BILL ANALYSIS
AB 1317
Page 1
Date of Hearing: April 28, 2009
ASSEMBLY COMMITTEE ON HEALTH
Dave Jones, Chair
AB 1317 (Block) - As Introduced: February 27, 2009
SUBJECT : Assisted oocyte production: advertisement:
information.
SUMMARY : Requires a specified warning in all advertisements
for human egg donations associated with the delivery of
fertility treatment. Specifically, this bill :
1)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.
2)Defines "assisted oocyte production" (AOP) as the surgical
extraction of oocytes following pharmaceutically induced
manipulation of oocyte production through ovarian stimulation.
EXISTING LAW :
1) 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.
2) 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.
FISCAL EFFECT : None.
COMMENTS :
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1)PURPOSE OF THIS BILL . 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 will help women make an informed donation decision
and increase donor awareness of the potential side effects of
this very recent medical development. According to the
author, 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.
2)BACKGROUND . The American College of Obstetricians and
Gynecologists, District IX, California (ACOG) finds that the
potential of stem cell treatments and the recent advances in
fertility treatments have very substantially increased demand
for human egg cells, scientifically known as "oocytes"
(pronounced "oh-sites"). In 2004, in the United States,
almost 50,000 babies were born - representing almost 1% of all
newborns - as the result of 128,000 In Vitro Fertilization
cycles done by 411 clinics. The oocyte donation process is
not without risks to the donors, but regulation of the
donation process varies based on what type of entity accepts
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.
Physicians who provide fertility treatments follow
recommended, voluntary guidelines on compensation of donors
and other practices promulgated by the American Society for
Reproductive Medicine (ASRM) and are required to secure
informed consent from donors. The federal Food and Drug
Administration, according to their website, has promulgated
regulations which include mandatory registration of all
assisted reproductive technology programs, requirements for
documentation of all services and implementation protocols
attendant to donor screening. However, according to ACOG, a
small number of private egg donor agencies operate in this
state without regulation or oversight, and these agencies may
offer substantial financial incentives to donors.
According to the Institute of Medicine (IOM) and the National
Research Council, the oocyte donation process involves
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stimulation of the ovaries with fertility medications
(gonadotropins) and the subsequent retrieval of the eggs from
the donor's ovaries, usually in an operative procedure under
light anesthesia with needle aspiration. The IOM organized a
comprehensive review of the potential acute and chronic risks
associated with oocyte donation and published their findings
in "Assessing the Medical Risks of Human Oocyte Donation for
Stem Cell Research (2007)." In this assessment, the IOM noted
that in order to increase the number of eggs retrieved from a
single donor, the donor normally takes a regimen of hormone
shots to increase fertility. The most prominent negative side
effect of this ovarian stimulation is ovarian hyperstimulation
syndrome which causes nausea and vomiting, breathing
difficulties, kidney and liver problems and, in the most
severe cases, blood clots. However, the IOM's research
indicated only about 0.1 to 0.2% (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. Researchers
found limited evidence on this aspect, but did not find a
positive association with cancer prevalence. The IOM report
indicated that more research on longer term cancer effects is
necessary, but found some indication of increased risk of
uterine cancer. 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. The IOM strongly recommended additional
research on the subject.
According to OBGYN.net, compensation of egg donors by fertility
treatment clinics has been the subject of much debate. Almost
all professionals working with donors agree that compensation
for the donor's time, effort and discomfort is appropriate.
However, the amount of compensation is variable depending on
clinic policy and the involvement of agencies and, according
to OBGYN.net; opinions of appropriate levels of compensation
differ dramatically among clinics. The ASRM advises that
donor compensation over $5,000 requires justification and that
compensation of more than $10,000 is unacceptable. Sixty-one
US agencies have signed an agreement to abide by the ASRM
guidelines governing payment to egg donors. Among these
agencies, the average fee was $4,353 for egg donation. Six
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agencies had premium fees for donors with preferred
qualifications and one agency offered donor compensation of
over $10,000 according to OBGYN.net.
3)SUPPORT . The author states that the high demand for human
oocytes has created a market often characterized by aggressive
outreach with substantial financial incentives to potential
oocyte donors. The author maintains 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.
4)OPPOSE UNLESS AMENDED . ACOG is requesting that this bill be
applied exclusively to non-physician, unregulated entities.
ACOG states that physician based fertility treatment centers
follow accepted protocols restricting incentives and strictly
screen and fully inform potential donors.
5)PREVIOUS AND RELATED LEGISLATION . SB 1260 (Ortiz), Chapter
483, Statutes of 2006, requires physicians, prior to obtaining
informed consent from subjects for assisted oocyte production
for use in cell research, to provide potential donors with
standardized written summaries of health and consumer issues
resulting from the donation.
6)AUTHOR'S AMENDMENTS : The author will offer amendments
requiring any physician who procures oocytes for fertility
treatments to provide oocyte donors the same medical
information now required to be provided oocyte donors for stem
cell research. The existing law requires that physicians,
prior to any procedure, provide the donor a standardized
medically accurate written summary of health and consumer
issues associated with AOP and oocyte retrieval. The summary
must be in plain language, must describe potential risks to
the donor, and must contain a warning in bold type face
stating the long term risks of AOP are unknown. In addition,
each donor is required to provide both written and verbal
informed consent to the physician. A physician's failure to
comply with this requirement will constitute unprofessional
conduct. The author's amendment incorporates requirements of
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SB 1260 (Ortiz), Chapter 483, Statutes of 2006.
REGISTERED SUPPORT / OPPOSITION :
Support
42 individuals
Oppose unless amended
American College of Obstetricians and Gynecologists, District IX
Opposition
None on file.
Analysis Prepared by : John D. Miller / HEALTH / (916)
319-2097