A Revised Research Agenda on Trade and Access to Medicines in a Post-Pandemic World
As the World Trade Organization (WTO) member states prepare to meet in Abu Dhabi in February for the 13th Ministerial Conference (MC13), arguably one of the most important decisions they face is whether to extend the much-embattled Waiver of certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to COVID-19 diagnostics and therapeutics.
Living through a global pandemic resurfaced the increasingly polarizing debate about whether the global intellectual property (IP) rules embodied in the TRIPS Agreement provide a net benefit or detriment to global public health. It is in response to this on-going debate that the urgent need for new research arises.
This debate is not new. In fact, since its establishment in 1995, there has been a concern that the TRIPS Agreement presents obstacles to securing access to medicines for populations in low- and middle-income countries (LMICs). A few years later, the Doha Declaration on TRIPS and Public Health was born out of a hope that global cooperation could begin to deliver on its promise of creating a multilateral system “for the benefit and welfare of [all] peoples.”
Despite the hope engendered by the Doha Declaration, the stress test of the COVID-19 pandemic revealed on-going unacceptable inequities in access to health products.
Four years ago, the Working Group on Trade and Investment Treaties and Access to Medicines convened to devise a research agenda to support increased access to medicines. In the wake of COVID-19, however, the Working Group, hosted at the Boston University Global Development Policy Center, reconvened to reassess what research questions had risen in importance in the quest for improved global public health.
In consultations within the group and with outside experts, we found large shifts in the international and national policy and legal landscapes, as well as rapid technology developments in part due to the global response to the pandemic. These changes warrant a significant rethink of the legal, econometric and political economy agenda for interdisciplinary research in IP, trade and access to medicines.
To that end, a revised research agenda was developed around three key topics: (1) the importance of further understanding best practices in TRIPS flexibilities, (2) the role of transparency in promoting technology transfer and limiting the impact of trade secret practices among pharmaceutical firms and (3) the role of regional production in both expanding the manufacturing base for pharmaceutical products worldwide while capitalizing on increased economies of scale.
Impacts of TRIPS flexibilities
TRIPS “flexibilities” – the legal loopholes for countries implementing policies to protect public health – have been under near-constant scrutiny over the past 30 years. These flexibilities include the range of possible IP policies a country may put in place, such as patent opposition, patent revocation and compulsory licensing mechanisms. Current research has shown that at least some of the flexibilities have been widely implemented, but many argue that they are not being used to their full potential. When countries do not effectively use these flexibilities, it reinforces the narrative from pharmaceutical firms that neither the current flexibilities nor any additional flexibilities are needed. Research highlighting best practices, legal approaches and real-world impacts of implementing TRIPS flexibilities could facilitate more effective use of these flexibilities.
Transparency, trade secrets and technology transfer
The pandemic also revealed new obstacles for manufacturers in the Global South to produce health technologies, such as the confidential information protected as trade secrets. Unlike patents, trade secrets are not filed publicly and can be kept secret indefinitely by private firms. In order to increase access to this confidential information, policymakers need to encourage greater transparency on biopharmaceutical research and development, manufacturing know how, costs, pricing, supply and licensing agreements, clinical trial data, and IP and regulatory rules. To support this work, policymakers will need new research to understand how best to increase transparency, as well as encourage technology transfer and the sharing of trade secret information, when necessary, especially in cases where time is of the essence, as it is during the onset of pandemics.
Importance of regional and national policies and regulations
Global production patterns and supply chains during the pandemic left many countries without access to essential products. While countries that could produce tests, treatments and vaccines tended to turn inward, supplying their own markets, the access gaps grew. Classical economic theory, however, would suggest that fully nationalizing all pharmaceutical manufacturing would drive-up prices, rather than increasing access. For that reason, a middle-ground seems attractive – to establish certain regional hubs for supplying essential health products and technologies. The World Health Organization’s mRNA technology transfer hub represents one effort to do just that. Given the dual importance of both regional-level and national-level policymaking, researchers must understand more about the national regulatory environments that contribute to and engage in regional supply chains.
By revealing existing weaknesses in both health systems and global governance structures, the COVID-19 pandemic brought to the forefront new priorities for interdisciplinary research to understand how access to medicines is impacted by the globalized trading system and how nation states navigate this complex system. Research in these areas can inform policy discussions surrounding the TRIPS Waiver extension, as well as amendments to the International Health Regulations, and negotiations of a multilateral pandemic accord. It can also provide tools for national governments to make policy decisions and coordinate action with regional partners.
New approaches of regional integration provide possibilities for new models of IP protection and IP incentives. Finally, national governments can learn from policy experiments, both in their own jurisdiction and externally. This revised research agenda not only informs national, regional and global decisions aimed at increasing access to medicines, but it also creates a feedback loop, by which researchers may assess the impacts of changes for future generations of decision-makers.
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