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COVID vaccines

Biden's vaccine patent waiver just start of global supply challenge

Complex tech and limited components restrict production, drugmakers say

President Joe Biden arrives at the State Dining Room of the White House on May 5. The U.S. announced support for a temporary waiver on patent protections for COVID-19 vaccines.   © AP

WASHINGTON/VIENNA/TOKYO -- President Joe Biden's decision to back a waiver on patent protections for COVID-19 vaccines lowers one hurdle to broader production, but the specialized skills required in quality control and manufacturing look likely to create another bottleneck.

The U.S. announced support Wednesday for temporarily suspending enforcement of the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) for vaccine patents. The move by one of the WTO's most powerful members opens the door for negotiations to move forward.

The waiver has been pushed by India -- as the country confronts a devastating second wave of coronavirus cases with vaccines in short supply -- and by South Africa. Both have sought support from the advanced economies where vaccine makers are headquartered.

French President Emmanuel Macron told reporters Thursday that he is "absolutely in favor" of a waiver.

"Our real bottleneck, what is making it difficult to provide access to vaccines," is "the transfer of technologies and production capacity," he said.

A vaccination center in Mumbai: Vaccines are in short supply in India as the coronavirus outbreak there continues to rage.   © Reuters

Germany is less enthusiastic about the proposal. Foreign Minister Heiko Maas said Thursday that while Berlin is "ready to have that discussion," it is not the top priority.

"We are in such a state of urgency that it would be wrong not to take all possible measures that would improve supply, and at the moment that's increasing production," he said.

The pharmaceutical industry is vehemently against the move, asserting that exempting vaccines from patent protections would do more harm than good.

"Discussions to waive intellectual property will do nothing to produce more doses in the world because there is no infrastructure in the world, particularly for our vaccine," Pfizer CEO Albert Bourla said in a virtual interview Thursday with Nikkei. "The mRNA vaccine is very new. No manufacturer in the world is capable of producing [one] like ours."

The global supply could even become lower than it would be otherwise, said Bourla, whose company partnered with Germany's BioNTech to develop its vaccine.

"Right now, every single gram of raw material" is "immediately converted" into vaccine doses, he said. Eliminating the patent barrier would create a rush of demand for these components from other countries, but "they won't be able to find a way to convert [them] into doses -- none of them will be able to do it within one or two years."

Moderna, which also produces a mRNA-based vaccine approved in the U.S. and Europe, was similarly skeptical of the immediate impact of a patent waiver.

"They will have to go run a clinical trial, get the data, get the product approved and scale manufacturing. This does not happen in 6 or 12 or 18 months," Moderna Chief Executive Stephane Bancel said on a post-earnings conference call.

The global supply of the technology and talent needed to handle production also is limited. Japan, for example, has only five companies with the necessary capabilities.

The question of how to handle patent protections on pharmaceuticals during a disease outbreak has been debated for many years. It was brought into the spotlight around 2000, when developing countries suffering from AIDS epidemics had difficulty accessing treatments from American and European drugmakers due to high prices.

The 2001 Doha Declaration on TRIPS and Public Health included a provision allowing for WTO members to grant compulsory licenses without the consent of patent holders in emergencies. In the 2000s, countries including Thailand, Indonesia and Mozambique issued compulsory licenses for antiretroviral drugs to treat AIDS.

But the process is slow and complex. India and South Africa have argued that a patent waiver on coronavirus vaccines is necessary to speed up supply.

Additional reporting by Yuko Nomura in New York

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