US backs temporary waiver of IP rights for COVID-19 vaccines

The US will support a proposal to temporarily lift intellectual-property (IP) protections for COVID-19 vaccines, joining an effort to increase supply and access of the inoculations around the world. In a move that marks a turn around from the government's previous opposition to the waiver, US trade representative Katherine Tai said Wednesday that while the Biden administration "believes strongly" in IP protections, "we are for what the proponents of the waiver are trying to accomplish, which is better access, more manufacturing capability, more shots in arms."

The news sent stock prices of major COVID-19 vaccine developers on a downward slope, with Moderna, BioNTech and Novavax shares falling as much as 9.7%, 8.9% and 11%, respectively. Meanwhile, Pfizer shares slipped as much as 2.6%, a day after saying it expects its BioNTech-partnered coronavirus vaccine to reach sales of $26 billion this year.

Drugmakers have argued that suspending IP rights would not be effective anyway, as even if countries knew the COVID-19 vaccine formulas, few have the capabilities to manufacture them. They have also highlighted the limited global supply of raw materials, and that building new factories equipped with the technology required for production could be years away.

Trade rep warns talks will 'not be easy'

Still, Tai said the US would "actively participate" in negotiations at the World Trade Organization (WTO) on the text of the waiver, but cautioned that those discussions will take time and will "not be easy" given the complexity of the issue and the consensus-based nature of the institution. "As our vaccine supply for the American people is secured, the administration will continue to ramp up its efforts — working with the private sector and all possible partners — to expand vaccine manufacturing and distribution," Tai said, adding "it will also work to increase the raw materials needed to produce those vaccines." She recently met with executives at Pfizer and AstraZeneca, as well as Seth Berkley, chief executive Gavi, the Vaccine Alliance, to discuss the IP waiver.

The original proposal was put forth at the WTO by India and South Africa last October to allow countries to temporarily sidestep patent protections for pandemic-related medical products. The measure now has the backing of dozens of countries, although the administration under former US President Donald Trump was against the plan, while the UK, EU and Switzerland have also been holdouts.

In November, the EU put together an action plan aimed at "making sure that critical IP can be made available" during emergency situations, even without the consent of patent owners. However, the EU has since signed multiple deals with pharmaceutical companies to secure COVID-19 vaccines and therapeutics for its population, and last week the European Parliament rejected a call to back India and South Africa's IP waiver plan for coronavirus vaccines. Meanwhile, at a WTO meeting on Wednesday, India and South Africa agreed to revise their proposal to present to members for another meeting tentatively scheduled for the second half of May.

'Who will make the vaccine next time?'

Industry response included a statement from Moderna saying it feels a "special obligation" to help bring the pandemic to and end, and so "while the pandemic continues, [we] will not enforce our COVID-19-related patents against those making vaccines intended to combat [COVID-19]." Moreover, the company added that in order to "eliminate any perceived IP barriers to vaccine development during the pandemic period, upon request we are also willing to license our [IP] for COVID-19 vaccines to others for the post-pandemic period."

However, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) called the Biden administration's support for waiving patents of COVID-19 vaccines "the wrong answer" to a complex problem. The group suggested the real challenges are trade barriers, bottlenecks in supply chains, scarcity of raw materials, and "willingness by rich countries to start sharing doses with poor countries." Meanwhile, Allgeran CEO Brent Saunders posted a tweeted asking, "Who will make the vaccine next time?"

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