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Where things stand with the TRIPS waiver

It’s been a while since we’ve talked about what’s going on at the WTO. Here’s the latest news — and why extending the waiver of COVID-19 vaccine IP is still a bad idea.

The status: The World Trade Organization is considering continuing to waive certain intellectual property rights on COVID-19 diagnostics and therapeutics, following a recent decision to do the same for vaccines with the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights for COVID-19 vaccine technology.

Every member of the Council of State Bioscience Associations, including NCBIO, signed a letter to President Joe Biden expressing serious concerns with the proposed expansion of IP protections for COVID technology.

U.S. Senators Tom Carper (D-Del.) and Pat Toomey (R-Pa.) led a bipartisan group of senators that includes North Carolina Senators Richard Burr and Thom Tillis in writing U.S. Trade Representative Katherine Tai to urge the Biden Administration to safeguard American innovation in the World Trade Organization’s negotiations.

We’ll say it again: Any extension of the TRIPS waiver will compromise global vaccination efforts, undercut American innovation, and jeopardize our ability to respond to future pandemics.

The waiver extension would make vaccines MORE expensive. The average cost of a new vaccine manufacturing facility is $700 million, BIO President and CEO Michelle McMurry-Heath, M.D., Ph.D., said in a STAT op-ed. Additionally, a waiver extension could cause competition for raw materials, leading to price increases of materials and, ultimately, vaccines.

North Carolina jobs depend on strong IP protections. Of the over 350 therapeutics being developed in the United States, 86% — totaling 307 therapeutics — originated from small- and medium-size enterprise biotech firms spanning over 28 states, the letter states. 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.

And there’s just no justification. 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.

What’s the alternative? 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.

TRIPS sets a bad precedent with regards to IP protection, causing a ripple effect throughout the biotech sector in North Carolina and the United States. “The innovation coming out of our 48 state affiliates and their member companies bolsters a robust economy across the country. We cannot afford to lose IP protections that advance these critical discoveries,” said Michele Oshman, BIO’s VP for external affairs and executive director of the Council of State Bioscience Associations.

The bottom line: We encourage policymakers to consider and propose policies that more concretely address public health concerns to improve the management of COVID-19, such as strengthening health systems’ infrastructure, addressing vaccine hesitancy, and supporting more robust COVID-19 testing and therapeutic procurement initiatives. Solutions to advance the global response to the COVID-19 vaccine cannot come at the expense of North Carolina’s innovation economy.