see saw with earth as fulcrum and a pile of vaccines weighing down one side with nothing on the other side.

What Happened to the COVID-19 Vaccine Patent Waiver?

By Sarah Gabriele

In June 2022, after almost two years of debate over a potential COVID-19 vaccine patent waiver, the World Trade Organization adopted the Ministerial Decision on the TRIPS Agreement (“WTO Decision”), which provided for a partial waiver of intellectual property rights.

More specifically, the WTO Decision waived patent rights on vaccines and allowed for the use of protected clinical trial data for regulatory approval of vaccines. However, after almost four months since the adoption of the WTO Decision, there is still a large gap in vaccination rates worldwide.

Indeed, while the patent waiver has helped some countries, like India, where already-existing infrastructure could facilitate an increase in manufacturing capacity, other countries, especially those on the African continent, still suffer from extremely low vaccination rates. Across the globe, only 23% of the population in low-income countries has received a dose, while 82% of the population in high- and upper-middle-income countries has been vaccinated. In this context, I can’t help but wonder whether the WTO Decision is insufficient.

The WTO Decision is substantially different from the initial proposal presented in 2020 by India and South Africa, which allowed for a broad waiver of all intellectual property rights protecting COVID-19 vaccines, as well as the rights over therapeutics and diagnostics. The departure from the initial waiver was the result of a long negotiation between countries, with many countries strongly opposing the adoption of any type of waiver until the end. Given this departure, some advocates and academics have highlighted the inadequacy of the recent WTO Decision, calling for a more comprehensive waiver. Indeed, notwithstanding the existence of a waiver, many developing countries still are prevented today from accessing the vaccine, as they lack access not only to other types of intellectual property, such as trade secrets, but also the necessary manufacturing capacity.

I, therefore, agree with the necessity of and urgency for a more permissible solution that would allow low- and middle-income countries to use not only patents, but also trade secrets, know-how, and other intellectual property rights. In addition, the current scenario and recent debate over patent rights make me question the opportunity and actual feasibility of advocating for a more comprehensive waiver at the present stage and under the current rules (and dynamics) of the TRIPS Agreement.

The negotiations leading to the WTO Decision proved once again the inadequacy of the debate over intellectual property rights, and compromising on a broader IP waiver led to an inadequate solution that is not working in practice. To overcome future challenges in the application of TRIPS flexibilities, we ought to look into the reasons and motivations that have led various countries to oppose the waiver in the first place, resulting in an inexcusable delay in reaching a solution. This requires a serious conversation about historical biases, systemic discrimination, and inequality in the application of the TRIPS Agreement.

The COVID-19 vaccine patent waiver also highlighted how the major focus on patent rights stole attention from other fundamental issues, such as practically increasing manufacturing capacity, an essential component of sufficient international vaccine supply, as well as ensuring a fast rollout of vaccination. Indeed, while the focus of the debate remained on patent rights, the negotiations failed to consider how to practically deliver the vaccine by building and providing the necessary infrastructure, as well as by addressing the challenges that low- and middle-income countries face in delivering the vaccine, such as the lack of health workers and the necessity for the vaccines to be refrigerated.

As we think about the WTO Decision and the need to advocate for a broader waiver of intellectual property rights, we cannot do so without considering the challenges that ultimately led to a compromised waiver this past June. Efforts should be made to analyze the systemic discrimination and inequality, as well as the historical biases and economic interests, which ultimately prevented countries from reaching a more appropriate solution. At the same time, we should look beyond intellectual property rights to focus on practically increasing manufacturing capacities, as well as ensuring fast and safe delivery of goods to low- and middle-income countries.

sgabriele

Sarah Gabriele is a second-year Master of Bioethics candidate at Harvard Medical School. She obtained her law degree from the University of Trento (Italy) and an LL.M. from the Washington University in St. Louis. After graduating from law school, she worked at Hogan Lovells in their Milan office, specializing in pharmaceutical patent litigation. Currently, she is a student fellow with the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and a research specialist at PORTAL, in the Division of Pharmacoepidemiology and Pharmacoeconomics of Harvard Medical School and Brigham and Women’s Hospital.

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