(1) For purposes of this part 2, the general assembly finds and determines that:
- (a) Some public and private entities operating under federal standards for the protection of human subjects in research develop individualized investigational drugs, biological products, and devices that are unique and produced exclusively for use by an individual patient based on the patient's genetic profile, including individual gene therapy, antisense oligonucleotides, and individualized neoantigen vaccines; and
- (b) A patient who has a life-threatening or severely debilitating illness may benefit from these individualized treatments.
- (2) Therefore, the general assembly declares that, in accordance with the recommendation of the patient's treating physician and with the safeguards described in this part 2, a patient should have the right to try an individualized investigational drug, biological product, or device, and the treating physician and manufacturer that provides the individualized investigational drug, biological product, or device, acting in accordance with this part 2, should be protected from adverse consequences resulting from the patient's decision to try the individualized investigational drug, biological product, or device.
Source: L. 2025: Entire part added, (HB 25-1270), ch. 211, p. 954, § 5, effective May 19.