SB 16

Under existing law, there is no provision to allow for the administering of certain investigational stem cell treatments to patients with severe chronic diseases or terminal illnesses

This bill would provide for the availability of stem cell treatment options for certain patients with terminal illnesses or severe chronic illnesses under certain conditions

Amendment 621 of the Constitution of Alabama of 1901, now appearing as Section 111.05 of the Official Recompilation of the Constitution of Alabama of 1901, as amended, prohibits a general law whose purpose or effect would be to require a new or increased expenditure of local funds from becoming effective with regard to a local governmental entity without enactment by a 2/3 vote unless: it comes within one of a number of specified exceptions; it is approved by the affected entity; or the Legislature appropriates funds, or provides a local source of revenue, to the entity for the purpose

The purpose or effect of this bill would be to require a new or increased expenditure of local funds within the meaning of the amendment. However, the bill does not require approval of a local governmental entity or enactment by a 2/3 vote to become effective because it comes within one of the specified exceptions contained in the amendment

Relating to health; to provide for the availability of certain investigational stem cell treatments; to provide for informed consent; to specify treatment requirements; to provide for oversight by an institutional review board; to provide certain record keeping requirements; to provide criminal penalties for the purchase or sale of adult stem cells for certain investigational treatments; and in connection therewith would have as its purpose or effect the requirement of a new or increased expenditure of local funds within the meaning of Amendment 621 of the Constitution of Alabama of 1901, now appearing as Section 111.05 of the Official Recompilation of the Constitution of Alabama of 1901, as amended.

Section 1

This act shall be known and may be cited as the Steve Bowman Act.

Section 2

For the purposes of this act, the following terms shall have the following meanings: (1) INVESTIGATIONAL STEM CELL TREATMENT. An adult stem cell treatment that satisfies both of the following: a. Is under investigation in a clinical trial and being administered to human participants in that trial. b. Has not yet been approved for general use by the United States Food and Drug Administration. (2) SEVERE CHRONIC DISEASE. A condition, injury, or illness that satisfies all of the following: a. May be treated. b. Is never cured or eliminated. c. Entails significant functional treatment or severe pain. (3) TERMINAL ILLNESS. An advanced stage of a disease with an unfavorable prognosis that, without life-sustaining procedures, will soon result in death or a state of permanent unconsciousness from which recovery is unlikely.

Section 3

In addition to any authority granted under Chapter 5D of Title 22, Code of Alabama 1975, a patient is eligible to access and use an investigational stem cell treatment under this act if both of the following are satisfied: (1) The patient has a severe chronic disease or terminal illness that is attested to by the patient's treating physician. (2) The patient's physician does both of the following: a. In consultation with the patient, has considered all other treatment options currently approved by the United States Food and Drug Administration and determined that those treatment options are unavailable or unlikely to alleviate the significant impairment or severe pain associated with the severe chronic disease or terminal illness. b. Has recommended or prescribed in writing that the patient use a specific class of investigational stem cell treatment.

Section 4

(a) Before receiving an investigational stem cell treatment, an eligible patient must sign a written informed consent. (b) If the patient is a minor or lacks the mental capacity to provide informed consent, a parent, guardian, or conservator may provide informed consent on the patient's behalf. (c) The Alabama Department of Public Health, by rule, may adopt a form for the informed consent under this section.

Section 5

(a) Treatment under this act must be administered directly by a physician certified under subsection (c) and overseen by an institutional review board described in subsection (d). The treatment must be provided at a hospital licensed under the laws of this state, an ambulatory surgical center licensed under the laws of this state, or a hospital associated with an accredited medical school and teaching facility. (b) A physician administering an investigational stem cell treatment under this act shall comply with all applicable rules of the Alabama Board of Medical Examiners. (c) All treatment shall be overseen by an institutional review board described in subsection (d). The board may certify a physician to provide an investigational stem cell treatment under this act. (d) An institutional review board that oversees investigational stem cell treatments administered under this act must be affiliated with a licensed hospital or an accredited medical school and teaching facility.

Section 6

(a) An institutional review board overseeing an investigational stem cell treatment under this act shall keep a record on each person to whom a physician administers the treatment and document in the record the provision of each treatment and the effects of the treatment on the person throughout the period the treatment is administered to the person. (b) Each institutional review board overseeing an investigational stem cell treatment under this act shall submit an annual report to the Alabama Board of Medical Examiners on the review board's findings based on records kept under subsection (a). The report may not include any patient identifying information and must be made available to the public in both written and electronic form.

Section 7

(a) This act does not affect or authorize a person to violate any state or federal law regulating the possession, use, or transfer of fetal tissue, fetal stem cells, adult stem cells, or human organs. (b) The Alabama Board of Medical Examiners may not revoke, fail to renew, suspend, or take any action against a physician's license in this state based solely on the physician's recommendations to an eligible patient regarding access to or use of an investigational stem cell treatment, provided that the care provided or recommendations made to the patient meet the standard of care and the requirements of this act.

Section 8

The Alabama Department of Pubic Health may adopt rules for the implementation and administration of this act.

Section 9

(a) For the purposes of this section, the following terms shall have the following meanings: (1) ADULT STEM CELL. An undifferentiated cell that satisfies both of the following: a. Is found in differentiated tissue. b. Is able to renew itself and differentiate to yield all or nearly all of the specialized cell types of the tissue from which the cell originated. (2) INVESTIGATIONAL STEM CELL TREATMENT. An adult stem cell treatment that satisfies both of the following: a. Is under investigation in a clinical trial and being administered to human participants in that trial. b. Has not yet been approved for general use by the United States Food and Drug Administration. (b) It shall be unlawful for a person to knowingly offer to buy, offer to sell, acquire, receive, sell, or otherwise transfer any adult stem cells for valuable consideration for use in an investigational stem cell treatment, except under the following circumstances: (1) A fee is paid to a physician or to other medical personnel for services rendered in the usual course of medical practice or a fee paid for hospital or other clinical services. (2) Reimbursement of legal or medical expenses incurred for the benefit of the ultimate receiver of the investigational stem cell treatment is made. (3) Reimbursement of expenses of travel, housing, and lost wages incurred by the donor of adult stem cells is made in connection with the donation of the adult stem cells. (c) A violation of subsection (b) is a Class A misdemeanor. Section 10. Although this bill would have as its purpose or effect the requirement of a new or increased expenditure of local funds, the bill is excluded from further requirements and application under Amendment 621, now appearing as Section 111.05 of the Official Recompilation of the Constitution of Alabama of 1901, as amended, because the bill defines a new crime or amends the definition of an existing crime. Section 11. This act shall become effective on the first day of the third month following its passage and approval by the Governor, or its otherwise becoming law.