BIOSECURE Act Timeline

The BIOSECURE Act passed the House of Representatives on September 9, 2024, with a bipartisan vote of 306–81. It has now moved to the Senate, which has its own version of the BIOSECURE Act already in play. If passed by the Senate and signed into law, this legislation would prohibit federal agencies from procuring, purchasing, or obtaining biotechnology equipment or services from a biotechnology company that is controlled or operated on behalf of a foreign adversary, most notably China. This includes several explicitly named Chinese companies and entities associated with those companies or the Chinese government. For a detailed overview of the original version of the act, read our alert “The BIOSECURE Act and Its Potential Implications.”

Below, we provide a short timeline of the BIOSECURE Act’s actions so far.

• December 2023/January 2024: The BIOSECURE Act was introduced — The Senate introduced its version of the act (S 3558) in December; the House introduced its version (HR 8333, formerly HR 7085) in January. 
• March 2024: Senate committee approval — The Senate Committee on Homeland Security and Governmental Affairs drafted an amendment and advanced S 3558 to the full Senate for a vote. 
• May 2024: House committee approval — The House Committee on Oversight and Accountability held a markup session and drafted an amendment, advancing it to a full House vote. This amendment includes a safe harbor provision and grandfather clause that would allow existing contracts with Chinese companies until January 1, 2032. 
• September 2024: House passed the bill — The House passed HR 8333 on September 9, including the amendment.

A full Senate vote on either the Senate version (S 3558) or the House version (HR 8333) is the next key milestone.

These bills differ in a few fundamental regards:

• S 3558 lists the following entities as “biotechnology companies of concern”: BGI, MGI, Complete Genomics, and WuXi AppTec. HR 8333 lists these entities as well as WuXi Biologics. Both bills give the federal government wide authority to name other entities in the future.
• HR 8333 includes wind-down provisions that would shield certain arrangements with named biotechnology companies of concern from BIOSECURE implications (if in effect as of the effective date of the legislation) until January 1, 2032. S 3558 does not contain a similar date; however, it does clarify that BIOSECURE implications would not apply to arrangements with named biotechnology companies of concern if in effect as of the effective date of the legislation.
• HR 8333 clarifies that the BIOSECURE Act’s implications for federal contracts would only apply to government contracts governed by the Federal Acquisition Regulation. S 3558 does not contain a similar provision.
• Finally, HR 8333 includes a safe harbor provision making it clear that the term “biotechnology equipment or services produced or provided by a biotechnology company of concern” does not include biotechnology equipment or services that were previously — but are no longer — produced or provided by those biotechnology companies of concern. S 3558 does not contain a similar provision.

If the Senate passes HR 8333 without further amendment, it will proceed to the president for signing. However, if the Senate version passes or the Senate introduces changes to HR 8333, the House needs to either accept them or send the bill to a conference committee to reconcile any differences.

Should the Senate and House agree on a version of the bill, agencies will begin enforcing the new rules upon the president’s signature. With the high level of bipartisan support, many commentators believe that the BIOSECURE Act will pass.

Contact Matt Wetzel to discuss the implications of the BIOSECURE Act for your business and learn how to be added to our BIOSECURE Update Distribution List. 

This informational piece, which may be considered advertising under the ethical rules of certain jurisdictions, is provided on the understanding that it does not constitute the rendering of legal advice or other professional advice by Goodwin or its lawyers. Prior results do not guarantee a similar outcome.