BILL NUMBER: AB 1317 AMENDED
BILL TEXT
AMENDED IN SENATE JULY 6, 2009
AMENDED IN ASSEMBLY MAY 6, 2009
INTRODUCED BY Assembly Member Block
FEBRUARY 27, 2009
An act to add Chapter 1.5 (commencing with Section
125325.10) 125325) to Part 5.5 of Division 106
of the Health and Safety Code, relating to public health.
LEGISLATIVE COUNSEL'S DIGEST
AB 1317, as amended, Block. Assisted oocyte production:
advertisement: information.
Existing law requires that an oocyte retrieval summary be provided
to the donor of oocytes for research purposes. Existing law requires
that a health care professional in the course of fertility treatment
provide prescribed information to an embryo donor relating to
donation of remaining embryos for research purposes.
This bill would , with certain exceptions, establish
similar requirements for donors of oocytes for fertility treatment,
and would require an advertisement seeking oocyte donation associated
with the delivery of fertility treatment that includes assisted
oocyte production and a financial payment, or compensation of
any kind , to contain a prescribed notice relating to the
potential health risks associated with human egg donation.
The bill would declare that it shall not be construed to amend
Proposition 71, approved by the voters at the November 2, 2004,
general election.
Vote: majority. Appropriation: no. Fiscal committee: no.
State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Chapter 1.5 (commencing with Section
125325.10) 125325) is added to Part 5.5 of
Division 106 of the Health and Safety Code, to read:
CHAPTER 1.5. OOCYTE RETRIEVAL FOR FERTILITY TREATMENT
125325.10. (a) Except as set forth in subdivision (b), an
125325. (a) An
advertisement seeking oocyte donation associated with the delivery of
fertility treatment that includes assisted oocyte production
and a financial payment or compensation of any kind, shall
include the following notice in a clear and conspicuous manner
:
"There are potential risks associated with human egg donation.
Long-term risks associated with human egg donation have not been
determined. Consultation with your physician and surgeon or other
health care provider prior to entering into a donor contract is
advised."
(b) Persons or entities that have signed and filed agreements
"Egg donation involves a screening process. Not all potential egg
donors are selected. Not all selected egg donors receive the
monetary amounts or compensation advertised. As with any medical
procedure, there may be risks associated with human egg donation.
Before an egg donor agrees to begin the egg donation process, and
signs a legally binding contract, she is required to receive specific
information on the known risks of egg donation. Consultation with
your doctor prior to entering into a donor contract is advised."
(b) A summary, as described in Section 125335, pertaining to
oocyte donation procedures, shall be provided to all potential egg
donors before signing a legally binding contract to become an egg
donor, or beginning any egg donation procedures, as part of
compliance with the informed consent requirements.
(c) Persons or entities that certify
compliance with the American Society for Reproductive Medicine
(ASRM) to comply with ASRM guidelines
guidelines by registering with ASRM are exempt from the notice
requirements set forth in subdivision (a). Use of the exemption
when the guidelines are violated shall constitute false advertising.
(d) Donors recruited through the advertisement shall undergo
the same disclosure, counseling, and informed consent process as
donors recruited by those exempt from subdivision (a).
125325.15. The following definitions shall apply to this chapter:
(a) "Assisted oocyte production" or "AOP" means surgical
extraction of oocytes following pharmaceutically induced manipulation
of oocyte production through the use of ovarian stimulation for the
purposes of fertility treatment.
(b) "Oocyte" means a female egg or egg cell of a human female.
(c) "Subject" means any person undergoing AOP or any alternative
method of ovarian retrieval for fertility treatment.
(d) "Alternate method of oocyte retrieval" means a method of
oocyte retrieval that does not involve the pharmaceutically induced
manipulation of oocyte production.
(e) "Institutional review board" means a body established in
accordance with federal regulations, including Part 46 (commencing
with Section 46.101) of Subchapter A of Subtitle A of Title 45 of the
Code of Federal Regulations.
125325.20. (a) Prior to obtaining informed consent from a subject
for AOP or any alternative method of ovarian retrieval on a subject
for the purpose of procuring oocytes for fertility treatment, a
physician and surgeon shall provide to the subject a standardized
medically accurate written summary of health and consumer issues
associated with AOP and any alternative methods of oocyte retrieval.
The failure to provide to a subject this standardized medically
accurate written summary constitutes unprofessional conduct within
the meaning of Chapter 5 (commencing with Section 2000) of Division 2
of the Business and Professions Code.
(b) The summary shall include, but not be limited to, medically
accurate disclosures concerning the potential risks of AOP or any
alternative method of oocyte retrieval, including the risks
associated with the surgical procedure and with using the drugs,
medications, and hormones prescribed for ovarian stimulation during
the AOP process or any alternative method of oocyte retrieval. The
summary shall also include a warning, in bold 14-point type, that the
long term effects of taking the drugs associated with the egg
retrieval process are unknown as of January 1, 2010.
(c) For purposes of subdivision (a), "written summary of health
and consumer issues" means the guide published and updated by the
American Society for Reproductive Medicine entitled, "Assisted
Reproductive Technology: A Guide for Patients" or an alternative
written medically accurate document prepared by a recognized
authority on oocyte retrieval for fertility treatment that also meets
the criteria included in this section. This alternative document may
be one that has been approved and recommended by the State
Department of Public Health and shall include all of the following:
(1) The document shall adhere to simplified reading standards,
including, but not limited to, those generally accepted and required
for government publications. The document shall be written in
layperson's language and shall be made available in languages spoken
by subjects in the study if their proficiency is largely in a
language other than English. All information in the document shall be
conveyed to the subject orally in easy to understand and
nontechnical terms.
(2) The document shall include additional resources for, or list
additional sources of, medical information on health and safety
issues surrounding oocyte retrieval.
125325.25. (a) Prior to dispensing or administering any drug for
AOP or any alternative method of ovarian retrieval to a subject for
the purposes of providing fertility treatment, a physician and
surgeon shall obtain written and oral informed consent for the
procedure from the subject. Informed consent for the purposes of this
chapter shall comply with the informed consent requirements of the
Protection of Human Subjects in Medical Experimentation Act (Chapter
1.3 (commencing with Section 24170) of Division 20).
(b) The failure to obtain written informed consent from the
subject prior to dispensing or administering any drug for AOP or any
alternative method of ovarian retrieval to a subject for the purposes
of fertility treatment constitutes unprofessional conduct within the
meaning of Chapter 5 (commencing with Section 2000) of Division 2 of
the Business and Professions Code. Nothing in this section shall be
construed to relieve the physician and surgeon from other existing
duties under the law, including, but not limited to, the duty to
obtain a subject's informed consent after fully explaining the
proposed procedure. The requirement that a physician and surgeon
provide the standardized written summary pursuant to this article is
in addition to, and does not supplant, other existing legal
requirements regarding informed consent, including, but not limited
to, compliance with the Protection of Human Subjects in Medical
Experimentation Act (Chapter 1.3 (commencing with Section 24170) of
Division 20, if applicable.
(c) This chapter shall not affect the suitability or availability
of oocytes procured for fertility treatment before January 1, 2010,
if the oocytes were donated pursuant to protocols or standards that
are generally recognized and accepted by national or international
scientific bodies.
(d) Any written document required pursuant to this article shall
adhere to simplified reading standards, including, but not limited
to, those generally accepted and required for government
publications, and in layperson's language. The document shall be made
available in languages spoken by subjects in the study if their
proficiency is largely in a language other than English. All
information in the written informed consent document shall also be
conveyed to the subject orally in easy to understand and nontechnical
terms.
SEC. 2. This act shall not be construed to amend Proposition 71,
approved by the voters at the November 2, 2004, general election.