Ryan Erdman is an IP Innovation Clinic Fellow and a 2L JD Candidate at Osgoode Hall Law School. This article was written as a requirement for Prof. Pina D’Agostino’s Directed Reading: IP Innovation Program course.
In October of 2020, India and South Africa submitted a proposal to the WTO for a waiver of provisions of the Trade-Related Aspects of the Intellectual Property Rights (“TRIPS”) Agreement in a response to global inequities in access to COVID-19 interventions. Namely, they intended to ensure that essential vaccines, medicines, and equipment would be made available “promptly, in sufficient quantities, and at affordable prices” on a global scale by eliminating both established and anticipated barriers created by intellectual property rights. In May 2021, after a long period of steady opposition from high income countries, the Biden Administration changed course and signaled support for a waiver of certain intellectual property protections. At the time, I commented on these developments, noting how the scope of a waiver that countries like the United States (and the others that would now come to the table) would agree to remained a key and complex issue. Critically, the Biden Administration’s announcement did not directly support the waiver initially proposed 7 months prior, which was purposefully broad, and many took this as a sign any waiver eventually agreed upon would be much narrower.
Almost 18 months later, the first real development in terms of an agreement has been reported with the US, EU, India and South Africa close to agreeing on a significant “compromise.” Where the original waiver proposal also looked to eliminate barriers created by IP protections related to accessibility to necessary technology in the areas of diagnostics, P.P.E., and other therapeutic drugs, the leaked text shows that the potential agreement will only immediately cover COVID-19 vaccine patents. While the text is said to have a provision where WTO members will vote on the inclusion of these additional interventions within 6 months, given how the negotiations have proceeded thus far, there are many reasons to doubt that the additional aspects to the agreement will come to fruition. While they note that no official agreement has been reached, the US confirmed that the leaked text offers “the most promising path toward achieving a concrete and meaningful outcome.”
Immediate reaction from both sides of the “waiver debate” have been somewhat negative, and continue to represent the complex balancing act between exclusive protection for IP and the need for appropriate and timely public access to health technology during a pandemic. Those in favour of a complete waiver have continued to express that these technologies, which include rapid and affordable testing and novel anti-viral treatments are becoming equally important in the short and long-term global effort against COVID-19 and emerging strains. Further, some have expressed how the leaked text creates novel barriers in relation to the use of compulsory licenses, as point 3(a) of the compromised text notes that while eligible WTO members may issue a single authorization for individual products, countries are required to “list all patents necessary” for production and supply. As this would include patents for all underlying fragments and processes related to the vaccine, it would be far more burdensome than what is currently required under the TRIPS agreement.
Those in opposition of the waiver remain with the view that the waiver does little practically (in addition to current flexibilities under the TRIPS agreement) to support greater accessibility to vaccines. Where there are also questions about whether supply is even a key issue at this time, a waiver of patent protections still does little to close key information gaps in technical processes and restrictions on use of trial data. The fear remains that the waiver would only serve to negatively impact the foundational incentive structure for research and development into vaccines, especially those targeting emerging pathogens.
While positive sentiment has been given by those like WTO Director-General Ngozi Okonjo-Iweala, who has called the leaked text a “breakthrough,” the true impact of any waiver remains uncertain. Certainly, the true effects on future use and liability of significant technological innovation created during the “COVID period” remains immeasurable.