BILL ANALYSIS
AB 1397
Page 1
CONCURRENCE IN SENATE AMENDMENTS
AB 1397 (Hill)
As Amended August 17, 2009
2/3 vote. Urgency
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|ASSEMBLY: |79-0 |(June 1, 2009) |SENATE: |31-0 |(September 1, |
| | | | | |2009) |
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Original Committee Reference: HEALTH
SUMMARY : Requires a physician providing insemination and
advanced reproductive technologies (ART) to inform the recipient
that she must document that she is under the ongoing care of a
physician, and clarifies that a physician providing insemination
or ART is not responsible for prophylactic testing, monitoring,
and followup of the recipient.
The Senate amendments :
1)Require a physician providing ART to inform a patient that she
must document that she has a physician to provide care during
and after her fertility services, and about guidelines for
testing after a donation from a donor who has tested positive
for human immunodeficiency virus (HIV) or human T-cell
lymphotropic virus (HTLV).
2)Clarify that a physician providing insemination or ART is not
responsible for prophylactic testing, monitoring, and followup
of the recipient. Requires the physician to recommend
followup testing for HIV or HTLV.
3)Restore the existing requirements that the Department of
Public Health (DPH), by January 1, 2010, adopt regulations
prescribing sperm processing facilities' handling and storage
of sperm from donors who are carriers of HIV, HTLV-I, or any
other virus DPH deems appropriate, and that sperm processing
facilities follow American Society of Reproductive Medicine
(ASRM) guidelines until DPH adopts regulations.
4)Authorize DPH to adopt ASRM guidelines as initial regulations
and requires DPH to post notice of the proposal for 45 days on
the DPH Web site, accept public comments for at least 30 days
after posting the notice, and, if requested, hold a public
AB 1397
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hearing prior to the adoption of regulations. Authorizes DPH
to modify ASRM guidelines based on comments received.
5)Exempts adoption of regulations for sperm processing
facilities from requirements for written responses to public
comments and the Administrative Procedure Act.
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,
as specified.
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.
AS PASSED BY THE ASSEMBLY , this bill authorized DPH to adopt
regulations for facilities that perform sperm processing for
insemination and ART; and, revised provisions related to the use
of sperm from donors infected with HIV and HTLV to include all
HTLV types.
FISCAL EFFECT : According to the Senate Appropriations
Committee, pursuant to Senate Rule 28.8, negligible state costs.
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
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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 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 processing of sperm from a donor testing reactive for HIV or
HTLV 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
studies report that the sperm-washing process reduces HIV levels
in sperm, and the technology and procedures continue to improve.
Analysis Prepared by : Allegra Kim / HEALTH / (916) 319-2097
FN: 0002407