BILL ANALYSIS                                                                                                                                                                                                    



                                                                       



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          |SENATE RULES COMMITTEE            |                  AB 1487|
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                                 THIRD READING


          Bill No:  AB 1487
          Author:   Hill (D), et al
          Amended:  6/14/10 in Senate
          Vote:     27 - Urgency

           
           SENATE HEALTH COMMITTEE  :  5-0, 6/9/10
          AYES:  Alquist, Cedillo, Leno, Negrete McLeod, Pavley
          NO VOTE RECORDED:  Strickland, Aanestad, Cox, Romero
           
          SENATE APPROPRIATIONS COMMITTEE  :  Senate Rule 28.8

           ASSEMBLY FLOOR  :  74-0, 5/18/09 - See last page for vote


           SUBJECT  :    Tissue donation

           SOURCE  :     American Society for Reproductive Medicine


           DIGEST  :    This bill amends existing guidelines that must  
          be adhered to between a physician who is providing  
          insemination, and other advanced reproductive technology  
          services, and a female patient.  This bill extends, until  
          January 1, 2014, the date for adopting regulations and  
          allows the Department of Public Health to adopt initial  
          regulations based on the "Guidelines for Reducing Risk of  
          Viral Transmission During Fertility Treatment" using a  
          specified process.

           ANALYSIS  :    

          Existing law:
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          1. 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 infection, and other diseases. 

          2. 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.

          3. 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. 

          4. 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. 

          5. 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. 

          6. Requires that, until DPH adopts these regulations,  
             facilities that perform sperm processing shall follow  
             facility and sperm processing guidelines developed by  
             the ASRM. 

          7. 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. 

          8. 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  







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             may have adverse effects on the sperm, and that sperm  
             may be tested to determine whether it is reactive for  
             HIV or HTLV.

          9. Requires the physician to provide prophylactic  
             treatments to the recipient, including, but not limited  
             to, antiretroviral treatments to reduce the risk of  
             acquiring 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. 

          10.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.

          11.Provides that DPH may adopt regulations requiring  
             additional screening tests of donors of tissue.  

          This bill:

          1. Allows DPH to use a modified expedited rulemaking  
             process to adopt regulations to regulate facilities that  
             perform sperm processing.  

          2. 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.

          3. Extends, until January 1, 2014, the date for adopting  
             regulations and allows DPH to adopt initial regulations  
             based on the "Guidelines for Reducing Risk of Viral  
             Transmission During Fertility Treatment" using a  
             specified process.








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          4. Requires the physician providing insemination or  
             assistive reproductive technology to notify the  
             recipient of the following:

             A.    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. 

             B.    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. 

          5. Deletes the following:

             A.    The requirement that physicians inform the  
                recipient of potential adverse effects the testing  
                may have on processed sperm. 

             B.    The requirement that physicians provide  
                prophylactic treatments and follow-up testing  
                following insemination.

             C.    The requirement that the physician inform the  
                recipient of appropriate treatments, in the event the  
                recipient tests reactive for HIV or HTLV following  
                insemination.

          6. 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. 

          7. 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. 

          8. Changes statutory references from HTLV-1 to HTLV, and  







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             makes other technical changes.

           NOTE:  This bill is virtually identical to last year's AB  
                 1397 (Hill), which passed the Senate (31-0), but was  
                 vetoed by the Governor.  In his veto message, the  
                 Governor expressed concern that "some provisions  
                 inappropriately restrict the administrative and  
                 regulatory authority the Department of Public  
                 Health."  The author's office maintains that the  
                 current version of AB 1487 addresses those concerns.  


           Background

          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 or in  
          vitro fertilization.  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  







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          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. 

           ASRM  .  The 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 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 transmissible 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.

           FISCAL EFFECT  :    Appropriation:  No   Fiscal Com.:  Yes    
          Local:  No

           SUPPORT  :   (Verified  6/29/10)

          American Society for Reproductive Medicine (source)


           ARGUMENTS IN SUPPORT  :    The bill's sponsor, ASRM, claims  
          that this bill is needed to allow HIV-discordant couples to  







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          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.


           ASSEMBLY FLOOR  : 
          AYES:  Adams, Ammiano, Anderson, Arambula, Beall, Bill  
            Berryhill, Tom Berryhill, Blakeslee, Block, Blumenfield,  
            Brownley, Buchanan, Caballero, Charles Calderon, Chesbro,  
            Conway, Cook, Coto, Davis, De La Torre, De Leon, DeVore,  
            Duvall, Emmerson, Evans, Feuer, Fletcher, Fong, Fuentes,  
            Fuller, Furutani, Gaines, Galgiani, Garrick, Gilmore,  
            Hagman, Hall, Harkey, Hayashi, Hernandez, Hill, Huber,  
            Huffman, Jeffries, Jones, Knight, Krekorian, Lieu, Logue,  
            Bonnie Lowenthal, Ma, Mendoza, Miller, Monning, Nava,  
            Nestande, Niello, Nielsen, John A. Perez, V. Manuel  
            Perez, Portantino, Ruskin, Salas, Silva, Smyth, Solorio,  
            Audra Strickland, Swanson, Torlakson, Torres, Torrico,  
            Tran, Villines, Bass
          NO VOTE RECORDED:  Carter, Eng, Price, Saldana, Skinner,  
            Yamada


          CTW:mw  6/29/10   Senate Floor Analyses 

                         SUPPORT/OPPOSITION:  SEE ABOVE

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