BILL ANALYSIS ------------------------------------------------------------ |SENATE RULES COMMITTEE | AB 1487| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ------------------------------------------------------------ THIRD READING Bill No: AB 1487 Author: Hill (D), et al Amended: 8/10/10 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 from January 1, 2010, 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, and requires testing for evidence of infection with human T lymphotrophic virus (HTLV) only in tissues that are rich in viable leukocytes. Senate Floor Amendments of 8/10/10 remove "tissue or organ" CONTINUED AB 1487 Page 2 from the definition of tissue, specify that tissues rich in viable leukocytes shall be tested for HTLV, and name spouses, partners, or designated donors, as donors whose sperm has tested reactive for HIV or HTLV. ANALYSIS : Existing law: 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 CONTINUED AB 1487 Page 3 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 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. Defines "tissue" as a human cell, group of cells, including the cornea, sclera, or vitreous humor and other segments of , or the whole eye, bones, skin, arteries, sperm, blood, other fluids, and any other portion of a human body. 2. Allows DPH to use a modified expedited rulemaking process to adopt regulations to regulate facilities that CONTINUED AB 1487 Page 4 perform sperm processing. 3. 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. 4. Extends, until January 1, 2014 from January 1, 2010, 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. 5. 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 recommendations made within the "Guidelines for Reducing the Risk of Viral Transmission During Fertility Treatment" published by the American Society for Reproductive Medicine regarding follow-up testing for HIV and HTLV after use of sperm from an HIV or HTLV reactive donor and have the recommendations regarding follow-up testing be documented in the recipient's medical record. 6. 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 CONTINUED AB 1487 Page 5 recipient of appropriate treatments, in the event the recipient tests reactive for HIV or HTLV following insemination. 7. 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. 8. 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. 9. Requires testing for evidence of infection with HTLV only in tissues that are rich in viable leukocytes. 10.Changes statutory references from HTLV-1 to HTLV, and 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 CONTINUED AB 1487 Page 6 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 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 CONTINUED AB 1487 Page 7 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 8/11/10) American Society for Reproductive Medicine (source) American Society of Tissue Banks ARGUMENTS IN SUPPORT : The bill's sponsor, ASRM, claims that this bill is needed to allow HIV-discordant couples to 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 CONTINUED AB 1487 Page 8 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 8/11/10 Senate Floor Analyses SUPPORT/OPPOSITION: SEE ABOVE **** END **** CONTINUED