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

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Globalization and Health

, 6:9

First Online: 25 May 2010Received: 21 February 2010Accepted: 25 May 2010DOI: 10.1186-1744-8603-6-9

Cite this article as: Waning, B., Kyle, M., Diedrichsen, E. et al. Global Health 2010 6: 9. doi:10.1186-1744-8603-6-9


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.

Electronic supplementary materialThe online version of this article doi:10.1186-1744-8603-6-9 contains supplementary material, which is available to authorized users.

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Author: Brenda Waning - Margaret Kyle - Ellen Diedrichsen - Lyne Soucy - Jenny Hochstadt - Till Bärnighausen - Suerie Moon


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