Amid a surge of COVID-19 cases in India and other parts of the world, the United States remains noncommittal on an October 2020 proposal by India and South Africa to waive certain provisions of the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
The proposal would loosen patent restrictions so that countries can manufacture generic versions of the coronavirus vaccines.
"We are working with our global partners to explore pragmatic and effective steps to surge production and equitable distribution of vaccines," a United States Trade Representative (USTR) official told VOA.
The administration is still weighing arguments from waiver proponents, including members of the progressive wing of President Joe Biden's own party who say that it could be a game changer in the global fight against the pandemic, and opponents, Republican senators as well as the pharmaceutical industry, who insist that strong intellectual property protection is key to innovation. They say waiving it could backfire, creating further backlog for limited vaccine ingredients and revealing trade secrets to international rivals.
"Our overall objective is to provide as much supply to the global community and do that in a cost-effective manner," said White House press secretary Jen Psaki, adding that USTR has not made a final recommendation on the issue.
U.S. indecision was met with disappointment by many WTO members convening in a working level meeting on TRIPS on Friday.
More than 80 members of the consensus-driven body support the proposal, but it has been blocked by some, including the European Union and the U.S. under the Trump administration.
Under the People's Vaccine campaign, humanitarian organizations, 60 former heads of state and 100 Nobel Prize winners have urged Biden to look seriously at the humanitarian cost of protecting intellectual property rights.
"The TRIPS waiver is one of the critical tools that can empower government to address the current situation of the scarcity of supply," said Yuanqiong Hu, senior legal and policy adviser of Doctors Without Borders, one of the organizations who support the campaign.
Lawmakers from the progressive wing of the Democratic Party, including Senators Elizabeth Warren and Bernie Sanders, have urged the Biden administration to stand up against intense pressure from the powerful pharmaceutical industry. In recent days, heads of pharmaceutical companies including Moderna, Pfizer and AstraZeneca have met with United States Trade Representative Katherine Tai to lobby against the waiver.
In March, the trade group PhRMA sent a letter to Biden, warning that undermining intellectual property would impede response to COVID-19 and emerging variants.
"An intellectual property waiver would not help accelerate COVID-19 vaccine access or address the very real supply chain and logistical constraints," a spokesperson for PhRMA told VOA via an email statement. "What can continue to help is global collaboration, partnerships and licensing agreements, which vaccine makers will continue pursuing."
But waiver proponents say that's simply not true.
"We know there is a lot of unused capacity in developing countries," Hu, of Doctors Without Borders, said. "Lifting the waiver can provide transformative and substantive help for companies who are ready and competent but worried about being sued."
Last week, USTR's Tai also spoke with Bill Gates who, through the Bill and Melinda Gates Foundation, sponsored Gavi, the Vaccine Alliance, a public-private global health partnership aiming to increase low-income countries' access to immunization. Gavi is the driving force behind COVAX, the United Nations' mechanism to improve low- and middle-income countries access to vaccines.
Despite more than two decades of philanthropic work on vaccines, Gates is a fierce defender of intellectual property protections and has spoken publicly against waiving vaccine patents. Responding to VOA's query, a Gates Foundation spokesperson said they are "focused on the policy and process barriers that stand in the way of equitable access to vaccines," but the TRIPS waiver is a decision for members of the WTO.
A spokesperson for Gavi said the best way to address the need for greater, more equitable global supply is through technology transfer in which the private sector invests in new manufacturing capacity and shares know-how with emerging economies. Such a partnership-based approach, the spokesperson said, "represents the quickest way to boost production as it brings together those that know how to make vaccines with those that need them most."
"It makes very little sense," said Matthew Kavanagh, director of the Global Health Policy and Politics Initiative at Georgetown University. "Sometimes we should listen to billionaires when it comes to things like global health, but sometimes we really shouldn't. And this is one where we don't want to listen to him."
With the World Health Organization reporting on Tuesday 5.7 million new global cases in the last week, an 8% weekly jump and the highest level on record, Kavanagh said now is the time for the administration to be decisive on the TRIPS waiver. "The fact that we haven't seen that is disappointing so far."
There is precedent in the global effort to loosen medical patent restrictions during a health crisis. The Doha Declaration, adopted in 2001, clarified flexibilities within the 1994 TRIPS Agreement. It has been used by countries, including Mozambique, Zambia, Zimbabwe, Indonesia, Malaysia and Brazil, to issue compulsory licenses for HIV/AIDS drugs, which means that these governments can waive intellectual property rights without the license owners' consent.
Proponents of the COVID-19 vaccine waiver are hoping to apply the same principle of the Doha Declaration, but opponents say that unlike the simpler HIV/AIDS drugs, vaccines are much more complex and encompass multiple layers of intellectual property protection, from their ingredients and manufacturing to delivery.
That is why Moderna's recent announcement that it will not enforce the intellectual property rights of its COVID-19 vaccine may not mean much. Moderna can change its mind at any time, and it is also not the sole holder of the mRNA technology used in its vaccines. In fact, hundreds of patents, held by various entities, are related to the mRNA technology, meaning that even if Moderna does not enforce its patent, the legal risk remains because other companies, such as Pfizer, could.
Waiving vaccine patents will again be in focus at the WTO General Council meeting on May 5.