BILL ANALYSIS
AB 1397
Page 1
GOVERNOR'S VETO
AB 1397 (Hill)
As Amended August 17, 2009
2/3 vote
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|ASSEMBLY: |79-0 |(June 1, 2009) |SENATE: |31-0 |(September 1, |
| | | | | |2009) |
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|ASSEMBLY: |78-0 |(September 3, | | | |
| | |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 follow-up 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 follow-up of
the recipient. Requires the physician to recommend follow-up
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
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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
require 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 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.
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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 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.
GOVERNOR'S VETO 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
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American Society for Reproductive Medicine guidelines.
"I would be willing to reconsider a bill that does not infringe on
the Department's regulatory authority."
Analysis Prepared by : Allegra Kim / HEALTH / (916) 319-2097 FN:
0003384