Contribution of product development partnerships to access to medicines and research capacity strengthening

Abstract

BackgroundProduct development partnerships can help to reduce disparities in global health. To improve health in low-income and middle-income countries, such partnerships should not only help development of new products for neglected diseases, but also improve access to these products and strengthen research capacity. Some product development partnerships have expanded their scope to include access and capacity-building activities. Nevertheless, some funders and board members of product development partnerships have questioned the appropriateness and effectiveness of product development partnerships' role in these areas, suggesting that they should focus solely on product development. Whether such claims are justified is unclear. Our aim was to assess the progress of three product development partnerships over the past 5 years—the Medicines for Malaria Venture, the Drugs for Neglected Diseases Initiative, and the Institute for One World Health. MethodsWe assessed access to eight products: fixed-dose combinations of artemether and lumefantrine, piperaquine and artemether, pyronaridine and artesunate, artesunate and amodiaquine, and artesunate and mefloquine for malaria, combination nifurtimox and eflornithine for human African trypanosomiasis, and paromomycin and combined sodium stibogluconate–paromomycin treatment for leishmaniasis. Sources included the websites of the product development partnerships, ACTwatch surveys, open access journals such as the Malaria Journal and PLoS One, Medicines for Malaria Venture and Drugs for Neglected Diseases Initiative annual reports, and clinical trial registries. For each product, we collected data about countries of registration, manufacturers, countries of distribution, cost and affordability, and adoption at national, provider, and end-user levels. We analysed annual reports and websites for self-reported capacity-building achievements, which we classed as individual, institutional, or systems improvements. FindingsThe partnerships support their products' registration in many disease-endemic countries, establish manufacturers in appropriate regions, develop cheap products, and support their products' adoption into national treatment policies in disease-endemic countries. Some products are cheaper in the public sector than in the private sector. The Medicines for Malaria Venture and Drugs for Neglected Diseases Initiative invest in capacity-building in low-income and middle-income countries to create trial sites that comply with good clinical practice guidelines to support the development of their products. Some such countries have very low research capacity—for example, Chad, Sudan, and Angola. Whether these efforts are likely to lead to locally sustainable outcomes is unclear. InterpretationProduct development partnerships have accomplished much with respect to product access in a short period. However, achievement of broad, equitable access requires high distribution coverage in the public and private sectors, affordability (particularly for poor people), and adoption by providers and users. Improvement of the affordability of drugs in the private sector is especially important because many people in low-income and middle-income countries rely on the private sector for medicines. Although the partnerships are involved in these activities, available information about their effect is insufficient. Furthermore, whether such processes should be the responsibility of product development partnerships is unclear; other global health partnerships might be better able to coordinate them. The effectiveness of product development partnerships in creating access to products should be compared to the achievements of the Global Fund and UNITAID. This approach will help to better identify what their comparative advantage is and how far their role in access should extend. We recommend that the Medicines for Malaria Venture and Drugs for Neglected Diseases Initiative formalise their capacity-building roles with the aim of developing competitive, independent research institutions and scientists in low-income and middle-income countries. FundingAustralian Postgraduate Award scholarship, Australian Federal Government, Monash University.