BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K. Alquist, Chair
BILL NO: AB 1487
A
AUTHOR: Hill
B
AMENDED: March 2, 2010
HEARING DATE: June 9, 2010
1
REFERRAL: Judiciary Committee
4
CONSULTANT:
8
Orr/
7
SUBJECT
Tissue donation
SUMMARY
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 the Department of Public Health (DPH),
sperm processing facilities are to follow guidelines
developed by the American Society for Reproductive Medicine
(ASRM). Allows DPH to use a modified rulemaking process to
develop the required regulations regulating facilities that
process sperm to minimize risk of HIV infection. and allows
DPH to adopt ASRM standards as initial regulations.
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
Continued---
STAFF ANALYSIS OF ASSEMBLY BILL 1487 (Hill) Page
2
infection, and other diseases.
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.
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).
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.
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 may have adverse effects
on the sperm, and that sperm may be tested to determine
whether it is reactive for HIV or HTLV.
Requires the physician to provide prophylactic treatments
to the recipient, including, but not limited to,
antiretroviral treatments to reduce the risk of acquiring
STAFF ANALYSIS OF ASSEMBLY BILL 1487 (Hill) Page
3
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.
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:
Allows DPH to use a modified expedited rulemaking process
to adopt regulations to regulate facilities that perform
sperm processing. 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.
Requires the physician providing insemination or assistive
reproductive technology to notify the recipient of the
following:
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.
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.
Deletes the following:
The requirement that physicians inform the recipient of
potential adverse effects the testing may have on
processed sperm.
The requirement that physicians provide prophylactic
treatments and follow-up testing following insemination.
The requirement that the physician inform the recipient
STAFF ANALYSIS OF ASSEMBLY BILL 1487 (Hill) Page
4
of appropriate treatments, in the event the recipient
tests reactive for HIV or HTLV following insemination.
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.
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.
Adds an urgency clause, to take effect immediately in order
to help prevent the spread of HIV.
Changes statutory references from HTLV-1 to HTLV, and makes
other technical changes.
FISCAL IMPACT
This bill has not been analyzed by a fiscal committee.
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 (ART). 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 consistent with the terms
used in the field.
AB 1487, sponsored by ASRM, seeks to clarify these
ambiguities by specifying which medical professionals are
responsible for the care of an HIV/HTLV infected sperm
donor, and for the follow-up care of the recipient. The
bill also changes references to HTLV-1 to HTLV to be more
inclusive of both types of HTLV viruses that affect humans.
STAFF ANALYSIS OF ASSEMBLY BILL 1487 (Hill) Page
5
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 (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
who promote standards of health care and scholarship in the
field of reproductive medicine. ASRM has developed
STAFF ANALYSIS OF ASSEMBLY BILL 1487 (Hill) Page
6
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 1397 (Hill) of 2009 is nearly identical to this bill. It
was vetoed by the Governor with the message: "While I
support the intent of this bill, some provisions
inappropriately restrict the administrative and regulatory
authority of the Department of Public Health for adopting
or modifying the American Society for Reproductive Medicine
guidelines. I would be willing to reconsider a bill that
does not infringe on the Department's regulatory
authority."
Prior legislation
AB 995 (Block), Chapter 497, Statutes of 2009, exempts a
licensed physician or podiatrist acting within the scope of
his or her license and practicing in a lawful practice
setting who stores and uses a human cell, tissue, or
cellular- or tissue-based product that is either a medical
device or a biologic product, as defined, from tissue bank
licensure. To be eligible for this exemption, the bill
requires the entity where the physician or podiatrist
practices to notify the Department of Public Health of
STAFF ANALYSIS OF ASSEMBLY BILL 1487 (Hill) Page
7
specified information.
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 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 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
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
STAFF ANALYSIS OF ASSEMBLY BILL 1487 (Hill) Page
8
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 AB 1487 is needed to allow
HIV-discordant couples to 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.
PRIOR ACTIONS
This bill was substantively amended since it was
transferred to the Senate. Prior votes are not relevant.
COMMENTS
1. Amendments to address AB 1397 veto message. When AB
1397 was brought before the Senate Health Committee in
2009, the author agreed to amend the bill to allow for a
modified rule-making process to address the fact that the
DPH was behind in their promulgation of these regulations.
The regulations were originally due to be adopted in
January 2010, but it is unclear how far the department has
gotten in their development of these regulations.
Regulations can generally take anywhere from two to three
years to complete. The modified process had been used
STAFF ANALYSIS OF ASSEMBLY BILL 1487 (Hill) Page
9
previously in other bills to expedite the often-lengthy
timeline of the regular rulemaking process, and has been
included in a number of other bills in the 2009-10 Session
that the committee has heard, including SB 975 (Price), SB
1332 (Dutton), and AB 995 (Block).
As staff understands the veto message, the administration's
concern was that AB 1397 as written would have limited
DPH's authority to modify or add to the ASRM guidelines.
The author's intent is to address the governor's concern,
however staff suggest additional amendments in the mock-up
below to reflect this.
2. Additional clarifications. In addition, the committee
suggests other clarifications to ensure the department can
effectively utilize the expedited rulemaking process, and
extending the deadline for the regulations to be adopted,
which are also included in this mock-up.
Mock -up of suggested amendments:
(Beginning page 4, line 30)
(ii) Not later than January 1, 2010 2014, the department
shall adopt regulations regulating facilities that perform
sperm processing, pursuant to this subparagraph, that
prescribe standards for the handling and storage of sperm
samples of carriers of HIV, HTLV, or any other virus as
deemed appropriate by the department. The department may
propose to adopt, as initial regulations, guidelines made
by the American Society for Reproductive Medicine. Notice
of the department's proposed adoption of the regulations
shall be posted on the department's Internet Web site for
at least 45 days. Public comment shall be accepted by the
department for at least 30 days after the conclusion of the
45-day posting period posting of the notice . If a member of
the public requests a public hearing during the 30-day
comment period, the hearing shall be held prior to the
adoption of the regulations. If no member of the public
requests a public hearing, the regulations will be deemed
adopted at the conclusion of the 30 day public comment
period. Comments received shall be considered prior to the
adoption of the final initial regulations. The department
may modify any guidance published by the American Society
for Reproductive Medicine based on the comments received .
Adoption of initial regulations by the department pursuant
STAFF ANALYSIS OF ASSEMBLY BILL 1487 (Hill) Page
10
to this subdivision shall not be subject to the rulemaking
requirements of Chapter 3.5 (commencing with Section 11340)
of Part 1 of Division 3 of Title 2 of the Government Code
and written responses to public comments shall not be
required. Updates to the regulations shall be adopted
pursuant to the same process. Until the department adopts
these regulations, facilities that perform sperm processing
pursuant to this section shall follow facility and sperm
processing guidelines for the reduction of viral
transmission developed by the American Society for
Reproductive Medicine. Nothing in this section shall
prevent the department from monitoring and inspecting
facilities that process sperm to ensure adherence to the
regulations, or, until regulations are adopted, to the
guidelines set forth by the American Society for
Reproductive Medicine.
3. Double referral. This bill has been double referred to
the Judiciary Committee.
POSITIONS
Support: American Society for Reproductive Medicine
Oppose: None received
-- END --