SB-0649, As Passed Senate, April 21, 2010
SUBSTITUTE FOR
SENATE BILL NO. 649
A bill to amend 1978 PA 368, entitled
"Public health code,"
(MCL 333.1101 to 333.25211) by adding sections 2694 and 2695.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec. 2694. (1) A physician or health facility or agency that
provides human in vitro fertilization services shall not deliver,
transmit, or otherwise convey oocytes or embryos to any person who
conducts research as permitted under section 2685 without first
obtaining the voluntary and written informed consent from the
individual who obtained the services. In a manner that complies
with the health insurance portability and accountability act of
1996, Public Law 104-191, a physician or health facility or agency
shall transmit a copy of the written informed consent obtained
under this section at the time it delivers, transmits, or otherwise
conveys oocytes or embryos to the person who conducts the research.
In addition to any information required to be provided by the
accepted standard of care, the documented informed consent shall
include the following information, as applicable:
(a) The oocytes and embryos are in excess of the clinical need
of the individual and would otherwise be discarded.
(b) The oocytes and embryos are not suitable for implantation
and would otherwise be discarded.
(c) That an individual who consents to the donation of oocytes
or embryos may withdraw that consent at any time up to the time the
oocytes or embryos are used in research.
(2) A physician or health facility or agency that provides
human in vitro fertilization services in this state shall not
provide the services without first informing the individual seeking
the services of all of the following:
(a) That Michigan law permits research using live human
embryos and that, subject to certain requirements, excess human
embryos may be donated for this research.
(b) The legal prohibitions on persons offering or providing
any valuable consideration in exchange for providing excess oocytes
or embryos to any other person.
(c) Options available to create, utilize, or store oocytes or
embryos in a quantity most acceptable to the individual seeking the
in vitro fertilization services and the potential or expected
financial obligations per annum if the individual chooses to
cryopreserve and store excess oocytes or embryos.
(3) A person who violates this section is responsible for a
Senate Bill No. 649 as amended April 21, 2010
state civil infraction and may be ordered to pay a civil fine of
not less than $5,000.00 per violation.
Sec. 2695. (1) Except as otherwise provided in this section, a
physician or health facility or agency that provides human in vitro
fertilization services shall annually submit a report as described
in subsection (2) 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 physician or health facility or agency 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 subsection (2), the
person may file the report required under federal law, rule,
regulation, or guideline to comply with this section. <<A
physician or health facility or agency that provides human in vitro
fertilization services is not required to file the report required
under this subsection until the department has developed and made
the form available under subsection (3).>>
(2) A physician or health facility or agency that provides
human in vitro fertilization services shall collect and report the
following information to the department as required under
subsection (1):
(a) Number of patients on whom oocyte extractions were
attempted.
(b) Number of patients from whom oocytes were successfully
extracted.
(c) Number of oocytes extracted from all patients.
(d) Number and type of complications experienced by patients
undergoing oocyte extraction.
(e) Number of oocytes retained in storage.
(f) Number of oocytes discarded before fertilization attempts.
Senate Bill No. 649 as amended April 21, 2010
(g) Number of oocytes exposed to sperm for fertilization.
(h) Number of embryos successfully created.
(i) Number of embryos undergoing genetic screening.
(j) Number of embryos discarded before implantation attempts.
(k) Number of embryos intentionally terminated in utero after
pregnancy has been established.
(l) Number of infants with disabilities or deformities
detectable at birth.
(m) Number of embryos thawed for implantation or donation.
(n) Number of embryos viable after thawing process.
(o) Number of embryos donated for implantation.
(p) Number of embryos donated for research and the health
facility or agency, academic institution, or other person to which
they were donated.
(q) Number of embryos discarded after storage at the direction
of the individual seeking in vitro fertilization services.
(r) Number of embryos held in storage at the beginning and end
of the reporting year.
(3) 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 physicians and health facilities and agencies 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
physician or health facility or agency to whom the 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.
(4) 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. 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 has obtained in vitro fertilization services. A
person shall not maintain statistical information that may reveal
the identity of an individual who has obtained in vitro
fertilization services.
(5) 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 (3)(b),
information submitted to the department by a physician or health
facility or agency 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 physician or health
facility or agency.
(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.
(6) A person who violates this section by disclosing
confidential identifying information 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. 647 of the 95th Legislature is enacted into
law.