BIOSECURE Act

The US House of Representatives has passed the BIOSECURE Act, a piece of legislation which impacts supply chains and partnerships across the global biotechnology sector. For biopharma companies with US market exposure, understanding the implications is critical to maintaining business continuity.

The Act prohibits US federal agencies from contracting with companies that use biotechnology equipment or services from designated "biotechnology companies of concern." 

This extends beyond direct government contracts, it captures the entire supply chain, including grant and loan recipients.

• Supply chain exposure
  If your organisation relies on any of the named companies for sequencing services, contract development and manufacturing (CDMO) arrangements, or research partnerships, you may find yourself ineligible for US government contracts or federal funding. This isn't limited to defence contractors, it touches anyone in the federal procurement ecosystem.
• The multiomic data question
  The legislation takes a particularly keen interest in human multiomic data, genomics, proteomics, metabolomics, and related datasets. Companies obtaining such data without express and informed consent, or sharing it with foreign adversary governments, risk designation as a company of concern. For organisations handling patient data or conducting clinical trials, this demands immediate attention to consent frameworks and data governance.
• Timeline pressures
  Whilst there are grandfather clauses for existing contracts (extending to January 2032 for named companies), the prohibition takes effect just 60 days after regulations are finalised. The window for strategic repositioning is narrower than it might appear.

This legislation reflects a broader trend towards dissecting biotechnology supply chains through a national security lens. Whether or not your organisation currently engages with US government contracts, the direction of travel is clear. Commercial partners and investors will increasingly expect visibility into supply chain provenance and data handling practices.

For companies with exposure to the named entities, the transition period offers an opportunity to diversify partnerships and de-risk operations. For those without direct exposure, the lesson is equally valuable: supply chain resilience and robust data governance are no longer merely operational considerations.

• Conduct a thorough supply chain review.
  Map your dependencies on the named entities, including indirect relationships through subcontractors and service providers. Many organisations will discover unexpected exposure.
• Review your partnership agreements.
  Consider whether existing arrangements with named companies can be transitioned and begin exploring alternative providers. The CDMO landscape is competitive, but capacity constraints are real, early movers will have more options.
• Strengthen your data governance
  Ensure robust consent mechanisms are in place for any human multiomic data collection. Document your data handling practices and be prepared to demonstrate compliance to partners and customers conducting their own due diligence.