BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 926|
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THIRD READING
Bill No: AB 926
Author: Bonilla (D)
Amended: 4/23/13 in Assembly
Vote: 21
SENATE HEALTH COMMITTEE : 6-1, 6/12/13
AYES: Hernandez, Beall, De León, DeSaulnier, Monning, Wolk
NOES: Anderson
NO VOTE RECORDED: Nielsen, Pavley
ASSEMBLY FLOOR : 54-20, 5/2/13 - See last page for vote
SUBJECT : Reproductive health and research
SOURCE : American Society for Reproductive Medicine
DIGEST : This bill repeals the prohibition against payments to
a woman to encourage her to produce human oocytes, or eggs, for
the purposes of medical research.
ANALYSIS :
Existing law:
1. Defines oocyte as a female egg or egg cell of a human female,
and defines "assisted oocyte production" (AOP) as surgical
extraction of oocytes following pharmaceutically induced
manipulation of oocyte production through the use of ovarian
stimulation.
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2. Prohibits any payment in excess of the amount of
reimbursement of direct expenses incurred as a result of the
procedure to be made to any subject to encourage her to
produce human oocytes for purposes of medical research.
3. Prohibits any human oocyte 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.
4. Requires a physician, prior to providing AOP for the purposes
of medical research, to obtain written and oral informed
consent for the procedure from the subject, and requires this
informed consent to comply with the requirements of the
Protection of Human Subjects in Medical Experimentation Act
(Experimentation Act), as specified.
5. Requires a physician, prior to obtaining informed consent
from a subject for AOP for the purpose of procuring oocytes
for research, to provide to the subject a standardized
medically accurate written summary of health and consumer
issues associated with AOP, as specified. Requires this
summary to include medically accurate disclosures concerning
the potential risks of AOP, including the risks associated
with the surgical procedure and with using the drugs,
medications, and hormones prescribed for ovarian stimulation
during the AOP process.
6. Requires an institutional review board (IRB) to require
research programs or projects under its review that involve
AOP 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.
7. Requires a research program that involves AOP to ensure that
a written record is maintained that includes specified
components, including the demographics of subjects,
information regarding every oocyte that has been donated or
used, and a record of all adverse health outcomes resulting
from the AOP.
8. Prohibits a physician performing the AOP from having a
financial interest in the outcome of the research.
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9. Establishes the Experimentation Act, which provides various
statutory protections for Californians involved in medical
experiments, including a detailed requirement for what
constitutes voluntary informed consent, and includes
penalties for violations of this Act.
10.Establishes in the California Constitution, via the passage
of Proposition 71 in 2004, the California Stem Cell Research
and Cures Act and the California Institute for Regenerative
Medicine (CIRM), to provide $3 billion in bond funding over a
period of 10 years to fund stem cell research. Requires the
Independent Citizens Oversight Committee of CIRM to establish
certain standards for the use of the funds provided by this
Act, including a prohibition against compensation to donors
or participants of the research, beyond reimbursement of
expenses.
This bill:
1. Repeals the prohibition against payments to a woman to
encourage her to produce human oocytes for the purposes of
medical research which are in excess of reimbursement for
direct expenses.
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.
3. Prohibits payments made pursuant to this bill to be for the
human oocytes themselves or predicated on the number of
oocytes obtained, including if no oocytes are obtained.
4. Requires a human subject research panel or IRB to determine
whether a proposed compensation is appropriate, and if a
proposed compensation amount is determined to be
inappropriate, the panel or board is required to determine an
appropriate compensation amount.
5. Requires an IRB to disregard the amount of compensation paid
to a woman providing human oocytes for the purposes of
fertility who offers for research any oocytes or embryos in
excess of those needed for fertility, if all of the following
conditions are met:
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A. The clinic performing oocyte retrieval is a member of
the Society for Assisted Reproductive Technology;
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 provided for the oocytes, as
specified.
6. Makes various legislative findings and declarations,
including concerns that the women will be exploited if
compensated for providing human oocytes for research have not
borne out in the states where compensation is allowed, and
that sufficient protections are in place to treat women
providing human oocytes for research, similar to any other
research subject, knowing women are competent and able to
make decisions for themselves.
Background
The egg donation process involves stimulation of the ovaries
with fertility medications and the subsequent retrieval of the
eggs from the donor's ovaries, usually in an operative procedure
under light anesthesia with needle aspiration. According to the
American Congress of Obstetricians and Gynecologists, District
IX, California, the potential of stem cell treatments and recent
advances in fertility treatments have significantly increased
the demand for human egg cells, scientifically known as
"oocytes" (pronounced "oh-sites"). In California, egg donations
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for research purposes require informed consent from the donor
and require donors to be provided medically accurate written and
oral information on the potential risks of the procedure.
Regulation of research studies involving egg donation is
overseen by IRBs.
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.
The oocyte donor compensation guidelines of the ASRM, adopted in
2007, 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 stated that total payments to donors in excess of
$5,000 require justification, and sums above $10,000 are not
appropriate.
According to the author's office, besides California, only
Massachusetts and South Dakota specifically prohibit
compensation for oocyte donors.
IRBs . An IRB is a committee that has been formally designated to
approve, monitor, and review biomedical and behavioral research
involving humans conducted under the auspices of the institution
with which it is affiliated. IRBs are regulated by the federal
Office for Human Research Protection, and are required to have
at least five members, including at least one member who is not
otherwise affiliated with the institution. IRBs have the
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authority to approve, require modifications in, or disapprove
all research activities under its review. Under California law,
regarding any research project involving AOP, the IRB is
required to ensure that the research program complies with
specified requirements.
Institute of Medicine Report . Following passage of Proposition
71 in 2004, CIRM asked the Institute of Medicine and the
National Research Council to convene a committee of experts to
ascertain the medical risks of oocyte donation for stem cell
research. A workshop was convened in 2006, and issued a report
in 2007 entitled "Assessing the Medical Risks of Human Oocyte
Donation for Stem Cell Research" (IMR report). According to the
IMR Report, years of experience with assisted reproduction have
identified a number of potential risks associated with egg
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 (OHSS), 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. The IMR Report noted
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.
Risk of OHSS . OHSS is the most common side effect of the use of
fertility drugs, and is described in the IMR Report as an
"exaggeration of a desired response" - which is to override the
female body's natural mechanism of getting a single egg during
an ovulation cycle. OHSS symptoms include enlarged ovaries, an
accumulation of fluid in the abdomen. Serious cases are rare -
about 100 to 200 cases for every 100,000 stimulation cycles, but
they can have serious complications, including blood clots or
kidney failure in the most severe cases, requiring
hospitalizations.
Risk of cancer . The IMR Report stated that there was no
evidence that fertility drugs elevate the risk of breast cancer,
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and that there was no systematic evidence at this point that
fertility drugs elevate the risk for invasive ovarian cancer.
But for uterine cancer, the IMR Report stated that while the
data are too sparse to lead to any conclusion, there is greater
concern. The IMR Report also noted a concern that these effects
may not be evident until a longer period of time has elapsed
between the exposure, the assisted reproduction therapy, and the
cancer. According to the Report, one study in particular found
that as time elapsed since the treatment, there did seem to be
an increased risk for breast, ovarian, and endometrial cancers,
stating that this study raised the possibility that many studies
have missed the increased cancer risk because they have not
followed their subjects for enough years.
National Academy of Sciences (NAS) . The 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."
Prior Legislation
AB 1317 (Block, Chapter 523, Statutes of 2009) required that all
advertisements for oocyte donations for fertility (non-research)
purposes to include a warning that there was a screening process
and that not all potential donors are selected, and that not all
selected donors receive the compensation amount advertised.
Also required the advertisement to include a warning that there
may be risks involved, and required oocyte donors for fertility
purposes to be provided with the same risk information required
to be provided to donors for research purposes, and to comply
with the same informed consent requirements.
SB 1260 (Ortiz, Chapter 483, Statutes of 2006) established
various requirements related to the donation of oocytes for
research. The prohibition against compensating donors beyond
reimbursement of direct costs, which this bill is seeking to
repeal, was among the provisions established by SB 1260.
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FISCAL EFFECT : Appropriation: No Fiscal Com.: No Local:
No
SUPPORT : (Verified 6/13/13)
American Society for Reproductive Medicine (source)
Acacio Fertility
American Association of University Women
American Congress of Obstetricians and Gynecologists, District
IX
California Chronic Care Coalition
California Cryobank
California National Organization for Women
Equality California
Fertile Action
Legislative Women's Caucus
National Center for Lesbian Rights
Planned Parenthood Affiliates of California
Reprogenetics
RESOLVE: The National Infertility Association
Southern California Institute for Reproductive Sciences
OPPOSITION : (Verified 6/13/13)
Alliance for Humane Biotechnology
Breast Cancer Action
California Catholic Conference
California Right to Life Committee, Inc.
Center for Bioethics and Culture
Center for Genetics and Society
Concerned Women for America of California
Forward Together
National Women's Health Network
Our Bodies, Ourselves
Pro-Choice Alliance for Responsible Research
Traditional Values Coalition
We are Egg Donors
ARGUMENTS IN SUPPORT : This bill is sponsored by the American
Society for Reproductive Medicine, which states that society
benefits from people being willing to participate in research,
and that in order to encourage participation, it is understood
there should be some reward for doing something to which people
otherwise would not subject themselves. ASRM notes that with
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financial reward comes the potential for persons to participate
in research purely for the financial benefit and disregarding
potential risks. In order to guard against this potential, ASRM
states that various protections were adopted in state and
federal law, including oversight by IRBs.
Several companies in the scientific research field have written
in support. Representative of these letters was Reprogenetics,
which states that the work it has done in the field of human
reproduction has resulted in fewer miscarriages for women over
the age of 35 who conceived via IVF, as well as better
implantation rates and healthier outcomes. According to
Reprogenetics, if you cannot compensate research participants,
you cannot recruit them, which is why every other type of
research involves compensation. Reprogenetics states it cannot
use its lab in California for research, and instead uses its lab
on the east coast.
The American Association of University Women and Planned
Parenthood Affiliates of California state that this bill will
remove barriers to women participating in research that could
result in improvement in care for reproductive health, including
infertility and cancer care. Equality California (EC) writes
that many of us are healthy today thanks to treatment derived
from clinical research, which involved voluntary human
participation. In order to encourage participation, EC notes
that a reward-based system compensates people, who, out of their
willingness to help society, subject themselves to clinical
exams, blood draws, medicines, diets and therapies they would
not otherwise undergo. It is consider ethically sound to
compensate human research subjects commensurate with their
clinical participation.
ARGUMENTS IN OPPOSITION : The Center for Genetics and Society,
the Alliance for Human Biotechnolog, Forward Together, the
National Women's Health Network, Our Bodies Ourselves, the
Pro-Choice Alliance for Responsible Research, and We Are Egg
Donors state in that egg harvesting exposes healthy young women
to multiple synthetic hormones in order to produce many times
the normal number of eggs per cycle. These groups claim that
one of the potential harms is OHSS, which has resulted in
hospitalizations and at least a few documented deaths. These
groups state that many experts remain concerned about the
long-term risks of these drugs, especially their potential
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impact on infertility and various cancers. These groups also
assert that in the case of egg providers, the reactions and
health outcomes of the healthy young women who provide eggs are
not part of their study, and as a result, researchers may
consciously or subconsciously be less interested in the effects
of retrieval on women who supply the eggs, and more interested
in obtaining as many eggs as possible. These groups state that
unfortunately, the more eggs retrieved, the greater the risks to
women's health, which creates a built-in conflict of interest
between the responsibilities of the physician and their goal of
retrieving eggs. Finally, these groups note that payment for
eggs for research runs counter to the most recent guidelines of
the NAS, as well as the language in the California constitution
pertaining to research funded by the CIRM.
Concerned Women for America of California (CWA) states that it
is concerned with the basic moral and ethical issue of what is
essentially creating a "commodity" in human eggs. CWA states
that college-aged women are the most sought-after donors and
also the most likely to be tempted by the money, given their
college bills and tough economic times. CWA claims the lure of
cash may well outweigh their consideration of the danger to
their health and future fertility.
ASSEMBLY FLOOR : 54-20, 5/2/13
AYES: Alejo, Allen, Ammiano, Bloom, Blumenfield, Bocanegra,
Bonilla, Bonta, Bradford, Brown, Buchanan, Ian Calderon,
Campos, Chau, Chesbro, Cooley, Daly, Dickinson, Eggman, Fong,
Fox, Frazier, Garcia, Gatto, Gomez, Gordon, Gray, Hall, Roger
Hernández, Holden, Jones-Sawyer, Levine, Lowenthal,
Maienschein, Medina, Mitchell, Mullin, Muratsuchi, Nazarian,
Pan, Perea, V. Manuel Pérez, Quirk, Quirk-Silva, Rendon,
Salas, Skinner, Stone, Ting, Torres, Weber, Wieckowski,
Yamada, John A. Pérez
NOES: Bigelow, Chávez, Conway, Dahle, Donnelly, Beth Gaines,
Grove, Hagman, Harkey, Linder, Logue, Mansoor, Melendez,
Morrell, Nestande, Olsen, Patterson, Wagner, Waldron, Wilk
NO VOTE RECORDED: Achadjian, Atkins, Gorell, Jones, Williams,
Vacancy
JL:k 6/14/13 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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