Big Pharma Refuses to Lift Patents on the Covid-19 Vaccines the World Desperately Needs

Doing so may be the only chance of ending the pandemic

Photo: japatino/Moment/Getty Images

On one side are the leaders of 57 nations, the Pope, and a coalition of nursing unions all over the world. On the other are the executives of the world’s biggest pharmaceutical corporations. At issue is an idea that may be the only chance of ending the Covid-19 pandemic — and also takes aim at the drug industry’s core business model.

The dividing question: Should Covid-19 vaccines remain the intellectual property of drug companies?

In October 2020, India and South Africa submitted a petition asking that the World Trade Organization waive the intellectual property rules relating to Covid-19 that currently restrict nations from manufacturing their own versions of any patented Covid-19 vaccines and drugs without a voluntary license deal.

Since then, Pfizer, Moderna, AstraZeneca, and Johnson & Johnson have all announced Covid vaccine breakthroughs. But access to the vaccines remains elusive in most of the world. Wealthy nations, such as Canada, the United States, the United Kingdom, Australia, Chile, Israel, and countries in the European Union represent only 16% of the world’s population but have secured 60% of available Covid-19 vaccines. Experts have said that the developing world may not have widespread access to any Covid-19 vaccine until 2024. When Future Human asked why, the drug industry’s international lobby group could not give an answer.

“Go and talk to COVAX,” said Abigail Jones, spokesperson for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), a lobbying group. COVAX is a World Health Organization program that, in partnership with a vaccine charity called Gavi, is supposed to provide 2 billion doses of Covid-19 vaccines to poor countries by the end of 2021.

The pharmaceutical industry describes COVAX as a success story. “COVAX started rolling out three weeks ago, and already 31 million vaccines have arrived in 51 countries,” added Jones.

But a report sent to the board of Gavi, obtained by the news agency Reuters last year, described the COVAX program as likely to result in failure because of a lack of funding. Experts also say that COVAX’s goal of a 20% vaccination rate in poor nations is insufficient at stopping the spread of infection.

By not vaccinating poor nations, of course, everyone is likely to suffer the consequences. “If the rich world continues to hoard vaccines, the pandemic will drag on for perhaps as long as seven more years,” warned Gavin Yamey, PhD, a public health researcher at Duke University, in the journal Nature last month.

And so the proposal from India and South Africa to waive intellectual property or IP protections on Covid-19 medication has picked up steam. Their petition is now co-sponsored by 55 other nations, most of them considered middle- to lower-income or less-developed, including Kenya, Eswatini, Mozambique, Pakistan, Egypt, and Bolivia. Supporters say that the policy would allow poor countries to help themselves rather than depend on charity.

“Is it the only hope? It seems so if you look at, what are the other alternatives?” Burcu Kilic, a researcher with the U.S. advocacy group Public Citizen, told Future Human. “All the vaccine reserves are already sold to developed countries. So what are your options? Wait until a lot of countries get vaccinated, and think they will come up with a solution for you, but this won’t be before 2022? Or help yourself? And that’s what countries have been asking. They’re saying, we really need this to help ourselves.”

The waiver would also cover any future advancements that humanity makes in its fight against Covid-19. The petition is limited just to Covid-19 but is written broadly enough to apply to any supply or medication used to fight the disease, even those that have not been invented yet.

But a group of wealthier nations, mainly those that already have secured vaccines, including the United States, have withheld their support for the petition so far, preventing the issue from coming up for a formal negotiation or vote at World Trade Organization meetings.

Nursing unions from those same wealthy nations have urged their governments to reconsider. Enabling more countries to produce their own versions of patented Covid vaccines “will allow us to move more swiftly towards ending this pandemic,” says a letter signed by the leaders of 27 nursing unions all over the world, including the U.S. group National Nurses United.

Speaking before the World Trade Organization last month, a representative from the Vatican cited intellectual property issues as the main barrier for why most of the developing world isn’t getting vaccinated.“In many countries, a large number of manufacturing facilities, with proven capacity to produce safe and effective vaccines, are unable to utilize those capacities,” said the Archbishop Ivan Jurkovič, the Vatican Permanent Observer to the United Nations.

In response to the increasingly popular proposal, pharmaceutical companies and their lobbying groups have been pressing the United States to support the status quo. Writing an editorial in the New York Times in December, Thomas Cueni, the director general of the IFPMA, said that lifting IP would “jeopardize future medical innovation, making us more vulnerable to other diseases.” BIO and PhRMA, two drug lobby groups based in the United States, have also asked the Biden administration to sanction countries requesting IP waivers, as The Intercept first reported.

More recently, on March 5, executives of 31 major drug companies signed a letter urging the Biden administration to maintain its “longstanding support for innovation and American jobs” by continuing to not support the IP waiver. Drug companies that have approved Covid-19 vaccines were among the co-signers. Moderna was a notable exception.

The drug companies see the issue as a symbolic threat to their industry because intellectual property protections are a key component of its business. IP rules explain why generic manufacturers can’t imitate other drugs on the market without special licensing deals, or why some medications that were invented as long as 100 years ago remain the property of a few companies. Drug companies also use intellectual property protections with increasing complexity to maintain market dominance. For example, the drugmaker Sanofi was found to have filed 74 patents in the United States related to its popular diabetes drug Lantus, potentially preventing any competition for the next 37 years.

“Production and supply ultimately is controlled by big industry, especially when it comes to vaccines,” Yuanqiong Hu, a policy advisor with Doctors Without Borders, tells Future Human. “They decide who can produce, where to produce, at what price, and supply to whom.”

In an interview, representatives from the drug lobby group IFPMA defended the industry’s use of patents, on the basis that others are free to launch their own pharmaceutical companies and create their own IP-protected medication. “It does not mean that no one else can come up as a new company. We’re not the mafia,” said Komal Kalha, the organization’s associate director of intellectual property and trade policy.

The IFPMA argues that intellectual property laws are what inspired drug companies to invent Covid-19 vaccines in the first place. They also say that lifting IP rules won’t deliver more vaccines because most of the world doesn’t have the capability or resources to produce Covid-19 vaccines. “There is so much expertise that goes behind it. You have a limited resource of skilled workers,” Kalha said.

But observers say that middle- and lower-income nations are plenty capable of manufacturing Covid-19 vaccines, as well as exporting to other nations that don’t have the manufacturing capacity. At one vaccine plant outside Bangladesh, journalists with the Associated Press described a modern facility operating at just a quarter capacity because its owner did not have a voluntary license deal with any Covid-19 vaccine maker.

Industry groups have downplayed the support that the IP waiver has received, declining to mention in their letter to Biden, for instance, that nursing unions and the Vatican are fighting for it. Jones, the spokesman for the IFPMA, described IP as an issue “that some people have latched upon.” She did not answer directly whether the Vatican or the nursing unions were mistaken in supporting IP waivers, but implied that they were. “We might know a little bit about patents because that’s actually what underpins the whole ecosystem of the industry,” she said.

Representatives from PhRMA, Pfizer, AstraZeneca, and Johnson & Johnson did not respond to a request for comment. In past statements, Moderna has offered a different view, promising last year that they would not enforce any of its Covid-19 vaccine patents. But Moderna has not taken the next necessary step of releasing the formula for its vaccines publicly, nor has it addressed other types of intellectual property protections on their vaccines beyond patents, advocates say, rendering their actions mostly symbolic so far. The company did not respond to a request for comment.

U.S. House Democrats have also taken up the issue, signing on a letter asking Biden to support the IP waiver. Sens. Bernie Sanders and Elizabeth Warren have also signaled their support of waiving IP rules. On March 26, Capitol Hill staffers told CNBC that the Biden administration was still thinking it over.

As a compromise, the WTO’s new director general, Ngozi Okonjo-Iweala, has proposed a “third way” involving voluntary licensing deals that she said could make both sides happy. But public health advocates dismiss the idea as more of the same.

“The third way is like the pharma way because they are talking about voluntary licenses which is exactly the same that has been happening all these months,” said Public Citizen’s Kilic. “There are two ways: the old way, or the waiver.”

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