A Case Study of the Registration of Essential Medicines in the East African Community

Abstract Objective: To quantify the essential medicine status of registered medicines in the East African Community (EAC) for antimicrobial medicines and medicines for non-communicable diseases.Methods: The National Drug Registers (NDRs) of Kenya, Tanzania, and Uganda (February 2018) were compared with their respective national Essential Medicine Lists (EMLs) to determine the registration status of essential medicines as an indicator of their availability. The number of registered products was analysed for essential medicines and selected non-essential medicines. Findings: Many essential medicines in the EAC are not registered: Kenya 28% (175/632), Tanzania 50% (400/797), Uganda 40% (266/663). Approximately, only one-third of products on the NDRs are essential medicines: Kenya (29%), Tanzania (36%), and Uganda (42%). 23% to 42% of registered essential medicines only have 1 or 2 products. 42 medicines accounted for over 4100 medical products, half of which were non-essential products. Conclusions: This novel analysis provides insight into how registration of medicines is likely to a be a major barrier to accessing essential medicines. The under registration of essential medicines and the over registration of non-essential medicines demonstrates a mismatch between the market of medicines being produced and registered and the health needs of the East African Community. Joint regional medicine authorisation programs such as the EAC Medicines Registration Harmonization Project have potential to improve access to key medicines if essential medicines are prioritised.