BILL NUMBER: AB 1060 AMENDED
BILL TEXT
AMENDED IN SENATE AUGUST 31, 2015
AMENDED IN SENATE JULY 16, 2015
AMENDED IN SENATE JUNE 17, 2015
AMENDED IN ASSEMBLY MARCH 26, 2015
INTRODUCED BY Assembly Member Bonilla
FEBRUARY 26, 2015
An act to add and repeal Chapter 2 (commencing with
Section 101990) to Part 6 of Division 101 of the Health and Safety
Code, relating to cancer, and making an appropriation
therefor. cancer.
LEGISLATIVE COUNSEL'S DIGEST
AB 1060, as amended, Bonilla. Cancer clinical trials.
Existing law establishes the scope and function of the California
Health and Human Services Agency, which includes departments charged
with administering laws pertaining to public health and social
services, among other things. Existing law also establishes the
Inclusion of Women and Minorities in Clinical Research Act, which is
designed to promote the inclusion of women and minority groups in
clinical research, including clinical trials.
This bill bill, until January 1, 2022,
would create establish the Cancer
Clinical Trials Foundation in the Health and Human Services Agency,
to be governed by a board of trustees. Members of the board would be
appointed as specified. The bill would also create the Cancer
Clinical Trials Fund, and would continuously appropriate
this fund to the board, thereby making an appropriation.
to be used to administer a grant program. The bill would limit
the amount the agency may spend to establish t he
foundation to $300,000 of appropriated funds, to be repaid by January
1, 2021, but would otherwise prohibit General Fund moneys from being
used for the foundation. The bill would authorize the board to
solicit and receive money, as specified.
specified, and would authorize the agency to apply for federal funds
for this purpose. The bill would require the board, upon
contribution of an unspecified amount of money
at least $500,000 to the fund, to establish the Cancer
Clinical Trials Grant Program, in order to increase patient access to
cancer clinical trials in specified populations. The bill would
require that grant money be used for designated purposes, and would
also require grant recipients to report to the board. The bill would
require the board to report to the Legislature, as specified. This
bill would make related findings.
Vote: majority. Appropriation: yes 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 are not finished
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 of low to moderate income are often unable to bear the
burden of the ancillary costs of participating, such as airfare,
lodging, rental cars, and fuel.
(d) The American Medical Association conducted a study on cancer
trial participation. The study found that from 1996 to 2002, of the
75,215 patients enrolled in the National Cancer Institute trials for
breast, lung, colorectal, and prostate cancers, only 3.1 percent were
Hispanic, 9.2 percent were Black, and 1.9 percent were Asian or
Pacific Islanders, while 85.6 percent were White. This lack of
diversity is of concern because of its impact on researchers' ability
to evaluate the effect of new treatments on different populations.
It also speaks to a lack of access to potentially lifesaving trials
for a large portion of the population.
(e) It is the intent of the Legislature to establish a program to
enable willing patients of low to moderate income to participate in
cancer clinical trials in order to boost participation rates, ensure
these trials are widely accessible, improve the development of cancer
therapies, and enhance innovation.
SEC. 2. Chapter 2 (commencing with Section 101990) is added to
Part 6 of Division 101 of the Health and Safety Code, to read:
CHAPTER 2. CANCER CLINICAL TRIALS
101990. (a) "Board" means the Board of Trustees of the Cancer
Clinical Trials Foundation.
(b) "Foundation" means the Cancer Clinical Trials Foundation.
(c) "Fund" means the Cancer Clinical Trials Fund.
101991. (a) The agency shall establish a nonprofit public benefit
corporation, to be known as the Cancer Clinical Trials Foundation,
that shall be governed by a board consisting of a total of five
members. Three members shall be appointed by the Governor. Of these
members, one shall be from a public cancer research institution, and
one shall be from a private cancer research institution. One member
shall be appointed by the Speaker of the Assembly. One member shall
be appointed by the President pro Tempore of the Senate.
(b) All persons appointed to the board shall have an interest in
increasing access to cancer clinical trials and the ability and
desire to solicit funds for the purpose of increasing access to
clinical trials as provided in this chapter.
(b)
(c) The Governor shall appoint the president of the
board from among those members appointed by the Governor, the Speaker
of the Assembly, and the President pro Tempore of the Senate.
(c)
(d) The foundation, or an authorized representative
thereof, shall apply for tax exempt status under Section 501(c)(3) of
the Internal Revenue Code.
(d)
(e) Members of the board shall serve without
compensation but shall be reimbursed for any actual and necessary
expenses incurred in connection with their duties as members of the
board.
(e)
(f) The foundation shall be subject to the Nonprofit
Public Benefit Corporation Law (Part 2 (commencing with Section 5110)
of Division 2 of Title 2 of the Corporations Code).
(f)
(g) The California Health and Human Services Agency
shall determine which department in the agency shall administer the
foundation.
101992. (a) Of the members of the board first appointed by the
Governor pursuant to Section 101991, one member shall be appointed to
serve a two-year term, one member shall be appointed to serve a
three-year term, and one member shall be appointed to serve a
four-year term.
(b) Of the members of the board first appointed by the Speaker of
the Assembly and the President pro Tempore of the Senate pursuant to
Section 101991, each member shall be appointed to serve a four-year
term.
(c) Upon the expiration of the initial appointments for the board,
each member shall be appointed to serve a four-year term.
101993. (a) There is hereby created in the State Treasury
the Cancer Clinical Trials Fund. Notwithstanding
Section 13340 of the Government Code, all money Moneys
in the fund is continuously appropriated to the board
without regard to fiscal years, shall be used
for the administration and support of the program created pursuant to
this chapter. chapter upon appropriation of
the Legislature.
(b) The Cancer Clinical Trials Foundation may solicit and receive
funds from business, industry, foundations, and other private and
public sources for the purpose of administering the Cancer Clinical
Trials Grant Program to increase patient access to cancer clinical
trials.
(c) The agency may apply for federal funds for the foundation.
(c)
(d) The board shall use no more than 20 percent of
funds made available for the Cancer Clinical Trials Grant Program for
administrative costs.
101993.5. (a) The agency may not spend more than three hundred
thousand dollars ($300,000) of moneys appropriated to the agency to
establish the foundation.
(b) Any money used to establish the foundation shall be paid back
to the agency on or before January 1, 2021, from moneys donated to
the Cancer Clinical Trials Fund.
(c) After the initial investment authorized by subdivision (a), no
General Fund moneys shall be used to operate the foundation.
101994. (a) Upon contribution of an unspecified amount
of moneys at least five hundred thousand dollars
($500,000) to the foundation, the board shall establish the
Cancer Clinical Trials Grant 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. The board shall determine the criteria
to award grants, and may award grants to either or both of the
following:
(1) Public and private research institutions and hospitals that
conduct cancer clinical trials approved by the federal Food and Drug
Administration.
(2) Nonprofit organizations described in Section 501(c)(3) of the
Internal Revenue Code of 1954 that are exempt from income tax under
Section 501(a) of that code and that specialize in direct patient
support for improved clinical trial enrollment and retention.
(b) Grants awarded pursuant to subdivision (a) shall be used for
activities to increase patient access to cancer clinical trials,
including, but not limited to, any of the following:
(1) Patient navigator services or programs.
(2) Education and community outreach.
(3) Patient-friendly technical tools to assist patients in
identifying available clinical trials.
(4) Translation and interpretation services of clinical trial
information.
(5) Counseling services for clinical trial participants.
(6) Well-being services for clinical trial participants,
including, but not limited to, physical therapy, pain management,
stress management, and nutrition management.
(7) 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) Local transportation via bus, train, or other public
transportation during the clinical trial.
(F) Meals during the clinical trial.
(G) Child care costs during the clinical trial.
(c) If the foundation does not receive five hundred thousand
dollars ($500,000) or more by January 1, 2021, moneys remaining after
the repayment required pursuant to subdivision (b) of Section
101993.5 shall be returned to the donors on a pro rata basis.
(d) If the grant program is established pursuant to this section,
all moneys in the fund shall be awarded by grant prior to the repeal
of this chapter.
101995. (a) Grant recipients shall report to the board to ensure
the appropriate use of funds within one year of receiving a grant.
(b) (1) The board shall report to the Legislature to ensure the
appropriate use of the funds. The report shall include accountability
measures, including, but not limited to, a description of how the
funds were used, an evaluation of the grant program, and
recommendations for the program. This report shall be submitted by
January 1, 2020.
(2) The requirement for submitting a report imposed under
paragraph (1) is inoperative on January, 1, 2024, pursuant to Section
10231.5 of the Government Code.
101996. This chapter shall remain in effect only until January 1,
2022, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2022, deletes or extends
that date.