Baldeh Ayo-Oley, Millard Colin, Pollock Allyson M, Brhlikova Petra
Institute of Population Health Sciences, Newcastle University, Newcastle Upon Tyne, NE2 4AX, Tyne and Wear, UK.
Ministry of Health, Kotu, The Gambia.
J Pharm Policy Pract. 2023 Jan 30;16(1):18. doi: 10.1186/s40545-022-00497-x.
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.
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.
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.
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.
基本药物是指能满足民众基本医疗保健需求的药物。然而，获取基本药物仍然是一项全球性的健康挑战。世界卫生组织（WHO）和东非共同体（EAC）2017 - 2027年生产计划支持基本药物的本地生产，以此作为改善药物可及性的一项战略。本研究的目的是确定肯尼亚、坦桑尼亚和乌干达国家基本药物清单（NEMLs）上每个治疗类别的基本药物在每个国家的生产数量。
2018年，我们分析了每个国家的国家基本药物清单和国家药品登记册（NDRs），以按基本药物状态识别本地制造商和本地产品。对于每个本地制造商，我们确定了基本药物产品和单个基本药物的数量，并按注册状态和是否本地生产分析了每个治疗类别的基本药物。
肯尼亚有9家公司在本地生产，坦桑尼亚有4家，乌干达有6家。大多数本地药品是非基本药物产品。在肯尼亚本地生产的946种产品中，310种是基本药物产品；在坦桑尼亚本地生产的97种产品中，39种是基本药物产品；在乌干达本地生产的181种产品中，100种是基本药物产品。许多本地基本药物产品是重复的。每个国家基本药物清单上只有一小部分基本药物是本地生产的：肯尼亚为21%（92/430），坦桑尼亚为5%（24/510），乌干达为10%（55/526）。肯尼亚、坦桑尼亚和乌干达在13/32、17/28和15/32个治疗类别中分别没有本地基本药物产品。已注册基本药物的比例在各国有所不同，肯尼亚为327种（76%），坦桑尼亚为269种（53%），乌干达为319种（60%）。
本研究强调了审核国家药品登记册和国家基本药物清单以进行本地生产的重要性，为区域和国家本地生产战略提供信息。应优先考虑基本药物的本地生产和药品注册，以确保生产与当地健康需求相匹配。
