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.