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Law360 (April 14, 2021, 6:51 PM EDT) -- U.S. Trade Representative Katherine Tai acknowledged on Wednesday that global intellectual property rules may need "modifications" in order to improve worldwide access to COVID-19 vaccines amid a fierce debate between drugmakers and public health advocates.
Addressing a virtual conference hosted by the World Trade Organization, Tai said that "the market once again has failed in meeting the health needs of developing countries." She added that while the "spirit" of the WTO's IP rules should be honored, the COVID-19 pandemic has amplified certain shortcomings.
"There are many aspects of the institution of the WTO and its rules that have not adapted to a changed world, a changed membership, changed practices and expectations," she said. "We must ensure that this time of crisis and suffering leads to breakthroughs and progress."
The WTO is wrestling with a proposal from India, South Africa and 100 other developing countries that would temporarily suspend the enforcement of global IP rules, including patents, copyrights and trade secrets. Those countries argue that doing so would unlock key vaccine formulas and boost global production.
That proposal has secured backing from hundreds of public health advocates and lawmakers, like Sens. Bernie Sanders, I-Vt., and Elizabeth Warren, D-Mass., who say it is crucial to improving access to vaccines in certain countries where some analysts currently project a yearslong wait for the treatment.
The powerful pharmaceutical lobby and its allies in Congress, however, say that a weakening of global IP rules — even temporarily — will undercut the protections that allowed for the rapid development of the vaccines in the first place. Eighteen Republicans on the House Ways and Means Committee wrote to Tai on Wednesday urging her to oppose the IP waiver.
Thus far, the U.S. and European Union have consistently resisted the developing countries' proposal. But Tai's office has begun deeper engagement on the issue, holding separate meetings with drugmakers, public health advocates and unions on Tuesday.
Tai stopped short of explicitly endorsing the waiver in her remarks at the WTO, but acknowledged that some changes may be coming.
"We have to consider what modifications and reforms to our trade rules might be necessary to reflect what we have learned," she said Wednesday.
The waiver is not the only solution being debated in Geneva. WTO Director-General Ngozi Okonjo-Iweala has thrown her weight behind the "third way" solution, which would encourage vaccine patent holders to strike licensing agreements with drugmakers around the world to expand vaccine production.
That is already happening to a certain extent, as AstraZeneca and other vaccine makers have struck licensing deals with India and certain other nations. But a February 26 letter spearheaded by Public Citizen said that relying on company-specific licensing agreements is too slow and cumbersome for what the pandemic demands.
"In contrast, the TRIPS waiver would remove a key obstacle to governments and manufacturers worldwide accessing the technology needed to invest in making COVID vaccines and treatments as rapidly as possible, in as many places as possible, for the billions who still need them," said the letter, which was signed by more than 400 civil society groups.
Okonjo-Iweala also spoke at Wednesday's WTO conference, expressing optimism that the vaccine distribution issue is under active discussion in Geneva. She called on governments to do all they can to remove vaccine export restrictions and supply chain barriers until a broader agreement can be reached.
"I hope that the discussion today, listening to each other, seeing that we all share a common goal, and that we may not be so far apart, will lead to the willingness to come to the middle, and work out something that will be acceptable to all," she said.
The WTO's Council for Trade-Related Aspects of Intellectual Property Rights is set to hold its next meeting on April 22.
--Editing by Regan Estes.
For a reprint of this article, please contact reprints@law360.com.
