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

Abstract

The Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) is one of the cornerstones of the World Trade Organization (WTO). TRIPS requires all WTO member countries (Members) to adopt minimum standards for the protection of intellectual property (IP). This international treaty is highly controversial. Its critics claim that TRIPS imposes a wealth transfer from poorer Members (net IP importers) to richer ones (net IP exporters). Its supporters maintain that trade between developing and developed economies cannot thrive without an internationally-harmonized IP framework. The most contentious issue has long been the impact of the TRIPS patents regime on access to medicines.

Our Article contributes to this debate by illuminating an oft-overlooked facet of TRIPS: Article 31bis. Enacted following the Doha Declaration of 2001, this provision was designed to enable Members with inadequate manufacturing capabilities to import patented pharmaceuticals produced by generics manufacturers under an export compulsory license (ECL) issued by another Member. Initially welcomed with enthusiasm, ECLs have enjoyed minimal success.

We propose an explanation for the current fallow state of Article 31bis and suggest approaches to fulfill its promise. First, we identify and analyze the factors that deter Members from making recourse to ECLs. Second, we posit that, under current law, pooled procurement is the only viable avenue to exploit ECLs and elucidate pathways for Members to pursue this strategy. Third, we advance the view that TRIPS reform is necessary to unlock fully the potential of Article 31bis. We proffer targeted amendments to enhance the flexibility and economic viability of ECLs, detailing the ways in which these revisions would bolster the flow of patented pharmaceuticals from the Global North to the Global South.

The Covid-19 pandemic has reawakened public opinion to the glaring disparity in access to medicines worldwide. It has also exposed the unprecedented extent to which production capacity for mRNA vaccines, antivirals, monoclonal antibodies and other life-saving medicines is concentrated in a small number of wealthy countries. It can only be hoped that this realization will spark the impetus to reform Article31bis.

Keywords: TRIPS, Intellectual Property Law, Patents, Right to life, Right to health, Right of access to medicines, compulsory licensing, Article 31bis, Article 31, Covid-19, WTO, CAMR

JEL Classification: K00, K10, K19, K12, O34, O30