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A BILL TO BE ENTITLED
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AN ACT
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relating to the provision of certain investigational stem cell |
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treatments to patients with certain severe chronic diseases or |
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terminal illnesses and regulating the possession, use, and transfer |
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of adult stem cells; creating a criminal offense. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. This Act shall be known as Charlie's Law. |
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SECTION 2. Chapter 1003, Health and Safety Code, is amended |
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by designating Sections 1003.001, 1003.002, and 1003.003 as |
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Subchapter A and adding a subchapter heading to read as follows: |
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SUBCHAPTER A. GENERAL PROVISIONS |
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SECTION 3. Chapter 1003, Health and Safety Code, is amended |
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by adding Subchapter B to read as follows: |
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SUBCHAPTER B. PROVISION OF INVESTIGATIONAL STEM CELL TREATMENTS TO |
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PATIENTS WITH CERTAIN SEVERE CHRONIC DISEASES OR TERMINAL ILLNESSES |
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Sec. 1003.051. DEFINITIONS. In this subchapter: |
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(1) "Investigational stem cell treatment" means an |
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adult stem cell treatment that: |
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(A) is under investigation in a clinical trial |
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and being administered to human participants in that trial; and |
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(B) has not yet been approved for general use by |
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the United States Food and Drug Administration. |
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(2) "Severe chronic disease" means a condition, |
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injury, or illness that: |
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(A) may be treated; |
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(B) is never cured or eliminated; and |
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(C) entails significant functional impairment or |
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severe pain. |
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(3) "Terminal illness" means an advanced stage of a |
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disease with an unfavorable prognosis that, without |
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life-sustaining procedures, will soon result in death or a state of |
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permanent unconsciousness from which recovery is unlikely. |
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Sec. 1003.052. RULES. The executive commissioner shall |
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adopt rules designating the medical conditions that constitute a |
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severe chronic disease or terminal illness for purposes of this |
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subchapter. |
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Sec. 1003.053. PATIENT ELIGIBILITY. A patient is eligible |
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to access and use an investigational stem cell treatment under this |
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subchapter if: |
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(1) the patient has a severe chronic disease or |
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terminal illness listed in the rules adopted under Section 1003.052 |
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and attested to by the patient's treating physician; and |
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(2) the patient's physician: |
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(A) in consultation with the patient, has |
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considered all other treatment options currently approved by the |
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United States Food and Drug Administration and determined that |
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those treatment options are unavailable or unlikely to alleviate |
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the significant impairment or severe pain associated with the |
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severe chronic disease or terminal illness; and |
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(B) has recommended or prescribed in writing that |
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the patient use a specific class of investigational stem cell |
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treatment. |
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Sec. 1003.054. INFORMED CONSENT. (a) Before receiving an |
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investigational stem cell treatment, an eligible patient must sign |
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a written informed consent. |
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(b) If the patient is a minor or lacks the mental capacity to |
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provide informed consent, a parent, guardian, or conservator may |
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provide informed consent on the patient's behalf. |
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(c) The executive commissioner by rule may adopt a form for |
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the informed consent under this section. |
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Sec. 1003.055. NO CAUSE OF ACTION CREATED. This subchapter |
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does not create a private or state cause of action against a |
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developer of an investigational stem cell treatment or against any |
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other person or entity involved in the care of an eligible patient |
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using the investigational stem cell treatment for any harm done to |
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the eligible patient resulting from the investigational stem cell |
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treatment. |
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Sec. 1003.056. EFFECT ON OTHER LAW. (a) This subchapter |
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does not affect the coverage of enrollees in clinical trials under |
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Chapter 1379, Insurance Code. |
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(b) This subchapter does not affect or authorize a person to |
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violate any law regulating the possession, use, or transfer of |
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fetal tissue, fetal stem cells, adult stem cells, or human organs, |
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including Sections 48.02 and 48.03, Penal Code. |
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Sec. 1003.057. ACTION AGAINST PHYSICIAN'S LICENSE |
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PROHIBITED. Notwithstanding any other law, the Texas Medical Board |
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may not revoke, fail to renew, suspend, or take any action against |
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a physician's license under Subchapter B, Chapter 164, Occupations |
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Code, based solely on the physician's recommendations to an |
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eligible patient regarding access to or use of an investigational |
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stem cell treatment, provided that the care provided or |
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recommendations made to the patient meet the standard of care and |
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the requirements of this subchapter. |
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Sec. 1003.058. GOVERNMENTAL INTERFERENCE PROHIBITED. (a) |
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In this section, "governmental entity" means this state or an |
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agency or political subdivision of this state. |
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(b) A governmental entity or an officer, employee, or agent |
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of a governmental entity may not interfere with an eligible |
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patient's access to or use of a stem cell treatment authorized under |
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this subchapter. |
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SECTION 4. Chapter 48, Penal Code, is amended by adding |
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Section 48.03 to read as follows: |
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Sec. 48.03. PROHIBITION ON PURCHASE AND SALE OF ADULT STEM |
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CELLS FOR CERTAIN INVESTIGATIONAL TREATMENTS. (a) In this |
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section: |
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(1) "Adult stem cell" means an undifferentiated cell |
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that is: |
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(A) found in differentiated tissue; and |
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(B) able to renew itself and differentiate to |
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yield all or nearly all of the specialized cell types of the tissue |
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from which the cell originated. |
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(2) "Investigational stem cell treatment" means an |
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adult stem cell treatment that: |
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(A) is under investigation in a clinical trial |
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and being administered to human participants in that trial; and |
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(B) has not yet been approved for general use by |
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the United States Food and Drug Administration. |
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(b) A person commits an offense if the person knowingly |
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offers to buy, offers to sell, acquires, receives, sells, or |
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otherwise transfers any adult stem cells for valuable consideration |
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for use in an investigational stem cell treatment. |
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(c) It is an exception to the application of this section |
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that the valuable consideration is: |
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(1) a fee paid to a physician or to other medical |
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personnel for services rendered in the usual course of medical |
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practice or a fee paid for hospital or other clinical services; |
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(2) reimbursement of legal or medical expenses |
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incurred for the benefit of the ultimate receiver of the |
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investigational stem cell treatment; or |
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(3) reimbursement of expenses of travel, housing, and |
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lost wages incurred by the donor of adult stem cells in connection |
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with the donation of the adult stem cells. |
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(d) It is an exception to the application of this section |
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that the actor engaged in conduct authorized under Chapter 162, |
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Health and Safety Code. |
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(e) A violation of this section is a Class A misdemeanor. |
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SECTION 5. As soon as practicable after the effective date |
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of this Act, the executive commissioner of the Health and Human |
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Services Commission shall adopt rules necessary to implement |
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Subchapter B, Chapter 1003, Health and Safety Code, as added by this |
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Act. |
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SECTION 6. This Act takes effect September 1, 2017. |