The bill amends the Code of West Virginia to redefine the criteria for "eligible patients" under the Right-to-Try Act, specifically changing the definition of a qualifying illness from a "terminal illness" to a "life-threatening or severely debilitating illness," as attested by a treating physician. It also removes the requirement that patients must have been unable to participate in a clinical trial for their terminal illness within a certain distance from their home. Additionally, the bill clarifies that investigational drugs, biological products, or devices can include those produced exclusively for individual patients based on their genetic profiles, such as individualized gene therapy and neoantigen vaccines.
Furthermore, the bill repeals the previous section outlining legislative findings and updates the definition of "life-threatening or severely debilitating illness" to align with federal regulations. It also modifies the requirements for written, informed consent, ensuring that patients are fully aware of the potential risks and implications of using investigational treatments, including financial liabilities and impacts on hospice care eligibility. These changes aim to broaden access to experimental treatments for patients facing serious health challenges.
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