In Closed-Door Talks, the U.S. and E.U. Are Excluding Covid-19 Tests, Antivirals From Intellectual Property Waiver Negotiations

The exclusion bucks the demands of global activists, who say diagnostics and therapeutics must be included in any final deal.

Sarah Lazare

The headquarters of the World Trade Organization (WTO) stands on December 11, 2019 in Geneva, Switzerland. Robert Hradil/Getty Images

The Biden administration has touted its seriousness about taking global action to end the Covid-19 pandemic. But a summary of a February 22 meeting of the TRIPS Council, which oversees the WTO’s intellectual property rules, shows that the United States is participating in high-level, closed-door negotiations for an intellectual property waiver that have effectively determined that any final agreement, if approved, will only apply to vaccines — excluding diagnostics and therapeutics.

The exclusion flies in the face of demands from global civil society organizations, which have called for an intellectual property waiver on all Covid-19 products, from vaccines to antivirals and tests. U.S. officials have themselves emphasized the importance of antivirals and tests for their own populations, these groups argue, so why shouldn’t those treatments also be important for tackling Covid-19 internationally?

Public health advocates are concerned that both the United States and the European Union are pushing for such narrow terms for a global vaccine agreement that the benefits of any final arrangement will be severely limited.

The summary of the TRIPS Council meeting, which was closed to the press, was drafted by Geneva-based diplomats. It paraphrases the remarks of participants in the meeting. The summary notes that the United States, European Union, India and South Africa have been holding private negotiations about an intellectual property waiver.

India and South Africa initially proposed the waiver in October 2020, with the goal of enabling access to cheaper, generic Covid-19 treatments, and the proposal has since garnered 65 cosponsors, with the Global South heavily represented among them. The proposal calls for an intellectual property waiver in relation to prevention, containment or treatment of Covid-19.” It proclaims that intellectual property rules should not create barriers to the timely access to affordable medical products including vaccines and medicines or to scaling-up of research, development, manufacturing and supply of medical products essential to combat Covid-19.” (The proposal was revised in May 2021 to clarify that the waiver applies to all vaccines, diagnostics, treatments and medical supplies.)

The European Union, whose de facto leader is Germany, has staunchly opposed the waiver, citing the primacy of intellectual property rules, much like the United States did under former President Trump. The proposal is also fiercely opposed by the pharmaceutical industry.

In May 2021, the Biden administration said it would support an intellectual property waiver of some kind, but, in practice, it has dragged its feet in backing such a measure, and has declined to support the India-South Africa proposal as-is. (The United States has never explicitly backed an intellectual property waiver for anything but vaccines.) Negotiations have been at a standstill, even amid tremendous global disparities in access to vaccines and treatments. Since the TRIPS waiver was initially proposed in October 2020, 4.6 million people around the world have died of Covid-19.

As progress lags, some are putting stock in the negotiations between major supporters and opponents of the proposal. According to the summary from the February 22 meeting, WTO ​​Deputy Director-General Anabel González stated that contacts among South Africa, India, the United States and the European Union have been difficult but are moving in the right direction.” González noted that these talks have intensified in the past weeks and days,” and she is hopeful that a compromise could be reached soon.”

Global activists have emphasized that any intellectual property waiver must apply to all Covid-19 treatments, not just vaccines. On February 16, more than 200 civil society organizations from around the world wrote a letter to the leadership of the WTO calling for the passage of a TRIPS waiver that includes diagnostics, therapeutics and vaccines.” The letter states, Testing and access to diagnostics, especially antigen rapid tests is essential to peoples’ knowledge of their health status, compliance with public health measures, connection to treatment and care.”

The letter, whose signatories include the AIDS and Rights Alliance for Southern Africa, Indonesia for Global Justice, and Médecins Sans Frontières (MSF) Access Campaign, notes that the United States has different standards for its own population:

Dr. Anthony Fauci, chief medical adviser to the President of the USA and NIAID Director has stated that New antivirals that prevent serious Covid-19 illness and death, especially oral drugs that could be taken at home early in the course of disease, would be powerful tools for battling the pandemic and saving lives,” while Dr. David Kessler, Chief Science Officer for the Biden Administration’s Covid-19 Response said, An easily administered oral antiviral drug would be an important part of our therapeutic arsenal that would complement the great success of our vaccine efforts.”

If testing and diagnostics are important for the residents of the United States, the letter argues, certainly they are also important for those beyond U.S. borders.

Yet, the remarks from González suggest that such treatments have already been excluded from these negotiations. DDG González also reminded that work is being done on what pertains to vaccines, with the hope for a second track to address diagnostics and therapeutics,” it states. But critics worry that delaying discussion of intellectual property waivers for diagnostics and therapeutics could mean that they will not happen at all, or come too late.

There is a risk that it won’t happen. Activists in the Global South are worried. They know how the WTO works, and they’re worried they won’t get anything,” Burcu Kilic, research director of Public Citizen’s Global Access to Medicines program, a watchdog organization, tells In These Times.

That same summary reveals that the United States remains focused on intellectual property waivers solely for vaccines: We have stated our support for a waiver of intellectual property protections for Covid-19 vaccines, and we will continue to engage with members to look for areas of convergence that can lead to a solution, and this includes our participation in the Director General’s consultations, the U.S. delegate said.”

The United States has consistently called for an intellectual property waiver to relate only to vaccines. When U.S. Trade Representative Ambassador Katherine Tai initially proclaimed support for an intellectual property waiver, she was very specific: The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for Covid-19 vaccines.”

That the discussion of vaccines has been separated from the discussion of diagnostics and treatments at these negotiations reveals that the United States is getting its wish.

Companies stand to make considerable profits from non-vaccine treatments for Covid-19. In a February 2022 earnings call with investors, Pfizer executives emphasized the importance of the antiviral treatment Paxlovid for company revenue. For Paxlovid, we expect sales of approximately $22 billion,” states Chief Financial Officer Frank D’Amelio. (Pfizer is an aggressive opponent of the TRIPS waiver proposal.) The drug was approved for emergency use in the United States in December 2021, and there are already signs that Pfizer is building patent barriers for the treatment.

Along with the exclusion of diagnostics and treatments, global health activists have expressed concern about how ambitious the final agreement will be as it relates to vaccines. In October 2021, Daniel Marans reported for HuffPost that the European Union was pressing for language that outlines procedures countries may use to issue compulsory licenses,” rather than an intellectual property waiver. Critics say that the European Union’s effort to change the conversation at the WTO to compulsory licensing presents a barrier to the proposed intellectual property waiver. The EU’s counter-proposal is a delaying tactic that is not designed to solve the problem but to obstruct any workable resolution,” Graham Dutfield, a professor of international law at the University of Leeds, told HuffPost.

There are signs, furthermore, that geographic restrictions are being floated. The Geneva-based journalist Priti Patnaik reported earlier this month that, according to sources,” the United States had suggested a proposal to exclude India and China from the geographical scope of the implementation of a potential waiver.” Such a restriction would be considerable, as India has a large pharmaceutical sector.

According to the summary, González acknowledged that no one side, proponents or non-proponents, will be completely happy” with the outcome of the negotiations.

And the remarks from the European Union suggest its leadership is pushing for a compromise that is considerably different from the initial proposal from India and South Africa: In the EU’s view, WTO members can find the bridge between those members who advocate for a waiver and those who believe that the TRIPS Agreement provides enough flexibilities to ensure that the enabling qualities of intellectual property can be used to the maximum.”

Meanwhile, countries that are not participating in these negotiations remain opposed to an intellectual property waiver. Among them was Switzerland, which was cited in the summary as underlining that [intellectual property] has played a positive role in fighting this pandemic effectively.”

Supporters of the initial proposal have expressed concern that the United States has not been adequately pushing the European Union to back an intellectual property waiver for vaccines, which the Biden administration says it supports. We don’t understand why they are not going for it,” says Kilic. If they want an intellectual property waiver for vaccines, why are they not getting an intellectual property waiver for vaccines? No one is doing anything to stop the EU.”

Supporters of the waiver are aware of the high stakes in getting something passed quickly. The summary notes, South Africa reiterated that delay in approving a TRIPS waiver is hampering efforts to diversify proper production of vaccines, and address vaccine inequity. In Africa, we are still faced with vaccine inequity as 80% of Africans are yet to receive vaccines.”

Sarah Lazare is the editor of Workday Magazine and a contributing editor for In These Times. She tweets at @sarahlazare.

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