BIO and PhRMA Urge Biden Administration to Oppose Proposed WTO TRIPS Waiver

McDonnell Boehnen Hulbert & Berghoff LLP

McDonnell Boehnen Hulbert & Berghoff LLP

One year ago, World Health Organization Director-General Tedros Adhanom declared the COVID-19 outbreak to be a pandemic. At the time of the announcement, the WHO noted that there were 118,000 cases reported globally, but in its most recent situation report, the WHO indicated that as of March 7, 2021 there have been 116,166,652 cases globally.

The response to the COVID-19 pandemic by the global biopharmaceutical industry over the past fourteen months has been unprecedented. From December 30, 2019, when SARS coronavirus was first detected in a patient sample, and January 10, 2020, when the complete genome of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was released, multiple treatments and vaccines have been developed and approved for use in combating COVID-19. And the rapid development of these treatments and vaccines has, as the Pharmaceutical Research and Manufacturers of America (PhRMA) recently put it, been "nothing short of incredible." For example, the U.S. Food and Drug Administration granted Emergency Use Authorization (EUA) for Gilead Sciences' remdesivir 123 days after the virus was first detected in a patient sample, granted EUA to Eli Lilly's antibody treatment 315 days after the virus was first detected, and granted EUA for the Pfizer-BioNTech vaccine 347 days after the virus was first detected. And since the pandemic was declared a year ago, the FDA has also granted EUA for Regeneron's antibody treatment, as well as for Moderna's and Johnson & Johnson's vaccines, with other vaccines expected to be granted EUA by the FDA shortly.

However, despite the speed with which the above treatments and vaccines have been developed, India and South Africa have been seeking since October to have the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization (WTO) recommend "a waiver from the implementation, application and enforcement of Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement in relation to prevention, containment or treatment of COVID-19" to the General Council of the WTO. The two countries also recommended that "[t]he waiver should continue until widespread vaccination is in place globally." According to their October 2, 2020 letter, the waiver is necessary because of "several reports about intellectual property rights hindering or potentially hindering timely provisioning of affordable medical products to the patients," as well as "urgent legal amendments to . . . national patent laws" being introduced by some WTO members "to expedite the process of issuing compulsory/government use licenses."

Last week, the Biotechnology Innovation Organization (BIO) and PhRMA sent separate letters to the Biden Administration to provide their thoughts on the Indian and South African proposal. In the PhRMA letter*, the organization congratulated President Biden for the more than 80 million vaccine doses that have been administered to Americans to date, adding that "[a]s we continue to work to vaccinate Americans, we must also acknowledge that COVID-19 anywhere in the world means our collective fight against this virus is not done." With respect to the importance of IP protections in combating the pandemic, PhRMA stated that:

Intellectual property protections have been essential not only to speed the research and development of new treatments and vaccines, but also to facilitate sharing of technology and information to scale up vaccine manufacturing to meet global needs. Eliminating those protections would undermine the global response to the pandemic, including ongoing effort to tackle new variants, create confusion that could potentially undermine public confidence in vaccine safety, and create a barrier to information sharing. Most importantly, eliminating protections would not speed up production.

Turning to the waiver proposal, PhRMA noted that "[i]n requesting the waiver, India and South Africa argued without evidence that intellectual property is hindering the global response to the pandemic and that the waiver would help scale up research, development, manufacturing and supply of needed products." PhRMA urged the Biden Administration to join the European Union, United Kingdom, Japan, Canada, Switzerland, Brazil, and Norway, as the United States did last year, in opposing the waiver, suggesting that "[p]erhaps more than any other time in history, society is seeing and benefiting from the innovation supported by intellectual property." PhRMA also pointed out that current estimates indicate that COVID-19 vaccine manufacturers will supply approximately 10 billion doses by the end of 2021, which would be sufficient to vaccinate the entire current global vaccine eligible population.

In the BIO letter, the organization began by noting that "[c]learly, the global pandemic can only be ended with global efforts that reach everywhere this deadly virus is prevalent," adding that the group "supports strong, efficient, and effective efforts to see that successful COVID products get to patients everywhere in the world that need them." The letter points out that within months following the outbreak, more than 800 global development projects had been initiated to create vaccines, treatments, and diagnostics.

However, like PhRMA, BIO noted that it had "strong concerns about some proposals being made that would set back and complicate such efforts," pointing to the waiver proposal, which BIO said was "both a wrong-headed and ineffective means of spurring further efforts at access." The letter argues that "the scientific and regulatory barriers required before one can safely and efficiently produce these advanced technologies are simply too high to be accomplished by anything other than cooperative, collaborative partnerships," asserting that:

The TRIPS waiver by contrast could spur a spate of confusing, mutually inconsistent and heavy-handed "compulsory" demands by governments all over the world for supply and technology transfer, which would distract from the need for coordinated international efforts and the cooperative work that currently is being advanced, and thus ultimately undermine the very goals of quick, safe access that it seeks to promote.

BIO concluded its letter by stating that "the world needs to be working together to advance the coordinated efforts that have been organized," while also declaring that "[t]he TRIPS waiver would be a divisive and ineffective detour from that critical work."

* The PhRMA letter was signed by the CEO's of thirty biopharmaceutical companies: Eli Lilly and Company; Takeda Pharmaceuticals U.S.A., Inc.; Novartis; AbbVie; Bayer AG; Amgen Inc.; Biogen, Inc.; Astellas Pharma US Inc.; BioMarin Pharmaceutical Inc.; AstraZeneca Pharmaceuticals LP; Boehringer Ingelheim USA Corporation; Bristol Myers Squibb Company; GlaxoSmithKline; CSL Behring; Incyte Corporation; Eisai Inc.; Ipsen Biopharmaceuticals, Inc.; Genentech, Inc.; Johnson & Johnson; Gilead Sciences, Inc.; Lundbeck LLC; Merck and Co., Inc.; Sanofi; Novo Nordisk Inc.; Sunovion Pharmaceuticals, Inc.; Otsuka North America Pharmaceutical Business; Teva Pharmaceutical Industries, Ltd.; Pfizer Inc.; UCB; and Sage Therapeutics.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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