BILL ANALYSIS
AB 1317
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Date of Hearing: April 21, 2009
ASSEMBLY COMMITTEE ON HEALTH
Dave Jones, Chair
AB 1317 (Block) - As Introduced: February 27, 2009
SUBJECT : Assisted oocyte production: advertisement:
information.
SUMMARY : This bill 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" 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 be provided a standardized,
medically accurate, written summary of health and consumer
issues associated with assisted reproductive production by
the investigator.
2) Requires 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 : This bill has not yet been analyzed by a fiscal
committee.
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COMMENTS :
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 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, 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 (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 (IVF) cycles done by 411
clinics. The oocyte donation process is not without risks to
the donors, but regulation of the donation process varies
depending on what type of entity accepts the donation. In
California, oocyte donations for research purposes require
informed consent from the donor and require that a potential
donor be provided medically accurate written and oral
information on potential risks. Medical groups which provide
fertility treatments must follow guidelines on compensation of
donors and secure informed consent from donors. However,
private egg donor agencies are unregulated and many offer
substantial financial incentives to donors.
According to the Institute of Medicine (IOM) and the National
Research Council, the oocyte donation process involves
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
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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.
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 believes that these 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
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informed consent from subjects for assisted oocyte production,
to provide potential donors with standardized written
summaries of health and consumer issues resulting from the
donation.
6)POLICY QUESTIONS AND COMMENTS . It is not clear how the
warning required in advertisements by this bill would be
enforced or what agency or entity would monitor compliance.
Further, it is likely that only a portion of potential donors
may see the warnings. The author may wish to consider
requiring that all potential subjects for assisted oocyte
production receive the same information in the same manner
mandated by SB 1260. This option would ensure all donors are
fully informed and have access to appropriate medical
information.
REGISTERED SUPPORT / OPPOSITION :
Support
None on file.
Oppose unless amended
American College of Obstetricians and Gynecologists, District IX
Opposition
None on file.
Analysis Prepared by : John Miller / HEALTH / (916) 319-2097