TRIP-ing Up: The Failure of TRIPS Article 31bis

Abstract

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), enacted as part of the World Trade Organization (WTO) in 1995, is the main international agreement covering international intellectual property rights. TRIPS establishes a minimum-standards framework, whereby all member nations are required to fulfill a certain set of intellectual property protections. By 2001, there was some desire to balance public health interests with intellectual property rights, especially with regards to access to medicines in developing and least-developed countries. This resulted in the Doha Declaration on the TRIPS Agreement and Public Health. The Doha Declaration proposed what would eventually become Article 31bis of the TRIPS Agreement, the first, and to-date only, amendment of the Agreement. Under Article 31bis, a country in need of a particular pharmaceutical product, and without the manufacturing capabilities to produce it, is able to import the drug under a compulsory license from a producing country without violating provisions found elsewhere in the Agreement. Although the framework was expected to be widely used, it has been used only once. Precise reasons abound for why the framework has not been more widely used.

In this paper, I argue that, in practice, the compulsory licensing system under Article 31bis does not meet the standards it aims to establish and represents little more than a patchwork to fix specific problems that arose from Article 31. The compulsory licensing system under Article 31bis does not factor in various considerations that importing countries must consider, including the administrative burden that falls on the importing country and recent developments in pharmaceuticals and clinical therapeutics that present challenges to the framework being applied as proposed. The recommendations and conclusions from this work serve not only to lay the groundwork for how the compulsory license process under Article 31bis could be better used, but also to shed light on future WTO amendment proceedings, should they arise in the future.

Keywords: International intellectual property, access to medicines, TRIPS Agreement, Article 31bis, IP, public international law, pharmaceuticals, WTO