BILL ANALYSIS
AB 1397
Page 1
ASSEMBLY THIRD READING
AB 1397 (Hill)
As Introduced February 27, 2009
Majority vote
HEALTH 18-0 APPROPRIATIONS 16-0
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|Ayes:|Jones, Fletcher, Adams, |Ayes:|De Leon, Nielsen, |
| |Ammiano, Block, Carter, | |Ammiano, |
| |Conway, De La Torre, De | |Charles Calderon, Davis, |
| |Leon, Emmerson, Hall, | |Duvall, Krekorian, Hall, |
| |Hayashi, Hernandez, | |Harkey, Miller, |
| |Bonnie Lowenthal, Nava, | |John A. Perez, Price, |
| |V. Manuel Perez, Salas, | |Skinner, Solorio, Audra |
| |Audra Strickland | |Strickland, Torlakson |
| | | | |
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SUMMARY : Authorizes, rather than requires, the Department of
Public Health (DPH) to adopt regulations for facilities that
perform sperm processing for insemination and advanced
reproductive technologies (ART); and, revises provisions related
to the use of sperm from donors infected with the human
immunodeficiency virus (HIV) and human T-cell lymphotropic
viruses (HTLV). Specifically, this bill :
1)Removes a requirement that DPH adopt regulations to regulate
facilities that perform sperm processing; and, instead
authorizes DPH to adopt regulations that prescribe standards
for the handling and storage of sperm samples of carriers of
HIV, HTLV, or any other virus DPH deems appropriate. Requires
sperm processing facilities to continue following the
guidelines of the American Society of Reproductive Medicine
(ASRM).
2)Deletes a provision requiring a physician to inform a
recipient of sperm from a donor who has tested reactive for
HIV or HTLV-I that the sperm may be tested and of the
potential adverse effects that the testing may have on the
sperm.
3)Deletes provisions requiring a physician providing
insemination or ART services to provide prophylactic treatment
to the recipient in order to reduce the risk of infection
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during and subsequent to the insemination or ART, and to
provide follow-up testing and recommend ongoing monitoring by
a physician during treatment and pregnancy.
4)Revises a provision to require, in the event that a sperm
recipient becomes HIV- or HTLV-positive during the pregnancy,
a physician who assumes ongoing management of the pregnancy
(rather than the physician providing the insemination or ART)
to inform the recipient of treatments or procedures that may
reduce the risk of transmission to the offspring, or provide
information regarding referral to a physician who can provide
that information.
5)Deletes a provision allowing sperm from an HIV- or
HTLV-positive donor to be used for insemination or ART if the
recipient already has the infection and mutual consent has
occurred.
6)Replaces references to "HTLV-I" with "HTLV."
EXISTING LAW :
1)Requires DPH to adopt, by January 1, 2010, regulations to
prescribe sperm processing facilities' handling and storage of
sperm from donors who are carriers of HIV, HTLV-I, or any
other virus DPH deems appropriate. Requires sperm processing
facilities to follow ASRM facility and sperm processing
guidelines until DPH adopts regulations.
2)Allows a recipient of sperm to consent to therapeutic
insemination of sperm or use of sperm in other ART even if the
sperm donor is found reactive for hepatitis B virus, hepatitis
C virus, HIV, HTLV-I, or syphilis if the sperm donor is the
spouse of, partner of, or designated donor for the recipient.
3)Allows the use of sperm from a donor who has tested reactive
for HIV or HTLV-I for insemination or ART after the sperm has
been processed to minimize the risk of infection for that
specific donation and where informed and mutual consent has
occurred, as specified.
FISCAL EFFECT : According to the Assembly Appropriations
Committee, this bill will have no direct fiscal impact to DPH to
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continue oversight of medical professionals providing
reproductive technologies to HIV-discordant couples.
COMMENTS : According to the author, HIV is now considered a
chronic disease, and many HIV-infected adults have near normal
life expectancy with typical life goals such as starting a
family. The author states that due to advances in reproductive
technologies, sperm washing can separate healthy sperm from the
other components in semen that may contain HIV, removing 99.9%
of HIV particles, so HIV- and HTLV-infected sperm can be used in
ART with virtually no risk of transmission to mother and baby.
Over 4,500 assisted reproduction procedures are documented in
the literature with no reports of HIV transmission when using
standardized sperm washing methods with either intrauterine
insemination or in-vitro fertilization. SB 443 (Migden),
Chapter 207, Statutes of 2007, was intended to ensure access to
reproductive treatment for HIV-discordant couples (HIV-positive
male partner and HIV-negative female). However, the author
states SB 443 was unclear about which medical professionals were
responsible for the care of the infected sperm donor and for
follow-up of the recipient, and included some medical
terminology that was inaccurate or insufficiently inclusive.
Also, sperm infected with different types of HTLV, not just
HTLV-I, can be safely used once processed, so this bill uses the
broader language. The author argues this bill is needed to fix
those problems. The author further states because this area of
medicine is changing quickly, this bill allows DPH to monitor
the activities of the ART profession and promulgate regulations
for ART only if it deems such regulations are necessary to
protect the public.
The processing of sperm from a donor testing reactive for HIV or
HTLV-I is commonly referred to as sperm washing. Numerous
studies have confirmed that HIV is primarily found in white
blood cells and plasma in semen, not generally within the sperm
itself. The sperm washing process involves centrifuging the
semen in order to separate it from the sperm. This process can
also involve a "swim-up" technique that removes inactive sperm.
The remaining active sperm can then be used for insemination or
ART. Numerous national and international research studies have
reported that the sperm-washing process markedly reduces HIV
levels in the sperm, and the technology and procedures continue
to improve. A 2004 study published by ASRM found that after
sperm washing procedures, more than 99% of HIV is removed from
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the sperm. In 2005, Japanese researchers reported the
development of an improved swim-up technique which resulted in
HIV-free sperm, and concluded that the method involves no risk
of HIV transmission to female partners. To ensure that sperm
that has undergone sperm washing is entirely free of HIV or
HTLV, the sperm must be tested post-washing. This testing
requires a portion of the washed sperm to be quarantined, or
frozen, while the remaining portion is tested for the viruses.
The Internet newsletter "hivandhepatitis.com" cites a study
published in the September 2007 issue of the journal AIDS which
reports on a European study which assessed the safety and
effectiveness of assisted reproduction using sperm washing for
HIV discordant couples. The study included 1,036 couples
treated at eight centers, and 3,390 assisted reproduction cycles
using various techniques. The treatments resulted in 580
pregnancies, though pregnancy outcomes were unknown in 47 cases.
The remaining 533 pregnancies resulted in 410 deliveries and
463 live births. None of the babies were infected with HIV, and
among the 93% of women who were not lost to follow-up, no women
tested positive for HIV at six months after the procedures.
According to the National Institutes of Health, HTLV-I and
HTLV-II are uncommon in the general population. HTLV-I and
HTLV-II are closely-related, and are most prevalent among
intravenous drug users and persons who have multiple sex
partners, genital ulcers, or a history of syphilis. HTLV-I and
HTLV-II can be transmitted by blood or intimate sexual contact,
and can be passed from mother to child during pregnancy and
through breast milk. Most infected persons remain healthy
carriers of the virus for life. However, according to the
Lymphoma Research Foundation, after many years, HTLV-I can cause
adult T-cell leukemia/lymphoma, a rare and aggressive cancer of
the blood, in 2% to 5% of those infected. In addition,
researchers think that HTLV-I plays a role in the development of
B-cell chronic lymphocytic leukemia. There is no established
treatment for HTLV-I. HTLV-II appears to be associated with
increased urinary and respiratory tract infections.
ASRM was founded in 1944 and states its membership includes
national fertility experts, including
obstetricians/gynecologists, urologists, reproductive
endocrinologists, embryologists, mental health professionals,
nurses, and others. ASRM publishes the peer-reviewed journal,
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"Fertility and Sterility," as well as various guidelines,
standards, opinions, and patient education materials. In 2008,
ASRM issued revised guidelines for reducing the risk of viral
transmission during fertility treatment, including
recommendations for facilities conducting sperm washing
procedures. The guidelines recommend that sperm samples from
viral carriers be processed and stored in a separate laboratory
or designated space within a main laboratory to minimize the
risk of cross-contamination. The guidelines also address
testing and treatment of couples at risk of viral transmission
during fertility treatment.
Analysis Prepared by : Allegra Kim / HEALTH / (916) 319-2097
FN: 0000935