2023 California Code › Health and Safety Code - HSC › DIVISION 104 - ENVIRONMENTAL HEALTH › PART 5 - SHERMAN FOOD, DRUG, AND COSMETIC LAWS › CHAPTER 6 - Drugs and Devices › ARTICLE 4.5 - Right to Try Act › Section 111548.1.

111548.1. For purposes of this article, unless the context otherwise requires, the following definitions shall apply:
(a) “Consulting physician” means a physician and surgeon licensed under the Medical Practice Act or an osteopathic physician and surgeon licensed under the Osteopathic Act who performs all of the following:
(1) Examines the qualified individual and his or her relevant medical records.
(2) Confirms, in writing, the primary physician’s diagnosis and prognosis.
(3) Verifies, in the opinion of the consulting physician, that the eligible patient is competent, acting voluntarily, and has made an informed decision.
(b) “Eligible patient” means a person who meets all of the following conditions:
(1) Has an immediately life-threatening disease or condition.
(2) Has considered all other treatment options currently approved by the United States Food and Drug Administration.
(3) Has not been accepted to participate in the nearest clinical trial to his or her home for the immediately life-threatening disease or condition identified in paragraph (1) within one week of completion of the clinical trial application process, or, in the treating physician’s medical judgment, it is unreasonable for the patient to participate in that clinical trial due to the patient’s current condition and stage of disease.
(4) Has received a recommendation from his or her primary physician and a consulting physician for an investigational drug, biological product, or device.
(5) Has given written informed consent for the use of the investigational drug, biological product, or device, or, if he or she lacks the capacity to consent, his or her legally authorized representative has given written informed consent on his or her behalf.
(6) Has documentation from his or her primary physician and a consulting physician attesting that the patient has met the requirements of this subdivision.
(c) “Health benefit plan” means a plan or program that provides, arranges, pays for, or reimburses the cost of health benefits. “Health benefit plan” includes, but is not limited to, a health care service plan contract issued by a health care service plan, as defined in Section 1345, and a policy of health insurance, as defined in Section 106 of the Insurance Code, issued by a health insurer.
(d) “Immediately life-threatening disease or condition” means a stage of disease in which there is a reasonable likelihood that death will occur within a matter of months.
(e) “Investigational drug, biological product, or device” means a drug, biological product, or device that has successfully completed phase one of a clinical trial approved by the United States Food and Drug Administration, but has not been approved for general use by the United States Food and Drug Administration and remains under investigation in a clinical trial approved by the United States Food and Drug Administration.
(f) “Primary physician” means a physician and surgeon licensed under the Medical Practice Act or an osteopathic physician and surgeon licensed under the Osteopathic Act.
(g) “State regulatory board” means the Medical Board of California or the Osteopathic Medical Board of California.
(h) (1) “Written, informed consent” means a written document that has been approved by the primary physician’s institutional review board or an accredited independent institutional review board, is signed by an eligible patient, or his or her legally authorized representative when the patient lacks the capacity to consent, and attested to by the patient’s primary physician and a witness that, at a minimum, does all of the following:
(A) Explains the currently approved products and treatments for the immediately life-threatening disease or condition from which the patient suffers.
(B) Attests to the fact that the patient, or when the patient lacks the capacity to consent his or her legally authorized representative, concurs with the patient’s primary physician in believing that all currently approved and conventionally recognized treatments are unlikely to prolong the patient’s life.
(C) Clearly identifies the specific proposed investigational drug, biological product, or device that the patient is seeking to use.
(D) Describes the potentially best and worst outcomes of using the investigational drug, biological product, or device and describes the most likely outcome. This description shall include the possibility that new, unanticipated, different, or worse symptoms might result and that death could be hastened by the proposed treatment. The description shall be based on the primary physician’s knowledge of the proposed treatment in conjunction with an awareness of the patient’s condition.
(E) Clearly states that the patient’s health benefit plan, if any, and health care provider are not obligated to pay for the investigational drug, biological product, or device or any care or treatments consequent to use of the investigational drug, biological product, or device.
(F) Clearly states that the patient’s eligibility for hospice care may be withdrawn if the patient begins curative treatment and that care may be reinstated if the curative treatment ends and the patient meets hospice eligibility requirements.
(G) Clearly states that in-home health care may be denied if treatment begins.
(H) States that the patient understands that he or she is liable for all expenses consequent to the use of the investigational drug, biological product, or device, and that this liability extends to the patient’s estate, except as otherwise provided in the patient’s health benefit plan or a contract between the patient and the manufacturer of the drug, biological product, or device.
(2) Written, informed consent for purposes of this article shall be consistent with the informed consent requirements of the Protection of Human Subjects in Medical Experimentation Act (Chapter 1.3 (commencing with Section 24170) of Division 20).
(Added by Stats. 2016, Ch. 684, Sec. 1. (AB 1668) Effective January 1, 2017.)