BILL ANALYSIS AB 52 Page 1 CONCURRENCE IN SENATE AMENDMENTS AB 52 (Portantino) As Amended August 30, 2010 2/3 vote. Urgency ----------------------------------------------------------------- |ASSEMBLY: |68-8 |(June 2, 2009) |SENATE: |33-1 |(August 31, | | | | | | |2010) | ----------------------------------------------------------------- Original Committee Reference: HEALTH SUMMARY : Requests the University of California (UC) to develop a plan to establish and administer the Umbilical Cord Blood Collection Program (UCBCP) on or before July 1, 2011, and imposes a temporary $1 fee on specified birth certificates to fund the program. The Senate amendments : 1)Shift administration of the UCBCP from the Department of Public Health (DPH) to UC, if UC elects to administer the program. 2)Define public use of umbilical cord blood as blood units from genetically diverse donors that will be owned by the UC. 3)Permit UC, for the purpose of implementing cord blood collection goals of the program, to contract with one or more entities that are in compliance with federal guidelines and regulations. 4)Allow UC to use a competitive process to select entities to administer the collection and research objectives of the program, if the UC chooses not to undertake these activities itself. 5)Require entities selected pursuant to 4) above to receive, process, and preserve, or bank cord blood units to have, at minimum, an investigational new drug exemption or a biological license from the Federal Drug Administration. 6)Express legislative intent that UC limit fees for access to cord blood units to the reasonable and actual costs of storage, handling, and providing units, as well as for related AB 52 Page 2 services, as specified. 7)Express additional legislative intent that UC develop a strategy to increase voluntary participation by hospitals in the collection and storage of umbilical cord blood, as specified; consider a medical contingency response program, as specified; and explore the feasibility of operating the program as a self-funding program. 8)Permit UC to deny further access to any confidential information maintained by UC to any person who violates its policies to maintain confidentiality of information, and subjects them to a civil penalty of up to $1,000. 9)Extend the sunset on the UCBCP from January 1, 2015, to January 1, 2018. EXISTING LAW : 1)Requires DPH to establish the UCBCP by January 1, 2010, and until January 1, 2015, for the purpose of increasing the amount of umbilical cord blood that is donated in the state and added to the NCBI. 2)Authorizes the UCBCP, to the extent private or public funds are identified and secured for these purposes, to identify and provide funds for grants or contracts with qualified blood banks that are licensed and accredited to collect and store umbilical cord blood for public transplantation services. Permits DPH to implement any additional standards for blood banks to collect and store umbilical cord blood through the adoption of regulations. 3)Requires DPH, contingent upon private funding, to conduct the Umbilical Cord Blood Community Awareness Campaign; establish an Internet Web site with specified information; and, undertake public education activities related to umbilical cord blood donation to targeted populations, as appropriate. AS PASSED BY THE ASSEMBLY , this bill extended for one year the date by which DPH is required to establish UCBCP; and, required DPH to contract with up to five licensed or accredited blood banks to collect and store umbilical cord blood, as specified. AB 52 Page 3 FISCAL EFFECT : According to the Senate Appropriations Committee: Fiscal Impact (in thousands) Major Provisions 2010-11 2011-12 2012-13 Fund Operating funds unknown, but cost pressure to fund Special/*Federal more than $3,000 annually Private/General $2 fee revenues Approximately $3,000 annually,Special* commencing January 1, 2011 Potential loss of a federal grant $471 $0 $0Federal *Umbilical Cord Blood Collection Fund COMMENTS : The author states that the National Cord Blood Inventory currently lacks ethnic and multiracial cord blood and the UCBCP is intended to collect cord blood for public use and increase the volume of cord blood that can be added to the national inventory. According to the author, DPH, with more than 300 varied health programs, is facing major budget cuts and significant reorganization and has not been willing to provide support for the funding or administration strategy of the UCBCP. The author argues that this bill shifts administration of the program to UC, given that many relationships already exist between the University and birthing hospitals throughout the state, UC has cord blood experts within its system, and it operated an umbilical cord blood bank at UCLA in the late 1990s. The author states that this bill will ensure collections from California's ethnically diverse communities will help to address shortages in cord blood donations from minority groups and increase the likelihood of transplant patients finding suitable donor matches. Analysis Prepared by : Cassie Rafanan / HEALTH / (916) 319-2097 FN: 0006865