The BIOSECURE Act: Key implications for U.S. Biotechnology, National security, and Federal funding

Abstract

The BIOSECURE Act is aimed at ensuring that U.S. taxpayer money isn’t going to fund biotech-aligned companies that can threaten national security. Specifically, the legislation prohibits federal contracting with companies tied to “foreign adversaries.” The legislation is a continuation of an earlier version that clearly targeted few key Chinese biotech firms. The law has laid out the process through which companies can be designated or exempted with an appeal process also provided. While the law does not name specific biotechnology companies of concern, the focus remains on some of Chinese entities. There will be pressure on U.S. companies to do reshoring of their manufacturing capabilities and adopt a China plus one strategy. The legislation also provides an opportunity for contract manufacturers/CDMOs including those from India, to make inroads in the U.S. market. Companies need strong cross-functional coordination and flexible strategies to maintain market access and resilience.

Conclusion: In the post-BIOSECURE environment, firms must comply with the Act’s restrictions while also identifying and taking advantage of new opportunities it creates.