Linking Research to Global Health Equity: The Contribution of Product Development Partnerships to Access to Medicines and Research Capacity Building |
| |
Authors: | Bridget Pratt Bebe Loff |
| |
Affiliation: | The authors are with the Michael Kirby Centre for Public Health and Human Rights, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia. |
| |
Abstract: | 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.1The 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.6Despite 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.8For 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 World Health (OWH) is undertaking access activities as well, although it does not have a formal access strategy. Both MMV and DNDi are involved in building research capacity in LMICs, but OWH is not. Even so, different objectives underlie DNDi and MMV’s research capacity–strengthening efforts. MMV sees capacity building as necessary for its performance of high-quality clinical trials; DNDi aims to contribute to the development of sustainable health research systems in LMICs.12,13Although MMV, DNDi, and OWH have expanded their scope to access and capacity building, some funders and even PDP board members have questioned the appropriateness and effectiveness of PDPs’ role in these areas, suggesting that they should focus solely on product development.15,16 Because most PDP products have only recently been launched, little investigation has been conducted into PDP achievements beyond product development to indicate whether such claims have substance. So far, PDPs have been evaluated against their success in financing and developing new vaccines and drugs, with their recent product approvals highlighted.5,6 Aside from acknowledging that listing these products on the World Health Organization’s Essential Medicine List does not amount to access,17 PDPs’ contribution to product accessibility or to research capacity strengthening in LMICs has undergone limited assessment.We examined the progress MMV, DNDi, and OWH have made in creating access to 8 of their recently launched products (Coartem Dispersible, Eurartesim, Pyramax, artesunate–amodiaquine [ASAQ], and artesunate–mefloquine [ASMQ] for malaria; nifurtimox–eflornithine combination therapy [NECT] for human African trypanosomiasis [HAT]; and paromomycin and sodium stibogluconate–paromomycin combination therapy for leishmaniasis). We selected these PDPs as the focus of our assessment because they are the first PDPs to have brought products to market.18 Relying on information derived from publicly available sources, we used the access framework developed by Frost and Reich to evaluate the 8 products for availability, affordability, and adoption.9 We assessed DNDi''s and MMV''s approaches to research capacity strengthening in LMICs for individual, institutional, and system achievements. This accords with a growing consensus that research capacity building at the country level requires strategies to be directed at these 3 distinct but complementary levels.10,19 We also compared PDPs’ access activities to those of the pharmaceutical industry to determine whether the 2 types of drug development organizations’ differing missions affected their access approaches.Because we only selected drug development PDPs for analysis, our conclusions may not reflect the approaches and achievements of vaccine development PDPs. Herman and Oudin argue that public health systems in LMICs are an adequate means of vaccine distribution to target populations.16 For certain vaccine PDPs, the GAVI Alliance also provides a centralized financing mechanism. As a result, access planning processes for new vaccines are potentially less complex and may require vaccine PDPs to take on fewer activities than do drug development PDPs. |
| |
Keywords: | |
|
|