The proposed legislation known as the BIOSECURE Act aims to prevent executive agencies from entering into contracts or providing loans and grants to any company that has existing or future commercial ties with a “biotechnology company of concern.” A biotechnology company of concern is generally defined as one that is either based in or falls under the jurisdiction of a foreign adversary’s government (defined by law as China, North Korea, Iran, Cuba, and Russia) and is considered a potential threat to national security.
This could have a substantial effect on academia, pharmaceutical, and biotechnology companies and supply chains, especially if they or their customers do business with the U.S. Federal Government.
The bill’s initial version clearly and comprehensively defines a “biotechnology company of concern.” It specifically identifies four companies based in China — BGI, MGI, Complete Genomics, and WuXi Apptec — along with any subsidiaries, parent affiliates, or successor entities linked to them, reflecting the bill’s primary focus on concerns related to the People’s Republic of China (PRC).
Additionally, the definition broadens its scope to include any entity that meets the following criteria:
(i) is “subject to the jurisdiction, direction, control, or operates on behalf of the government of a foreign adversary”
(ii) is involved in the manufacturing or distribution of biotechnology equipment or services
(iii) poses a threat to U.S. security by engaging in joint research with or receiving support from a foreign adversary’s military
(iv) providing genetic data to a foreign adversary’s government, or acquiring multiomic data without obtaining express and informed consent.
The Act would prevent the U.S. government from entering into, extending, or renewing contracts with any entity that either (a) utilizes biotechnology equipment from, or services provided by, a “biotechnology company of concern” in fulfilling the contract, or (b) holds a contract that mandates the direct use of services or equipment from such a company. As a result, biopharmaceutical companies with U.S. government contracts are likely to reassess or move away from their commercial relationships with these firms.
The enactment of this bill is expected to greatly impact the industry. It would require companies with existing or prospective U.S. government contracts to implement substantial and significant changes to their operations while also increasing demand for alternative equipment and services.
The BIOSECURE Act could disrupt many U.S. supply chains, making reconfiguration challenging and costly. While most provisions won’t take effect until 2032, companies should start preparing to prevent significant disruptions to their operations.
Biosynth has manufacturing capabilities and specialists located in both Europe and the U.S. We offer a range of custom and catalog peptides, encompassing services such as discovery, optimization, and large-scale GMP manufacturing. Additionally, our End-to-End Manufacturing Services for Complex Chemicals feature a wide variety of bulk and custom products designed to enhance supply chain security.
Our production facilities are well established in the U.S., including our sites in Gardner (MA) and Louisville (KY), as well as our European hub, which includes locations in the Netherlands, the UK, Switzerland, and Germany.
Since our operations and manufacturing span the U.S. and Europe, we will remain unaffected by the BIOSECURE Act. This means our customers’ supply chains will continue to function uninterrupted, and our services will remain constant.
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