36-1312. Availability of investigational drugs, biological products or devices; costs; insurance coverage

(Caution:  1998 Prop. 105 applies)

A. A manufacturer of an investigational drug, biological product or device may make available the manufacturer's investigational drug, biological product or device to eligible patients pursuant to this article. This article does not require that a manufacturer make available an investigational drug, biological product or device to an eligible patient.

B. A manufacturer may:

1. Provide an investigational drug, biological product or device to an eligible patient without receiving compensation.

2. Require an eligible patient to pay the costs of or associated with the manufacture of the investigational drug, biological product or device.

3. Require an eligible patient to participate in data collection relating to the use of the investigational drug, biological product or device.

C. This article does not require a health care insurer or any state agency to provide coverage for the cost of any investigational drug, biological product or device.  A health care insurer may provide coverage for an investigational drug, biological product or device.