§ 22 §2671 — Definitions

Maine § 22 §2671

• Jurisdiction: Maine
• Title 22: HEALTH AND WELFARE
• Part 5: FOODS AND DRUGS
• Ch. 602-A: ACCESS TO INVESTIGATIONAL TREATMENTS FOR TERMINALLY ILL PATIENTS

Text

As used in this chapter, unless the context otherwise indicates, the following terms have the following meanings.
1.
Eligible patient.
"Eligible patient" means a person who has:
2.
Investigational drug, biological product or device.
"Investigational drug, biological product or device" means a drug, biological product or device that has successfully completed Phase I of a United States Food and Drug Administration-approved clinical trial but has not yet been approved for general use by the United States Food and Drug Administration and remains under investigation in such a clinical trial.
3.
Terminal illness.
"Terminal illness" means a disease or condition that, without life-sustaining measures, will soon result in death or in a state of permanent unconsciousness from which recovery is unlikely.
4.
Treating physician.
"Treating physician" means a physician who has primary responsibility for the care of a patient and treatment of that patient's terminal illness.
5.
Written, informed consent.
"Written, informed consent" means a written document signed by a patient or, if the patient is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian of the patient. The document must be attested by the patient's treating physician and a witness and include the following information:

Legislative History

PL 2015, c. 418, §1 (NEW).