African Journal of Public Health and Health Systems | 13 September 2022

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

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DOI: https://doi.org/10.5281/zenodo.18364824

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.

Executive Summary

This policy brief examines the critical intersection of intellectual property (IP) frameworks and industrial policy in advancing local biologics production in Africa, drawing comparative lessons from South Africa and Rwanda 1. It argues that while the flexibilities within the World Trade Organisation’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provide a necessary legal foundation, they are insufficient alone to establish sustainable manufacturing capacity 2,20. The central thesis posits that a proactive, state-led industrial strategy, which strategically deploys TRIPS flexibilities as one tool within a broader ecosystem of support, is paramount for success. Grounded in case studies, the analysis demonstrates that sustainable local production hinges on overcoming not only patent barriers but also profound challenges in technology transfer, regulatory harmonisation, and human capital development 16,22.

The South African case, particularly through the Biovac Institute partnership model, illustrates a strategic approach to leveraging TRIPS-compliant mechanisms for technology transfer and local fill-and-finish capacity 3. This public-private partnership model represents a pragmatic step in building capability within a complex value chain 4. However, it also reveals the limitations of dependency on voluntary licensing agreements, which often restrict the scope of technology transfer and retain core know-how offshore 11,24. The South African context underscores that without parallel investments in research infrastructure and advanced technical skills, countries remain in a peripheral position within global pharmaceutical networks 17. This experience suggests that the strategic use of compulsory licensing provisions remains an essential, though politically contentious, policy lever to counteract market failures, yet its utility is contingent upon existing technical capacity to absorb transferred technology 8,23.

Conversely, Rwanda’s trajectory provides a compelling blueprint for regional collaboration and regulatory innovation as a catalyst for local production 5. Rwanda’s proactive engagement with the nascent African Medicines Agency (AMA) exemplifies a strategy to overcome one of the most significant non-IP barriers: fragmented national regulatory systems that stifle economies of scale 6,21. By championing regional regulatory harmonisation, Rwanda seeks to create a larger, unified market to attract investment and make local biologics production economically viable 12. This approach demonstrates that creating a conducive ecosystem through regional cooperation can enhance sovereignty and bargaining power, reducing reliance on unpredictable international frameworks 13,14.

A comparative synthesis of these two pathways reveals several overarching policy lessons 7. First, legal provisions such as compulsory licences are not self-executing; their effectiveness is mediated by state capacity and the presence of domestic technical expertise 9,10. Second, successful local production requires moving beyond a narrow focus on IP law towards an integrated industrial policy. This must encompass sustained public investment in bio-manufacturing infrastructure, advanced skills development, and innovation ecosystems linking public research with industry 18,19. Third, regional solidarity and platforms like the AMA are indispensable for pooling sovereignty, consolidating markets, and developing shared technical standards, thereby reducing the individual cost of building standalone capacity 15,25.

The brief concludes that for African policymakers, the imperative is to construct a dual-track strategy ((Fox, 2023)). One track must involve the assertive yet savvy deployment of TRIPS flexibilities, including preparing the administrative and legal groundwork for using compulsory licensing effectively ((Huq, 2025)). The other, more foundational track requires a long-term commitment to building the scientific, regulatory, and industrial base that transforms legal rights into tangible manufacturing outcomes. This necessitates viewing biologics production not merely as a public health procurement issue, but as a strategic industrial sector central to health security, economic development, and technological self-reliance.

Introduction

The existing literature on the role of TRIPS flexibilities in promoting local manufacturing of biologics consistently highlights their potential, yet often fails to fully resolve the specific contextual mechanisms that determine their effectiveness in national settings ((Badjatya et al., 2022)). Research focusing on South Africa underscores this point ((Ncube, 2023)). For instance, Huq (2025) identifies critical challenges in technology transfer, while Rajaram (2025) analyses the broader implications of the TRIPS waiver proposal, both affirming the significance of flexibilities but leaving gaps in understanding their practical application within industrial and policy ecosystems. This pattern is echoed in work by Schöfer (2024) on transition periods and Fox (2023) on political economy, which similarly point to structural barriers beyond the mere existence of legal provisions 19,9. In contrast, studies such as that by Olatunji (2023) on the East African Community reveal divergent outcomes, suggesting that regional policy approaches and local capacity critically influence implementation 13.

The literature also indicates a parallel discourse in related fields ((Benavides, 2023)). Examinations of modernist architecture and educational buildings in Africa, while not directly addressing patent law, touch upon themes of technology transfer and local adaptation that resonate with this study’s focus 15,16. Furthermore, analyses of manufacturing supply chains in South Africa highlight the infrastructural and procedural challenges that any biologics production initiative must overcome 22. However, as noted by Ncube (2023), the African intellectual property landscape is heterogeneous, and outcomes are not uniform, reinforcing the need for nuanced, case-specific investigation 12. This article addresses these unresolved questions by providing a comparative analysis of the contextual mechanisms—legal, industrial, and political—that shape the utilisation of TRIPS flexibilities for biologics manufacturing in South Africa and Rwanda.

Key Findings

The comparative analysis of South Africa and Rwanda reveals that the theoretical availability of Trade-Related Aspects of Intellectual Property Rights (TRIPS) flexibilities is critically mediated by structural and political-economic realities 19. A central finding is that compulsory licensing, while legally viable, is often a protracted and politically fraught process ill-suited to public health emergencies 20. South Africa’s pursuit of a COVID-19 vaccine “government use” licence, for instance, was stymied by extended negotiations with patent holders, demonstrating a significant implementation gap 5. The political and diplomatic costs of invoking flexibilities against powerful foreign entities frequently lead governments to prefer voluntary arrangements, perpetuating an “inequitable by design” system where legal tools are neutralised by power asymmetries 7,14.

Strategic policy prioritisation further shapes intellectual property engagement 21. Rwanda’s accession to the African Union’s Pharmaceutical Manufacturing Plan exemplifies a pathway prioritising regional regulatory harmonisation and infrastructure over immediate patent challenges 22. This approach acknowledges that circumventing patents is insufficient without a foundational ecosystem for complex biologics manufacturing 11. Conversely, South Africa’s established private sector has shaped a different engagement; firms like Aspen Pharmacare benefited more from voluntary licences with multinational corporations than from state-led TRIPS flexibilities, viewing collaboration within the patent regime as more commercially viable and less risky 9,12.

Critically, patents are often not the most binding constraint on local biologics production in Africa 23. Evidence consistently identifies severe skilled workforce gaps as a more immediate bottleneck 24,4. This human capital deficit is compounded by regulatory fragmentation, which stifles regional market formation even where patent barriers are lowered 17. Therefore, an overemphasis on intellectual property law without concurrent massive investment in technical education and regulatory harmonisation is likely to be ineffective 10.

Underlying political economies and historical legacies profoundly influence implementation 25. In South Africa, the state’s capacity is mediated by its position within global capital networks and domestic corporate power, with historical structures hindering equitable access to medicines 1,13. Broader governance challenges, mirrored in studies on service delivery, impede complex industrial policy execution 6. In Rwanda, the drive for pharmaceutical sovereignty is part of a state-coordinated vision, yet its success remains contingent on deepening regional cooperation and managing external technology dependencies 8,16.

Finally, the findings underscore a growing discourse advocating for sui generis innovation governance models that better balance private rights with public health and the knowledge commons 2,3. For biologics, where foundational research is often publicly funded, a purely defensive strategy of bypassing patents must evolve into building alternative innovation ecosystems 18. This entails proactive measures like technology transfer partnerships and South-South collaboration to create resilient, equitable manufacturing networks 15,19. Harnessing TRIPS flexibilities is thus not merely a legal act but a multidimensional political, industrial, and educational endeavour requiring coherent long-term strategy.

Policy Implications

The case studies of South Africa and Rwanda demonstrate that while the strategic use of TRIPS flexibilities is necessary, it is insufficient alone for building a viable local biologics sector 4. Effective policy requires an integrated approach, combining intellectual property (IP) law with coherent industrial strategy, regional cooperation, and sovereign capability building 5. Firstly, industrial policy for biologics must be holistic, explicitly linking IP strategy to long-term investment in physical infrastructure, regulatory systems, and human capital 20. South Africa’s experience with Biovac illustrates that state-backed entities can facilitate technology transfer, yet such initiatives demand sustained public investment and clear mandates to overcome high capital and technical barriers 11,22. Developing domestic technical and regulatory expertise is crucial to reduce external dependency and nurture local innovation 14.

Secondly, the limited scale of most national markets in Africa presents a fundamental economic constraint 6. This underscores the imperative for regional collaboration to achieve viable economies of scale 7. Rwanda’s engagements, though often bilateral, highlight the potential of pooled procurement and regulatory harmonisation. The African Medicines Agency (AMA) could be pivotal in creating a continent-sized market by reducing duplicative costs 21. Consequently, national production strategies must actively support regional frameworks, including a pan-African approach to patent examination that robustly applies TRIPS flexibilities to prevent granting low-quality patents across multiple jurisdictions 17.

A third implication addresses critical gaps in national IP legislation 8. TRIPS flexibilities are not self-executing; they require precise transposition into domestic law 9. Governments must therefore undertake comprehensive legislative reform to incorporate stringent patentability criteria, robust compulsory licensing provisions, and facilitated parallel importation 23,24. Without this fortified legal infrastructure, countries remain in a weakened negotiating position. This work should engage with evolving debates on innovation governance, including sui generis systems that better balance monopolies with public health 16.

Furthermore, the COVID-19 pandemic revealed the profound fragility of relying on voluntary licences and corporate goodwill for health security 10. Such licences are often geographically restricted, controlled, or withheld for newer products 2. Policy, therefore, cannot be predicated on voluntary mechanisms. Building sovereign capability—encompassing regulatory autonomy, technical know-how, and production infrastructure—is non-negotiable, as it provides the leverage to use TRIPS flexibilities effectively and act independently when necessary 3.

Collectively, these points necessitate a paradigm shift in governing IP for public health ((Extreme South Africa, 2022)). The view of IP as a private commercial right must be balanced against constitutional and human rights obligations to health 12. Policy must be guided by a principle of equitable design, ensuring innovation governance prioritises access from the outset 15. Achieving this requires sustained political will, cross-ministerial coordination, and active civil society engagement to hold states accountable. The experiences of South Africa and Rwanda confirm that harnessing TRIPS flexibilities is not a mere technical exercise, but a deeply political project for health justice and industrial transformation.

Recommendations

To translate policy implications into tangible outcomes, a multi-faceted and actionable strategy is required to address legislative, technical, economic, and governance barriers ((Huq, 2025)). The following recommendations provide a concrete pathway for harnessing TRIPS flexibilities to build resilient, sustainable local biologics manufacturing ecosystems in South Africa and across the continent 1,14.

First, national patent laws must be amended to establish explicit, expedited procedures for issuing compulsory and government-use licences ((Ncube, 2023)). South Africa’s protracted processes, particularly regarding the 2018 Intellectual Property Policy, demonstrate how ambiguity and political economy constraints stymie timely action 16,24. Legislation must codify clear pathways for declaring health emergencies and invoking flexibilities, incorporating predefined remuneration frameworks to enhance legal certainty and deter protracted legal challenges 5,23. This legal fortification is a prerequisite to ensure patent rights, especially within complex biologics patent thickets, do not constitute an insurmountable barrier 3,20.

Concurrently, substantial investment is needed in regional Centres of Excellence for biomanufacturing training ((Pillay, 2025)). Building upon South Africa’s existing academic infrastructure, these centres should focus on advanced skills in Good Manufacturing Practice (GMP), quality control, and regulatory science specific to biologics 11,12. A regional, collaborative model is essential to foster south-south technology transfer and develop a pan-African cadre of experts, thereby addressing the critical human capital shortage and moving beyond mere physical infrastructure to tacit knowledge transfer 7,21.

To mitigate profound market failures, African states should establish a regional pooled procurement mechanism specifically for biologics. Rwanda’s success in regional health initiatives provides a valuable model for such collective action 8,9. Aggregating demand across countries creates the predictable, volume-guaranteed market necessary to attract investment and achieve economies of scale, directly countering volatile, donor-driven procurement patterns that disadvantage local producers 2,17. This de-risks initial investment and incentivises private sector engagement, addressing a fundamental structural barrier 10,22.

Furthermore, ensuring accountability requires mandating full transparency in all public-sector licensing and technology transfer agreements. As advocated by South African civil society monitoring, this prevents inequitable terms that undermine public health objectives 6. Contracts involving public funding, intellectual property licensed under government-use authorisations, or foreign partnerships should be publicly disclosed, with redactions only for absolute commercial necessity. This enables public scrutiny, prevents corruption, and allows assessment of whether agreements genuinely promote technology transfer and access 4,13.

Finally, these efforts require sustained commitment to strengthening national and regional regulatory authorities. Harmonised pathways, as explored in other emerging markets, are essential to avoid duplicative, costly approvals that delay access and burden manufacturers 18,19. South Africa’s SAHPRA can lead in advancing the African Medicines Agency’s harmonisation agenda, as robust regulation is a critical enabler of quality-assured local production and builds trust in domestically produced biologics 15,25.

In conclusion, these recommendations are interlinked and mutually reinforcing. Streamlined patent laws create legal space, Centres of Excellence build human capital, pooled procurement ensures viability, and transparency safeguards the public interest. Implementing this integrated approach, with South Africa leveraging its industrial and institutional advantages for regional benefit, is crucial for moving from aspirational policy to sustainable production. This will enhance access to essential biologics and contribute to a more equitable global health architecture where African agency is realised 14,24.

Conclusion

The evidence from South Africa and Rwanda demonstrates that while the strategic use of TRIPS flexibilities is a necessary legal precondition, it is profoundly insufficient for building a viable African biologics manufacturing ecosystem 1,24. Success requires moving beyond ad-hoc intellectual property responses to an integrated industrial policy, where IP management is embedded within a complex matrix of technological, regulatory, and human capital development 14,17.

South Africa’s experience underscores that even with a relatively advanced industrial base and legal history, domestic capacity is not a panacea. Its struggles to rapidly scale COVID-19 vaccine production revealed critical gaps in technology transfer, regulatory alignment, and the political will to operationalise flexibilities like compulsory licensing under diplomatic pressure 9,22. This illustrates a central tension: the legal right under TRIPS does not confer the technical capability or political capital to exercise it effectively 5,12. The state must therefore evolve into an active facilitator and de-risking agent, orchestrating partnerships and navigating internal governance complexities to foster a cohesive national mission 11,20.

Conversely, Rwanda’s strategy highlights regional coordination and pragmatic partnership as a force multiplier for smaller nations. By leveraging the African Medicines Agency and pooled procurement, it seeks to overcome domestic market limitations 2,4. Its agreement with BioNTech for modular mRNA facilities represents a novel model of technology transfer, offering a potential pathway to bypass certain IP barriers through direct collaboration, albeit with ongoing dependencies 8,19. This suggests that for many nations, the immediate path may lie less in domestic patent challenges and more in constructing favourable terms within global partnerships and South-South frameworks, underpinned by regional regulatory harmonisation 16,21.

Consequently, sustainable success requires embedding IP strategies within a holistic industrial policy. This necessitates massive investment in local research and development, strengthening regulatory authorities to international standards, and developing a skilled biomanufacturing workforce 7,23. Future efforts must also cultivate proactive African expertise in patent landscaping and opposition, fostering a strategic rather than reactive IP culture 3,25. Furthermore, governance models for nascent initiatives must be scrutinised to ensure benefits are equitably distributed and technology sovereignty is genuinely advanced, not merely relocating assembly under foreign intellectual control 10,15.

In conclusion, the two cases offer complementary lessons: South Africa exemplifies the need for strong state capacity to lead complex industrial policy and withstand external pressure, while Rwanda demonstrates the strategic advantage of agility, regional solidarity, and innovative partnerships 6,13. Ultimately, harnessing TRIPS flexibilities is a means to the larger objectives of health equity and economic transformation. The path forward lies in constructing a resilient pharmaceutical ecosystem where intellectual property law serves public health imperatives, demanding a persistent, well-resourced continental effort 18.

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