BILL NUMBER: AB 1060 AMENDED
BILL TEXT
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 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.
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 would create 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. The bill would authorize the board to solicit and
receive money, as specified. The bill would require the board, upon
contribution of an unspecified amount of money 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. 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 alarming 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) 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) The foundation, or an authorized representative thereof, shall
apply for tax exempt status under Section 501(c)(3) of the Internal
Revenue Code.
(c)
(d) 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.
(d)
(e) 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), except
that if there is a conflict with this chapter and the Nonprofit
Public Benefit Corporation Law, this chapter shall prevail.
Code).
(e)
(f) 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 the Cancer Clinical Trials
Fund. Notwithstanding Section 13340 of the Government Code, all money
in the fund is continuously appropriated to the board without regard
to fiscal years, for the administration and support of the program
created pursuant to this chapter.
(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 board shall use no more than 20 percent of funds made
available for the Cancer Clinical Trials Grant Program for
administrative costs.
101994. (a) Upon contribution of an unspecified amount of moneys
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.
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.