Burton Ong

Compulsory Licences of Pharmaceutical Patents to Remedy Anti-Competitive Practices Under Article 31(k) of the TRIPS Agreement: Can Competition Law Facilitate Access to Essential Medicines?

While the TRIPS Agreement has been amended, through the introduction of the Article 31bis system, to enable patented pharmaceuticals manufactured under a compulsory licence to be exported to patients in less-developed countries upon satisfaction of specific criteria, it is unclear whether this mechanism provides a satisfactory legal framework to enable sufficient life-saving drugs to reach those who are unable to pay the full prices charged by the major pharmaceutical companies in their home markets. This chapter examines the possibility of relying, as an alternative, on another exception within the TRIPS Agreement—the Article 31(k) provision, which permits compulsory patent licences to be granted to remedy anti-competitive practices—to facilitate access to essential medicines by enabling generic versions of patented drugs to be exported to, and imported by, less-developed countries without having to seek the prior consent of the relevant pharmaceutical patent proprietors. It is submitted that, in the hands of courageous and inventive competition authorities who are able to surmount various tricky political, jurisdictional, and doctrinal hurdles, competition law principles may be able provide the means of facilitating such an endeavour.