A chorus of activists are calling for changes to intellectual property laws in hopes of beginning to boost Covid-19 vaccine manufacturing globally, and addressing the gaping disparity between rich and poor nations’ access to coronavirus vaccines.
The US and a handful of other wealthy vaccine-producing nations are on track to deliver vaccines to all adults who want them in the coming months, while dozens of the world’s poorest countries have not inoculated a single person.
Activists have dubbed the disparity a “vaccine apartheid” and called for the world’s largest pharmaceutical companies to share technical know-how in an effort to speed the global vaccination project.
“The goal of health agencies right now is to manage the pandemic, and that might mean not everyone getting access – and not just this year – in the long-term,” said Peter Maybarduk, director of Public Citizen’s access to medicine program.
“If we want to change that, if we’re not going to wait until 2024, then it requires more ambitious and a different scale of mobilization of resources,” said Maybarduk. Right now, “it’s not even clear the goal is to vaccinate the world”.
The pressure to get more vaccines to poor nations has also weighed on the Joe Biden administration, which is now considering whether to repurpose or internationally distribute 70m vaccine doses. After outcry, the US has shared 4m AstraZeneca vaccine doses with Canada and Mexico.
“There’s no question poorer countries are having a hard time affording doses,” said Dr Howard Markel, a pandemic historian at the University of Michigan School of Public Health. “Even if they were at wholesale or cost there are a lot of different markups.”
As it stands, 30 countries have not received a single vaccine dose. Roughly 90m vaccine doses expected to be distributed through Covax, the global alliance to distribute vaccines to poor countries, have been delayed through March and April by a Covid-19 outbreak in India. In Europe, rising Covid-19 cases and a slow vaccination campaign have also prompted vaccine export controls.
Beyond existing vaccine supply, many activists see a bigger fight in patent laws, and are drawing on experience advocating for greater access to antiretroviral drugs for HIV.
“More is possible than we believe,” said Maybarduk. “It was assumed Aids drugs could not be produced for less than $10,000 per person per year, right up until the moment they could, and they were produced for $1 per person per day.”
Similarly, Maybarduk said the technology for Covid-19 vaccines, along with other supplies, should be shared among the countries of the world. Activists have used Moderna as a key example of the leverage the US government might have, if it chose to use it.
Though popular shorthand often refers to it as just the Moderna vaccine, it was developed in partnership with the US National Institute of Allergy and Infectious Disease (NIAID). American taxpayers provided $6bn in late-stage development funds, in return for potential vaccine doses. It was also tested on Americans, who volunteered for research across 99 research sites.
“It is literally the people’s vaccine,” said Maybarduk.
Part of the proposal from activists focuses on a petition to temporarily suspend intellectual property laws governing World Trade Organization member states. Suspending those patent laws could urge companies to share technology, they argue, and better protect the whole world from emerging variants that can blunt vaccine efficacy.
“This is a classic case where you have an industry that has a very direct stake in protecting itself, and there’s very little understanding among the public how much is at issue,” said Dean Baker, an economist and co-founder of the Center for Economic and Policy Research. Activists argue pharmaceutical companies should share production know-how, and be appropriately compensated.
One part of this fight centers on a provision of international trade law called the Trips agreement, or more formally, the agreement on trade-related aspects of intellectual property rights. Put in force in 1995, Trips requires all member states to recognize 20-year monopoly patents for pharmaceuticals, including vaccines.
“What Trips was about was imposing US-European style copyright on the whole world,” said Baker. “Most developing countries had very little idea what they were dealing with.”
In October 2020, South Africa and India introduced a petition to suspend the Trips agreement through the pandemic. India is home to one of the largest generic drug manufacturing industries in the world. South Africa has the largest HIV epidemic in the world, and is part of a group of sub Saharan African countries which were priced out of antiretroviral therapies in the 1990s.
“Even if we say, ‘OK, this is highly specialized knowledge’ … the idea it wouldn’t benefit everyone to share that knowledge is kind of crazy,” Baker said. “The industry’s argument – we’re just stuck – that makes zero sense.”
However, some vaccine researchers counter that the lack of vaccine access is far more complicated than lifting patent restrictions, because there is so little manufacturing outside of the US and Europe.
“In my experience from working on vaccines for the last few decades, the patents are not the biggest problem [and] the intellectual property is not the biggest problem,” said Dr Peter Hotez, a vaccine researcher and dean of the National School of Tropical Medicine at Baylor College of Medicine in Texas.
Hotez is currently working to develop a low-cost, easily manufactured vaccine that can be distributed in low- and middle-income countries. “The problem with vaccines is having the infrastructure and the human capital to know how to make vaccines,” Hotez said.
Reliance on these major pharmaceutical companies, Hotez said, has resulted in a dearth of vaccine candidates designed for regional Covid-19 variants and suited for local administration. “We’ve still not fixed a broken financial model for how to get vaccines for the poor,” Hotez said.
On this, both camps agree.
“There should be major facilities in Africa and Asia and Latin America, as well as North America, that help respond to future pandemics,” said Maybarduk. “What is not agreed on is what the political economy of that looks like: who controls those facilities, will the technology be openly available, will they be publicly accountable.”
The fight also comes at a time when annual or booster Covid-19 shots appear increasingly likely – in part driven by the possibility variants could emerge in populations without vaccine access – and as pharmaceutical companies eye future profits.
“The big players are Astrazeneca, Moderna, BioNtech – these are not really vaccine companies,” said Hotez. They are involved because technological advances will, “provide a glidepath so they can accelerate their technology to down the line make actual money making products”, such as vaccines to treat cancer and neurodegenerative disorders.
The Trips agreement is expected to be discussed again in April, though it is unclear whether the coalition of more than 80 poorer nations will succeed. Opposition to the Trips petition has come from wealthy countries, including the US, which for the last four decades has traditionally argued for enhanced patent protections. It is unclear how the recently confirmed US trade representative, Katherine Tai, might handle the talks.
“Here you’ve got the equivalent of a blockbuster vaccine, because everybody needs it,” said Markel. “If you need it every year, boy, what a boon.”