Enrolled HB 43: Relating to prescribing, dispensing, and administering an investigational drug, biological product, or device by physicians for patients who are terminally ill for the purpose of sustaining the patient's life; providing immunity related to manufacturing, distributing, or providing investigational drugs, biological products, or devices; and relating to licensed health care facility requirements.
00Enrolled HB 43 01 Relating to prescribing, dispensing, and administering an investigational drug, biological 02 product, or device by physicians for patients who are terminally ill for the purpose of 03 sustaining the patient's life; providing immunity related to manufacturing, distributing, or 04 providing investigational drugs, biological products, or devices; and relating to licensed health 05 care facility requirements. 06 _______________ 07 * Section 1. AS 08.64.367 is amended by adding new subsections to read: 08 (c) A physician may not be subject to disciplinary action by the board for 09 prescribing, dispensing, or administering an investigational drug, biological product, 10 or device, or providing related treatment, to a patient for the purpose of sustaining the 11 patient's life if the patient 12 (1) has a terminal illness; 13 (2) is ineligible or unable to participate in a current clinical trial for the
01 investigational drug, biological product, or device; 02 (3) has considered, after consultation with the physician, all other 03 treatment options currently approved by the United States Food and Drug 04 Administration; and 05 (4) has given informed consent in writing for the use of the 06 investigational drug, biological product, or device. 07 (d) In this section, 08 (1) "investigational drug, biological product, or device" means a drug, 09 biological product, or device that has successfully completed Phase 1 studies of 10 clinical trials for investigation and remains in ongoing clinical trials under Phase 2 or 11 Phase 3 or is in the new drug application process following Phase 3 of clinical trials, 12 but has not been approved for general use by the United States Food and Drug 13 Administration; 14 (2) "terminal illness" means a disease that, without life-sustaining 15 procedures, will result in death in the near future or a state of permanent 16 unconsciousness from which recovery is unlikely. 17 * Sec. 2. AS 09.65 is amended by adding a new section to read: 18 Sec. 09.65.325. Immunity relating to use or nonuse of investigational 19 drugs, biological products, and devices. (a) A person is not liable in an action for 20 damages for the injury or death of a patient with a terminal illness resulting from the 21 patient's use of an investigational drug, biological product, or device for the purpose of 22 sustaining the patient's life if the person, acting in good faith and with reasonable care, 23 is a 24 (1) physician or member of the medical team who prescribed, 25 dispensed, or administered the investigational drug, biological product, or device, or 26 provided related treatment, to the patient and, before prescribing, dispensing, or 27 administering the drug, product, or device, or providing related treatment, the 28 physician or member of the medical team 29 (A) obtained the informed consent of the patient in writing after 30 presenting to the patient all treatment options currently approved by the United 31 States Food and Drug Administration for treatment of the patient's terminal
01 illness; and 02 (B) provided to the patient written notice of the immunity 03 provided under this section; or 04 (2) manufacturer, importer, or distributor of the investigational drug, 05 biological product, or device and, before providing the drug, product, or device to the 06 patient's physician, presented to the physician all treatment options currently approved 07 by the United States Food and Drug Administration for treatment of the patient's 08 terminal illness and provided to the patient written notice of the immunity provided 09 under this section. 10 (b) A person, acting in good faith and with reasonable care, is not liable in an 11 action for damages solely for declining to 12 (1) prescribe, dispense, or administer an investigational drug, 13 biological product, or device to a patient; or 14 (2) provide an investigational drug, biological product, or device to a 15 patient's physician. 16 (c) In this section, "investigational drug, biological product, or device" and 17 "terminal illness" have the meanings given in AS 08.64.367. 18 * Sec. 3. AS 17.20.110 is amended by adding a new subsection to read: 19 (b) This section does not apply to a physician who prescribes or administers a 20 new drug in accordance with the conditions set out in AS 08.64.367(c). 21 * Sec. 4. AS 47.32.030 is amended by adding a new subsection to read: 22 (d) The department may not require a licensed entity to increase services for 23 the sole purpose of accommodating a physician's practice of prescribing, dispensing, 24 or administering an investigational drug, biological product, or device, or providing 25 related treatment, to a patient. In this subsection, "investigational drug, biological 26 product, or device" has the meaning given in AS 08.64.367.