With more than 153 million cases and 3 million deaths worldwide, very few countries have been spared the devastation of the Covid-19 pandemic. But when it comes to vaccination—one of the most important public health tools to combat this crisis—there is a stark divide. High-income countries have secured 4.9 billion doses, while low- and middle-income countries, which make up nearly 85% of the world’s population, hold less than 3 billion doses combined, according to a Duke University tracker.
On Wednesday, diplomats at the World Trade Organization are slated to discuss a proposal led by the India and South Africa delegations that would waive certain intellectual property rights related to Covid-19 vaccines and therapeutics, with the aim of speeding up access and affordability across the globe. The proposal was first introduced in October 2020, but has been blocked twice so far. Advocates say that waiving these rights are essential to combating the pandemic. “If the U.S. and Europe hadn’t said no to the waiver when India and South Africa first proposed it last year, we would be in a different world,” argues Madhavi Sunder, a professor of law at Georgetown University. “These six months have cost so many lives. We would have had much more massive global production of these vaccines.”
Other experts, however, counter that intellectual property rights aren’t the bottleneck in producing enough vaccines for the whole population. They note that there are also significant shortages in supply chains, and few existing factories that are capable of producing mRNA vaccines like the ones developed by Pfizer/BioNTech and Moderna. Retrofitting existing sites could cost billions of dollars. Solving these problems requires more than waiving rights—it will require significant investments from high-income countries.
Intellectual property for pharmaceuticals has been a longstanding political football that has pitted the United States, where most drugs are developed, against lower income countries during international negotiations. “We can’t make highly innovative vaccine technology the purview of only the rich and the powerful,” says Lawrence Gostin, a professor of global health law at Georgetown University and director of a World Health Organization collaboration center. “We have to share it.”
Right now, pharmaceutical intellectual property rights are subject to an international agreement called trade-related aspects of international property rights, or TRIPS for short. This agreement includes a provision that allows national governments to override pharmaceutical patents during public health emergencies in order to increase access through compulsory licensing. But India and South Africa argue that these TRIPS flexibilities come with legal and political barriers that will continue to slow down the response, and are pushing for a broader waiver of intellectual property rights during the pandemic. “Internationally, there is an urgent call for global solidarity, and the unhindered global sharing of technology and know-how in order that rapid responses for the handling of Covid-19 can be put in place on a real time basis,” the proposal states.
The mounting political pressure from abroad, as well as from progressive activists, underscores the differences between the current administration’s domestic and international approaches to the pandemic, says Gostin. While President Joe Biden has “turned the U.S. from the world’s worst performer to its best performer,” when it comes to the Covid-19 response, he’s done “nothing audacious, big and bold for the world.”
We can’t vaccinate the world only from U.S. factories.
Patents and intellectual property rights are only one constraint in a much bigger and complex vaccine manufacturing global supply chain that requires technology transfers, equipment and trained personnel. While AstraZeneca has already entered into voluntary licensing agreements with manufacturers in India, South Korea and Argentina, Pfizer/BioNTech’s and Moderna’s mRNA vaccines are based on a new technology.
Few sites outside of the United States, Europe and Japan are likely to have some of the necessary equipment, like specialized manufacturing columns, to produce mRNA vaccines, says Prashant Yadav, an expert on healthcare supply chains and a professor at INSEAD. There is also a shortage of chemistry, manufacturing and control specialists, who are trained in producing biological materials needed to manufacture these vaccines. “They were always in high demand, but they’re even more in demand,” says Yadav.
Setting up manufacturing facilities also requires significant upfront capital. That means even if intellectual property rights are waived temporarily, as Moderna did in October 2020, companies in lower and middle income countries may be reluctant to make such a big investment only to have it taken away if the patent holder chooses to exercise its rights at a future date, says Yadav. “That’s the cycle in which it has remained stuck.”
Sunder suggests the key to solving this problem is retrofitting existing sites, which could ramp up vaccine production following the waiving of patents and technology transfer in countries such as India, Brazil, Thailand and South Africa. The initial investment for that, she argues should be made by the vaccine manufacturers that have already benefited from significant public funding. “Studies suggest that a $4 billion investment could be enough to really help support the retrofitting of a number of global factories which could begin production within four to six months of safe and effective and affordable COVID-19 vaccines,” says Sunder.
In Gostin’s view, the solution is for the United States and other public and private actors to step up and make a massive investment along the lines of PEPFAR, a response to the HIV/AIDS crisis that has provided $85 billion globally since 2003. “We’re going to have to provide financial and technical assistance on a massive scale to actually start to put the capacities in these regional facilities,” Gostin says. “We can’t vaccinate the world only from U.S. factories.”
But manufacturing is only half the battle, says Anant Bhan, a public health and bioethics researcher in Bhopal, India. “It’s one thing to produce a vaccine, but to be able to distribute it and have mechanisms to ensure oversight is also important,” he says. The world needs to take this opportunity to redefine collaborations in global health, adding: “We can show that it is possible to work together in the interest of saving more lives.”