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Background: Essential medicines (EMs) are those that satisfy the basic healthcare needs of the population. However, access to EMs remains a global health challenge. The World Health Organization (WHO) and the East African Community (EAC) manufacturing plan 2017–2027 support local production of EMs as a strategy to improve access to medicines. The aim of this study was to determine for each therapeutic class on the national essential medicine lists (NEMLs) of Kenya, Tanzania and Uganda, the number of EMs produced in each country. Methods: In 2018, we analysed NEMLs and national drug registers (NDRs) in each country to identify local manufacturers and local products by EM status. For each local manufacturer we determined the number of EM products and individual EMs, and analysed EMs in each therapeutic class by registration status and whether produced locally. Results: There were nine companies manufacturing locally in Kenya, four in Tanzania and six in Uganda. Most local medicine products were non-EM products. Of the 946 locally produced products in Kenya, 310 were EM products; of the 97 locally produced products in Tanzania, 39 were EM products; and of the 181 locally produced products in Uganda, 100 were EM products. Many local EM products were duplicate. Only a small proportion of EMs on each NEML were produced locally: 21% (92/430) in Kenya, 5% (24/510) in Tanzania, and 10% (55/526) in Uganda. Kenya, Tanzania and Uganda had no local EM products in 13/32, 17/28 and 15/32 therapeutic classes, respectively. The proportion of EMs that were registered varied across the countries from 327 (76%) in Kenya, 269 (53%) in Tanzania, and 319 (60%) in Uganda. Conclusions: This study highlights the importance of auditing NDRs and NEMLs for local production to inform regional and national local manufacturing strategies. EMs should be prioritized for local production and drug registration to ensure that production is aligned with local health needs. [ABSTRACT FROM AUTHOR]

Background: Universal access to high quality essential medicines is critical to sustainable development (SDG 3.8). However low- and middle-income countries struggle to ensure access to all medicines on their national essential medicines lists (EML). Market registration is the first step in determining both access and availability yet the extent to which essential medicines are registered for use at country level is not known. Companies apply for a marketing authorisation, however low price or lack of a market is a disincentive. Local production has been promoted to ensure availability of essential medicines but research in this area is also limited. Methods: The study took place between 2011 and 2015. We systematically examined the registration status of medicines and vaccines listed in the Ugandan 2012 EML and conducted 20 interviews with regulators, ministry of health representatives, donors, and pharmaceutical producers and analysed quality assurance issues affecting registration, procurement, and local production of medicines in Uganda. In 2017 we conducted a further three interviews to clarify issues around non-registration of essential medicines highlighted by our analysis. Results: Of the 566 essential medicines and vaccines nearly half (49%; 275/566) had no registered product in 2012. Of the 3130 registered products, just over a quarter (28%; 880/3130) were listed on the EML. Six local producers had registered 138 products of which 40 corresponded to 32 unique essential medicines. Interviews highlighted alternative routes to availability other than registration. Local producers faced considerable barriers to achieving international quality standards required for international procurement of medicines for the domestic market. Conclusions: Monitoring and audit of the registration of essential and non-essential medicines should be a priority nationally and, regionally through harmonisation of registration requirements in the East African Community. National and regional manufacturing plans should consider local production of unregistered essential medicines. [ABSTRACT FROM AUTHOR]