Expanding WTO IP waiver would hurt SMEs, CSBA tells Biden

Every member of the Council of State Bioscience Associations (CSBA) signed a letter to President Biden expressing serious concerns with the proposed expansion of a WTO waiver removing IP protections for COVID-19 technology, Good Day BIO reports today.

The WTO is now considering a waiver of international IP protections for COVID-19 therapeutics and diagnostics. This would be an expansion of a waiver of IP protections for COVID-19 vaccines that the WTO approved in June, with support from the Biden administration.

Serious consequences for SMEs

A new waiver would have “serious consequences…for small and medium enterprises (SMEs)—most of which have yet to bring a product to the market,” according to the CSBA letter.

“Of the over 350 therapeutics being developed in the United States, 86%—totaling 307 therapeutics—originated from SME biotech firms spanning over 28 states,” the letter explains. “For SME biotech firms, the expansion of a TRIPS waiver to therapeutics creates significant market risk for the commercialization of their products for indications unrelated to COVID-19.”

The letter notes that a waiver is not necessary to ensure global distribution of COVID technology. “Manufacturers are supplying therapeutics at a rate that outpaces demand. Biotech antiviral manufacturers have entered into dozens of voluntary licensing agreements with companies in South America, Africa, and Asia to manufacture generic antivirals and distribute these products to countries throughout the developing world,” it says.

More meaningful measures

“Strengthening health systems infrastructure, addressing vaccine hesitancy, and supporting more robust COVID-19 testing and therapeutic procurement initiatives are examples of some initiatives that can have a meaningful impact,” CSBA members say in the letter.

Every state biotech association signed the letter—“a sign of just how significant the issue of the TRIPS waiver is for our innovators across the country,” notes David Lachmann, BIO’s Senior Director of Federal Government Relations.