Access To Medicines and The Failure of Export Licenses

Abstract

Medicine has made vast progress over the past century. Diseases that were once a death sentence have been vanquished—for some. In rich countries, those covered by well-funded healthcare systems have access to treatments that have failed to “trickle down” to the world’s poorest nations. Politicians, lawmakers, and activists have acknowledged, lamented, and sought to address this disparity for thirty years. So why does this paradigm of inequality persist?

The Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) has long stood accused of exacerbating this imbalance. Enacted in 1994, TRIPS has enabled pharmaceutical companies to enforce their patent rights in almost every country, precluding cheaper generics from being distributed, regardless of how many lives they might save. But in 2001, TRIPS was amended in an attempt to right this injustice, 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 so dramatically despite such good intentions 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