Pkdl) (United States Food and Drug Administration (US FDA), Osaka University, et al.);
– The Development for easy to use and affordable biomarkers as diagnostics for types II and III diseases (African Network for Drugs and Diagnostics Innovation (ANDI), China Tropical Diseases Drugs and Diagnostics Innovation Network (China NDI), et al.).
The two leishmaniasis projects were later combined into one (The Visceral Leishmaniasis Global R&D and Access Initiative,” which is managed by DNDi in cooperation with the USFDA, according to the WHO.
In November, two additional projects were deemed to meet the necessary criteria
-The Multiplexed point-of-care test for acute febrile illness, (Translational Health Science and Technology Institute, India)
– The 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 (Oswaldo Cruz Foundation, Brazil). The two projects were noted by the EB at this session.
A project by Thailand was withdrawn and a project from the Council of Scientific and Industrial Research from South Africa (Demonstration of the potential of a single dose malaria cure of artemether-lumefantrine through reformulation in a nano-based drug delivery system) was found to require further improvement to qualify as a demonstration project, according to the WHO. More work is to be done on the project by South Africa, which was confirmed by the South Africa delegate.
Several countries said further discussion was needed on the pooled fund. In particular, Lithuania said the pool must attract new funding and increased commitments, as did Namibia and the United Kingdom.
Funding Still Falls Short for Demonstration Projects, WHO Says
WHO’s Kieny said on the status of the global observatory that the WHO is working to link two existing databases, one of funding flows, and the other one on a pipeline of global R&D projects. It is also gathering information about R&D projects on anti-microbial resistance, and further information on R&D projects for diseases with epidemic potential like Ebola.
On the financial sustainability of the pooled fund, two options are being considered, she said. One relies on voluntary funding, and another option would be a replenishment model like the one used by vaccine funder Gavi. Member states have not indicated which option is better so far, she said.
The ongoing demonstration projects are going well, said Kieny, but financially, “they are scoring very low.” Some US$50 million is lacking to address the cost of the current demonstration projects with the addition of the two new ones, she said.
MSF Calls for Action, New Innovation Model
Médecins Sans Frontières (MSF, Doctors without Borders) said in its statement that it “is concerned by the lack of action by WHO and Member States in the face of clear and urgent recommendations in the CEWG report to address the collective under-investment in research and development to meet developing country health needs.”
Mentioning the Ebola epidemic, the MSF representative added “We have been caring for Ebola patients in West Africa as if we were living before the advent of modern medicine: no vaccines and no treatments.”
“The failings of our innovation model are evident in the looming crisis of antimicrobial resistance and the woeful inadequacies in available treatments for drug-resistant tuberculosis,” she said.
MSF urged member states “to focus on the open-ended meeting of member states ahead of the 69th WHA and the need to agree to a sustainable framework that comprehensively addresses the persistent R&D challenges of diseases that primarily affect developing countries.”
