BILL ANALYSIS Ó SENATE COMMITTEE ON APPROPRIATIONS Senator Ricardo Lara, Chair 2015 - 2016 Regular Session AB 1060 (Bonilla) - Cancer clinical trials ----------------------------------------------------------------- | | | | | | ----------------------------------------------------------------- |--------------------------------+--------------------------------| | | | |Version: July 16, 2015 |Policy Vote: HEALTH 9 - 0 | | | | |--------------------------------+--------------------------------| | | | |Urgency: No |Mandate: No | | | | |--------------------------------+--------------------------------| | | | |Hearing Date: August 17, 2015 |Consultant: Brendan McCarthy | | | | ----------------------------------------------------------------- This bill meets the criteria for referral to the Suspense File. Bill Summary: AB 1060 would require the California Health and Human Services Agency to establish a nonprofit Cancer Clinical Trials Foundation, to increase patient access to clinical trials. Fiscal Impact: Anticipated one-time costs of $650,000 to establish the nonprofit foundation, develop grant guidelines, provide initial administrative support to the foundation, and begin the initial fundraising effort before sufficient donations have been received to support the foundation (General Fund). Unknown annual costs to award grants and provide administrative support to the new foundation (private funds). The amount of grant funding that the foundation will be able to award will depend on future donations from the public as will the level of administrative support needed to award the grants and manage the foundation. AB 1060 (Bonilla) Page 1 of ? Background: Clinical trials are conducted by pharmaceutical companies seeking approval to market new drugs or existing drugs for additional conditions. In addition, the federal government provides financial support for clinical trials designed to study medical effectiveness or other characteristics of new or existing drugs. In recent years, concerns have been raised that participants in clinical trials tend not to reflect the larger society, which may bias the results of those trials. Research findings indicate that participants in clinical trials are more likely to be male and to be Caucasian than the general population. Clinical trials tend to be conducted at academic medical centers, often require patients to receive their care from a new doctor participating in the trial and often require substantial paperwork for patients to enroll. These factors and others have tended to limit participation in clinical trials. Proposed Law: AB 1060 would require the California Health and Human Services Agency to establish a nonprofit Cancer Clinical Trials Foundation, to increase patient access to clinical trials. Specific provisions of the bill would: Require the Agency to establish the Cancer Clinical Trials Foundation as a nonprofit public benefit corporation, with an appointed board; Specify the process for appointing board members; Require the Agency to determine which department within the agency shall administer the foundation; Establish a new special fund to support the foundation and continuously appropriate monies in that fund; Authorize the Foundation to solicit donations from public and private sources; Limit administrative costs to 20% of total program expenditures; Require the Foundation board to establish a grant program, upon receipt of an unspecified amount of donations; Authorize grants to be made to research institutions and hospitals and to nonprofit organizations that specialize in patient support for clinical trial participation; AB 1060 (Bonilla) Page 2 of ? Specify the allowed uses of the grant funds, including a variety of services and reimbursement of patient costs all intended to support patient participation in clinical trials; Require the Foundation to report to the Legislature on its activities by January 1, 2020. Staff Comments: The intent of the bill is for the Foundation to be supported by public and private donations, rather than the General Fund. However, the Agency or a delegated department would incur initial costs to establish the Foundation as a nonprofit before any donations could be received. Staff recommends that the bill be amended to ensure that any startup costs incurred by a state department be reimbursed by initial donations to the foundation. Staff recommends that the continuous appropriation be removed from the bill to allow for Legislative oversight of the Foundation. Also, staff recommends that an appropriate sunset date be added to the bill, to ensure that the state does not continue to provide administrative support indefinitely if future donations do not materialize. -- END --