Bill Text: AZ HB2121 | 2019 | Fifty-fourth Legislature 1st Regular | Introduced
Bill Title: Investigational stem cell treatment
Spectrum: Partisan Bill (Republican 4-0)
Status: (Introduced - Dead) 2019-04-29 - Assigned to House RULES Committee [HB2121 Detail]
Download: Arizona-2019-HB2121-Introduced.html
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REFERENCE TITLE: investigational stem cell treatment |
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State of Arizona House of Representatives Fifty-fourth Legislature First Regular Session 2019
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HB 2121 |
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Introduced by Representatives Barto: Allen J, Bolick, Lawrence
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AN ACT
Amending title 13, chapter 37, Arizona Revised Statutes, by adding section 13-3731; Amending Title 36, Arizona Revised Statutes, by adding chapter 11.3; relating to medical treatment.
(TEXT OF BILL BEGINS ON NEXT PAGE)
Be it enacted by the Legislature of the State of Arizona:
Section 1. Title 13, chapter 37, Arizona Revised Statutes, is amended by adding section 13-3731, to read:
13-3731. Purchase and sale of adult stem cells for certain investigational treatments; classification; definitions
A. It is unlawful for a person to knowingly offer to buy, offer to sell, acquire, receive or sell or otherwise transfer any adult stem cells for valuable consideration for use in an investigational stem cell treatment, unless the valuable consideration is any of the following:
1. A fee 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.
3. Reimbursement of expenses of travel, housing and lost wages incurred by the donor of adult stem cells in connection with the donation of the adult stem cells.
B. This section does not apply to a person who is engaged in conduct relating to blood banks and the donation of blood.
C. A violation of this section is a class 1 misdemeanor.
D. For the purposes of this section:
1. "Adult stem cell" means an undifferentiated cell that is both:
(a) Found in differentiated tissue.
(b) 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" has the same meaning prescribed in section 36‑1331.
Sec. 2. Title 36, Arizona Revised Statutes, is amended by adding chapter 11.3, to read:
CHAPTER 11.3
INVESTIGATIONAL STEM CELL TREATMENTS
ARTICLE 1. GENERAL PROVISIONS
36-1331. Definitions
In this article, unless the context otherwise requires:
1. "Department" means the department of health services.
2. "Director" means the director of the department.
3. "Investigational stem cell treatment" means an adult stem cell treatment that meets 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.
4. "Severe chronic disease" means a condition, injury or illness that meets all of the following:
(a) May be treated.
(b) Is never cured or eliminated.
(c) Entails significant functional impairment or severe pain.
5. "Terminal illness" means a disease that, without life‑sustaining procedures, will result in a patient's death in the near future and is not considered by a treating physician to be reversible even with the administration of current treatments that are approved by the United States food and drug administration and that are available.
36-1332. Rules; designation of severe chronic diseases and terminal illnesses; petition process
A. The director shall adopt rules designating severe chronic diseases and terminal illnesses for the purposes of this article.
B. The director shall establish a petition process for members of the public to designate additional severe chronic diseases and terminal illnesses for the purposes of this article.
36-1333. Patient eligibility
A patient is eligible to access and use an investigational stem cell treatment under this article if both of the following apply:
1. The patient has a severe chronic disease or terminal illness designated in the rules adopted pursuant to this article and attested to by the patient's treating physician.
2. The patient's physician has both:
(a) In consultation with the patient, considered all other treatment options currently approved by the United States food and drug administration and determined that those treatment options are unavailable or are unlikely to alleviate the significant functional impairment or severe pain associated with the severe chronic disease or terminal illness.
(b) Recommended or prescribed in writing that the patient use a specific class of investigational stem cell treatment.
36-1334. Informed consent
A. Before receiving an investigational stem cell treatment, an eligible patient must sign a written informed consent form. If the patient is a minor or lacks the mental capacity to provide informed consent, the patient's parent, guardian or conservator may provide informed consent on the patient's behalf.
B. The director by rule may adopt an informed consent form to be used pursuant to this section.
36-1335. Treatment requirements; institutional review boards; rules
A. Investigational stem cell treatment provided under this article must be all of the following:
1. Administered directly by a physician who is certified under subsection C of this section.
2. Overseen by an institutional review board described by subsection D of this section.
3. Provided at one of the following:
(a) A hospital.
(b) An ambulatory surgical center.
(c) A public or private medical school in this state.
B. A physician administering an investigational stem cell treatment under this article shall comply with all applicable rules adopted pursuant to title 32, chapter 13 or 17.
C. An institutional review board described by subsection D of this section may certify a physician to provide investigational stem cell treatment under this article.
D. The Arizona medical board and the Arizona board of osteopathic examiners in medicine and surgery may adopt rules regarding institutional review boards as necessary to implement this section.
36-1336. Action against a physician's license; prohibition
Notwithstanding any other law, the Arizona medical board and the Arizona board of osteopathic examiners in medicine and surgery may not revoke, fail to renew, suspend or take any action against a physician's license pursuant to title 32, chapter 13 or 17 based solely on the physician's recommendations to an eligible patient regarding accessing or using an investigational stem cell treatment if the care provided or recommendations made to the patient meet the standard of care and the requirements of this article.
36-1337. Government interference prohibited; definition
A. A governmental entity or an officer, employee or agent of a governmental entity may not interfere with an eligible patient's access to or use of an investigational stem cell treatment authorized under this article.
B. for the purposes of this section, "governmental entity" means this state or an agency or political subdivision of this state.
36-1338. Institutional review boards; documentation; annual report
Each institutional review board overseeing an investigational stem cell treatment pursuant to this article shall:
1. 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 treatment period.
2. Submit an annual report to the Arizona medical board and the Arizona board of osteopathic examiners in medicine and surgery on the institutional review board's findings based on records kept pursuant to paragraph 1 of this section. The report may not include any patient identifying information and must be made available to the public in both written and electronic form.
36-1339. Application; effect on other laws
This article does not:
1. Apply to any participants who are enrolled in clinical trials.
2. Have any affect on laws regulating possessing, using or transferring fetal tissue, fetal stem cells, adult stem cells or human organs in this state.
Sec. 3. Short title
This act may be cited and shall be known as the "Medical Freedom Act".
