What’s happening with the COVID IP waiver expansion?

The United States and the Biotechnology Innovation Organization (BIO) have been taking action in light of ongoing negotiations concerning extending the Trade-Related Aspects of Intellectual Property Rights (TRIPS) waiver to COVID therapeutics and diagnostics.

Recently, World Trade Organization (WTO) members agreed to continue talking about the request to extend the COVID IP waiver beyond the initial deadline of December 17.

On December 6, the Office of the U.S. Trade Representative (USTR) announced they agreed with the decision to extend the deadline.

In a press release, Ambassador Katherine Tai stated, “Real questions remain on a range of issues, and the additional time, coupled with information from the [U.S. International Trade Commission], will help the world make a more informed decision on whether extending the Ministerial Decision to COVID-19 therapeutics and diagnostics would result in increased access to those products. Transparency is critical and USTR will continue to consult with Congress, stakeholders, and others as we continue working to end the pandemic and support the global economic recovery,”

The Biden administration cited the need for an interagency review of the proposed expansion, as well as an in-depth analysis from the USITC.

BIO expresses concerns about COVID IP waiver

A recent letter from BIO President and CEO Rachel King to Ambassador Katherine Tai and White House COVID-19 Response Coordinator Ashish Jah stated that the expanded waiver “would send U.S.-developed innovative technologies and biomanufacturing jobs overseas.”

As a result, this would “weaken the ability for U.S. biotech firms—including the hundreds of small and medium-sized enterprises (SMEs) involved in the development of COVID-19 therapeutics—to compete globally and grow jobs domestically.”

The letter continues that it is both unwarranted and at odds with President Biden’s Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.

Expect more activity in 2023, with USITC’s Federal Register notice to launch its investigation and at least one hearing. We’ll continue to follow this issue.

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