Vaccine Patent Waivers: A Major Step Towards Ending the Covid-19 Pandemic?

By: Xiang Li

It has been two years now since the World Health Organization (WHO) declared the existence of the COVID-19 global pandemic on March 11, 2020. Through the concerted efforts of healthcare systems, vaccine manufacturers, governments, and members of the public, the world finally has the upper hand in the uphill battle against the COVID-19 pandemic. However, given how infectious the virus is and the speed at which it evolves to escape sufficient human immune response, it is not yet the time to let our guard down and it is critical to redouble efforts to increase global vaccination rates

Importantly, the inequality in vaccination rates seen between low-income countries and the rest of the world remains a prominent problem. As of March 31, 2022, 79.0% of the populations of “high-income” countries have received at least one dose of the COVID-19 vaccine, and so have 81.2% of the populations of upper middle income countries. Approximately 59.2% of the populations of lower middle income countries have received at least one dose. On the other end of the spectrum, only 14.5% of the population of low-income countries have received at least one dose of the vaccine. The disparity is largely caused by the unaffordability of vaccines to people in low-income countries.

To solve this disparity, the national governments of India and South Africa submitted on October 2, 2020 a communication (IP/C/W/669) to the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Council of the WTO, proposing that the obligation of TRIPS members to recognize and enforce patent rights should be temporarily waived with respect to patents relating to COVID-19 vaccines, medicines, and equipment necessary for treating and preventing COVID-19. The patent waiver as proposed is not mandatory, it simply allows TRIPS members to waive patent protection in their own countries, if they choose to do so.

The legal basis of adopting a patent waiver lies in Article IX.3 of the Marrakesh Agreement, which establishes the WTO. Specifically, Article IX.3 provides that the Ministerial Conference of the WTO, with the support of three-quarters of WTO members, may waive an obligation imposed by the TRIPS Agreement.

The waiver proposal has gained support from more than 100 low-income countries, but has encountered obstructions from many high-income countries, including European Union countries, the United Kingdom, and Switzerland. On May 5, 2021, the Biden administration announced support for a patent waiver; however, it was not until recently that major parties of the WTO made progress towards the negotiation of the terms of the waiver. 

Specifically, a news report published on March 16, 2022 indicated that the European Union, the United States, India and South Africa have reached a compromise on the terms of the waiver. Notably, only countries that have exported less than 10% of the total global exports of COVID-19 vaccine doses in 2021 are entitled to invoke the waiver to use the patented materials. These criteria effectively exclude the European Union, China, and the United States from invoking the waiver, since these countries account for 39.3%, 33.7%, and 14.2% of global vaccine exports respectively. 

The United States could have taken a stronger stance on waiving intellectual property protections, but it has not — possibly because a waiver suspending domestic patent protection might violate the Takings Clause of the Fifth Amendment of the United States Constitution. The Supreme Court of the United States has recognized that patent rights are subject to the protection of the Takings Clause, just as property rights in a piece of land. At the same time, the United States has a strong interest in preventing China from obtaining the right to invoke the patent waiver, to make sure China cannot use United States’ proprietary technologies to gain an advantage in vaccine development and other related biotechnology.

This recent compromise on the terms of the waiver might be a significant step towards passing the waiver at the WTO, since the European Union (composed of 28 countries, each having a vote) has been the strongest opponent of the waiver, as indicated by its statements made at several WTO meetings. Many scholars and policy makers believe that passing the waiver is a necessary step to provide equal and affordable access to vaccines to people in low-income countries. If the entire world community is vaccinated before the coronavirus can evolve into other highly contagious and potentially even more deadly variants, the world may be able to finally declare victory over the pandemic.