Access To Medicines and Pharmaceutical Patents: Fulfilling The Promise Of TRIPS Article 31bis

The tension between patent protection for pharmaceutical innovations and access to essential medicines in developing countries has long been one of the most contentious issues in international intellectual property law. In 2001, the Doha Declaration on TRIPS and Public Health affirmed that the TRIPS Agreement should be interpreted to support public health measures. Subsequently, in 2003, the World Trade Organization adopted a waiver mechanism—later formalized as Article 31bis of the TRIPS Agreement—to address situations where countries with insufficient manufacturing capacity need to import generic versions of patented medicines. Nearly two decades after its adoption, however, Article 31bis has been invoked only once, raising serious questions about whether this mechanism can effectively facilitate access to medicines. This Article provides the first comprehensive analysis of the legal, practical, and political barriers that have prevented Article 31bis from fulfilling its promise. Through detailed examination of the procedural requirements, notification obligations, and legal uncertainties embedded in the mechanism, we reveal how the complexity of the system deters potential users. We also analyze how bilateral and regional trade agreements have undermined the flexibilities that Article 31bis was designed to provide. Drawing on case studies from countries that have considered using the mechanism, we demonstrate that the current framework fails to balance patent protection with public health needs adequately. The Article concludes by proposing concrete reforms to the Article 31bis framework that would make it more accessible and effective, while also examining alternative approaches that might better serve the goal of expanding access to essential medicines in resource-limited settings.