Identical to H 1029, filed 5/2/24.

Adds new Part 3, Individualized Treatments, to Article 23A of GS Chapter 90, providing as follows.

Allows a manufacturer operating within an eligible facility and in accordance with federal laws to make available to an eligible patient, and an eligible patient may request, the manufacturer's individualized investigational drug, biological product, or device. Specifies that this does not require the manufacturer to make the item available. Allows such a manufacturer to provide the individualized investigational drug, biological product, or device to an eligible patient for free or may require the patient to pay the costs of, or the costs associated with, the manufacture of the individualized investigational drug, biological product, or device.

Defines an eligible patient as an individual who meets all of the following: (1) has a life-threatening or severely debilitating illness, attested to by a treating physician; (2) has, in consultation with a treating physician, considered all other treatment options currently approved by the US Food and Drug Administration; (3) has received a recommendation from the treating physician for use of an individualized investigational drug, biological product, or device for treatment of the life-threatening or severely debilitating illness; (4) has given informed consent in writing (as defined) to use of the individualized investigational drug, biological product, or device for treatment of the life-threatening or severely debilitating illness or, if the individual is a minor or is otherwise incapable of providing informed consent, the parent or legal guardian has given informed consent in writing to use of the individualized investigational drug, biological product, or device; and (5) has documentation from the treating physician that the individual meets all of the criteria for this definition. Defines an eligible facility as any institution operating under Federalwide Assurance for the Protection of Human Subjects in accordance with 45 C.F.R. § 46 and 42 U.S.C. § 289(a). Defines individualized investigational drug, biological product, or device as a drug, biological product, or device that is unique and produced exclusively for use for an individual patient, based on their own genetic profile, including individualized gene therapy antisense oligonucleotides and individualized neoantigen vaccines.

Provides that if a patient dies during treatment with the investigational drug, biological product, or device, their heirs are not liable for any outstanding debt related to the treatment.

Prohibits taking disciplinary action against a licensed health care provider, or action against their Medicare certification, based solely on their recommendation to an eligible patient regarding access to or treatment with the individualized item.

Prohibits State officials, employees, or agents from blocking or attempting to block an eligible patient's access to an individualized investigational drug, biological product, or device. Also prohibits bringing a private right of action against a manufacturer, or against any other person or entity involved in the patient’s care for any harm resulting from use of the individualized investigational drug, biological product, or device as long as the manufacturer or other person or entity has made a good-faith effort to comply with the provisions of this Part and has exercised reasonable care in actions undertaken pursuant to this Part.

Effective October 1, 2024.

Appropriates $50,000 for 2024-25 from the General Fund to the Department of Health and Human Services to implement the act. Effective July 1, 2024.