BILL ANALYSIS
AB 1397
Page 1
Date of Hearing: April 28, 2009
ASSEMBLY COMMITTEE ON HEALTH
Dave Jones, Chair
AB 1397 (Hill) - As Introduced: February 27, 2009
SUBJECT : Tissue donation.
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 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-1 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
during and subsequent to the insemination or ART, and to
provide followup 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
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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-1" 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-1, or any
other virus DPH deems appropriate.
2)Requires sperm processing facilities to follow ASRM facility
and sperm processing guidelines until DPH adopts regulations.
3)Prohibits the transplantation of tissue into the body of
another, unless the donor of the tissue has been screened and
found to be free from infection with HIV, hepatitis B virus
(HBV), hepatitis C virus (HCV), HTLV-1, and syphilis, except
under specified conditions.
4)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 HBV, HCV, HIV, HTLV-1, or
syphilis if the sperm donor is the spouse of, partner of, or
designated donor for the recipient. Requires the physician
providing insemination or ART services to advise the donor and
recipient of the potential medical risks associated with
receiving sperm from a reactive donor. Requires the donor and
recipient to sign a document affirming their consent and
comprehension of the medical repercussions.
5)Allows the use of sperm from a donor who has tested reactive
for syphilis for insemination or ART after the donor has been
treated for syphilis. Allows the use of sperm from a donor
who has tested reactive for HBV for insemination or ART after
the recipient has been vaccinated against HBV.
6)Allows the use of sperm from a donor who has tested reactive
for HIV or HTLV-1 for insemination or ART after the sperm has
been processed to minimize the risk of infection for that
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specific donation and where informed and mutual consent has
occurred. Requires the physician to inform the recipient that
processing may not remove all risks of HIV or HTLV-1
transmission, that the sperm may be tested to determine
whether it is free of HIV or HTLV-1, and the harmful effects
that testing may have on the sperm.
7)Requires the physician to verify that a donor who has tested
reactive for HIV or HTLV-1 is under the care of a physician
managing the HIV or HTLV-1 infection, in order to minimize the
risk of transmission. Requires the physician to provide
appropriate prophylactic treatment to the recipient to
minimize the risk of infection.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1)PURPOSE OF THIS BILL . 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. 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
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promulgate regulations for ART only if it deems such
regulations are necessary to protect the public.
2)SPERM WASHING . The processing of sperm from a donor testing
reactive for HIV or HTLV-1 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. A 2004 study published by the ASRM found that after
sperm washing procedures, more than 99% of HIV is removed from
the sperm. Additionally, sperm washing technology and
procedures continue to improve. For example, in 2004, Harvard
Medical School, with support from the National Institutes of
Health (NIH), developed sperm washing techniques that resulted
in a higher yield of sperm and a lower rate of contamination
of the sperm. In 2005, Japanese researchers reported the
development of an improved swim-up technique which resulted in
HIV-free sperm samples, and concluded that the method involves
no risk of HIV transmission to female partners. The only way
to ensure that sperm that has undergone sperm washing is
entirely free of HIV or HTLV is to test the sperm
post-washing. This testing requires a portion of the washed
sperm to be quarantined, or essentially 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.
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3)HTLV-I and HTLV-II . According to the NIH, HTLV-I and HTLV-II
are uncommon in the general U.S. 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. According to
the Lymphoma Research Foundation, HTLV-I can cause adult
T-cell leukemia/lymphoma, a rare and aggressive cancer of the
blood, in 2% to 5% of those infected after many years.
Persons infected with HTLV-I or HTLV-II may develop
myelopathy, which is an inflammation of nerves in the spinal
cord that causes stiffness and weakness of the legs, backache,
bladder problems, and constipation; inflammation of the eye;
arthritis, inflammation of the lungs; and, infectious
dermatitis. 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;
corticosteroids may relieve some symptoms, but are not likely
to change the course of the disorder. HTLV-II also appears to
be associated with increased urinary and respiratory tract
infections.
4)ASRM GUIDELINES . 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,
"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, including
recommendations that couples be advised of the following: the
possibility of transmission of HIV and HTLV-1 in fertility
treatments; treatment with antiretroviral drugs prior to
fertility treatment for a male partner infected with HIV;
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testing and monitoring of an uninfected female partner during
treatment and pregnancy; and, if HIV infection is detected,
the female partner should be advised on how the use of
antiretroviral drugs during pregnancy and labor, use of
caesarean section, and avoidance of breastfeeding, can reduce
the risk of transmission to the offspring.
5)FEDERAL REGULATIONS . Tissue banks, including sperm banks,
must register with the federal Food and Drug Administration
(FDA) and adhere to all FDA regulations governing tissue
banking, and are subject to inspection by the FDA. The FDA
Center for Biologics Evaluation and Research regulates human
tissues intended for transplantation (although the U.S. Health
Resources and Services Administration regulates the
transplantation of organs such as kidneys, livers, and
hearts). According to a 2007 report of the FDA Human Tissue
Task Force, FDA began regulating human tissue intended for
transplantation in 1993, when it issued requirements for donor
screening and testing. In 1997, FDA issued a revised approach
with three rules, which was finalized and became effective in
2005. One rule requires firms to register and list their
tissue products with FDA. The second rule requires tissue
establishments to evaluate donors, through screening and
testing, to reduce the transmission of infectious diseases
through tissue transplantation. The third rule establishes
current good tissue practices for tissues intended for
transplantation. FDA also requires review and must approve of
instruments and materials used in sperm processing.
6)RELATED AND PRIOR LEGISLATION .
a) AB 995 (Block), pending in the Assembly, deletes
requirements that DPH regulate tissue banks, and instead
requires tissue banks to comply with the current standards
of the American Association of Tissue Banks. In its
current form, AB 995 could be interpreted to apply to sperm
donation. The Assembly Health Committee passed AB 995 on
April 21, 2009.
b) SB 443 authorizes the use of sperm from a donor who has
tested reactive for HIV or HTLV-1, for the purposes of
insemination and ART, and requires DPH to adopt, by January
1, 2010, regulations for sperm processing facilities.
c) AB 441 (Richter), Chapter 511, Statutes of 1997,
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authorizes a recipient of sperm to consent to therapeutic
insemination of sperm even if the donor of the sperm is
found reactive for HBV, HCV, or syphilis, if the donor is
the recipient's spouse, partner or designated donor, and
authorizes the use of tissues from donors who test reactive
for HBV, HCV, or syphilis for therapeutic insemination
under certain circumstances.
7)SUPPORT . ASRM writes it is sponsoring this bill so
HIV-discordant couples can become parents using ART, which
provides significant safeguards against infection as compared
to natural conception. ASRM writes its Practice Guidelines
for reducing the risk of viral transmission during fertility
treatment cover patient counseling, facilities, sperm washing
methods, and virus-specific risk reduction strategies. ASRM
writes there are hundreds of HIV-discordant couples anxiously
awaiting this law to be fixed. Kaiser Permanente writes it
believes this bill is necessary to allow HIV-discordant
couples to safely create biological families and is good
public policy. The AIDS Legal Referral Panel (ALRP) states
that soon after the passage of SB 443, couples soon realized
that physicians remained unwilling to perform reproductive
procedures using sperm due to ambiguity in responsibilities
for patient care. ALRP states this bill has been crafted with
the input of relevant stakeholders to ensure the removal of
further obstacles.
8)POLICY COMMENTS .
a) Oversight . The author states this bill allows DPH to
monitor the activities of the ART profession. If it is the
author's intention that DPH will monitor the ART
profession, the author may wish to clarify that DPH is
required or authorized to monitor facilities that process
sperm to ensure adherence to ASRM standards. For example,
DPH currently monitors health facilities pursuant to
federal Medicare requirements.
b) Potential Conflict Regarding Tissue Bank Standards . As
noted in 5) a) above, this bill and AB 995 may require
potentially conflicting standards for facilities that
process sperm. The authors may wish to address this as the
bills move forward.
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REGISTERED SUPPORT / OPPOSITION :
Support
American Society of Reproductive Medicine (sponsor)
AIDS Legal Referral Panel
Kaiser Permanente
Opposition
None on file.
Analysis Prepared by : Allegra Kim / HEALTH / (916) 319-2097