As India registered nearly 400,000 new COVID-19 cases in a single day, the vaccination centers in its wealthiest city, Mumbai, were shuttered all weekend. There weren't any vaccine doses available to give.
While some of the world's wealthiest nations move closer to mass immunity, dozens of low- and middle-income countries have been left clamoring for scarce coronavirus vaccines and treatments as death tolls soar.
Infectious disease experts have warned for months that allowing the virus to spread and mutate unchecked in any population poses a threat to people everywhere, because a variant could emerge with resistance to existing vaccines. That threat, along with the fundamental concern for human life, has fueled increasing calls to waive intellectual property rights around vaccines and treatments for COVID-19. The Biden administrationthat it supports such a waiver.
Moderna, which has said it will not enforce its patents on its vaccine during the pandemic, announced Monday that it would provide 34 million doses to middle- and low-income countries through the global COVAX distribution program. Pfizer said it was donating more than $70 million worth of coronavirus treatments to India. But donations have so far provided nowhere near enough doses to stem the growing crisis.
Intellectual property issues might seem far removed from the on-the-ground realities of a massive global health crisis, but private drug companies possess both the patents and technological know-how of the world's best weapons against COVID-19, largely preventing manufacturers in poorer countries from producing potentially cheaper versions. Some argue waiving those intellectual property rights would allow them to scale up vaccine manufacturing fast.
What is the proposed waiver?
Late last year, the governments of India and South Africa proposed a waiver of certain intellectual property rights at the World Trade Organization (WTO). The idea was to put some of the international rules against patent infringement on hold so life-saving coronavirus drugs and vaccines could be produced and distributed more quickly by countries around the world.
The proposal to waive parts of the Agreement on Trade-Related Aspects of Intellectual Property Rights, known as TRIPS, has been supported by over 80 countries and championed by humanitarian organizations. Under the proposal, the waiver would remain in place until global herd immunity is reached.
The U.S., along with some other wealthy nations, had previously blocked the proposal, which has been opposed by major pharmaceutical groups. But in a statement Wednesday, U.S. Trade Ambassador Katherine Tai said the "extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures."
"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," Tai said. Further negotiations on the proposal will need to be held at the WTO, and Tai cautioned that the negotiations will take time "given the consensus-based nature of the institution and the complexity of the issues involved."
PhRMA, the U.S. pharmaceutical industry trade group, previously argued against the waiver, writing to President Biden in March that "Eliminating (intellectual property) protections would undermine the global response to the pandemic, including ongoing efforts to tackle new variants, create confusion that could potentially undermine public confidence in vaccine safety, and create a barrier to information sharing."
The letter, which was signed by, among others, the leaders of Pfizer, Johnson & Johnson and AstraZeneca, also argued, "Most importantly, eliminating protections would not speed up production." Moderna is not a member of PhRMA and did not respond to CBS News' request for comment.
In their own letter to Mr. Biden, a group of over 175 former heads of state and Nobel laureates wrote that a waiver was "a vital and necessary step to bringing an end to this pandemic" that must be combined with "ensuring vaccine know-how and technology is shared openly."
In response to the administration's Wednesday announcement, PhRMA president and CEO Steve Ubl told CBS News in a statement that the decision will "undermine our global response to the pandemic and compromise safety," and will "sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines."
"This decision does nothing to address the real challenges to getting more shots in arms, including last-mile distribution and limited availability of raw materials," the statement said. "These are the real challenges we face that this empty promise ignores."
Learning from the past
Bernie Sanders, Elizabeth Warren and eight other Democratic senators, as well as a majority of Democrats in the House of Representatives, urged President Biden to back the TRIPS waiver late last month, and U.S. Trade Representative Katherine Tai discussed the issue with stakeholders including executives at Pfizer, AstraZeneca and Novavax earlier this week.
There is historical precedent for compulsory intellectual property waivers during a public health emergency. Two decades ago, during the HIV/AIDS crisis, life-saving medication was too expensive for many countries, and after talks with pharmaceutical companies failed, some governments moved to seize intellectual property rights without the drug companies' consent.
"We saw this 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," Tai told WTO member states last month.
"Poor countries watched during the HIV/AIDS crisis, they could not get hold of drugs. They were too expensive… and people died," WTO Director-General Dr. Ngozi Okonjo-Iweala told CBS News in March, explaining the rationale behind the proposed waiver. "That memory hurts."
Okonjo-Iweala added that during the H1N1 flu pandemic that struck in 2009, "rich countries bought up all the vaccines and poor countries had no access. So that lies behind this desire to have the intellectual property waiver — for all to have access."
Dr. Anthony Fauci told the Financial Times on Monday that he was "agnostic" about an intellectual property waiver and that he would support whatever would get the most people vaccinated the quickest.
But some drug companies and opponents of a TRIPS waiver say vaccines are much more difficult to make than the medicines used during the HIV/AIDS crisis, and waiving intellectual property protections on patents without the originators teaching new manufacturers how to actually make the vaccines would not be helpful. Opponents say getting companies to share that information could be difficult.
"You could get the recipe of Mary Berry, but without her really showing how to put the ingredients together, you wouldn't be able to replicate her cake," Tomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers and Association, which represents biopharmaceutical companies, told CBS News.
Cueni said vaccine creators had already voluntarily entered into an unprecedented number of licensing and technology sharing agreements around the world, and that he "would feel much more… in a much more difficult situation if the industry hadn't done what it does, you know, this huge tech transfer, this huge volunteer licensing."
An intellectual property waiver, he argued, is too simple a solution for a complicated problem that involves specialized manufacturing and multiple supply chains.
"When I look at the waiver debate, I'm a little bit reminded of an almost philosophical saying from somebody: To every complex problem, there's a simple answer, which is normally wrong."
Brook Baker, a law professor at Northeastern University who specializes in intellectual property and access to medicines, told CBS News that the current system "has resulted in artificially restricted supplies, artificially high prices and grotesquely inequitable distribution."
"The waiver is saying we cannot let the status quo stand," Baker said. "We cannot let those intellectual property protections stand in the way of mobilizing the kind of response that the pandemic requires, which is massively increasing vaccine production as quickly as possible and vaccinating everyone in the world as quickly as possible so that we get herd immunity before the virus mutates over and over again."
Priti Krishtel, co-founder of I-MAK, an organization that campaigns for equitable access to medicines, told CBS News that claims that manufacturing would become less safe if big pharmaceutical companies shared their vaccine intellectual property and know-how were wrong.
"It becomes a sort of very patronizing and frankly racist argument of 'companies in other countries really don't have capacity, it wouldn't be safe.' There's all of this language that's thrown around to create confusion, and it's just not true. And we have the opportunity right now to save so many lives, and we're just delaying," she said.
"There won't be a quality problem because we still have vaccine regulators that are going to look at any new product carefully," Baker said.
Krishtel argued that the case for a waiver was especially strong because governments fronted a great deal of the financial risk for developing the vaccines. Typically, developing a vaccine is a gamble — and the knowledge that a formula may not work can give companies little incentive to try something new. But during the pandemic, the governments of some wealthy nations, including the U.S., invested billions of dollars before coronavirus vaccines were approved to encourage development on an unprecedented timescale.
Cueni asserted that the world currently has more than one safe and effective coronavirus vaccine "because we do have a strong innovation ecosystem. Because we do have patents." He said he believes a TRIPS waiver could stifle the partnerships that are being made currently by vaccine owners and manufacturers.
But Krishtel told CBS News that with the pandemic continuing to worsen in some parts of the world, access to vaccines must increase fast.
"Where you live, how much money you have, how much access you have directly determines whether you're going to get sick, whether you're going to get treated, whether you're going to live or die. And I hope that it's a wake-up call," she said.
"We've been sold a bill of goods that somehow if we prioritize ourselves, we'll be safe," Baker, the law professor, said. "It's in fact not true. We have to prioritize everyone, everywhere and not let intellectual property stand in the way of achieving that."