Amended in Senate August 31, 2015

Amended in Senate July 16, 2015

Amended in Senate June 17, 2015

Amended in Assembly March 26, 2015

California Legislature—2015–16 Regular Session

Assembly Bill No. 1060

Introduced by Assembly Member Bonilla

February 26, 2015

An act to add begin insert and repeal end insert Chapter 2 (commencing with Section 101990) to Part 6 of Division 101 of the Health and Safety Code, relating to begin delete cancer, and making an appropriation therefor. end delete begin insert cancer. end insert

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 begin delete bill end delete begin insert bill, until January 1, 2022, end insert would begin delete create end delete begin insert establish end insert 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, begin delete and would continuously appropriate this fund to the board, thereby making an appropriation. end delete begin insert to be used to administer a grant program. The bill would limit the amount the agency may spend to establish the 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. end insert The bill would authorize the board to solicit and receive money, as begin delete specified. end delete begin insert specified, and would authorize the agency to apply for federal funds for this purpose. end insert The bill would require the board, upon contribution of begin delete an unspecified amount of money end delete begin insert at least $500,000 end insert 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:  begin delete yes end delete begin insert no end insert . 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.

begin insert

(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.

end insert begin delete

(b)

end delete

begin insert (c) end insert  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.

begin delete

(c)

end delete

begin insert (d) end insert  The foundation, or an authorized representative thereof,
shall apply for tax exempt status under Section 501(c)(3) of the
Internal Revenue Code.

begin delete

(d)

end delete

begin insert (e) end insert  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.

begin delete

(e)

end delete

begin insert (f) end insert  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).

begin delete

(f)

end delete

begin insert (g) end insert  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 begin insert in the State Treasury end insert the
Cancer Clinical Trials Fund. begin delete Notwithstanding Section 13340 of
the Government Code, all money end delete begin insert Moneys end insert in the fund begin delete is
continuously appropriated to the board without regard to fiscal
years, end delete begin insert shall be used end insert for the administration and support of the
program created pursuant to this begin delete chapter. end delete begin insert chapter upon
appropriation of the Legislature. end insert

(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.

begin insert

(c) The agency may apply for federal funds for the foundation.

end insert begin delete

(c)

end delete

begin insert (d) end insert  The board shall use no more than 20 percent of funds made
available for the Cancer Clinical Trials Grant Program for
administrative costs.

begin insert

begin insert 101993.5. end insert   

(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.

end insert

101994.  

(a) Upon contribution of begin delete an unspecified amount of
moneys end delete begin insert at least five hundred thousand dollars ($500,000) end insert 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.

begin insert

(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.

end insert begin insert

(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.

end insert

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.

begin insert

begin insert 101996. end insert   

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.

end insert