Updated: May 6, 2021 7:56:10 am
Written by Thomas Kaplan, Sheryl Gay Stolberg and Rebecca Robbins
The Biden administration came out on Wednesday in support of waiving intellectual property protections for coronavirus vaccines, siding with international efforts to bolster production amid concerns about vaccine access in developing nations.
The United States had been a major holdout at the World Trade Organization over a proposal to suspend some of the world economic body’s intellectual property protections, which could allow drugmakers across the globe access to the closely guarded trade secrets of how the viable vaccines have been made. But President Joe Biden had come under increasing pressure to throw his support behind the proposal, drafted by India and South Africa and backed by many congressional Democrats.
Katherine Tai, the United States trade representative, announced the administration’s position on Wednesday afternoon, as the pandemic continues to spiral in India and South America.
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“This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures,” she 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.”
Support from the White House is not a guarantee that a waiver will be adopted. The European Union has also been standing in the way, and changes to international intellectual property rules require unanimous agreement. Tai said the United States would participate in negotiations at the World Trade Organization over the matter, but that they would “take time given the consensus-based nature of the institution and the complexity of the issues involved.”
Standing against her will be the pharmaceutical industry, which responded angrily to the extraordinary decision. Stephen J. Ubl, the president and chief executive of the Pharmaceutical Research and Manufacturers of America, called the announcement “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,” he said in a statement, adding that the move would have the effect of “handing over American innovations to countries looking to undermine our leadership in biomedical discovery.”
The pharmaceutical industry has argued that a suspension of patent protections would undermine risk-taking and innovation.
“Who will make the vaccine next time?” Brent Saunders, the former chief executive of Allergan, which is now part of AbbVie, wrote on Twitter.
Global health activists, who have been pressing for the waiver, praised the administration’s decision. It is “a truly historic step, which shows that President Biden is committed to being not just an American leader, but a global one,” said Priti Krishtel, an executive director of the Initiative for Medicines, Access & Knowledge.
But the activists said a waiver alone would not increase the world’s vaccine supply. It must be accompanied by a process known as “tech transfer,” in which patent holders supply technical know-how and personnel. Activists are also demanding that Biden use his leverage to ensure that manufacturing is scaled up around the globe, and not just by the pharmaceutical companies that now hold the patents.
“No USTR has made a pronouncement like this,” said Asia Russell, the executive director of Health GAP, a global AIDS treatment advocacy group, using the acronym for the trade representative. “And now the actions have to match the words.”
The United States’ announcement is only one step toward a potential international agreement on suspending intellectual property rights. Negotiating the fine print of an agreement that satisfies countries around the world is a tall order. If an agreement can be reached at the World Trade Organization, it is far from clear what would happen next.
Lisa Larrimore Ouellette, a patent law professor at Stanford Law School, suggested that the Biden administration’s move may help sway the drug industry to reach “deals that they can live with.”
Ana Santos Rutschman, a health law expert at St. Louis University School of Law, said the drug industry now has a clear incentive to “shift the debate to the global equity problem in accessing doses that we can actually produce, as opposed to getting into this enormous fight.” Companies’ best bet, she said, may be to take steps like donating more vaccine doses or selling them on a nonprofit basis to lower-income countries in need.
The debate over whether to relax intellectual property rules has stretched on for months. India and South Africa proposed the waiver last fall, seeking to suspend portions of an international intellectual property agreement dealing with issues like patents, copyrights and trade secrets. Under President Donald Trump, the United States opposed the effort. Other opponents have included Britain and the European Union.
The pharmaceutical industry argued that waiving intellectual property rights would not speed up vaccine production, pointing to other barriers like access to raw materials and distribution issues. Pfizer has said the company’s vaccine requires 280 components from 86 suppliers in 19 countries, as well as highly specialized equipment and personnel.
“Handing needy countries a recipe book without the ingredients, safeguards and sizable workforce needed will not help people waiting for the vaccine,” Dr. Michelle McMurry-Heath, the president and chief executive of the Biotechnology Innovation Organization, said in a statement. “Handing them the blueprint to construct a kitchen that — in optimal conditions — can take a year to build will not help us stop the emergence of dangerous new COVID variants.”
Shares of the pharmaceutical companies BioNTech, Moderna and Novavax dropped on Wednesday afternoon as news broke of the Biden administration’s decision.
Moderna, which partnered with the National Institute of Allergy and Infectious Diseases to develop its vaccine using new mRNA technology, announced in October that it would “not enforce our COVID-19-related patents against those making vaccines intended to combat the pandemic,” and it was willing to license its intellectual property for post-pandemic use.
Critics of the waiver proposal worry that eliminating patent protections after the development and approval of the vaccines might discourage pharmaceutical companies from investing in cures for future public health crises.
“Sadly, this action won’t help get more vaccines available to the world,” Dr. Luciana Borio, who oversaw public health preparedness for the National Security Council under Trump and was the acting chief scientist at the Food and Drug Administration under President Barack Obama, wrote on Twitter, suggesting that the United States donate vaccine doses instead. “There is no reason to celebrate. We wouldn’t have our amazing vaccines without U.S. innovative companies. These vaccines are hard to develop and manufacture, and our companies do that most efficiently.”
Craig Garthwaite, a professor of strategy at the Kellogg School of Management at Northwestern University, said he worried that the move would “signal that we, at a certain point, will not respect IP if the global health need becomes big enough,” using the initials for intellectual property. “I worry about COVID-20,” he added.
Garthwaite also noted that, unlike many drugs, the coronavirus vaccines are complex technologies that will be difficult to copy without the help of the companies that developed them. “People think you’re going to pick up this patent and read it like a cheesecake recipe, and make this awesome cheesecake,” he said. “You really want Moderna and Pfizer helping you.”
Supporters of the proposal cast it as a moral imperative that would allow for increased vaccine production and help get shots to countries where supplies are urgently needed.
Biden faced considerable pressure both at home and abroad. In his presidential campaign, he pledged to liberal health activist Ady Barkan that he would not let patents impede global production of a vaccine if the United States developed one first.
Many Democrats were also pushing Biden to take action, with more than 100 in the House signing a letter urging him to back the waiver.
“We, the most powerful nation in the world that can help bring an end to this catastrophe, cannot sit idly by — constrained by Big Pharma — watching millions of people die,” Rep. Rosa DeLauro, D-Conn., who helped lead the push among House members, said in a statement.
Supporters in the Senate included two leading progressives: Bernie Sanders, I-Vt., and Elizabeth Warren, D-Mass. On Wednesday, Sanders praised Biden, declaring that “this is exactly the kind of leadership the world needs right now.”
Tai’s announcement came after members of the World Trade Organization held a round of discussions about waiving intellectual property protections. Further discussions are expected in the coming weeks, as India and South Africa are preparing a revised version of their proposal for nations to consider.
At a meeting of the World Trade Organization’s General Council, Ngozi Okonjo-Iweala, the director general, urged members to proceed with negotiations over the text of the plan.
“I am firmly convinced that once we can sit down with an actual text in front of us,” she said, “we shall find a pragmatic way forward.”
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