BILL ANALYSIS �
AB 2356
Page 1
Date of Hearing: May 1, 2012
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
AB 2356 (Skinner) - As Amended: April 25, 2012
SUBJECT : Tissue Donation.
SUMMARY : Exempts sperm donated by a sexually intimate partner
(SIP), as defined, of the recipient for reproductive use from
the requirement that all tissues transferred into the body of
another person be screened and found nonreactive by laboratory
tests for evidence of infection with human immunodeficiency
virus (HIV), agents of viral hepatitis (HBV and HCV), syphilis,
and human T lymphotrophic virus (HTLV), as specified. Exempts
physicians and surgeons from: 1) liability for damages for any
cause of action; and, 2) disciplinary action against his or her
professional license, or subject to a professional association
peer review, for providing insemination or advanced reproductive
technology services using sperm from a SIP of the recipient, as
specified. Specifically, this bill :
1)Exempts sperm donated by a SIP of the recipient for
reproductive use from current requirements that prohibit the
transfer of any tissues into the body of another person unless
the donor has been screened and found nonreactive of infection
with HIV, HBV and HCV, syphilis, and HTLV, as specified.
2)Defines 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 and surgeon from liability for damages for
any cause of action for providing insemination or advanced
reproductive technology services using sperm from a SIP of the
recipient when the physician and surgeon 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.
4)Exempts a physician and surgeon from any disciplinary action
against his or her professional license, or subject to
professional association peer review for providing
insemination or advance reproductive technology services using
sperm from a SIP of the recipient when the physician and
surgeon has obtained the informed consent of the recipient who
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acknowledges and accepts the risks of using sperm that has not
undergone quarantine and repeat testing, as specified.
5)Exempts a clinical laboratory or tissue bank from any
disciplinary action against its license for providing
insemination or advanced reproductive technology services
using sperm from a SIP of the recipient when the physician and
surgeon 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.
6)Exempts a physician and surgeon from liability for a cause of
action based upon discrimination against an individual or
group if the physician and surgeon refuses to provide
insemination or advanced reproductive technology services
using sperm from a SIP of the recipient if the physician and
surgeon determines that the insemination or services do not
meet the 2008 American Society for Reproductive Medicine
(ASRM) guidelines for gamete and embryo donation.
7)Specifies numerous findings and declarations, including the
following:
a) Single women and same-sex female couples using a known
donor are unable to access the same fertility services as
women seeking to conceive using a male partner.
b) Federal Food and Drug Administration (FDA) regulations
require extensive testing, except when the donor is a SIP.
This term is not defined in regulations, but its explicit
purpose is to allow donation without testing when the
recipient has already been exposed. Thus, this term can be
interpreted to include women who have already attempted
at-home inseminations with their donors' sperm because they
have already been exposed through these attempts.
8)States that until the term SIP is explicitly defined by the
FDA, it is the intent of the Legislature to provide a
clarification that, for the purposes of tissues donated for
reproductive use, SIP includes any woman who has been exposed
to the donor's sperm outside of a medical setting.
9)Limits the definition of SIP to this bill and is not intended
to have any effect on any provision of the Family Code,
including the definition of a "donor" for purposes of
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determining legal parentage of a child.
10)Makes other technical, non-substantive, and conforming
changes.
EXISTING FEDERAL LAW:
1)Establishes the FDA, to among other functions, regulate and
inspect fertility centers. Requires fertility centers to
register with the FDA and to comply with specified FDA
fertility center regulations.
2)Sets requirements for determining donor-eligibility, including
screening and testing, for donors of human cells, tissues, and
cellular-and tissue-based products (HCT/Ps). Specifies that
the screening and testing includes screening and testing for
specified communicable disease agents and diseases, including
HIV, HBV, HCV, and HTLV, as specified.
3)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.
States that examples of HCT/Ps include, but are not limited
to, bone, ligament, skin, dura mater, heart valve, cornea,
hematopoietic stem/progenitor cells derived from peripheral
and cord blood, manipulated autologous chondrocytes,
epithelial cells on a synthetic matrix, and semen or other
reproductive tissue.
4)Provides an exemption for donor-eligibility determination or
donor screening or testing for: a) cells and tissues for
autologous use; b) reproductive cells or tissue donated by a
sexually intimate partner of the recipient for reproductive
use; or, c) cryopreserved cells or tissue for reproductive
use, as specified.
5)Requires HCT/Ps to be quarantined until completion of the
donor-eligibility requirements. 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 use of other procedures, such as
automated designation.
EXISTING STATE LAW :
1)Establishes the Department of Public Health (DPH) to, among
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other functions, regulate the transfer of tissue into the body
of another person.
2)Prohibits the transfer of any tissue 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, and HCV virus,
and syphilis. Requires, for tissues that are rich in viable
leukocytes, the tissue to be tested for evidence of infection
with HTLV and found nonreactive.
3)Authorizes DPH to adopt regulations requiring additional
screening tests of donors of tissues when, in the opinion of
DPH, the action is necessary for the protection of the public,
donors, or recipients.
4)Exempts the following from the screening specified in 2)
above:
a) A recipient of sperm, from a sperm donor known to the
recipient, may waive a second or other repeat testing of
that donor if the recipient is informed of the requirements
for testing donors, as specified, and signs a written
waiver.
b) A recipient of sperm may consent to therapeutic
insemination of sperm or use of sperm in other advanced
reproductive technologies even if the sperm donor is found
reactive for HBV, HCV, syphilis, HIV, or HTLV 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. Requires the donor and the recipient to sign a
document 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.
c) Sperm whose donor has tested reactive for syphilis, HBV,
HIV, or HTLV may be used for the purposes of insemination
or advanced reproductive technology only after certain
requirements are met.
5)Requires DPH, no later than January 1, 2014, to adopt
regulations for facilities that perform sperm processing, as
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specified. Specifies that until DPH adopts these regulations,
facilities that perform sperm processing must follow facility
and sperm processing guidelines for the reduction of viral
transmission developed by the ASRM.
6)Defines the following terms for purposes of tissue transfer:
a) Tissue means a human cell, group of cells, including the
cornea, sclera, or vitreous humor and other segments of, or
the whole eye, bones, skin, arteries, sperm, blood, other
fluids, and any other portion of a human body.
b) Tissue bank means a place, establishment, or institution
that collects, processes, stores, or distributes tissue for
transplantation into human beings.
c) Transplantation means the act or process of transferring
tissue, including by ingestion, from a donor to the body of
the donor or another human being.
FISCAL EFFECT : None
COMMENTS :
1)PURPOSE OF THIS BILL . Equality California and the National
Center for Lesbian Rights are the sponsors of this measure.
According to the sponsors, this bill would provide same-sex
female couples or single women seeking to conceive using a
known sperm donor access to certain fertility services on the
same terms as different-sex couples. According to the author,
a woman who receives fertility services with a male partner is
able to use fresh sperm for insemination, greatly increasing
the likelihood of the woman conceiving. However, a woman who
receives fertility services with a known male donor can only
receive frozen sperm, reducing her chances of conceiving.
Women using a known donor for an at home insemination attempt
have already been exposed to the donor's semen, the same way
women with a male partner have been exposed. However, due to
ambiguity in the law, physicians will only inseminate women
using a known donor with frozen sperm after the donor has been
screened for sexually transmitted diseases. Typically, for
these women sperm must be quarantined for six months and
re-screened before insemination. Not only is frozen sperm
less effective, but the six months waiting period can reduce
the chances of becoming pregnant for women over forty.
Insemination with frozen sperm is also significantly more
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expensive than insemination with fresh sperm.
2)BACKGROUND .
a) Assisted Reproductive Technology (ART) . According to
the federal Centers for Disease Control and Prevention
(CDC), ART 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 the woman's body or donating them to another woman.
CDC points out that of the approximately 62 million women
of reproductive age in 2002, about 1.2 million, or 2%, had
an infertility-related medical appointment within the
previous year, and 8% had an infertility-related medical
visit at some point in the past. Infertility services
include medical tests to diagnose infertility, medical
advice and treatments to help a woman become pregnant, and
services other than routine prenatal care to prevent
miscarriage. CDC also states that the number of infants
born after ART doubled in the United States from 1996-2004,
and in 2005, more than 134,000 ART procedures were
performed and approximately 52,000 infants were born as a
result of these procedures. According to a CDC 2008
report, infants conceived with ART are two to four times
more likely to have certain types of birth defects than
children conceived naturally. CDC points out that ART has
been used in the United States since 1981 to help women
become pregnant, most commonly through the transfer of
fertilized human eggs into a woman's uterus (in vitro
fertilization or IVF). All fertility centers are required
to register with the FDA as an ART facility. The FDA is
also responsible for inspecting these facilities to ensure
compliance with FDA regulations.
b) Guidelines for Gamete and Embryo Donation: A Practice
Committee Report. Currently, there are two organizations
to which physicians who practice reproductive medicine
generally belong. One is ASRM and the other is the Society
for Reproductive Technology, an affiliate of ASRM.
According to ASRM, sexually transmitted infections are of
major concern to reproductive specialists, most importantly
HIV types 1 and 2, HBV, and HCV viruses. These pathogens,
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
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newborn. Other common sexually transmissible viruses
include HTLV, and several members of the herpes virus
family. The ASRM indicated that sexually transmitted
viruses can cause chronic lifelong infections but
recognizes that fertility services cannot be withheld
ethically from individuals with chronic viral infections,
if a treatment center has the resources or facilities
necessary to manage such patients. ASRM currently provides
guidelines on requirements for treatment, facilities, sperm
wash methods, and virus-specific risk reduction strategies
for all the viruses.
In "2008 Guidelines for Gamete and Embryo Donation: A
Practice Committee Report" (Guidelines), the ASRM laid out
various recommendations or guidelines for potential sperm,
oocyte, and embryo donors. The Guidelines incorporate FDA
requirements and recent information about optimal screening
and testing for sexually transmitted infections, genetic
diseases, and psychological assessments. Generally,
physicians who are members of ASRM adhere to these
guidelines as the standard in the practice. Current law
also requires that until DPH adopts regulations for
facilities that perform sperm processing, such facilities
must follow the Guidelines.
The Guidelines for sperm donation include recommendations on
the evaluation of the male and female partner, specifically
requiring HIV testing for both partners. Additionally, the
following are recommended in the screening and testing of
donors: examination of several samples before proceeding
with a more extensive evaluation; genetic evaluation,
extensive review of medical history, physical examinations,
including a physical examination before acceptance, and
every six months while remaining an active donor;
laboratory testing, including testing for HIV, HBV, HCV,
syphilis, and HTLV, consistent with FDA requirements.
The Guidelines state the following: Specimens (sperm)
donated by anonymous donors must be tested, then
quarantined for a minimum of 180 days, then retested, and
can be released if the results of the repeat testing are
negative. For directed (non-anonymous or known) donors,
although the FDA exempts these specimens from the 180 days
quarantine requirements and only requires retesting within
seven days before donation, the Guidelines recommend
following the strict testing requirements that apply to
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anonymous donors.
For sexually intimate couples, the Guidelines indicate that
although there is no FDA or legal requirement for viral
testing of sexually intimate partners undergoing fertility
treatment, such testing can help ensure that appropriate
precautions are taken to minimize risk of viral
transmission to partners and offspring. ASRM also opines
that the use of fresh semen can be justified only for
sexually intimate couples. It states that it is possible
for HIV and other infectious organisms to be transmitted by
fresh donor semen before the donor has become seropositive
(showing positive results), and the potential for
transmission of infections cannot be eliminated. The ASRM
also recommends that all frozen specimens should be
quarantined for a minimum of 180 days, and the donor
retested after the quarantine period.
c) Recent Case Involving Sperm Donation . Last year, the
FDA served an order to an individual in Fremont, California
to cease manufacturing or giving away his fresh semen to
women hoping to conceive. Several Bay Area newspapers,
including the San Francisco Chronicle and the San Jose
Mercury News, indicate that the FDA's Center for Biologics
Evaluation and Research inspected this individual's home
and found him in violation of numerous regulations,
including failing to properly protect himself against
communicable diseases. At the heart of the dispute is
whether this individual is a sexually intimate partner to
women he donates his sperm to, and, therefore would exempt
him from regulatory requirements. The case is pending and
the individual faces potential financial penalties and jail
time. The FDA has not indicated whether it will clarify
the term SIP for purposes of this case and future cases.
d) DPH regulations on facilities that perform sperm
processing . Current law requires DPH, no later than
January 1, 2014, to adopt regulations regulating facilities
that perform sperm processing, that prescribe standards for
the handling and storage of sperm samples of carriers of
HIV, HTLV, and any other virus as deemed appropriate by
DPH. It also states that DPH may propose to adopt, as
initial regulations, the recommendations made within the
"Guidelines for Reducing Risk of Viral Transmission During
Fertility Treatment," as developed by the ASRM. Until DPH
adopts these regulations, facilities that perform sperm
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processing must follow these guidelines. According to
DPH, it plans to adopt the recommendations made within the
Guidelines as regulations with an expected publication in
2013. DPH also points out that the regulations would also
recommend sexually transmitted diseases testing for couples
at risk for infection and all women receiving treatments
from sperm donors.
3)SUPPORT . Supporters such as API Equality, Colage, Rainbow
Flag Health Services, and Sperm Bank, and Tres Lunas Midwifery
all state that this bill would provide lesbian, bisexual, and
transgender people and single women seeking to conceive using
a known sperm donor access to certain fertility services on
the same terms as different-sex couples. They state that a
disparity arises between different-sex couples and other women
using known donors when they may need to 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 sexually transmitted diseases.
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 intercourse with male
partners to conceive. They state that 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. Supporters
claim that all donors will continue to be tested for sexually
transmitted diseases initially, and this bill only addresses
requirements for repeated testing.
4)SUPPORT IF AMENDED . The California Medical Association (CMA)
has taken a support if amended position on this bill. CMA
states that many of its members remain uncertain how this
bill, if enacted, would correlate with existing FDA
regulations, which many physicians use as guidance when
performing fertility treatment. CMA is requesting that the
author consider amendments that would help protect physicians
from liability for their actions, including the recipient
receiving informed consent and an assumption of the risk. The
most recent amendments to this bill may address CMA's
concerns.
5)OPPOSE UNLESS AMENDED . The Consumer Attorneys of California
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state that this bill creates the large and unprecedented
immunities for physicians.
6)OPPOSITION . The California Right to Life Committee, Inc
states that this measure is not good public health policy and
sets a precedent for other exemptions in the future which
might be deleterious to women.
7)PREVIOUS LEGISLATION .
a) AB 1487 (Hill), Chapter 444, Statutes of 2010, among
other provisions, required testing for HTLV infections and
extends until January 1, 2014, the date for DPH to adopt
regulations for facilities that perform sperm processing.
b) AB 1397 (Hill) of 2009 was nearly identical to the
provisions of AB 1487. AB 1397 was vetoed by the Governor
with the message: "While I support the intent of this
bill, some provisions inappropriately restrict the
administrative and regulatory authority of the Department
of Public Health for adopting or modifying the American
Society for Reproductive Medicine guidelines. I would be
willing to reconsider a bill that does not infringe on the
Department's regulatory authority."
c) SB 1184 (Kuehl), Chapter 347, Statutes of 2008, requires
each clinical laboratory to report all CD4+ T-Cell test
results to the local health officer within seven days of
the completion of the test. If a CD4+ T-Cell test result
is related to a case of HIV infection, the local health
officer would be required to report the case of HIV
infection or AIDS to DPH within 45 days of receipt of the
laboratory report. Also requires a physician providing
insemination or advanced reproductive technologies 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 advanced reproductive
technology services.
d) 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
advanced reproductive technology only after the donor's
sperm has been effectively processed to minimize the
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infectiousness of the sperm for that specific donation, and
where informed and mutual consent has occurred. Requires
DPH to adopt regulations by January 1, 2010, regulating
facilities that perform sperm processing pursuant to
specified provisions. Requires a physician providing
insemination or advanced reproductive technologies to
provide prophylactic treatments, including, antiretroviral
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 advanced reproductive technology.
e) AB 441 (Mazzoni/Richter), Chapter 511, Statutes of 1997,
creates an exception to the prohibition of the transfer of
any tissues, as defined, into the body of another person
unless the donor of the tissues has been screened and found
nonreactive for evidence of infection with HIV, HBV, HCV,
HTLV, and syphilis. AB 441 also authorizes a recipient of
sperm to consent to therapeutic insemination of sperm or
other reproductive use of sperm even if the donor of the
sperm is found reactive for hepatitis B, hepatitis C, or
syphilis, if the sperm donor is the spouse, partner, or
designated donor, of the recipient and if certain other
conditions are met.
f) AB 525 (Speier), Chapter 659, Statutes of 1993,
authorized 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. Revised the definition of "transplantation" to
include the transfer of tissue from a donor to the body of
another human being.
8)COMMITTEE AMENDMENTS.
a) Intent Language . Include intent language to specify
that "It is not the intent of the Legislature to prevent
federal regulators from exercising federal authority over
facilities that provide insemination or advanced
reproductive technology services using sperm from a SIP."
b) Testing . Clarify that a recipient of sperm donated by a
SIP may waive a second or repeat testing if the recipient
is informed of the requirements for testing donors, and
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signs a written waiver.
c) Peer Review . Clarify that this bill applies only to
peer review body as defined in Section 805(B)(iii) of the
Business and Professions Code.
d) Clinical Laboratory or Tissue Banks . Clarify that the
exemption from disciplinary action against the license
applies only to clinical laboratories that are owned and
operated by physicians and surgeons, or tissue banks that
are owned and operated by physicians and surgeons that
offer reproductive services.
9)POLICY COMMENTS . The ASRM Guidelines, which have been adopted
in state statute to apply to all facilities that perform sperm
processing until DPH adopts the regulations specified in the
background above, recommends strict testing for sperm
regardless of whether the donor is known or anonymous, and
recommends quarantine and retesting for all situations except
for sexually intimate couples. This bill seems to lower the
standard of care that is recommended for known or directed
donors as long as the recipient has been previously exposed in
a nonmedical setting by defining such arrangements as a SIP.
Does a parent's desire to have a child override the health and
safety justifications for the testing? By passing this bill,
California would allow a physician to depart from the standard
of practice and be exempt from liability and disciplinary
action with the patient's consent.
REGISTERED SUPPORT / OPPOSITION :
Support
Equality California (cosponsor)
National Center for Lesbian Rights (cosponsor)
Betty T. Yee, Member, First District, State Board of
Equalization
American Civil Liberties Union
API Equality - Northern California
Asian & Pacific Islander Wellness Center
American Federation of State, County and Municipal Employees,
AFL-CIO
At Home Fertility
California Fertility Partners
Colage
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GroundSpark
Laparoscopic Institute for Gynecologic Oncology
Leslie Oldershaw Acupuncture & Herbal Medicine
MAIA Midwifery & Fertility Services
Our Family Coalition
Paul Robeson Chapter of the ACLU
Rainbow Flag Health Services and Sperm Bank
Somos Familia
Tres Lunas Midwifery
Numerous individuals
Opposition
California Right to Life Committee, Inc.
Analysis Prepared by : Rosielyn Pulmano / HEALTH / (916)
319-2097