BILL ANALYSIS �
------------------------------------------------------------
|SENATE RULES COMMITTEE | AB 2356|
|Office of Senate Floor Analyses | |
|1020 N Street, Suite 524 | |
|(916) 651-1520 Fax: (916) | |
|327-4478 | |
------------------------------------------------------------
THIRD READING
Bill No: AB 2356
Author: Skinner (D)
Amended: 8/7/12 in Senate
Vote: 21
SENATE HEALTH COMMITTEE : 6-2, 6/27/12
AYES: Hernandez, Alquist, Blakeslee, DeSaulnier, Rubio,
Wolk
NOES: Harman, Anderson
NO VOTE RECORDED: De Le�n
SENATE JUDICIARY COMMITTEE : 4-1, 7/3/12
AYES: Evans, Blakeslee, Corbett, Leno
NOES: Harman
ASSEMBLY FLOOR : 50-24, 5/31/12 - See last page for vote
SUBJECT : Tissue donation
SOURCE : Equality California
National Center for Lesbian Rights
DIGEST : This bill 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. This bill
exempts physicians, clinical laboratories, or tissue banks
CONTINUED
AB 2356
Page
2
that provide insemination or assisted reproductive
technology services from liability and disciplinary
actions, as specified.
ANALYSIS : 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 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.
AB 2356
Page
3
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
AB 2356
Page
4
the medical records of each, affirming that 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 assisted 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:
AB 2356
Page
5
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.
1.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 assisted 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.
2.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 assisted 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.
3.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
assisted reproductive technology services.
Background
Infertility treatment . According to the federal Centers
for Disease Control and Prevention's (CDC) 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
AB 2356
Page
6
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.
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
risk-reduction strategies to provide a basis for informed
consent.
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
AB 2356
Page
7
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.
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.
FISCAL EFFECT : Appropriation: No Fiscal Com.: No
Local: No
SUPPORT : (Verified 8/7/12)
Equality California (co-source)
National Center for Lesbian Rights (co-source)
Betty T. Yee, First District Member, Board of Equalization
AB 2356
Page
8
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
OPPOSITION : (Verified 8/7/12)
California Right to Life Committee, Inc.
ARGUMENTS IN 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
AB 2356
Page
9
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.
ARGUMENTS IN 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.
ASSEMBLY FLOOR : 50-24, 05/31/12
AYES: Alejo, Allen, Ammiano, Atkins, Beall, Block,
Blumenfield, Bonilla, Bradford, Brownley, Buchanan,
Butler, Campos, Carter, Cedillo, Chesbro, Davis,
Dickinson, Eng, Feuer, Fong, Fuentes, Furutani, Galgiani,
Gatto, Gordon, Hall, Hayashi, Roger Hern�ndez, Hill,
Huber, Hueso, Huffman, Lara, Bonnie Lowenthal, Ma,
Mitchell, Monning, Pan, Perea, V. Manuel P�rez,
Portantino, Skinner, Solorio, Swanson, Torres,
Wieckowski, Williams, Yamada, John A. P�rez
NOES: Achadjian, Bill Berryhill, Conway, Cook, Donnelly,
Beth Gaines, Garrick, Gorell, Grove, Hagman, Halderman,
Harkey, Jeffries, Jones, Knight, Logue, Miller, Morrell,
Nestande, Nielsen, Olsen, Silva, Smyth, Wagner
NO VOTE RECORDED: Charles Calderon, Fletcher, Mansoor,
Mendoza, Norby, Valadao
CTW:n 8/7/12 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
**** END ****