BILL ANALYSIS
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|SENATE RULES COMMITTEE | AB 1487|
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THIRD READING
Bill No: AB 1487
Author: Hill (D), et al
Amended: 6/14/10 in Senate
Vote: 27 - Urgency
SENATE HEALTH COMMITTEE : 5-0, 6/9/10
AYES: Alquist, Cedillo, Leno, Negrete McLeod, Pavley
NO VOTE RECORDED: Strickland, Aanestad, Cox, Romero
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
ASSEMBLY FLOOR : 74-0, 5/18/09 - See last page for vote
SUBJECT : Tissue donation
SOURCE : American Society for Reproductive Medicine
DIGEST : This bill amends existing guidelines that must
be adhered to between a physician who is providing
insemination, and other advanced reproductive technology
services, and a female patient. This bill extends, until
January 1, 2014, the date for adopting regulations and
allows the Department of Public Health to adopt initial
regulations based on the "Guidelines for Reducing Risk of
Viral Transmission During Fertility Treatment" using a
specified process.
ANALYSIS :
Existing law:
CONTINUED
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1. 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.
2. Allows a recipient to be inseminated with sperm found to
be 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.
3. 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.
4. 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.
5. 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.
6. Requires that, until DPH adopts these regulations,
facilities that perform sperm processing shall follow
facility and sperm processing guidelines developed by
the ASRM.
7. Stipulates 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.
8. Requires the physician providing insemination or
assistive reproductive technology to notify the
recipient that sperm processing may not eliminate all
risks of HIV or HTLV transmission, testing of the sperm
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may have adverse effects on the sperm, and that sperm
may be tested to determine whether it is reactive for
HIV or HTLV.
9. 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.
10.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.
11.Provides that DPH may adopt regulations requiring
additional screening tests of donors of tissue.
This bill:
1. Allows DPH to use a modified expedited rulemaking
process to adopt regulations to regulate facilities that
perform sperm processing.
2. Allows DPH to adopt ASRM guidelines as initial
regulations until the department promulgates
regulations. In the absence of any regulations from
DPH, sperm processing facilities are to follow
guidelines developed by the ASRM.
3. 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.
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4. Requires the physician providing insemination or
assistive reproductive technology to notify the
recipient of the following:
A. That the recipient must provide documentation of
an established ongoing relationship with another
physician to ensure the provision of proper medical
care during and after completion of fertility
services.
B. ASRM's medical guidelines for HIV and HTLV testing
after use of sperm from an HIV or HTLV reactive
donor, and that recommendations regarding follow-up
testing will be documented in the recipient's medical
record.
5. Deletes the following:
A. The requirement that physicians inform the
recipient of potential adverse effects the testing
may have on processed sperm.
B. The requirement that physicians provide
prophylactic treatments and follow-up testing
following insemination.
C. The requirement that the physician inform the
recipient of appropriate treatments, in the event the
recipient tests reactive for HIV or HTLV following
insemination.
6. Requires that the physician, assuming ongoing care of
the recipient, shall treat or provide information
regarding referral to a physician who can provide
ongoing treatment, in the event the recipient tests
reactive for HIV or HTLV following insemination.
7. Deletes the requirement 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.
8. Changes statutory references from HTLV-1 to HTLV, and
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makes other technical changes.
NOTE: This bill is virtually identical to last year's AB
1397 (Hill), which passed the Senate (31-0), but was
vetoed by the Governor. In his veto message, the
Governor expressed concern that "some provisions
inappropriately restrict the administrative and
regulatory authority the Department of Public
Health." The author's office maintains that the
current version of AB 1487 addresses those concerns.
Background
Sperm washing . 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 is one such advancement.
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 or in
vitro fertilization. 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
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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.
ASRM . The ASRM is a professional organization of
physicians, psychologists, nurses, educators, researchers,
administrators and lawyers who promote standards of health
care and scholarship in the field of reproductive medicine.
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 transmissible 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.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
SUPPORT : (Verified 6/29/10)
American Society for Reproductive Medicine (source)
ARGUMENTS IN SUPPORT : The bill's sponsor, ASRM, claims
that this bill is needed to allow HIV-discordant couples to
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safely pursue assisted reproduction technologies to start
biological families, without putting the non-HIV positive
partner or baby at risk. The sponsor contends that
hundreds of people are waiting to use ART services, but the
physicians that provide these services believe current law
is unworkable and need the clarifications in this bill in
order to provide their services. 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.
ASSEMBLY FLOOR :
AYES: Adams, Ammiano, Anderson, Arambula, Beall, Bill
Berryhill, Tom Berryhill, Blakeslee, Block, Blumenfield,
Brownley, Buchanan, Caballero, Charles Calderon, Chesbro,
Conway, Cook, Coto, Davis, De La Torre, De Leon, DeVore,
Duvall, Emmerson, Evans, Feuer, Fletcher, Fong, Fuentes,
Fuller, Furutani, Gaines, Galgiani, Garrick, Gilmore,
Hagman, Hall, Harkey, Hayashi, Hernandez, Hill, Huber,
Huffman, Jeffries, Jones, Knight, Krekorian, Lieu, Logue,
Bonnie Lowenthal, Ma, Mendoza, Miller, Monning, Nava,
Nestande, Niello, Nielsen, John A. Perez, V. Manuel
Perez, Portantino, Ruskin, Salas, Silva, Smyth, Solorio,
Audra Strickland, Swanson, Torlakson, Torres, Torrico,
Tran, Villines, Bass
NO VOTE RECORDED: Carter, Eng, Price, Saldana, Skinner,
Yamada
CTW:mw 6/29/10 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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