When United States Trade Representative Katherine Tai announced this past May that the U.S. would support the TRIPS waiver on COVID-19 vaccines at the World Trade Organization (WTO), we at the Revolving Door Project celebrated the administration’s decision as “a transformative, hopeful event.” The waiver proposal calls on the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council to suspend intellectual-property protections on COVID-19 therapeutics, diagnostics, and vaccines to ensure materials necessary for combating the pandemic are “available promptly, in sufficient quantities and at affordable price to meet global demand.”
However, since that announcement, the Biden administration has slow-walked the text -based negotiations that would determine the scope of the waiver. This posture belies the urgency needed to effectively handle the coronavirus pandemic. Instead of prioritizing alternatives such as sharing vaccine formulas or the suspension of IP rights on the vaccines, the Biden administration has relied on vaccine charity—a strategy that broadly leaves pharmaceutical companies in control of global vaccination goals lest people independent of Big Pharma learn mRNA production techniques.
Most recently, on September 14, 2021, during an informal meeting of the TRIPS Council, the U.S. declined to support the proposal as it was presented by South Africa and India in October 2020. Zane Dangor, adviser to the South African Trade Ministry and a key official in the WTO TRIPS waiver negotiations, stated that U.S. leadership could meaningfully “shift the needle in the negotiations and make people come around the table and discuss these issues.” Yet the U.S. has chosen not to exercise its influence to boost vaccine access. According to Sangeeta Shashikant of the global research and advocacy organization Third World Network, the U.S. did not appear to be actively engaged in discussing the text or actively trying to get the EU on board with the TRIPS waiver.
As recent reports highlight, the Biden administration has struggled to convince Pfizer and Moderna to share their vaccine technology. Consequently, the administration has been forced to settle for a deal with Pfizer that would provide an additional 500 million Pfizer-BioNTech vaccines to low- and middle-income countries. That figure is tragically shy of what is needed to immediately address this crisis.
This begs the question: Is the Biden administration’s slow movement on waiver negotiations a result of senior officials prioritizing corporate-friendly alternatives? There are key officials within the Biden administration who may have a stake in opposing the waiver. Take, for example, Jeffrey Zients, the White House coronavirus response coordinator. Zients and Secretary of State Antony Blinken recently penned an op-ed in The Washington Post describing the purchase of the additional Pfizer vaccines as a monumental commitment. Make no mistake, sharing 500 million additional vaccines is worthy of some praise, but the lack of reference to the TRIPS waiver in the piece is telling. Zients became wealthy by advising pharmaceutical companies on boosting profits, and bought a firm that issued surprise medical bills to patients. Having gotten rich by helping the health care industry boost its profits, it may come as no surprise that he would favor donating vaccines over sharing vaccine technology. Similarly, Commerce Secretary Gina Raimondo and White House counselor Steve Ricchetti each has a history of supporting pharmaceutical companies. Raimondo’s record of running favors for Johnson & Johnson may suggest that she is committed to keeping Big Pharma happy. Ricchetti co-founded the lobbying firm Ricchetti, Inc., with his brother Jeff and profited for decades off of corporate clients, including pharma giant Eli Lilly. These career histories provide cause for concern. Without personnel dedicated to pushing for vaccine equity, the Biden administration will struggle to uphold its commitment to the world.
As President Biden noted earlier this week, the world needs more than “half measures or middle-of-the-road ambitions” to “solve this crisis.” And there are a few options available should the Biden administration decide to take a truly comprehensive approach to dealing with the pandemic globally.
One simple and immediate option would be to solidify the administration’s support for the TRIPS waiver by joining over 100 other nations and signing on to the waiver text introduced by South Africa and India. More than five months of text-based negotiations have proceeded since U.S. Trade Rep Tai announced the United States’ support of the waiver. If there are still any concerns about the content of the proposal developed by low- and middle-income countries, the Biden administration should introduce a counterproposal addressing these concerns rather than slow-walk the negotiation process.
This situation also presents the Biden administration with an opportunity to showcase the long-promised return of the United States to diplomatic tables. Now is the time for the United States to negotiate with the United Kingdom and European Commission to change their views on the TRIPS waiver. There is little doubt of the sway that the United States holds over the World Trade Organization, and this is a chance for the Biden administration to use that leverage in support of the global public interest. The Biden administration can use its clout to corral richer countries to stop blocking the TRIPS waiver, thereby allowing poorer countries to manufacture vaccines, or it can sit back and lock in a cycle of dependence.
Biden also has several other options that flow from the government’s contracts with and funding of the drug companies. He needs to invoke them quickly to compel Moderna to share its vaccine recipe as well as technical know-how. Both Moderna’s and Pfizer’s COVID-19 vaccines are a product of federal government funding; in Moderna’s case, the U.S. government’s $1 billion contribution covered 100 percent of the company’s COVID-19 research costs. What’s more, both vaccines are based on two fundamental discoveries that emerged from federally funded programs: viral protein designs and RNA modification.
As part of the deal to fund its COVID-19 vaccine research and development, Moderna entered into a contract with the Biomedical Advanced Research and Development Authority (BARDA), an office within the Department of Health and Human Services. Research by Public Citizen shows that in exchange for funding the company’s COVID-19 vaccine, BARDA received access to Moderna’s vaccine recipe. This includes “dossiers containing chemistry, manufacturing, and controls information, which provide manufacturing instructions in step-by-step detail.” Crucially, BARDA also obtained “unlimited rights” to data produced by Moderna as a result of BARDA’s funding, which allows the government agency to share that data for any purpose. However, the contract restricts BARDA from sharing information that falls under “limited rights data”—categories of information developed at Moderna’s expense.
According to Public Citizen’s research, the contract fails to clearly highlight what counts as unlimited rights or limited rights data, which creates some uncertainty on what the Biden administration can immediately share. However, this opacity need not be a deterrent. The Biden administration can on its own clarify what counts as unlimited rights data and share that information. Beyond that, Biden can declare the pandemic a national-security threat and draw on the Defense Production Act. This would grant the administration the right to compel Moderna to accept contracts for technology transfer in exchange for reasonable compensation.
Other options include sharing information from Moderna’s previous contracts with U.S. federal government agencies, especially considering the company’s acknowledgment that the mRNA and lipid technology used in the development of its Zika vaccine (which is also a result of government support) is similar to the technology used in its coronavirus vaccine. Another potential pressure point would be to demand compensation from Moderna for its unlicensed use of the National Institutes of Health’s patent on stabilization of coronavirus spike proteins in its COVID-19 vaccine.
Moderna surely would complain that transferring this technology to pharmaceutical firms in countries like South Africa and India might increase the number of firms able to compete in the business of producing mRNA solutions to vexing medical challenges. While we understand why that might worry Moderna, the Biden administration should understand that the upside of more rapid medical progress across the globe far eclipses the consequences for Moderna’s stock price, which has soared since the advent of COVID-19.
Reports point out that the Biden administration has been hesitant to utilize its broad powers to challenge Moderna and Pfizer due to fears of legal pushback. At a time like this, Biden administration officials should worry more about ongoing loss of lives and the threat of a mutating virus than the competence of Big Pharma’s lawyers.