The COVID-19 pandemic underscored the urgent need for equitable access to vaccines. As the world scrambled to develop, manufacture, and distribute vaccines, stark disparities emerged. Many low- and middle-income countries faced prolonged shortages while wealthier nations secured abundant supplies. These inequities sparked intense debate over the role of intellectual property (IP) rights in global health governance, particularly whether they serve as a necessary incentive for medical innovation or an unjust barrier to access.
For some observers and stakeholders, IP protections – such as patents on vaccines and other medical products – are a cornerstone of pharmaceutical innovation. Proponents, including the US and the EU, argue that these rights incentivise research and development (R&D) by ensuring that innovators can recoup their investments, creating life-saving products that will become more widely available over time. Critics, however, contend that IP protections are not always a fundamental driver of innovation and often impede equitable access, especially when vaccines and treatments have been developed with substantial public funding. Low- and middle-income countries tend to be the ones to raise these concerns and push for greater flexibility in IP rules. In 2020, India and South Africa co-sponsored a proposal at the World Trade Organization (WTO) calling for a temporary waiver of certain IP protections on COVID-19-related medical countermeasures.
After prolonged and contentious negotiations, WTO members reached a compromise enabling a waiver of some IP obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). This compromise reflected a growing recognition that standard IP rules could be too rigid during a pandemic such as COVID-19. Even high-income countries resorted to mechanisms such as compulsory licences – government-issued licences that authorise making, using, selling, or importing a product without the patent owner’s consent – to facilitate domestic vaccine supply during the pandemic.
This agreement left many unsatisfied. Staunch advocates of IP rights credited the existing system for the rapid development of COVID-19 vaccines and viewed the TRIPS waiver as a dangerous precedent that could weaken the WTO. Both supporters and sceptics criticised the waiver for offering little beyond the flexibilities already built into the TRIPS framework. Some also warned that narrowly focusing on debates over patents risked overshadowing other critical barriers to vaccine access in low- and middle-income countries, such as limited manufacturing capacity, insufficient knowledge transfers (which are subject to a different type of IP protection), weak healthcare infrastructure, and vaccine hesitancy.
Thus, the pandemic sparked renewed interest in the intersections of IP and public health. While the WTO’s TRIPS Agreement has attracted the most scrutiny, this issue area also involves the World Health Organization (WHO) and the World Intellectual Property Organization (WIPO). Following Kal Raustiala and David G. Victor (2004), this report posits that these three institutions form a ‘regime complex’ – defined as “an array of partially overlapping and non-hierarchical institutions governing a particular issue-area” (p. 279). While collaboration has become more institutionalised over time, philosophical differences and competing legitimacy claims persist.
How has regime complexity shaped the robustness, effectiveness, and democracy of global governance in the IP–public health nexus?
This report examines how the institutional fragmentation of IP–public health governance – structured around the WTO, WIPO, and WHO – has shaped policy responses and created opportunities for forum shopping. It analyses key stakeholder positions, historical policy shifts, and institutional interactions to assess how forum shopping has influenced rule-setting, enforcement, and reform efforts concerning the IP–public health nexus.
Drawing on historical policy developments, stakeholder interviews, and institution analysis, the report finds that:
- Regime complexity has often been detrimental across the board.
- The most common pattern has been that high-income countries have redirected discussions about public health concerns – prevalent within the WHO – towards narrower debates about IP protection, as spearheaded by WIPO and the WTO.
- Despite significant contestation, the global regime complex governing the intersection of IP and public health is likely to remain broadly stable.
- Although regime complexity will likely continue shaping global health governance, there are some potential pathways to mitigate existing challenges.
Citation Recommendation: Fernández, Óscar and Mirko Heinzel. 2025. “The Intellectual Property and Public Health Regime Complex: Considerations on Vaccine Access and Equity.” ENSURED Research Report, no. 7 (May): 1-38. https://www.ensuredeurope.eu
*This is one of five research reports on global governance published by ENSURED in May 2025. Read the others to learn about WTO reform, UNFCCC decision-making, the UN Human Rights Council, and cyberspace governance.
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