An Act To Allow Terminally Ill Patients To Choose To Use Experimental Treatments
Sec. 1. 22 MRSA c. 602-A is enacted to read:
ACCESS TO INVESTIGATIONAL TREATMENTS FOR TERMINALLY ILL PATIENTS
§ 2671. Definitions
As used in this chapter, unless the context otherwise indicates, the following terms have the following meanings.
§ 2672. Availability of investigational drug, biological product or device by manufacturer
A manufacturer of an investigational drug, biological product or device may make available the investigational drug, biological product or device to an eligible patient.
§ 2673. Insurance
This chapter does not expand the coverage required of a carrier under the Maine Insurance Code.
§ 2674. Action against health care practitioner license prohibited
A licensing board may not revoke, refuse to renew or suspend the license of or take any action against a health care practitioner as defined in Title 24, section 2502, subsection 1-A based solely on the health care practitioner's recommendations to an eligible patient regarding access to or treatment with an investigational drug, biological product or device, as long as the recommendations are consistent with medical standards of care.
§ 2675. Officials, employees and agents of the State
§ 2676. No cause of action created
This chapter does not create a private cause of action against a manufacturer of an investigational drug, biological product or device or against any other person or entity involved in the care of an eligible patient using the investigational drug, biological product or device for any harm done to the eligible patient resulting from the investigational drug, biological product or device if the manufacturer or other person or entity is complying in good faith with the provisions of this chapter and has exercised reasonable care.
§ 2677. Clinical trial coverage
This chapter does not affect the mandatory health care coverage for participation in clinical trials pursuant to Title 24-A, section 4310.
This bill authorizes manufacturers of drugs, biological products and devices that have completed Phase I of a United States Food and Drug Administration-approved clinical trial but have not yet been approved for general use and remain under clinical investigation to make them available to eligible terminally ill patients. The bill does not require health insurers to provide coverage for the cost of such a drug, biological product or device but authorizes insurers to provide such coverage. The bill prohibits licensing boards from revoking, refusing to renew or suspending the license of or taking any other action against a health care practitioner based solely on the practitioner's recommendation to an eligible patient regarding access to or treatment with such a drug, biological product or device. It prohibits any official, employee or agent of the State from blocking or attempting to block access by an eligible patient to such a drug, biological product or device.