Learning from practice: compulsory licensing cases and access to medicines.
Compulsory license is one of the safeguards that international IP law provides to address the undesired effects of pharmaceutical patents on access to important medicines. This article looks into three important case examples to analyze the mechanism's effectiveness and feasibility: the first uses of the newer compulsory license regime established in 2003 under the WTO legislative framework to export medicines to third countries, which lack pharmaceutical manufacturing capacities; and further, the first compulsory license grant in India in March 2012. The case analyses are based on the historical, factual and legal background. They reveal the main challenges of the 2003 WTO regime, including the lack of economic incentives for the generic pharmaceutical companies' participation. In the case of India's compulsory license grant, the article takes as in depth look into possible reasons for the reluctance to use the safeguard until recently, and the important aspects and implications of the Indian authorization to manufacture and sell a generic version of a patented cancer drug.
Institute of Health Law, University of Neuchâtel, Avenue du 1er Mars 26, 2000 Neuchâtel, Switzerland. beatrice.stirner@unine.ch.
Beatrice
B
Stirner
Harry
H
Thangaraj
D000970:Antineoplastic Agents; D001938:Brazil; D002170:Canada; D003132:Commerce; D003906:Developing Countries; D004345:Drug Industry; D016568:Drugs, Generic; D006297:Health Services Accessibility; D007194:India; D008004:Licensure; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D000077157:Sorafenib
D000970:Antineoplastic Agents; D016568:Drugs, Generic; D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib