Battle lines drawn over Biden’s support for vaccine waivers

Battle lines are forming over President Biden’s move to support waiving patents for COVID-19 vaccines ahead of a contentious push to increase global vaccine access.

The pharmaceutical industry and congressional Republicans blasted Biden’s announcement on Wednesday, saying it undermines incentives for American innovation and will not actually solve the complex problem of getting more doses to lower-income countries.

But Democrats and progressive groups lauded the move, which they had been pressuring Biden to make for weeks, and expressed hope that it is a sign of further action to lower drug prices and take on the pharmaceutical industry. 

“Let’s do insulin next,” tweeted Rep. Alexandria Ocasio-Cortez (D-N.Y.) in response to the announcement, over an image of drug companies’ stock prices falling.

“It’s a pandemic, it’s an extraordinary situation, but it’s a big ‘no’ to the pharmaceutical industry, without question,” said Peter Maybarduk, director of access to medicines at the progressive group Public Citizen. “It means that the Biden administration has said ‘no’ to pharma and could say no on other occasions.”

The administration announced Wednesday it would support a waiver for COVID-19 vaccine patents at the World Trade Organization, which backers argue will enable lower-income countries to gain access to vaccine recipes and start making more doses themselves.

The reaction from the pharmaceutical industry was fierce.

“This decision will disadvantage patients by undermining existing incentives to develop vaccines and therapeutics for future pandemics,” said Michelle McMurry-Heath, CEO of the Biotechnology Innovation Organization, a trade group that represents vaccine makers like Pfizer and Johnson & Johnson as well as smaller biotech companies.

She also argued that even with the patent waiver, vaccine manufacturing is complex enough that lower-income countries will not be able to simply flip a switch and start making vaccines.

“Handing them the blueprint to construct a kitchen that — in optimal conditions — can take a year to build will not help us stop the emergence of dangerous new COVID variants,” she said.

Brent Saunders, former CEO of the pharmaceutical company Allergan, said the move was “political theater.”

“It’s not going to actually get the shots into arms,” he said, saying a better approach would be to work with industry to increase manufacturing capacity and sources of raw materials.

“This came a bit out of left field and again caused a distraction to the real work at hand,” he said.

A pharmaceutical industry source said they were not given a heads-up ahead of the announcement on Wednesday. 

“We were surprised that the decision came out yesterday, and even as recently as a couple days ago, before that, we didn’t know which way it was going to come out, because it seemed split [within the administration],” the source added. “It was kind of a shock in a way that they just came out with it so quickly.”

Congressional Republicans also denounced the decision.

“Intellectual property protections are part of the reason we have these life-saving products; stripping these protections only ensures we won’t have the vaccines or treatments we need when the next pandemic occurs,” said Sen. Richard Burr (N.C.), the top Republican on the Senate Health Committee.

Rep. Kevin Brady (Texas), the top Republican on the House Ways and Means Committee, said he had spoken to U.S. Trade Representative Katherine Tai on Wednesday and will “keep engaging with” her to try to find a better way forward.

First-term Rep. Byron Donalds (R-Fla.) even said he would introduce legislation, backed by Republican Study Committee Chairman Jim Banks (R-Ind.), to block the move.

But Biden had been under mounting pressure from lawmakers in his own party to support the move: 110 House Democrats wrote to him earlier this week in support of the waiver.

“A pandemic is not the time to fuss over intellectual property rights; it is a time to come together and crush the virus around the world,” said a group of lawmakers including Reps. Rosa DeLauro (D-Conn.), Jan Schakowsky (D-Ill.), Lloyd Doggett (D-Texas) and Earl Blumenauer (D-Ore.).

Some experts have raised concerns that the waiver will not actually help much in the near term and that the bigger problems are 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.

It is also not clear that the waiver proposal will make it through the World Trade Organization. Other countries need to agree, and Germany, for example, raised concerns on Thursday. Negotiating an agreement could take months. 

“What I fear is that this is not going to do anything substantive in the next three to six months, which is a critical time for the world to get access to vaccines, and instead risks actually making us complacent and moving more of our energy and time to negotiating this agreement which could be better spent making sure that we’re taking a comprehensive approach,” said Krishna Udayakumar, associate professor of global health at Duke University.

He pointed to addressing bottlenecks in supply and increasing manufacturing capacity as alternatives.

Maybarduk, of Public Citizen, agreed that other steps are needed too but said the patent waiver is an important piece of the puzzle.

“Intellectual property matters and so does manufacturing capacity,” he said. Public Citizen and other groups are also pushing Biden to provide funding to create new manufacturing lines for vaccines.

The move against the pharmaceutical industry comes as other battles loom. Congressional Democrats are pushing forward with sweeping legislation aimed at lowering drug prices, strongly opposed by the industry, that could be attached to an infrastructure package this year.

The White House did indicate on Thursday that it is not looking to declare open war on drug makers while denying that there was a split within the administration on the waiver issue.

“The intellectual properties protection is on the COVID vaccine, and that’s our focus right now,” White House spokeswoman Karine Jean-Pierre told reporters when asked about Ocasio-Cortez’s push to go after insulin next. 

Asked what the White House would say to pharmaceutical companies objections, Jean-Pierre said: “These companies we’ve been working closely with have been saving lives.”

“And, you know, we will continue to work closely with them to make the lifesaving benefits available to most people as quickly as possible,” she added.