Harnessing TRIPS Flexibilities for Local Biologics Production: Policy Lessons from South Africa and Rwanda

This policy brief examines how African nations can expand access to complex, patent-protected biologic medicines by strategically implementing intellectual property flexibilities to stimulate local production. It analyses the core policy objective of using the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to overcome patent barriers, a crucial step towards medicine security and health equity. Employing a rigorous comparative case study methodology, it assesses policy documentation, legislative texts, and implementation reports from 2021 to 2026 in South Africa and Rwanda. Key findings demonstrate that South Africa’s amended Patents Act, through substantive examination and stricter patentability criteria, is curbing evergreening and fostering a more conducive environment for biosimilars. Rwanda’s experience, meanwhile, shows how compulsory licensing, bolstered by regional collaboration, can proactively facilitate importation and technology transfer. The brief contends that a dual strategy—combining robust domestic patentability standards with regional mechanisms for pooled procurement and licensing—is essential. Its significance lies in offering actionable, evidence-based policy lessons for African governments aiming to operationalise TRIPS flexibilities effectively. This approach is imperative for building resilient local pharmaceutical manufacturing capacity, reducing import dependency, and sustainably improving access to high-cost biologic treatments for prevalent continental health conditions.