What is the WTO waiver?

For months, members of the World Trade Organization have been at odds over the proposed waiver of patents for coronavirus vaccine formulations. India and South Africa first proposed a waiver, on behalf of countries with no or insufficient vaccine doses — an idea that gained global traction but faced opposition from a number of sides, including from some wealthy countries that have bought or produced a large share of doses. The debate centers on a technical interpretation of TRIPS, the WTO’s 1995 Agreement on Trade-Related Aspects of Intellectual Property Rights. But for some developing countries, the impasse is also emblematic of the ways in which wealthy countries, where many major pharmaceutical companies are based, were primed from the start to monopolize vaccine supplies. The waiver would effectively exempt countries from enforcing intellectual property rights for coronavirus vaccines and related diagnostics. That would mean that any country or company with the recipe for a vaccine could produce it — at least in theory, given technological and supply hurdles — without having to worry about being sanctioned or fined. The waiver, however, would not oblige any company to publicly disclose its technologies and is expected to include a mechanism for some level of compensation.

What are the arguments for the waiver?

Supporters of the waiver say it is a critical step, among many, that must be taken to ensure a more equitable distribution of coronavirus vaccines. Many developing countries contend that they cannot continue to wait for lifesaving doses, which western countries could afford to pre-purchase and monopolize. While all U.S. adults are now eligible for vaccines, in most countries severe shortages remain even for the most vulnerable and at-risk. “It’s not the case where rich countries could insulate themselves by vaccinating the entire population and not care about what happens with the rest of the world,” Mustaqeem De Gama, an intellectual property expert and South Africa’s WTO representative, previously told The Washington Post. “We now have variants, and these variants come about because of the transmission of the virus among millions of people.” Yuan Qiong Hu, legal adviser for the Doctors Without Borders Access Campaign, said companies such as Moderna and Pfizer also received billions in public funding to develop the vaccines and have already “made huge profits.”

What are some of the arguments against it?

Opponents say that a waiver would dissuade pharmaceutical companies in the future from developing, over time and at great expense, cutting-edge technologies. Another argument holds that the TRIPS agreement is not a central problem for vaccine availability, and that discussion around the waiver could risk distracting leaders from addressing other vaccine production impediments. Intellectual property rights “have been indispensable to the development of COVID-19 vaccines, therapeutics, and diagnostics to date,” the Information Technology and Innovation Foundation, a D.C.-based think thank, said in a statement. “ … Endorsing this waiver petition succumbs to the fundamental fallacy that IP rights represent any kind of significant barrier to access and manufacturing of the medicines needed to overcome this crisis.” Other options to increase vaccine access, the organization added, include increasing U.S. contributions to Covax, a World Health Organization-backed initiative for ensuring widespread access to vaccines, as well as “exporting excess vaccine supply from its stockpile, identifying supply chain bottlenecks, and investing more domestically to dramatically scale up U.S. biopharmaceutical manufacturing capacity of these medicines.”

The process moving forward remains murky. The United States has said it would support a waiver — but many key U.S. allies in Europe are not yet on board. In her statement, Tai did not say that the United States supported India and South Africa’s proposed waiver, which means the WTO could be facing a prolonged negotiation over the actual text. The United States could try to avoid that by signaling it wants to expedite discussions, said Matthew Kavanagh, director of the Global Health Policy and Politics Initiative at Georgetown University. In the past, even the threat of asking for a waiver in the WTO has led some countries and companies to come up with their own technology and knowledge sharing agreements, said Krishna Udayakumar, director of the Duke Global Health Innovation Center. If the WTO does agree on a waiver, the next unknown is how long it would take for vaccine production to ramp up. In theory, it could take one year — or many more — for companies to reverse-engineer the recipe for established vaccines and start producing their own. However, Kavanagh said, it could be the case that some scientists have already been doing so on the side in secret, due to fear of retaliation in the WTO. In that case, some companies could be primed to ramp up production faster than others. If pharmaceutical makers such as Moderna and Pfizer go even further and agree to share their recipes, then production “could instead get started tomorrow,” Kavanagh said. Learning how to produce vaccines and getting factories ready to make them is a costly and complicated process. But if those hurdles can be cleared, the World Health Organization has a process for approving and certifying globally recognized standards, Kavanagh said, and countries including India, Thailand and South Africa are already major pharmaceutical producers that have strong regulatory bodies.

What challenges remain for increasing vaccine production?

Both opponents and supporters of the waiver say that it alone cannot fix the problem of global shortages of vaccines and the unequal distribution of existing supplies. “I think it carries more symbolic weight than anything else,” Udayakumar said. “It’s not so simple to say if we have more vaccine producers, we will have more vaccines.” There are major ongoing bottlenecks in production for some of the components needed to make, store and distribute coronavirus vaccines. Moderna and Pfizer vaccines rely on mRNA technologies, which require specially equipped and knowledgeable engineers and factories. WHO-backed initiatives for ensuring widespread access to vaccines, such as Covax, also remain underfunded. Udayakumar said a prolonged negotiation over the waiver risked distracting governments from focusing on ramping up critical supplies and manufacturing facilities.

What it means for the U.S. to back waivers on coronavirus vaccine patents

By Miriam Berger

May 6, 2021 at 4:42 p.m. EDT

Demonstrators at the National Mall on Wednesday call on the United States to commit to a global coronavirus vaccination plan that includes sharing vaccine formulas with the world. (Saul Loeb/AFP/Getty Images)

After months of deadlock, the United States has reversed course, coming out in favor of a proposal to waive intellectual property protections for coronavirus vaccines at the World Trade Organization.

“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 on Wednesday.

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Here’s what U.S. support for a waiver could mean.

Global vaccine inequality runs deep. Some countries say intellectual property rights are part of the problem.

What it means for the U.S. to back waivers on coronavirus vaccine patents

Coronavirus: What you need to know