Expanding COVID IP waiver would harm small, medium enterprises, CSBA says

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

In June, the WTO agreed to waive IP protections for COVID-19 vaccines, a decision supported by the Biden administration. The WTO is now considering expanding the waiver to include COVID-19 therapeutics and diagnostics.

Here is the text of the letter.

Dear Mr. President,

The Council of State Bioscience Associations is a coalition of independent, state and territory based non-profit trade associations, each of which advocates for public policies that support responsible development and delivery of innovative life-enhancing and life-saving biotechnology solutions. We write today to express our serious concerns with the proposed expansion of the WTO TRIPS waiver to include not only vaccines, but also COVID-19 therapeutics and diagnostics.

The U.S. government’s support for an intellectual property waiver would have serious consequences for the companies CSBA represents, namely small and medium sized enterprises -- most of which have yet to bring a product to the market.

Inconsistency with the executive order

A waiver would allow U.S.-developed innovative technologies to be manufactured overseas and exported without regard to intellectual property protections, meaning that U.S. biomanufacturing jobs would be lost. There is no question that waiver expansion is inconsistent with your executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy, issued on Sept. 12.

The executive order states that the U.S. must “safeguard the United States bioeconomy, as foreign adversaries and strategic competitors alike use legal and illegal means to acquire United States technologies and data ... and proprietary or precompetitive information, which threatens United States economic competitiveness and national security.”

While we applaud your leadership in issuing this executive order, a TRIPS waiver expansion would fundamentally undermine a key objective of the order itself, which is to ensure United States’ global leadership in the field of biotechnology.

Protecting America’s small- and medium-sized enterprises

Over 50% of COVID-19 therapeutics in development worldwide originated in the United States thanks to the robust entrepreneurial and innovative biotech ecosystem in our country. Of the over 350 therapeutics being developed in the United States, 86% -- totaling 307 therapeutics -- originated from SME biotech firms spanning more than 28 states. A waiver of IP rights applied to COVID-19 therapeutics would give away the tremendous innovative potential, benefiting America’s foreign competitors at the expense of hundreds of U.S.-based biotech firms.

Furthermore, over 60% of all COVID-19 therapeutics in development have other indications beyond COVID-19. Accordingly, waiving IP rights for these therapies could unintentionally impact medicines across a range of therapeutic areas and would result in a disproportionate impact on U.S.-based enterprises, particularly the U.S. based entrepreneurial and SME biotech community. 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.

Global voluntary licensing agreements abound

There is no global supply challenge that justifies the extension of an IP waiver to therapeutics and diagnostics. 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. Through these collective efforts, our members are illustrating the impact of collaborative, as opposed to coercive, approaches to technology transfer and IP licensing. These collaborations strengthen global interconnectedness and efficiently address global demand for therapeutics(see Annex for a representative list of current global R&D and manufacturing collaborations).

Alternatives for consideration

As an alternative to the Geneva-driven WTO TRIPS waiver discussion, we encourage the Administration to consider and propose other potential options that more concretely address genuine public health concerns that would improve the management of COVID-19 and, consequently, the health of vulnerable populations around the world. 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.

The White House National COVID-19 Preparedness Plan commits that the United States would be the “world’s arsenal of vaccines.” The President’s Action Plan on Resilience in the Americas provides an effective model for U.S. leadership in responding to the global pandemic.

CSBA shares a key tenet of the recent White House executive order, which is to maintain United States technological leadership and economic competitiveness in biotech and biomanufacturing innovation. To truly be the world’s arsenal of COVID-19 vaccines and therapeutics and to realize the full potential of the executive order, there is no other decision to make than to firmly oppose the expansion in any form of the WTO TRIPS waiver to COVID-19 therapeutics and diagnostics.

Please contact CSBA Executive Director, Michele Oshman at moshman@bio.org with any questions.

Sincerely,