1. I. A manufacturer of an investigational drug, biologic, or device may make available an investigational drug, biologic, or device to eligible patients pursuant to this chapter. A manufacturer may:

   1. (a) Provide an investigational drug, biologic, or device to an eligible patient without receiving compensation.
   2. (b) Require an eligible patient to pay the costs of or associated with the manufacture of the investigational drug, biologic, or device.
   3. (c) Require an eligible patient to participate in data collection relating to the use of the investigational drug, biologic, or device.
2. II. This chapter shall not require a health care insurer or any state agency to provide coverage for the cost of any investigational drug, biologic, or device.
3. III. Nothing in this chapter shall require the manufacturer of an investigational drug, biologic, or device to include an eligible patient in a particular clinical trial or study.
4. IV. Nothing in this chapter shall require a health care provider, health care facility, or the manufacturer of an investigational drug, biological product, or device, to make an experimental treatment available to an eligible patient.

Source. 2016, 206:2, eff. June 6, 2016. 2024, 124:1, eff. Jan. 1, 2025. 2025, 304:6, eff. Jan. 1, 2026.