Despite the over $3.4 billion in funding reported by the 2015 G-Finder to support research and development (R&D) of new products for neglected diseases, R&D pipelines are still limited for products treating diseases primarily targeting low- and middle-income countries, compared to products with higher market values.
TDR, the Special Programme for Research and Training in Tropical Diseases, has published Health Product Research and Development Fund: a Proposal for Financing and Operation, describing how a potential pooled fund could operate under the governance of the World Health Organization (WHO) Member States. It also provides new financial modelling tools and mechanisms to guide the fund’s operation.
TDR is a global program of scientific collaboration that helps facilitate, support, and influence efforts to combat diseases of poverty. It is hosted at WHO, and is sponsored by the United Nations Children’s Fund (UNICEF), the United Nations Development Program (UNDP), the World Bank and WHO.
There is currently no one agreed approach to identifying and funding R&D based on a global assessment of disease burden. Most health products – drugs and diagnostics – are developed based on the potential future commercial market paid by patients or insurance schemes. However, the most vulnerable groups can’t afford to pay for drugs, so this new TDR report offers fresh analysis into how to increase development for many diseases that affect millions of people.
Key report recommendations, to be considered by WHO Member States at a special meeting in May prior to decision-making at the 69th World Health Assembly, include:
- A fund of sufficient scale (e.g. incremental increase starting at US$ 10–15 million annually, gradually going up to US$ 100 million annually over a 10-year period) should be set up to support health product R&D;
- The fund’s portfolio of projects (e.g. gradual increase in number of funded projects starting from 5–7 projects per year to an average of 35–40 projects) should be balanced between short-term repurposing and longer-term discovery efforts;
- The fund should have transparent, objective and non-political evidence-based decision-making processes;
- The fund should be able to accept “new” funders and maximize leverage by encouraging new partnerships and collaborations.
TDR was asked in 2014 by the WHO Director-General to investigate potential mechanisms and tools; its governance, structure and experience in the field were evaluated and judged to provide a supportive framework.
TDR Director John Reeder says, “We feel confident, after this very careful review, that we could establish a transparent and efficient governance mechanism to manage this fund.”
The products would be designed according to TDR principles of being affordable, accessible, acceptable, and available to those most in need. This includes over 1.4 billion people in the low- and middle-income countries, including 500 million children, who are affected by a range of diseases like malaria, tuberculosis, dengue, Ebola and Zika viruses.
The report includes a new financial modelling tool that helps identify the minimum funding needed for a specific product. It also provides a framework to determine which financial incentives are the most effective for which types of development. This includes direct grants, prizes, procurement guarantees, vouchers, and R&D tax credits.
A template for Target Product Profiles, which are minimum and/or ideal characteristics for a potential health product, is also provided. There is no universally agreed format, so this is suggested as a new standardized approach for the Scientific Working Group that would be convened to review and adapt.
Decisions on what to fund would come from the WHO Prioritization Mechanism based on data collected by the WHO Global Observatory on Health Research and Development.