As billions of people in the Global South continue to confront Covid-19 unprotected because they cannot access vaccines, a recent announcement regarding a new, potentially effective therapy offered a glimmer of hope.
In late-stage clinical trials, a new antiviral pill from Merck, called molnupiravir, cut hospitalizations and deaths from Covid-19 by one-third. A federal advisory committee, in a narrow vote, recommended that the Food and Drug Administration authorize emergency use of the drug as the first oral treatment for Covid-19. If authorized, it could potentially become available for patients in the United States within weeks.
But the deal struck between Merck and the Medicines Patent Pool (a Unitaid-backed initiative aiming to increase access to and facilitate the development of lifesaving medicines for low- and middle-income countries) to enable generic production of the medicine by a limited number of low- and middle-income countries included a particularly harmful provision that could in fact threaten global access to this potentially lifesaving medication.
The clause in question is a termination-for-challenge clause. It would give the Medicines Patent Pool the power to instantly terminate agreements with generic companies that might wish to challenge a specific patent related to the drug. It could harm the production of more-affordable generic versions of molnupiravir and would subsequently reduce supply for the people who’d need it most.
The clause was insisted upon not by Merck but by Emory University, the original patent holder. The drug was discovered and developed at Emory with significant financial support from American taxpayers. Even the Medicines Patent Pool’s own Expert Advisory Group said that the provision goes against some of the organization’s long-established principles — which begs the question of why the organization agreed to sign the agreement in the first place.
Emory University’s president, Gregory L. Fenves, celebrated that the license “will support global public health and address unmet medical needs — reflecting Emory’s mission to serve humanity.” But he neglected to mention that the license would exclude humanity living in upper-middle-income countries like Brazil and China, where there is existing capacity to produce medicines and which could be an important source of generics. Fenves also framed the institution’s massive bicentennial fundraising campaign as “investing in people for the benefit of people” while the university is actively working to undermine the potential impact of a publicly funded innovation for millions of people, if not billions, by securing monopoly price protections in countries where the impact of Covid-19 has been particularly devastating.
(I reached out to Emory multiple times to comment on this article, but the university has not responded to any of these requests.)
Universities Allied for Essential Medicines (UAEM), the student-driven organization I lead in North America, and Doctors without Borders are calling on Emory to live up to its moral mission “to create, preserve, teach, and apply knowledge in the service of humanity” by immediately withdrawing its patent claims globally and removing the termination-for-challenge clause in order to increase access to this publicly funded medicine. We also call on Merck to grant global licensing of molnupiravir with no territorial restrictions.
To be sure, Pfizer’s recent license to the Medicines Patent Pool for another antiviral, ritonavir (Paxlovid), similarly excludes middle-income countries, many of which have been devastated by Covid-19, like Brazil. Yet even Pfizer’s separate license with the Medicines Patent Pool does not include the harmful termination-for-challenge patent clause Emory insisted on including in its contract.
A mapping tool developed by UAEM tracks the pipeline of public funding that has been granted for Covid-19 health technology research and development. It shows that, since the start of the pandemic, Emory University was among the top three U.S. universities receiving funding from public sources for research into Covid-19. For 20 different Covid-related projects, the institution was awarded at least $84,179,885 of disclosed public funding. At least $16 million of public funds was spent directly on research into molnupiravir.
In its third iteration since 2013 for schools in the U.S., the UAEM University Report Card, released earlier this year, exposed the general failure of leading institutions like Emory to put equity at the heart of their patenting and licensing decisions — even in the midst of a global crisis — with more than half of the institutions receiving grades of F. Emory received a D grade overall and an F in the report’s “access section,” which analyzes measurable actions (or lack thereof), such as the percentage of nonexclusive university licenses granted for health technologies or the percentage of medical science reports published in open access journals.
So, then, it comes as no surprise to me or others that the institution might be comfortable making decisions even pharmaceutical corporations would wince at, and that the deaths of more than 800,000 Americans and 5.3 million global citizens are not enough to convince the university’s leadership to make an exception to its for-profit rules for the duration of the pandemic.
To be fair, Emory is not alone in its approach. Not a single university has yet to commit to mechanisms that would ensure sharing Covid-19 health technologies with the rest of the world via the Open Covid Pledge or the World Health Organization’s Covid-19 Technology Access Pool, even though many have received billions of taxpayer dollars via federal grants for research into Covid-19 diagnostics, treatments, and vaccines. Instead, they have flocked to more performative pledges that might look good on paper but in reality don’t translate into meaningful action when it comes to ensuring equity or access.
This is not, however, the first time Emory has found itself in hot water over its failure to prioritize public health in the licensing of a life-saving medicine developed on its campus. Sofosbuvir, a drug used to treat hepatitis C, was developed at Emory University by researcher Raymond Schinazi as a result of federally funded university-based research and then licensed to Pharmasset, a spinoff company Schinazi founded. Gilead eventually paid $11.2 billion to acquire Pharmasset, with Schinazi profiting $440 million. Emory University profited from the appreciated value of its liquidated shares of stock in the deal. The drug was marketed to Americans at $84,000 for a course of treatment, or $1,000 a pill. At that price, it would have cost the state of Louisiana $764 million to cover the 35,000 uninsured and Medicaid-dependent people living with hepatitis C, a sum the state would have been unable to pay without pulling funds from other public services.
When universities like Emory are allowed to profiteer from millions of dollars of public investment, the price the public pays is more than just a high sticker-price at the pharmacy. Universities, in how they choose to license medicines developed on their campuses with support from taxpayer funding, directly affect the availability and affordability of those medicines when they reach the market. The current business model for biomedical R&D socializes the risk and privatizes the gain, allowing universities and corporations to profit from a system that perpetuates inequity through high drug prices. In the last five years, 13% of Americans have a lost a family member because they could not afford one or more medications. That number is twice as high for people of color. Ensuring access to lifesaving medicines is not simply an issue of economic and health equity. It is also an issue of racial justice and human rights.
While universities have every reason to expect a reasonable return on their investment to continue innovating, the public must too. And that should translate into medicines that are not only available but affordable to ordinary citizens and whose prices do not gouge health systems anywhere in the world. Institutions like Emory have a choice: be complicit in prolonging the pandemic and preventing access to lifesaving medicines or ensure global access to their publicly funded innovations to curb Covid-19 for everyone, everywhere.
Merith Basey is the executive director of Universities Allied for Essential Medicines.
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