The BIOSECURE Act, first introduced in Congress last year, has now been reintroduced for inclusion in Senate’s draft of the annual National Defense Authorization Act (NDAA) for FY2026. The NDAA is a must-pass piece of legislation that often ends up as a vehicle for moving many different bills forward—and reflects a complex process that epitomizes DC horse-trading. As originally proposed, the Act sought to restrict federal funding and contractual relationships between the U.S. government and any entities engaging with “biotechnology companies of concern” for the procurement of equipment or services. In practice, the Act would force biopharmaceutical companies to sever ties with Chinese biotechs. The reintroduced version retains much of the substance of prior House and Senate iterations, although certain revisions may significantly impact a subset of existing relationships with Chinese biotechs.
Revisions to the BIOSECURE Act. The revised draft of the Act seeks to address a number of the concerns raised by the first iteration of the proposed legislation.
As initially proposed, the Act had expressly identified WuXi AppTec, MGI, BGI, Complete Genomics, and (in the House draft only) WuXi Biologics. The revised text no longer identifies specific entities. Rather, the text expands on the procedure by which the list of biotechnology companies of concern would be prepared by the Director of the Office of Management and Budget (OMB). Such list would be published within one year of the enactment of the Act. Notably, this list would include entities identified in the annual list published in the Federal Register by the Department of Defense of Chinese military companies operating in the United States pursuant to Section 1260H of NDAA for FY2021 (the 1260H List). The earlier iterations of the Act did not leverage the 1260H List in identifying biotechnology companies of concern. While MGI and BGI were included on the 2025 iteration of the 1260H list, the list does not include Complete Genomics or any WuXi entity.
Additionally, earlier iterations of the Act had included broad transitional language that would have given entities until January 1, 2032 to phase out any existing contractual relationships with Chinese biotechs. Under the revised version of the Act, there would be no grace period for contracts with entities on the 1260H List. With respect to any other Chinese biotech not included on the 1260H List, companies would have five years from the date that such Chinese biotech was designated a biotechnology company of concern to exit any pre-existing arrangements.
Certain core features of the BIOSECURE Act as originally proposed remain intact. For example, impacted entities may still apply for a one-year waiver under the Act’s requirements (which may be further extended on a one-time basis for an additional 180 days). Additionally, the definition of “biotechnology equipment or service” has generally remained unchanged – although the amended list now omits “combined mass spectrometry technologies” and “polymerase chain reaction machines” that were previously included.
Current Stage of Legislation. At this stage, the outlook for the new BIOSECURE Act is uncertain. The sponsors of the new bill are hoping their changes are enough to address critics’ concerns but they still need to convince House and Senate gatekeepers. The chairs of the key committees – here, primarily the chair of the Senate Homeland Security and Government Affairs Committee, Senator Rand Paul (KY) -- have significant discretion over whether bills end up included in the massive NDAA package. Chairs can hold up a bill over substantive objections, either forcing changes or blocking it entirely, or trade inclusion for other legislative priorities. Even if a bill is included in the final NDAA package, it can fall out through late amendments and dealmaking.
Notably, the previous iteration BIOSECURE Act reached this stage, too. The House passed the bill in September of 2024, but it was left out of the Senate NDAA.
Implications. While the BIOSECURE Act’s future yet remains unclear, the revisions may meaningfully impact biopharmaceutical companies partnering with Chinese biotechs. Importantly, the exclusion of entities on the 1260H List from the applicable phase-out period could necessitate an abrupt termination of these arrangements, affording companies little opportunity to transition supply chains or modify their business operations.
Looking Ahead. While industry response to the revival of the BIOSECURE Act has been relatively muted, additional reactions from key stakeholders in the biopharmaceutical industry and in China are expected if the Act gains additional traction later this year. The House and Senate are expected to advance their respective versions of the NDAA in September, with final passage of the legislation typically slated for late November or (more likely) right before the December holidays. If BIOSECURE isn’t included in the NDAA package, observers suggest its sponsors may try to get it included in another package, such as the year-end funding legislation. Freshfields’ Life Sciences and Congressional Investigations practices will be watching.
