top of page
Search

COVID-19 Vaccine Patent Protections


ree

On May 5th, 2021 United States Trade Representative Katherine Tai released a statement clarifying the Biden administration’s unequivocal support for waiving COVID-19 vaccine patent protections. In her statement, she expressed the administration’s desire to get the maximum number of people safely vaccinated as quickly as possible. She outlined ending the pandemic, which would require some degree of unified effort on a global scale, as a major goal of the administration and discussed waiving intellectual property (IP) protections, including patents and copyrights, as a means to fulfill this goal. In a later tweet, she reaffirmed the contents of her statement and highlighted the US’ active participation in World Trade Organization (WTO) negotiations:


“These extraordinary times and circumstances of [sic] call for extraordinary measures. The US supports the waiver of IP protections on COVID-19 vaccines to help end the pandemic and we’ll actively participate in @WTO negotiations to make that happen.”

Katherine Tai’s full statement can be read here. But what exactly are COVID-19 vaccine patent protections, and what would happen if they were to be waived?


The Issue: COVID-19 Vaccine Patents

A group of majority world countries led by India and South Africa proposed a temporary waiver of IP protections for COVID-19 vaccines and related medical equipment in late 2020. This was done to reduce gaps in access to crucial medical supplies between minority and majority world countries. The WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which was negotiated in the 1980s, attempted to create an international framework for IP protection and its enforcement. In addition to establishing IP protections, TRIPS introduced a 20-year term of protection for pharmaceutical patents and conferred a set of minimum rights to patent holders, including their right to stop unauthorized parties from producing, using, or importing patented products. However, there is a caveat; the TRIPS agreement also includes limitations on and exceptions to the rights granted to patent holders. One such limitation is the ability of WTO members to allow use by third parties through a compulsory license without the authorization of the patent holder, so long as a set of conditions are met.


India and South Africa’s proposal was initially met with hesitancy by minority world countries including the United States. However, after increasing pressure by lawmakers and activists, the Biden administration reversed course and on 25th May, a revised proposal was issued by a group of South American, African, and Southeast Asian countries to the WTO Council. It called for TRIPS to waive IP protections for three years with the possibility of an extension. This comes as two contrasting realities unfold in majority and minority world countries: as the pandemic intensifies and resources become scarce in countries like India, comparatively wealthy countries like the United States are easing restrictions as most of their adult population is vaccinated. For the WTO to grant the patent waivers, all 164 member nations must agree, and even then it might be too little too late. Director-general Ngozi Okonjo-Iweala warned that a holistic and time-sensitive approach would be needed to address the so-called “vaccine apartheid”, and that the waiver alone would not be enough.


Arguments for Waiving

“Every country should have the right to make its own vaccines during a pandemic.”

According to an editorial published in Nature, this concept is the foundation of the movement to waive patent protections on COVID-19 vaccines. Currently, production and distribution are concentrated in a few minority world countries, and this naturally leads to an inequitable distribution of medical resources to poorer countries. High-income countries own more than half of all globally purchased doses, according to data from the Duke Global Health Innovation Center Launch and Scale Speedometer, and estimates predict that there will not be enough doses for the global population until at least 2023.


Essentially, while the pandemic may be ‘over’ (in terms of a return to a pre-pandemic normal) in countries like the United States as early as this fall, this will not be the case in less economically developed countries (LEDCs) throughout the world. This is because LEDCs lack the economic capacity to pre-order doses in high volumes like comparatively wealthy countries do. Africa, for example, imports 99% of its vaccines, and only 2% of its people have received a single dose.


Currently, the World Health Organization (WHO), Joint United Nations Programme on HIV/AIDS (UNAIDS), and more than 100 countries support waiving COVID-19 IP protections. The argument for waiving is both a moral and practical one. Waiving IP protections would allow countries to manufacture their own vaccines without relying on imports and pre-orders, which would greatly benefit LEDCs by bridging the resource gap between minority and majority world countries. While countries can rely on the compulsory licensing exception in TRIPS to produce their own vaccines without facing repercussions from patent holders, the application process for this is “complex and time-consuming”. This poses a problem because time is something LEDCs cannot afford, hence the emphasis on action to be taken as soon as possible.


ree

Pharmaceutical Companies’ Response


Albert Bourla, CEO of Pfizer (the first pharmaceutical company to have their COVID-19 vaccine approved in the United States), said that waiving IP protections would “unleash a scramble” for the raw materials needed to produce the vaccine, which would “disrupt the flow” of critical materials used by the company to produce safe vaccines effectively. Leaked documents show that Jared Michaud, a lobbyist with a trade group that represents Pfizer, J&J, AstraZeneca, and other drug firms, sent an email that contained an unreleased letter by House Republicans to President Biden urging him to oppose waiving IP protections for the vaccine. The letter echoes Bourla’s concerns but also includes comments about the “transfer of critical U.S. technology” to major competitors like Russia and China.


Pharmaceutical companies’ opposition to a potential waiver is predictable, as they would be losing IP protection over the manufacturing process. According to the Wall Street Journal, if the patents were to be waived, it would directly undermine their business model of retaining an effective monopoly over certain technologies for extended periods of time.


Another concern is that a waiver would set a precedent of waiving IP protections for a wider variety of drugs, including HIV medications which are inaccessible in many majority world countries. These oppositions have manifested as aggressive lobbying and public relations work. Although pharmaceutical companies oppose the most direct and long-term ‘solution’, many are undertaking initiatives to provide LEDCs with vaccine doses, including directing doses to heavily impacted countries.



What Can You Do to Help?


As always, keep yourself educated and informed about the topic by reading and acknowledging arguments from both sides before forming an opinion. In general, contacting your legislators is the best way to ensure your point of view is heard. If a legislator hears a consensus among their constituents about a certain issue, they are more likely to vocalize their support or opposition to a given policy (in this case, waiving vaccine patents). This principle applies internationally- in this case if you are in Japan, South Korea, the UK, or one of the EU member states, your voice is especially critical. This is because currently, these countries are the major players opposed to the waiver. If you are in the United States, consider calling your senators and representatives and telling them to urge the Biden administration to either be more aggressive in its negotiations with the WTO or to reverse course and stop supporting the waiver.



Edited by: Karyn Sethi


Sources and References






Comments

bottom of page