Letter to US Trade Representative Tai urges to oppose request by India, other nations for TRIPS waiver on COVID-19 vaccines

Washington: In a letter to US Trade Representative Katherine C Tai on Tuesday (local time), Ranking Member Jim Jordan, and Darrell Issa, Ranking Member, Subcommittee on Courts, Intellectual property, and the Internet urged Washington to oppose a request by India, other nations for TRIPS waiver on COVID-19 vaccines.India, South Africa, and other nations requested to waive certain portions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) for all members of the World Trade Organization (WTO).

The requested waiver will provide many people with possible access to vaccines and treatments for COVID-19, including in developing countries.But as per the letter by Jordan and Issa, the waiver would undermine the very innovation that has led to the record-breaking rapid development of COVID-19 vaccines already saving lives around the world, and it would not meaningfully improve vaccine availability.

The international community should instead focus on overcoming the real obstacles faced by developing countries in accessing vaccines and treatments, which does not require waiving intellectual property (IP) rights, said the letter.The justification for the waiver rests on an incorrect assumption that IP rights are a significant bottleneck to the widespread availability of COVID-19 vaccines and treatments. The waiver`s sponsors have presented no convincing evidence to support this assertion.

Instead, the sponsors mainly just point out that relevant IP rights exist and speculate that those rights could serve as a barrier to access to COVID-19 vaccines and treatments--not that IP rights have actually blocked or significantly hindered their availability, said the letter."In reality, factors other than IP have had a far greater effect on the availability of vaccines and treatments for COVID-19. For example, logistical challenges such as the lack of cold storage, transportation and infrastructure problems, and shortages in basic supplies like syringes have posed significant challenges to widespread COVID-19  vaccination, particularly in developing countries. These issues are nothing new; vaccines have presented such problems for years. Cancelling IP rights would do nothing to alleviate these problems now," said the members in a letter to Tai.

In fact, allowing potentially any manufacturer to ignore IP rights and produce complex COVID-19 drugs on their own could instead increase the risk that defective and potentially unsafe medicines are produced, harming the patients who receive them, damaging public confidence,  and ultimately undermining global vaccination efforts, said the letter.Rather than attack the IP rights of innovative companies that have invested billions of dollars in developing these life-saving medicines, the international community should focus on addressing the real obstacles to widespread access to COVID-19 vaccines and treatments, said Jordan and Issa.

As per the letter, a broad coalition of countries, including the United States, are supporting the Access to COVID-19 Tools (ACT) Accelerator initiative and the related COVAX program. COVAX has already begun supplying over 140 countries with nearly 240 million doses of vaccines from AstraZeneca and Pfizer/BioNTech."In fact, relevant IP rights have been successfully licensed to expand access to COVID-19 innovations while maintaining IP protections. For example, the Serum Institute of India has secured licenses to produce multiple vaccines, including the AstraZeneca and Novavax vaccines," it said.South Africa`s Aspen Pharmacare has secured a license to produce the Johnson & Johnson vaccine. Several vaccine makers have licensed direct competitors to increase vaccine manufacturing capacity.

Moderna has announced that it would not seek to enforce any of its COVID-19-related patents against other vaccine makers for the rest of the pandemic and has pledged to license its COVID-19 vaccine patents.Gilead has licensed nine generic pharmaceutical manufacturers (including in India) to produce its COVID-19 therapeutic drug Remdesivir for 127 countries, most of which are developing nations.

Moreover, TRIPS already allows countries to impose compulsory licenses to access vital IP rights, and no country has availed itself of that capability to date for COVID-19 vaccines or treatments.The proposed waiver is not limited to patents on vaccines or treatments for COVID-19--the waiver would also gut protections for copyrights, industrial designs (e.g., textile patterns or other ornamental designs), and trade secrets. The waiver`s supporters have only offered vague, unsubstantiated explanations for how waiving IP protections for copyrights or industrial designs would lead to an improved vaccine or therapeutics availability, said the letter.