The bill amends and reenacts section 16-51-3 of the Code of West Virginia, 1931, while repealing section 16-51-2. The primary focus of the bill is to redefine the criteria for "eligible patients" who may seek 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 the previous requirement of having a "terminal illness." Additionally, the bill removes the stipulation that patients must have been unable to participate in a clinical trial within a certain distance from their home and instead emphasizes the need for written, informed consent from the patient or their legal guardian.

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 term "terminal illness" is replaced with "life-threatening or severely debilitating illness," aligning the definitions 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.

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