Ending the R&D Crisis in Public Health:

Promoting pro-poor medical innovation

Diseases that disproportionately affect the developing world cause immense suffering and ill health. Medical innovation has the potential to deliver new medicines, vaccines, and diagnostics to overcome these diseases, yet few treatments have emerged. Current efforts to resolve the crisis are inadequate: financing for research and development (R&D) is insufficient, uncoordinated, and mostly tied to the system of intellectual property rights. Delivering appropriate medicines and vaccines requires reforms to the existing R&D system and a willingness to invest in promising new approaches.

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Summary

Insufficient resources are dedicated to developing the new vaccines, diagnostics, and medicines that can address health needs in developing countries. Less than ten percent of global health research spending is dedicated to diseases that primarily afflict the poorest ninety percent of the world's population: the '10/90 gap'. The lack of appropriate medicines to prevent and treat the causes of mortality and morbidity in developing countries has dramatic consequences. Neglected tropical diseases kill 500,000 people every year. Diseases that are controlled in the rich world, such as tuberculosis, cause up to 2 million deaths annually. Existing medicines are often inappropriate for particular groups of patients with special needs, such as women and children.

Research and development (R&D) on diseases prevalent in poor countries is lacking for several reasons. Donor governments and developing countries have not invested sufficient resources into research for these diseases. In 2007, the total contribution from Germany for neglected diseases was only 20.7 million Euros, or 0.12 per cent of its overall research budget.

Pharmaceutical companies do not prioritise R&D to address diseases of the developing world, due to lower financial returns in poor country markets. Furthermore, the WTO TRIPS Agreement, which in 1995 introduced twenty years of patent protection worldwide, failed to boost R&D in pharmaceuticals to satisfy the needs of developing countries, and it provides monopolies to pharmaceutical companies that result in unaffordable prices for medicines.

Only three new medicines for neglected diseases emerged out of global R&D activities between 1999 and 2004. This is woefully inadequate. Three main barriers hinder progress:

• • Insufficient financing: R&D for neglected tropical diseases receives only $1 out of every $100,000 spent worldwide on biomedical research and product development, and only 16 percent of funding for product development partnerships (PDPs) is provided by governments of rich countries.
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• • Lack of bold and creative thinking about incentive mechanisms: New mechanisms, such as advanced market commitments, priority review vouchers, PDPs, and orphan drug programmes, should be commended for their support to vital R&D and are evidence of an openness to new ideas. However, each of these has its specific drawbacks, which need to be addressed before widespread implementation is planned.

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  • Absence of coordination concerning R&D: Without coordination within and between countries, resources are used less efficiently and important needs are neglected.

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Date of publication: November 2008