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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.

SUBMITTER: Brhlikova P

PROVIDER: S-EPMC7419186 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Registration and local production of essential medicines in Uganda.

Brhlikova Petra P Maigetter Karen K Murison Jude J Agaba Amon G AG Tusiimire Jonans J Pollock Allyson M AM

Journal of pharmaceutical policy and practice 20200811

<h4>Background</h4>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 pric ...[more]

PMID: 32793355

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Project description:BackgroundNon-communicable diseases (NCDs) are the leading cause of death worldwide. Inadequate and inequitable access to essential NCD medicines is a major concern, particularly in low- and middle-income countries. National Essential Medicines Lists (EMLs) are important policy tools that indicate which medicines are prioritized as essential within a country's health system. This study sought to analyze a wide range of national essential medicines lists (EMLs) for their inclusion of priority non communicable disease (NCD) interventions recommended by the World Health Organization (WHO).MethodsThree lists of WHO endorsed priority NCD interventions were included. A database with 137 national EMLs and the WHO EML was created from the WHO Repository and these EMLs were compared for listing of priority NCD interventions.ResultsAcross 137 countries with national EMLs, the median percentage of 20 Best Buys interventions listed was 90% (IQR 80-95) and 31 Package of essential noncommunicable disease interventions (PEN) interventions listed was 94% (IQR 90-97), of 9 HEARTS interventions was 100% (IQR 89-100), and of the 43 unique interventions across the three priority lists was 88% (IQR 84-93). Less than 80% of the 43 interventions were listed by 22 (16%) countries and less than half of the interventions were listed by 2 countries: Angola (35%) and Cambodia (23%). Interventions listed on the fewest number of national EMLs were: influenza vaccine, HPV vaccine, hepatitis B vaccine, cervical cancer chemotherapy, codeine, promethazine, senna, and oxygen.ConclusionMost NCD interventions have been prioritized in national policy in most cases. The majority of priority medicines for NCDs described within key WHO NCD technical packages are listed on nearly all national EMLs across 137 countries of all income levels. Most NCD interventions have been prioritized in national policy in most cases, but in some countries and for select interventions such as the HPV vaccine, prioritization may be reviewed.

Project description:BACKGROUND:Essential medicines lists and related policies are intended to meet the priority health needs of populations and their implementation is associated with more appropriate use of medicines. The World Health Organization (WHO) recommends that countries carefully select the medicines to be included in their national essential medicines lists. Lists that are used to prioritize access to important treatments should not include medicines that have been withdrawn elsewhere because of an unfavourable benefit-to-harm balance; however, countries still list and use medicines that have been withdrawn worldwide. The objective of this study was to determine whether the national essential medicines lists of 137 countries include medicines that have been withdrawn in other countries. METHODS AND FINDINGS:We performed an audit of national essential medicines lists for medicines that had been withdrawn. Medicines withdrawn from worldwide markets between 1953 and 2014 were identified using a systematic review of published literature and regulatory documents. The reviewers used sources including the WHO's database of drugs, PubMed, and the websites of regulatory agencies to obtain information regarding adverse effects associated with the medicines, the year of first withdrawal, markets of withdrawal, and the level of evidence supporting each withdrawal. We recorded the number of countries with a withdrawn medicine included in their national medicines list, the number of withdrawn medicines included in each nation's list, and the number of national essential medicines including each withdrawn medicine. 97 medicines were withdrawn in at least one country but still included in one more national essential medicines list. Of 137 countries with a national essential medicines list, 136 lists included at least one withdrawn medicine, with 54% of the lists containing 5 or fewer withdrawn medicines, and 27% including 10 or more withdrawn medicines. 11 medicines were withdrawn worldwide but still included on at least one national essential medicines list. Countries with longer essential medicines lists had more withdrawn medicines included in their lists. CONCLUSIONS:This study found that withdrawn medicines are included in all but one national essential medicines list, representing a need for more stringent processes for selecting and removing medicines on these lists. Countries may wish to apply special scrutiny to medicines withdrawn in other nations when selecting medicines to include on their lists.

Project description:ObjectiveTo explore the perspectives of a diverse group of stakeholders engaged in medicines decision making around what constitutes an "essential" medicine, and how the Essential Medicines List (EML) concept functions in a high income country context.MethodsIn-depth qualitative semi-structured interviews were conducted with 32 Australian stakeholders, recognised as decision makers, leaders or advisors in the area of medicines reimbursement or supply chain management. Participants were recruited from government, pharmaceutical industry, pharmaceutical wholesale/distribution companies, medicines non-profit organisations, academic health disciplines, hospitals, and consumer groups. Perspectives on the definition and application of the EML concept in a high income country context were thematically analysed using grounded theory approach.FindingsStakeholders found it challenging to describe the EML concept in the Australian context because many perceived it was generally used in resource scarce settings. Stakeholders were unable to distinguish whether nationally reimbursed medicines were essential medicines in Australia. Despite frequent generic drug shortages and high prices paid by consumers, many struggled to describe how the EML concept applied to Australia. Instead, broad inclusion of consumer needs, such as rare and high cost medicines, and consumer involvement in the decision making process, has led to expansive lists of nationally subsidised medicines. Therefore, improved communication and coordination is needed around shared interests between stakeholders regarding how medicines are prioritised and guaranteed in the supply chain.ConclusionsThis study showed that decision-making in Australia around reimbursement of medicines has strayed from the fundamental utilitarian concept of essential medicines. Many stakeholders involved in medicine reimbursement decisions and management of the supply chain did not consider the EML concept in their approach. The wide range of views of what stakeholders considered were essential medicines, challenges whether the EML concept is out-dated or underutilised in high income countries.

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Registration and local production of essential medicines in Uganda.

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Registration and local production of essential medicines in Uganda.

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