Innovative Approaches for Pharmaceutical Policy Research in Developing Countries: The View Through a Market Lens

Abstract

Despite one-third of the world lacking access to essential medicines, a dearth of pharmaceutical policy research in developing countries has resulted in policy decisions based upon opinion and conventional wisdom rather than evidence. While historical approaches to improve access to medicines focused on public sector interventions, organizations now recognize the role of the private sector, adopting market-based approaches to improve access to medicines. The main goal of this thesis is to further develop methodological approaches for examining pharmaceutical policy and access to medicines issues in developing countries with particular emphasis on how policies affect market evolution. Each study was designed to inform real life policy and also aimed to: identify new data sources; use analytic methods not frequently applied to pharmaceutical policy research in developing countries; and, determine which policy strategies increase access to medicines. Descriptive and multivariate analyses of medicines claims from a national health insurance system in Kyrgyzstan revealed competitor private sector medicines price changes after the introduction of a not-for-profit pharmacy network for 70% (21/30) of medicines studied, decreasing prices for 57% (17/30) of medicines and increasing prices for 13% (4/30). Another Kyrgyzstan study utilized financial and inventory records from pharmacy outlets and cost accounting methods to reveal dramatic variation in medicine mark-ups (32-244%) in non-profit pharmacies, highlighting the need to balance medicine affordability with business sustainability and the inherent limitations of price controls to improve access to medicines. Five studies utilize information harnessed from more than twenty existing data sources to examine impacts of global policies on evolution of antiretroviral (ARV) medicines markets in developing countries. One study describes the rapid emergence of a competitive ARV market where some branded ARVs were cheaper than generic counterparts while other generic ARVs revealed cumulative price decreases up to 72%. The second study uses generalized estimating equation regression on ARV procurement transactions to find most (19/24) ARVs showed no association between purchase volume and price and no advantage to innovator pricing schemes compared to generic prices for most (15/18) ARVs. The third ARV study quantifies first-line ARV market changes after WHO’s HIV/AIDS treatment guidelines, approvals by WHO Prequalification Programme and United States Food and Drug Administration, and group purchase arrangements. The fourth ARV study details a fragile pediatric ARV market and limited diffusion of new, better-adapted pediatric ARVs despite donor interventions and innovation. The final study uses market segmentation analyses to reveal Indian-produced generic ARVs accounted for more than 80% of ARVs purchased, providing timely information as India engages in bilateral and regional free trade agreements. All studies show how policies affect market evolution and how market dynamics serve as proxies for access to medicines in developing countries. These studies refute conventional wisdoms in global health, with profound impact on pharmaceutical policies at national and global levels. After a dearth of pharmaceutical policy research, this thesis fills some major gaps and provides a model for identifying new data sources, applying new analytic methods, and effectively disseminating and communicating research results towards increased access to medicines in developing countries.