BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 2531|
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THIRD READING
Bill No: AB 2531
Author: Burke (D)
Introduced:2/19/16
Vote: 21
SENATE HEALTH COMMITTEE: 8-1, 6/15/16
AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Pan, Roth,
Wolk
NOES: Nielsen
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
ASSEMBLY FLOOR: 65-3, 4/28/16 - See last page for vote
SUBJECT: Reproductive health and research
SOURCE: American Society for Reproductive Medicine
DIGEST: This bill requires women providing human oocytes for
research to be compensated for their time, discomfort, and
inconvenience in the same manner as other research subjects, as
prescribed and determined by a human subject research panel or
institutional review board.
ANALYSIS:
Existing law:
1)Prohibits any payment in excess of the amount of reimbursement
of direct expenses incurred as a result of the procedure to be
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made to any subject to encourage her to produce human eggs for
purposes of medical research. Prohibits any human egg or
embryo from being acquired, sold, offered for sale, received,
or otherwise transferred for valuable consideration for the
purposes of medical research or development of medical
therapies.
2)Requires an institutional review board (IRB) to require
research programs or projects under its review that involve
"assisted oocyte production" to comply with certain
requirements, including that the research program perform
psychological and physical screening for all subjects, and
that subjects be given a post-procedure medical examination.
This bill:
1)Repeals the ban on compensation in excess of the amount of
reimbursement of direct expenses incurred, as specified.
Requires compensation amounts to be determined by human
subject research panels and IRBs.
2)Requires a woman providing human oocytes for research to be
compensated for her time, discomfort, and inconvenience in the
same manner as other research subjects. Prohibits this payment
from being for the human oocytes themselves or predicated on
the number of oocytes obtained, including if no human oocytes
are obtained.
3)Requires a human subject research panel or IRB to determine
whether a proposed compensation amount is appropriate.
Requires the panel or IRB, in the event that a proposed
compensation amount is determined to be inappropriate, to
determine an appropriate compensation amount.
4)Requires the IRB, if a woman providing human oocytes for the
purposes of fertility is compensated, and any human oocytes or
embryos in excess of those needed for fertility are offered
for research, to disregard the amount of compensation if:
a) The clinic performing oocyte retrieval is a member of
the Society for Assisted Reproductive Technology;
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b) The procurement and disposition for research purposes of
human oocytes initially provided for reproductive uses,
either for use by the donor or another woman, does not
knowingly compromise the optimal reproductive success of
the woman in the infertility treatment;
c) The infertility treatment protocol is established prior
to requesting or obtaining consent for donation for
research purposes and the prospect of donation for research
does not alter the timing, method, or procedures selected
for clinical care;
d) The woman in infertility treatment makes the
determination that she does not want or need the oocytes
for her own reproductive success; and,
e) The donation of oocytes for research is done without
valuable consideration, as specified.
Background
Over the past two decades, millions of women have had oocytes
collected for the purpose of assisted reproduction. Most of
these were women undergoing in vitro fertilization (IVF) with
their own eggs, but a significant minority donate eggs to help
other women get pregnant. During the normal ovulation cycle, 10
or 20 egg follicles will begin to grow, eventually leading to
one "dominant follicle" producing a single egg, and the other
egg follicles dying off. In the process, hormones are used to
basically trick the body into keeping the other follicles alive
and also produce eggs. The process involves the woman
self-injecting hormones to stimulate the growth of ovarian
follicles, plus a gonadotropin-releasing hormone (GnRH) agonist
to block the normal surge of luteinizing hormone (LH), which
could cause the woman to ovulate before the physician retrieves
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the eggs. Typically, GnRH agonists are administered a week
before stimulation to control the stimulation cycle and avoid a
spontaneous LH surge. The woman subsequently self-injects the
hormone chorionic gonadotropin (similar to LH) to affect egg
maturation. When the eggs are ready, the woman is brought into
surgery, where the eggs are harvested via needle aspiration. A
woman who has undergone the usual hormone treatment will have a
dozen or so eggs that can be collected.
Compensation of oocyte donors. Under California law, the
prohibition against compensation to oocyte donors applies only
to donors for research purposes, not to assist someone else get
pregnant (fertility purposes). According to a March 2010 report
by the Hastings Center, a research institution focusing on
bioethics, entitled "Self-Regulation, Compensation, and the
Ethical Recruitment of Oocyte Donors," the fertility industry in
the United States relies heavily on self-regulation, which
generally takes the form of guidelines issued by the American
Society for Reproductive Medicine (ASRM - the sponsor of this
bill) and its affiliated organization, the Society for Assisted
Reproductive Technology. The report looked at egg donor
recruitment advertisements on college campuses, and found that
nearly half offered compensation that exceeded recommended
levels. The average compensation offered was approximately
$9,000, with a maximum offer of $50,000. ASRM's 2007 donor
compensation guidelines state that compensation should be
structured to acknowledge the time, inconvenience, and
discomfort associated with the process, and should not vary
according to the planned use of the oocytes, the number or
quality retrieved, or the donor's ethnic or other personal
characteristics. The guidelines state that total payments to
donors in excess of $5,000 require justification, and sums above
$10,000 are not appropriate.
Institute of Medicine report. Following passage of Proposition
71 in 2004, the Institute of Medicine and the National Research
Council convened a committee of experts to ascertain the medical
risks of oocyte donation for stem cell research. The committee
issued a report in 2007 entitled "Assessing the Medical Risks of
Human Oocyte Donation for Stem Cell Research" (IMR report),
which stated that years of experience with assisted reproduction
have identified a number of potential risks associated with egg
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donation, falling into three main categories: (1) the potential
risks arising from the hormone regimen that women are given to
stimulate egg production, including ovarian hyperstimulation
syndrome, perhaps problems with long-term fertility, and breast,
ovarian, and endometrial cancers; (2) the risks associated with
the surgical procedure, including the anesthesia, which involves
many of the same issues that anyone having surgery faces; and
(3), the potential risks that are psychological in nature,
including anxiety, mood swings, and post-donation adjustment.
However, the IMR Report stated that there was a need for more
and better data and that one of the most striking facts about
IVF is just how little is known for sure about the long term
health outcomes for the women who undergo the procedures. The
IMR Report notes that there are no registries that track the
health of the people who have taken part, and without such
registries to draw from, most of the studies have focused on
relatively small groups of people. The IMR Report did
acknowledge that the available data come primarily from IVF
patients and not from healthy subjects, yet it is healthy women
and not those coping with infertility who will be donating eggs
for research, which raises the possibility that the existing
data overstates the potential risks for healthy donors. The
bottom line, according to the IMR Report, is that there is a
great deal of uncertainty about the potential risks for oocyte
donation for research.
National Academy of Sciences. The National Academy of Sciences'
(NAS) Guidelines for Human Embryonic Stem Cell Research states
that women who undergo hormonal induction to generate oocytes
specifically for research purposes should be reimbursed only for
direct expenses incurred as a result of the procedure, as
determined by an IRB. The Guidelines go on to state that "no
payments beyond reimbursements, cash or in-kind, should be
provided for donating oocytes for research purposes. Similarly,
no payments beyond reimbursements should be made for donations
of sperm for research purposes." When developing the 2010
amendments to these guidelines (the most recent update), NAS
noted that since the prior update in 2008, the ethics committee
of the State of New York's Empire State Stem Cell Board adopted
a resolution allowing New York State-funded stem cell
researchers to compensate women who donate their oocytes
directly and solely to research for the time, risk and burden
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involved in donating. Amounts of compensation are to be
comparable to those received by women in New York State for
similar donations for reproductive purposes. NAS stated that
while it "acknowledges that the circumstances surrounding the
issue of compensation to oocyte donors continues to evolve, it
chose not to change the National Academies' Guidelines." NAS
went on to state that while it was leaving its guideline on no
payments in place, it recognized that "other states and entities
may choose to set their own policies, as New York has done."
Comments
Author's statement. According to the author, AB 2531 promotes
medical research in California while ensuring research
participants are fairly treated by removing the prohibition on
compensation for women participating in oocyte (egg) donation
for medical research. We all benefit from those willing to
participate in research, and the current processes in place are
designed to appropriately reward participants, while protecting
them from abusive or coercive practices. AB 2531 ensures that
women are treated equally to all other research subjects -
allowing them to actively evaluate their participation in
research studies and be paid for their time, trouble and
inconvenience when they do participate. Given that compensation
is allowed in 47 other states, and there is no evidence of
abuse, it's time to reconsider our ban, just as New York did.
Lifting the ban will allow women providing oocytes, just as any
other research subject, to make an informed decision as to
participation, and justly compensate them for doing so. We
should no longer deny a woman's fundamental ability to make
informed decisions or think for herself, or tell her if she
wants to participate, she can only participate on terms
different than for any other procedure.
FISCAL EFFECT: Appropriation: No Fiscal
Com.:NoLocal: No
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SUPPORT: (Verified 8/1/16)
American Society for Reproductive Medicine (source)
Adventist Health
Alliance for Fertility Preservation
American Association of University Women
American Congress of Obstetricians and Gynecologists
California Chronic Care Coalition
California Cryobank
California Hepatitis C Task Force
California Life Sciences Association
Equality California
Fair Allocation in Research Foundation
Fertile Action
Loma Linda University Health
National Association of Hepatitis Task Forces
National Center for Lesbian Rights
Resolve: The National Infertility Association
OPPOSITION: (Verified 8/1/16)
Alliance for Humane Biotechnology
Black Women for Wellness
Black Women's Health Imperative
Breast Cancer Action
California Catholic Conference, Inc.
California Nurses for Ethical Standards
California Right to Life Committee, Inc.
Center for Genetics and Society
Friends of the Earth
Forward Together
Life Priority Network
National Women's Health Network
Our Bodies Ourselves
Pro-Choice Alliance for Responsible Research
We Are Egg Donors
Seven Individuals
ARGUMENTS IN SUPPORT: The American Association of University
Women and the American Congress of Obstetricians and
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Gynecologists, District IX (California) (AAUW/ACOG) state that
all other research subjects can be compensated for their time,
trouble, and inconvenience related to participating in research,
except for this population. AAUW/ACOG contend that this bill
ensures that women are treated equally to all other research
subjects - allowing them to actively evaluate their
participation in research studies, and that it will remove
barriers to women participating in research that could result in
improvement in care for reproductive health, including
infertility and cancer care. AAUW/ACOG state that this research
could benefit untold numbers of women in the future. The
California Life Sciences Association states that California is
one of three states banning compensation for oocytes, which
ultimately deters participation among women who are willing
donors and stalls research excellence. California Cryobank
states that to single out egg donors is inherently
discriminatory so few, if any women, participate in oocyte
research in California, creating barriers to reproductive and
other biomedical research that could result in major medical
advancements in cancer and degenerative diseases. The National
Association of Hepatitis Task Forces, the California Hepatitis C
Task Force, and the Fair Allocation in Research Foundation state
that the gender inequality regarding women and research will be
resolved by having a requirement for women providing human
oocytes for research to be compensated. Equality California
writes that despite all of the protections to guard against the
dangers of exploitation in laws and informed consent procedures,
women are the only ones singled out and prohibited from being
compensated for research purposes in cases of oocyte donation
and that as a result of the prohibition, all research is
suffering due to lack of needed tissues. Resolve states that
while some fear potential exploitation of women for their
oocytes, in the 47 other states which permit compensation there
is no evidence of exploitation or abuse. The National Center for
Lesbian Rights states that if paying for oocyte donors is an
acceptable practice for infertility treatment, it should also be
acceptable to compensate donors who provide their eggs for
research. The California Chronic Care Coalition writes that this
bill will ensure that women are treated equally to all other
research subjects, allowing them to actively evaluate their
participation in research studies and be paid for their time,
trouble, and inconvenience when they do participate.
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ARGUMENTS IN OPPOSITION:Former California State Senator Deborah
Ortiz, who authored the legislation that this bill seeks to
repeal, states that in 2006, she stood alongside women's health
and reproductive rights advocates to call for more studies on
the long-term health outcomes for women undergoing egg
retrieval. Senator Ortiz states that the health risks to women
are not only significant, but there is wide recognition that
they are understudied and that the many reports of harm to women
who provide eggs in the fertility context should not be ignored.
Senator Ortiz further states that the research has advanced very
little in the last 10 years, reinforcing the need for more data
before expanding the market in eggs and that the absence of data
should urge caution, not serve as a rationale to support
inducements for medical procedures that carry risks. A number
of organizations, including Breast Cancer Action, Black Women
for Wellness, Friends of the Earth, and National Women's Health
Network write that while they support reimbursing women for the
reasonable expenses of egg donation, they oppose paying women
over and above those amounts because women providing eggs are
not research subjects, and egg harvesting is very different from
a clinical trial and the health risks of egg harvesting are
substantial, but there is insufficient evidence about their
extent and severity to be able to provide true informed consent.
These opponents further state that this bill conflicts with
recommendations by the National Academy of Sciences, and with
policies that apply to California Institute for Regenerative
Medicine-funded researchers and are part of the California
Constitution. Black Women for Wellness also writes that they are
concerned about the lack of oversight to protect vulnerable
women from being preyed upon for research purposes, especially
with the lack of clarity around the longer term health
consequences of egg harvesting. We Are Egg Donors states that
they understand that research with human oocytes can contribute
to important knowledge that can be used for the greater good,
but with no provision in this bill to protect the health of
women who would be providing these oocytes, based on their
collective experiences as egg providers, feel it would be
imprudent to pass it. The Alliance for Humane Biotechnology
states that in clinical trials, investigators study the
reactions and health outcomes of subjects who take a drug, use a
device, or undergo a procedure and that in a case of egg
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harvesting, investigators are not studying, or seeking to
understand, the effects of the procedures on women. The
Alliance for Humane Biotechnology states that egg providers are
thus quite different from research subjects. The California
Catholic Conference states that this bill puts women's health in
jeopardy by creating and, in effect, resulting in a marketing
dynamic designed to exploit women who are most in need of
resources, including college students, immigrants and women with
economic challenges.
ASSEMBLY FLOOR: 65-3, 4/28/16
AYES: Achadjian, Alejo, Arambula, Atkins, Baker, Bloom,
Bonilla, Bonta, Brown, Burke, Calderon, Campos, Chang, Chau,
Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dodd, Eggman,
Frazier, Beth Gaines, Cristina Garcia, Eduardo Garcia, Gatto,
Gipson, Gomez, Gonzalez, Gordon, Roger Hernández, Holden,
Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder,
Lopez, Low, Maienschein, Mayes, McCarty, Medina, Mullin,
Nazarian, Obernolte, O'Donnell, Quirk, Ridley-Thomas,
Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond,
Ting, Wagner, Weber, Wilk, Williams, Wood, Rendon
NOES: Grove, Harper, Mathis
NO VOTE RECORDED: Travis Allen, Bigelow, Brough, Dahle, Daly,
Gallagher, Gray, Hadley, Melendez, Olsen, Patterson, Waldron
Prepared by:Melanie Moreno / HEALTH / (916) 651-4111
8/3/16 19:10:59
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