The move, which is not supported by the pharmaceutical industry, would allow other countries to design and manufacture COVID-19 vaccines without fear of litigation.

In a sharp reversal of past policy, President Biden last week (May 5) came out in favor of a World Trade Organization proposal that would waive certain intellectual property protections around COVID-19 vaccines. The move, meant to boost the production of vaccines and address issues of inequity in their distribution, would reveal proprietary information held by companies designing the shots, although some proponents wonder whether the waiver is enough.

“This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures,” Katherine Tai, the US trade representative, says in a statement. “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.”

The proposal at the center of the argument was submitted to the World Trade Organization (WTO) last fall by India and South Africa, two countries currently beset by aggressive SARS-CoV-2 variants. India alone is reporting roughly 300,000 new infections each day, a tally that accounts for roughly half of the world’s new cases, according to The New York Times.

Both countries requested a waiver that would exempt WTO member countries from enforcing certain laws related to patents and industry trade secrets that are covered under the organization’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. If approved unanimously, the waiver would give countries and companies access to vaccine ingredients and manufacturing processes, allowing drug companies worldwide to make generic versions of COVID-19 vaccines for distribution in developing countries that currently do not have access.

Opponents to the measure in the US say that making these details public would hurt the bottom line of companies and undermine American competitiveness, all while doing nothing to expand the global supply of vaccines.

Anthony Fauci, President Biden’s chief medical adviser, also came out in support of the waiver, although the consensus among the President’s advisers was split, according to the Times. “I always respect the needs of the companies to protect their interests to keep them in business, but we can’t do it completely at the expense of not allowing vaccine that’s lifesaving to get to the people that need it,” Fauci tells the newspaper, adding: “You can’t have people throughout the world dying because they don’t have access to a product that rich people have access to.”

The White House’s decision to support the proposal angered pharmaceutical companies and prompted statements from other WTO member countries, the Associated Press reports. While the US had been a holdout under former President Donald Trump, other countries had also been lukewarm. In response to the US announcement last week, German chancellor Angela Merkel voiced her opposition through a government spokesperson, who stated that the ruling would cause “severe complications” for the production of vaccines.

Companies behind the world’s vaccines, such as Moderna and Pfizer, have already spoken out, with both announcing plans to increase their vaccine production in an effort to show that worldwide distribution can be done without the release of trade secrets. Moderna had also previously announced that it would not enforce its patents pertaining to COVID-19 research while the pandemic is ongoing. 

Pharmaceutical patents and trade secrets are heavily guarded, and opponents to the measure in the US say that making these details public would hurt the bottom line of companies and undermine American competitiveness, all while doing nothing to expand the global supply of vaccines.

Geoffrey Porges, an investment analyst for the bank SVB Leerink, tells the Times that this ruling would set “a terrible, terrible precedent” and make companies think twice before developing products that could be usurped by the government. “It would be intensively counterproductive, in the extreme, because what it would say to the industry is: ‘Don’t work on anything that we really care about, because if you do, we’re just going to take it away from you.’”

Stephen Ubl, the CEO of the lobbying group PhRMA, says in a statement that the proposal “flies in the face of President Biden’s stated policy of building up American infrastructure and creating jobs by handing over American innovations to countries looking to undermine our leadership in biomedical discovery.”

Several experts told STAT that the waiver would be largely symbolic, at least in the short term, as any increases in vaccine production wouldn’t materialize until at least 2022. And giving companies access to secretive vaccine recipes does nothing to ease the worldwide shortage of supplies, nor does it grant them the knowledge and expertise needed to manufacture highly complex vaccines. The Pfizer vaccine, according to spokeswoman Sharon Castillo, requires 280 components from 86 suppliers in 19 countries. “[I]t’s unrealistic to think that a waiver will facilitate ramping up so quickly as to address the supply issue,” she tells the Times, suggesting instead that the WTO should work with companies to give them the money and resources needed to increase their own production. 

See “Supply Shortages Hit Life Science Labs Hard”

Craig Garthwaite, a professor of strategy at the Kellogg School of Management at Northwestern University, similarly noted to the Times that the waiver would lack any real impact without an accompanying transfer of intellectual know-how, known as tech transfer. “People think you’re going to pick up this patent and read it like a cheesecake recipe, and make this awesome cheesecake,” he says. “You really want Moderna and Pfizer helping you.”