The U.S. is typically the staunchest defender of intellectual property rights on the international stage, so it was something of a shock when the Biden Administration on Wednesday announced its support for waiving patents on Covid-19 vaccines. “This is a global health crisis, and the extraordinary circumstances of the Covid-19 pandemic call for extraordinary measures,” U.S. Trade Representative Katherine Tai said 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 move comes in response to a World Trade Organization proposal led by India and South Africa to suspend some provisions of an international trade agreement in a bid to boost vaccine manufacturing and access, especially in lower- and middle-income countries. But it remains unclear how quickly production could increase, as patents are only one constraint in a complex global supply chain.
The pharmaceutical industry was quick to respond, noting that drug manufacturers are already working with governments and nonprofits to provide access to vaccines. Trade groups warned that waiving intellectual property protections would slow down innovation while doing little to actually help meet demand.
“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,” Steve Ubl, president and CEO of the trade group PhRMA said in a statement. “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.”
Meanwhile, some global public health experts, like World Health Organization chief Tedros Adhanom Ghebreyesus, embraced the move. “This is a monumental moment in the fight against #Covid-19,” he tweeted, calling it a “powerful example of [American] leadership to address global health challenges.”
It remains to be seen how the European Union will respond given the U.S. reversal, given that the bloc typically is a strong defender of intellectual property rights as well (even though there may be some dissent among member countries). “It’s absolutely a great day,” says Madhavi Sunder, a professor of law at Georgetown University. “This temporary waiver, in the face of a once in a century pandemic is appropriate, necessary and not a moment too soon. We all hope that now the EU will endorse it soon as well.”
Billionaire Mark Cuban, who recently backed a manufacturing company for low-cost generic drugs, also cheered the move and said the Mark Cuban Cost Plus Drugs Company might be interested in helping produce vaccines as a long-term goal, though it doesn’t have the capacity to do so now. “I think it’s great,” he told Forbes in an email. “And it’s certainly something we would consider if there were unmet demands.”
We are extremely disappointed that the Administration has chosen to support waiving critical protections for American ingenuity.
The Biden administration has come under fire in recent weeks for its “America First” approach to vaccine manufacturing and distribution, especially as countries like India face skyrocketing cases, deaths and a shortage of oxygen and the raw materials needed to manufacture vaccines. There has been a stark difference between the 4.9 billion doses acquired by high-income countries and the less than 3 billion doses for the low- and middle-income countries that make up nearly 85% of the world’s population, according to a Duke University tracker.
The U.S. subsequently said it would provide assistance to India. Vaccine manufacturers, including Moderna, NovaVax, AstraZeneca, Pfizer and Johnson & Johnson, have also all pledged billions of doses to Covax, the World Health Organization’s vaccine-sharing program, even though some doses won’t be available until 2022.
Historically, the U.S. pharmaceutical industry significantly discounted prices and donated drugs and vaccines in order to avoid low- and middle-income countries invoking compulsory licensing during a public health emergency. Its argument is that weak patent protections would mean there would be no incentive for incredibly costly and time consuming research and development.
“We are extremely disappointed that the Administration has chosen to support waiving critical protections for American ingenuity,” Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization, said in a statement. “Handing needy countries a recipe book without the ingredients, safeguards, and sizable workforce needed will not help people waiting for the vaccine.”
The World Trade Organization takes a consensus-based approach, so there won’t be an immediate change to vaccine makers’ intellectual property protections, as the negotiations and horse-trading continues, but McMurry-Heath warned waivers would “set a dangerous precedent.” The pharma industry has often warned of a slippery slope effect—once intellectual property rights are eroded, there’s no turning back.
“I never thought I would live to see the day the US would use its political muscle to waive IP rights and do so in the face of implacable opposition by the pharmaceutical industry,” says Lawrence Gostin, a professor of global health law at Georgetown University and director of a World Health Organization collaboration center. But he also warned that it could take months to negotiate the text of the agreement and major funding would be needed to provide technical assistance and increase manufacturing in lower income countries. “The task is massive but the need is just as great. We have no time to lose.”