Regional Approach to Boosting Local Pharmaceutical Manufacturing Capacity: A Critique of the East African Community Pharmaceutical Manufacturing Plan of Action

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Abstract The East African Community (EAC) has had a chequered history, evidenced by multiple changes of names and objectives, and a hiatus lasting more than two decades following a collapse in 1977. It was resuscitated in 1999 by its founding members (Uganda, Tanzania, and Kenya). That four other partner states have since joined is a clear testament to the effectiveness of its overhaul. The community is regulated by the EAC Treaty which promotes collective actions in several areas of mutual interests. Plagued by an ongoing access-to-medicines conundrum, EAC governments have considered collective action as recommended by the Treaty. This effort began around the 2010s when policy measures aimed at exploring collective solutions were adopted with a view to replacing reliance on importation and external drug donation with a gradually developed regional pharmaceutical production capacity. EAC policies such as the Policy/Protocol on TRIPS Flexibilities, the Medicines Registration Harmonisation Initiative, the Draft Anti-Counterfeit Policy, and a Pharmaceutical Manufacturing Plan of Action (EAC PMP) have since been developed to achieve this ambitious goal. Using both doctrinal and empirical (semi-structured interviews) methods, this paper examines the EAC PMP – the ‘be all’ of the policies. The priority actions outlined under the plan’s six pillars and presented as a bankable pathway to self-sufficiency in pharmaceutical production are critiqued. The paper finds considerable implementation of the drug harmonisation theme, while the others (leveraging TRIPS flexibilities, ensuring coherence, and boosting research and development and technology transfer) remain largely unimplemented.