Biden Administration Makes Official Call on COVID-19 Vaccine IP Waiver

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These are extraordinary times. Do they call for exceptional measures like waiving intellectual property (IP) protections for COVID-19 vaccines to assist the many countries where the virus is still raging? On Wednesday, the Biden administration said ‘yes.’

“This is a global health crisis, and the extraordinary circumstances of the Covid-19 pandemic call for extraordinary measures,” said United States trade representative, Ambassador Katherine Tai in a statement outlining the United States' position. “The administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines. We will actively participate in text-based negotiations at the World Trade Organization (WTO) needed to make that happen."

As the World Trade Organization (WTO)’s General Council continues to meet this week, India and South Africa are imploring the organization to waive trade-related aspects of the current intellectual property agreement that protects pharmaceutical trade secrets.

In October, the two countries put together a proposal that would suspend certain provisions of the WTO’s current Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), to make it easier for developing countries to manufacture or import COVID-19 vaccines, diagnostics and therapeutics. The meetings this week are in response to this request. It is the eleventh meeting on the subject in seven months.

"In this pandemic, vaccines as well as diagnostic kits, ventilators, and other essential provisions are covered by Trips so a firm in SA or India or Brazil may not utilize their intellectual knowledge without the agreement of the patent holder. What the waiver would do, for a limited time, it would exempt certain kinds of products from the Trips agreement and enable countries and firms to produce those on scale, that's the heart of the proposal,” said Ebrahim Patel, South African Trade, Industry and Competition Minister, in April.  

Pressure had been mounting in recent weeks for the Biden-Harris administration to put a temporary pause on certain aspects of TRIPS, which requires all 164 member countries – with the exception of the least-developed – to protect the IP rights of their peers.

Critics have expressed concern that the move would take away incentives for pharma companies to keep innovating. But Stanford law professor Lisa Larrimore Ouellette questioned the rationale behind these fears.

“I don’t understand the strength of their opposition in this context because the WTO’s IP waiver would not force them to give up what is actually the most valuable IP here, which is the secrets and the know-how that they have for manufacturing the vaccine,” Ouellette told BioSpace. “I think the concern may be with the longer-term incentives going forward if it becomes normal that in a time of health crisis, IP rights are not respected. I think there’s a concern about what precedent that sets for creating incentives for products that would help in the crisis.”

While the U.S. had been one of a few rich nations holding out – along with Canada, the European Union and Britain – on some level, Wednesday’s announcement of support for the proposal is not unexpected.

While a presidential candidate, Biden took part in a series of meetings with Medicare for All activist and amyotrophic lateral sclerosis (ALS) patient advocate Ady Barkan. During these meetings, Biden promised that if the U.S. developed a vaccine for the coronavirus first, he would “absolutely positively” share access and the technology used to create such a vaccine.

But does the U.S. support come too late for countries like India, which is currently the epicenter of the COVID-19 crisis? As of this morning, there were 21,077,400 confirmed cases of COVID-19 in the country, and 230,168 confirmed deaths, representing a 46% increase over the past two weeks.  

“Those negotiations will take time given the consensus-based nature of the institution and the complexity of the issues involved,” Tai said in Wednesday’s statement. 

Given this complexity, even a final decision this week would likely do little to help with the current crises in India and Brazil.

“I think it’s important to know that, even if the IP waiver happens today, that would not help India right now with this crisis. What it would do is remove one potential barrier to a company that wants to produce its own version of a vaccine that’s under IP protection, but it’s not going to rapidly increase supply because even if the original manufacturer of the vaccine helps that new company actively transfer the technology, it takes time to get the manufacturing up and running,” Ouellette said.

"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 stated. “It will also work to increase the raw materials needed to produce those vaccines.”

Unsurprisingly, representatives from the private sector, specifically the U.S. pharmaceutical industry, are nonplussed.

Steve Ubl, president and CEO of PhRMA, came out with an unequivocal statement in opposition of the move this morning.

 “This change in longstanding American policy will not save lives. It also flies in the face of President Biden’s stated policy of building up American infrastructure and creating jobs by handing over American innovations to countries looking to undermine our leadership in biomedical discovery,” Ubl said. “This decision does nothing to address the real challenges to getting more shots in arms, including last-mile distribution and limited availability of raw materials.”

Stock market reactions were swift, as investors watched shares of Pfizer, Moderna, Novavax and U.S. shares of Germany-based BioNTech open 2-6% lower on Thursday morning. BioNTech took the biggest hit, as its Frankfurt-listed shares fell by as much as 19%.

Despite “very active” conversations with its G7 counterparts, Canadian Foreign Affairs Minister Marc Garneau said Thursday that Canada is still weighing its options.

“Canada’s position is that we need to obtain more vaccines, we need to all put more money into the COVAX program, and by the way Canada is the fourth largest contributor to the COVAX program, and we need to discuss with manufactures whether they’re prepared to make licensing arrangements to allow greater production of the vaccine,” Garneau told CTV News.

As to when a final decision will come down from the WTO in response to the proposal, Tai stated earlier this week:

“As with everything in this pandemic, time is of the essence.”