TThe United States is generally the most ardent defender of intellectual property rights on the international stage, so it came as 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,” said US Trade Representative Katherine Tai said in a press release. “The Administration firmly believes in the protection of intellectual property, but in the service of the end of this pandemic, it supports the lifting of these protections for Covid-19 vaccines.”
The move follows a World Trade Organization proposal led by India and South Africa to suspend certain provisions of an international trade agreement in a bid to boost the manufacture of and access to vaccines, by especially in low- and middle-income countries. But it’s unclear how quickly production could increase, as patents are only a constraint in a complex global supply chain.
The pharmaceutical industry was quick to respond, noting that drug makers are already working with governments and nonprofits to provide access to vaccines. Business groups have warned that forgoing intellectual property protection will slow innovation while doing little to help meet demand.
“This long-standing US policy change will not save lives. It also flies in the face of President Biden’s stated policy of building American infrastructure and creating jobs by transferring American innovations to countries that seek to undermine our leadership in biomedical discovery, ”said Steve Ubl, president and CEO of the PhRMA business group in a statement. “This move does nothing to address the real challenges of getting more shots, including last mile distribution and limited availability of raw materials.”
Meanwhile, some global public health experts, like the head of the World Health Organization, Tedros Adhanom Ghebreyesus, have embraced the initiative. “This is a monumental moment in the fight against # Covid-19,” he tweeted, calling it a “powerful example of [American] leadership to meet the challenges of global health. ”
It remains to be seen how the European Union will react to the American turnaround, given that the bloc is generally a strong advocate of intellectual property rights as well (although there may be some dissent among member countries). “It really is a beautiful day,” says Madhavi Sunder, a law professor at Georgetown University. “This temporary exemption, in the face of a pandemic that occurs once a century, is appropriate, necessary and not a moment too soon. We all hope the EU will approve it soon as well. “
Billionaire Mark Cuban, who recently backed a low-cost generic drug manufacturing company, also applauded the move and said Mark Cuban Cost Plus Drugs Company may be interested in helping produce vaccines as a long-term goal. term, although she did not. the ability to do it now. “I think it’s great,” he told Forbes in an email. “And that’s definitely something we would consider if there were any unfulfilled demands.”
We are extremely disappointed that the Administration has chosen to support the lifting of protections essential to American ingenuity.
TThe Biden administration has come under fire in recent weeks for its “America First” approach to vaccine manufacturing and distribution, especially as countries like India are facing a spike in cases, deaths and an outbreak. shortage of oxygen and raw materials needed to manufacture vaccines. There has been a marked difference between the 4.9 billion doses acquired by high-income countries and the less than 3 billion doses for low- and middle-income countries which make up nearly 85% of the world’s population, according to a Duke University Tracker.
The United States subsequently declared provide assistance in India. Vaccine makers, including Moderna, NovaVax, AstraZeneca, Pfizer and Johnson & Johnson, have also pledged billions of doses to Covax, the World Health Organization’s vaccine sharing program, though some doses will not be available before 2022.
Historically, the US pharmaceutical industry has drastically reduced prices and donated drugs and vaccines to prevent low- and middle-income countries from invoking compulsory licensing during a public health emergency. His argument is that weak patent protections would mean there would be no incentive for incredibly expensive 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 over to countries in need a cookbook without the ingredients, guarantees and the significant manpower required will not help people wait for the vaccine.”
The World Trade Organization takes a consensus-based approach, so there will be no immediate change in the protection of the intellectual property of vaccine manufacturers, as negotiations and bargaining continue, but McMurry-Heath warned that the waivers “would set a dangerous precedent. “The pharmaceutical industry has often warned of a slippery slope effect: once intellectual property rights are eroded, there is no turning back.
“I never thought I would live to see the day when the United States would use its political force to relinquish intellectual property rights and face relentless opposition from the pharmaceutical industry,” says Lawrence Gostin, professor of Global Health Law at Georgetown University. and director of a World Health Organization Collaborating Center. But he also warned that it could take months to negotiate the text of the agreement and that significant funding would be needed to provide technical assistance and increase manufacturing in low-income countries. “The task is enormous, but the need is just as great. We have no time to waste. ”
Additional reporting by Aayushi Pratap, Alex Knapp and Leah Rosenbaum.