Learning from practice: compulsory licensing cases and access to medicines

Abstract

In March 2012, India issued its first compulsory license for a kidney cancer drug. India is one of several countries that have applied the flexibility incorporated in the Agreement on Trade-related Aspects of IP rights. It is expected that the importance of compulsory licenses may grow in the future due to the loss of generic drugs sources after the introduction of pharmaceutical product patents in India, the continuing high prevalence of epidemics, such as of HIV/AIDS, in developing countries and the increase in noncommunicable diseases in these nations. This article analyses the effectiveness and feasibility of compulsory licenses to ameliorate access to medicines based on the historical, factual and legal backgrounds of case examples, such as in Thailand, Canada/Rwanda and India. It addresses challenges and controversial questions, such as the interpretation of the compulsory licensing conditions, the questions surrounding a systematic use of compulsory licenses and the lack of economic incentives for generic pharmaceutical companies’ participation to export drugs to countries without manufacturing capacities. Lessons from the cases discussed and implications for policymakers are outlined.