SB-0647, As Passed Senate, April 21, 2010
SUBSTITUTE FOR
SENATE BILL NO. 647
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending sections 2685, 2690, 2691, and 2692 (MCL 333.2685,
333.2690, 333.2691, and 333.2692) and by adding sections 2693 and
2696.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec.
2685. (1) A Except as otherwise
provided in subsection
(3) and subject to section 2693, a person shall not use a live
human embryo, fetus, or neonate for nontherapeutic research if, in
the best judgment of the person conducting the research, based upon
the available knowledge or information at the approximate time of
the research, the research substantially jeopardizes the life or
health of the embryo, fetus, or neonate. Nontherapeutic research
shall not in any case be performed on an embryo or fetus known by
the person conducting the research to be the subject of a planned
abortion being performed for any purpose other than to protect the
life of the mother.
(2) For purposes of subsection (1) the embryo or fetus shall
be conclusively presumed not to be the subject of a planned
abortion if the mother signed a written statement at the time of
the research, that she was not planning an abortion.
(3) Pursuant to section 27 of article I of the state
constitution of 1963, a person shall not conduct research that
substantially jeopardizes the life or health of a human embryo
unless all of the following requirements are met:
(a) The research is permissible under federal law and
conducted pursuant to the requirements of federal law.
(b) The human embryo was created for in vitro fertilization
purposes.
(c) The human embryo was in excess of the clinical need of or
was not suitable for implantation in the individual seeking the in
vitro fertilization services and would otherwise be discarded.
(d) The human embryo was donated for research with the
voluntary and written informed consent by the individual seeking
the in vitro fertilization services and the person does either of
the following:
(i) Obtains a copy of the written informed consent given under
section 2694 from the physician or health facility or agency that
provided the in vitro fertilization services.
(ii) Obtains written informed consent that meets the
requirements of section 2694 from the individual who obtained the
Senate Bill No. 647 as amended April 21, 2010
in vitro fertilization services and is donating the human embryo
for research.
(e) The human embryo has not been allowed to develop more than
14 days after cell division begins, not including any time during
which the embryo was frozen.
(f) The research involves the extraction or utilization of
embryonic stem cells from the human embryo.
<<(4) A person that conducts research using live human embryos
as permitted in subsection (3) shall establish a stem cell research
oversight committee substantially in accordance with the guidelines
for human embryonic stem cell research issued by the national
research council and the institute of medicine of the national
academies in 2005. Not less than once per year, the stem cell
research oversight committee shall conduct continuing review of
research using live human embryos in order to ensure that the
research continues to meet the standards of this part. Pursuant
to its review under this subsection, a stem cell research oversight committee may revoke its prior approval of research under this
subsection and require modifications to the plan or design of a continuing research project before permitting the research to
continue. A stem cell research oversight committee may provide
scientific and ethical review of research consistent with this
part.>>
Sec.
2690. (1) A person shall not knowingly sell, transfer,
distribute,
or give away donate an embryo, fetus, or neonate for a
use
which that is in violation of sections 2685 to 2689.
(2) A person shall not, for valuable consideration, purchase
or sell, offer to purchase or sell, or attempt to purchase or sell
a human embryo or oocyte for stem cell research or stem cell
therapies and cures as allowed under section 27 of article I of the
state constitution of 1963, or for any other purpose.
Sec. 2691. A person who violates sections 2685 to 2690 or
section
2693 is guilty of a felony , punishable by imprisonment for
not more than 5 years or a fine of not more than $5,000.00, or
both.
Sec.
2692. As used in sections 2685 to 2691, "nontherapeutic
2696:
(a) "Created for in vitro fertilization purposes" means
created for implantation and gestation in a woman's uterus by
either of the following:
(i) In vitro fertilization.
(ii) The intentional division of a human embryo created by in
vitro fertilization.
Senate Bill No. 647 as amended April 21, 2010
(b) "Health facility or agency" means that term as defined in
section 20106.
(c) "Human embryo" means an organism consisting entirely of
biological components of the species homo sapiens capable of
differentiation and maturation, regardless of the means of
creation, including, but not limited to, fertilization and somatic
cell nuclear transfer, beginning from the single cell stage through
the seventh week of development.
(d) "Nontherapeutic research" means scientific or laboratory
research, or other kind of experimentation or investigation not
designed to improve the health of the research subject.
<<(e) "Not suitable for implantation" means that the human
embryo exhibits genetic or morphological characteristics that, in
the best judgment of the attending physician, negatively affect the
potential for successful implantation, gestation, or healthy
development of the embryo; or lead to a disease likely to be fatal
to the embryo or any human derived from the embryo. Not suitable
for implantation does not include genetic characteristics that do
not affect the health of the human embryo or any human derived from
the embryo, including, but not limited to, gender or physical
appearance.>>
(f) "Physician" means a physician licensed under part 170 or
part 175, or an individual performing an act, task, or function
under the delegatory authority of that physician.
(g) "Unique identifier" means a number or other identifier
assigned by protocols established by the department.
(h) "Valuable consideration" means the payment or provision of
anything of value, including, but not limited to, cash, gifts,
reduced or waived fees for services rendered, medical treatment, or
payment for expenses or accommodations. Valuable consideration does
not include medical treatment or services provided at no cost as
part of a clinical trial or experimental therapy related to the
treatment of infertility where the trial or experiment is not
conducted by a person directly involved in research authorized
under section 2685.
Sec. 2693. (1) A person shall not create or attempt to create
a human embryo for the purpose of conducting nontherapeutic
research upon that embryo.
(2) A person shall not create or attempt to create a human-
animal chimeric embryo consisting of biological components from the
species homo sapiens and 1 or more other species where the embryo
is capable of differentiating and maturing in a manner
substantially similar to the embryonic maturation process of either
a human embryo or of an embryo of any of the other species
constituting the chimeric embryo.
Sec. 2696. (1) Except as otherwise provided in this
subsection, a person that conducts research using live human
embryos as permitted under section 2685 shall annually submit a
report as described in subsections (2) and (3) on forms prescribed
and provided by the department, using the unique identifier
provided by the department, and at the time and in the manner
prescribed by the department. If the person is required to file a
report under federal law, rule, regulation, or guideline applicable
to research using live human embryos, which report contains all of
the information required to be reported under subsections (2) and
(3), the person may file the report required under federal law,
Senate Bill No. 647 as amended April 21, 2010
rule, regulation, or guideline to comply with this section. <<A
person that conducts research using live human embryos is not
required to file the report required under this subsection until
the department has developed and made the form available under
subsection (4).>>
(2) A person that conducts research using live human embryos
shall collect and report the following information to the
department as required under subsection (1):
(a) Name of the company, corporation, academic institution, or
other person managing or overseeing the research.
(b) Name and address of the physician's office or health
facility or agency where embryos were donated and the number of
embryos acquired from each office or facility or agency.
(c) Number of embryos thawed for use in research.
(d) Number of embryos discarded without being utilized for
research.
(e) Number of embryos held in storage at the beginning and
ending of the reporting year.
(3) A person that conducts research using live human embryos
shall report its research, oversight, and review policies and
procedures with regard to the research conducted. The person that
files a report under this subsection shall certify that its
research, oversight, and review policies and procedures with regard
to the research conducted are in compliance with federal law,
rules, regulations, and guidelines applicable to that research. A
violation of a federal law, rule, regulation, or guideline
applicable to research using live human embryos is a violation of
this section.
(4) The department shall do all of the following:
(A) <<On or before the expiration of 1 year after the
effective date of this section,>> develop and make available in
print and electronic format
a form for persons to utilize in filing the report required in
subsection (1).
(b) Make available annually in aggregate a statistical report
summarizing the information submitted in each individual report
required by this section. The department shall not identify the
person who conducts research using live human embryos to whom any
specific information applies.
(c) Destroy each report required by this section and each copy
of the report after retaining the report for 5 years after the date
the report is received.
(d) Establish a program that will issue to each person
required to submit a report under subsection (1) a unique
identifier under which the person is to submit the report.
(5) A person submitting a report under subsection (1) shall
not include the name, common identifiers such as social security
number or motor vehicle operator's license number, or other
information or identifiers that would make it possible to identify
in any manner or under any circumstances an individual who has
obtained in vitro fertilization services and who subsequently
donated human embryos for research purposes. A state agency shall
not compare data in an electronic or other information system file
with data in any other electronic or other information system that
would result in identifying in any manner or under any
circumstances an individual who donated human embryos for research.
A person shall not maintain statistical information that may reveal
the identity of an individual who has donated human embryos for
research.
(6) Except as otherwise provided in this section, a person
shall not disclose confidential identifying information about an
individual who obtains in vitro fertilization services. The reports
required under this section are statistical reports to be used only
for medical and health purposes and shall not be incorporated into
the permanent official records of the system of vital statistics.
Except for the statistical report under subsection (4)(b),
information submitted to the department by a person who conducts
research using live human embryos under this section is
confidential and is not subject to the disclosure requirements of
the freedom of information act, 1976 PA 442, MCL 15.231 to 15.246,
except that disclosure of that information may be made in any of
the following circumstances:
(a) With the written consent of the person who conducts
research using live human embryos.
(b) Pursuant to a court proceeding.
(c) The disclosure is made to an agent or employee of the
department.
(d) The disclosure is made to an agent or employee of a state
or the federal government authorized by law to see or review the
information.
(7) A person that violates this section by disclosing
confidential identifying information or by violating a federal law,
rule, regulation, or guideline is guilty of a felony punishable by
imprisonment for not more than 1 year or a fine of not more than
$5,000.00, or both. A person who violates this section by failing
to file a required report is responsible for a state civil
infraction and may be ordered to pay a civil fine of not less than
$5,000.00 per violation.
Enacting section 1. This amendatory act does not take effect
unless Senate Bill No. 649 of the 95th Legislature is enacted into
law.