Vol. 3 No. 1 (2022)
Harnessing TRIPS Flexibilities for Local Biologics Production: Policy Lessons from South Africa and Rwanda
Abstract
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.
Read the Full Article
The HTML galley is loaded below for inline reading and better discovery.
How to Cite
Keywords
Research Snapshot
Desktop reading viewReferences
- Badjatya, J.K., Jangid, A., Dodiya, P., Soni, S.S., Parekh, A., Patel, D., & Patel, J. (2022). Comparative study of Regulatory requirements of Drug Product in Emerging market. International Journal of Drug Regulatory Affairs. https://doi.org/10.22270/ijdra.v10i1.510
- Benavides, X. (2023). Inequitable by Design: The Patent Culture, Law, and Politics Behind COVID-19 Vaccine Global Access. University of Michigan Journal of Law Reform. https://doi.org/10.36646/mjlr.56.2.inequitable
- Cho, D.T. (2024). Transitional Justice in Anglophone Cameroon: Perspectives and lessons from South Africa and Rwanda. Potchefstroom Electronic Law Journal. https://doi.org/10.17159/1727-3781/2024/v27i0a15661
- Cifrodelli, G. (2024). Can you patent the sun? Towards a sui generis inclusive right to manage the relationship between intellectual property and Commons. Journal of Intellectual Property Law & Practice. https://doi.org/10.1093/jiplp/jpae044
- Davies, T. (2022). Unicorn Sightings: The Corporate Moral Apology in South Africa. Unsettling Apologies. https://doi.org/10.1332/policypress/9781529227956.003.0012
- Dayal, D.N. (2022). Sexual Orientation Microaggressions in South Africa. Gender Violence, the Law, and Society. https://doi.org/10.1108/978-1-80117-127-420221005
- Elias, M.M., Victor, N.M., & John, M. (2022). DEMYSTIFYING AND DETERMINING THE ROLE OF TRADITIONAL LEADERSHIP IN WARD COMMITTEE PARTICIPATION. EURASIAN JOURNAL OF SOCIAL SCIENCES. https://doi.org/10.15604/ejss.2022.10.01.002
- Extreme South Africa, K. (2022). [RETRACTED] Keto Extreme South Africa v1. https://doi.org/10.17504/protocols.io.b4xgqxjw
- Fox, A. (2023). Market Failure, State Failure: The Political Economy of Supply Chain Strengthening to Ensure Equitable Access to Vaccines and Medicines in Low- and Middle-Income Countries. Journal of Health Politics Policy and Law. https://doi.org/10.1215/03616878-10910242
- Huq, A. (2025). What are the Key Challenges and Opportunities for UK-led Tech Transfer at LDCs. https://doi.org/10.19088/k4dd.2025.061
- Mabetshe, N., Obioha, E., Mugari, I., & Cishe, E. (2022). Prevention of Child Sexual Abuse in South Africa: Assessing the Role of Parents, Community Leaders, Educators, and Social Workers. Dignity: A Journal of Analysis of Exploitation and Violence. https://doi.org/10.23860/dignity.2022.07.04.02
- Ncube, C.B. (2023). Intellectual Property Law in Africa. https://doi.org/10.4324/9781003310198 http://dx.doi.org/10.4324/9781003310198
- Olatunji, O.A. (2023). Going It Alone or Acting as a Collective? Evaluating the East African Community Policy on Implementing TRIPS Obligations. Journal of African Law. https://doi.org/10.1017/s0021855323000323 http://dx.doi.org/10.1017/s0021855323000323
- Pillay, A. (2025). Psychology and Law in South Africa. Psychology and Law in South Africa. https://doi.org/10.4324/9780367198459-reprw269-1
- Pottgiesser, U., & Tostões, A. (2024). Modernism in Africa. https://doi.org/10.1515/9783035628357
- Pottgiesser, U., & Uduku, O. (2024). Educational Buildings in Africa: A Modernist Review. Modernism in Africa. https://doi.org/10.1515/9783035628357-002
- Rajaram, S. (2025). Access to Medicines and the Role of TRIPS Agreement: An Analysis of India-South Africa Waiver. https://doi.org/10.2139/ssrn.5172661
- Ribeiro, A.A., Ricardi, L.M., Pontes, M.A., & Leite, S.N. (2022). Pharmaceutical Services and global health governance in times of COVID-19. Saúde em Debate. https://doi.org/10.1590/0103-1104202213318i
- Schöfer, T. (2024). Conflicts over transition periods for developing countries in intellectual property rights. Edward Elgar Publishing eBooks. https://doi.org/10.4337/9781035325986.00015
- Smith, H.J., Trytsman, G., Nel, A.A., Strauss, J.A., Kruger, E., Mampholo, R.K., Van Coller, J.N., Otto, H., Steyn, J.G., Dreyer, I.D., Slabbert, D., Findlay, R., Zunckel, E., & Visser, L. (2022). From theory to practice: key lessons in the adoption of Conservation Agriculture in South Africa. Burleigh Dodds Series in Agricultural Science. https://doi.org/10.19103/as.2021.0088.09
- Ssenyange, K., & Chodokufa, K. (2024). The Mediation Role of Stakeholders’ Engagement in Enhancing Public Construction Projects Success – The Case of Uganda. European Project Management Journal. https://doi.org/10.56889/gbec3568
- Tau, A.L., Edoun, E.I., Mbohwa, C., & Pradhan, A. (2023). Improvement of SME’s Manufacturing and Supply Process Flow: A Case Study. The Business and Management Review. https://doi.org/10.24052/bmr/v14nu03/art-07
- Thambisetty, S., McMahon, A., McDonagh, L., Kang, H.Y., & Dutfield, G. (2022). ADDRESSING VACCINE INEQUITY DURING THE COVID-19 PANDEMIC: THE TRIPS INTELLECTUAL PROPERTY WAIVER PROPOSAL AND BEYOND. The Cambridge Law Journal. https://doi.org/10.1017/s0008197322000241
- Uche, O.L. (2023). Plastic Waste Regime in Rwanda, Kenya and South Africa: A Comparative Case Study. American Journal of Law. https://doi.org/10.47672/ajl.1652
- Yu, P.K. (2024). The COVID-19 TRIPS Waiver and the WTO Ministerial Decision. Edward Elgar Publishing eBooks. https://doi.org/10.4337/9781035323579.00006