BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Sheila J. Kuehl, Chair
BILL NO: SB 443
S
AUTHOR: Migden
B
AMENDED: As Amended March 26, 2007
HEARING DATE: March 28, 2007
4
FISCAL:
4
3
CONSULTANT:
Patterson
SUBJECT
Tissue donors: sperm donors
SUMMARY
This bill authorizes the use of sperm from a donor who has
tested reactive for human immunodeficiency virus (HIV) or
human T lymphotropic virus-1 (HTLV-1), for the purposes of
insemination or advanced reproductive technology (ART).
CHANGES TO EXISTING LAW
Existing law:
Existing law requires all sperm donors to be screened and
found non-reactive for HIV, Hepatitis B virus (HBV),
Hepatitis C virus (HCV), HTLV-1, and syphilis. The law
contains exceptions that allow donors who are found
reactive for HBV, HCV or syphilis to donate sperm for
insemination or ART. For example, a recipient of donated
sperm may consent to receive sperm from a donor found
reactive for HBV, HCV or syphilis if the donor is the
spouse or partner of, or the designated donor for, that
recipient. In this instance, the physician assisting the
insemination or ART must advise both the donor and the
recipient of the potential medical risks associated with
the use of the sperm, and both the donor and the recipient
Continued---
STAFF ANALYSIS OF SENATE BILL 443 (Migden) Page
2
must sign a document affirming that they understand the
risks and consent to the procedure. Another exemption
allows sperm, whose donor has tested reactive for syphilis,
to be used after the donor is treated for syphilis. A third
exemption allows sperm whose donor has tested reactive for
HBV to be used after the recipient has been vaccinated
against HBV. The law also allows recipients of sperm, upon
signed informed consent, to waive second or repeat testing
of a sperm donor known to the recipient.
Existing law makes it a felony to donate semen to any
medical center or semen bank when the donor is aware that
he has tested reactive for HIV or has been diagnosed with
Acquired Immune Deficiency Syndrome (AIDS).
This bill:
SB 443 allows a recipient of sperm to consent to
insemination or use of sperm in ART if the sperm donor is
found reactive for HIV or HTLV-1, if the donor is the
spouse or partner of, or designated donor for, that
recipient.
The bill requires that sperm from a donor who tests
reactive for HIV or HTLV-1, and who is donating to a
recipient who tests negative for HIV or HTLV-1, be
processed to minimize infectiousness before it is used for
insemination or ART. The recipient and the donor must
mutually consent to the use of the sperm, and the sperm
processing must be performed by a facility recognized by
the American Society of Reproductive Medicine (ASRM).
The bill requires the physician providing insemination or
ART using processed sperm to provide prophylactic
treatments to the recipient, as appropriate, to reduce the
risk of infection during, and subsequent to, insemination.
The bill also requires the physician to test the recipient
of the processed sperm for HIV or HTLV-1 after performing
insemination or ART.
The bill allows unprocessed sperm from a donor who has
tested reactive for HIV or HTLV-1 to be used for
insemination or ART if the recipient has been documented
with HIV or HTLV-1 infection and where informed and mutual
STAFF ANALYSIS OF SENATE BILL 443 (Migden) Page
3
consent has occurred. Additionally, the bill indemnifies
donors from provisions in existing law that criminalize the
donation of semen by individuals who are aware that they
have tested reactive to HIV or have been diagnosed with
AIDS.
FISCAL IMPACT
Unknown.
BACKGROUND AND DISCUSSION
Purpose of the bill
According to the author, current law discriminates against
HIV and HTLV-1 infected patients and prevents them from
accessing available technology designed to prevent HIV
transmission during reproduction. This legislation would
allow for assisted reproduction for HIV and HTLV-1
patients.
HTLV-1
HTLV-1 is a retrovirus that can be transmitted by sexual
contact, from mother to child (primarily through breast
feeding), through blood transfusion and by sharing
contaminated needles. HTLV-1 is associated with adult
T-cell leukemia/lymphoma. HTLV-1 has low endemic rates in
the United States, and is generally spread through sexual
contact and transmission from mother to child. Overall,
the prevalence of HTLV-1 is significantly lower than that
of HIV. There is no cure for HTLV-1 and infection is
lifelong.
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 semen's white blood cells and plasma, 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 involve a "swim-up" technique that
removes inactive sperm. The remaining active sperm can
STAFF ANALYSIS OF SENATE BILL 443 (Migden) Page
4
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 percent 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,
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-1, is to test the
sperm post-washing. The testing process requires a portion
of the washed sperm to be quarantined, or essentially
frozen, while the remaining portion is tested for the
viruses.
According to officials at Bay Area Perinatal AIDS Center at
the University of California, San Francisco, out of 3,800
cases reported outside of California in which couples with
an HIV-positive man have used sperm washing in their
fertility treatments, no cases of HIV transmission have
occurred.
American Society of Reproductive Medicine Guidelines
In 2006, the ASRM issued guidelines for reducing the risk
of viral transmission during fertility treatments that
describe the sperm washing process and include
recommendations for facilities conducting sperm washing
procedures. For example, the guidelines recommend that
STAFF ANALYSIS OF SENATE BILL 443 (Migden) Page
5
sperm samples from viral carriers be processed and stored
in a separate laboratory or designated space within a main
laboratory in order 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 that couples be
advised of the possibility of transmission of HIV and
HTLV-1 in fertility treatments, that if the male partner is
infected with HIV he should be treated with antiretroviral
drugs prior to fertility treatment, and that an uninfected
female partner should be tested and monitored for HIV
during treatment and pregnancy. If HIV infection is
detected, she should be advised about how the use of
antiretroviral drugs during pregnancy and labor, use of
cesarean section, and avoidance of breastfeeding can reduce
the risk of transmission to the offspring.
Prior legislation
AB 441 (Richter), Chapter 511, Statutes of 1997, 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.
Arguments in support
Supporters such as the ASRM, American College of
Obstetricians and Gynecologists and the San Francisco AIDS
Foundation state that, due to the advancement of medical
treatment and evolution of public health policies, HIV
positive individuals who are given standard treatment can
be expected to live normal lives for decades. With the
changing impact of HIV, many infected patients now desire
to have their own families. Supporters argue that
HIV-positive patients ought not to be denied fertility
services, and that such denials are discriminatory. They
also argue that, without the bill, HIV patients will be
tempted to put themselves at a greater risk of transmission
by trying to conceive a child without medical help and the
safeguards that processes like sperm washing can provide.
STAFF ANALYSIS OF SENATE BILL 443 (Migden) Page
6
Numerous studies have documented that ART can prevent the
spread of infection from the semen of an HIV-infected male
to his female partner, and access to these technologies
allow for the safe reproduction of individuals with HIV and
the potential protection of their partners and future
offspring.
Arguments in opposition
None received.
COMMENTS AND QUESTIONS
1. Need stronger oversight. This bill requires sperm
washing to be performed by a facility that is
recognized by the ASRM, a national non-profit
organization made up of various types of medical
professionals that provides information, education,
advocacy and guidelines in the field of reproductive
medicine. It is unclear how the ASRM recognizes
facilities that perform sperm processing, and such
facilities do not appear to have federal or state
oversight specific to the sperm washing process.
These facilities should be required to follow
established procedures for the handling and processing
of sperm from carriers of HIV and HTLV-1.
2. Option for testing processed sperm. Although research
suggests that sperm washing significantly reduces the
risk of transmission of HIV or HTLV-1, recipients of
sperm should be informed that testing the sperm after
washing is the only way to ensure it is free of HIV or
HTLV-1, and given the option to test the sperm prior
to insemination or ART. The recipient should also be
made aware of the impact on fertility that the testing
may have on the sperm.
3. Treatment of male partner and monitoring of female
partner. ASRM guidelines recommend that a sperm donor
who has been tested reactive for HIV or HTLV-1 be
treated with antiretroviral drugs prior to fertility
treatment, and that the sperm recipient be monitored
for HIV during treatment and pregnancy. Both of these
recommendations appear to be valid measures to prevent
transmission and to protect the health of the sperm
STAFF ANALYSIS OF SENATE BILL 443 (Migden) Page
7
recipient, and should be required in statute.
4. Information to reduce risk of transmission to infant.
In an event that transmission does occur, the sperm
recipient should be informed of available treatments
during and after pregnancy, and ways to minimize the
risk of transmission to the infant.
Suggested amendments:
The mock-up below incorporates suggested amendments for
the three comments listed above, and also contains
suggested technical and clarifying amendments.
Subdivision (c), paragraph (3), subparagraph (B) is
amended as follows:
(B) (1) Sperm whose donor has tested reactive for HIV
or HTLV-1 may be used for the purposes of insemination or
advanced reproductive technology for a recipient testing
negative for HIV or HTLV-1 only after the donor's sperm
has been effectively processed to minimize the
infectiousness of the sperm for that specific donation,
where informed and mutual consent has occurred , . and
where the sperm processing has been performed by a
facility recognized by the American Society of
Reproductive Medicine.
(2) The department shall adopt regulations relating to
facilities which perform
sperm processing, pursuant to subparagraph (B), that
prescribe standards for the handling and storage of sperm
samples of carriers of HIV, HTLV-1, or any other virus as
deemed by the department. Until the department adopts
these regulations, facilities which perform sperm
processing shall follow facility and sperm processing
guidelines developed by the American Society of
Reproductive Medicine.
(3)Prior to insemination or other advanced
reproductive technology services, the physician shall
inform the recipient of sperm from a donor who has tested
reactive for HIV or HTLV-1 that sperm processing may not
eliminate all risks of HIV or HTLV-1 transmission, and
that the sperm may be tested to determine whether or not
it is free of HIV or HTLV-1. The physician shall also
inform the recipient of potential adverse effects the
STAFF ANALYSIS OF SENATE BILL 443 (Migden) Page
8
testing may have on the processed sperm.
(4) The physician providing insemination or advanced
reproductive technology services shall provide, as
appropriate, prophylactic treatments , including
antiretroviral treatments, available to the recipient to
reduce the risk of acquiring infection during, and
subsequent to, insemination or advanced reproductive
technology . The physician shall also treat, as
appropriate, the donor of sperm that tests reactive for
HIV or HTLV-1 with antiretroviral treatments prior to
insemination or advanced reproductive technology
services.
(5) The physician shall also perform appropriate
followup testing of the recipient for HIV or HTLV-1
following the insemination or other advanced reproductive
technology, and recommend ongoing monitoring by a
physician during treatment and pregnancy. The physician
shall also recommend in the sperm recipient's medical
record that the recipient be monitored during treatment
and pregnancy.
(6) In the event that the recipient tests reactive for
HIV or HTLV-1 following insemination or other advanced
reproductive technology, the physician shall inform the
recipient of appropriate treatments during and after
pregnancy, and of treatments or procedures that may
reduce the risk of transmission to the offspring.
(7) Sperm whose donor has tested reactive for HIV or
HTLV-1 may be used for the purposes of insemination or
advanced reproductive technology if the recipient already
has been previously documented with HIV or HTLV-1
infection, and where informed and mutual consent has
occurred.
POSITIONS
Support: AIDS Legal Referral Panel
Alta Bates Summit Medical Center
American Civil Liberties Union
American College of Obstetricians and Gynecologists,
District IX/CA
American Society for Reproductive Medicine
California Fertility Partners, Los Angeles
City and County of San Francisco, Department of
Public Health
STAFF ANALYSIS OF SENATE BILL 443 (Migden) Page
9
City and County of San Francisco, Department of
Public Health, Forensic AIDS Project
Kaiser Permanente
San Francisco AIDS Foundation
Women Organized to Respond to Life-Threatening
Diseases
University of California San Diego, Mother Child
Adolescent HIV Program
University of California, San Francisco, AIDS
Research Institute
University of California, San Francisco, Departments
of Laboratory Medicine and
Epidemiology/Biostatistics
University of California, San Francisco, Division of
Hematology/Oncology
University of California, San Francisco, Obstetrics,
Gynecology and Reproductive Services
University of California, San Francisco, Positive
Health Program
18 individuals
Oppose: None received.
-- END --