Description: A pooled fund proposed to the WHO for Type II and III diseases, which would allocate funding to health product R&D based on evidence-based processes.
Start date: Commissioned in 2014, proposed in 2016.
Status: Proposed.
In 2014 the TDR (Special Programme for Research and Training in Tropical Diseases) was commissioned by the WHO to investigate a mechanism for funding health product R&D.1
In 2016, TDR published a report proposing the Health Product Research and Development Fund. This would be a pooled fund of eventually \$100m a year for Type II and III diseases.2 The fund would be allocated according to the WHO Prioritization Mechanism, which was under construction at the time of the report.3 The fund would be agnostic as to the most appropriate disbursement mechanism, which would depend on the type of research prioritised.4
The original report stated that ‘Clarification on the handling of intellectual property (IP) ownership should be made on a case-by-case basis. An open IP approach might be more relevant in cases where R&D projects are fully funded throughout the pipeline, but may be less relevant if the fund only finances a portion of the R&D costs.’5 By 2017, this had become a core part of the proposal: ‘Recipients of grants would have to adhere to these principles of transparency and knowledge sharing.’6 Extent of delinkage of drug prices from R&D costs would be a selection criteria.7
The 2016 report was presented to the 69th WHA in 2016, which noted the report and passed resolution WHA69.23, calling for ‘a proposal with goals and an operational plan for a voluntary pooled fund to support research and development for Type III and Type II diseases and specific research and development needs of developing countries in relation to Type I diseases, to be submitted to the Seventieth World Health Assembly’.8 At WHA70, TDR presented this operational plan, with case studies for cutaneous leishmaniasis and schistosomiasis.9 However, it was decided not to fund the proposal further.
Scope: The fund would address Type II and III diseases, and all stages of R&D.
Access: Accessibility of health products would be one of the selection criteria for the fund, so drugs would get cheaper. There is no explicit distribution incentive included.
Innovation: Incentives would be linked to health impact in as far as the selection procedure is informed by strategic priorities which relate to health impact. However, see governability.
Efficiency: Having a single pooled fund increases efficiency of fund allocation. The system is partially market based: there would be competition for funds and in some cases subsequent competition in manufacture and sale. In other cases exclusivity would be maintained. The fund would be centralised, but contributions would be voluntary. The report authors envisage a \$100m fund which would support 25-40 projects including 5 innovation focused projects using 14 staff.10 The fund would cost around \$7.6m to run.11
Governability: It might be hard to maintain a selection process free from bias and political influence.12 Initially the fund would be managed under existing TDR structures, but might eventually need to relocate.13
Political Feasibility: Contributions would be voluntary, which might risk sustainability.14
The Health Product Research and Development Fund is a mixed proposal, and as such might look something like the 3P Project. Both proposals would disburse funds in a variety of ways. A key difference is that the 3P Project is tuberculosis specific, whereas the Health Product Research and Development Fund targets all Type II and III diseases. The WHO global consortium is also mixed, and targets antibiotics.
The pooled funding element is common to the Health Product Research and Development Fund, the Health Impact Fund (HIF) and the Fund for research in Neglected Tropical Diseases (FRiND). HIF would target all diseases and be allocated exclusively through remuneration rights awarded in proportion to Quality-Adjusted Life Years (QALYs) generated. FRiND would focus on neglected diseases, and would select in a similar way to the Health Product Research and Development Fund, using portfolio management techniques and a scientific advisory board. FRiND would only target late-stage research.
There are also disease specific prize funds with a pooled funding element, notably the Chagas Disease Prize Fund and the Cancer Innovation Fund. The Chagas Disease Prize Fund would disburse exclusively through prizes, and the Cancer Innovation Fund (CIF) is still embryonic.
The Antimicrobial Resistance (AMR) Review proposed a fund for antibiotics which would disburse via a number of different mechanisms (grants, milestone prizes etc.). This would look similar to the Health Product Research and Development Fund, with the added level of selection criteria to incentivise conservation of antibiotics. In the antibiotics space, Antibiotics Innovation Funding Mechanism (AIFM), Antibiotic Conservation Effectiveness (ACE) Program and the WHO Global Consortium would also be pooled funds with a variety of disbursement methods.
The WHO biomedical convention proposals would be very similar to the Health Product Research and Development Fund, save that the contributions would be compulsory rather than voluntary.
Developing Economies\’ Fund for Essential New Drugs (DEFEND) is fairly similar in scope to the Health Product Research and Development Fund. Both use WHO governance mechanisms and state funding to tackle medical R&D for diseases of the poor. Where the Health Product Research and Development Fund is a mixed fund incorporating grants and prizes, DEFEND is more narrow and would only operate through license purchasing.
Targeted at: WHO member states
Stakeholders on board:
Robert Terry
Piero Olliaro
TDR
The report: “Health Product Research & Development Fund: A Proposal for Financing and Operation.” Special Programme for Research and Training in Tropical Diseases (TDR), 2016.
The official webpage describing the proposal:
“TDR | New Approach Proposed for Funding and Managing Health Product R&D.” WHO. Accessed July 18, 2017. http://www.who.int/tdr/news/2016/funding_managing_health_product_R_D/en/.
A presentation on the proposal given at the World Health Summit: Rob Terry. “Proposal for Financing and Operation of a Health Product R&D Fund.” presented at the World Health Summit, Geneva, 2016.
News article outlining plans for the discussion of the fund: “TDR | TDR Report Recommendations for Potential Pooled Fund to Be Discussed.” WHO. Accessed August 10, 2017. http://www.who.int/tdr/news/2016/recommend-potential-pooled-fund/en/.
A narrower operational proposal made in 2017: “Health Product Research and Development Fund: Operational Plan for Voluntary Pooled Funding Mechanism.” WHO, 2017.
A news report summarising the content of the proposal: “Innovative R&D Financing Discussed At Geneva Health Forum.” Intellectual Property Watch, 2016. https://www.ip-watch.org/2016/04/26/innovative-rd-financing-discussed-at-geneva-health-forum/.
