US backs waiver for intellectual property rights for COVID-19 vaccines

In a stunning reversal, U.S. President Joe Biden’s administration came out in favor of waiving intellectual property protections for COVID-19 vaccines Wednesday.

The move follows months of U.S. opposition that began under former President Donald Trump to a proposal from South Africa and India to temporarily set aside intellectual property rights around products that would protect, contain, and treat COVID-19. Its supporters have argued that the proposal, first tabled at the World Trade Organization in October and now backed by more than 100 countries, is necessary to expand vaccine production and overcome global shortages.

But the soaring global COVID-19 case count, fueled by the disastrous outbreak in India, upped both international and domestic pressure to change that stance.

“This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures,”  U.S. Trade Representative Katherine Tai said in a statement released in the midst of a two-day WTO General Council meeting, which concludes today. “The administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines.”

Tai’s announcement confirmed that the United States is now prepared to participate in text-based negotiations around the proposal, a critical step toward adoption of the waiver. Its supporters still have to overcome opposition from other high-income nations, though, if the waiver is to be adopted at WTO — a body that is governed by consensus.

Activists said they are also preparing to push for an expansion of the U.S. position to include waiving intellectual property protections on COVID-19 treatments and diagnostics and to speed up the dissemination of key technology to accelerate vaccine manufacturing.

“Biden’s playbook on global vaccine access has been colonial, determined by charity rather than equity and scientific evidence,” Asia Russell, the executive director of Health GAP, told Devex. “Biden has taken a first important step away from disastrous and self-defeating policies — and now the real work begins.”

The U.S. reversal came despite intense opposition from the pharmaceutical industry. U.S. Representative Jan Schakowsky for Illinois who had led a group of Democratic lawmakers in calling for Biden to support the waiver, said she had seen unprecedented lobbying against it.

“Pharma is dead set against it and has, I think, been in large part the reason this thing has dragged on,” she said during a briefing organized by the Third World Network and other advocacy groups on Tuesday.

The industry’s main trade association, the Pharmaceutical Research and Manufacturers of America, was quick to blast the Biden administration’s announcement.

“This decision will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines,” PhRMA CEO Stephen Ubl said in a statement.

U.S. support is no guarantee that the waiver will be adopted by WTO, particularly as most high-income players such as the U.K., the EU, and Canada remain opposed to the waiver. But activists are hopeful the shift in U.S. support will encourage other nations to abandon their opposition.

During the TWN briefing, Kathleen van Brempt, a Belgian lawmaker in the European Parliament, said there is an opening for reversing the European Commission’s opposition to the waiver, but it could take time. She said she is attempting to organize a vote during the May plenary meeting of the European Parliament to demonstrate majority support for the waiver and encourage the EU’s executive body to change its position.

“I think I can establish a majority in the European Parliament,” she said. “It may require compromises, but I want a shift in how the Commission looks at it.”

Tai offered a preview of what those compromises might look like. Her announcement stopped short of fully endorsing the proposal by South Africa and India, which also calls for a waiver on intellectual property for COVID-19 treatments, diagnostics, and equipment, including personal protective equipment.

Following Tai’s announcement, Priti Krishtel, the co-executive director of the Initiative to Medicines, Access & Knowledge, told Devex that the waiver’s sponsors were likely to respond with their own feedback. She said supporters could use that as an opening to “absolutely be advocating that the temporary IP waiver apply to all medical-products, including testing, treatment, and other products needed to save lives right now.”

Even before the U.S. announcement, the waiver’s sponsors said they were already in the process of revising the proposal to include a more specific timeframe, a move that seemed designed to assuage the pharmaceutical industry and governments allied with it.

“We are not against IP rights,” Brajendra Navnit, India’s ambassador to and permanent representative at WTO, explained during this week’s briefing. “When we talk about a temporary waiver, we do not want to be judged as we are against intellectual property rights. But if we are not delivering in a couple of quarters, larger damage is going to happen.”

Supporters of the waiver also cautioned that it will not be an immediate panacea. Even if it is ultimately approved, it will not result in an immediate scale-up in vaccine production and distribution. Unless the companies already producing vaccines are willing to begin transferring the technology needed to create them, new manufacturers may not even be able to start trials until the end of 2021, Krishtel said.

Activists are pressuring the government and companies to transfer that technology now through the COVID-19 Technology Access Pool, or C-TAP. Established a year ago, C-TAP is a mechanism to pool technology, intellectual property, and data related to COVID-19, allowing for broader access. It has largely been ignored, though, since its launch.