The Biden administration’s support of a petition to ease patent protections for vaccines elevated the global battle against the coronavirus as a central plank of U.S. foreign policy, but myriad hurdles remain before that stance could become international policy — if ever.
“I genuinely think it’s pretty marginal,” said Rachel Silverman, a policy analyst with the Center for Global Development, a nonprofit think tank, who has warned that an intellectual property waiver raises complicated questions and won’t immediately boost supply to virus-ravaged countries such as India and Brazil. “I think it will not have disastrous effects. I don’t think it will do much to speed production.”
Still, Silverman praised President Biden’s willingness to take “bold and unprecedented action” to prioritize the global virus fight “above some of our more conventional foreign policy interests” and signal to developing countries that “we are not indifferent, that we are listening, and that we care about vaccinating them.”
Others suggested that the United States putting its muscle behind the proposal brings pressure on all players, including vaccine makers and other developed countries, to find other, more practical ways to speed vaccines to the developing world, especially amid the growing outcry over the gap between rich and poor countries. The desperation in India, where only 2.2 percent of the population is fully vaccinated as hospitals run out of oxygen, compared with almost 33 percent of the U.S. population being fully vaccinated, has underscored the issue.
The head of the World Trade Organization said Thursday that she would press member countries to reach an agreement on the waiver petition no later than December, setting Dec. 3 as the target for a final agreement.
“It’s not overnight that we’re going to be able to scale up,” Director General Ngozi Okonjo-Iweala acknowledged in an interview with The Washington Post, adding, “It is very difficult to say now whether there is going to be a consensus, but I think they will be able to come to some pragmatic agreement that will give both sides the necessary comfort that they need.”
Even with the support of the United States, a major victory for the developing world, a deal is far from a guarantee, as any one of the 164 member nations could torpedo the effort.
After months of pressure from liberal lawmakers and the international community, the Biden administration announced its support Wednesday for the waiver. It also said its support of the waiver was one of many tools it would leverage in the global vaccination effort. Last month, the White House announced it would export its entire supply of the AstraZeneca vaccine — totaling up to 60 million doses — after the Food and Drug Administration completed safety checks. That vaccine has not yet been authorized in the United States.
“Text-based negotiations at the WTO will take time given the consensus-based nature of the institution and the complexity of the issues involved, but this is a chance for the WTO to come together to deliver solutions that help save lives and we will use our convening power at the WTO to bring members together,” a spokesperson for the U.S. Trade Representative said in a statement.
The White House decision to support the waiver enraged pharmaceutical companies, which warned of dire consequences for the industry’s long-term incentives. But the chief executive of one major vaccine manufacturer shrugged off the near-term impact for his firm, saying he “didn’t lose a minute of sleep.”
“I believe it doesn’t change anything for Moderna,” CEO Stéphane Bancel said on an investor call Thursday morning, listing the barriers that he said would limit other companies and countries from taking advantage of the waivers.
“There is no mRNA manufacturing capacity in the world — this is a new technology,” Bancel added. “You cannot go hire people who know how to make mRNA. Those people don’t exist. And then even if all those things were available, whoever wants to do mRNA vaccines will have to, you know, buy the machine, invent the manufacturing process, invent creation processes and ethical processes, and then they will have to go run a clinical trial, get the data, get the product approved and scale manufacturing. This doesn’t happen in six or 12 or 18 months.”
Several officials involved in the U.S. coronavirus response said they worried the decision would damage their relationship with the drug industry, noting the Biden administration is relying on it not just to boost vaccine supply but also to devise additional coronavirus treatments and vaccines, particularly given the risk of variants.
“We’re all counting on pharma to come up with vaccine booster shots, and what happens when we try to get to the front of the line?” said one official, speaking on the condition of anonymity because they were not authorized to publicly comment.
An administration official, who also spoke on the condition of anonymity because he was not authorized to discuss the issue, countered that view, saying senior leaders “still have confidence in our ability to work constructively with the vaccine manufacturers to make the lifesaving benefits available to the most people as quickly as possible — including through our existing contracts.”
Biden has praised the pharmaceutical industry, touring a Pfizer manufacturing plant in Michigan in February on one of his first trips as president and stopping to thank CEO Albert Bourla four times in a 20-minute speech.
While the European Union signaled its willingness Thursday to begin talks on the waiver, a spokesperson for German Chancellor Angela Merkel on Thursday warned that lifting intellectual property protections would hamper pharmaceutical development. BioNTech, which has partnered with Pfizer on its vaccine, is based in Germany.
Pharmaceutical advocates said they hoped other nations would echo Germany’s concerns.
“It’s a bad idea, it doesn’t solve the problem, and actually Merkel and her government were pretty clear about that,” said Joseph Damond, who oversees international policy for the Biotechnology Innovation Organization, or BIO.
However, Damond said that BIO was also preparing for a potential “domino effect” where other countries followed the Biden administration’s lead and called for WTO talks. If so, the group laid out a list of recommendations for the resulting waiver talks, such as ensuring that American firms were protected from being “coerced” by foreign governments to transfer their technology.
As the negotiations on the waiver proceed, one of the most pressing issues is how to navigate whether China, Russia and other American adversaries will get access to the coveted technology, an issue Republicans have already seized on to criticize the Biden administration’s decision.
Congressional Republicans have framed Biden’s decision as a national security failure, saying that the decision would hand taxpayer-funded technological breakthroughs to the nation’s rivals.
“It is dangerous for America to consent to strip away patents on lifesaving COVID vaccines now that cost businesses billions of dollars to develop at a historic pace — and to reward China with access to U.S. innovation for a world pandemic China created,” Rep. Kevin Brady (R-Tex.), the top Republican on the House Ways and Means Committee, said in a statement.
Joe Grogan, who ran the Domestic Policy Council during the Trump administration and previously lobbied for Gilead Sciences, said pharmaceutical companies are particularly angry the Biden administration supported the waiver while slowing the companies’ efforts to sell their vaccines overseas.
“This is a total betrayal,” said Grogan, a fellow at the University of Southern California. “I’ve spoken to people in the industry who voted for Biden who are extremely mad about this,” he said.
The White House said it does not have an export ban on coronavirus vaccines and has not prevented companies from selling vaccines overseas.
But waiver advocates said they remained optimistic despite the significant hurdles.
Lori Wallach, who oversees global trade policy for the consumer advocacy organization Public Citizen, said it was “impossible to overstate” the impact of Wednesday’s decision.
Wallach cited the United States’ historic role in prioritizing intellectual property protections over public health, saying the administration’s “announcement alone sends powerful signals to developing-country governments and drugmakers to plan more production.”
She also compared Biden’s message to U.S. vaccine manufacturers to “Igor telling Dracula to temporarily try a vegan diet to save the world or else.”
“Yes, pharma will try to derail the actual waiver negotiations. There is big battling ahead. But there will be a waiver,” Wallach predicted.
Lesley Wroughton in Cape Town, South Africa, contributed to this report.