Compulsory Licensing: A Potential Tool to Increase Vaccine Supply in Canada?

Since the beginning of the pandemic, efforts have been focused on developing a vaccine capable of providing immunity against SARS-CoV-2. With multiple vaccine candidates now demonstrating exceptionally high efficacy against the virus and receiving regulatory approval in countries worldwide, the problem has shifted from development to availability. As the most coveted product in the world, supply chain issues have thwarted some countries’ hopes for a timely vaccine roll-out.

Canada has notably faced challenges in its ability to procure vaccines, quickly falling behind other countries in our vaccination campaigns despite contracting to receive more than enough vaccines for the population. While Canada’s vaccine rollout has increased in recent weeks, still less than 2% of our population has been fully vaccinated as of March 14th, 2021. This is compared to over 10% of the population in the United States and a staggering 48% of the population in Israel.

One proposed mechanism for increasing the availability of vaccines worldwide is to loosen patent protections held by vaccine makers over their products. Some countries, including South Africa and India, have sought a waiver under the Trade-Related Aspects of Intellectual Property, or TRIPS, agreement from the World Trade Organization, which would temporarily suspend global intellectual property protections for COVID-19 vaccines during the pandemic. While attempts to secure a waiver have thus far been unsuccessful, another potentially useful tool available under TRIPS is compulsory licensing.

Compulsory licensing refers to the circumstance where a government permits a third party to produce a patented product without the patent holder’s consent. While compulsory licensing typically requires the user to make an effort to obtain the patent holder’s consent to produce the product, this requirement may be waived during a “national emergency”, of which the pandemic would qualify according to Article 31(b) of TRIPS.

Canada has a history of using compulsory licensing, including to support the availability of more affordable pharmaceuticals. For instance, in June 1969, Parliament amended the Patent Act to allow companies to produce generic copies of pharmaceutical products that were still under patent protection. Recent amendments to the Patent Act under Canada’s COVID-19 Emergency Response Act have strengthened the Federal Government’s ability to address vaccine shortages through the use of compulsory licenses. Specifically, the amendments are aimed at allowing the Federal Government to permit the “construct[ion], use, and [sale of] a patented invention to the extent necessary to respond to a public health emergency that is a matter of national concern”. The Government must still provide notice and pay royalties to the patent holder; however, the government has no further obligations to negotiate with patent holders.

While compulsory licensing is an attractive potential tool to increase the availability of vaccines, if Canada pursues these licenses, it must first address domestic vaccine production capacity. Unfortunately, similar to the Federal Government’s lack of investment in domestic vaccine candidates, Canada’s vaccine manufacturing capacity is also deficient. If Canada commits to increasing its domestic vaccine production capacity, whether through the construction of new facilities or by fitting existing industrial facilities to be capable of producing vaccines, then the use of compulsory licensing could be a future tool to produce generic COVID-19 vaccines or boosters in Canada. These efforts will be particularly important given recent concern that COVID-19 could become endemic and boosters may be required in the future to control the spread of COVID-19.

Regardless of the strategy employed, Canada clearly needs to improve its approach to secure vaccines for Canadians, and the domestic production of generic vaccines through compulsory licensing should be considered as a potential strategy moving forward.

Claire La Mantia is a 2023 JD Candidate at Osgoode Hall Law School interested in intellectual property, privacy, and health law.

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