Sunday, August 1, 2021

Will a waiver work? Don’t expect COVID-19 vaccine patents to lift quickly, if ever, analysts say


When the Biden administration unveiled its support for waiving patent protections for COVID-19 vaccines, the tremors were felt worldwide.

But less than a week later, the shock and awe has subsided and cooler heads are questioning whether the move would have an effect at all.

With existing vaccine producers ramping up supplies significantly and tough negotiations ahead to make the World Trade Organization (WTO) waiver a reality, can the initiative reach the finish line in time to make a difference? 

“There could be a significant delay between the WTO agreement on the waiver details and the increased supplies of vaccines,” wrote Thomas Hess, principal at Avalere Health.

In addition to the period needed to make the waiver happen, there would be a significant time gap to scale up manufacturing capacity, supply raw materials, hire and train employees on new technology platforms and manage import and export challenges, Hess pointed out.

RELATED: Biden administration backs proposal to suspend intellectual property on COVID-19 vaccines, angering industry

Cory Kasimov, a biotechnology expert at J.P. Morgan, took it a step further in a note to investors, suggesting the initiative was window dressing by the Biden administration.

“If this were to actually play out, there are certainly some draconian downside scenarios on a company and industry level,” Kasimov wrote. “But at this stage, we’re assuming this is more noise than anything else.” 

The United States initially opposed the waiver when it was presented in October by a group of countries, including South Africa and India, who contend that lifting the Trade-Related Aspects of Intellectual Property Rights (TRIPS) would make vaccines more readily available around the world.

In a letter to colleagues which he posted on Linkedin, Albert Bourla the CEO of Pfizer, one of the most prolific producers of COVID-19 vaccines, wrote that the scarcity of raw materials to produce vaccines is causing a bottleneck in vaccine production and that waiving patent protections would only exacerbate the problem.

“It will unleash a scramble for the critical inputs we require,” Bourla wrote. “Entities with little or no experience in manufacturing vaccines are likely to chase the very raw materials we require to scale our production, putting the safety and security of all at risk.”

Moderna’s CEO Stéphane Bancel made similar points on a conference call last week. In addition, Bourla echoed industry sentiment as he warned that waiving patent protection will “disincentivize” companies from taking a big risk.

“We deployed $2 billion before we knew whether we could successfully develop a vaccine because we understood what was at stake,” Bourla wrote.

On the flip side, groups such as Oxfam and Public Citizen have lauded the Biden administration’s move. They thanked administration for challenging the pharma industry’s position.

RELATED: Moderna CEO says he’s not losing any sleep over Biden’s support for COVID-19 vaccine waiver

When U.S. trade representative Katherine Tai announced Biden’s support of the measure, she said that the “extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures.” 

But perhaps even more extraordinary would be to actually get the measure done and have it make a real impact. 

The best way to solve the pandemic, according to Gillian Woollett, the principal research scientist at Avalere, is through cooperation between vaccine makers and needy countries. 

“Waiving patents sets an unfavorable precedent for continued innovation and investment in the next generation of pandemic countermeasures and is unlikely to deliver more vaccine doses faster,” Woollett wrote. “Effort should be placed behind expanding capacity, improving access to raw materials and donating existing supplies to areas of need.”



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