The Biden administration on Wednesday took the major step of announcing its support for waiving intellectual property protections on COVID-19 vaccines as the deadly virus continues to rage around the world.
“The Administration’s aim is to get as many safe and effective vaccines to as many people as fast as possible,” United States Trade Representative Katherine Tai wrote in a statement announcing the decision. “As our vaccine supply for the American people is secured, the Administration will continue to ramp up its efforts—working with the private sector and all possible partners—to expand vaccine manufacturing and distribution.”
The move comes after the World Trade Organization (WTO) asked leaders to consider loosening patent protections on coronavirus vaccines amid the ongoing pandemic, which has had a devastating effect on India and South American countries in recent weeks. Tai said that the U.S. would now join negotiations at the WTO, adding that those talks “will take time.”
“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,” her statement added.
Big Pharma was quick to slam the move, with Stephen Ubl, president of Pharmaceutical Research and Manufacturers of America (PhRMA), insisting it would do nothing to save lives.
“In the midst of a deadly pandemic, the Biden Administration has taken 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 wrote in a statement. “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.”
He claimed that drug manufacturers are “fully committed to providing global access to COVID-19 vaccines, and they are collaborating at a scale that was previously unimaginable, including more than 200 manufacturing and other partnerships to date.”
Biden had backed such a waiver during the presidential campaign, promising healthcare activist Ady Barkan that the United States would waive patent restrictions in order to help other countries manufacture the vaccine.
“Absolutely, positively,” Biden told Barkan in an interview in July. “This is the only humane thing in the world to do.” Hours before the waiver announcement, Barkan tweeted that “if President Biden wants Americans to believe him, ever, he must keep his ironclad promise.” “No hedging. No delays.”
Vice President Kamala Harris, too, had supported a loosening of patent restrictions for certain vaccines and medications during the Democratic presidential primary. Harris, then the junior senator from California, went even further, advocating for the government to use the power of eminent domain to seize intellectual property pertaining to certain medicines if pharmaceutical companies were seen as hoarding them to the detriment of public health.
Dr. Anthony Fauci, the Biden administration’s top COVD-19 adviser, has had a seeming turn-around on patent waivers.
On Tuesday, he told MSNBC host Mehdi Hasan that he was “agnostic” on the issue, saying he’s more focused on the “end game.”
“I want to see people now in the developing counties getting vaccinated. However you do that as quickly as possible is fine with me,” he said.
But on Wednesday afternoon, Fauci told Politico that the U.S. has a “moral obligation” to pitch in with the global vaccine effort—and that includes temporarily waiving Big Pharma’s vaccine patents.
Peter Hotez, a professor of pediatrics and molecular virology & microbiology and dean of the National School of Tropical Medicine at Baylor College of Medicine, told The Daily Beast that while waiving patent protections would be “helpful” for vaccine distribution, it doesn’t address other major hurdles, including having the human capital to create the billions of doses needed across the globe.
“Patents are not even close to being at the top of barriers for vaccine access,” he said. “With vaccines, the problem is you don’t have the human capital to scale it up and make billions of doses and also do it under... quality control. And you need the regulatory authority.”
Hotez said what the Biden administration needs to do most is provide financial support for vaccine creation.
“We need someone to produce 5 billion doses of our vaccine for Africa,” he explained. “If you wanted to make billions of doses of mRNA vaccine for Africa, what you need is Moderna and Pfizer to send a team of scientists and create a manufacturing plant.”
Irwin Redlener, the founding director of Columbia University’s National Center for Disaster Preparedness, said the issue is even broader than just the COVID-19 vaccines.
“It’s going to be controversial, with manufacturing pushing back like crazy, but it’s critical to the world to have open access to these technologies for vaccines and not just vaccines but new treatments, including an oral antiviral medication we’ll probably see this summer to get treated as an outpatient with COVID, and that technology is also going to have to be available,” he said.
“The trouble is the incentive for them to develop these technologies is making a profit and there’s going to have to be some way to be sure the manufacturers are still motivated to produce everything we need, including vaccines, and how that happens in an environment where they don’t have the patent protection they’d typically enjoy,” he said, adding that “saving the world is not really a motivation in corporate America, or anywhere really.”