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Registration and Local Production of Essential Medicines in Uganda Petra Brhlikova1* , Karen Maigetter2, Jude Murison3, Amon G

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Registration and Local Production of Essential Medicines in Uganda Petra Brhlikova1* , Karen Maigetter2, Jude Murison3, Amon G Brhlikova et al. Journal of Pharmaceutical Policy and Practice (2020) 13:31 https://doi.org/10.1186/s40545-020-00234-2 RESEARCH Open Access Registration and local production of essential medicines in Uganda Petra Brhlikova1* , Karen Maigetter2, Jude Murison3, Amon G. Agaba4, Jonans Tusiimire4 and Allyson M. Pollock1 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 Introduction quality and adequate information, and at a price the in- Universal access to essential medicines is necessary to dividual and the community can afford.” [1]. The con- provide for the priority health care needs of the popula- cept of essential medicines is widely accepted and many tion (Sustainable Development Goal 3.8). Essential medi- countries have their own national essential medicines list cines “are intended to be available within the context of (EML), yet multiple barriers to universal access persist functioning health systems at all times in adequate and more evidence and support are needed for effective amounts, in the appropriate dosage forms, with assured implementation of medicine policies in low- and middle- income countries (LMICs) [2]. * Correspondence: [email protected] World Health Organization and Health Action Inter- 1Population Health Sciences Institute, Newcastle University, Baddiley Clark Building, Richardson Road, Newcastle upon Tyne NE2 4AX, UK national (WHO/HAI) standardised surveys on availabil- Full list of author information is available at the end of the article ity and affordability of registered medicines show that © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Brhlikova et al. Journal of Pharmaceutical Policy and Practice (2020) 13:31 Page 2 of 8 essential medicines are more available than non- registration, licensing and post-marketing surveillance essential medicines in both public and private sectors (ISO 9001:2015) and WHO pre-qualification and ISO [3]. accreditation of the National Drug Quality Control La- An unexplored aspect is the registration of essential boratory (NDQCL) for testing of medicines and medical medicines. There is anecdotal evidence of non- devices [13]. registration of essential medicines at country level but According to the Ministry of Health (MoH), availabil- there has been no research in this area. ity of essential medicines and health supplies improved Continued support for local production of pharmaceu- from 43 to 63.8% between 2009/10 and 2014/15 due to ticals to improve access to medicines has been pledged increased funding by both government and foreign do- by five United Nations institutions and the Global Fund nors. Foreign funds accounted for more than 70% of [4]. The evidence on their extent and contribution to public spending on medicines and mainly targeted HIV/ improved access to medicines, especially in low income AIDS, malaria and TB which in turn accounted for more countries, is limited [5, 6]. than half of government spending on essential medicines In this case study in Uganda we systematically exam- and supplies [14]. ined the registration and local production of essential medicines. We undertook qualitative interviews with Data sources and methods regulators, ministry of health representatives, donors, The main study was conducted between 2011 and 2015. and local manufacturers to understand the registration and quality assurance issues for imported and locally produced pharmaceuticals. EML registration status and local producers EML: The 2012 Ugandan EML is publicly available and Ugandan context lists 566 essential medicines and vaccines [15] as general The National Drug Authority (NDA) of Uganda is man- or specialist medicines, designated for a specific level of dated by the National Drug Policy and Authority the health care system, and classified as vital, essential, (NDP&A) Act to implement the National Drug Policy or necessary (VEN) to help facilities prioritise medicines “to ensure the availability, at all times, of essential, effi- in the context of limited budgets (See details in Table 1). cacious and cost-effective drugs to the entire population of Uganda” [7]. NDA regulates pharmaceutical products Table 1 Categorisation of medicines and vaccines in the for marketing; controls the quality of medicines used in Ugandan Essential Medicine List (MoH 2012) the country; and licenses local pharmaceutical manufac- Level of use – each item has a specified lowest level of use within the health care system and can be prescribed and dispensed in the turers, wholesalers, distributors and pharmacies. Since specified and all higher levels 2001, the Ministry of Health’s Pharmacy Section has NR National referral hospital been responsible for the Essential Medicines and Health RL Regional laboratory Supplies List for Uganda (‘Ugandan EML’ hereafter). Uganda is a member of the East African Community RR Regional referral hospital (EAC), which in collaboration with New Partnership for H Hospital Africa’s Development (NEPAD) launched the EAC Med- HC4 Health centre 4 (Medical Officer) icines Registration Harmonization (EAC MRH) project HC3 Health centre 3 (Clinical Officer) in 2012. The project has been supported by the WHO, HC2 Health centre 2 (Enrolled Comprehensive Nurse) the Bill & Melinda Gates Foundation and the World HC1 Health centre 1 (Community level) Bank [8, 9]. The EAC MRH aims to harmonise technical requirements for quality assurance such as good manu- Specialist list further restricts to facilities with a specific type of clinical and/or diagnostic expertise (e.g., certain ophthalmological preparations) facturing practice (GMP) standards and registration pro- cesses. Cooperation between participating national VEN classification takes into account health impact medicines regulatory authorities (NMRAs) is expected to Vital (V)—medicines used to treat life-threatening diseases and health supplies and laboratory commodities that are necessary for basic strengthen local regulatory expertise and lower the regu- healthcare latory workload. Essential (E)—medicines are effective to treat less severe, but The occurrence of falsified and substandard medicines nevertheless, widespread illnesses in the country [10, 11] has been attributed to NDA’s in- Necessary (N)—medicines used for diseases with less impact on the adequate staffing levels that limit their ability to inspect population,
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