The bill amends and reenacts section 16-51-3 of the Code of West Virginia, 1931, while repealing section 16-51-2, which contained legislative findings. The primary focus of the bill is to redefine the terms related to the "Right-to-Try Act," particularly concerning the eligibility of patients seeking access to investigational treatments. The definition of an "eligible patient" is updated to include individuals with a "life-threatening or severely debilitating illness," as opposed to just a "terminal illness," and it specifies that the patient's treating physician must attest to this condition. Additionally, the criteria for participation in clinical trials have been modified, removing the requirement that patients must have been unable to participate in a trial within a certain distance from their home.

Furthermore, the bill expands the definition of "investigational drug, biological product or device" to include treatments that are uniquely produced for individual patients based on their genetic profiles, such as individualized gene therapy and neoantigen vaccines. The definition of "terminal illness" is replaced with "life-threatening or severely debilitating illness," aligning with federal regulations. The bill also outlines the requirements for written, informed consent, ensuring that patients are fully aware of the potential risks and implications of using investigational treatments. Overall, the bill aims to enhance access to experimental therapies for patients facing serious health challenges while ensuring they are informed about the associated risks and responsibilities.

Statutes affected:
Introduced Version: 16-51A-1, 16-51A-2, 16-51A-3, 16-51A-4, 16-51A-5, 16-51A-6, 16-51A-7, 16-51A-8
Committee Substitute: 16-51-1
Committee Substitute for the Committee Substitute: 16-51-3, 16-51-2
Engrossed Committee Substitute for the Committee Substitute: 16-51-3, 16-51-2