When the Biden administration announced last Wednesday that it would support waiving intellectual property rights for COVID-19 vaccines, it sounded like a big deal. World Health Organization chief Tedros Adhanom Ghebreyesus hailed it as “a monumental moment in the fight against COVID-19.” That’s the kind of reaction the administration was hoping for, but this change in the U.S. position may ultimately make little difference on the ground.
The mechanics of this waiver involve a somewhat byzantine process at the World Trade Organization to ease rules under the organization’s Trade-Related Aspects of Intellectual Property (TRIPS) agreement. South Africa and India first proposed a TRIPS waiver for COVID-19 vaccines last October, which won the support of dozens of developing nations but has been stalled amid a lack of support from the U.S. and other rich Western countries. Ghebreyesus’s hope is that President Joe Biden’s thumb will be heavy enough to tip the scale of those talks in the other direction. However, the WTO makes these decisions by consensus, so all 164 members need to agree to enact the waiver. The U.K., Switzerland, Germany, and other E.U. states remain opposed.
The argument for waiving patent protections on the vaccines is that doing so would make it faster, easier, and cheaper for developing countries to roll them out by enabling them to produce the vaccines locally rather than waiting for shipments from abroad or negotiating more complicated licensing deals with drugmakers.
The pharmaceutical companies obviously oppose the move, as it would make the vaccines less profitable for them. They and their allies (including supposed global-health champion Bill Gates) argue perennially that without strong IP protections, they would have no incentive to undertake the extremely expensive and risky work of developing new vaccines or other drugs. In this case, however, the vaccines are already developed, and their risk was significantly mitigated by government financial support from Operation Warp Speed and other public-private partnerships. Will Pfizer and Moderna halt development of COVID booster shots just because they might not be able to sell them globally at a price of their choosing?
A more reasonable objection to the TRIPS waiver is that making vaccines is a complicated and delicate process that is difficult for non-specialist manufacturers. Recall the problems at the Emergent BioSolutions plant in Maryland that forced it to discard millions of doses of the Johnson & Johnson vaccine in March; it’s not hard to imagine something similar happening at a plant in the developing world, with potentially disastrous consequences (then again, that story also puts paid to the condescending notion that these problems only happen in developing countries). The pharma companies also note that they already have hundreds of partnership agreements in place with plants around the world and that TRIPS rules already allow governments to issue compulsory licenses to local producers to make a patented product without the consent of the patent owner.
The upshot is that a TRIPS waiver will take many months to negotiate, if it ever comes to fruition at all, and might not have much impact on the race to distribute vaccines globally and prevent outbreaks like the one now infecting hundreds of thousands daily in India. But this outcome may suit the Biden administration just fine.
Biden had pledged during his campaign last year to force the drug companies to relinquish their IP rights with regard to the vaccines, but neither the industry nor many U.S. officials thought he would follow through. Major players in the administration were vocally against a waiver, including Commerce Secretary Gina Raimondo and David Kessler, the chief science officer of the COVID-response team. Even Anthony Fauci was worried that attempting to expand the global vaccine supply through a TRIPS waiver would bog the administration down in litigation with drug companies.
The shift in the administration’s thinking came amid the crisis in India and the reality that other countries, including Russia and China, were eating America’s lunch in the vaccine-diplomacy game. The shift may also have come just in time to be too late. In other words, Biden wins a PR and diplomatic victory by standing up to Big Pharma on behalf of the developing world — but in the end, the drug companies never lose their patent protections as other countries block the waiver, the process gets gummed up, and the global vaccine shortage is eventually solved by other means.
This is not to say that Wednesday’s announcement won’t do anything. It sends a message that Biden isn’t too afraid of the pharma lobby to take actions it opposes. It also puts pressure on the drug companies to prove that they can adequately supply the world with vaccines without having to lose their patent protections. Perhaps most importantly, it signals that the administration is confident that it has shored up domestic supply to the point that it can start looking outward and leading the global vaccination drive.
But again, the U.S. is very late to this party. The Trump administration, of course, had no plan for vaccinating Americans, much less the rest of the world. Biden’s first few months in office were consumed with solving that first problem, managing the supply and distribution of vaccines domestically. The president can’t snap his fingers and make vaccine exports appear out of thin air; a project like this requires planning, none of which took place before January 22. Biden was also reluctant to divert any vaccines to the global market, at least until he kept his promises regarding the pace of vaccination at home. It’s easy to criticize this as a continuation of Trump’s “vaccine nationalism,” but prioritizing American lives is pretty fundamental to the president’s job description. One can imagine the fit congressional Republicans would be throwing if Biden had started exporting vaccines without first ensuring an adequate domestic supply.
Meanwhile, other countries have been engaged in far more robust vaccine diplomacy for months. Russia and China have used their Sputnik V and Sinopharm vaccines as currency in their diplomatic overtures to the global south, implicitly trading vaccines for influence. Though both countries deny it, when Chinese vaccine donations are met with pledges to oppose international intervention in China’s internal affairs or support its Belt and Road Initiative of global transportation infrastructure, it’s not hard to see what’s going on. Poor countries are often willing to parrot a superpower’s talking points in exchange for life-saving medicines, and this kind of transactional soft-power initiative is consistent with Moscow’s and Beijing’s ambitions to expand their spheres of influence, including in the Western hemisphere. Even India had supplied vaccines to over 90 countries, until its latest wave of cases forced it to suspend exports.
Unfortunately, the need to play catch-up on building a domestic vaccination strategy means Biden is now playing catch-up on vaccine diplomacy. The administration didn’t really get these efforts off the ground until last month. In late April, as the virus was already spreading uncontrollably through India, he announced that the U.S. would ship its entire supply of the AstraZeneca vaccine, some 60 million doses, to countries in need over the coming months. These doses, however, represent a drop in the bucket compared to what is needed and won’t arrive in time to help alleviate the current crisis. The following week, the administration expressed its support for Pfizer’s plan to start exporting U.S.-made doses, and followed that up with the announcement about the TRIPS waiver.
The U.S. and the rest of the world would be much better off had these efforts begun earlier, but there is still an opportunity for the U.S. to reclaim its leadership role in global health. The mRNA vaccines developed by Pfizer/BioNTech and Moderna are exceptionally effective, and the evaluation process for U.S.-made vaccines is more trustworthy than those from Russia and China. The WHO has authorized the Sinopharm vaccine for emergency use, but the Chinese-made vaccines are believed to be much less effective, and the countries that rely on them are facing higher vaccine refusal rates (as in Hungary) and even some resurgent outbreaks (as in the Seychelles). China’s two vaccine makers, Sinopharm and Sinovac, are also struggling to produce enough doses to meet China’s domestic needs. Russia has also had trouble producing Sputnik V at a sufficient rate to meet its international commitments. And India’s sudden de facto ban on vaccine exports has left much of the developing world in a lurch. Despite a late start, the U.S. could still outpace and outdo its rivals by shipping more reliable vaccines around the world more consistently.
The stakes are obviously high, considering the lives that hang in the balance, but vaccine diplomacy also has a darker, uglier side. Russian and Chinese state media have spread disinformation about Western vaccines and promoted conspiracy theories, while Russia is also accused of taking advantage of the chaotic vaccine rollout in Europe to sow division within the European Union. These propaganda operations make it even more important for the Biden administration to assert global leadership, support our allies, and push back against attempts to undermine trust in American- and European-made vaccines.
The potential rewards of vaccine diplomacy are considerable, but the risks of not engaging in it are even greater.