Effective implementation of TRIPS flexibilities to enhance pharmaceutical production capacity in a regional setting : an in-depth evaluation of the East African community framework

The deplorable state of access to safe and affordable medicines among the world’s populations continues to elicit reactions from various quarters, including the academics, governments, non governmental organisations and intergovernmental groups. Often scapegoated for this global access conundrum is the international patent system introduced by the World Trade Organisation’s Agreement for the Trade Related Aspect of Intellectual Property Rights (hereafter TRIPS). This system, for the first time, introduced a patent protection mandate for pharmaceutical products and processes, thereby ending the discretion which national governments once enjoyed under the Paris Convention for the Protection of Industrial Property 1883. While opinions remain vastly polarised as to the extent to which the TRIPS patent system is responsible for the global access gap, commentators agree that this gap has continued to widen, especially for the populations of low and middle income countries (LMICs), and that urgent national, regional and international responses are imperative to stem the tide. The East African Community (EAC) is a regional economic community comprising Kenya, Uganda, Tanzania, Rwanda, Burundi and South Sudan. All partner states except Kenya are ranked as least developed countries, while Kenya is the only developing country in the region. As would be expected of countries of this economic status, both communicable and non communicable diseases are widespread in the EAC. Even though most of these diseases are treatable (and in some cases preventable) and the medicines required to treat or prevent them available, the pervasiveness of poverty in the region makes affordability a confounding problem. The result is a dismal situation where people die of conditions which could have been otherwise prevented or treated. This thesis thus examines the global access conundrum through the prism of the state of affairs in the EAC. In search of a bespoke long-lasting solution, the EAC adopted the EAC Regional Pharmaceutical Manufacturing Plan of Action 2012–2016 (EAC PMP) (the lifespan of which was later extended to 2017–2027). This policy outlines a regional roadmap aimed at guiding partner states towards achieving enhanced pharmaceutical production capacity. It also commendably recommends that its implementation must be done in synchrony with other related policy initiatives which the region may have adopted or may subsequently adopt. In the category of ‘other related policy initiatives’ are the EAC Medicines Regulatory Harmonisation adopted in 2012 to harmonise drug regulatory systems and achieve mutual recognition of assessment outcomes among partner states; and the EAC Policy on TRIPS Flexibilities adopted in 2013 to guide partner states on the implementation and optimal utilisation of TRIPS flexibilities. This thesis examines the above framework, focusing particularly on whether partner states have effectively implemented TRIPS flexibilities in a manner which may yield the desired end goal of improved access to medicines. Although the EAC Policy on TRIPS Flexibilities is the major policy at the centre of evaluation, the thesis also analyses other related policy initiatives in order to assess the extent to which they contribute to an effective implementation of TRIPS flexibilities. One other important policy area which the thesis critiques is the composition of the anti-counterfeiting regime prevalent in Tanzania, Kenya and the region. This critique becomes necessary to understand the impacts which an anti-counterfeiting regime based on TRIPS-plus enforcement obligations may have on a framework for boosting pharmaceutical production capacity based on an optimal use of the TRIPS flexibilities. The thesis adopts three variants of the qualitative research methodology to answer its research questions: case study, doctrinal and interviewing. The need to interview relevant stakeholders especially became necessary in view of the dearth of literature discussing the level of implementation of the EAC PMP. Overall, the thesis finds that the recommendations in the EAC framework for enhancing pharmaceutical production capacity are, with few exceptions, theoretically sound and unassailable. The thesis, nonetheless, finds a gap between these theoretical recommendations and actual implementation across partner states. In closing, the thesis offers suggestions which may help revitalise the regional framework for better effectiveness