Compulsory licences in a regional context : An appraisal of the TRIPS Amendment's special regional treatment

Against the backdrop of the regional mechanism carved out under Art. 31bis(3) of the TRIPS Agreement for issuing compulsory licences, the paper critically appraises the mechanism’s viability or otherwise in addressing the challenge of access to essential medicines in a regional context. The paper finds that the mechanism remains severely restricted. First, it does not exempt an importing country within the regional alliance from issuing a separate compulsory licence where a patent is in force on the pharmaceutical product in question. Second, the logic of the mechanism is counterintuitive in that it is prohibited from being used as an instrument to pursue industrial policy objectives, and in a broad sense, a public-health-related industrial agenda. Using the East African Community (EAC) as a case study, the paper practically reveals how the identified distortions inhibit the use of compulsory licences within a regional coalition. The paper also examines how the potency of the TRIPS transition period, which excludes 80% of EAC member states from granting pharmaceuticals patents until 2034, is being whittled down by the African Regional Intellectual Property Organization’s (ARIPO) obligations and unclear domestic legislation. The paper recommends an overhaul of the TRIPS amendment’s regional mechanism for better effectiveness in driving pharmaceutical access.

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