House Bill No. [insert number] proposes the Louisiana Clinical Trial Competitiveness and Patient Access Act, which aims to enhance the state's competitiveness in clinical trials by supporting sponsor-facing readiness, improving access, and facilitating collaboration among research entities. The bill establishes definitions for key terms and outlines the responsibilities of the Louisiana Economic Development department in coordinating clinical trial capabilities. It emphasizes voluntary participation and nonexclusive coordination, ensuring that no entity is designated as the exclusive provider for clinical projects. The department is restricted from approving or disapproving protocols or contracts and cannot require the disclosure of sensitive information without consent.

The bill introduces provisions for the use of external central institutional review boards (IRBs) for Phase II and III trials, clarifying that a lack of a preexisting master agreement does not prevent their use if a lawful reliance arrangement can be executed. It also specifies that local IRB processes should not duplicate ethical reviews or delay projects based on administrative convenience. The Act establishes that only aggregate, non-identifiable information may be required for evaluation purposes, and it prohibits the disclosure of sensitive patient information. The requirements of the Act will apply prospectively to covered clinical projects initiated after its effective date, which will be upon the governor's signature or after the designated time for bills to become law without a signature.