BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K Alquist, Chair
BILL NO: AB 1317
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AUTHOR: Block
B
AMENDED: May 6, 2009
HEARING DATE: June 25, 2009
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CONSULTANT:
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Tadeo/
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SUBJECT
Assisted oocyte productions: advertisement: information
SUMMARY
Requires a specified warning in all advertisements for
human egg donations associated with the delivery of
fertility treatment. Requires donors to fertility
treatment centers be provided with medically accurate
information regarding potential risks.
CHANGES TO EXISTING LAW
Existing law:
Requires investigators to provide subjects making egg
donations for research purposes a standardized, medically
accurate, written summary of health and consumer issues
associated with assisted reproductive production by the
investigator.
Requires the written summary to specify potential risks
associated with the surgical procedure and the use of
drugs, medications and hormones prescribed for ovarian
stimulation and requires written and oral informed consent
of all donors prior to the procedures.
Continued---
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This bill:
Requires any advertisement seeking oocyte (human egg cell)
donation associated with the delivery of fertility
treatment that includes assisted oocyte production to
contain the following warning: "There are potential risks
associated with human egg donation. Long-term risks
associated with human egg donation have not been
determined. Consultation with your reproductive care
specialist prior to entering into a donor contract is
advised."
Exempts fertility clinics and donation agencies who
formally agree to abide by the American Society for
Reproductive Medicine guidelines from providing the
specified warning.
Requires physicians at fertility treatment clinics to
provide donors the same medically accurate summary of
health and consumer issues associated with oocyte retrieval
as is required for research donors. Requires the summary
to 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.
Requires physicians at fertility treatment clinics to
follow specified procedures for obtaining informed consent
from egg donors who provide eggs for fertility treatments.
Clarifies that it does not amend Proposition 71 - Stem Cell
Research, passed in 2004.
FISCAL IMPACT
This bill is keyed non-fiscal.
BACKGROUND AND DISCUSSION
According to the author, the warning required by this bill
is intended to motivate women considering egg donation to
consult with reproductive health care specialists prior to
any donation. The author states this bill seeks to help
women make an informed donation decision and to increase
donor awareness of the potential side effects of this
recent medical development. According to the author,
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California has become one of the leading centers for the
recruitment of egg donors and as the demand for human eggs
to assist in fertility treatments has grown, financial
incentives for donations have also increased and may unduly
influence the judgment of young women.
The author contends that financial incentives may cause
young women to put themselves unknowingly at risk of future
injury by donating their eggs without full knowledge of the
potential or long-term consequences of their actions. The
author further points out that the hormones administered to
stimulate donor egg production have in the past had serious
health consequences and that there is wide professional
recognition that the long-term health consequences of
oocyte donation have not been determined.
Human egg donation and fertility treatments
According to the American College of Obstetricians and
Gynecologists, (ACOG) the potential of stem cell
treatments and the recent advances in fertility treatments
have very substantially increased demand for oocytes. In
2004, in the United States, almost 50,000 babies were born
- representing almost 1 percent of all newborns - as the
result of 128,000 fertility treatments by 411 clinics.
Regulation of the donation process varies based on what
type of entity seeks the donation. In California, oocyte
donations for research purposes require informed consent
from the donor and require donors be provided medically
accurate written and oral information on the potential
risks of the procedure. Most physicians who provide
fertility treatments follow recommended, voluntary
guidelines on compensation of donors and other practices
promulgated by the American Society for Reproductive
Medicine and are required to secure informed consent from
donors. However, according to ACOG, a number of private
egg donor agencies operate in this state without formal
regulation or oversight, and these agencies may offer
substantial financial incentives to donors.
ACOG guidelines include, but are not limited to the
following:
Financial compensation of women donating oocytes
for infertility therapy or for research is justified
on ethical grounds.
Compensation should be structured to acknowledge
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the time, inconvenience, and discomfort associated
with screening, ovarian stimulation, and oocyte
retrieval.
Compensation should not vary according to the
planned use of the oocytes, the number or quality of
oocytes retrieved, the number or outcome of prior
donation cycles, or the donor's ethnic or other
personal characteristics.
Total payments to donors in excess of $5,000
require justification and sums above $10,000 are not
appropriate.
To discourage inappropriate decisions to donate
oocytes, programs should adopt effective information
disclosure and counseling processes.
Donors independently recruited by prospective
oocyte recipients or agencies should undergo the same
disclosure and counseling process as donors recruited
by the program.
Egg donors go through a selection process which includes
psychological, genetic and medical screening. Eggs donors
that go through assisted oocyte production, which is a
pharmaceutically induced manipulation of egg production,
inject a series of hormones to stimulate the growth of
ovarian follicles, effect egg maturation and block
ovulation before a physician retrieves the eggs. The eggs
are later surgically retrieved with a probe which is
inserted into the ovary where a number of eggs are
aspirated under ultrasound guidance. The eggs retrieved
become the property and responsibility of the recipient.
Options for eggs that are not used for fertility treatment
include storage for later use or donation for research.
The Centers for Disease Control and Prevention, Institute
of Medicine (IOM) undertook a comprehensive review of the
potential acute and chronic risks associated with oocyte
donation which found the most prominent negative side
effect is ovarian hyper stimulation syndrome which causes
nausea and vomiting, breathing difficulties, kidney and
liver problems. However, the IOM's research indicated only
about 0.1 to 0.2 percent (roughly 1.4 cases per 100,000
women) experienced any of these symptoms. The IOM also
evaluated the concern that the fertility drugs would
increase the risks of hormone dependent cancers - in
particular breast, ovarian, and uterine cancers - but did
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not find a positive association with cancer prevalence.
The IOM reported low risks associated with the surgical
procedures of oocyte donation and did not find data
suggesting that donation surgery posed a risk to future
fertility. The IOM did express concern that very little is
known about the long-term health outcomes of women who
undergo these procedures and recommended additional
research.
Advertising for human egg donation
Private egg donor agencies recruit and match up egg donors
and individuals looking for egg donors. They advertise on
websites, in university campus papers, and on craigslist,
as well as other locations. Examples of these
advertisements are as follows:
Listings for employment on craigslist, under part
time jobs list several agencies and provide links to
their websites. A typical ad reads "Egg donation is a
great way to help loving couples or singles create
their families while earning the money you want for
college, travel or to supplement your personal income.
First time donors earn $8,000.00 while previous egg
donors earn $10,000.00. We are looking for women
between the ages of 21 and 29.5 years of age, normal
body mass index, non-smoker, enrolled in
college/college degree or show success in a chosen
career field and know all health history of your
parents, grandparents, siblings, aunts, uncles and
cousins."
One egg donor website boasts that it is the "Agency
for Superdonors" and is "Known for representing the
brightest, most beautiful and accomplished donors in
the country". Another website states that "There are
many reasons young women choose to donate. Many know
someone who has struggled to get pregnant and has not
been able to, or she can imagine what that would be
like to need another person to step forward to help.
Others feel that it would not be a big deal for them
and the money involved could certainly help. Everyone
is different."
An ad in the UC Berkeley campus newspaper reads, "A
Loving & Caring Chinese Family is looking for healthy,
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young (under 32), highly intelligent, Chinese egg
donor, remuneration $100,000 and negotiable."
Related bills
AB 995 (Block) would repeal a current requirement that DPH
adopt regulations governing licensed tissue banks and
instead require tissue banks to comply with standards
published by the American Association of Tissue Banks. This
bill is set to be heard in Senate Health Committee on June
24, 2009.
Prior legislation
SB 1260 (Ortiz), Chapter 483, Statutes of 2006, requires
physicians, prior to obtaining informed consent from
subjects for assisted oocyte production, for research, to
provide potential donors with standardized written
summaries of health and consumer issues resulting from the
donation.
Arguments in support based on a prior version of the bill
Supporters state that the appeal of advertising for egg
donation, especially at college settings is powerful, given
the current recession and rising cost of tuition, but
students are not cautioned to consider any long-term health
effects. The California Family Council states that AB 1317
will not result in a decrease of potential donors, but
rather encourage greater understanding and knowledge of the
process and potential effects of egg donation.
Oppose unless amended
The American College of Obstetricians and Gynecologists,
District IX, California and American Society for
Reproductive Medicine requests an amendment to apply this
bill exclusively to non-physician, unregulated entities.
The opponents contend that physician- based fertility
treatment centers follow accepted protocols restricting
incentives and strictly screen and fully inform potential
donors.
PRIOR ACTIONS
Assembly Floor: 48-20
Assembly Health: 11-0
COMMENTS
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1)The advertisement criteria needs to be expanded.
The bill limits compliance to advertisements for an egg
donation that is associated with the delivery of
fertility treatment only. The bill also limits
compensation to financial payment, and a potential donor
could be offered something else of value, for example, a
car, vacation or scholarship.
Suggested amendment: Page 2, lines 8-11:
125325.10. (a) Except as set forth in subdivision (b), an
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:
2)The notice required on advertisements needs to be
expanded.
The notice does not address the known risks of egg
donation. A potential egg donor goes through an
extensive screening process and may not be selected.
Once selected, she may not receive the compensation
advertised. It would benefit the potential egg donor to
be advised of these issues before responding to the
advertisement. Additionally, the use of the word doctor
is appropriate for the purposes of the advertisement.
Suggested amendments:
Page 2, lines 13-17:
"There are potential risks associated with human egg
donation. Long-term risks associated with human egg
donation have not been determined . "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 will receive specific information on the
known risks of egg donation. Consultation with your
physician and surgeon or other health care provider
doctor prior to entering into a donor contract is
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advised.
3) Informed consent procedures required by the bill may
be redundant.
An egg donor becomes a patient when she undergoes the
medical/physical component of the egg donation procedure
at a fertility clinic. A full informed consent by the
physicians and clinics is already required. It is the
author's intention to make sure that a woman receives
information before she considers becoming an egg donor,
and assure that a woman that is recruited through an
advertisement is given the same information as any other
donor.
Suggested amendments:
(b) A summary, as described in Section 125335 in the
Health and Safety Code, 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 full informed
consent.
Page 2, line 21:
(b) (c)
(d) Donors recruited through the advertisement shall
undergo the same disclosure, counseling and informed
consent process as donors recruited by those exempt from
section (a).
Strike page 2, line 31 through page 5, line 2.
4)Clarification of exemption and compliance:
Suggested amendment:
Page 2, lines 21 - 24:
(b) Persons or entities that certify compliance have
signed and filed agreements with the American Society for
Reproductive Medicine (ASRM) guidelines by registering to
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comply with ASRM guidelines are exempt from the notice
requirements set forth in subdivision (a). Use of the
exemption when the guidelines are violated constitute
false advertising.
POSITIONS
Support: California Family Council ( previous version of
bill)
Center for Genetics in Society ( previous
version of bill)
95 individuals ( previous version of
bill)
Oppose: American College of Obstetricians and
Gynecologists, District IX, California
American Society for Reproductive Medicine
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