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: 8/24/12 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 or tissue banks that provide CONTINUED AB 2356 Page 2 insemination or assisted reproductive technology services from liability and disciplinary actions, as specified. Senate Floor Amendments of 8/24/12 strike the term "clinical laboratories." 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 CONTINUED AB 2356 Page 3 C. Retesting of anonymous semen donors by collecting a 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 CONTINUED AB 2356 Page 4 physician providing insemination or advanced reproductive technology services to advise the donor and recipient of 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 CONTINUED AB 2356 Page 5 and 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, 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 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 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 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 CONTINUED AB 2356 Page 6 procedure in which the woman is injected with specially 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 CONTINUED AB 2356 Page 7 affiliate, ASRM, offers guidelines for sperm donation in 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 8/27/12) 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 and Fertility Services, LLC Our Family Coalition Rainbow Flag Health Services Somos Familia Tres Lunas Midwifery OPPOSITION : (Verified 8/27/12) 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 CONTINUED AB 2356 Page 9 supporters state that this bill would address the situation 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, 5/31/12 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 8/27/12 Senate Floor Analyses SUPPORT/OPPOSITION: SEE ABOVE **** END **** CONTINUED