Back in October 2020 – as the world recorded its first million COVID-19 deaths – South Africa and India presented a proposal at the World Trade Organization for “a waiver from the implementation, application and enforcement” of global intellectual property rights “in relation to prevention, containment or treatment of COVID-19.” Along with other western countries, the Trump administration strenuously opposed the idea. But on Wednesday the Biden administration said it is prepared to go along with such a waiver, at least for coronavirus vaccines.
What happened?
At first the South Africa-India proposal seemed like the usual political dancing that goes on in Geneva’s different multilateral venues – idealistic, ideological and disconnected from reality. By contrast, in the first months of the pandemic and without much transparency or concern for WTO rules, 80 countries in the WTO individually imposed controls on exports of medicines, ventilators, PPE, disinfectants, foodstuffs, and, yes, toilet paper.
When President Joe Biden met with the prime ministers of Australia, India and Japan in March, the outcome was a pledge to fund more vaccine production in India and to “collaborate to strengthen equitable vaccine access for the Indo-Pacific.” Nothing was said about patents or other intellectual property.
First duty is protect your own citizens
During its first 100 days, the Biden administration was laser focused on vaccinating Americans. Critics complained about how unequal the global vaccine rollout was (and is), but Biden understood that whether you’re an autocrat or a democratically-elected leader, your first duty is to protect your own citizens.
Now, with over 40% of American adults fully vaccinated and vaccines effectively available to all Americans who want it, the Biden team has rightly turned some of its focus to global needs and, frankly, vaccine diplomacy. With the United States now committed to a temporary WTO waiver of intellectual property rights “for COVID-19 vaccines,” the trick will be to negotiate what is included in the waiver and benchmarks for when the pandemic is sufficiently under control that such a waiver ends.
That will be no easy task, especially since the WTO works by consensus. It took years to agree to a modification of WTO rules for HIV and malaria medicines; it took four years of negotiations in a sister Geneva organization to get an agreement on providing copyrighted books to the blind. In short, the administration may be thinking that its own well-executed vaccine diplomacy – think billions of doses being shipped out from the U.S., Europe, and India – will halt the pandemic before the ink can dry on any temporary changes in WTO rules.
President Joe Biden and U.S. Secretary of State Anthony Blinken in virtual meeting with leaders of Quadrilateral Security Dialogue countries on March 12, 2021, in Washington, D.C. (Photo: Alex Wong/Getty Images)
But let’s assume that agreement on the details of a waiver could be reached quickly.
Will a temporary waiver of intellectual property rights in relation to COVID-19 vaccines make any practical difference in getting billions of doses produced, distributed, and administered? Perhaps, but there are reasons to be doubtful.
Practically everyone agrees that the issue in production of these drugs – whether conventional vaccines or the new mRNA vaccines – is not the patented technology, but (a) proper manufacturing facilities, (b) raw materials, (c) production know-how, and (d) logistical hurdles in administering the shots.
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First, the mRNA vaccines – the Moderna and Pfizer/BioNTech shots – require different manufacturing facilities. At a March 8 World Health Organization event, Dr. Özlem Türeci, co-founder and Chief Medical Officer of BioNTech, put it bluntly: “it is about novel platforms and novel technologies for which even the setup of production facilities need to be expanded, and you cannot just repurpose existing facilities. So patents are one thing, but there are so many other things we have to ensure.”
Yes, there are conflicting claims about whether and how quickly existing pharmaceutical plants can be refitted to make these vaccines – with a scattering of companies claiming they could do it. But no one really knows if repurposing existing facilities could produce more vaccines than ramping up production in the U.S., Europe, and India. On this one, I’m going to believe Dr. Türeci.
Production and distribution hurdles
Similarly, supplies of the raw materials for vaccine production are limited – and that has little to do with the relevant intellectual property. At that same WHO event in March, Sarah Gilbert, developer of the Oxford/AstraZeneca vaccine, said: “I don’t think that just making IP freely available goes anywhere close to solving this problem, because it’s not just to the right to use the technology that’s needed, it’s the feedstocks, the cell banks, the protocols, the assays, the standards, the reagents to do everything.”
Those are non-intellectual property hurdles to get the vaccines produced. Next, there are the hurdles to get it distributed and administered. The cold storage needed for the mRNA vaccines and the double dosage requirements for all but the Johnson & Johnson vaccine make for epic logistical challenges in developing countries. Even in the United States – where 97% of adults have cellphones – we are having significant problems getting people to show up for their second dose. And you might be surprised to know that the Pfizer/BioNTech vaccine is not yet approved for use in India. It wouldn’t matter if there were 100 million doses sitting in storage in a Mumbai warehouse: It cannot yet be legally administered.
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So, if the WTO waiver isn’t likely to directly trigger more vaccine production and distribution, what is all this about?
First, it’s easy to imagine that Biden has calculated that this policy shift will be a huge political positive for the United States. It shows our commitment to the cause without significant damage to America’s pharmaceutical industry. Between this and an activist aid program to help India pull through the COVID storm, we can prove to India that we are now intent on the kind of close relationship the world’s two largest democracies should have always had.
Meanwhile, the message to the pharmaceutical industry – and the message everyone sees Biden telling them — is to put profits aside and focus on human well-being. While the WTO waiver may take months to negotiate, even the idea of the waiver will push pharmaceutical companies to work even harder and more collaboratively with governments to get the world’s 7.7 billion people vaccinated.
This wasn’t a decision about intellectual property or about the logistics of vaccination. It was a decision about America’s global leadership.
Justin Hughes teaches international trade and intellectual property courses at Loyola Law School in Los Angeles. He was the chief U.S. negotiator for two multilateral intellectual property treaties during the Obama administration.
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