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On the morals of giants: Patent rights, waivers during COVID-19

Wednesday, June 23, 2021 @ 1:05 PM | By Nik Khakhar and Alyssia Sanchez


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Alyssia Sanchez
With the COVID-19 pandemic continuing to devastate nations worldwide, many are questioning the balance between private profits and public health. Professionals and activists believe that intellectual property (IP) rights enforced by the World Trade Organization (WTO) restrict developing countries from obtaining access to crucial medicine and equipment. Others argue that IP rights are essential to drive innovation and provide incentive for pharmaceutical companies. In response, vaccine producers have increased lobbying and public-relations efforts to support IP rights. Countries must now decide whether vaccine patents should be waived during this critical time of a global health crisis.

In April, the Biden administration announced that the United States would support a proposal to waive patents on vaccines and other products required to fight the pandemic. Although this event sparked media coverage, the campaign was initiated last October when a coalition of developing countries led by India and South Africa presented the proposal to the WTO. Since then, the campaign has gained the support of more than 100 countries, along with international organizations such as UNAIDS and the World Health Organization (WHO). Disclosed within the proposal were specifications that the waiver would include pandemic-related “health products and technologies,” comprising vaccines, therapeutics, diagnostics, medical devices, personal protective equipment, their materials or components, and their methods and means of manufacture. The waiver would be enforced for at least three years from the date of the decision, with opportunity for extension.

The last time that rules on the sale of patented medical products were changed by the WTO was in 2003, through alteration of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). The TRIPS Agreement allows for flexibilities such as “compulsory licensing,” which governments grant to companies to allow the production of a patented product without the right holder’s consent.

In the Doha Ministerial Conference in 2001, ministers stressed the importance of using the TRIPS agreement to protect and support public health by allowing access to both existing medicines and the innovation of new medicines. Central to this decision was the granting of compulsory licences to generic suppliers for the sole purpose of exporting and manufacturing essential medicines to countries with low production capacity. This aimed to address public health problems present in developing and least-developed countries, including those afflicted with HIV/AIDS, malaria and tuberculosis 

The principle underlying the patent waiver campaign is that all countries should readily have access to vaccines during a pandemic. Although compulsory licensing is an option, those in support of a waiver argue that the process is time-consuming and extremely complicated. Moreover, proponents believe the waiver can increase the production of vaccines and critical life-saving products. Since vaccine manufacturing and research and development is primarily concentrated in high to middle income countries, waivers could theoretically ensure that the production of vaccines is not restricted to wealthier nations at the expense of developing ones. 

The concerns against restrictive licensing practices in today’s vaccine debate is an echo from the prevailing discussions following the discovery of triple-therapy drugs to combat AIDS in 2006. Around this time, Thailand had produced a generic version of an AIDS therapeutic drug, which reduced deaths by 79 per cent. However, a condition to a bilateral trade agreement with the United States involved a restriction against the production of generic drugs on Thai soil. Because Thailand could only obtain medications by relying on U.S. supply chains, they were forced to buy drugs at higher prices.

Similar to the case of 2006, the global nature of the COVID-19 pandemic forces us to question the degree to which the dissemination of medical treatments — which could save the lives of countless citizens — should be subject to this ambit of control. In an effort to ensure that all nations around the world, regardless of wealth, have access to vaccines, the COVID-19 Vaccines Global Access (COVAX) initiative was founded in April 2020 by the WHO, the European Commission and France. COVAX is a pillar of the Access to COVID-19 Tools accelerator which aims to promote internationally equitable access to vaccines, diagnostics, and treatments used to fight the pandemic. Vaccine producers have demonstrated their support to COVAX through efforts to increase their capacities in sending doses to developing countries.

Despite the potential of patent waivers that has been outlined by the coalition, there are compelling reasons for the WTO to reject the proposal of patent waivers. These will be discussed in part two: On the morals of giants: How patents encourage innovation during COVID-19.

Nik Khakhar is currently a summer legal intern at Baylis Medical, a Canadian medical device company. He will be entering his second year at the University of Toronto, Faculty of Law. His graduate research in sociolegal studies and undergraduate background in ethics, society and law inform his analysis on the ethical, societal, and global implications of vaccine patent law. Alyssia Sanchez currently works as a junior intellectual property associate at Baylis Medical, as part of her co-op as a biomedical engineering student at the University of Guelph where she has recently completed her fourth year. Her research in biomedical technology informs her technical perspective when examining the nuances, challenges, and potential of current industrial trends in the global vaccine trade.

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