Registration and local production of essential medicines in Uganda
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Date
2020
Journal Title
Journal ISSN
Volume Title
Publisher
Journal of pharmaceutical policy and practice
Abstract
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.
Description
Keywords
Access to essential medicines, Essential medicines list, Registration
Citation
Brhlikova, P., Maigetter, K., Murison, J., Agaba, A. G., Tusiimire, J., & Pollock, A. M. (2020). Registration and local production of essential medicines in Uganda. Journal of pharmaceutical policy and practice, 13(1), 1-8.