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US Trade Representative Recommends Waiving COVID-19 Vaccine Patents

May 6, 2021
Critics say the move may undermine other vaccine distribution issues like raw material unavailability and safety.

On May 5, U.S. trade representative Katherine Tai announced the Biden administration supports waiving intellectual property protections for COVID-19 vaccines and will negotiate with other members of the World Trade Organization to do so.

If the other member countries of the World Trade Organization agree to a waiver, companies other than patent-holders will be allowed to produce drugs based on those under patent without the usual penalties. In the United States, most pharmaceutical patents last 20 years.

According to science publishing journal Nature, the actual creation of an international patent waiver may be a lengthy process: Member countries of the WTO will have to agree first on whether a waiver should be put in place at all before they begin to discuss the specifics of what vaccines or drugs it will apply to. South Africa and India have also proposed adding waivers to vaccines.

In a tweet, Tai said that the “extraordinary times and circumstances” of the COVID-19 pandemic “call for extraordinary measures.” In a statement, Tai said the Biden administration stands by intellectual property protections, but that it also aims “to get as many safe and effective vaccines to as many people as fast as possible.” She also said the administration would work with the private sector to expand production and distribution of the vaccine and raw materials to make it.

The private pharmaceutical sector has not responded positively to the recommendation, and pharmaceutical manufacturers say the move is more likely to hinder vaccine production than help it. Stephen Ubl, CEO of the Pharmaceutical Research and Manufacturers of America, said that waiving intellectual property productions would actually “undermine” the global pandemic response.

“This decision will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines,” Ubl warned, and said the recommendation ignores the issues of raw material unavailability and last-mile distribution.

The National Association of Manufacturers also criticized the recommendation. CEO Jay Timmons cautioned that the recommendation would exacerbate the existing challenges in manufacturing and distributing the drug.

“Rather than rushing to suspend critical protections and standards, investing in even greater production capacity would result in expanded vaccine access,” said Timmons.

The USTR recommendation, released May 5, comes on the heels of Pfizer’s May 4 quarterly earnings results. The New York pharmaceutical manufacturer saw revenues increase by 45% on a year-over-year basis, including $4.9 billion in vaccine revenue. BNT162b2, the company’s COVID-19 vaccine, contributed $3.5 billion. The day after the USTR recommendation, Moderna, Inc. released its own quarterly earnings, which showed that Q1 2021 was the company’s first-ever GAAP profitable quarter.

And on May 6, Pfizer announced it would be donating COVID-19 vaccines to athletes and delegations to the 2021 Olympic Games. “With hundreds of millions of vaccines already administered, and hundreds of millions more to go, Pfizer is committed, together with BioNTech, to doing all we can to help end this pandemic and help return the world to a sense of normalcy,” said Albert Bourla, Pfizer’s CEO.

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