BILL ANALYSIS Ó
SENATE COMMITTEE ON EDUCATION
Senator Carol Liu, Chair
2015 - 2016 Regular
Bill No: AB 1823
-----------------------------------------------------------------
|Author: |Bonilla |
|-----------+-----------------------------------------------------|
|Version: |June 23, 2016 Hearing |
| |Date: June 29, 2016 |
-----------------------------------------------------------------
-----------------------------------------------------------------
|Urgency: |No |Fiscal: |Yes |
-----------------------------------------------------------------
-----------------------------------------------------------------
|Consultant:|Kathleen Chavira |
| | |
-----------------------------------------------------------------
Subject: California Cancer Clinical Trials Program
SUMMARY
This bill requests the University of California (UC) to
establish a board representing institutions and individuals
performing, participating in and supporting eligible cancer
clinical trials in California to solicit and receive funds from
federal or private sources for the California Cancer Clinical
Trials Program, as specified, to provide grants to increase
patient access to eligible cancer clinical trials in underserved
or disadvantaged communities, as specified.
BACKGROUND
The California Constitution establishes the UC, a public trust
to be administered by the Regents of the UC and grants the
Regents full powers of organization and government, subject only
to such legislative control as may be necessary to insure
security of its funds, compliance with the terms of its
endowments, statutory requirements around competitive bidding
and contracts, sales of property and the purchase of materials,
goods and services. (Article IX, Section (9)(a) of the
California Constitution)
ANALYSIS
This bill establishes the California Cancer Clinical Trials
Program. It:
AB 1823 (Bonilla) Page 2
of ?
1) Requests the UC to:
a) Establish or designate an institute or
office with the university to administer the program.
b) Establish the Board of Trustees of the
California Cancer Clinical Trials Program, as
specified, to represent institutions and individuals
performing, participating in and supporting eligible
cancer clinical trials in California.
c) Publicize the opportunity to submit
nomination for board membership.
d) Publicize the availability of grants
that are available through the Program to
organizations, as specified.
2) Establishes requirements for the board of the program. It:
a) Requires that appointees to the board
have an interest ability and desire to solicit funds
for purpose of increasing and diversifying access to
clinical trials.
b) Requires that board members serve
without compensation but be reimbursed for expenses,
as specified.
3) Provides for the use of funds for administrative costs by
authorizing adjustment of these costs based on the size of
the program and funds received and caps the amount allowed
for these costs at 20 percent of funds received cover the
costs of administration.
4) Authorizes the University of California (UC) to:
a) Participate as the program
administrator, a beneficiary, or both.
b) Pursue any approvals, authorizations,
AB 1823 (Bonilla) Page 3
of ?
or advice it deems necessary prior to establishing the
program.
c) Decline to establish or participate in
the program.
d) Terminate the program if it is
determined not viable.
5) Authorizes the program administrator to solicit funds, as
specified, for the purposes of program administration or
awarding grant awards, limits funds for administration to
those received from federal or private sources and
authorizes the UC to use state source funds for
administration and oversight of the program, provided the
UC is reimbursed from these sources, and makes
implementation of the program contingent upon the receipt
of at least $500,000 in funding for this purpose.
6) Requires reimbursement for any resources allocated by the
UC for purposes of the program prior to the distribution of
any grants.
7) Requires the board to determine criteria to award and
administer grants, outlines those entities authorized to be
granted awards, encourages consideration of groups that
meet specified criteria and outlines the uses of grant
awards.
8) Authorizes the program administrator to require reporting
by grantees, as specified.
9) Authorizes the UC to terminate the program if it determines
funds are insufficient to establish/sustain it, authorizes
the program administrator to dissolve the program if
$500,000 is not received by January 1, 2021, or if the
administrative cap of 20 percent is determined to be
inadequate.
10) Requires that money remaining in the fund after payment of
expenses be allocated to an organization that meets the
qualifications of a grant recipient as outlined in the
bill.
AB 1823 (Bonilla) Page 4
of ?
11) Clarifies that nothing in the bill's provisions precludes
the UC from establishing or operating other similar
programs under specified federal regulations.
STAFF COMMENTS
1) Need for the bill. According to the author, this bill
seeks to remedy the problem of low patient participation in
FDA-approved cancer clinical trials. More importantly, it
is an effort to address the disproportionately low number
of patients from underrepresented communities including
African Americans, Latinos/Hispanics, Asians and Pacific
Islanders, and American Indians. The author contends that
nationwide, only 3 percent of eligible cancer patients
participate in clinical trials and of those, only 5 percent
are from these underrepresented communities. According to
the author, barriers to participation include a lack of
awareness, mistrust of research and the medical system,
loss of income, and transportation and lodging costs.
These ancillary costs of participation fall onto the
clinical trial participant who may be unable to pay, and
therefore unable to enroll in the trial.
This bill proposes to address this issue by creating a
privately funded grant program through the University of
California (UC) to assist patients in paying for the
ancillary costs associated with participation in these
trials.
2) Impact on UC and state funds? This bill requires that funds
for program administration and grant awards come from
federal and private sources. It also authorizes the UC to
use state source funds for administration and oversight of
the program, provided the UC is reimbursed from federal or
private sources. According to the author, the UC has
already expended state funds for purposes of gaining
permission from federal regulators and engaging in other
administrative activity to establish the program and these
provisions are intended to authorize reimbursement of the
funds used for these purposes. There is no intent to use
state funds for any ongoing administrative or oversight
expenses.
Staff recommends the bill be amended on page 7 lines 19-21
AB 1823 (Bonilla) Page 5
of ?
to clarify that these provisions apply to "start-up"
oversight and administration costs only.
Staff notes that the bill authorizes up to 20 percent of
funds to be used for administrative costs. State funded
programs typically authorize up to 5 percent of funding for
these costs. The 20 percent figure combines all
administrative costs (direct, indirect, and administrative)
into one. According to the UC, administrative costs for
research programs typically run greater than 20 percent and
this cap would be among the lowest in the state for
research program administration.
Staff also notes that the UC is authorized to establish,
decline to establish or participate, or terminate the
program. According to the author, the intent of the bill
and for the program is that, once established, the program
will operate exclusively on private or federal funds. If
the program does not collect sufficient funding to continue
operation of the program using private or federal funds,
the University is under no obligation to continue program
operations. The language in the bill is explicit about the
UC's ability to determine whether or not to establish or
terminate the program, to ensure the University will not be
compelled to expend state-sourced dollars in operation of
the program.
3) Prior legislation. AB 1060 (Bonilla, 2015) proposed
establishment of the Cancer Clinical Trials Foundation in
the Health and Human Services Agency, to be governed by a
board of trustees, to administer a grant program
substantively similar to that proposed by this bill. AB
1060 was vetoed in October 2015, by the Governor whose
message read, in pertinent part:
"Numerous private organizations already perform
this fundraising function. While I support
eliminating barriers to take part in clinical
trials, I am hesitant to place this new burden on
the Health and Human Services Agency which is
managing a huge expansion of our health care
system."
SUPPORT
AB 1823 (Bonilla) Page 6
of ?
Association of California Healthcare Districts
Susan G. Komen California Collaborative
OPPOSITION
None received.
-- END --