U.S. President Joe Biden, riding high in the polls, touted his administration’s 100-day record in a speech to a joint session of Congress on Wednesday. Focusing his remarks largely on the COVID-19 crisis, Biden spoke of how the United States was “leading the world again” in getting vaccines to “hard-to-reach communities.”
But Biden, striking a nationalist tone, said nothing of helping the rest of the world in what continues to be a global pandemic. And with the president’s first priority—COVID-19—now raging out of control in India and other developing nations, health experts say Biden is neglecting his own promise to stop at nothing in getting vaccines to nations most in need. In the end, that will only prolong an unprecedented health crisis and come back to endanger the United States itself, critics say.
A key issue is whether the administration will agree to a six-month-old proposal by India and South Africa to temporarily waive patents and intellectual property rights in order to quickly step up vaccine production around the world. Critics say Biden is too willing to cater to major pharmaceutical companies, despite active efforts being made to find a compromise led by U.S. Trade Representative Katherine Tai. In a speech earlier this month, Tai herself warned of a “gaping divide between developed and developing countries when it comes to access to medicines.”
“Biden is starting out his tenure in the White House bringing despair to millions who will have to wait years for a vaccine,” said Gregg Gonsalves, an epidemiologist at the Yale School of Public Health. “We need to crush COVID now, not in 2022, 2023, or 2024. Right now, Biden is punting, relying on theatrics—pledging 60 million doses from AstraZeneca when billions are in need—rather than stepping up with a bold policy.”
Such a policy would entail rapid transfer of technical knowhow to India and other countries in need, along with production capability. These views are widely shared by other global health experts who say the pharmaceutical industry has less claim on intellectual property rights to vaccines than usual because billions of U.S. taxpayer dollars went into developing these vaccines quickly. The U.S. government, for example, funded 100 percent of Moderna’s vaccine project to get U.S. Food and Drug Administration approval, reported Public Citizen, an advocacy group. Pfizer got a $1.95 billion government deal.
“I am completely baffled by the massive gap in leadership on this issue,” said Matthew Kavanagh of Georgetown University’s Global Health Policy and Politics Initiative. “I would have thought this would have certainly been done in the first months, and here we are approaching the first 100 days. The world is waiting.”
India and Brazil in particular are suffering from new COVID-19 strains, and Indian Prime Minister Narendra Modi pleaded with Biden in a phone call this week to support a waiver on patents in the face of a massive second wave of the pandemic. India has reported at least 300,000 new infections every day in the past week, and crematoria there are said to be operating nonstop.
Ironically, India is the world’s biggest vaccine maker, and Modi offered free vaccines to the world under a controversial “vaccine diplomacy” policy starting in January. But suddenly, India is a desperate state, having vaccinated less than 6 percent of its nearly 1.4 billion population as new mutations of COVID-19 appear—and experts believe these strains are now spreading to other countries, including the United States.
Administration officials say Tai has been actively trying to resolve the patent issue, having solicited opinions in recent days from major pharmaceutical companies like Pfizer, Moderna, and AstraZeneca; the administration’s COVID-19 point man, Anthony Fauci; Seth Berkley of Gavi, the Vaccine Alliance, a global public-private health partnership overseeing vaccine distribution; Bill Gates; and other public health advocates. There appears to be room for compromise: Last fall Moderna President Stephen Hoge said the company wouldn’t enforce patents related to its COVID vaccine as long as the pandemic continued. Gates, who has personally spent billions of dollars on global health as part of his foundation, said waiving IP rights too quickly could create safety problems.
The president has been pushing for a solution, administration officials say, but in the end he needs to work with the same pharmaceutical corporations that, to their credit, delivered vaccines in record time. “I don’t believe we’re dealing with callous human beings here,” said Priti Krishtel, co-founder of I-MAK, a major advocacy group supporting wider access to medicines. “I think we live in a market-based system. This pandemic has further exposed that the ways in which we have structured our economy are fundamentally inequitable.”
Still, some critics suggest that Biden, by hesitating so long over the issue, may be in danger of breaking a promise he made last July when the then-Democratic candidate said he would “absolutely, positively” not let intellectual property rights stand in the way of getting vaccines to the world. At the time, Biden criticized his predecessor, Donald Trump, for doing so, saying his patent-protecting policies lacked “any human dignity.” Biden added: “It’s not only a good thing to do. It’s overwhelmingly in our interest to do.”
Vaccine advocates say Biden is trying to avoid confronting the pharmaceutical industry and the Republicans at a time when he is consumed with getting his big domestic programs passed. In his speech Wednesday, Biden trotted out his third nearly $2 trillion plan in as many months. To help pay for it, he’s asking Congress to approve $1.5 trillion in tax hikes that will fall on wealthy Americans, and Republicans are balking.
For weeks, the administration has failed to give a direct response to questions about patent waivers. Officials have pointed instead to Biden’s signing of a $4 billion investment in COVID-19 Vaccines Global Access (COVAX), a United Nations-orchestrated plan for wealthier nations to buy up and share vaccines worldwide, and Monday’s announcement that Biden would send 60 million AstraZeneca vaccines to nations in need.
“Along with our investments in COVAX, we are working with our global partners to explore pragmatic and effective steps to surge the production and equitable distribution of vaccines,” Adam Hodge, a spokesperson for Tai, told Foreign Policy.
But the COVAX program is barely a drop in the bucket, health experts say, and is already well short of effort to supply a target of two billion doses for 2021. “COVAX is wholly unequipped to resolve many of the most pressing threats,” The Lancet said in an editorial in March. “COVAX’s current conservative aim is to immunize 20 percent of people in each country, which it estimates is enough to cover high-risk groups and health workers.”
Meanwhile, vaccine inequities are only widening. A February study published by scholars at the London School of Economics and other academics reported that states representing only 16 percent of the global population have secured 70 percent of the available doses for the five leading vaccines this year.
Under the waiver proposed by India and South Africa last October, World Trade Organization (WTO) member nations would have the right to bypass intellectual property licenses in cases of national emergency. The proposal was based on the Doha Declaration on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. The TRIPS declaration evolved out of the HIV/AIDS crisis, during which nations were unable to get necessary medicine because of patents for years.
Yet the Biden administration is shying away from that plan, and since several of the major pharmaceutical companies producing vaccines are from the United States, including Moderna, Pfizer and Johnson & Johnson, no one can do much without Washington’s say-so.
World Health Organization Director-General Tedros Adhanom Ghebreyesus has supported the TRIPS plan, saying the United States’ “me first” approach is self-defeating. Even new World Trade Organization Director-General Ngozi Okonjo-Iweala has pledged to “forget business as usual,” though she has stopped short of endorsing the India-South Africa proposal outright. The TRIPS proposal is also supported by leading progressive senators like Bernie Sanders and Elizabeth Warren.
In the past month, Sanders sent several letters to Biden about the issue and discussed it with Secretary of State Antony Blinken, but he has received no response, said an aide. “Our vaccination efforts here at home will only be successful if vaccination efforts in the developing world happen simultaneously,” Sanders said in an April letter signed by Warren and nine other Democratic senators.
In her speech to the WTO in mid-April, Tai herself said the U.S. government should not repeat the mistakes it made during the HIV/AIDS epidemic, “where various policies and actions constrained access to medicines, contributing to unnecessary deaths and suffering. We must learn from, and not repeat, the tragedies and mistakes of the past.”
But critics say that is just what is happening—only this time it may be worse in that COVID-19 is so much more infectious than HIV, and the global economy can’t fully restart while much of the world is under-vaccinated and producing new strains. “India’s health system has collapsed,” said Krishtel, who just returned from a trip to India. “So are others. New variants are going to emerge, and then what are we going to do?”
“The Biden administration is making the same mistakes made during the AIDS crisis by dragging its feet on the calls to scale-up access to life-saving medical interventions. Then it was anti-retroviral drugs. Today, it is COVID vaccines,” Gonsalves said. “But this is far worse than AIDS. An enormous coalition of scientists, world leaders, advocates—far larger than the one that emerged 20 years ago to push for AIDS drugs for Africa—has emerged for COVID vaccine scale-up, and the Biden administration has turned its back on all of us.”
Biden could also do a lot more even without backing the TRIPS proposal. The National Institutes of Health (NIH) owns some of the vaccines’ intellectual property, and Barney Graham, deputy director of the NIH’s Vaccine Research Center, has suggested that could be used as leverage with the pharmaceutical companies. Graham told the Financial Times in an interview this week that “virtually everything that comes out of the government’s research labs is a nonexclusive licensing agreement so that it doesn’t get blocked by any particular company.”
The U.S. government could easily deploy its own intellectual property rights “to get companies to the table to start a process of tech transfer to companies in India, South Africa, and elsewhere,” Gonsalves said. “They could announce a global scale-up plan—coordinating supplies, procurement of precursor materials, identifying manufacturing sites, subsidizing their retrofitting, etc. None of this is on the table.”
The pharmaceutical industry argues that preserving intellectual property rights is only helping facilitate the industry’s pandemic response, since companies will agree to cooperate only if they know their property rights are secure. In a letter to Biden in March, the Pharmaceutical Research and Manufacturers of America, a trade organization, said there is no evidence a waiver would boost vaccine production or access; instead, the group said, it would only “polarize legitimate conversations on countries’ engagement to combat the pandemic.”
Critics dismiss this argument. Although lifting intellectual property restrictions won’t solve the issue by itself, Krishtel said: “It’s the first step. Based on all the pandemics of the past, IP is the first barrier. You’ve got to transfer intellectual property to make manufacturing capacity available.”
“There’s no way to get to vaccine equity without radically scaling up production of vaccines in lower- and middle-income countries,” Kavanagh added, and for that, these nations need the waiver. “The really remarkable thing about this pandemic is that we are talking about how to allocate vaccines globally but have put that power completely into private hands.”
In his speech on Wednesday, Biden called on U.S. corporations to pay their “fair share” for the public good, but he said nothing of the pharmaceutical industry. Nor did he mention global cooperation, focusing a small part of his speech on “competition” with other nations, especially China. Critics contend Biden is also backing down from a fight with the pharmaceutical industry and the health insurance lobby over his just-announced American Families Plan, a $1.8 trillion package that avoids progressive proposals to lower prescription drug prices and expand Medicare benefits.
Administration officials insist various proposals are being considered to pressure companies to share their know-how on vaccines. “There are a lot of different ways to do that. Right now, [the TRIPS waiver] is one of the ways, but we have to assess what makes the most sense,” White House spokesperson Jen Psaki said Tuesday. She said U.S. officials were still studying whether to boost existing manufacturing of vaccines in the United States rather than transfer know-how abroad.
But in his speech, Biden sounded a neo-isolationist theme that was somewhat reminiscent of his predecessor, Trump. He spoke of his plan to “buy American” and of “winning the future for America,” barely mentioning the rest of the world except to warn of the threat from China and Russia. He also spoke of the United States dominating the technologies of the future, which appeared to underline his reluctance to encumber U.S. pharmaceutical companies. Indeed, critics say, Biden’s new theme of competition with the rest of the world runs in direct contradiction to the resurgent global threat from COVID-19.
The issue may be resolved at least somewhat at a May 5 WTO meeting, but it could linger at least until early June, when the WTO’s TRIPS Council, which monitors intellectual property issues, is scheduled to meet.
In the meantime, thousands more are dying around the world. “How can they ignore the suffering of millions?” Gonsalves asked. “I’ll tell you why. … It’s a surrender to the market.”
