U.S. legislation could disrupt drug supply chain

This week’s Policy Highlight looks at the BIOSECURE Act, a bill currently being debated in Congress. The Act aims to limit collaboration between U.S. companies and certain Chinese firms in the biotechnology industry, raising concerns about potential disruptions to the drug supply chain.

What is the BIOSECURE Act?

The Act would restrict federal agencies from contracting with or providing grants to companies that work with Chinese “companies of concern.” These companies are identified by the White House, with some, like WuXi AppTec, being automatically blacklisted.

Why are lawmakers concerned?

Lawmakers worry that collaboration with Chinese firms could compromise national security and intellectual property.Additionally, they aim to protect sensitive genetic data from potential misuse.

What are the concerns from the industry?

The biotechnology industry heavily relies on Chinese companies for manufacturing and development services. A survey by the Biotechnology Innovation Organization (BIO) found that nearly 80% of its members work with Chinese firms in some capacity. Companies fear the Act could lead to shortages of essential drugs and delays in bringing new treatments to market.

What are the proposed solutions?

The latest draft of the Act includes a grandfather clause allowing existing contracts with “companies of concern” to continue until 2032. This provides companies with a transition period to find alternative suppliers. Additionally, new companies added to the blacklist would have a five-year grace period to wind down contracts. BIO released a statement in support of the changes to the ACT, praising lawmakers for taking into consideration the industry’s concerns.

What are the next steps?

The House Oversight Committee is expected to vote on the bill this week. The response from the industry and the specific companies named in the bill will be crucial to watch as the legislation progresses.


This article was originally published on iBIO NewsBrief. Gain a head start on your day with iBIO NewsBrief. Subscribe to receive top industry headlines delivered straight to your inbox.