The COVID-19 Vaccine Patent Waiver Fight Is Far From Over

The Biden administration’s announcement last Wednesday that it planned to support waiving intellectual property (IP) protections for COVID-19 vaccines prompted praise from global public health advocates and outcry from the pharmaceutical industry and corporate America more broadly.

But the historic statement of support, issued by U.S. Trade Representative Katherine Tai, does not make the waiver a done deal. Even if successful, the availability of vaccines could vary greatly based on the final details of the waiver.

The World Trade Organization requires unanimous consensus to both proceed with the discussion of changes to intellectual property agreements and to adopt those changes.

The United States’ declaration of support for a waiver merely unblocks a negotiation process at the WTO that the international body’s director-general, Ngozi Okonjo-Iweala, estimated could take until December.

“The declaration of support for a waiver of intellectual property rights for vaccines by Ambassador Tai, is momentous, but is only a first step,” said Asia Russell, executive director of Health GAP, an affordable medicines advocacy group founded to expand access to HIV treatments in low-income countries. “What comes next is that the U.S. must deliver on the substance of Ambassador Tai’s statement, not merely the letter.”

A business lobbyist involved in fighting the waiver confirmed to HuffPost that the pharmaceutical industry plans to try to stop the waiver’s adoption, or short of that, limit the policy’s scope as much as possible.

“This is a terrible precedent, a terrible precedent ― not just on COVID,” said the lobbyist, who asked for anonymity to speak freely. “But if the U.S. takes the position, that, ‘Hey, when the going gets tough, we’re going to waive IP,’ that’s tough.”

Already, leaders of Germany and the European Union ― who jointly rank just behind the U.S. in terms of influence at the WTO ― have expressed skepticism of the waiver bordering on opposition.

And the December limit on a resolution is a source of concern for Russell and her allies, who note that the WTO has been willing to reach agreements over urgent priorities over much shorter time periods in the past.

Finalizing negotiations in December would be “outrageous,” Russell said.

Referring to WTO director-general Okonjo-Iweala’s remarks, she continued, “The WTO leadership needs to slam on the gas and that’s exactly what Ambassador Tai’s announcement should have enabled.”

Every day that passes without an agreement delays not only the legal freedom foreign companies need to mass-produce the vaccine, but also the process of scaling up the manufacturing capacity to make the vaccines in developing countries, according to proponents of the vaccine IP waiver.

And even if a strong waiver is implemented, global public health advocates see it as the first step in a three-part approach that must also include the transfer of technological know-how and the subsidization of industrial capacity in the developing world.

Gregg Gonsalves, an epidemiologist at the Yale School of Public Health, said releasing the intellectual property associated with vaccines but failing to include additional investments was like distributing copies of a cookbook without providing the tools or cooking know-how to make the dishes in the book.

“You can’t just open up the ‘Art of Cooking.’ You have to have Julia Child come into your kitchen,” he said. “This is the next battle. You don’t get to say, ‘We supported the TRIPS waiver. Didn’t you get what you wanted?’ No. We want vaccine doses and we want them before 2022.”

‘A Wartime Effort’

To pharmaceutical companies and their allies, Gonsalves’ admission that the waiver is insufficient might sound, in itself, like an indictment of the waiver.

The U.S. and Europe-based vaccine manufacturers and the organizations that represent them have been arguing that the implementation of the waiver would undermine intellectual property rights while doing little to alleviate the shortage of vaccines.

“There is more to developing any kind of product than just what is patented. What about the underlying know-how and technology?” said Daniel Staudt, president of the Intellectual Property Owners Association, a Washington trade group that advocates for pharmaceutical companies and other corporations that rely on intellectual property regimes.

But Gonsalves, Russell and others push back on these claims, arguing that the lack of capacity is at once exaggerated ― the AP identified three vaccine factories in the developing world ready to mass-produce the vaccines if given the chance ― and a reflection of the intellectual property restrictions discouraging countries and companies from developing production infrastructure that they would not legally be able to use.

What’s more, the waiver’s proponents note, pharmaceutical companies in the United States also initially lacked the capacity to develop the vaccine without a massive infusion of research funding from the U.S. and German government and billions of dollars in guaranteed pre-orders. Within months, Moderna, in particular, used its shell-factory model to develop two state-of-the-art facilities in Switzerland and New Hampshire.

Scaling up similar operations in the developing world, these advocates maintain, is an enormous challenge, but one that is necessary to confront the scale of the pandemic.

“We need a wartime effort and other powers of the U.S. government to be invoked,” Gonsalves said.

It’s clear that the global supply of vaccines is inadequate for the need. Global vaccine production capacity is currently at 3.8 billion doses a year, according to the World Trade Organization’s estimate. And since vaccinations began in December, over 1.3 billion shots have been administered, suggesting that the world is very far from achieving its 10-billion dose target.

Pharmaceutical companies maintain that forcing them to partner with generic drug makers in developing countries on a greater scale than they are already doing will invariably result in a decline in quality and an inability to police counterfeits. They also warn against encouraging competition for scarce raw materials that could jeopardize the ability of established firms in wealthy nations to produce effective vaccines in time and even increase vaccine hesitancy.

“The consequences of this are enormous and the benefits of this are minimal ― short of the political benefit, to show, ‘We poked our finger at the biopharma guys and Doctors without Borders, who want to waive IP on everything, we got them on our side,’” the lobbyist opposed to the waiver said.

But Gonsalves said the lipids that encase the vaccine itself are just one example of a product for which production capacity exists — but that a patent, separate from the patents on the mRNA vaccine itself, prevents from being utilized.

Critics of pharmaceutical companies suspect they are so fiercely opposed to the IP waiver not because of legitimate concerns about safety, but because they would rather invest their resources on booster shots they can charge more money for in Western countries than engage in less-lucrative partnerships in developing nations.

The waiver could also break their monopoly on new mRNA research, allowing greater competition in the development of the next generation of mRNA products from drug companies in countries like India.

“I don’t think Pharma cares whether India supplies Africa with this specific vaccine,” said David Barclay, an attorney who has brought antitrust lawsuits against pharmaceutical companies. “It’s more about the precedent of opening up IP.”

Barclay predicted that the threat of the waiver would make brand-name U.S. drugmakers “come to the table more” in the hopes of negotiating voluntary licensing agreements with foreign manufacturers that could also protect some of their interests.

The business lobbyist opposed to the waiver doesn’t see any more licensing deals coming from the threat of the waiver, though he said companies might agree to export more vaccines produced by proprietary facilities or existing licensees to low- and middle-income countries.

Lessons From The HIV Fight

One reason proponents of the waiver are confident in their course of action is that compelling drugmakers to loosen their grip on IP succeeded in expanding access to HIV drugs in developing countries in the early 2000s.

After years of outcry at how patents and other intellectual property were making life-saving HIV drugs inaccessible to African nations plagued by the virus, the WTO finally agreed in November 2001 to adopt language recognizing member nations’ right to compel generic drug production to address public health crises.

Gonsalves, who has been an advocate for affordable HIV medicines for decades, conceded that the science behind the COVID-19 vaccines is different and more complex than the science behind the HIV drugs.

The commonality between now and then is that wealthy nations and their brand-name pharmaceutical companies offered the same pessimistic warnings that scaling up production and making drugs cheaper through competition was unrealistic.

“‘HIV and vaccines are not the same’ ― well, they are the same in that you said it couldn’t be done,” Gonsalves said.

The doomsayers were wrong. The cost of a year’s supply of first-line HIV treatment drugs went from $10,000 per person in 2000 to less than $100 per person in 2012, according to UNAIDS, a United Nations program aimed at ending AIDS. The number of people in sub-Saharan Africa receiving HIV treatment drugs grew 100-fold over this period, the U.N. group wrote.

Gonsalves believes that they proved the pessimists wrong because people like him seeing the mass deaths on the ground in countries like South Africa ― years after witnessing something similar in the United States in the1980s and ’90s ― made it so failure was not an option.

To people saying, “Sorry, you don’t understand the constraints on the global health systems,” Gonsalves recalled responding: “Fuck you, we’re going to figure out how to make it work.”

The 2001 intellectual property agreement, adopted at a meeting in Doha, Qatar, and updated at subsequent meetings, was the result of years of pressure from developing countries and activists.

But the negotiations came together relatively quickly, making them a model for the type of action that can be taken when wealthy nations feel sufficient pressure to act with urgency.

Developing countries proposed new language creating exceptions to the WTO’s Trade-Related Aspects of Intellectual Property (TRIPS) agreement that would enable the production of cheaper HIV drugs in June 2001. A deal was finally reached five months later, but most of the negotiating occurred over a six-day period at the Doha meeting itself.

By contrast, if the COVID-19 TRIPS waiver only gets finalized in December, it will have been more than a year since developing countries proposed the idea in October 2020 and almost two years since the COVID-19 pandemic began spreading across the world.

“That is completely inconsistent with the timeline that was driving the Doha declaration,” Russell said. “If not now, when?”

The Coming Battles

Representatives of the pharmaceutical industry acknowledge that proponents of waiving vaccine IP have the upper hand in the public relations battle.

The lobbyist maintains that many Democrats in Congress privately agreed with arguments against the IP waiver, but were afraid not to support it for political reasons.

“Many of them said, ‘We understand that the substance on this thing ― there may not be the greatest causal link between waiving IP and driving up actual access and supply, but the politics of it is so challenging for us, we felt like we had to sign the letter,’” he said, referencing a letter to Biden calling for the waiver signed by a majority of the House Democratic Caucus. “In fact, several people said, ‘Gosh, we had to sign the letter, because there was so much political pressure coming down on us.’”

In the process, though, the pharmaceutical industry identified adversaries and champions on the Democratic side ― the latter, a necessity for any interest group right now, given the party’s unified control of the federal government.

U.S. Trade Representative Tai, national security adviser Jake Sullivan and White House chief of staff Ron Klain are all believed to have pushed for the waiver in internal discussions, according to the lobbyist.

On the other hand, Commerce Secretary Gina Raimondo and Sen. Chris Coons (D-Del.), a Biden confidant and top recipient of contributions from pharmaceutical company political action committees, opposed the waiver, the lobbyist and other people familiar with Biden administrations discussions confirmed.

In Congress, as HuffPost first reported, Democratic Reps. Scott Peters (Calif.) and Ron Kind (Wis.), who are also major recipients of pharmaceutical company PAC contributions, led efforts to solicit signatures for a letter opposing the IP waiver.

Peters and nine other centrist Democrats, including freshman Reps. Jake Auchincloss (Mass.), Marilyn Strickland (Wash.) and Frank Mrvan (Ind.), are now rallying opposition to a bill that Democrats passed last Congress that empowers the federal government to negotiate lower prices on an array of prescription drugs, according to a Politico report on Tuesday.

In a letter to House Speaker Nancy Pelosi (D-Calif.), the Democrats, who effectively have the votes to kill a party-line bill, insist on adopting a more modest, bipartisan measure that would “preserve our invaluable innovation ecosystem.”

In addition, the pharmaceutical industry and other corporate sectors that rely on intellectual property hope that Biden will appoint a strong supporter of the current corporate-friendly intellectual property regime as director of the U.S. Patent Office (PTO), who will serve under Raimondo in the Commerce Department. At the top of Biden’s list are Ellisen Turner and Jannie Lau, two patent lawyers who have worked for companies that watchdogs have described as “patent trolls,” according to an Ars Technica report.

At the same time, progressive critics of the pharmaceutical industry see a chance for Biden to build on his support for the COVID-19 vaccine IP waiver with an appointee more committed to considering public health and patent abuse concerns, as well as corporate demands for innovation. Two names that come up on their shortlist are Duke University law professor Arti Rai and Santa Clara University law professor and former Obama administration PTO official Colleen Chien. (Biden is considering Chien as well, according to Ars Technica.)

“Intellectual property exists to serve people, not the other way around,” said Priti Krishtel, a co-founder of the Initiative for Medicines, Access, and Knowledge (iMAK), which is leading efforts to turn the PTO appointment into a progressive priority. “There are boundaries to the rights of private actors that have to be balanced for the greater public good.”

Krishtel, who has worked on drug affordability since the HIV treatment battles of the early 2000s, believes that without reforms to the United States’ intellectual property regime as a whole, the world will be faced with similar shortages and affordability issues during the next major epidemic.

“We have to figure out how not to just make this about waiving specific patents for a specific disease,” she said. “It has to be systemic ― we can’t go through this for each pandemic.”

This article originally appeared on HuffPost and has been updated.