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