(CNSNews.com) – President Biden’s decision Wednesday to support the temporary waiver of intellectual property protections on COVID-19 vaccines follows appeals by Democrats arguing that it will help end the global pandemic more quickly, but some Republicans warn it could mean handing over critical American IP to adversaries like China and Russia.
Welcoming the move, World Health Organization chief Tedros Adhanom Ghebreyesus commended what he called a “historic decision for vaccine equity and prioritizing the well-being of all people everywhere at a critical time.”
Some in the pharma industry argue that infrastructure capacity problems and raw material shortages, not intellectual property (IP) protections, are what’s holding up a quicker distribution of COVID-19 vaccines around the world.
They also warn that the unintended consequences of waiving patent protections for vaccines could include quality control issues affecting safety and efficacy, and a dampening effect on future investment and innovation.
The decision to support a temporary TRIPS (Trade-Related Aspects of Intellectual Property Rights) waiver was announced at the World Trade Organization (WTO) by U.S. Trade Representative Katherine Tai, who said although the administration believes strongly in IP protections, it supports the waiver “in service of ending this pandemic.”
A proposal submitted at the WTO by India and South Africa last fall relates to patents, copyright, industrial designs, trade secrets, and test data protection. It would last for the duration of the pandemic, until widespread global immunity has been achieved.
Around 100 countries have backed the proposal, but up to now the U.S. had withheld approval, together with allies including Britain, Japan, and the European Union.
Sens. Tom Cotton (R-Ark.) and Thom Tillis (R-N.C.) in a joint statement deplored Biden’s decision, saying it would “do little to end the COVID-19 pandemic and help developing nations, but it will hand over America’s medical technology to adversarial states like China and Russia.”
“We support distributing vaccines to countries that need them, but not in a way that jeopardizes America's successful vaccine development,” they said. “It’s astonishing that President Biden is now providing the Chinese Communist Party with access to America’s intellectual property, medical research, and innovation.”
In an earlier letter to Biden, Cotton and Sens. Joni Ernst (R-Iowa), Mike Lee (R-Utah), and Todd Young (R-Ind.) wrote, “By destroying the intellectual property of every American company that has worked on COVID-19 vaccines and treatments we would be ending the progress – started under Operation Warp Speed – that led to the fastest development of life-saving vaccines in history.”
Also pressing Biden were more than 100 House Democrats and ten senators, who in separate but similar letters said a waiver would be “vital to ensuring sufficient volume of and equitable access to COVID-19 vaccines and therapeutics around the world.”
“Congress has paid industry giants billions of taxpayer dollars to expedite research and development of COVID-19 vaccines and therapeutics,” they wrote. “The American people deserve the best possible return on that investment, not corporate monopolies that restrict access and threaten to extend the length of the pandemic.”
The signatories told Biden he had an opportunity “to reverse the damage done by the Trump administration to our nation’s global reputation and restore America’s public health leadership on the world stage.”
The senators’ letter called on Biden to “prioritize people over pharmaceutical company profits.”
‘Not a barrier, but a facilitator’
Not all Democrats are in favor of waiving IP protections, however.
During a discussion last month hosted by the Renewing American Innovation Project at CSIS, Sen. Chris Coons (D-Del.) said that in the context of the pandemic, IP has “not been a barrier but a facilitator of critical, cutting-edge innovation.”
“If we were to simply open up to the world all of the IP at the core of these groundbreaking developments, I think we would then be at risk of losing the private sector investment in development that’s critical to this moment of personalized medicine, of breakthrough vaccines and breakthrough medical diagnostics, and I think frankly the world would suffer as a result,” Coons warned.
“I don’t think that waiving IP rights will suddenly enable others the ability to ramp up the manufacturing of complex vaccines,” he said. “Instead I’m urging that the Biden administration and the private sector work together in a coordinated effort to manufacture, distribute and administer vaccines rapidly and equitably, globally.”
Also taking part in the CSIS event, Johnson & Johnson chief IP counsel Robert DeBerardine said the reason the company created a vaccine so quickly was because it already had a proprietary platform that had been developed over more than a decade, at the cost of hundreds of millions of dollars of investment (before last year’s significant public investment.)
DeBerardine said the biggest hurdles to getting vaccines administered widely around the world was not IP protections, but limited infrastructure.
Having control of the IP enables J & J to choose good partners around the world with which to work, he said, but “if you want to give everything to everybody, you may see a flood of vaccines, but you would have no idea if they’re safe or effective.”
Pointing to recent reports about counterfeit versions of the Pfizer vaccine turning up in Mexico and Poland, DeBerardine said if vaccine IP was made freely available, companies wouldn’t know whether the vaccines made around the world were authentic, or safe and effective.
Pfizer chief patent counsel Bryan Zielinski, also taking part, said it was the IP system that allowed vaccine manufacturers in the U.S. to rapidly create vaccines at a commercial scale, so quickly.
“We think that the IP system is critical in ensuring that these various technologies on different platforms all can be leveraged to create a portfolio of COVID-19 vaccines to be deployed around the world,” he said. “This is essential; patients need options for this. It’s going to continue to mutate and we’re going to need all these options to vaccinate everybody in the world.”
Asked how a TRIPS waiver may affect private investors Earl Bright, president and general counsel of health technology incubator t ExploraMe, said if a waiver robs investors of the abilit to get any kind of return, it would be both “unfair to them” but also discourage them from investing in the healthcare sector in the future.
“You know stealing, no matter for what reason, has a negative effect over time,” he said. “And it has a chilling effect on future activities.”