BILL NUMBER: AB 1174 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY APRIL 20, 2015
INTRODUCED BY Assembly Member Bonilla
FEBRUARY 27, 2015
An act to amend Section 137 of add
Sections 100240, 100241, 100242, and 100243 to the Health and
Safety Code, relating to public health. health
research.
LEGISLATIVE COUNSEL'S DIGEST
AB 1174, as amended, Bonilla. Women's health.
Health research: women's health.
Existing law establishes the Inclusion of Women and Minorities in
Clinical Research Act, which requires a grantee, as defined, in
conducting or supporting a project of clinical research, as defined,
to ensure that women of all ages, and members of minority groups, as
defined, are included as subjects in the clinical research projects,
except under prescribed circumstances. Existing law also requires
state agencies to, and would declare legislative intent that the
University of California include in specified progress reports, data
on the extent to which state funds administered by state agencies and
the University of California are used by grantees for research on
diseases, disorders, and health conditions, that includes women and
minorities in the research trials, and that studies diseases,
disorders, and health conditions of particular concern to women and
minorities. Existing law also states the legislative intent that
research include, but not be limited to, specified diseases,
disorders, and health conditions.
This bill would create the State Contingency Fund for Ancillary
Costs and the Ancillary Costs Committee. The bill would authorize the
fund to receive private donations. The bill would require the
committee to develop grant criteria once a to be determined amount is
deposited into the fund. The bill would authorize the committee to
award, on a competitive basis, grants to various organizations, to
increase patient access to cancer clinical trials.
Existing law imposes various functions and duties on the State
Department of Public Health with respect to the administration and
oversight of various health programs and facilities relating to the
prevention of disease and the promotion of health. The department is
required to develop a coordinated state strategy for addressing the
health-related needs of women, including implementation of goals and
objectives for women's health.
This bill would require the State Department of Public Health to
report to the Assembly Committee on Health and the Senate Committee
on Health the state strategy, goals established, and progress made
toward achieving those goals on or before January 1, 2017, and
biennially thereafter. The bill would make related changes.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. The Legislature finds and declares the
following:
(a) Almost 50 percent of clinical trial studies do not finish in
time due to low patient participation, recruitment and navigation
difficulties, and other barriers for patients. Due to economic and
socioeconomic circumstances and lack of patient knowledge, clinical
oncology trial participation and retention are both very low as they
relate to eligible participants.
(b) Overall, only 3 percent of eligible cancer patients
participate in clinical trials and of those, only 5 percent of trial
participants are from racial or ethnic minority communities.
(c) One barrier that prevents patients from participating in
federal Food and Drug Administration clinical trials is finances.
Patients can't bear the burden of the ancillary costs of
participating, such as airfare, lodging, rental cars, and fuel.
SEC. 2. Section 100240 is added to the
Health and Safety Code , to read:
100240. The Ancillary Costs Committee is hereby created to be
made up of private and public health stakeholders.
SEC. 3. Section 100241 is added to the
Health and Safety Code , to read:
100241. (a) The State Contingency Fund for Ancillary Costs is
hereby created in the State Treasury to be made up of donations from
private entities. Moneys in the State Contingency Fund for Ancillary
Costs shall, upon appropriation by the Legislature to the committee,
be allocated by the committee as provided by Section 100242.
(b) The board shall not use more than 10 percent of funds made
available for the grant program for administrative costs.
SEC. 4. Section 100242 is added to the
Health and Safety Code , to read:
100242. (a) Upon an unspecified amount of moneys being donated to
the fund, the committee shall establish a grant program to determine
grant parameters and criteria, and to make grant awards.
(b) In order to increase patient access to clinical trials, the
committee may award grants from any funds that may be made available
pursuant to Section 100241, on a competitive basis, to both of the
following:
(1) Public and private research institutions and hospitals that
conduct cancer trials approved by the federal Food and Drug
Administration approved cancer clinical trials.
(2) A nonprofit organization described in Section 501(c)(3) of the
Internal Revenue Code of 1954 which is exempt from income tax under
Section 501(a) of that code that specializes in direct patient
support for improved clinical trial enrollment and retention.
(c) The funds awarded pursuant to subdivision (b) shall be used
for activities to increase patient access to clinical trials,
including, but not limited to:
(1) Payment of ancillary costs for patients and caregivers,
including, but not limited to:
(A) Airfare during the clinical trial.
(B) Lodging during the clinical trial.
(C) Rental cars during the clinical trial.
(D) Fuel during the clinical trial
(E) Meals during the clinical trial.
(F) Child care costs during the clinical trial.
(2) Patient navigator services or programs.
(3) Education and community outreach.
(4) Patient-friendly technical tools to assist patients in
identifying available clinical trials.
SEC. 5. Section 100243 is added to the
Health and Safety Code , to read:
100243. Grant recipients shall report to the committee to ensure
the appropriate use of the funds.
SECTION 1. Section 137 of the Health and Safety
Code is amended to read:
137. (a) The State Department of Public Health shall develop a
coordinated state strategy for addressing the health-related needs of
women, including implementation of goals and objectives for
maintaining and improving women's health.
(b) The approved programmatic costs associated with this strategy
shall be the responsibility of the State Department of Public Health
unless otherwise provided by law.
(c) (1) The State Department of Public Health shall report to the
Assembly Committee on Health and the Senate Committee on Health on
the state strategy, goals established, and progress made toward
achieving those goals. This report shall be submitted on or before
January 1, 2017, and biennially thereafter.
(2) Pursuant to Section 10231.5 of the Government Code, the
requirement for submitting a report imposed under paragraph (1) is
inoperative on January 1, 2021.