"The Biosecure Act, as it is known, is focused on what it describes as biotechnology companies of concern, or BCCs. The legislation, contained within the National Defense Authorization Act, specifically bars biotech entities that receive federal dollars from working with companies connected to foreign adversaries namely China, but also Russia, North Korea and Iran. The bill will force most biotech firms to re-evaluate their relationships with foreign companies of concern or hope for a federal waiver, say lawyers and biotech compliance experts."
"This will impact the entire pipeline, said Matt McLoughlin, senior vice president of compliance and categories at Scientist.com. Working from his Solana Beach office, McLoughlin advises more than 140 biopharmaceutical companies, including pharma giants with local offices like Sanofi, Novartis, and Pfizer all of which could be affected by the legislation. A number of smaller companies like Biopharma, Neurocrine, and Kura Oncology will also have to review their foreign relationships."
The Biosecure Act bars biotech entities that receive federal funding from working with companies connected to foreign adversaries, including China, Russia, North Korea, and Iran. The law designates such firms as biotechnology companies of concern (BCCs) and will require most affected biotech firms to re-evaluate foreign relationships or seek federal waivers. The restriction affects the entire R&D and supply pipeline, touching large pharma and smaller biotech firms alike. Early-stage startups will be impacted indirectly when suppliers are linked to BCCs. Companies will need to review thousands of contracts to determine exposure and compliance needs. The Office of Management and Budget must publish a list of BCCs by December 2026, so implementation may phase in over time.
Read at www.sandiegouniontribune.com
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