Compulsory licensing often did not produce lower prices for antiretrovirals compared to international procurement.
Compulsory licensing has been widely suggested as a legal mechanism for bypassing patents to introduce lower-cost generic antiretrovirals for HIV/AIDS in developing countries. Previous studies found that compulsory licensing can reduce procurement prices for drugs, but it is unknown how the resulting prices compare to procurements through the Global Fund to Fight AIDS, Tuberculosis, and Malaria; UNICEF; and other international channels. For this study we systematically constructed a case-study database of compulsory licensing activity for antiretrovirals and compared compulsory license prices to those in the World Health Organization's (WHO's) Global Price Reporting Mechanism and the Global Fund's Price and Quality Reporting Tool. Thirty compulsory license cases were analyzed with 673 comparable procurements from WHO and Global Fund data. Compulsory license prices exceeded the median international procurement prices in nineteen of the thirty case studies, often with a price gap of more than 25 percent. Compulsory licensing often delivered suboptimal value when compared to the alternative of international procurement, especially when used by low-income countries to manufacture medicines locally. There is an ongoing need for multilateral and charitable actors to work collectively with governments and medicine suppliers on policy options.
Reed F. Beall (Reed.Beall@uottawa.ca) is a PhD candidate in the Institute of Population Health, University of Ottawa, in Ontario.
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Randall Kuhn is a professor in and director of the Global Health Affairs Program, Josef Korbel School of International Studies, at the University of Denver, in Colorado, and a research associate at the Institute of Behavioral Science at the University of Colorado at Boulder.
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Amir Attaran is a professor of common law and of population health at the Institute of Population Health, University of Ottawa, in Ontario.
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D044966:Anti-Retroviral Agents / Q000191:economics* / Q000627:therapeutic use; D003906:Developing Countries; D017277:Drug Approval / Q000331:legislation & jurisprudence; D016527:Drug Costs / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence; D016568:Drugs, Generic / Q000494:pharmacology / Q000592:standards*; D014943:Global Health; D006801:Humans; D038622:Internationality; D008004:Licensure / Q000191:economics*; D011050:Policy Making
D044966:Anti-Retroviral Agents; D016568:Drugs, Generic
AIDS/HIV; Cost of Health Care; Developing World < International/global health studies; Legal/Regulatory Issues; Pharmaceuticals