The proposed bill aims to establish a new article in the Code of West Virginia that grants eligible patients the right to access individualized investigational treatments for life-threatening or severely debilitating illnesses. It defines key terms such as "eligible facility," "eligible patient," and "individualized investigational drug, biological product, or device." The bill outlines the criteria for patients to qualify for these treatments, including the necessity of informed consent and documentation from a treating physician. Additionally, it specifies that manufacturers may provide these treatments without compensation or may charge for associated costs, and it protects the heirs of deceased patients from liability for any outstanding debts related to the treatment.

Furthermore, the bill prohibits sanctions against healthcare providers for recommending individualized treatments and prevents state officials from obstructing patient access to these treatments. It also establishes that no private right of action can be taken against manufacturers or entities involved in the care of patients using these investigational products, provided they have acted in good faith. Importantly, the bill clarifies that it does not alter health benefit plans' obligations to cover participation in clinical trials. The provisions of this article are set to take effect on January 1, 2026.

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