ABSTRACT
Against the backdrop of the regional mechanism carved out under Article 31 bis(3) of the TRIPS Agreement, this chapter critically appraises the mechanism's viability or otherwise in addressing the challenge of access to essential medicines in a regional context. The chapter finds that the mechanism remains severely restricted. First, it does not exempt an importing country within a regional alliance from issuing a separate compulsory licence where a patent is in force on the pharmaceutical product for which a compulsory licence is to be invoked. Second, the logic of the mechanism is counter-intuitive 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, this chapter practically reveals how the identified distortions inhibit the use of compulsory licences and other TRIPS flexibilities within a regional coalition. The chapter also examines how the potency of the TRIPS’ transitional period, which excludes 80% of EAC partner 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 chapter recommends an overhaul of TRIPS amendment's regional mechanism for increased effectiveness in driving pharmaceutical access.
