In November 2020, only eight months after the World Health Organization (WHO) declared covid-19 a pandemic, the scientific community achieved the unimaginable: It delivered an effective vaccine against the new virus.
Around the same time, several low- and middle-income countries, led by India and South Africa, began petitioning (pdf) the World Trade Organization (WTO), asking for a waiver of patents and intellectual property rights for all drugs, vaccines, diagnostics, and other technologies related to covid-19 for the duration of the pandemic.
Western countries had already secured the rights to large volumes of vaccines that were yet to be made, and despite efforts such as Covax, countries in the so-called global south wanted to increase their covid-19 manufacturing capacity, and to produce diagnostics and therapeutics as needed, without having to pay pricey licensing fees to pharmaceutical companies. The research and development of covid-19 treatments had been heavily subsidized by governments, and pharma companies were guaranteed to profit from vaccines.
With the virus in all corners of the world, and an understanding that global herd immunity could help prevent variants from emerging and end the pandemic in the shortest possible timeframe, waiving the intellectual property protections granted within the WTO by the Agreement on Trade-Related Aspects of Intellectual Property Rights, or TRIPS, should have been a no-brainer. Instead, a year-and-a-half after it was proposed, there is still no consensus on the waiver—other than a tentative leaked compromise with a much narrower scope.
The lack of an agreement on a waiver has contributed directly to the current state of vaccine inequality. Western countries, where vaccination rates are between 70% and 90%, are discussing a fourth round of vaccinations. The global south, on the other hand, struggles to meet vaccination goals: initially, it was set to be 40% of the population of every country by the end of 2021 and 70% by mid-2022; since it seems unlikely this goal will be met, some are now proposing (pdf) getting 90% of the world’s vulnerable population vaccinated by the end of 2022 instead. In turn, low vaccination rates have also been a central factor in the emergence of new covid-19 variants, prolonging the pandemic even for areas with high vaccination rates.
Efforts to improve vaccine equity and end the pandemic continue. On April 12, 2022 the WHO opened public hearings to craft a global pandemic treaty that will focus on prevention, preparedness, and response. One thing though, appears clear: The current system failed everyone—with the exception of pharmaceutical companies. So, might this collective failure help forge a new path toward preparedness for the next pandemic? Will what what happened over the course of the past two years lead to a paradigm shift in how the world handles international public health crises—including in the role it delegates to the WTO?
What happened to the covid-19 vaccine patent waiver?
Since they don’t have the information they need to produce their own covid-19 vaccines, countries in the global south have had to rely on leftovers from wealthy nations. This has not been a sustainable approach, as a small number of manufacturers and partners weren’t able to provide the estimated 12 billion doses needed to fully vaccinated the entire eligible population quickly.
It was to be expected that western countries would hold on to the doses they needed to vaccinate their populations, and only share with poorer countries once their own citizens were vaccinated, irrespective of their initial pledges. “The African Union pointed this out from the very, very beginning that there was going to be a supply crunch. They knew that they were going to get squeezed,” says Ben Phillips, an anti-inequality activist and the author of How to Fight Inequality. “Every single time when there is scarcity, then always without exception, the dominant will dominate,” he says.
Covax, the distribution program designed by the WHO and other organizations to deliver vaccines to low- and middle-income countries, wasn’t able to get enough doses to meets its goal of getting 20% of the population of every country vaccinated by the end of 2021. While the program had been set up to facilitate delivery of vaccines, it couldn’t overcome supply constraints caused by several obstacles. The initial shortage of doses was one, as was poor coordination of donations from wealthy countries. But another key problem was export limitations imposed by countries producing vaccines. Pharmaceutical companies point to export limitations as the main obstacle to vaccine equity.
As a result, many countries still have not received sufficient doses to vaccinate their populations, or at times received them with insufficient shelf-life. In Africa, for instance, only about about 15% of the population has been fully vaccinated, according to the latest WHO data. The rates vary across the continent, too. Richer nations such as South Africa have higher vaccination rates (about 30%) while countries such as Burundi or the Democratic Republic of Congo don’t even reach 1%.
The TRIPS is an international trade agreement between the members of the WTO—most countries in the world, with the exception of 14 mostly small states. The treaty establishes international standards for copyrights and patents, as well as minimum intellectual property protection criteria individual countries have to meet. But when it comes to new technologies, including many drugs and public goods, the agreement puts poorer countries in the position of having to pay hefty fees to companies from rich companies, which has made the agreement an obstacle to the fast and free circulation of medical products.
The TRIPS waiver has the support of over 100 countries, including the US, which has historically been unlikely to promote intellectual property release. Fighting a pandemic while cutting off a large part of the world from producing necessary medications, and relying on a limited supply of vaccines, does seem foolish.
“Imagine if you’d written the safety manual for a nuclear power plant and you said, no, you can’t have it […]—we wouldn’t tolerate that,” says Phillips.
Yet European countries oppose the deal, siding with pharmaceutical companies that have been campaigning against the waiver. Drugmakers claim that poor countries can’t be trusted to make their own vaccines, and that it would be dangerous to allow them to; they promised vaccine donations in large quantities instead and they even invested in manufacturing facilities that will make mRNA vaccines in Africa.
But there are broader issues that those opposing patent releases, including many economists, highlight. Drugmakers could risk seeing their profits diminished by intellectual property right waivers, and decide not to pursue research for the very global health threats that most urgently demand their expertise. Even for the current crisis, if vaccine makers were forced to give up their secrets through the waiver, they would likely do so in an antagonistic climate that is not conducive to the collaboration needed for know-how transfer.
Proponents of the waiver consider these bad faith arguments meant to distract from the essence of the matter: even when it comes to one of the most lucrative drugs in history, big pharma doesn’t want to lose any profits. For one, they point out, western pharmaceutical companies routinely work with manufacturers in other parts of the world, and know their standards can be sufficient. Further, building proprietary facilities to manufacture more doses of vaccines in Africa is a strategy to keep control of the patent, since there are over 100 facilities outside of western countries ready to be converted to vaccine manufacturing, including some in Africa, according to an analysis by Médecins Sans Frontières (MSF).
Proponents of the waiver note that it is possible to reward patents in different ways (particularly when they come from substantial public investments), and ensure drugmakers make enough profits in rich countries to continue their business without having to deny poor ones access to medications. “You can totally value and love the pharmaceutical industry, and you can want the people that run the pharmaceutical industry to be able to water ski and drink champagne—you can have a system that enables them to do that, but doesn’t hand them the key for so many life saving medicines,” says Phillips.
How a TRIPS waiver could help vaccine equity
For many working in global health, this is deja vu. In 1997, at the height of the AIDS pandemic, a similar situation occurred with antiretroviral medications. Pharmaceutical companies refused to allow countries in the global south to manufacture generic versions of lifesaving drugs, which resulted in millions of unnecessary deaths.
Eventually, the years-long fight to get access to lifesaving AIDS medications—which included big pharma taking Nelson Mandela to court—led to a WTO declaration that established, among other provisions, the right of countries to issue compulsory licenses of essential public health tools, and for medicines in particular. Through these licenses, countries can bypass patents and commission the making of drugs needed to tackle national emergencies—such as epidemics.
Yet this time around, the precedent was not triggered automatically. Many of the covid-19 vaccines used a new mRNA technology, so a transfer of know-how was needed, and knowing the recipe for the vaccine wasn’t enough. “Wealthy countries put their own interests and the interests of pharmaceutical companies ahead of those of other countries,” says Rohit Malpani, an international public health consultant who advises several organizations on access to medication issues.
WTO director general Ngozi Okonjo-Iweala, who as the former director of GAVI, the global vaccine organization that subsidizes vaccines for low-income countries, has years of experience in the issue of vaccine equity, promoted negotiations on the waiver between India, South Africa, the EU and US. The four have reached an unofficial compromise (pdf), which the WTO hopes will reach consensus before the next ministerial meeting on June 13, 2022, when an agreement could be reached.
The framework has two main changes. The first is it puts stricter limitations on the waiver. The initial proposal asked for it to be terminated only under the total consensus of WTO members, which means one disagreeing country would be enough for the TRIPS waiver to be renewed again and again, essentially becoming the norm. “What it now says is it will last three to five years, and then that’s it—unless the general counsel agrees by consensus to extend it,” says Keith Rockwell, a spokesperson for the WTO.
The other difference from the original proposal is a lot more significant in substance. The new waiver is limited to vaccines, and doesn’t cover therapeutic and diagnostic technologies—which are particularly essential after vaccination campaigns, when the need to test and treat becomes crucial. It also doesn’t mandate access to know-how—or how to actually manufacture produce the new vaccines—beyond the patents, which makes it scarcely more useful than a compulsory license.
Advocates for patent release consider this a rare case when the compromised version of the agreement is worse than nothing. “It’s a step backward,” says Tahir Amin, the co-founder of I-MAK, a US-based organization working to increase global access to medicines. “It’s better to have no deal than an agreement that doesn’t provide the release of any other trade secrets,” he says.
This failure of equitable distribution of vaccines has served as a final wake-up call for many in the global south—be it in government, academia, or even in the general population. “We are coming to the realization again that the powers that be globally and in certain high income countries are not really as invested in the global solidarity we’ve been talking about,” says Nadia Sam-Agudu, an advisor on HIV at the Institute of Human Virology-Nigeria and a professor of pediatrics in the Institute of Human Virology at the University of Maryland School of Medicine.
Why is the TRIPS waiver taking so long?
“The question to ask is not whether the agreement is perfect in your eyes, but whether it represents an improvement on the status quo. Because you have to get 164 members to agree,” says Rockwell. The WTO is very much a forum for negotiations, he says, and with something as complex as the TRIPS agreement and a waiver, the concerns and interests are so multifaceted a compromise would be a success, even if it left many countries wanting.
About a year ago, Okonjo-Iweala brought together drugmakers—both patent-holders and licensees—government officials, and heads of international organizations, to discuss vaccine inequity, and its causes. While all parties involved agreed that vaccine inequity was a serious problem, they pointed to different issues as the main obstacle to it. “Some people said, the problem is in there is concentrated production—there’s not enough diversity in terms of production locations. And then the people who were producing the drugs […] said, the biggest problem that we’re encountering is export restrictions in our own countries,” says Rockwell.
The world currently has enough supply to vaccinate the entire population—an estimated 19 to 24 billion doses by the middle of the year. The reasons those doses aren’t getting into people’s arms have more to do with export limitations, local infrastructure challenges, and vaccine hesitancy across the world than with the issue of patent release, he says.
The consensus of economic experts is that at this point the fastest way to get vaccines to everyone would be to buy them from current producers, rather than pursue patent release and disseminated production, provided the prices are affordable to low-income countries.
This doesn’t mean the TRIPS waiver negotiations shouldn’t continue, or that the WTO is unable to help with a solution, just that whatever agreement is reached is a compromise that in some form reflects international power dynamics. “In international fora, you’re not going to get everything you want. What you have to do is get an outcome that addresses the problem as effectively as possible—and we’re getting there, but it’s not happening as fast as we’d like,” says Rockwell.
Does the WTO help poor countries?
The failure of the TRIPS waiver negotiation shouldn’t be seen as an aberration, but as a product of the WTO working exactly as it was designed to, activists say. “The World Trade Organization was negotiated at a time of significant amount of power in one set of countries, and in a way in which it reflected the aims and interests of those countries,” says Malpani.
With covid-19, the WTO has once again behaved more like an obstacle than a helpful platform, says Matt Kavanagh, the director of Georgetown University’s Global Health Policy & Politics initiative, and a UN special advisor on HIV/AIDS. Unlike two decades ago with AIDS, poor- and middle-income countries are now less inclined to engage with the status quo, and are instead looking for alternative ways to tackle this and the next crisis that don’t go through the existing system.
“We are supposed to be discussing global health and solidarity with global institutions that have shown us time and again that they are not interested in the welfare of billions of people in low- and middle-income countries. And that is a realization that keeps being evidenced to us over and over again and is a very, very hard truth to face,” says Sam-Agudu.
Compared to previous crises, covid-19 has seen an increase in cooperation between countries in the global south, which are pooling their resources to develop vaccines and medications without the help of western manufacturers, including through the WHO-supported knowledge transfer hub. There is still a lot of work to do to emancipate poorer countries from their dependence on the technology controlled by rich countries, she says, but covid was a catalyst for leaders in many countries to commit more resources, and adopt better governance. Continuing to rely on the current system is simply out of the question.
“I think there’s a real threat to the legitimacy of the World Trade Organization and the TRIPS agreement overall. We see the rise of regional trade agreements and external to the World Trade Organization,” says Kavanagh. “There’s a very significant chance that in the years to come after covid-19, there will be a lessening of commitment to actually engage the WTO, because it has been so ineffective.”
Rockwell is skeptical that this might solve the problems that are currently being discussed at the WTO. Licensing, export, and trade would still be factors even within regional agreements, and there is no certainty they would be able to bypass all essentially intellectual property needs. “You will always have circumstances in which ideas are going to be produced in some countries and not in others. And the idea of trade is that goods, services, people, ideas can flow from places that may have surplus,” he says.
Creating a precedent for future pandemics
The best way to fight future pandemics is tackling the one at hand, says Kavanagh. The movement toward so-called south-south cooperation, including through initiatives such as the mRNA hub in South Africa, could prove essential to strengthening low- and middle-income countries in the face of future, and current, health threats.
But it will take time—and funding—for those countries to become self-reliant in the manufacture of covid-19 vaccines. Until then, advocates believe it remains essential to get patent release—and encode it in international agreements so that it is automatically triggered whenever the WHO declares a public health emergency of international concern. It is a matter of creating a precedent, and the right one.
That should be the first step (pdf) toward a new preparedness plan, says Kavanagh. The other pieces would be: a vaccine research and development facility that funded by compulsory country contributions whether or not there is an ongoing pandemic; access to all intellectual property related to treatment for any public health emergency of international concern—particularly those developed with public funding, such as the covid-19 vaccines; and globalized manufacturing, since access to vaccines has been easier for countries in which they were manufactured, even when the production was done under license or partnership agreements with western makers.
Further, there needs to be a pushback against the outsized influence that pharmaceutical companies have on western economies, says Kavanagh. After all, though the industry is large, it isn’t bigger than all other industries combined, and in this case the protection of its profits is happening at the expenses of many other sectors that are still struggling through an extended pandemic.
Ultimately, if covid-19 has taught us any lesson it is that international cooperation and equity in treatment distribution isn’t just ethically right, but indispensable. “Public health challenges [for wealthy countries] are more entwined with the interests of low- and middle-income countries than they are with their own pharmaceutical industry,” says Malpani. “Until that calculus is made differently, we’re not likely to see any real solutions.”