Intervening in global markets to improve access to HIV/AIDS treatment: an analysis of international policies and the dynamics of global antiretroviral medicines markets

Brenda Waning,Suerie Moon,Lyne Soucy,Ellen Diedrichsen,Margaret Kyle,Till Bärnighausen,Jenny Hochstadt

doi:10.1186/1744-8603-6-9

Abstract

BackgroundUniversal access to antiretroviral therapy (ART) in low- and middle-income countries faces numerous challenges: increasing numbers of people needing ART, new guidelines recommending more expensive antiretroviral (ARV) medicines, limited financing, and few fixed-dose combination (FDC) products. Global initiatives aim to promote efficient global ARV markets, yet little is known about market dynamics and the impact of global policy interventions.MethodsWe utilize several data sources, including 12,958 donor-funded, adult first-line ARV purchase transactions, to describe the market from 2002-2008. We examine relationships between market trends and: World Health Organization (WHO) HIV/AIDS treatment guidelines; WHO Prequalification Programme (WHO Prequal) and United States (US) Food and Drug Administration (FDA) approvals; and procurement policies of the Global Fund to Fight AIDS, Tuberculosis, and Malaria (GFATM), US President's Emergency Plan for AIDS Relief (PEPFAR) and UNITAID.ResultsWHO recommended 7, 4, 24, and 6 first-line regimens in 2002, 2003, 2006 and 2009 guidelines, respectively. 2009 guidelines replaced a stavudine-based regimen ($88/person/year) with more expensive zidovudine- ($154-260/person/year) or tenofovir-based ($244-465/person/year) regimens. Purchase volumes for ARVs newly-recommended in 2006 (emtricitabine, tenofovir) increased >15-fold from 2006 to 2008. Twenty-four generic FDCs were quality-approved for older regimens but only four for newer regimens. Generic FDCs were available to GFATM recipients in 2004 but to PEPFAR recipients only after FDA approval in 2006. Price trends for single-component generic medicines mirrored generic FDC prices. Two large-scale purchasers, PEPFAR and UNITAID, together accounted for 53%, 84%, and 77% of market volume for abacavir, emtricitabine, and tenofovir, respectively, in 2008. PEPFAR and UNITAID purchases were often split across two manufacturers.ConclusionsGlobal initiatives facilitated the creation of fairly efficient markets for older ARVs, but markets for newer ARVs are less competitive and slower to evolve. WHO guidelines shape demand, and their complexity may help or hinder achievement of economies of scale in pharmaceutical manufacturing. Certification programs assure ARV quality but can delay uptake of new formulations. Large-scale procurement policies may decrease the numbers of buyers and sellers, rendering the market less competitive in the longer-term. Global policies must be developed with consideration for their short- and long-term impact on market dynamics.

Highlights

Universal access to antiretroviral therapy (ART) in low- and middle-income countries faces numerous challenges: increasing numbers of people needing ART, new guidelines recommending more expensive antiretroviral (ARV) medicines, limited financing, and few fixed-dose combination (FDC) products
We examine ARV market trends in relation to three areas of intervention: World Health Organization (WHO) HIV/AIDS treatment guidelines; certification decisions of WHO Prequal and Food and Drug Administration (FDA); and pooled procurement policies of GFATM, President's Emergency Plan for AIDS Relief (PEPFAR) and UNITAID
Information on approvals of quality-assured FDC ARVs was obtained from WHO Prequal [16] and the United States (US) FDA [17,18] and added to an analytic dataset that contains ARV product information obtained from MSF Untangling the Web of Price Reductions [24], Clinton Health Access Initiative (CHAI) consortium ARV price lists [25], and various manufacturer and national drug regulatory authority websites

Summary

Methods

We utilize several data sources, including 12,958 donor-funded, adult first-line ARV purchase transactions, to describe the market from 2002-2008. Information on approvals of quality-assured FDC ARVs was obtained from WHO Prequal [16] and the US FDA [17,18] and added to an analytic dataset that contains ARV product information (manufacturer, strength, dosage form, and price when available) obtained from MSF Untangling the Web of Price Reductions [24], CHAI consortium ARV price lists [25], and various manufacturer and national drug regulatory authority websites All of this information was used to systematically validate ARV products and prices for ARV purchase transactions obtained from the WHO Global Price Reporting Mechanism [26] and the GFATM Price Quality Report [27] from 2002-2008, after merging and removal of duplicates.

Results

Discussion

Conclusion