With international efforts to administer the Covid-19 vaccinations underway, a glaring disparity in the vaccine distribution has emerged. High-income countries, composing about 16% of the world’s population, have purchased approximately 60% of available vaccines. The EU, Israel, the UK, US, and other developed countries are expected to achieve widespread immunization between 2021 and 2022. Despite the World Health Organization’s efforts to encourage equitable vaccine distribution through COVAX, projections estimate that the world’s poorest countries will not achieve mass vaccination coverage until 2024. As the director of Global Justice Now, Nick Dearden stated in November, “You couldn’t get a clearer example of how unequal the pharmaceutical system is – some make billions of pounds, while many others die because they cannot afford treatments or there are no more left for them to buy.”
Efforts to ameliorate this alarming trend have shifted concerns to the role of patent protection in restricting access to pharmaceuticals. The tension between the global intellectual property regime, regulated by the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and human rights is at the forefront of this discussion. TRIPS requires ratifying countries to adopt a minimum standard of intellectual property rights to protect creators and promote innovation. Considerable lobbying by developing nations, concerned that their socio-economic development would be unduly impaired by patent restrictions, led to the incorporation of protective mechanisms into the agreement. Known as TRIPS flexibilities, these include tools such as parallel importing and compulsory licensing of pharmaceuticals. While developing nations view these flexibilities as critical for protecting the right to health, nations with strong pharmaceutical infrastructures frequently oppose the implementation of these flexibilities when they view the mechanisms as an infringement on guaranteed intellectual property protection.
While compulsory licensing allows for patent protection to be circumvented during public health emergencies, the continued protection of undisclosed information often impairs the ability of other manufacturers to quickly begin pharmaceutical production. This delay holds particularly true in vaccine production. Discerning the “know-how” involved in vaccine development takes considerable time and research. Moreover, unlike with generic medications, where demonstrating therapeutic equivalence is sufficient, vaccine manufacturers must develop a production process and conduct timely clinical vaccine trials to test for efficacy and safety. Unless the undisclosed data describing the “know-how” can be obtained directly from originators, patent waiver is insufficient to bring vaccines to market in a timely manner.
In an effort to bring Covid-19 vaccines to in-need regions sooner, India and South Africa submitted a proposal to the World Trade Organization in October 2020 advocating for the waiver of TRIPS obligations, including undisclosed information beyond the purview of the agreement’s flexibilities, in the interest of public health. Developed countries and pharmaceutical companies currently remain in opposition to this proposal, maintaining, in part, that it will create a disincentive to innovate in future pandemics, and arguing that existing TRIPS flexibilities will permit sufficient Covid-19 vaccine access. Whether these claims hold true remain to be seen. These arguments do highlight the consistent conflicting interests in the international intellectual property regime, in which an inherent tension exists between human rights and innovation rights.
Written by Ally Maddeaux, a second year JD candidate at Osgoode Hall Law School. She is a guest contributor to the IPilogue and a Coordinator with the IP Osgoode Innovation Clinic.