BIOSECURE Act Returns to Congressional Agenda with Revised Amendment Targeting Chinese Biotechnology Companies
核心洞察
The BIOSECURE Act has re-emerged in Congress through a bipartisan amendment to the National Defense Authorization Act of 2026, after failing to pass in 2024.
The revised version removes specific company names like WuXi AppTec and instead uses broader criteria based on the Department of Defense (搜索)'s List of Chinese Military Companies.
The legislation aims to prohibit federal agencies from contracting with Chinese biotechnology companies deemed to pose national security risks, with potential significant impacts on pharmaceutical supply chains.
The controversial BIOSECURE Act has returned to the U.S. legislative agenda through a revised bipartisan amendment submitted by Senators Bill Hagerty (R-TN) and Gary Peters (D-MI) to the National Defense Authorization Act of 2026. The amendment passed through both Senate and House versions of the NDAA, marking a potential comeback for legislation that stalled in 2024 despite bipartisan support.
Key Changes Address Previous Concerns
The 2025 amendment represents a significant departure from the 2024 version that explicitly named Chinese companies as "biotechnology companies of concern" (BCCs). Most notably, the revised legislation no longer specifically identifies WuXi AppTec, WuXi Biologics, BGI (搜索), MGI (搜索), and Complete Genomics (搜索) by name—a change that addresses due process concerns raised by critics.
"Generally, [certain Senators] opposed the previous iteration's explicit naming of certain entities and, in their view, its insufficient protections for due process," explained law firm Arnold & Porter (搜索) in August 2025.
Instead, the amendment establishes two pathways for designating BCCs. The first automatically includes entities listed in the Department of Defense (搜索)'s "List of Chinese Military Companies," which currently includes BGI (搜索) Group companies but excludes WuXi AppTec and WuXi Biologics. The second pathway allows the Office of Management and Budget (搜索) director to designate companies that are controlled by foreign adversary governments, involved in biotechnology services, and pose national security risks.
Implementation Timeline and Grandfathering Provisions
The legislation maintains different implementation timelines based on designation method. Companies on the Defense Department's list would face restrictions 60 days after Federal Acquisition Regulation revisions, while OMB-designated companies would have 180 days. The amendment preserves a five-year grandfathering window for existing contracts with OMB-designated BCCs, though this protection does not extend to companies on the military list.
"There are no companies explicitly identified in the new legislation; however, WuXi AppTec and others could potentially be designated as a biotechnology company of concern," noted law firm Goodwin (搜索).
Industry Impact and Supply Chain Disruption
The pharmaceutical industry has expressed significant concerns about potential supply chain disruptions. WuXi AppTec operates one of the largest biologics manufacturing networks globally and serves as a frequent partner among major pharmaceutical companies. GlobalData (搜索) analysis from 2024 indicated that the pharmaceutical industry could face significant destabilization due to BIOSECURE legislation.
GlobalData (搜索) Life Sciences research analyst Cyrus Fan commented: "The amendments to the Senate's Biosecure Act give some relief for the biopharma industry. In the original bill, the inclusion of the WuXi companies had caused concern within the biopharma industry, as the companies are key to a significant number of US-based manufacturer supply chains."
However, Fan noted continued uncertainty about whether the Act will become law, given its exclusion from defense legislation in 2024.
New Exceptions and Waiver Provisions
The revised amendment introduces a new exception for medical countermeasures, medical products, and related supplies procured in direct response to declared public health emergencies. This addition to existing exceptions for intelligence activities and certain overseas healthcare services reflects lessons learned from recent public health crises.
The legislation maintains waiver provisions allowing agency heads to exempt contracts for national security interests, including overseas healthcare supporting U.S. government employee missions. Waivers last one year with a possible 180-day extension.
Legislative Outlook
The amendment's inclusion in both House and Senate NDAA versions increases its chances of becoming law, as presidential approval of defense authorization acts is typically considered certain. Law firm Goodwin (搜索) stated: "The next step is for the House of Representatives and Senate to reconcile their versions of the NDAA. We do expect to see BIOSECURE 2.0 (as we are calling it) in the final."
If not included in the NDAA, sponsors could pursue alternative legislative vehicles such as end-of-year funding packages or continuing resolutions. The legislation's revival comes as the Trump administration has shown renewed interest in manufacturing onshoring and pharmaceutical supply chain security.
Company Responses and Ongoing Opposition
The named Chinese companies have maintained their opposition to the legislation. WuXi has previously called it "a pre-emptive and unjustified designation," while BGI (搜索) characterized the bill as containing "falsehoods and baseless allegations." Both companies have emphasized their compliance with data privacy laws and denied ties to the Chinese government or military.
Critics continue to argue that restricting Chinese biotechnology companies could impede scientific progress, disrupt drug development supply chains, and hinder efforts to address global health challenges. They warn that isolating the U.S. from international biotechnology collaboration could undermine competitiveness and slow medical advancements.