Amended in Assembly April 20, 2015

California Legislature—2015–16 Regular Session

Assembly Bill No. 1174

Introduced by Assembly Member Bonilla

February 27, 2015

An act to begin delete amend Section 137 of end delete begin insert add Sections 100240, 100241, 100242, and 100243 to end insert the Health and Safety Code, relating to begin delete public health. end delete begin insert health research. end insert

LEGISLATIVE COUNSEL’S DIGEST

AB 1174, as amended, Bonilla. begin delete Women’s health. end delete begin insert Health research: women’s health. end insert

begin insert

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.

end insert begin insert

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.

end insert begin delete

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.

end delete begin delete

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.

end delete

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: no.

The people of the State of California do enact as follows:

begin insert

begin insert SECTION 1. end insert   

end insert

begin insert The Legislature finds and declares the following: end insert

begin insert

(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.

end insert begin insert

(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.

end insert begin insert

(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.

end insert

begin insert

begin insert SEC. 2. end insert   

end insert

begin insert Section 100240 is added to the end insert begin insert Health and Safety Code end insert begin insert ,
to read: end insert

begin insert

begin insert 100240. end insert   

The Ancillary Costs Committee is hereby created to
be made up of private and public health stakeholders.

end insert

begin insert

begin insert SEC. 3. end insert   

end insert

begin insert Section 100241 is added to the end insert begin insert Health and Safety Code end insert begin insert ,
to read: end insert

begin insert

begin insert 100241. end insert   

(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.

end insert

begin insert

begin insert SEC. 4. end insert   

end insert

begin insert Section 100242 is added to the end insert begin insert Health and Safety Code end insert begin insert ,
to read: end insert

begin insert

begin insert 100242. end insert   

(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.

end insert

begin insert

begin insert SEC. 5. end insert   

end insert

begin insert Section 100243 is added to the end insert begin insert Health and Safety Code end insert begin insert ,
to read: end insert

begin insert

begin insert 100243. end insert   

Grant recipients shall report to the committee to
ensure the appropriate use of the funds.

end insert

begin delete

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.

end delete