Pharmaceutical Sovereignty | Pharmaceutical sovereignty or self-sufficiency strives to establish autonomous healthcare economies and involves African countries in the research, development, and production of their essential pharmaceutical products. (7) | African Medicines Agency (AMA), Partnerships for African Vaccine Manufacturing (PAVM), and the mRNA Technology Transfer Hubs: They focus on the capacity of the region to research, develop and produce essential medicines. (10, 11, 12) | Intellectual property rights: Foreign companies’ reluctance to share patents and technology impedes local innovation. (13, 14) Regulatory hurdles: Only five African national regulatory systems have been indicated as a WHO maturity level 3. This limited maturity level restricts quality control and market confidence. (15) Historical dependency and[JO1] systemic global health imbalances: Africa shoulders a significant portion, 25%, of the global disease burden. Despite this, it relies heavily on imported medical supplies, importing 99% of its vaccines and 95% of its medicines. Notably, Africa consumes about a quarter of the world's vaccines, a proportion anticipated to increase due to an expected annual population growth of 2.5%. (16) Market dynamics favoring imported medicines: A majority of African countries do not purchase local pharmaceuticals. Instead, African governments exhibit a preference for foreign medicines and vaccines over local products. (14) Limited Funding: Pharmaceuticals, including vaccines, demands significant and sustained financial investment. For instance, vaccine manufacturing can entail expenses ranging from $500 million to $1 billion depending on the scale of production. Despite these substantial costs, healthcare receives limited funding from governments in Africa, with most nations allocating less than 1% of their GDP to Pharmaceutical research and development (R & D). (14, 17) | The development of policies and strategies that support the manufacture and purchase of locally made vaccines such as the African Union’s African Union’s Pharmaceutical Manufacturing Plan for Africa (PMPA). Regional research, development, and supply collaborations like PAVM and Afya na Haki’s advancing Regional Vaccine Manufacturing and Access in Africa (ARMA) Programme. The establishment of more pharmaceutical manufacturing hubs Increase in governmental and international funding for pharmaceutical R&D. | Pharmaceutical sovereignty empowers African nations, reducing dependency on the Global North, promoting local innovation, and improving access to medicines thus addressing systemic health inequalities. It challenges the assumed expertise gradient of the Global North by advocating for African nations to develop pharmaceutical solutions to their own identified health challenges. |
Intellectual Property Rights and Regulatory Framework | The role of IP rights and regulations in pharmaceutical production is integral. Unfortunately, within the pharmaceutical manufacturing sector, intellectual property (IP) rights often establish production monopolies, resulting in elevated medication costs and reduced accessibility. (18) | The TRIPS waiver: The TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement imposes restrictions on the sharing of vaccines, medicines, and life-saving equipment. Amidst the COVID-19 pandemic, India and South Africa proposed temporarily waiving TRIPS to ensure equity, accessibility, and affordability of vaccines. (19) | TRIPS waiver proposal has faced strong opposition from some high-income countries, including members of the European Union, Canada, and the United Kingdom. (19) The debate over the TRIPS waiver has become a major obstacle to pharmaceutical production. (19) In all, resistance from wealthy nations emphasizes the power of asymmetry in global health and stringent IP laws. | Advocacy for the TRIPS waiver and a commitment to technology transfers and knowledge sharing will promote equity in access to vaccines, expediting regulatory manufacturing approval processes in Africa. | Intellectual property rights facilitate access to essential medicines and technologies, paving the way for local production capabilities and healthcare equity. |
Strategic Initiatives and Partnerships | Collaborations between government entities, pharmaceutical companies, and international organizations are essential for overcoming obstacles and establishing sustainable pharmaceutical production in resource-limited settings. (13, 15) | The Pharmaceutical Manufacturing Plan for Africa (PMPA), the African Medicines Agency (AMA), The Partnerships for African Vaccine Manufacturing (PAVM), and the Advancing Regional Vaccine Manufacturing and Access (ARMA) Programme: These collaborations aimed at enhancing the pharmaceutical manufacturing capacity within Africa. (10, 11, 20) | Regulatory fragmentation across several African nations results in medication shortages as delays in registration caused by fragmentation, along with duplicative and resource-intensive regulatory processes, compel companies to allocate significant financial resources to obtain drug approval. (21, 22) Limited funding and investment leads to a lack of innovative initiatives, and a lack of partnerships to undertake these initiatives. Limited manufacturing infrastructure and capacities in Africa limit the continents’ capacity to engage in pharmaceutical manufacturing. This includes infrastructure challenges that impact transportation systems, communication networks, and power supply. (23) Intellectual Property Limitations and Knowledge Transfer contribute to fewer initiatives and partnerships on the African continent. This is because initiatives and innovations in Africa heavily rely on technological transfers, knowledge sharing, and technical assistance. (13, 15) | Development of a harmonized regulatory framework in Africa Exploration of innovative financing options include public-private partnerships. Investment in infrastructure and engagement with global pharmaceutical companies and international organizations to negotiate IP agreements that allow for technology transfer and local production of patented medicines. The African Continental Free Trade Area could serve as a platform for facilitating such agreements. | Strategic initiatives and partnerships strengthen the pharmaceutical industry in Africa, promoting sustainable development and regional cooperation. |
Role of Civil Society | Civil society organizations advocate for and support the development of local pharmaceutical industries by providing technical assistance and contributing to resource mobilization and cross-border collaboration | Afya na Haki: Champion the utilization of Africentric evidence and experience in the East African region for localized vaccine production by civil society organizations. (20) | Limited funding: Civil society organizations frequently face a reliance on donor funding. This impedes sustainability, diverts focus from their objectives, and fosters a short-term approach to seeking funds. With a global decrease in donor support, the challenges of dependency and lack of sustainability become even more critical. This lack of sustainability undermines the efforts of CSOs to advocate for pharmaceutical self-sufficiency on the African continent. (24) Shrinking space for CSOs: CSOs engaged in advocacy are often challenged by significant and vague restrictions on their operations, thereby shrinking civil society spaces. This further impacts the sustainability of CSOs and hinders their advocacy work. (24) | Mobilizing community support by leveraging Africentric evidence for localized solutions | Civil Society Organizations (CSOs) play a vital role in decolonizing global health by advocating for pharmaceutical sovereignty and promoting positive African narratives that counter colonial stereotypes. They also contribute to amplifying African-centered initiatives for localized pharmaceutical solutions. |