Biden Administration Urges Global Trade Chief To Release COVID-19 Patent Waiver Text

Nearly a year after President Joe Biden’s administration expressed support for waiving international intellectual property rules for COVID-19 vaccines, U.S. officials are nudging the World Trade Organization and its member nations to release the draft text of such a waiver.

The U.S. Trade Representative, in a diplomatically worded statement provided to HuffPost, aims to move along a process that has stalled. The Biden administration wants WTO Director-General Ngozi Okonjo-Iweala to release an official draft of a waiver agreement so the administration can seek input on it from members of Congress and take other steps needed before it can be adopted, according to two administration officials.

“Since last May, [the office of the U.S. Trade Representative] has worked hard to facilitate an outcome on intellectual property that can achieve consensus across the 164 Members of the World Trade Organization to help end the pandemic,” Adam Hodge, assistant U.S. trade representative for public affairs, said in the statement. USTR joined discussions led by the WTO with South Africa, India and the European Union “to try to break the deadlock,” he continued.

“While no agreement on text has been reached, the U.S. will continue to engage with WTO Members as part of the Biden-Harris Administration’s comprehensive effort to get as many safe and effective vaccines to as many people as fast as possible,” added Hodge, a spokesperson for U.S. Trade Representative Katherine Tai.

Hodge’s statement is timed to precede the next major WTO gathering, suggesting a potential deadline for an officially sanctioned text. Trade representatives of WTO member nations are due to convene in person in Geneva in mid-June.

A draft of a possible compromise accord between representatives of the U.S., the European Union, South Africa, and the WTO leadership leaked in March, but the parties have yet to publicize an official text. The Biden administration believes that making such a text public, even if it is not final, is necessary to advance the ratification process, according to the two administration officials.

Tai announced in May 2021 that the administration would be withdrawing its objections to a waiver of trade-related aspects of intellectual property rights for COVID-19 vaccines. Global advocates for affordable medicines celebrated the decision at the time as an important, albeit preliminary, step toward expanding access to vaccines in the developing world.

Tai’s announcement came in response to appeals from a group of developing nations led by South Africa and India. The developing nations had pressed wealthier countries to grant the limited waiver so that generic drugmakers would be free to replicate not only the patents for Western-designed vaccines, but also the complex basket of copyrighted and trademarked materials that make those vaccines usable. They argued that residents of richer nations also stood to benefit from the fastest possible containment of the pandemic.

But even with the United States’ support for the waiver, unanimity among the WTO’s 164 member nations would be needed to adopt a new policy. And the European Union, led by Germany, immediately voiced objections, echoing the concerns of the brand-name pharmaceutical and biologics industries. Big drugmakers argued that even if the waiver took effect, developing nations with generic drugmakers lack the manufacturing capacity to scale up production of vaccines.

The draft text that leaked in March confirmed the worst fears of many advocates that the E.U. and the U.S. had managed to restrict the language of a potential waiver almost to the point of meaninglessness.

The leaked language would fail to enable mass reproduction of the brand-name COVID-19 vaccines by generic drugmakers because, among other things, it does nothing to expand access to the “thickets” of additional intellectual property rights needed to make use of patents on individual drugs, according to Lori Wallach, director of the American Economic Liberties Project’s Rethink Trade program. It also would not apply to medications that treat COVID-19 infections, which have become viable in the months since the U.S. announced the waiver, Wallach noted.

“The leaked text represents the lowest common denominator of E.U. fealty to Big Pharma by not actually waiving intellectual property monopolies and the U.S. insistence that only vaccines be covered,” Wallach wrote in a lengthy response to the leak.

Wallach nonetheless held out hope that the draft text’s language could improve before the WTO votes whether to adopt it.

“This text is more than disappointing,” Wallach wrote. “But it also is not the final word.”