Linking Research to Global Health Equity: The Contribution of Product Development Partnerships to Access to Medicines and Research Capacity Building

摘要

Certain product development partnerships (PDPs) recognize that to promote the reduction of global health disparities they must create access to their products and strengthen research capacity in developing countries. We evaluated the contribution of 3 PDPs—Medicines for Malaria Venture, Drugs for Neglected Diseases Initiative, and Institute for One World Health—according to Frost and Reich’s access framework. We also evaluated PDPs’ capacity building in low- and middle-income countries at the individual, institutional, and system levels. We found that these PDPs advance public health by ensuring their products’ registration, distribution, and adoption into national treatment policies in disease-endemic countries. Nonetheless, ensuring broad, equitable access for these populations—high distribution coverage; affordability, particularly for the poor; and adoption at provider and end-user levels—remains a challenge. PRODUCT DEVELOPMENT partnerships (PDPs) are not-for-profit organizations that build partnerships between the public, philanthropic, academic, and private sectors to drive the development of new products for underserved markets and thereby improve health in low- and middle-income countries (LMICs). The PDP mission differs from that of the pharmaceutical industry, whose main objective is to maximize profits for shareholders by creating interventions for lucrative markets. Key features of the PDP model are a public health objective, use of the portfolio management approach, focus on a neglected disease target, and development of technical interventions (vaccines, drugs, or diagnostics). Yet PDPs vary on several parameters, including their core choice of disease and product targets, scope or breadth of activities (basic research, clinical research, access activities, capacity building), financial model, and operations model. 1 The World Health Organization recognizes that PDPs can contribute to the reduction of global health disparities. 2 This idea has been reiterated by high-income country governments and influential organizations such as the United States’ Institute of Medicine, which identified the PDP platform as “one of the most promising approaches” to combat health disparities between and within countries. 3 (p30),4 Accordingly, high-income country aid agencies, such as the US Agency for International Development and the United Kingdom’s Department for International Development, and philanthropic organizations have increasingly supported the PDP platform. 5 Of the more than 60 existing drug projects for neglected diseases, three quarters are being performed by PDPs. 6 Despite their capacity to generate much-needed interventions for neglected diseases, PDPs are not without their critics. It has been suggested that the paradigm perpetuates research disparities and power inequities between high-income countries and LMICs. Financial control and decision-making power within PDPs rest with first-world head offices and senior staff primarily from the United States and Europe. 7 We recently contended that because the majority of PDPs’ investment in research infrastructure and personnel goes to high-income countries, their ability to promote global health equity may be impaired. 8 For PDPs to improve the health of LMIC populations, it has been argued that they must not only develop new products for diseases identified as a priority by these countries but also, at a minimum, help to create access to their products and make meaningful efforts to strengthen research capacity. 9,10 PDPs have expertise in the conduct of clinical research, making them an appropriate vehicle for capacity building in that area. PDPs can thus promote LMICs’ ability to one day conduct their own research to develop products for neglected diseases and to improve their health systems. Some PDPs appear to have recognized this and have expanded their scope to include access and capacity building. The access strategy of the Drugs for Neglected Diseases Initiative (DNDi) aims to facilitate a consistent and affordable treatment supply of DNDi products to LMICs; this entails ensuring rapid regulatory approval, making agreements with manufacturing partners, forecasting, ensuring supply to LMICs, and updating in-country treatment guidelines. Its strategy involves eventually shifting access activities for products to in-country champions. 11 The access approach of the Medicines for Malaria Venture (MMV) is similar but involves an element—expanding reach—that could extend its role further than DNDi’s. Expanding reach means working with partners to achieve availability not just at the country level but also at the clinic level (point of use) and to ensure uptake by patients. Unlike DNDi, MMV’s strategy does not discuss an endpoint of involvement. 12 In 2010, DNDi and MMV spent €?2.9 million (10.6% of total expenditure) and US?$4.78 million (8.6% of total expenditure) on access and delivery, respectively. 13,14 The Institute for One