BILL ANALYSIS Ó
AB 1823
Page 1
Date of Hearing: April 27, 2016
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Lorena Gonzalez, Chair
AB
1823 (Bonilla) - As Amended April 12, 2016
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| |Higher Education | |13 - 0 |
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Urgency: No State Mandated Local Program: NoReimbursable: No
SUMMARY:
This bill requests the University of California (UC) establish
and designate a nonprofit public benefit corporation with the
authority to solicit and receive funds from business, industry,
foundations, and other private and public sources for the
purpose of administering the Cancer Clinical Trials Program (the
program) to increase patient access to cancer clinical trials.
Specifically, this bill:
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1)Allows the program administrator to solicit and receive funds
from business, industry, foundations, research organizations,
government agencies, individuals, and other private and public
sources, to be deposited in a fund established by the program
administrator for these purposes.
2)Requires that the UC be reimbursed from the fund for any money
allocated by the UC to establish and operate the program.
3)Requires a board, upon receipt of $500,000 funding, to
establish the program to increase patient access to cancer
clinical trials in underserved or disadvantaged communities
and populations, including among women and patients from
racial and ethnic minority communities.
4)Requires the board to determine the criteria to award grants,
and authorize grants to be awarded to either research
institutions or nonprofits.
5)Requires grants to be used for activities to increase patient
access to cancer clinical trials, including, but not limited
to: patient navigator services or programs; education and
community outreach; translation and interpretation services of
clinical trial information; patient-friendly technical tools
to assist patients in identifying available clinical trials;
payment of ancillary costs for patients and caregivers.
6)Authorizes the UC to terminate the program if it determines
that moneys in the fund are insufficient to establish or
sustain the program. Specifies that all moneys in the fund
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(after repayment of expenses) must be distributed to
appropriate organizations before such dissolution.
7)Requires that if the fund has not received $500,000 by January
1, 2021, then all moneys (after repayment of startup expenses)
shall be returned to the donors on a pro rata basis.
FISCAL EFFECT:
1)One-time costs in the range of $500,000 to establish the
nonprofit foundation, develop grant guidelines, provide
initial administrative support to the foundation, and begin
the program (GF or other unknown public and private funds).
Any costs to UC would be reimbursed by the fund specified in
the bill.
2)Unknown annual cost pressure to award grants and provide
administrative support to the new foundation (GF or other
unknown public and private funds). The amount of grant funding
the foundation will be able to award will depend on future
donations, as will the level of administrative support needed
to award the grants and manage the foundation. Given the
types of direct services that the grants are expected to fund,
it is reasonable to assume the level of funding required to
make this a meaningful program would be in the millions
annually.
COMMENTS:
1)Purpose. This bill is intended to improve the diversity of
patients participating in FDA-approved cancer clinical trials.
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The author asserts underrepresentation of certain ethnic and
socioeconomic groups will be addressed by creating a privately
funded state grant program to help patients pay for the
ancillary costs associated with participation in these trials.
The bill is supported by oncologists, the California Chronic
Care Coalition, Health Access California, and other groups,
and has no opposition.
2)Background. Clinical trials are a critical step in the
discovery of new prevention, diagnostic, and treatment methods
for cancer. Racial and ethnic minorities, older adults, rural
residents, and individuals of lower socioeconomic status are
underrepresented among participants in cancer-related trials.
Without adequate representation of these populations in
clinical trials, researchers cannot learn about potential
difference among groups and cannot ensure the generalization
of results. In addition, participation in clinical trials
increases access to state-of-the-art cancer care.
Barriers to participation include lack of awareness,
language/linguistic differences, mistrust, practical
obstacles, public misconception, and physician lack of
awareness.
3)Prior legislation. AB 1060 (Bonilla) of 2015, was similar to
this bill, but housed the program within the California Health
and Human Services Agency (CHHSA). It was vetoed by Governor
Brown, stating "[n]umerous 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 [CHHSA] which is managing a huge
expansion of our health care system." This bill establishes
the program in the UC instead of within a state agency.
4)Staff Comments. It appears the intent of the bill is that the
program be privately funded through donations. The author may
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wish to clarify that the program is not envisioned to be
funded by the state.
Analysis Prepared by:Lisa Murawski / APPR. / (916)
319-2081