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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