California Life Sciences urges President Biden to support the life sciences ecosystem by opposing proposed IP giveawayBack
October 25, 2022
President Joseph R. Biden
The White House
1600 Pennsylvania Ave., NW
Washington, DC 20500
Dear Mr. President,
The Council of State Bioscience Associations (CSBA) 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 US Government’s support for an intellectual property (IP) waiver would have serious consequences for the companies CSBA represents, namely small and medium sized enterprises (SMEs) — 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 September 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 EO itself, which is to ensure United States’ global leadership in the field of biotechnology.
Protecting America’s SMEs
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 over 28 States. A waiver of IP rights applied to COVID-19 therapeutics would give away the tremendous innovative potential, benefitting 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 US 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 [email protected] with any questions.
Arizona BioIndustry Association, Inc.
California Life Sciences
Southern California Biomedical Council
Colorado BioScience Association
Delaware BioScience Association
CGHI: Georgia Bio
Idaho Technology Council
Illinois Biotechnology Innovation Organization
Indiana Health Industry Forum
Iowa Biotechnology Association
Kentucky Life Sciences Council
Bioscience Association of Maine
Maryland Technology Council
Massachusetts Biotechnology Council
Michigan Biosciences Industry Association
Medical Alley Association
Missouri Biotechnology Association
Montana BioScience Alliance
Nevada Biotechnology & Health Science
New Mexico Biotechnology & Biomedical Association
North Carolina Biosciences Organization
Bioscience Association of North Dakota
Oklahoma Bioscience Association
Oregon Bioscience Association
Life Sciences Pennsylvania
Rhode Island Bio
South Carolina BIO
South Dakota Biotech Association
Life Science Tennessee
Texas Healthcare and Bioscience Institute
Vermont Biosciences Alliance
Virginia Biotechnology Association
Life Science Washington
Bioscience Association of West Virginia