BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 2356
AUTHOR: Skinner
AMENDED: May 30, 2012
HEARING DATE: June 27, 2012
CONSULTANT: Rubin
SUBJECT : Tissue donation.
SUMMARY : Permits the recipient of sperm donated by her sexually
intimate partner (SIP) for reproductive use to waive a second or
repeat testing of that donor for human immunodeficiency virus
(HIV), agents of viral hepatitis (HBV and HCV), syphilis, and
human T lymphotropic virus (HTLV), if the recipient is informed
of existing donor testing requirements and signs a written
waiver. Exempts physicians, clinical laboratories, or tissue
banks that provide insemination or advanced reproductive
technology services from liability and disciplinary actions, as
specified.
Existing federal law:
1.Establishes procedures to prevent the introduction,
transmission, and spread of communicable diseases by human
cells, tissues, and cellular and tissue-based products
(HCT/Ps).
2.Defines HCT/Ps as articles containing or consisting of human
cells or tissues that are intended for implantation,
transplantation, infusion, or transfer into a human recipient,
including semen or other reproductive tissue.
3.Requires a donor-eligibility determination, based on donor
screening and testing for relevant communicable disease agents
and diseases, for all donors of cells and tissues used in
HCT/Ps, and prohibits the implantation, transplantation,
infusion, or transfer of HCT/Ps until the donor has been
determined to be eligible, with specified exemptions.
4.Requires, before the completion of a donor-eligibility
determination:
a. Screening a donor's medical records for specified risk
factors for, and clinical evidence of, relevant
communicable disease agents and diseases;
b. Keeping semen from anonymous donors quarantined for at
Continued---
AB 2356 | Page 2
least six months after the date of donation. Defines
quarantine as the storage or identification of an HCT/P, to
prevent improper release, in a physically separate area
clearly identified for such use, or through other
procedures, such as automated designation; and
c. Retesting of anonymous semen donors by collecting a new
specimen from the donor and testing it for evidence of
infection due to HIV, HBV and HCV, syphilis, and HTLV.
1.Exempts from specified donor eligibility requirements and
HCT/P-use prohibitions:
a. Cells and tissue for autologous use;
b. Reproductive cells or tissue donated by a SIP of the
recipient for reproductive use; and
c. Cryopreserved cells or tissue for reproductive use, as
specified;
1.Authorizes the Food and Drug Administration (FDA) to regulate
establishments that engage in the manufacture of HCT/Ps,
including any individual, partnership, corporation,
association, or other legal entity engaged in the manufacture
of HCT/Ps.
Existing state law:
1.Prohibits the transfer of any tissues into the body of another
person by means of transplantation, unless the donor of the
tissues has been screened and found nonreactive by laboratory
tests for evidence of infection with HIV, HBV, HCV, syphilis,
and HTLV, with specified exemptions.
2.Permits a recipient of sperm, from a sperm donor known to the
recipient, to waive a second or other repeat testing of that
donor if the recipient is informed of specified requirements
for testing donors and signs a written waiver.
3.Permits a recipient of sperm to consent to therapeutic
insemination of sperm or use of sperm in other advanced
reproductive technology services even if the sperm donor is
found reactive for HIV, HBV, HCV, syphilis, or HTLC if the
sperm donor is the spouse of, partner of, or designated donor
for that recipient. Requires the physician providing
insemination or advanced reproductive technology services to
advise the donor and recipient of the potential medical risks
associated with receiving sperm from a reactive donor; and
further requires the donor and recipient to sign a document,
to be placed in the medical records of each, affirming that
AB 2356 | Page
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each comprehends the potential medical risks of using sperm
from a reactive donor for the proposed procedure and that each
consents to it.
4.Permits sperm whose donor has tested reactive for HIV, HBV,
HCV, syphilis, or HTLC to be used for the purposes of
insemination or advanced reproductive technology services only
after specified requirements are met.
5.Authorizes the Department of Public Health (DPH) to regulate
the transfer of tissues into the body of another person.
6.Requires DPH to, not later than January 1, 2014, adopt
regulations regulating facilities that perform sperm
processing to minimize the infectiousness of sperm from a
donor who has tested reactive to HIV or HTLV, as specified,
and requires facilities that perform this sperm processing to
follow facility and sperm processing guidelines for the
reduction of viral transmission developed by the American
Society for Reproductive Medicine (ASRM).
This bill:
1.Permits the recipient of sperm donated by her SIP for
reproductive use to waive a second or repeat testing of that
donor for HIV, HBV, HCV, syphilis, and HTLV, if the recipient
is informed of existing donor testing requirements and signs a
written waiver.
2.Defines, for the purposes of this bill, "SIP of the recipient"
to include a known or designated donor to whose sperm the
recipient has previously been exposed in a nonmedical setting
in an attempt to conceive.
3.Exempts a physician, when the physician provides insemination
or advanced reproductive technology services and has obtained
the informed consent of the recipient, who acknowledges and
accepts the risks of using sperm that has not undergone
quarantine and repeat testing, as specified, from the
following:
a. Liability for damages for any cause of action based
solely on the use of sperm donated by a SIP of the
recipient; and
b. Disciplinary action against his or her professional
license and peer review by a professional organization peer
review body, as defined.
AB 2356 | Page 4
4.Exempts a clinical laboratory or tissue bank that is owned and
operated by a physician and/or tissue bank from disciplinary
action against its license because of the use of sperm donated
by a SIP of the recipient in providing insemination or
advanced reproductive technology services when any physician
affiliated with the clinical laboratory or tissue bank has
obtained the informed consent of the recipient, who
acknowledges and accepts the risks of using sperm that has not
undergone quarantine and repeat testing, as specified.
5.Prohibits anything in this bill from creating a duty for a
physician to use sperm donated by a recipient's SIP in
providing insemination or advanced reproductive technology
services if the physician reasonably concludes that the
insemination or services do not meet the 2008 ASRM guidelines
for gamete and embryo donation.
6.Prohibits anything in this bill from being construed to affect
any liability that may be imposed pursuant to federal rule or
regulation when a physician, clinical laboratory, or tissue
bank provides insemination or advanced reproductive technology
services.
FISCAL EFFECT : This bill is keyed non-fiscal.
PRIOR VOTES :
Assembly Health:13- 5
Assembly Floor:50- 24
COMMENTS :
1.Author's statement. This bill is necessary in order to remove
unnecessary barriers, provide equal access to medical care and
establish regulations to support women wishing to form a
family of their own. According to the sponsors, this bill
would provide same-sex couples or single women seeking to
conceive using known sperm donor access to certain fertility
services on the same terms as different-sex couples.
2.Infertility. According to the website of the federal Centers
for Disease Control and Prevention (CDC), infertility means
not being able to get pregnant after one year of trying, or,
six months, if a woman is 35 years of age or older. Women who
can get pregnant but are unable to stay pregnant may also be
infertile. Infertility is a common problem; about 10 percent
of women in the United States ages 15 to 44 have difficulty
AB 2356 | Page
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getting or staying pregnant. Both women and men can have
problems that cause infertility. Age increases a woman's risk
of infertility; a woman's chances of having a baby decrease
rapidly every year after the age of 30.
3.Infertility treatment. According to the CDC's website,
infertility can be treated with medicine, surgery, artificial
insemination, assisted reproductive technology (ART), or a
combination of these treatments. Intrauterine insemination,
often called artificial insemination, is a procedure in which
the woman is injected with specially prepared sperm. ART is a
group of different methods that includes all fertility
treatments in which both eggs and sperm are handled. In
general, ART procedures involve surgically removing eggs from
a woman's ovaries, combining them with sperm in the
laboratory, and returning them to a woman's body or donating
them to another woman (for example, in vitro fertilization).
Today, over one percent of infants born in the United States
every year are conceived using ART. A woman's age affects the
success rate of ART; according to CDC's 2010 Preliminary ART
Success Rates, the average percentage of ART cycles that led
to a live birth decreased from 42 percent in women younger
than 35 to 5 percent in women ages 43 and 44.
4.Sexually transmitted infections (STIs). According to the 2008
"Guidelines for reducing the risk of viral transmission during
fertility treatment" produced by ASRM's Practice Committee
(ASRM Guidelines), the most serious pathogens are HIV, HBV,
and HCV, which may cause incurable, often fatal, infections,
have been transmitted through ART and insemination procedures,
and can be transmitted from infected mothers to the fetus or
newborn. HTLV is another common sexually transmitted virus.
The Ethics Committee of ASRM has stated that fertility
services cannot be withheld ethically from individuals with
chronic viral infections, including HIV, in a center that has
the resources to provide care. Those centers that do not have
the resources or facilities to provide care should facilitate
referral to a center with protocols in place to manage such
patients. The ASRM Guidelines provide strategies, based on
scientific principles and clinical experience, for reducing
the risk of virus transmission in couples seeking treatment
from fertility clinics. Recommendations are based on reducing
viral load in infected partner(s), reducing exposure and
susceptibility of a noninfected partner, and frank, detailed
discussions of available scientific evidence and
AB 2356 | Page 6
risk-reduction strategies to provide a basis for informed
consent.
5.Sperm donation. The Society for Assisted Reproductive
Technology (SART), whose membership according to its website
includes more than 85 percent of the ART clinics in the
country and 55 clinics in California, along with its
affiliate, ASRM, offers guidelines for sperm donation in the
"2008 Guidelines for gamete and embryo donation" (ASRM/SART
Guidelines). Recommended laboratory tests include those for
HIV, HBV, HCV, syphilis, and HTLV. The ASRM/SART Guidelines
make specific recommendations for anonymous donation, directed
(non-anonymous or known) donation, and sexually intimate
couples. Anonymous donors should be tested, as specified by
the FDA, for determining donor eligibility; if testing is
negative, semen samples should be collected, cryopreserved,
and quarantined for a minimum of 180 days, after which the
donors should be retested, and if again found negative, the
samples can be released. Directed donors should undergo the
same screening and testing as anonymous donors, and directed
donor specimens should be treated in the same manner as
anonymous donor specimens despite being exempt from quarantine
under FDA guidelines. Viral testing for SIPs undergoing
fertility treatment is recommended to help ensure that
appropriate precautions are taken to minimize risk of viral
transmission to partners and offspring, despite the absence of
FDA or legal requirements.
6.Pending sperm donation investigation. Recent reports in the
Los Angeles Times and San Francisco Chronicle describe the
case of an individual residing in Fremont, California, who has
donated sperm for free to at least 46 women he has met on the
internet since December 2006. On November 1, 2010, the FDA
issued an Order to Cease Manufacturing of HCT/Ps to the
individual, citing an inspection of his home that revealed
significant violations of regulations regarding failures to
provide adequate protections against the risks of communicable
disease transmission, including HIV, HBV, HCV, and HTLV.
Critical to the case is the whether the individual is
considered a SIP, which would determine whether he is exempt
from donor eligibility requirements. The case is pending, and
the individual potentially faces a $100,000 fine or up to a
year in prison. The FDA has not defined the term SIP nor given
an indication that it plans to do so in the future.
7.Double referral. This bill is double referred. Should it pass
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out of this committee, it will be referred to the Senate
Committee on Judiciary.
8.Prior legislation. AB 1487 (Hill), Chapter 444, Statutes of
2010, requires testing for evidence of infection with HTLV
only in tissues that are rich in viable leukocytes, extends
until January 1, 2014, the date for adopting regulations, and
allows DPH to adopt initial regulations based on the
"Guidelines for Reducing Risk of Viral Transmission During
Fertility Treatment," using a specified process.
AB 1397 (Hill) of 2009 was nearly identical to AB 1487. AB
1397 was vetoed by the Governor, stating: "some provisions
inappropriately restrict the administrative and regulatory
authority of ÝDPH] for adopting or modifying ÝASRM]
guidelines."
SB 1184 (Kuehl), Chapter 347, Statutes of 2008, requires a
physician providing insemination or ART to, among other
things, verify and document in the recipient's medical record,
that the donor of sperm who tests reactive for HIV or HTLV-1
is under the care of a physician managing the HIV or HTLV-1 to
minimize the risk of transmission during the course of
insemination or ART services.
SB 443 (Migden), Chapter 207, Statutes of 2007, authorizes the
use of sperm whose donor has tested reactive for HIV or HTLV-1
for the purposes of insemination or ART only after the donor's
sperm has been effectively processed to minimize the
infectiousness of the sperm for that specific donation, and
where informed and mutual consent has occurred. Required DPH
to adopt regulations by January 1, 2010 to regulate facilities
that perform sperm processing pursuant to those provisions.
Requires a physician providing insemination or ART to, among
other things, provide appropriate prophylactic treatments to
the recipient to reduce the risk of acquiring infection during
and subsequent to insemination, and to perform appropriate
follow-up testing of the recipient for HIV or HTLV-1 following
the insemination or other ART.
AB 441 (Richter and Mazzoni), Chapter 511, Statutes of 1997,
creates an exception to the prohibition on the transfer of
tissues into another person unless the tissue donor has been
screened and found nonreactive for evidence of infection with
HIV, HBV, HVC, HTLV-1, and syphilis; the exception authorizes
AB 2356 | Page 8
a recipient of sperm to consent to therapeutic insemination or
other reproductive use of sperm even if the sperm donor is
found reactive to HBV, HVC, or syphilis, if the sperm donor is
the spouse, partner, or designated donor of the recipient, and
if certain other conditions are met.
AB 525 (Speier), Chapter 659, Statutes of 1993, authorizes the
recipient of sperm, from a donor known to the recipient, to
waive a second or repeat screening of that donor if the
recipient is informed of the requirements for testing donors
under California law and signs a written waiver.
9.Support. Equality California, the National Center for Lesbian
Rights, and other organizations state that a disparity arises
between different-sex couples and same-sex couples or single
women using known donors when they seek fertility services in
a medical setting after failed attempts to conceive at home.
Whereas different-sex couples are permitted to use fresh sperm
to inseminate when using fertility services, all other women
must typically have their donor's sperm frozen and quarantined
for up to six months to allow for repeated donor screening for
STIs, yet women who have attempted to inseminate at home with
a designated donor are exposed to exactly the same risk of
disease transmission as women who have sex with male partners
to conceive. The process of freezing and quarantining sperm
significantly reduces the chances of achieving pregnancy and
often means that conception is not possible without much more
expensive procedures. These supporters state that this bill
would address the situation by providing that an exception is
made to screening requirements when sperm is donated by a SIP,
and would benefit many women each year who are seeking access
to fertility services. The California Medical Association
indicates that this bill not only provides equal access to
fertility treatment but also puts in place appropriate
standards to protect both the patient and the providers.
10.Opposition. The California Right to Life Committee believes
that this bill is not good public health policy and sets a
precedent for other exemptions in the future which might be
deleterious to women.
11.Technical amendments.
a. Change references from "advanced reproductive
technology" and "advanced reproductive technologies" to
"assisted reproductive technology" and "assisted
reproductive technologies".
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b. On Page 3, Lines 20-21, strike out "includes any woman
who has been exposed to the donor's sperm outside of a
medical setting" and insert "includes a known or designated
donor to whose sperm the recipient has previously been
exposed in a nonmedical setting in an attempt to conceive".
SUPPORT AND OPPOSITION :
Support: Equality California (co-sponsor)
National Center for Lesbian Rights (co-sponsor)
ACLU of California
ACLU, Paul Robeson Chapter
American Federation of State, County and Municipal
Employees, AFL-CIO
API Equality-Northern California
Asian & Pacific Islander Wellness Center
At Home Fertility
California Medical Association
Colage
GroundSpark
Kaiser Permanente
L.A. Gay & Lesbian Center
Laparoscopic Institute for Gynecologic Oncology
MAIA Midwifery & Fertility Services, LLC
Our Family Coalition
Rainbow Flag Health Services
Somos Familia
Tres Lunas Midwifery
Betty T. Yee, First District Member, BOE
One individual
Oppose: California Right to Life Committee, Inc.
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