BILL ANALYSIS                                                                                                                                                                                                    Ó



          SENATE COMMITTEE ON APPROPRIATIONS
                             Senator Ricardo Lara, Chair
                            2015 - 2016  Regular  Session

          AB 1060 (Bonilla) - Cancer clinical trials
          
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          |Version: July 16, 2015          |Policy Vote: HEALTH 9 - 0       |
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          |Urgency: No                     |Mandate: No                     |
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          |Hearing Date: August 17, 2015   |Consultant: Brendan McCarthy    |
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          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  
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          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  
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                 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.




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