Compulsory licensing of pharmaceuticals reconsidered: Current situation and implications for access to medicines

Abstract

To examine patterns and trends in attempts, distinguished from issuance, to issue compulsory licensing of pharmaceuticals and to assess related implications in the era of high-cost medicines. Documents from various civil society organisations were primarily used to search attempts, as well as published literature. The identified attempts were analysed by pharmaceutical level, national level, claimers, and the outcomes of the attempts. There have been 108 attempts to issue compulsory licensing for 40 pharmaceuticals in 27 countries since 1995. Most of the attempts were in Asian, Latin American, and African countries and mainly for HIV/AIDS medicines. Moreover, when the claimer was the government, the likelihood of approval and positive outcomes increased. Compulsory licensing, which was devised to cope with the HIV/AIDS pandemic in low-income countries, became a practical measure in several Asian and Latin American countries, even for non-HIV/AIDS medicines. Resurgent compulsory licensing in 2012 and 2014, influenced by the global justice movement, might represent a policy window in the near future as the Doha Declaration did in the 2000s. In this context, various experiences should be circulated and analysed at the global level to better understand the circumstances under which successful issuance has been achieved at the country level.

Keywords: Compulsory licensing; HIV/AIDS; access to medicine; high-cost medicines; medicine; pharmaceuticals.