Registration and local production of essential medicines in Uganda

Abstract

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.

Keywords:

• Access to essential medicines
• Essential medicines list
• Registration
• Good manufacturing practice
• Quality assurance
• Uganda
• Universal health coverage

Supplementary information

Supplementary information accompanies this paper at https://doi.org/10.1186/s40545-020-00234-2.

Acknowledgements

We wish to thank Celestino Obua and Paul Waako, who were Ugandan PIs, for their support of the project; interviewees for their time and willingness to share their experience; and Patricia McGettigan for her advice on methods. We thank the editors and reviewers for their suggestions for improvement.

Authors’ contributions

All authors conducted interviews and contributed to design, methodology, analysis, manuscript drafting and revision. PB – Lead; AMP - Acquisition of funding. All authors read and approved the final manuscript.

Funding

This paper results from research funded by the European Union Seventh Framework Programme Theme: Health-2009-4.3.2-2 (Grant no. 242262) under the title ‘Access to Medicines in Africa and South Asia’. The project team included partners at the Swiss Tropical and Public Health Institute at the University of Basel (Switzerland), University of Edinburgh (UK), The Queen Mary University (London), University of Ghent (Belgium), Makerere University (Uganda) Mbarara University of Science and Technology (Uganda), University of the Western Cape (South Africa), and the Foundation for Research in Community Health (India). Neither the EU nor any of the partner institutions is responsible for views advanced here.

Availability of data and materials

All data used in quantitative analysis were sourced from publicly available sources and are available from the corresponding author on reasonable request.

Full transcripts arising from this study are not publicly available due to concerns about identifying participants. Participants of this study did not provide consent for transcripts to be publicly shared or used in another project. We are following our ethics procedures for the AMASA project, for which institutional ethical approval was given. For the purposes of validating and verifying our data requests by qualified researchers may be directed to the corresponding author.

Ethics approval and consent to participate

Ethical approval was obtained from the Institutional Review Board of Mbarara University of Science and Technology and the Uganda National Council for Science and Technology. Consent, ethics and data storage were discussed with interviewees prior to the interview.

Consent for publication

Not applicable.

Competing interests

Authors declare that no competing interests exist.

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