Eric Kayne/AP Images for People's Vaccine Coalition
Protesters hoisted a large banner outside the White House calling on German Chancellor Angela Merkel to stop blocking an emergency waiver of intellectual-property rules needed to increase global production of COVID-19 vaccines and treatments, July 13, 2021, in Washington.
A compromise text on intellectual-property rights for COVID-19 vaccines, treatments, and tests comes up far short of what is needed to vaccinate the world and limit the threat of mass death in dozens of countries, according to several experts. Under the agreement, companies would still have the ability to block access to most of their supplies.
The outcome is an embarrassment for the Biden administration, which promised nearly a year ago to support waiving IP protections on COVID-related vaccines and treatments and tests, to encourage mass production around the world. Despite uniting the West and particularly European Union states on the situation in Ukraine, President Biden failed to bring around European allies who held out against the IP waiver, in fealty to their home-state health and pharmaceutical companies that stand to gain billions of dollars from the pandemic.
Indeed, it was the U.S., according to published reports, that insisted that only vaccines be considered under the agreement, not treatments like Pfizer’s Paxlovid pill, Merck’s antiviral molnupiravir, or Regeneron’s antibody cocktail. After six months, the agreement could be reconsidered to cover therapeutics, as well as tests, but critics doubt that reconsideration process will ever happen.
Politico EU initially broke the story of the leaked text.
“It sounds like the demand for a waiver of IP barriers limiting COVID medicine access led by South Africa and India and supported by the U.S. and 70 other countries is being crushed by Big Pharma and their advocates in Europe,” said Lori Wallach, the longtime trade advocate with Public Citizen who is now director of Rethink Trade at the American Economic Liberties Project.
Companies holding patent rights to the intellectual property of prescription drugs and other medical treatments and tests can bar other manufacturers from mass-producing their products. In a pandemic with global reach, that means these companies can restrict supply of something everyone around the world needs, thereby raising the price and profit they can extract.
As vaccine development neared completion in October 2020, South Africa and India asked the World Trade Organization (WTO) to temporarily nullify patents and other IP barriers on COVID-related materials to facilitate mass production. This would require a waiver of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) that all 164 member nations of the WTO have signed on to.
Dozens of nations agreed with South Africa and India that COVID materials should get the TRIPS waiver. And they got a big boost last May, when President Biden endorsed the waiver as well. It was a temporary triumph for Katherine Tai, the U.S. trade representative, who overcame resistance among colleagues in the White House to get Biden on board. However, Biden only stated his support for a waiver for COVID vaccines, not treatments or diagnostics.
Agreeing to these other limitations may end up being worse than the status quo, say some critics.
The EU, meanwhile, was always opposed to waivers on anything. In particular, Germany, home to BioNTech, the partner to Pfizer in its COVID vaccine, did not support the waiver proposal. A couple of months after announcing his support, Biden did not secure then–German Chancellor Angela Merkel’s support for the waiver, despite praising her at a joint summit as someone who “never fails to stand for human dignity.”
With mRNA vaccines inaccessible in much of the world through 2021, this meant that China and Russia’s vaccines were distributed globally, and they have not performed well against the delta and omicron variants. Plus, the short supply of vaccines globally makes it easier for new variants to mutate and spread, threatening the effectiveness of all current treatments for COVID-19.
Nearly 18 months after the initial proposal, quadrilateral discussions between South Africa, India, the U.S., and EU produced the tentative agreement. The text, dated March 14, does appear to allow countries to produce vaccines without negotiating with or obtaining consent of the company holding the patent. Vaccines produced with this authority could then be exported to another country that is a member of the WTO. All patents for a particular vaccine could be bundled and waived. The agreement would be in place for either three or five years.
But as expected, it only applies initially to vaccines. “That is a complete give-in to Big Pharma that, bafflingly, has the Biden administration’s fingerprints all over it,” said Arthur Stamoulis, executive director of the Trade Justice Education Fund.
One key limitation on the waiver compromise is that it only applies to developing nations that have contributed less than 10 percent of total global exports of COVID vaccine doses last year. This was also reportedly a condition favored by the U.S., and it means that midsized countries with enough manufacturing capacity to export doses previously would be barred from the waiver.
The agreement focuses on the patents for vaccines (and potentially treatments and tests later), while ignoring other barriers to manufacturing development, like copyright, industrial data and designs, and other technological know-how termed “trade secrets.” This forces manufacturers who want to make vaccines to reverse engineer the formula, causing more delays.
In this sense, the proposal only restates the existing ability for WTO members to waive patents in an emergency. Agreeing to these other limitations may end up being worse than the status quo, say some critics. “Many key COVID-19 vaccines and medicines are protected by thorny thickets of intertwined IP protection, not just a patent or two,” said Melinda St. Louis of Public Citizen’s Global Trade Watch in a statement. “If the proposal is for patents only, it is extremely disappointing that the U.S. caved on its longstanding position to support the waiver for all categories of IP (at least for vaccines).”
Adam Hodge, a spokesperson for the U.S. trade representative’s office, publicly confirmed the compromise, calling it the result of a “difficult and protracted process” that “offers the most promising path toward achieving a concrete and meaningful outcome.” He noted that a final agreement on the text has not been reached. WTO members would have to sign on to the quad text. There’s a WTO ministerial meeting the week of June 13 that could potentially take this up.
The pharmaceutical industry would stand to be the biggest winners from the agreement, with much of their products protected for the next six months at least, and hindrances placed on developing nations even to manufacture vaccines without a patent.
St. Louis recommended that WTO members reject the agreement. “It would be a mistake for WTO members to prematurely agree to a weakened waiver that provides political cover to the U.S. and EU while not making any meaningful difference in increasing access to vaccines, tests, and treatments,” she said. “No waiver is better than a weak waiver designed solely to save face.”
The difference between the world quickly speaking with one voice on the war in Ukraine and its lassitude on a pandemic that directly affects every citizen on the planet is striking.
“This proposal effectively abandons the billions of people still without access to COVID vaccines and treatments,” Stamoulis said. “The obstinance and greed of rich nations who continue to block a real waiver is costing countless lives, and putting the world at risk of new variants that threaten to undo the progress made against the virus everywhere.”
