BILL ANALYSIS ------------------------------------------------------------ |SENATE RULES COMMITTEE | SB 962| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ------------------------------------------------------------ UNFINISHED BUSINESS Bill No: SB 962 Author: Migden (D) Amended: 9/7/07 Vote: 21 SENATE HEALTH COMMITTEE : 6-3, 4/18/07 AYES: Kuehl, Alquist, Cedillo, Ridley-Thomas, Steinberg, Yee NOES: Aanestad, Cox, Wyland NO VOTE RECORDED: Maldonado, Negrete McLeod SENATE JUDICIARY COMMITTEE : 3-2, 4/24/07 AYES: Corbett, Kuehl, Steinberg NOES: Harman, Ackerman SENATE APPROPRIATIONS COMMITTEE : 10-6, 5/31/07 AYES: Torlakson, Cedillo, Corbett, Florez, Kuehl, Oropeza, Ridley-Thomas, Simitian, Steinberg, Yee NOES: Cox, Aanestad, Ashburn, Dutton, Runner, Wyland NO VOTE RECORDED: Battin SENATE FLOOR : 25-14, 6/6/07 AYES: Alquist, Calderon, Cedillo, Corbett, Ducheny, Florez, Kehoe, Kuehl, Lowenthal, Machado, Margett, Migden, Negrete McLeod, Oropeza, Padilla, Perata, Ridley-Thomas, Romero, Scott, Simitian, Steinberg, Torlakson, Vincent, Wiggins, Yee NOES: Aanestad, Ackerman, Ashburn, Cogdill, Correa, Cox, Denham, Dutton, Harman, Hollingsworth, Maldonado, McClintock, Runner, Wyland NO VOTE RECORDED: Battin CONTINUED SB 962 Page 2 ASSEMBLY FLOOR : 61-13, 9/10/07 - See last page for vote SUBJECT : Umbilical cord blood: research SOURCE : American Association of University Women Planned Parenthood Affiliates of California DIGEST : This bill requires the Department of Public Health, as part of the Hereditary Disorders Act, to provide umbilical cord blood samples to the Birth Defect Monitoring Program, for storage and research. Makes legislative findings and declarations, as specified Assembly Amendments removed the Umbilical Cord Blood Biomedical Resources Birth Defects Monitoring Program Fund and related provisions, and re-established the Birth Defects Monitoring Program Fund that is in current law. Amendments also clarified that cord blood research is a donation option for pregnant women, required researchers to pay the state for use of cord blood and other blood samples and gave the state options to address the initial start-up cost of the research program. ANALYSIS : Existing law: 1.Governs the licensure of blood banks, including licensure or accreditation for purposes of umbilical cord blood banking, as specified. 2.Specifies that implementation of all provisions relating to umbilical cord blood banking are implemented when the Director of the Department of Finance has determined that sufficient private donations have been collected and deposited into the Umbilical Cord Blood Education Account. This bill requires the Department of Public Health (DPH), as part of the Hereditary Disorders Act, to provide umbilical cord blood samples to the Birth Defect Monitoring Program (BDMP), for storage and research. CONTINUED SB 962 Page 3 This bill: 1. Adds to the information that the Department of Health Services (DHS) is required to develop and to inform pregnant women about the possible uses of umbilical cord blood, and specifies that these options must be outlined in the DPH information: a) discard the umbilical cord blood, b) donate the umbilical cord blood to a public umbilical cord blood bank, or, c) store the umbilical cord blood in a family umbilical cord blood bank for use by immediate and extended family members. Expands the languages in which DHS is required to provide this information to women, and requires DHS to update this information as needed. 2. Revises current law to authorize a primary prenatal care provider to provide a woman on her first prenatal care visit, information regarding the options described in #1) above to her for the disposition of her umbilical cord blood at the end of her pregnancy. 3. Requires DPH to provide any umbilical cord blood samples it receives to BDMP for storage and research. 4. Requires that all information collected pursuant to BDMP be confidential and used solely for the purposes of BDMP. Prohibits the disclosure of confidential information beyond BDMP. Requires that access to confidential information be limited to authorized persons who agree, in writing, to maintain confidentiality. Provides penalties, as specified, for any unauthorized disclosure of confidential information. 5. Requires that disclosure of confidential information is permitted only with written agreement that the information be kept confidential and not further disclosed. Requires that DPH maintain an accurate record of all persons who receive confidential information, and to whom there has been the disclosure of confidential information. 6. Requires DPH to establish fees to cover administrative CONTINUED SB 962 Page 4 costs to BDMP, to be collected from researchers and health care providers approved by DPH who seek to use umbilical cord blood samples for research. 7. Requires fees collected as provided in #6) above be deposited in the BDMP Fund, which is also created by this bill. Requires that moneys in this special program fund be used for costs related to this bill, including data management, linkage and entry, and umbilical cord blood storage, retrieval, processing, inventory, and shipping. 8. Requires DPH to adopt rules and regulations pursuant to existing requirements in the BDMP statutes. 9. Requires DPH, health care providers, and local health departments to maintain the confidentiality of patient information in accordance with existing law and in the same manner as other medical record information with patient identification that they possess and to use the information only for the following research purposes: A. To identify risk factors for children's and women's disease. B. To develop and evaluate screening tests. C. To develop and evaluate prevention strategies; and. D. To develop and evaluate treatments. 1. Requires that the State Committee for the Protection of Human Subjects, prior to the release of any personal information associated with BDMP samples from DPH for research purposes, to: A. Determine whether the requested personal information is needed to conduct the research. B. Permit access to personal information only if it is needed for the research activity. C. Permit access only to the minimum necessary personal information needed for the research activity. CONTINUED SB 962 Page 5 D. Require the assignment of unique subject codes that are not derived from personal information in lieu of social security numbers if the research can still be conducted without social security numbers. E. If feasible, and if cost, time, and technical expertise permit, require the agency to conduct a portion of the data processing for the researcher to minimize the release of personal information. 1. Authorizes DPH to bill an investigator for the costs associated with DPH's process of protecting personal information. 2. States that nothing in this bill prohibits DPH from using its existing authority to enter into written agreements to enable other institutional review boards to approve research activities, projects or classes of projects for DPH, provided the data security requirements set forth in this bill are satisfied. 3. Conditions enactment of this bill on AB 34 (Portantino) and becomes operative on or before January 1, 2008. Background In December 2005, the federal government enacted H.R. 2520, the Stem Cell Therapeutic and Research Act of 2005, which establishes a national umbilical cord blood program and provides federal funding to expand and administer cord blood transplants and research. Among the many provisions in that measure is a requirement that the Secretary of Health and Human Services, through a public process, examine the issues of informed consent, including the appropriate timing of such consent, and the information provided a donor regarding medically appropriate cord blood donation options. The National Institute of Medicine (IOM) recommends that women be provided with balanced and clear information in order to actively and knowledgeably participate in the choice of whether or how to donate cord blood, with informed consent procedures. The IOM also recommends that appropriate measures should be taken to ensure the security, safety, and confidentiality of medical CONTINUED SB 962 Page 6 records, transplantable products, and patients. According to the Cord Blood Donor Foundation, "cord blood" (also known as "placental blood") is the blood that remains in the umbilical cord and placenta following birth and after the cord is cut. Newborn cord blood is recognized as a rich and powerful source of stem cells, which can be stored to retain their unique biological properties and before exposure to bacterial, viral, or other environmental factors. Stem cells recovered from umbilical cords can be used to treat as many as 70 blood diseases, including leukemia, myeloma and lymphoma; immunodeficiencies; and genetic diseases, including sickle cell anemia, thalassemia, inherited marrow failure disorders; and inherited disorders or errors of metabolisms. Comments This bill was significantly amended in the Assembly Rules Committee, the amendments incorporated key programmatic provisions of SB 164 (Migden). SB 164 requires DPH to establish the Birth Defects Monitoring and Biomedical Resources Program, for the purposes of creating an umbilical cord blood banking system that, along with prenatal genetic samples already collected by the BDMP, would provide one of the most comprehensive and genetically diverse databases of this nature for research and transplant resources available anywhere in the country. According to the author's office, the research provisions of SB 164 establish a database for research which will be a significant contribution to making available important material to the scientific community in search of the causes of genetic diseases and develop targeted treatment solutions and prevention strategies Prior Legislation SB 1555 (Speier), Chapter 484, Statutes of 2006 . Created the Maternal and Child Health Advancement Act, which provided, among other things, that in order to provide umbilical cord blood banking storage services, a blood bank shall be licensed to do so under current blood bank licensing law. In addition, SB 1555, provided that a primary prenatal care provider of a pregnant woman may, CONTINUED SB 962 Page 7 during the first prenatal visit, provide a pregnant woman with information developed by DHS regarding her options with respect to cord blood banking at the same time the provider provides required information regarding the use and availability of prenatal screening for birth defects of the fetus. Related Legislation AB 34 (Portantino) - 2007-08 Session . Requires DPH to establish, by July 1, 2009, the Umbilical Cord Blood Collection Program for the purpose of collecting and storing umbilical cord blood for public use. The bill also required DPH to contract with up to five blood banks that are licensed or accredited to provide umbilical cord blood banking storage services to collect, and make available to doctors and their patients, umbilical cord blood. FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes Local: Yes Major annual fee-supported special fund costs of $12 million to collect, screen, and store 12,000 cord blood samples. This assumes two percent of families delivering babies each year will request cord blood extraction pursuant to this bill at a cost of $1,000 per unit. Actual per unit collection costs range from below $1,000 to $2,000 depending on the volume of samples being processed. SUPPORT : (Verified 9/10/07) American Association of University Women (co-source) Planned Parenthood Affiliates of California (co-source) Asian American Donor Program California Catholic Conference Cord Blood Donor Foundation Cord Blood Registry Maternal, Child and Adolescent Director (MCAH Action, CA) National Marrow Donor Program Sickle Cell Disease Association of America, Inc. ASSEMBLY FLOOR : AYES: Aghazarian, Arambula, Bass, Beall, Berg, Berryhill, Blakeslee, Brownley, Caballero, Charles Calderon, Carter, CONTINUED SB 962 Page 8 Cook, Coto, Davis, De La Torre, De Leon, DeSaulnier, DeVore, Dymally, Emmerson, Eng, Evans, Feuer, Fuentes, Galgiani, Garcia, Hayashi, Hernandez, Horton, Houston, Huffman, Jones, Karnette, Keene, Krekorian, Laird, Leno, Levine, Lieber, Lieu, Ma, Mendoza, Mullin, Nakanishi, Nava, Niello, Parra, Plescia, Portantino, Price, Ruskin, Salas, Saldana, Smyth, Solorio, Spitzer, Swanson, Torrico, Tran, Wolk, Nunez NOES: Adams, Anderson, Benoit, Duvall, Fuller, Gaines, Huff, Jeffries, La Malfa, Maze, Silva, Villines, Walters NO VOTE RECORDED: Garrick, Hancock, Sharon Runner, Soto, Strickland, Vacancy AGB:nl 9/11/07 Senate Floor Analyses SUPPORT/OPPOSITION: SEE ABOVE **** END **** CONTINUED