Section 41-147-1 - DefinitionsAs used in this act, the following terms shall have the meanings ascribed herein:
(a) "Life-threatening or severely debilitating illness," means as it is defined in Section 312.81 of Title 21, Code of Federal Regulations (or any successor law or regulation, as applicable).(b) "Eligible patient" means an individual who meets the following conditions: (i) Has considered all other treatment options currently approved by the United States Food and Drug Administration;(ii) Has received a recommendation from his or her physician for an individualized investigational treatment, based on analysis of the patient's genomic sequence, human chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene products (such as enzymes and other types of proteins), or metabolites;(iii) Has a life-threatening or severely debilitating illness, or serious disease or condition associated with morbidity that has a substantial impact on day-to-day functioning, attested to by the patient's treating physician;(iv) Has given written, informed consent for the use of the investigational drug, biological product, or device; and(v) Has documentation from his or her physician that he or she meets the requirements of this paragraph; or(vi) An individual who has documentation from his or her physician that the individual has been diagnosed with the human immunodeficiency virus (HIV).(c) "Individualized investigational treatment" means drugs, biological products, or devices that are unique to and produced exclusively for use for an individual patient, based on their own genetic profile, or long-acting injectable antiretroviral drugs for the treatment of patients with HIV.(d) "Individualized investigational treatment" includes, but is not limited to, individualized gene therapy antisense oligonucleotides (ASO) and individualized neoantigen vaccines. Individualized investigational treatment" does not include any drug, biological product, or device derived from human primary or secondary embryonic stem cells or cell lines, or tissues or cells derived from abortion, but does include any drug, biological product, or device derived from human perinatal tissues, cells, and secreted factors not obtained from an abortion.(e) "Written, informed consent" means a written document that is signed by the patient; or if the patient is a minor, by any person authorized to consent under Section 41-41-3; and attested to by the patient's physician and a witness and that, at a minimum, includes all of the following:(i) An explanation of the currently approved products and treatments for the illness, disease or condition from which the patient suffers;(ii) An attestation that the patient concurs with his or her physician in believing that all currently approved and conventionally recognized treatments are unlikely to prolong the patient's life;(iii) Clear identification of the specific proposed individualized investigational drug, biological product or device that the patient is seeking to use;(iv) A description of the potentially best and worst outcomes of using the individualized investigational drug, biological product, or device and a realistic description of the most likely outcome. The 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 physician's knowledge of the proposed treatment in conjunction with an awareness of the patient's condition;(v) A statement that the patient's health plan or third party administrator and provider are not obligated to pay for any care or treatments consequent to the use of the individualized investigational drug, biological product, or device, unless they are specifically required to do so by law or contract;(vi) A statement that the patient's eligibility for hospice care may be withdrawn if the patient begins curative treatment with the individualized investigational drug, biological product, or device and that care may be reinstated if this treatment ends and the patient meets hospice eligibility requirements; and(vii) A statement that the patient understands that he or she is liable for all expenses consequent to the use of the individualized investigational drug, biological product, or device and that this liability extends to the patient's estate, unless a contract between the patient and the manufacturer of the drug, biological product, or device states otherwise.(f) "Eligible facility" means an institution that is operating under a Federal-wide Assurance (FWA) for the Protection of Human Subjects under 42 U.S.C. 289(a) and 45 CFR Part 46 . and eligible facility is subject to the FWA laws, regulations, policies, and guidelines including renewals or updates.Added by Laws, 2024, ch. 432, SB 2858,§ 1, eff. 7/1/2024.