Biden backs COVID-19 vaccine patent waivers

The Biden administration will support a proposal to waive international patent protections for COVID-19 vaccines, according to a top administration official.

U.S. Trade Representative Katherine Tai said in a statement Wednesday that the “extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures.”

The U.S. will begin participating in World Trade Organization (WTO) negotiations over the exact language of the waiver, which supporters say would make the details of vaccine production widely available and allow lower-income countries to make doses themselves.

“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,” Tai said.

She added that the WTO negotiations “will take time given the consensus-based nature of the institution and the complexity of the issues involved.” 

Any WTO action needs the support of every member.

While many lower income countries backed the waiver proposal, it was opposed by others, including the European Union, United Kingdom, Switzerland, Japan, Brazil, Canada and Australia. 

The argument centers on temporarily lifting patents and other intellectual property protections to help expand the production and deployment of vaccines during supply shortages. 

The aim is to suspend the rules until the end of the pandemic. The debate has exploded in the U.S., as dire scenes in countries like India contrast with rosy domestic predictions and millions of Americans getting vaccinated daily. 

Lower-income countries are struggling to acquire and manufacture the lifesaving vaccines, as wealthy countries stockpile doses.

Wealthy countries currently account for more than half of nearly 9 billion doses that have been pre-purchased to date, according to the Duke Global Health Innovation Center.

The Biden administration has been facing pressure from the international community, drug pricing advocates and congressional Democrats to back the waiver proposal, which was spearheaded by India and South Africa.

Progressives cheered the announcement as an important step toward ending the COVID-19 pandemic around the world.

“With this waiver, we can share vaccine recipes, largely developed with taxpayer dollars, while assuring reasonable royalties to American manufacturers,” said Rep. Lloyd Doggett (D-Texas), who chairs the House Ways and Means health subcommittee.

The best way to end the deadly global vaccine shortage is to enable more manufacturers to make vaccines,” Doggett said.

In addition to the House lawmakers, Sen. Bernie Sanders (I-Vt.) led a letter to the administration with nine Democratic senators last month. Health groups like Oxfam, Doctors Without Borders and Partners in Health have also joined the calls.

“I applaud the Biden administration for taking this bold step to speed up the production and availability of coronavirus vaccines. I also recognize the dedicated work done by activists around the world to put this issue on the global agenda. We are all in this together,” Sanders said Wednesday. 

The pharmaceutical industry has vehemently pushed back against the waiver idea, saying it would stifle innovation and hurt their ability to produce the hundreds of millions of vaccine doses needed. 

“In the midst of a deadly pandemic, the Biden Administration has taken an unprecedented step that will undermine our global response to the pandemic and compromise safety. This decision will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines,” said Stephen Ubl, president and CEO of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Ubl called the waiver an “empty promise,” and pointed to companies ramping up manufacturing capacity, an increase in American-made vaccine exports, new commitments to the COVAX initiative, and “unprecedented” aid for India.

“This change in longstanding American policy will not save lives. It also 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. This decision does nothing to address the real challenges to getting more shots in arms, including last-mile distribution and limited availability of raw materials,” Ubl said.

Some experts, including White House chief medical adviser Anthony Fauci, have said that waiving patent protections is not necessarily the fastest way to solve the crisis.

Earlier Wednesday, Fauci said he thought the U.S had a “moral obligation to make sure that the rest of the world does not suffer and die, as it were, from something that we can help them with and help to prevent.” 

While Fauci said he didn’t want to take the idea of a waiver off the table, there are other options too.

“Whether that involves taking a look and examining whether you want to waive patent protection, whether it means making investments in a lot of money to have tech transfer go to the developing world so they can make their own vaccines,” Fauci said.

— Updated at 4:57 p.m.