On January 25, 2024, Chairman of the House Select Committee on the Strategic Competition between the United States and the Chinese Communist Party (the "Select Committee"), Mike Gallagher (R-WI-8), and Ranking Member of the Select Committee, Raja Krishnamoorthi (D-IL-8), introduced the bipartisan BIOSECURE Act,1 a bill to ensure foreign adversary biotech companies of US national security concern do not gain access to US taxpayer dollars.2 Co-sponsors of the Act include Representatives Neal Dunn (R-FL-2), Seth Moulton (D-MA-6), and Jake Auchincloss (D-MA-4), as well as Senators Bill Hagerty (R-TN) and Gary Peters (D-MI and Chairman f the Homeland Security and Governmental Affairs Committee). Senators Mitt Romney (R-UT) and Roger Marshall (R-KS) also introduced corresponding legislation in the Senate. Biotechnology is also highlighted for US national security concern vis-à-vis China in other contexts, such as export control. As discussed below, the proposed bill continues the trend, names specific Chinese companies as the targets while providing a basis to designate additional "biotechnology companies of concern," and seeks to regulate both government and private dealings with these companies.
In general, if passed, the legislation would prohibit the heads of US executive agencies from:
- procuring or obtaining "any biotechnology equipment or service produced or provided by a biotechnology company of concern";
- entering into contracts or renewing contracts with any entity that "uses biotechnology equipment or services produced or provided by a biotechnology company of concern" or that will require "the direct use of biotechnology equipment or services produced or provided by a biotechnology company of concern"; and
- expending or obligating loans or grant funds to "procure or obtain any biotechnology equipment or services produced or provided by a biotechnology company of concern."3
Thus, the Act not only would prohibit the US government from dealing with or providing financing for equipment or service from a "biotechnology company of concern," but also it would extend the transaction ban to government contractors that are private parties.
The Act would define "Foreign Adversary" as the Democratic People's Republic of North Korea, the People's Republic of China, the Russian Federation, and the Islamic Republic of Iran.4 "Biotechnology companies of concern" would be defined as:
- BGI, MGI, Complete Genomics, Wuxi Apptec, and any subsidiary, parent affiliate, or successor of such entities (the "Named Biotechnology Companies of Concern"); and
- "[A]ny entity that— (i) is subject to the jurisdiction, direction, control, or operates on behalf of the government of a foreign adversary; (ii) is to any extent involved in the manufacturing, distribution, provision, or procurement of a biotechnology equipment or service; and (iii) poses a risk to the national security of the United States based on—
(I) engaging in joint research with,
being supported by, or being affiliated with a foreign
adversary's military, internal security forces, or intelligence
agencies;
(II) providing multiomic data obtained via biotechnology equipment
or services to the government of a foreign adversary; or
(III) obtaining human multiomic data via the biotechnology
equipment or services without express and informed
consent."5
Moreover, under the Act, no later than 120 days after the date of its enactment, the Director of the Office of Management and Budget, in consultation with the Secretaries of Defense, Health and Human Services, Commerce, Homeland Security, and State, the Attorney General, and the Director of National Intelligence, would need to 1) develop a list of the entities that constitute "biotechnology companies of concern," consistent with the relevant provisions of the Act and 2) issue "guidance necessary to implement the requirements" of the Act (the "Implementing Guidance").6
The Act was referred to the House Oversight and Accountability Committee on January 25, 2024 but no further action has been taken. The BIOSECURE Act demonstrates another area viewed by the United States as important to address China-related risks, including by restricting certain private-party transactions. Interested parties should continue to monitor the Act as it moves through the legislative process, including any amendments that may be introduced.
Footnotes
1. H.R. 7085, https://www.congress.gov/bill/118th-congress/house-bill/7085/text [hereinafter the Act].
3. Id. at Sec. 3(a)–(b).
4. Id. at Sec. 3(i)(5); 10 U.S.C. § 4782(d).
5. The Act at Sec. 3(f)(2)(A). "Multomic" would mean "data types that include genomics, epigenomics, transcriptomics, proteomics, and metabolomics." Id. at Sec. 3(i)(6). The definition of "control" would be the same as the definition under CFIUS regulations Id. at Sec. 3(i)(3).
6. Id. at Sec. 3(f)(1), (3).
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