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 related to the Right-to-Try Act. The updated section 16-51-3 provides detailed definitions pertinent to the act, including the criteria for an "eligible patient," which encompasses individuals with life-threatening or severely debilitating illnesses who have exhausted all FDA-approved treatment options and received a recommendation for investigational treatments from their physician. It also specifies the requirements for written, informed consent, which must be signed by the patient or their legal guardian and includes comprehensive information about the proposed investigational treatment and its potential outcomes.
The bill clarifies that an "eligible patient" does not include individuals receiving inpatient treatment in a licensed hospital. Additionally, it defines "investigational drug, biological product or device" as those that have completed phase one of clinical trials but are not yet FDA-approved, as well as unique treatments tailored to individual patients based on their genetic profiles. The legislation aims to enhance access to potentially life-saving treatments for patients facing severe health challenges while ensuring they are fully informed of the risks and implications of such 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: 16-51-3, 16-51-2
Engrossed Committee Substitute: 16-51-3, 16-51-2
Enrolled Committee Substitute: 16-51-3, 16-51-2