126-Z:2 Availability of Investigational Drugs, Biological Products, or Devices; Costs; Coverage. –
I. A manufacturer of an investigational drug, biological product, or device may make available an investigational drug, biological product, or device to eligible patients pursuant to this chapter. A manufacturer may:
(a) Provide an investigational drug, biological product, or device to an eligible patient without receiving compensation.
(b) Require an eligible patient to pay the costs of or associated with the manufacture of the investigational drug, biological product, or device.
(c) Require an eligible patient to participate in data collection relating to the use of the investigational drug, biological product, or device.
II. This chapter shall not require a health care insurer or any state agency to provide coverage for the cost of any investigational drug, biological product, or device.
III. Nothing in this chapter shall require the manufacturer of an investigational drug, biological product, or device to include an eligible patient in a particular clinical trial or study.