BILL ANALYSIS SB 962 Page 1 Date of Hearing: July 3, 2007 ASSEMBLY COMMITTEE ON HEALTH Mervyn Dymally, Chair SB 962 (Migden) - As Amended: May 1, 2007 SENATE VOTE : 25-14 SUBJECT : Umbilical cord blood biomedical resources program. SUMMARY : Requires the Department of Public Health (DPH) to establish the Umbilical Cord Blood Biomedical Resources Program (UCBBRP) for the purpose of collecting, processing, and storing umbilical cord blood stem cells to be used for transplantation and research. Specifically, this bill : 1)Requires information about umbilical cord blood donation, which under existing law DPH is required to develop, to enable a pregnant woman to be informed of her option to do any of the following: a) Discard umbilical cord blood; b) Donate 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 the use by immediate and extended family members. 2)Permits public, as well as private funds, to be deposited into the Umbilical Cord Blood Education Account. 3)Requires DPH to establish the UCBBRP for the purpose of collecting, processing, and storing umbilical cord blood stem cells to be used for transplantation and research. Requires DPH to establish a public repository for umbilical cord blood cells, a system to retrieve and transport donations, and a system for matching donors with recipients. 4)Requires that all information collected pursuant to the UCBBRP be confidential and be used solely for the purposes of the program. 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 information. SB 962 Page 2 5)Requires DPH to establish fees to be collected from researchers and health care providers approved by DPH to use umbilical cord blood for research or transplantation and creates the UCBBRP Fund in the State Treasury into which the fees collected will be deposited. 6)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 that the information shall only be used for the following research purposes: a) To identify risk factors or children's and women's diseases; b) To develop and evaluate screening tests; c) To evaluate and develop prevention strategies; and, d) To develop and evaluate treatments. 7)Provides that, for purposes of ensuring the security of a donor's personal information, before any umbilical cord blood released for research purposes, the State Committee for the Protection of Human Subjects (CPHS) must determine if specified criteria and conditions are met. 8)Permits DPH to bill a researcher for the costs associated with the DPH's process of protecting personal information, including, but not limited to, DPH's costs for conducting a portion of the data processing for the researcher, removing personal information, encrypting or otherwise securing personal information, or assigning subject codes. EXISTING LAW : 1)Imposes various responsibilities on the DPH and prenatal care providers with respect to prenatal care, screening and counseling. 2)Governs the licensure of blood banks, including licensure or accreditation for purposes of umbilical cord blood banking. 3)Requires DPH to conduct the Umbilical Cord Blood Community SB 962 Page 3 Awareness Campaign (UCBCAC), which provides that a primary prenatal care provider, as defined, may provide to a pregnant woman during the first prenatal visit, certain information developed by DPH regarding her options with respect to umbilical cord blood banking. 4)Requires DPH, under the Hereditary Disorders Act, to establish regulations and standards for a hereditary disorders program, including prenatal testing programs for newborns. Requires clinicians, by regulation, to provide all pregnant women, at the first prenatal visit, with information about the use and availability of prenatal screening for birth defects. Requires a clinician, if a pregnant woman voluntarily requests prenatal screening, to make available to the pregnant woman the opportunity to read and sign a consent document, as specified. 5)Establishes the Umbilical Cord Blood Education Account, in which private donations are collected and deposited for the purpose of funding the information developed by DPH pursuant to the UCBCAC, and requires these funds to be available upon a determination of the Director of the Department of Finance that sufficient private donations have been collected and deposited into the account, and provides that no public funds may be used. 6)Provides, under the Information Practices Act, certain specified privacy and security provisions for personal information held, used, or disseminated by a state agency. 7)Specifies that CPHS serve as the institutional review board for the Health and Human Services Agency for the purpose of assuring that research involving human subjects is conducted ethically and with minimum risk to participants. FISCAL EFFECT : According to the Senate Appropriations Committee, fiscal impact (in thousands): Major Provisions 2007-08 2008-09 2009-10 Fund Collection/storage $200 $1,000 $1,000 General DPH administration $200 $600 $600 General/Special Fee revenue Undetermined SB 962 Page 4 Special* *Umbilical Cord Blood Biomedical Resources Program Fund COMMENTS : 1)PURPOSE OF THIS BILL . According to the author, this bill addresses the two primary reasons why more cord blood transplants are not done today: the lack of cord blood inventory and infrastructure in the state and the lack of awareness and consequently opportunity on the part of pregnant women to exercise their personal choice regarding the distribution of their cord blood. This bill creates a state infrastructure for the use of umbilical cord blood to save lives, increases cord blood donations and responds to the Institute of Medicine's (IOM's) estimate that umbilical cord blood could help treat 11,700 Americans a year with leukemia and other devastating diseases, yet is routinely discarded by the medical community. At present, only a handful of public banks exist in California, although a public/private company in Florida, Cryobanks International, will accept and process donated cord blood units from anywhere in the United States. The author believes that by increasing cord blood resources, California will be able to provide more treatment options for persons with blood diseases, including those patients who are awaiting bone marrow transplants, but who have not donors to provide marrow. This bill also seeks to stimulate research into the use of cord blood for the treatment of other serious illnesses and regenerative therapies. According to the author, it builds upon portions of SB 1555 (Speier), Chapter 484, Statutes of 2006 and this year's SB 164 (Migden) which gives DPH the authority to create and implement the Birth Defects Monitoring and Biomedical Resources Program, which will essentially be the largest database in the world to store prenatal and genetic screening samples for research. This bill will allow DPH, (or allow it to contract with an existing facility) to create a similar repository and database for cord blood stem cells. Given that California has the most ethnically diverse population in the nation, the author believes this database will be particularly helpful in addressing the current transplant needs of minority populations. Expanding the capacity of DPH to provide another bioresource for research SB 962 Page 5 activities through fee-supported cord blood sample storage and testing would tremendously increase research potential and scientific findings about causes of major children's diseases including birth defects, prematurity, low birth weight and infant mortality. According to the author, these research findings will significantly reduce medical and special education costs, providing savings for both the public and private sector. 2)CORD BLOOD . Cord blood is the blood that remains in the umbilical cord and placenta following birth. According to a July 2002 fact sheet by the March of Dimes (MOD), following the birth of a baby, the umbilical cord usually is discarded along with the placenta. However, blood retrieved from the umbilical cord is a rich source of stem cells. Like bone marrow, cord blood can be used to treat various genetic disorders that affect the blood and immune system, leukemia and certain cancers, and some inherited disorders of body chemistry. Stem cells from cord blood offer some advantages over those retrieved from bone marrow. Cord blood stem cells are much easier to obtain; a broader range of recipients may benefit from them; and, a potentially fatal complication called graft versus host disease (GVHD), in which donor cells can attack the recipient's tissues, appears to occur less frequently with cord blood than with bone marrow. A 2000 study found that children who received a cord blood transplant from a closely matched sibling were 59% less likely to develop GVHD than children who received a bone marrow transplant from a closely matched sibling. According to the MOD fact sheet, expectant parents who have a family history of certain genetic diseases, such as severe anemias, immune disorders, or some cancers may consider the family benefit of storing cord blood. However, most families have no such risk factors, and have only about a one in 20,000 chance of needing stem cell transplantation. The MOD and the American Academy of Pediatrics (AAP) state that it is unlikely that a child will require a stem cell transplant but, if he or she does, that the child's own cord blood would be the desired source of stem cells. Storing a child's cord blood is also worthwhile when there is a sibling with a disease which can be treated by a transplant. Under these circumstances there is a one-in-four chance that the new baby will be a match for his or her sibling. The AAP favors the collection and storage of cord blood in public banks to be used for unrelated recipients who need cord blood cell transplants, including ethnic and racial SB 962 Page 6 groups who are poorly represented in national bone marrow volunteer registries. 3)CORD BLOOD BANKS . Cord blood collected immediately after birth can be stored by a commercial blood bank for a family's own use or it can be donated to a public bank for an individual needing a transplant. Commercial blood banks typically charge an initial fee of between $1000 to $2000 and an annual maintenance fee of between $50 and $150. Public banks typically do not charge for donations of cord blood for public use. The Food and Drug Administration has not issued rules for licensure and federal supervision of cord blood banking. An IOM survey of 21 cord blood banks found that the accreditation status of the banks varies substantially, with 11 reporting American Association of Blood Banks (AABB) accreditation, six reported Foundation for the Accreditation of Cellular Therapy (FACT) accreditation, and one accredited by both AABB and FACT. One bank indicated that FACT accreditation is pending, and two other banks responded that they will be or are in the process of accreditation. 4)CALIFORNIA BANKS AND COLLECTION FACILITIES . According to the National Marrow Donor Program (NMDP), because cord blood donation is a growing field, not all hospitals currently receive cord donations. The NMDP's registry is the largest listing of cord blood in the world (over 190,000 units), and includes banks outside of the U.S. StemCyte International Cord Blood Center in West Covina and Children's Hospital of Orange County Cord Blood Bank are the only NMDP participating public banks in California. Children's Hospital Oakland Research Institute operates a Sibling Donor Cord Blood Program for families that have a child with a transplant-treatable condition, and are expecting a baby who is a full sibling of the affected child. UCLA operated a cord blood bank which originated with NIH grants, but could continue due to a lack of funding. Another public bank in San Diego, the Ashley Ross Cord Blood Bank, collected 2300 cord blood units but is now releasing only one unit per month and is not accepting new donors as a result of lack of funding. 5)NEED FOR DIVERSITY . According to NMDP, marrow and cord blood transplants require matching certain tissue traits of the donor and patient. Because these traits are inherited, a patient's most likely match is someone of the same heritage. American Indian and Alaska Native, Asian, Black and African SB 962 Page 7 American, Hispanic and Latino, Native Hawaiian and Other Pacific Islander, and multiple-race patients face a greater challenge in finding matched donors or cord blood than white patients. NMDP and other organizations, such as the National Cord Blood Program, are working to raise awareness and recruit more cord blood donors in diverse communities. 6)HRSA GRANTS . In November 2006, the federal Health Recourses and Services Administration (HRSA) announced $12 million had been awarded to six institutions in California, Colorado, New York, North Carolina, Texas, and Washington to begin collections for the National Cord Blood Inventory (NCBI). According to HRSA, the NCBI will collect and maintain high-quality cord blood units and make them available for transplantation through the newly created C.W. Bill Young Cell Transplantation Program. The statutory target for the NCBI is 150,000 new units of high quality cord blood collected from diverse populations, including those that have historically been the least able to find a suitable matched adult bone marrow donor. The targeted demographics of the initial cord blood collections are: 19% African-American; 26% Latino; 6.5% Asian; 37.5% Caucasian; 10% multi-race; and, 1% other underrepresented populations 7)SUPPORT . Supporters argue that umbilical cord blood has quickly become the alternative to bone marrow to treat blood and immune systems disorders because cord blood contains stem cells and thus the match between donor and recipient need not be as close as it must be with bone marrow transplants. Supporters also argue that this bill will help women make an informed decision about cord blood banking and understand the differences between public and private banking and will help insure adequate representation of various racial and ethnic groups so that cord blood and their stem cells will be available for all. Supporters state that hundreds of children with sickle cell anemia have been cured through the transplantation of stem cells taken from cord blood and that many more children with sickle cell anemia and other blood diseases could be helped. Supporters add that many other people with chronic or possibly life-threatening diseases may be aided including those with leukemia, lymphoma, and diabetes. Supporters also argue that this bill embodies the IOM recommendations and makes California the eighteenth state to introduce or enact legislation pertaining to cord blood and will establish a critically needed state infrastructure for a SB 962 Page 8 state cord blood system in California. 8)OPPOSITION . The American College of Obstetricians and Gynecologists, District IX (ACOG), which is the sponsor of AB 34 (Portantino), a bill that would also develop an umbilical cord blood banking program, opposes this bill, claiming that it is too broad. ACOG argues that California has neither the need nor the infrastructure to obtain umbilical cord blood from every birth and that the IOM report demonstrates we must be strategic about what blood should be in the inventory in order for people to find a match. According to ACOG, if we have a genetically diverse inventory, we only need 250,000 units nationwide. ACOG further argues that the targeted approach called for in AB 34 will increase donations and achieve genetic diversity by tailoring education to certain ethnic communities and working with specific hospitals with high volume deliveries and certain racial and ethnic populations. 9)PREVIOUS LEGISLATION . SB 1555 (Speier), Chapter 484, Statutes of 2006, requires blood banks, in order to provide umbilical cord blood banking storage services, to be licensed to do so and requires DPH, contingent upon private funding, to conduct the UCBCAC. 10)RELATED LEGISLATION . a) AB 34 (Portantino) requires DPH to establish the Umbilical Cord Blood Collection Program (UCBCP) by July 1, 2009 for the purpose of collecting and storing umbilical cord blood for public use. Requires DPH to contract with up to five cord blood banks to build an inventory of umbilical cord blood units and make the inventory available to medical providers and research facilities. Establishes an implementing committee with expertise and experience in all aspects of umbilical cord collection and requires DPH to consider policy recommendations offered by that committee. Sunsets the program no later than December 31, 2018. AB 34 passed the Senate Health Committee and is currently before the Senate Rules Committee. b) SB 164 (Migden) changes the name of the Birth Defects Monitoring Program to the Birth Defects Monitoring and Biomedical Research Program, directs DPH to charge approved investigators a fee for access to the program for research, requires the program and to develop protocols for actions related to blood specimens, and creates the Birth Defects SB 962 Page 9 Monitoring and Biomedical Research Fund. SB 164 passed the Assembly Health Committee and is currently before the Assembly Judiciary Committee. REGISTERED SUPPORT / OPPOSITION : Support American Association of University Women (co-sponsor) Planned Parenthood Affiliates of California (co-sponsor) Asian American Donor Program California Alliance for Consumer Protection California Catholic Conference Cord Blood Donor Foundation National Marrow Donor Program Sickle Cell Disease Association of America Two individuals Opposition American College of Obstetricians and Gynecologists, District IX/California Analysis Prepared by : John Gilman / HEALTH / (916) 319-2097