- within Food, Drugs, Healthcare and Life Sciences topic(s)
- in United States
- within Food, Drugs, Healthcare and Life Sciences topic(s)
On December 18, 2025, President Trump signed into law the BIOSECURE Act as part of the National Defense Authorization Act (NDAA), which is the U.S. Congress's annual defense policy bill.
The BIOSECURE Act is intended to strengthen protections around the U.S. biotechnology sector in response to concerns that companies linked to certain foreign governments—particularly China—are collecting genomic data from U.S. citizens, which could be used to identify genetic vulnerabilities in specific populations, accelerate China's own biotechnology capabilities and otherwise undermine the United States' competitive position in the biotech sector.
In particular, the law restricts U.S. federal agencies—and entities that receive U.S. federal grants or contracts—from procuring biotechnology-related services or equipment from companies linked to governments designated as "foreign adversaries," which the law defines as North Korea, China, Russia and Iran.
The BIOSECURE Act should not have any implications for Japanese pharmaceutical companies, except in two scenarios:
- Scenario 1: Where a Japanese pharmaceutical company both:
o (A) outsources all or part of its drug development or manufacturing activities to a company designated by U.S. regulators as having ties to a foreign adversary (e.g., a Chinese government-linked CDMO)—such entities being classified as "Biotechnology Companies of Concern"; and
o (B) sells, or plans to sell, such pharmaceutical products directly to U.S. Executive Agencies.
"Executive Agencies" include any executive department, a corporation owned or controlled by the U.S. government, or an independent establishment, which would include Department of Defense (DoD), Department of Veterans Affairs, Department of Health and Human Services and Department of Homeland Security.
- Scenario 2: Where a Japanese pharmaceutical company both:
o (A) receives, or plans to receive, U.S. federal funding to support new drug development; and
o (B) uses, or plans to use, such funding to procure equipment or services from a Biotechnology Company of Concern.
The BIOSECURE Act establishes two ways that companies can be designated as "Biotechnology Companies of Concern":
- by a rule-making process led by the Office of Management and Budget (OMB) ("OMB Rulemaking"); and
- by inclusion on a list of "Chinese military companies operating in the United States" that is updated by the DoD at least annual ("Section 1260H List").
To view the current Section 1260H List, please click here.
Notably, while there is a five-year grace period for preexisting contracts with entities designated as Biotechnology Companies of Concern through OMB Rulemaking, there is no such grace period for preexisting contracts with companies designated as Biotechnology Companies of Concern via the Section 1260H List.
To read our full client alert regarding the BIOSECURE Act, please click here.
Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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