BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                      



           ------------------------------------------------------------ 
          |SENATE RULES COMMITTEE            |                  AB 2356|
          |Office of Senate Floor Analyses   |                         |
          |1020 N Street, Suite 524          |                         |
          |(916) 651-1520         Fax: (916) |                         |
          |327-4478                          |                         |
           ------------------------------------------------------------ 
           
                                         
                                 THIRD READING


          Bill No:  AB 2356
          Author:   Skinner (D)
          Amended:  8/22/12 in Senate
          Vote:     21

           
           SENATE HEALTH COMMITTEE  :  6-2, 6/27/12
          AYES:  Hernandez, Alquist, Blakeslee, DeSaulnier, Rubio, 
            Wolk
          NOES:  Harman, Anderson
          NO VOTE RECORDED:  De León

           SENATE JUDICIARY COMMITTEE  :  4-1, 7/3/12
          AYES:  Evans, Blakeslee, Corbett, Leno
          NOES:  Harman

           ASSEMBLY FLOOR  :  50-24, 5/31/12 - See last page for vote


           SUBJECT  :    Tissue donation

           SOURCE  :     Equality California
                      National Center for Lesbian Rights


           DIGEST  :    This bill permits the recipient of sperm donated 
          by her sexually intimate partner (SIP) for reproductive use 
          to waive a second or repeat testing of that donor for human 
          immunodeficiency virus (HIV), agents of viral hepatitis 
          (HBV and HCV), syphilis, and human T lymphotropic virus 
          (HTLV), if the recipient is informed of existing donor 
          testing requirements and signs a written waiver.  This bill 
          exempts physicians, clinical laboratories, or tissue banks 
                                                           CONTINUED





                                                               AB 2356
                                                                Page 
          2

          that provide insemination or assisted reproductive 
          technology services from liability and disciplinary 
          actions, as specified.

           Senate Floor Amendments  of 8/22/12 are technical and 
          clarifying.

           ANALYSIS  :    Existing federal law:

          1.Establishes procedures to prevent the introduction, 
            transmission, and spread of communicable diseases by 
            human cells, tissues, and cellular and tissue-based 
            products (HCT/Ps).

          2.Defines HCT/Ps as articles containing or consisting of 
            human cells or tissues that are intended for 
            implantation, transplantation, infusion, or transfer into 
            a human recipient, including semen or other reproductive 
            tissue.

          3.Requires a donor-eligibility determination, based on 
            donor screening and testing for relevant communicable 
            disease agents and diseases, for all donors of cells and 
            tissues used in HCT/Ps, and prohibits the implantation, 
            transplantation, infusion, or transfer of HCT/Ps until 
            the donor has been determined to be eligible, with 
            specified exemptions.

          4.Requires, before the completion of a donor-eligibility 
            determination:

             A.   Screening a donor's medical records for specified 
               risk factors for, and clinical evidence of, relevant 
               communicable disease agents and diseases;

             B.   Keeping semen from anonymous donors quarantined for 
               at least six months after the date of donation. 
               Defines quarantine as the storage or identification of 
               an HCT/P, to prevent improper release, in a physically 
               separate area clearly identified for such use, or 
               through other procedures, such as automated 
               designation; and

             C.   Retesting of anonymous semen donors by collecting a 

                                                           CONTINUED





                                                               AB 2356
                                                                Page 
          3

               new specimen from the donor and testing it for 
               evidence of infection due to HIV, HBV and HCV, 
               syphilis, and HTLV.

          1.Exempts from specified donor eligibility requirements and 
            HCT/P-use prohibitions:

             A.   Cells and tissue for autologous use;

             B.   Reproductive cells or tissue donated by a SIP of 
               the recipient for reproductive use; and

             C.   Cryopreserved cells or tissue for reproductive use, 
               as specified;

          1.Authorizes the Food and Drug Administration (FDA) to 
            regulate establishments that engage in the manufacture of 
            HCT/Ps, including any individual, partnership, 
            corporation, association, or other legal entity engaged 
            in the manufacture of HCT/Ps.

          Existing state law:

          1.Prohibits the transfer of any tissues into the body of 
            another person by means of transplantation, unless the 
            donor of the tissues has been screened and found 
            nonreactive by laboratory tests for evidence of infection 
            with HIV, HBV, HCV, syphilis, and HTLV, with specified 
            exemptions.

          2.Permits a recipient of sperm, from a sperm donor known to 
            the recipient, to waive a second or other repeat testing 
            of that donor if the recipient is informed of specified 
            requirements for testing donors and signs a written 
            waiver.

          3.Permits a recipient of sperm to consent to therapeutic 
            insemination of sperm or use of sperm in other advanced 
            reproductive technology services even if the sperm donor 
            is found reactive for HIV, HBV, HCV, syphilis, or HTLC if 
            the sperm donor is the spouse of, partner of, or 
            designated donor for that recipient. Requires the 
            physician providing insemination or advanced reproductive 
            technology services to advise the donor and recipient of 

                                                           CONTINUED





                                                               AB 2356
                                                                Page 
          4

            the potential medical risks associated with receiving 
            sperm from a reactive donor; and further requires the 
            donor and recipient to sign a document, to be placed in 
            the medical records of each, affirming that each 
            comprehends the potential medical risks of using sperm 
            from a reactive donor for the proposed procedure and that 
            each consents to it.

          4.Permits sperm whose donor has tested reactive for HIV, 
            HBV, HCV, syphilis, or HTLC to be used for the purposes 
            of insemination or advanced reproductive technology 
            services only after specified requirements are met.

          5.Authorizes the Department of Public Health (DPH) to 
            regulate the transfer of tissues into the body of another 
            person.

          6.Requires DPH to, not later than January 1, 2014, adopt 
            regulations regulating facilities that perform sperm 
            processing to minimize the infectiousness of sperm from a 
            donor who has tested reactive to HIV or HTLV, as 
            specified, and requires facilities that perform this 
            sperm processing to follow facility and sperm processing 
            guidelines for the reduction of viral transmission 
            developed by the American Society for Reproductive 
            Medicine (ASRM).

          This bill:

          1.Permits the recipient of sperm donated by her SIP for 
            reproductive use to waive a second or repeat testing of 
            that donor for HIV, HBV, HCV, syphilis, and HTLV, if the 
            recipient is informed of existing donor testing 
            requirements and signs a written waiver.

          2.Defines, for the purposes of this bill, "SIP of the 
            recipient" to include a known or designated donor to 
            whose sperm the recipient has previously been exposed in 
            a nonmedical setting in an attempt to conceive.

          3.Exempts a physician, when the physician provides 
            insemination or assisted reproductive technology services 
            and has obtained the informed consent of the recipient, 
            who acknowledges and accepts the risks of using sperm 

                                                           CONTINUED





                                                               AB 2356
                                                                Page 
          5

            that has not undergone quarantine and repeat testing, as 
            specified, from the following:

             A.   Liability for damages for any cause of action based 
               solely on the use of sperm donated by a SIP of the 
               recipient; and

             B.   Disciplinary action against his or her professional 
               license and peer review by a professional organization 
               peer review body, as defined.

          1.Exempts a clinical laboratory or tissue bank that is 
            owned and operated by a physician and/or tissue bank from 
            disciplinary action against its license because of the 
            use of sperm donated by a SIP of the recipient in 
            providing insemination or assisted reproductive 
            technology services when any physician affiliated with 
            the clinical laboratory or tissue bank has obtained the 
            informed consent of the recipient, who acknowledges and 
            accepts the risks of using sperm that has not undergone 
            quarantine and repeat testing, as specified.

          2.Prohibits anything in this bill from creating a duty for 
            a physician to use sperm donated by a recipient's SIP in 
            providing insemination or assisted reproductive 
            technology services if the physician reasonably concludes 
            that the insemination or services do not meet the 2008 
            ASRM guidelines for gamete and embryo donation.

          3.Prohibits anything in this bill from being construed to 
            affect any liability that may be imposed pursuant to 
            federal rule or regulation when a physician, clinical 
            laboratory, or tissue bank provides insemination or 
            assisted reproductive technology services.

           Background
           
           Infertility treatment  .  According to the federal Centers 
          for Disease Control and Prevention's (CDC) website, 
          infertility can be treated with medicine, surgery, 
          artificial insemination, assisted reproductive technology 
          (ART), or a combination of these treatments.  Intrauterine 
          insemination, often called artificial insemination, is a 
          procedure in which the woman is injected with specially 

                                                           CONTINUED





                                                               AB 2356
                                                                Page 
          6

          prepared sperm.  ART is a group of different methods that 
          includes all fertility treatments in which both eggs and 
          sperm are handled. In general, ART procedures involve 
          surgically removing eggs from a woman's ovaries, combining 
          them with sperm in the laboratory, and returning them to a 
          woman's body or donating them to another woman (for 
          example, in vitro fertilization).  Today, over one percent 
          of infants born in the United States every year are 
          conceived using ART.  A woman's age affects the success 
          rate of ART; according to CDC's 2010 Preliminary ART 
          Success Rates, the average percentage of ART cycles that 
          led to a live birth decreased from 42 percent in women 
          younger than 35 to 5 percent in women ages 43 and 44.

           Sexually transmitted infections (STIs).   According to the 
          2008 "Guidelines for reducing the risk of viral 
          transmission during fertility treatment" produced by ASRM's 
          Practice Committee (ASRM Guidelines), the most serious 
          pathogens are HIV, HBV, and HCV, which may cause incurable, 
          often fatal, infections, have been transmitted through ART 
          and insemination procedures, and can be transmitted from 
          infected mothers to the fetus or newborn.  HTLV is another 
          common sexually transmitted virus.  The Ethics Committee of 
          ASRM has stated that fertility services cannot be withheld 
          ethically from individuals with chronic viral infections, 
          including HIV, in a center that has the resources to 
          provide care.  Those centers that do not have the resources 
          or facilities to provide care should facilitate referral to 
          a center with protocols in place to manage such patients. 
          The ASRM Guidelines provide strategies, based on scientific 
          principles and clinical experience, for reducing the risk 
          of virus transmission in couples seeking treatment from 
          fertility clinics.  Recommendations are based on reducing 
          viral load in infected partner(s), reducing exposure and 
          susceptibility of a noninfected partner, and frank, 
          detailed discussions of available scientific evidence and 
          risk-reduction strategies to provide a basis for informed 
          consent. 

           Sperm donation  .  The Society for Assisted Reproductive 
          Technology (SART), whose membership according to its 
          website includes more than 85 percent of the ART clinics in 
          the country and 55 clinics in California, along with its 
          affiliate, ASRM, offers guidelines for sperm donation in 

                                                           CONTINUED





                                                               AB 2356
                                                                Page 
          7

          the "2008 Guidelines for gamete and embryo donation" 
          (ASRM/SART Guidelines). Recommended laboratory tests 
          include those for HIV, HBV, HCV, syphilis, and HTLV.  The 
          ASRM/SART Guidelines make specific recommendations for 
          anonymous donation, directed (non-anonymous or known) 
          donation, and sexually intimate couples. Anonymous donors 
          should be tested, as specified by the FDA, for determining 
          donor eligibility; if testing is negative, semen samples 
          should be collected, cryopreserved, and quarantined for a 
          minimum of 180 days, after which the donors should be 
          retested, and if again found negative, the samples can be 
          released.  Directed donors should undergo the same 
          screening and testing as anonymous donors, and directed 
          donor specimens should be treated in the same manner as 
          anonymous donor specimens despite being exempt from 
          quarantine under FDA guidelines.  Viral testing for SIPs 
          undergoing fertility treatment is recommended to help 
          ensure that appropriate precautions are taken to minimize 
          risk of viral transmission to partners and offspring, 
          despite the absence of FDA or legal requirements. 

           Pending sperm donation investigation  .  Recent reports in 
          the Los Angeles Times and San Francisco Chronicle describe 
          the case of an individual residing in Fremont, California, 
          who has donated sperm for free to at least 46 women he has 
          met on the internet since December 2006.  On November 1, 
          2010, the FDA issued an Order to Cease Manufacturing of 
          HCT/Ps to the individual, citing an inspection of his home 
          that revealed significant violations of regulations 
          regarding failures to provide adequate protections against 
          the risks of communicable disease transmission, including 
          HIV, HBV, HCV, and HTLV.  Critical to the case is the 
          whether the individual is considered a SIP, which would 
          determine whether he is exempt from donor eligibility 
          requirements.  The case is pending, and the individual 
          potentially faces a $100,000 fine or up to a year in 
          prison.  The FDA has not defined the term SIP nor given an 
          indication that it plans to do so in the future.

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

           SUPPORT  :   (Verified  8/22/12)


                                                           CONTINUED





                                                               AB 2356
                                                                Page 
          8

          Equality California (co-source) 
          National Center for Lesbian Rights (co-source) 
          Betty T. Yee, First District Member, Board of Equalization
          ACLU of California
          ACLU, Paul Robeson Chapter
          American Federation of State, County and Municipal 
          Employees, AFL-CIO
          API Equality-Northern California
          Asian & Pacific Islander Wellness Center
          At Home Fertility 
          California Medical Association
          Colage
          GroundSpark
          Kaiser Permanente
          L.A. Gay & Lesbian Center
          Laparoscopic Institute for Gynecologic Oncology
          MAIA Midwifery & Fertility Services, LLC
          Our Family Coalition
          Rainbow Flag Health Services
          Somos Familia
          Tres Lunas Midwifery 

           OPPOSITION  :    (Verified  8/22/12)

          California Right to Life Committee, Inc.

           ARGUMENTS IN SUPPORT  :    Equality California, the National 
          Center for Lesbian Rights, and other organizations state 
          that a disparity arises between different-sex couples and 
          same-sex couples or single women using known donors when 
          they seek fertility services in a medical setting after 
          failed attempts to conceive at home.  Whereas different-sex 
          couples are permitted to use fresh sperm to inseminate when 
          using fertility services, all other women must typically 
          have their donor's sperm frozen and quarantined for up to 
          six months to allow for repeated donor screening for STIs, 
          yet women who have attempted to inseminate at home with a 
          designated donor are exposed to exactly the same risk of 
          disease transmission as women who have sex with male 
          partners to conceive. The process of freezing and 
          quarantining sperm significantly reduces the chances of 
          achieving pregnancy and often means that conception is not 
          possible without much more expensive procedures.  These 
          supporters state that this bill would address the situation 

                                                           CONTINUED





                                                               AB 2356
                                                                Page 
          9

          by providing that an exception is made to screening 
          requirements when sperm is donated by a SIP, and would 
          benefit many women each year who are seeking access to 
          fertility services.  The California Medical Association 
          indicates that this bill not only provides equal access to 
          fertility treatment but also puts in place appropriate 
          standards to protect both the patient and the providers.  

          ARGUMENTS IN OPPOSITION  :    The California Right to Life 
          Committee believes that this bill is not good public health 
          policy and sets a precedent for other exemptions in the 
          future which might be deleterious to women. 
          

           ASSEMBLY FLOOR  : 50-24, 05/31/12
          AYES: Alejo, Allen, Ammiano, Atkins, Beall, Block, 
            Blumenfield, Bonilla, Bradford, Brownley, Buchanan, 
            Butler, Campos, Carter, Cedillo, Chesbro, Davis, 
            Dickinson, Eng, Feuer, Fong, Fuentes, Furutani, Galgiani, 
            Gatto, Gordon, Hall, Hayashi, Roger Hernández, Hill, 
            Huber, Hueso, Huffman, Lara, Bonnie Lowenthal, Ma, 
            Mitchell, Monning, Pan, Perea, V. Manuel Pérez, 
            Portantino, Skinner, Solorio, Swanson, Torres, 
            Wieckowski, Williams, Yamada, John A. Pérez
          NOES: Achadjian, Bill Berryhill, Conway, Cook, Donnelly, 
            Beth Gaines, Garrick, Gorell, Grove, Hagman, Halderman, 
            Harkey, Jeffries, Jones, Knight, Logue, Miller, Morrell, 
            Nestande, Nielsen, Olsen, Silva, Smyth, Wagner
          NO VOTE RECORDED: Charles Calderon, Fletcher, Mansoor, 
            Mendoza, Norby, Valadao


          CTW:n  8/23/12   Senate Floor Analyses 

                         SUPPORT/OPPOSITION:  SEE ABOVE

                                ****  END  ****








                                                           CONTINUED