Vaccine patent waivers face more hurdles despite Biden support

The Biden administration made a splash this past week when it backed a temporary waiver of international patent protections for COVID-19 vaccines at the World Trade Organization (WTO).

The sudden announcement delighted U.S. progressives and drug pricing advocates, but roiled the pharmaceutical industry, sending stock prices tumbling.

Yet the move by administration officials was largely symbolic, and carefully worded.

Numerous hurdles need to be overcome before the intellectual property (IP) waiver can be turned into policy. And despite the immediate pushback from the pharmaceutical industry, experts are skeptical of just how big of an impact it will have on those companies.

“I think the IP issue is an important one, but I think, frankly, opening up IP is really just one part of a much larger effort,” said Tom Frieden, who was director of the Centers for Disease Control and Prevention during the Obama administration.

“It may signal to parts of the society that the government is serious about it, it may signal to industry that the government is serious about it, but it is not in itself going to make any difference in a short term in terms of vaccine access,” Frieden said.

It will be many months before the WTO even votes on the matter, and if a waiver passes it will likely be even longer before manufacturing can be scaled up to develop enough vaccines to have a meaningful impact in the global fight against the coronavirus.

In an interview with The Washington Post, the head of the WTO said she would press member countries to reach an agreement on the waiver petition no later than December, setting up a vote on the final language at the body’s Dec. 3 meeting.

The lengthy timeline raises questions about the effectiveness of an IP waiver, especially since it might only be narrowly tailored for the length of the global pandemic.

U.S. Trade Representative Katherine Tai on Wednesday said she will pursue “text-based negotiations” on the WTO waiver, acknowledging that they “will take time given the consensus-based nature of the institution and the complexity of the issues involved.”

Tai did not say the U.S. supports the waiver that was drafted by India and South Africa, which specifically focuses on vaccines for countries that have been struggling to obtain enough doses.  

Negotiating an agreement could be a long and messy process.

“It’s really crucial that we begin ramping up manufacturing immediately, because we’re going to have the likelihood of big outbreaks around the world in the coming months and years,” Frieden said. “So, a multi-month negotiation is not a formula for rapid improvement in global vaccine and supply.”

In order for a waiver to pass, every country needs to agree. While the hope is that U.S. support will drive the movement forward, key American allies in Europe have been raising concerns, and any one of them could block the move.

“If history is any guide, you know those negotiations are long, protracted, difficult, complex,” said Josh Michaud, an associate director for global health policy at the Kaiser Family Foundation.

Some experts have raised concerns that bigger problems exist, like ramping up manufacturing capacity, increasing supplies of raw materials and providing the technical know-how to be able to make the vaccines, which could occur under voluntary agreements between companies without waiving patents.

Michaud, like Frieden, said the waiver itself “won’t move the needle” in terms of creating more manufacturing capacity.

But the U.S. decision to enter the negotiation process puts pressure on other countries and the pharmaceutical industry to find a way forward. Governments might use their leverage to work with pharmaceutical companies, or move companies toward technology transfer and licensing deals.

“This decision could lay the foundation for companies to start taking the idea more seriously about sharing the know-how, and for supply chains to be ramped up as much as possible, even more than they are now, to support the goal of manufacturing,” Michaud said.

“Those are the things that are going to really start to make a difference, maybe not immediately, but over a longer period of time,” he said, adding that the “waiver kind of sets the tone. It lays the groundwork for the debate that is yet to come.”

There is also concern that President Biden’s decision to support a patent waiver could have long-term ramifications on his relationship with the drug industry.

Pushback against the announcement was swift.

Michelle McMurry-Heath, CEO of the Biotechnology Innovation Organization, said her group has warned numerous times that such a waiver “has the potential to drastically hinder existing efforts to scale up global manufacturing, disrupt efforts to equitably distribute the vaccines to every corner of the globe through COVAX, and further strain the global supply chain.”

Covax is a World Health Organization-backed initiative to distribute the vaccine to low- and middle-income countries.

Biden has largely avoided picking fights with the industry to date, but there’s been a long simmering debate in Congress around drug prices, and some may see the announcement as an opening salvo.

But at least one pharmaceutical CEO shrugged off any major impact from U.S. support for waivers.

“I didn’t lose a minute of sleep over the news during the night,” said Stéphane Bancel, CEO of Moderna.

Bancel told analysts during an earnings call that he doesn’t think waivers would “change anything for Moderna,” and he was skeptical of other companies being able to duplicate his company’s success with mRNA technology without considerable time and money.

“This is a new technology. There’s no mRNA manufacturing capacity in the world, you cannot go hire people who know how to make mRNA. Those people don’t exist.”

Morgan Chalfant contributed.