Celebrating the Working Group on Trade Treaties and Access to Medicines

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By Rachel Thrasher and Samantha Igo

Established in 2018, the Working Group on Trade Treaties and Access to Medicines was convened by the Boston University Global Development Policy Center (GDP Center) to advance an evidence-based understanding of the impacts of trade and investment treaties on access to medicines. The goal of the Working Group—which was comprised of a dynamic group of economists, legal scholars, medical scientists and policy analysts from around the world—was to offer concrete policies and advice to help the trade and investment system serve as a tool in expanding global access to secure and affordable medicines.

Over seven years, Working Group members have conducted empirical research exploring the relationship between trade and investment treaties and pharmaceutical prices, political economy analyses of the challenges to domestic institutions in securing access to medicines and legal research on the prevalence of treaty terms that increase global intellectual property (IP) protection. In that same timeframe, the Working Group built relationships, published new research and established a functional research agenda for researchers in the field to carry this work forward. Most notably, Working Group members were directly involved with the US Trade Representative (USTR) and US International Trade Commission (USITC) in pushing for access to COVID-19 countermeasures, ultimately being cited widely in a USITC report.

In many ways, the Working Group reflects the ethos of the GDP Center as a policy-oriented research center that encourages research convergence across not only departments and schools at Boston University, but also with partners from around the world. These relationships and the Working Group’s accomplishments will have longstanding implications for research in access to medicines.

Now five years after the onset of the COVID-19 pandemic and in a rapidly evolving policy landscape, the Working Group is going on hiatus and would like to take this opportunity to celebrate the work we have done, as well as elevate the work that is ongoing among our Working Group members and their colleagues around the world. For a list of our Working Group and collaborators and their recent publications, click here.

Our work in brief:
  • 7 Working papers with or by Working Group members
  • 3 Policy briefs with or by Working Group members
  • 5 Events (workshops and webinars)
  • 4 Reports with and by Working Group members
  • 4 Direct contributions to policymakers (open letters, contributions to hearings, etc.)
  • 7 Peer-reviewed journal articles
  • 11 Other thought leadership pieces (blogs, op-eds and policy briefs)
Impact of trade and investment treaties on access to medicines
Photo by Kristine Wook via Unsplash.

In its first couple of years, the Working Group explored the universe of research assessing the impact of trade and investment treaties on access to medicines, especially in low- and middle-income countries. Two initial reviews of empirical studies showed that while both ex-ante and ex-post research indicates that stronger IP protection (mandated in modern trade treaties) increases medicine prices, the effect is much smaller in ex-post studies. This suggests that government policy intervention can make a difference in mitigating the otherwise negative impacts of strong IP protection on access to medicines.

At the first meeting of the Working Group in March 2019, participants presented their most recent research in access to medicines and collectively identified remaining gaps in the legal, empirical/economic and political economy literature. The resulting report of the Working Group urged (1) better analysis of relevant treaty texts, as well as their implementation in domestic law and subsequent use in domestic and international litigation; (2) more rigorous empirical studies to systematically quantify the effects of those treaties on access to medicines; and (3) more comprehensive analysis of the political economy factors which influence the process and effects of governments signing and implementing those treaties.

Research by Working Group members (linked below) included both country-specific and cross-country impacts of IP legal provisions in trade agreements, as well as legal analysis and recommendations of the same.

The bottom line: Although there is much work still to be done to improve and expand our knowledge about the ways that free trade agreement IP provisions impact access to medicines, the existing evidence indicates that stronger IP protection leads to more expensive medicines and less consumer welfare. Moreover, stronger IP protection does not, on its own produce the boost to innovation it promises in most of the world’s developing economies. These findings have held up over time. Indeed, much of the work of the Working Group and our colleagues around the world was cited in the 2023 report of the United States International Trade Commission (USITC).

Highlights:
Bangladesh—LDC graduation and access to medicines
Photo by Md Wabayadur Rahman Chowdhury via Unsplash.

In 2021, the United Nations Committee on Development Policy adopted a resolution that Bangladesh would graduate from least developed country (LDC) status after a period of five years. As a result, Bangladesh will have to forego its exemption to the World Trade Organization’s (WTO’s) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) by 2026. As an LDC, Bangladesh took advantage of the policy space it was granted to build a generic medicines industry that not only serves Bangladesh, but also other LDCs. However, upon graduation from LDC status, Bangladesh will have to navigate a new IP landscape, with potential impacts to the accessibility of medicines domestically.

The core team of the Working Group spent several years providing research to help partners in Bangladesh prepare for the upcoming changes and preserve their existing policy space. The team deployed econometric modeling tools to show that introducing IP protection for medicines (specifically insulin) will trigger a significant jump in insulin prices that could cause about a 15 percent decline in the welfare of households in Bangladesh where people are living with diabetes, increasing the poverty rate of such households. This finding holds unless policy adjustments are carried out by the Bangladesh government to shield vulnerable households and populations.

Other research identified the existing out-of-pocket expenditures that households spend on medicines, further driving home the point that many Bangladeshi households will suffer if medicine prices increase at the point of sale. Working Group members have continued this research by exploring the similar yet distinct context of Cambodia’s upcoming LDC graduation.

The bottom line: Bangladesh, like other LDCs on the verge of graduating from that status, has taken advantage of the policy space granted to it by building up strategic industries and ensuring medicines are available and affordable. Nevertheless, the prize of graduation comes with a new burden of complying with the rules of the TRIPS Agreement. To ensure that Bangladesh can continue to prioritize access to medicines, it will need to try to preserve that policy space by pushing to extend the pharmaceuticals transition period for graduating LDCs, and making sure they do not take on additional commitments to extend IP protection for pharmaceuticals.

Highlights:
COVID-19 policy space
Photo by Pam Menegakis via Unsplash.

When COVID-19 hit in December 2019 and grew to a crescendo in mid-2020, the Working Group shifted its efforts to applying learnings from all the existing research on IP protection and access to medicines to the new context of a global pandemic. Initially, we focused on increasing access to personal protective equipment, diagnostics and (albeit still developing) therapeutics. As countries poured money into the development of a vaccine, however, and new vaccines became available, much of our research was focused on increasing vaccine equity for countries that did not have their own manufacturing hub of these essential products.

Members of the Working Group signed onto an open letter to the members of the TRIPS Council, as well as to the USTR and the European Union trade commissioner, urging them to remove barriers to access to critical COVID-19 countermeasures. This translated into advocacy for a waiver of TRIPS Agreement commitments for COVID-19 products. Other Working Group members sought to advance different proposals to rapidly ramp up manufacturing of these scarce products. Several Working Group members participated, both in oral hearings and through written submissions, in the USITC’s inquiry into whether the narrow TRIPS Waiver (applicable only to vaccines) should be extended to COVID-19 diagnostics and therapeutics. Those members were ultimately cited in the USITC report of their findings.

As the acute crisis of the COVID-19 pandemic began to wane, members of our Working Group began to undertake analyses of what happened in those early days and how we, as a global community, responded to the crisis. We explored patterns in policymaking to highlight the extent to which the existing trade and investment rules pose potential obstacles to countries deploying  crisis-era policies. Even beyond intellectual property rules, we found potential constraints in the rules governing subsidies, import and export trade barriers, investment measures and even government procurement measures. We also highlighted the specific ways that the global rules governing IP may need reform to respond to future pandemics.

The bottom line: The Working Group reunited four years after the publication of our first report for an assessment of how the field of access to medicines research changed in the wake of the pandemic. Many of the same conclusions hold—that generally stronger IP protection leads to higher medicine prices, that those barriers were one among many obstacles to effective countermeasures during the pandemic and that more research is needed to help us prepare for the future. There were new themes however, which rose to the top. In our Revised Research Agenda, the Working Group noted the need to (1) better understand the impacts of implementing TRIPS Agreement flexibilities; (2) improve our understanding of how to increase transparency and encourage technology transfer and the sharing of trade secret information when necessary; and (3) understand more about the national regulatory environments within which regional and global supply chains operate.

Highlights:
Post-COVID—research agenda and new research
Photo by Mikhail Pavstyuk via Unsplash.

Following our Revised Research Agenda, several members of the Working Group initiated new research to understand the extent to which countries in the Global South had implemented the full scope of TRIPS flexibilities in their own domestic law. One study explored the relative underutilization of compulsory licensing by lower- and middle-income countries, including offering recommendations for national and international legal reform. The BU GDP Center team likewise focused new research on the implementation of compulsory licensing provisions, selecting 15 middle-income countries for the study. We found that, while all countries had adopted some TRIPS-compliant flexibilities, none in the study had maximized the policy space by adopting fully efficient and effective compulsory licensing legislation.

The bottom line: While a lot of progress has been made to encourage access to medicines over the past 30 years, there is still room for improvement both at the national level and in international organizations and institutions. In the first place, there remains additional policy space under existing rules that countries have not utilized—and they should. At the same time, they must cooperate and coordinate with one another to share best practices in law reform and implementation. At the multilateral level, countries must not give up efforts to shape global institutions so they are fit for purpose to meet the crises of this generation.

Highlights:
  • Report: Report on Compulsory Licensing Provisions in the National Patent Legislation of 15 Middle-Income Countries’: National Patent Legislation: A Content Analysis and Recommendations (forthcoming)
  • Journal article: Compulsory Licensing Provisions in 15 Middle-Income Countries’ National Patent Legislation (submitted)
Ongoing work toward supporting access to medicines now and in the future

Even as the Working Group is moving into a period of lower activity, our members continue to push forward the work of increasing equitable and affordable access to medicines worldwide. Some are working to promote US policies that would improve the landscape of medicines access. These include comparisons between pricing and reimbursement regulations in the US and in other developed countries worldwide, a critical assessment of the Hatch-Waxman Act with recommendations for improvement, and a historical analysis of other burdensome legal barriers to medications entering the US market.

Others are working on learning from the outcomes of the COVID-19 pandemic at a global scale and making policy recommendations to better promote health equity. These include lessons learned from several case studies of effective (and ineffective) technology transfer by pharmaceutical firms during the pandemic, drawing from human rights norms to advocate for affordable vaccine access in Africa and assessing whether proposals for the global Pandemic Agreement give countries sufficient power over pharmaceutical firms’ profit-seeking behavior. Another proposal ties together US policy and global access by recommending equity terms be integrated into licensing agreements for firms using government-funded technology.

The efforts of the Working Group and its collaborators over the years have contributed to real outcomes, particularly in terms of US policy. Under the Biden-Harris administration, the US not only supported a TRIPS Waiver (albeit limited to vaccines), but also began to embrace other access to medicines principles. One important area where this emerged is in the USTR’s annual Special 301 Reports, where it explicitly articulated a “policy of declining to call out countries for exercising TRIPS flexibilities, including with respect to compulsory licenses, in a manner consistent with TRIPS obligations.” As this demonstrates, the research of the Working Group and its collaborators has consistently supported increased access to medicines in the past, and that work is ongoing and effective.

We want to take this opportunity to thank all the people who have supported this work—our Working Group Members, our faithful staff members and research assistants, our research collaborators and co-authors, our institutional partners and especially our funders who have made this work possible. We look forward to working with you all again!

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