A group of experts summoned to select projects presenting innovative ways to foster research and development of medical products for diseases primarily affecting developing countries at the World Health Organization this week finished their work and selected eight projects out of 22. Civil society was quick to express concern that the selected projects do not propose a new way forward. Now WHO member states must narrow the list down further.
The Global Technical Consultative Meeting on Identification of Health R&D Demonstration Projects took place from 3-5 December.
The seven projects which passed examination against a list of criteria are:
1) Visceral Leishmaniasis (VL) Global R&D & Access Initiative (proposed by the Drug for Neglected Diseases initiative)
2) Multiplexed Point-of-Care test for acute febrile illness (put forward by Translational Health Science and Technology Institute [THSTI], India)
3) Demonstration of the potential of a single dose malaria cure of artemether-lumefantrine through reformulation in a nano-based drug delivery system (proposed by the University of Cape Town [South Africa], Kenya Medical Research Institute (KEMRI), Centre for Research in Therapeutic Sciences (CREATES) [Kenya], Muhimbili University of Health and Allied Sciences (MUHAS) [Tanzania], the African Institute of Biomedical Science and Technology (AiBST) [Zimbabwe], et al
4) Exploiting the Pathogen Box: an international open source collaboration to accelerate drug development in addressing diseases of poverty (submitted by Medicines for Malaria Venture [Switzerland based]
5) 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 (put forward by Oswaldo Cruz Foundation, Ministry of Health [Brazil]
6) Development Of Class D Cpg Odn (D35) As An Adjunct To Chemotherapy For Cutaneous Leishmaniasis And Post Kala- Azar Dermal Leishmaniasis (Pkdl) (US FDA and others)
7) Development for Easy to Use and Affordable Biomarkers as Diagnostics for Types II and III Diseases (proposed by ANDI-African Network for Drugs and Diagnostics Innovation)
An eighth chosen project is the Dengue vaccine development (Health System Research Institute [HSRI] [Thailand]), under different conditions.
A Step in the Process
The meeting followed a decision by the May 2013 World Health Assembly (WHA 66.22 [pdf[) for the WHO “to facilitate… the implementation of a few health research and development demonstration projects to address identified gaps that disproportionately affect developing countries, particularly the poor, and for which immediate action can be taken.”
The authors of the selected proposals have been instructed to provide additional information on specific questions by 15 January. The projects and the answers to the additional questions will be submitted at the WHO Executive Board in January, and subsequently to the WHA in May 2014.
According to the WHO, the experts have been appointed by the WHO director general, in consultation with the regional directors, as requested by the WHA decision.
Criteria
The 22 projects have been evaluated against a set of criteria [pdf] by 19 experts, Marie-Paule Kieny, WHO assistant director-general for health systems and innovation, said in a 6 December briefing. Each region nominated four experts but due to last-minute adverse events, only 19 of them could attend the expert consultative meeting, she said.
The criteria included three categories.
Category A criteria requested that the project answer a public health need for the poorest and address a market failure.
Category B focussed on the scientific excellence, feasibility and timescale of the project.
Category C criteria looked at how innovative the projects are in terms of support to R&D, including de-linkage of R&D from final product prices and use, open innovation approaches, pooled funding, prizes, and patent pools.
Clearing Conflicts of Interest
Kieny also said WHO had a “strict conflict of interest declaration” which was asked from experts, and some of them were asked to refrain from consideration and decision-making regarding the proposals with which they had a conflict of interest. Conflicts of interest declared by seven of the experts are disclosed in a document [pdf] posted on the WHO website.
Scoring of Proposals
Experts scored each proposal according to the set of questions under each category, she said.
Proposals reaching 60 percent of maximum score on one category were then shortlisted for the following scoring round, she said. Seven projects met the challenge.
The eighth project on a Dengue vaccine also met the experts’ approval, according to Kieny, but the project would be developed in a public setting context, answering to the delinking requirement and for which the production would be made by state-owned manufacturers.
Some sources reported that some member states, such as Brazil and Argentina, insisted on the importance of de-linkage. \
Additional Questions
Kieny said that following discussions between member states, proponents of the selected projects should provide more elaboration on the innovative aspects of their proposal. Each of them will be invited to answer a set of six questions by 15 January.
The questions are the following:
– How the project intends to delink the price of the final product from the cost of the R&D
– How it utilises collaborative approaches including open knowledge innovation
– How it utilises licensing approaches that secure access to research outputs and final products
– How it proposes and fosters financing mechanisms including innovative, sustainable and pooled funding
– How it fosters an effective and efficient coordination mechanism amongst existing organisations and initiatives
– How it strengthens the capacity for R&D and production, including technology transfer in developing countries
Assessment Criteria Too Late for Some
According to sources, some member states questioned the fact that the criteria were published only a few days before the meeting. According to Zafar Mirza, coordinator of the WHO Department of Public Health, Innovation and Intellectual Property, the criteria were developed with the help of experts working in the field and involved for a long time in assessment of such proposals through the development of assessment criteria. Those experts were not the experts assessing the proposal, he clarified.
Once the criteria were developed, he told Intellectual Property Watch, 10 days before the conference, the criteria were shared with all experts of the Global Technical Consultative meeting and they were asked for their input, which was considered and used to add questions in category C.
Civil Society Mixed Reaction
Knowledge Ecology International (KEI), delivering a statement on behalf of Health Action International, said the group was concerned “that the recommendations of the Expert Group often favoured rather traditional R&D funding models.”
“It was our hope that the WHO would be more ambitious as regards testing de-linkage models,” they said. They recommended that when the expert group’s recommendations are considered by the Executive Board, the Board also has the opportunity to review all of the 22 proposals considered.
According to James Love, KEI director, all the proposals were compelling and the quality and health benefits are not in question, but the choice made “proves nothing about finance systems and delinking.” It gives the impression that there is no need to change the current system, he told Intellectual Property Watch. He also said on a positive note that most selected projects have “decent licensing terms.”
Médecins Sans Frontières (MSF, Doctors without Borders) also delivered a statement after the selection process. MSF said that” the current innovation model is failing our patients every single day.”
The group said that the exercise was “not about funding individual R&D projects,” but about “testing approaches that could demonstrate new ways of conducting R&D in a manner that supports innovation with access for the many patients neglected and underserved by the current innovation system.”
MSF said it was concerned by the criteria for the selection, which they found “incomplete” and striking “the wrong balance.” For example, they said de-linkage and open collaboration were only used as third-level criteria.
In addition, they said some proposals “were marked favourably for having concretely identified potential partners to develop as well as to produce the technology.” This is of concern, according to MSF, as such criteria “may actually have actively driven the selection of projects away from proposals that seek to demonstrate new ‘delinkage’ models of innovation.”
[…] The list of projects is here (IPW, WHO, 6 December 2013). […]
[…] 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 […]