81R2463 JSC-D
By: Shapleigh S.B. No. 208
A BILL TO BE ENTITLED
AN ACT
relating to the regulation of the use of human cells and tissue,
including a ban on human cloning; providing penalties.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subtitle H, Title 2, Health and Safety Code, is
amended by adding Chapter 176 to read as follows:
CHAPTER 176. BIOMEDICAL RESEARCH OVERSIGHT
SUBCHAPTER A. GENERAL PROVISIONS
Sec. 176.001. DEFINITIONS. In this chapter:
(1) "Fertilization" means the fusion of a female germ
cell containing a haploid nucleus with a male gamete or sperm cell.
(2) "Human cloning" means implanting or attempting to
implant into a uterus or the functional equivalent of a uterus a
human embryo created by a method other than fertilization.
(3) "Human embryo" means an organism of the species
homo sapiens from the single cell stage to eight weeks of
development.
(4) "Oocyte" means the female germ cell, the egg.
[Sections 176.002-176.050 reserved for expansion]
SUBCHAPTER B. HUMAN CLONING
Sec. 176.051. HUMAN CLONING PROHIBITED. A person may not
engage in or attempt to engage in human cloning.
Sec. 176.052. LICENSED VIOLATORS. A person licensed by a
state agency as a health care practitioner or health care facility
who violates Section 176.051 is subject to the same consequence,
other than a civil penalty, that the person would be subject to if
the person had violated the licensing law applicable to the person
or rules adopted under that law.
Sec. 176.053. CIVIL PENALTY. (a) A person who violates
Section 176.051 is liable to the state for a civil penalty of not
more than $10 million for each violation.
(b) The amount of the penalty shall be based on:
(1) the seriousness of the violation;
(2) the history of previous violations;
(3) the amount necessary to deter a future violation;
and
(4) any other matter that justice may require.
(c) The attorney general may sue to collect a civil penalty
under this section. In the suit the attorney general may recover
the reasonable expenses incurred in obtaining the penalty,
including investigation and court costs, reasonable attorney's
fees, witness fees, and other expenses.
Sec. 176.054. CRIMINAL OFFENSE. A person commits an
offense if the person intentionally engages in or attempts to
engage in human cloning. An offense under this section is a felony
of the first degree.
[Sections 176.055-176.100 reserved for expansion]
SUBCHAPTER C. RESEARCH USING CERTAIN HUMAN CELLS OR TISSUES
Sec. 176.101. PROTECTION OF RESEARCH. This chapter does
not restrict or prohibit:
(1) scientific research, including nuclear
transplantation, to develop regenerative or reparative medical
therapies or treatments; or
(2) any other research not specifically prohibited by
this chapter.
Sec. 176.102. RESEARCH OVERSIGHT. Research described by
Section 176.101(1) must be:
(1) conducted with full consideration for the ethical
and medical implications of the research; and
(2) reviewed, in each case, by an institutional review
board for compliance with applicable state and federal law and
after consideration of applicable ethical guidelines developed by
the National Institutes of Health and the guidelines developed
under Section 176.103.
Sec. 176.103. ADVISORY COMMITTEE ON RESEARCH TO DEVELOP
REGENERATIVE OR REPARATIVE MEDICAL THERAPIES OR TREATMENTS. (a)
The executive commissioner of the Health and Human Services
Commission shall establish an advisory committee to develop
guidelines for research described by Section 176.101(1).
(b) The advisory committee consists of members appointed by
the executive commissioner of the Health and Human Services
Commission as follows:
(1) seven scientists with experience in biomedical
research in the fields of cell differentiation, nuclear
reprogramming, tissue formation and regeneration, stem cell
biology, developmental biology, regenerative medicine, or related
fields;
(2) one representative from each health science center
in this state;
(3) one person who is a member of or leader in the
biotechnology industry;
(4) one medical ethicist;
(5) one person with a background in legal issues
related to research described by Section 176.101(1), in vitro
fertilization, or family law, as it applies to the donation of
embryos and oocytes; and
(6) one person who is a member or leader of a religious
organization.
(c) The advisory committee shall revise and update the
guidelines developed under this section as necessary.
(d) The advisory committee may work with existing
institutional review boards in developing guidelines.
(e) Section 2110.008, Government Code, does not apply to the
advisory committee.
Sec. 176.104. VOLUNTARY DONATION OF OOCYTES. A person may
not use an oocyte in nuclear transplantation research unless the
oocyte was donated voluntarily by and with the informed consent of
the woman donating the oocyte.
[Sections 176.105-176.150 reserved for expansion]
SUBCHAPTER D. DISPOSITION OF HUMAN EMBRYOS
Sec. 176.151. DONATION OF HUMAN EMBRYO. (a) A person may
donate an embryo created in the course of fertility treatment for
the purpose of assisted reproduction, as defined by Section
160.102, Family Code, to be used in scientific research or to be
used by an intended mother for the purpose of conceiving a child.
(b) If both a man and a woman contracted for the creation of
the embryo, both parties must consent to the donation.
(c) Consent to the donation under Subsection (c) terminates
any parent-child relationship with respect to the embryo.
Sec. 176.152. SALE OF HUMAN EMBRYO PROHIBITED; CRIMINAL
PENALTY. (a) A person may not purchase, sell, or otherwise
transfer for valuable consideration a human embryo.
(b) In this section, "valuable consideration" does not
include reasonable payments associated with the transportation,
processing, preservation, or storage of the human embryo.
(c) A person commits an offense if the person knowingly
violates Subsection (a). An offense under this subsection is a
felony of the first degree.
SECTION 2. (a) The executive commissioner of the Health and
Human Services Commission shall appoint members to the advisory
committee as required by Section 176.103, Health and Safety Code,
as added by this Act, not later than November 1, 2009.
(b) The advisory committee shall adopt research guidelines
as required by Section 176.103, Health and Safety Code, as added by
this Act, not later than June 1, 2010.
SECTION 3. This Act takes effect September 1, 2009.