Mulumba Moses, Oga Jessica, Koomson Nana, Kara Tasha-Aliya, Cynthia Adanze Nge, Forman Lisa
Afya na Haki, Kampala, Uganda.
Dalla Lana School of Public Health, Toronto, Canada.
BMC Health Serv Res. 2025 Aug 1;25(1):1015. doi: 10.1186/s12913-025-13211-9.
Africa's continued reliance on imported medicines, vaccines, and active pharmaceutical ingredients is the direct legacy of colonial extraction, intensified by the structural-adjustment era's dismantling of state-owned drug plants and cemented by intellectual-property regimes that keep critical know-how offshore. The COVID-19 vaccine scramble exposed the full cost of this vulnerability and has triggered a continent-wide push for pharmaceutical sovereignty-an explicit, decolonizing agenda to localize research, regulation, and production. This review distils the latest evidence on the barriers that still block that transition and maps the regulatory, financial, technological, and civic opportunities most likely to accelerate it.
A critical narrative literature review was conducted. Six databases (PubMed, Scopus, ProQuest, Google Scholar, BMJ Global Health and the Institute for Economic Justice repository) were searched for English-language records published January 2000-May 2025 using the terms Africa AND (pharmaceutic OR vaccine OR API) AND (sovereign OR manufactur OR decoloni). Grey literature from AU agencies, Africa CDC, WHO and UNIDO was added. Forty-five documents met inclusion criteria and were included in the article. Reflexive thematic analysis identified recurrent barriers and enabling pathways; intercoder reliability was ensured through independent coding and consensus meetings.
Four structurally reinforcing barriers dominate the evidence base: (i) TRIPS-based patent exclusivities that restrict technology transfer; (ii) fragmented and immature regulatory capacity (iii) chronic under-investment; and (iv) import-biased procurement. The countervailing opportunities center on (i) AMA-led regulatory harmonization, (ii) pooled-demand instruments (iii) technology-transfer partnerships and (iv) civic-sector mobilization.
Africa now possesses the regulatory blueprint, pooled-demand incentives, and emerging technology platforms to localize production of medicines and vaccines. However, its realization is dependent on synchronizing these levers by easing IP constraints, completing AMA-led regulatory convergence, mobilizing concessional finance for API and bulk-drug capacity, and reforming procurement to reward local value. If pursued in concert, these steps can convert pharmaceutical sovereignty from a political slogan into a resilient, continent-wide industrial reality- anchoring Africa's wider agenda to decolonize global health.
非洲持续依赖进口药品、疫苗和活性药物成分，这是殖民掠夺的直接遗留问题，在结构调整时代，国有制药厂被拆解，情况进一步恶化，而知识产权制度又将关键技术诀窍拒于境外，使其得以巩固。新冠疫苗抢购潮暴露了这种脆弱性的全部代价，并引发了全非洲对制药主权的推动——这是一项明确的非殖民化议程，旨在实现研究、监管和生产的本地化。本综述提炼了仍阻碍这一转变的最新证据，并梳理了最有可能加速这一转变的监管、金融、技术和公民机会。
进行了一项批判性叙述性文献综述。在六个数据库（PubMed、Scopus、ProQuest、谷歌学术、《英国医学杂志全球健康》和经济正义研究所知识库）中搜索2000年1月至2025年5月发表的英文记录，使用的关键词为非洲和（制药或疫苗或活性药物成分）和（主权或制造或非殖民化）。还补充了来自非盟机构、非洲疾病预防控制中心、世界卫生组织和联合国工业发展组织的灰色文献。45份文件符合纳入标准并被纳入本文。反思性主题分析确定了反复出现的障碍和促成途径；通过独立编码和共识会议确保了编码员间的可靠性。
有四个在结构上相互强化的障碍在证据基础中占主导地位：（i）基于《与贸易有关的知识产权协定》的专利排他性，限制了技术转让；（ii）分散且不成熟的监管能力；（iii）长期投资不足；（iv）偏向进口的采购。与之相对的机会集中在：（i）由非洲药品管理局牵头的监管协调；（ii）集中需求工具；（iii）技术转让伙伴关系；（iv）公民部门动员。
非洲现在拥有实现药品和疫苗生产本地化的监管蓝图、集中需求激励措施和新兴技术平台。然而，要实现这一目标，取决于通过放宽知识产权限制、完成由非洲药品管理局牵头的监管趋同、为活性药物成分和原料药生产能力筹集优惠资金以及改革采购以奖励本地价值来同步这些杠杆。如果协同推进这些步骤，这些措施可以将制药主权从一个政治口号转变为一个有韧性的、全非洲范围的产业现实——支撑非洲更广泛的全球健康非殖民化议程。
