Access to Medicines and Pharmaceutical Patents: Fulfilling the Promise of TRIPS Article 31bis

Abstract

The Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) has long stood accused of reducing access to medicines for the poorest and most vulnerable nations. Enacted in 1994 as one of the founding pillars of the World Trade Organization, TRIPS has enabled pharmaceutical companies to enforce their patent rights in almost every country, precluding cheaper generics from being distributed, save for very limited exceptions.

But in 2001, TRIPS was amended expressly to address this issue, allowing countries with limited resources to lodge a formal request to obtain patented medicines at a sustainable cost. Generics manufacturers worldwide can answer this call, operating under the protection of a special export compulsory license which shields them from the patent holder. And yet this mechanism has been successfully utilized only once.

In this Article, we explain why export compulsory licenses have failed and suggest reforms that would help fulfill their promise. First, we identify and analyze the factors that deter countries from making recourse to export compulsory licenses. Second, we argue that the only way for nations to use the current legal framework effectively is to act jointly through pooled procurement initiatives. Finally, we advance the view that TRIPS reform is necessary to unlock the potential of export compulsory licenses, proposing targeted amendments and explaining how these revisions would bolster the flow of patented pharmaceuticals from the Global North to the Global South.

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