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A BILL TO BE ENTITLED
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AN ACT
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relating to the regulation of the use of human cells and tissue, |
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including a ban on human cloning; providing penalties. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Subtitle H, Title 2, Health and Safety Code, is |
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amended by adding Chapter 176 to read as follows: |
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CHAPTER 176. BIOMEDICAL RESEARCH OVERSIGHT |
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SUBCHAPTER A. GENERAL PROVISIONS |
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Sec. 176.001. DEFINITIONS. In this chapter: |
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(1) "Embryo" means an organism from the single cell |
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stage to eight weeks of development. |
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(2) "Fertilization" means the fusion of a female germ |
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cell containing a haploid nucleus with a male gamete or sperm cell. |
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(3) "Human cloning" means implanting or attempting to |
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implant into a uterus or the functional equivalent of a uterus a |
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human embryo created by a method other than fertilization. |
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(4) "Oocyte" means the female germ cell, the egg. |
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[Sections 176.002-176.050 reserved for expansion] |
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SUBCHAPTER B. HUMAN CLONING |
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Sec. 176.051. HUMAN CLONING PROHIBITED. A person may not |
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engage in or attempt to engage in human cloning. |
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Sec. 176.052. LICENSED VIOLATORS. A person licensed by a |
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state agency as a health care practitioner or health care facility |
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who violates Section 176.051 is subject to the same consequence, |
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other than a civil penalty, that the person would be subject to if |
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the person had violated the licensing law applicable to the person |
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or rules adopted under that law. |
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Sec. 176.053. CIVIL PENALTY. (a) A person who violates |
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Section 176.051 is liable to the state for a civil penalty of not |
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more than $10 million for each violation. |
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(b) The amount of the penalty shall be based on: |
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(1) the seriousness of the violation; |
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(2) the history of previous violations; |
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(3) the amount necessary to deter a future violation; |
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and |
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(4) any other matter that justice may require. |
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(c) The attorney general may sue to collect a civil penalty |
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under this section. In the suit the attorney general may recover |
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the reasonable expenses incurred in obtaining the penalty, |
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including investigation and court costs, reasonable attorney's |
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fees, witness fees, and other expenses. |
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Sec. 176.054. CRIMINAL OFFENSE. A person commits an |
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offense if the person intentionally engages in or attempts to |
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engage in human cloning. An offense under this section is a felony |
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of the first degree. |
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[Sections 176.055-176.100 reserved for expansion] |
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SUBCHAPTER C. RESEARCH USING CERTAIN HUMAN CELLS OR TISSUES |
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Sec. 176.101. PROTECTION OF RESEARCH. This chapter does |
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not restrict or prohibit: |
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(1) scientific research, including nuclear |
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transplantation, to develop regenerative or reparative medical |
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therapies or treatments; or |
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(2) any other research not specifically prohibited by |
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this chapter. |
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Sec. 176.102. RESEARCH OVERSIGHT. Research described by |
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Section 176.101(1) must be: |
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(1) conducted with full consideration for the ethical |
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and medical implications of the research; and |
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(2) reviewed, in each case, by an institutional review |
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board for compliance with applicable state and federal law and |
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after consideration of the guidelines developed under Section |
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176.103. |
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Sec. 176.103. ADVISORY COMMITTEE ON RESEARCH TO DEVELOP |
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REGENERATIVE OR REPARATIVE MEDICAL THERAPIES OR TREATMENTS. (a) |
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The executive commissioner of the Health and Human Services |
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Commission shall establish an advisory committee to develop |
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guidelines for research described by Section 176.101(1). |
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(b) The advisory committee consists of members appointed by |
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the executive commissioner of the Health and Human Services |
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Commission as follows: |
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(1) seven scientists with experience in biomedical |
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research in the fields of cell differentiation, nuclear |
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reprogramming, tissue formation and regeneration, stem cell |
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biology, developmental biology, regenerative medicine, or related |
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fields; |
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(2) one representative from each health science center |
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in this state; |
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(3) one person who is a member of or leader in the |
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biotechnology industry; |
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(4) one medical ethicist; |
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(5) one person with a background in legal issues |
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related to research described by Section 176.101(1), in vitro |
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fertilization, or family law, as it applies to the donation of |
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embryos and oocytes; and |
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(6) one person who is a member or leader of a religious |
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organization. |
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(c) The advisory committee shall revise and update the |
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guidelines developed under this section as necessary. |
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(d) The advisory committee may work with existing |
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institutional review boards in developing guidelines. |
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(e) Section 2110.008, Government Code, does not apply to the |
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advisory committee. |
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Sec. 176.104. VOLUNTARY DONATION OF OOCYTES. A person may |
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not use an oocyte in nuclear transplantation research unless the |
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oocyte was donated voluntarily by and with the informed consent of |
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the woman donating the oocyte. |
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[Sections 176.105-176.150 reserved for expansion] |
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SUBCHAPTER D. PROHIBITED PURCHASE OR SALE; CRIMINAL PENALTY |
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Sec. 176.151. PURCHASE OR SALE OF OOCYTE. (a) A person may |
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not purchase, sell, or otherwise transfer for valuable |
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consideration a human oocyte. |
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(b) In this section, "valuable consideration" does not |
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include reasonable payments: |
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(1) associated with the transportation, processing, |
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preservation, or storage of a human oocyte; or |
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(2) to compensate a donor for expenses directly |
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associated with the donation. |
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(c) A person commits an offense if the person knowingly |
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violates Subsection (a). An offense under this subsection is a |
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felony of the first degree. |
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SECTION 2. (a) The executive commissioner of the Health and |
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Human Services Commission shall appoint members to the advisory |
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committee as required by Section 176.103, Health and Safety Code, |
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as added by this Act, not later than November 1, 2009. |
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(b) The advisory committee shall adopt research guidelines |
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as required by Section 176.103, Health and Safety Code, as added by |
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this Act, not later than June 1, 2010. |
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SECTION 3. This Act takes effect September 1, 2009. |