BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K Alquist, Chair
BILL NO: AB 1397
A
AUTHOR: Hill
B
AMENDED: June 16, 2009
HEARING DATE: July 8, 2009
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CONSULTANT:
3
Orr/sh
9
7
SUBJECT
Tissue donation
SUMMARY
Removes the mandate for the Department of Public Health
(DPH) to adopt regulations regulating facilities that
process sperm to minimize risk of HIV infection. Modifies
the responsibilities of physicians providing insemination
or advanced reproductive technologies to HIV discordant
couples where one partner is HIV positive and one is HIV
negative. Requires that, in the absence of any regulations
from DPH, sperm processing facilities are to follow
guidelines developed by the American Society for
Reproductive Medicine (ASRM).
CHANGES TO EXISTING LAW
Existing law:
Provides that no tissues shall be transferred into the body
of another person unless the donor of the tissues has been
screened and found nonreactive for evidence of HIV
infection, and other diseases.
Allows a recipient to be inseminated with sperm found to be
Continued---
STAFF ANALYSIS OF ASSEMBLY BILL 1397 (Hill) Page
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reactive for HIV or other diseases if the recipient is
properly informed and signs a waiver, or gives consent to
therapeutic insemination or the use of advanced
reproductive technology.
Provides that the physician providing insemination or
advanced reproductive technology services shall advise the
donor and recipient of potential medical risks associated
with receiving sperm from a reactive donor.
Allows for sperm whose donor has tested reactive for HIV or
human T-Cell Lymphotophic Virus Type-1 (HTLV-1) to be used
for the purpose of insemination or advanced reproductive
technology, only after the sperm has been processed to
minimize its infectiousness.
Mandates that the Department of Public Health (DPH) shall
adopt regulations by January 1, 2010 to regulate facilities
that perform sperm processing, to establish standards for
the proper handling and storage of sperm samples that carry
HIV or HTLV-1.
Requires that, until DPH adopts these regulations,
facilities that perform sperm processing shall follow
facility and sperm processing guidelines developed by the
American Society for Reproductive Medicine (ASRM).
Requires the physician providing insemination or advanced
reproductive technologies to inform the recipient that
sperm processing may not eliminate all risks of viral
transmission, and that testing of the sperm may have
adverse effects on the sperm.
Requires the physician to provide prophylactic treatments
to the recipient, including, but not limited to,
antiretroviral treatments to reduce the risk of acquiring
infection during the insemination or advanced reproductive
technology. After the insemination or other advanced
reproductive technology, the physician must also perform
appropriate follow-up testing of the recipient for HIV or
HTLV-1, and recommend ongoing monitoring by a physician
during treatment and pregnancy. If the recipient tests
reactive for either disease, the physician must inform the
recipient of appropriate treatments.
STAFF ANALYSIS OF ASSEMBLY BILL 1397 (Hill) Page
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Additionally, requires the physician to verify and document
that the donor of the HIV or HTLV-1 reactive sperm is under
a physician's care to minimize the risk of transmission
during the course of the insemination or advanced
reproductive technology.
Provides that DPH may adopt regulations requiring
additional screening tests of donors of tissue.
This bill:
Changes statutory references from HTLV-1 to HTLV.
Removes the mandate that DPH adopt regulations for proper
handling and storage of HIV and HTLV-1 carrying sperm
samples, and removes the date by which those regulations
were to be adopted. Maintains DPH's ability to adopt
regulations as the department deems appropriate.
Stipulates that in the absence of any regulations from DPH,
sperm processing facilities are to follow guidelines
developed by the ASRM.
Requires the physician to notify the recipient of ASRM's
medical guidelines for HIV and HTLV testing after use of
sperm from an HIV or HTLV reactive donor.
Requires the physician providing the insemination or
advanced reproductive technology to recommend follow-up
testing according to ASRM guidelines.
Absolves physicians performing insemination or advanced
reproductive technology from all of the following
requirements:
providing prophylactic treatments to the recipient to
reduce the risk of acquiring infection during the
insemination or advanced reproductive technology;
performing follow-up testing of the recipient; and,
recommending ongoing monitoring during treatment and
pregnancy.
Transfers responsibility of recommending follow-up testing
and informing the recipient of available treatments and
procedures in the event of viral transmittal, to a
transferring physician or another unspecified physician.
STAFF ANALYSIS OF ASSEMBLY BILL 1397 (Hill) Page
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Deletes the requirement that sperm be tested to determine
if it is free of HIV or HTLV-1 prior to insemination.
Deletes the stipulation that sperm whose donor has tested
reactive for HIV or HTLV-1 may be used for purposes of
insemination if the recipient already has been previously
documented with HIV or HTLV-1 infection and where informed
and mutual consent has occurred.
Adds an urgency clause, to take effect immediately in order
to help prevent the spread of HIV.
FISCAL IMPACT
The Assembly Appropriations Committee estimates no direct
fiscal impact to DPH to continue oversight of medical
professionals providing reproductive technologies to
HIV-discordant couples.
BACKGROUND AND DISCUSSION
Prior to 2007, California and Delaware were the only states
to prohibit the use of sperm from an HIV-infected man from
being used in assistive reproductive technologies. SB 443
(Migden, Chapter 207, Statutes of 2007) was passed in 2007
for the purpose of removing that prohibition. However, the
American Society for Reproductive Medicine (ASRM) contends
that two technical issues arose in the implementation of
the bill: 1) the language in SB 443 was vague regarding
physician responsibilities, and 2) the terms used in
statute were not current with the terms used in the field.
AB 1397, sponsored by ASRM, seeks to clarify these
ambiguities by specifying which medical professionals are
responsible for the care of the HIV/HTLV infected sperm
donor, and for the follow-up care of the recipient. AB 1397
also seeks to remove the requirement that the state create
regulations regarding sperm processing, and instead allows
the state to monitor the activities of the professionals
and professional associations engaged in these practices.
DPH reserves the right to promulgate regulations at any
time.
The author changed references to HTLV-1 to HTLV to be more
inclusive of both types of HTLV viruses that affect humans.
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Individuals infected with HIV are now living longer,
healthier lives and are choosing to have children. Many
are seeking fertility services to maximize reproductive
potential and/or minimize the transmission risk to their
partners and children. Medical advances have dramatically
reduced the vertical transmission rate (mother to fetus)
and neonatal morbidity of several viruses, including HIV.
Sperm washing
Sperm washing is a standard procedure used in infertility
treatments, in which individual sperm are separated from
the seminal fluid by spinning it in a centrifuge. The sperm
are then used in intrauterine insemination (IUI) or invitro
fertilization (IVF). Since HIV infection is carried in the
seminal fluid, rather than the sperm, it has come to be
used by HIV discordant couples (one partner is infected
with the virus and the other is not) to reduce the risk of
passing the virus from the father to the mother or child.
According to ASRM, quantitative assessment of HIV in semen
before and after the sperm wash procedure indicates that
more than 99 percent of HIV is removed by this procedure.
Similar sperm preparation techniques have been used to
separate other diseases from sperm, such as Hepatitis C.
Existing donor screening guidelines
The Food and Drug Administration (FDA) mandates that all
anonymous and known directed semen donors be screened for
high-risk factors and clinical evidence of infectious
diseases, and be tested serologically (meaning an analysis
of the blood serum) for chronic viral infections, including
HTLV. Though there is no FDA or other legal requirement for
viral screening of sexually intimate partners undergoing
fertility treatment, the ASRM contends that such screening
can help ensure that appropriate precautions are taken to
minimize the risk of viral transmission to partners and
offspring.
American Society for Reproductive Medicine
The American Society for Reproductive Medicine (ASRM) is a
professional organization of physicians, psychologists,
nurses, educators, researchers, administrators and lawyers
dedicated to promotion of the highest standards of health
care and scholarship in the field of reproductive medicine.
STAFF ANALYSIS OF ASSEMBLY BILL 1397 (Hill) Page
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ASRM has developed practice guidelines for reducing the
risk of viral transmission during fertility treatment, that
cover patient counseling, facilities, sperm washing
methods, and virus-specific risk reduction strategies. ASRM
contends that their guidelines establish updated standards
of clinical care and are modified as the field changes with
ongoing research.
Some of ASRM's recommendations include excluding anonymous
and known directed sperm donors who engage in any high-risk
sexual activities from donating sperm. They also recommend
that any couple in which one or both partners are infected
with a sexually transmissable pathogenic virus should
receive in-depth preconceptional counseling on the risks of
sexual and vertical transmission of their infections. In
circumstances involving an infected man and uninfected
woman, ASRM recommends donor insemination as the safest
option.
ASRM claims that the field of assisted reproduction for
HIV-discordant couples is rapidly evolving and it is most
appropriate to avoid mandating specific requirements in
statute that may quickly become obsolete as the field
advances.
Related bills
AB 995 (Block) This bill would require the collection,
processing, storage, or distribution of human tissue by
licensed tissue banks and tissue for use in California to
comply with specified standards, and would require future
amendments of these standards to be evaluated and
considered for adoption by the department pursuant to a
specified process. This bill would also allow the
department to impose on licensed tissue banks, as an
alternative to suspension or revocation of a tissue bank's
license, a civil administrative penalty of $100 per day of
noncompliance per violation not to exceed an aggregate of
$3,000 per day. Scheduled to be heard in the Senate Health
Committee on June 24, 2009.
Prior legislation
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
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related to a case of HIV infection, the local health
officer would be required to report the case of HIV
infection or AIDS to the department 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.
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 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.
AB 1910 (Harman) Chapter 775, Statutes of 2004, stipulates,
among other things, that any entity that receives genetic
material of a human being that may be used for conception
shall provide a form to the person depositing his or her
genetic material for use by the depositor that, if signed
by the depositor, would satisfy specified conditions
regarding the decedent's intent for the use of that
material. The use of the form is not mandatory, and the
form is not the exclusive means of expressing a depositor's
intent.
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
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unless the donor of the tissues has been screened and found
nonreactive for evidence of infection with HIV, agents of
viral hepatitis, human T lymphotrophic virus-1, and
syphilis. The bill 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.
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. Revised the definition of "transplantation" to
include the transfer of tissue from a donor to the body of
that donor.
Arguments in support
The sponsor (ASRM) claims that there are hundreds of
HIV-discordant couples currently waiting for this bill to
be passed so that they can safely pursue assisted
reproduction technologies to start biological families,
without putting the non-HIV positive partner or baby at
risk. The sponsor contends that without this bill, many of
these couples will likely try to conceive naturally, which
could lead to transmission of the virus.
PRIOR ACTIONS
Assembly Floor 79-0
Assembly Appropriations 16-0
Assembly Health: 18-0
COMMENTS
1. Removing regulatory authority from DPH
The bill relieves the Department of Public Health from
the duty to adopt regulations by January 1, 2010,
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regulating facilities that perform this processing,
pursuant to SB 443 (Migden, Chapter 207, Statutes of
2007). It is unclear how far the department got in their
development of these regulations. It is also unclear if
DPH believes it will be jeopardizing the public's health
by relinquishing some of their authority over the
governance of this area.
ASRM contends that part of the reason for the removal of
DPH's regulatory mandate is due to the fast-paced nature
of this field of medical science. A recommended
amendment would be to require DPH to adopt the ASRM
standards, as well as updates to those standards over
time, through a modified rulemaking process similar to
that contained in AB 995 dealing with tissue banks, which
will be heard in this committee on July 8. This would
ensure departmental review of the standards and provide
an opportunity for public comment. Another recommended
amendment is to clarify that DPH retains the authority to
monitor and inspect sperm processing facilities.
2. Patient protections
This bill deletes several explicit patient protections
that were contained in SB 443, which authorizes use of
sperm from an HIV positive donor. The author contends
that those deletions are not meant to reduce the number
of patient protections provided in statute, but that the
language is either unnecessary because existing law
already provides adequate protections, or because the
language did not reflect terminology used in the field.
For instance:
a. The bill deletes the requirement that sperm be
tested to determine if it is free of HIV or HTLV-1
prior to insemination. The sponsor contends that it is
not fully accurate to describe sperm as being "free"
from HIV or HTLV-1, and that a more medically accurate
description is "nonreactive." Existing law already
stipulates that no tissues will be transferred into
the body of another person unless the donor of the
tissues has been found nonreactive for evidence of HIV
and other agents.
b. The bill removes the requirement that the physician
providing insemination also provide the recipient with
prophylactic treatments, including antiretroviral
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treatments, follow-up testing and monitoring, in order
to reduce the risk of acquiring infection during the
insemination. The sponsor claims that physicians
providing insemination or advanced reproductive
technology do not typically have expertise in the
management of antiretroviral medication and therefore
may not be the most appropriate professional to
provide this service to the recipient. The sponsor
contends that it is not currently the standard of care
for physicians providing insemination services to
provide on-going care to recipients following the
insemination. In the case of a pregnancy, it is more
appropriate to allow the physician caring for the
pregnant recipient to manage follow-up testing and
make referrals as needed in the event of a viral
transmission.
Suggested amendments to ensure that recipients continue
to be protected would be to: (1) clarify the requirement
that sperm be tested to determine if it is nonreactive of
HIV or HTLV prior to insemination; (2) require the
physician providing insemination or advanced reproductive
technology services to verify and document in the
recipient's medical record that the recipient is, or will
be, under the care of a physician who will be providing
prenatal care; and (3) clarify that the physician
providing the services must recommend to the physician
who will be providing care to the recipient follow-up
testing and monitoring for HIV and HTLV.
POSITIONS
Support: American Society for Reproductive Medicine
(sponsor)
AIDS Legal Referral Panel
Fertility Physicians of Northern California
Kaiser Permanente
American College of Obstetricians and Gynecologists,
District IX
One individual
Oppose: None
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