Amended in Senate June 17, 2015

Amended in Assembly March 26, 2015

California Legislature—2015–16 Regular Session

Assembly BillNo. 1060


Introduced by Assembly Member Bonilla

February 26, 2015


An act tobegin delete amend Section 491 of the Business and Professions Code, relating to professions and vocations.end deletebegin insert 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.end insert

LEGISLATIVE COUNSEL’S DIGEST

AB 1060, as amended, Bonilla. begin deleteProfessions and vocations: licensure. end deletebegin insertCancer clinical trials.end insert

begin insert

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.

end insert
begin insert

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.

end insert
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Existing law provides for the licensure and regulation of various professions and vocations by boards within the Department of Consumer Affairs. Existing law authorizes a board to suspend or revoke a license on the ground that the licensee has been convicted of a crime, if the crime is substantially related to the qualifications, functions, or duties of the business or profession for which the license was issued. Existing law requires the board, upon suspension or revocation of a license, to provide the ex-licensee with certain information pertaining to rehabilitation, reinstatement, or reduction of penalty, as specified.

end delete
begin delete

This bill would require the board to provide that information through first-class mail and by email if the board has an email address on file for the ex-licensee.

end delete

Vote: majority. Appropriation: begin deleteno end deletebegin insertyesend insert. Fiscal committee: yes. State-mandated local program: no.

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

P2    1begin insert

begin insertSECTION 1.end insert  

end insert
begin insert

The Legislature finds and declares the following:

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begin insert

2(a) Almost 50 percent of clinical trial studies are not finished
3in time due to low patient participation, recruitment and navigation
4difficulties, and other barriers for patients. Due to economic and
5socioeconomic circumstances and lack of patient knowledge,
6clinical oncology trial participation and retention are both very
7low as they relate to eligible participants.

end insert
begin insert

8(b) Overall, only 3 percent of eligible cancer patients participate
9in clinical trials, and of those only 5 percent of trial participants
10are from racial or ethnic minority communities.

end insert
begin insert

11(c) One barrier that prevents patients from participating in
12federal Food and Drug Administration clinical trials is finances.
13Patients of low to moderate income are often unable to bear the
14burden of the ancillary costs of participating, such as airfare,
15lodging, rental cars, and fuel.

end insert
begin insert

P3    1(d) The American Medical Association conducted a study on
2cancer trial participation. The study found that from 1996 to 2002,
3of the 75,215 patients enrolled in the National Cancer Institute
4trials for breast, lung, colorectal, and prostate cancers, only 3.1
5percent were Hispanic, 9.2 percent were Black, and 1.9 percent
6were Asian or Pacific Islanders, while 85.6 percent were White.
7This lack of diversity is alarming because of its impact on
8researchers’ ability to evaluate the effect of new treatments on
9different populations. It also speaks to a lack of access to
10potentially lifesaving trials for a large portion of the population.

end insert
begin insert

11(e) It is the intent of the Legislature to establish a program to
12enable willing patients of low to moderate income to participate
13in cancer clinical trials in order to boost participation rates, ensure
14these trials are widely accessible, improve the development of
15cancer therapies, and enhance innovation.

end insert
16begin insert

begin insertSEC. 2.end insert  

end insert

begin insertChapter 2 (commencing with Section 101990) is added
17to Part 6 of Division 101 of the end insert
begin insertHealth and Safety Codeend insertbegin insert, to read:end insert

begin insert

18 

19Chapter  begin insert2.end insert Cancer Clinical Trials
20

 

21

begin insert101990.end insert  

(a) “Board” means the Board of Trustees of the
22Cancer Clinical Trials Foundation.

23(b) “Foundation” means the Cancer Clinical Trials Foundation.

24(c) “Fund” means the Cancer Clinical Trials Fund.

25

begin insert101991.end insert  

(a) The agency shall establish a nonprofit public
26benefit corporation, to be known as the Cancer Clinical Trials
27Foundation, that shall be governed by a board consisting of a total
28of five members. Three members shall be appointed by the
29Governor. Of these members, one shall be from a public cancer
30research institution, and one shall be from a private cancer
31research institution. One member shall be appointed by the Speaker
32of the Assembly. One member shall be appointed by the President
33pro Tempore of the Senate.

34(b) The Governor shall appoint the president of the board from
35among those members appointed by the Governor, the Speaker of
36the Assembly, and the President pro Tempore of the Senate.

37(c) Members of the board shall serve without compensation but
38shall be reimbursed for any actual and necessary expenses incurred
39in connection with their duties as members of the board.

P4    1(d) The foundation shall be subject to the Nonprofit Public
2Benefit Corporation Law (Part 2 (commencing with Section 5110)
3of Division 2 of Title 2 of the Corporations Code), except that if
4there is a conflict with this chapter and the Nonprofit Public Benefit
5Corporation Law, this chapter shall prevail.

6(e) The California Health and Human Services Agency shall
7determine which department in the agency shall administer the
8foundation.

9

begin insert101992.end insert  

(a) Of the members of the board first appointed by
10the Governor pursuant to Section 101991, one member shall be
11appointed to serve a two-year term, one member shall be appointed
12to serve a three-year term, and one member shall be appointed to
13serve a four-year term.

14(b) Of the members of the board first appointed by the Speaker
15of the Assembly and the President pro Tempore of the Senate
16pursuant to Section 101991, each member shall be appointed to
17serve a four-year term.

18(c) Upon the expiration of the initial appointments for the board,
19each member shall be appointed to serve a four-year term.

20

begin insert101993.end insert  

(a) There is hereby created the Cancer Clinical Trials
21Fund. Notwithstanding Section 13340 of the Government Code,
22all money in the fund is continuously appropriated to the board
23without regard to fiscal years, for the administration and support
24of the program created pursuant to this chapter.

25(b) The Cancer Clinical Trials Foundation may solicit and
26receive funds from business, industry, foundations, and other
27private and public sources for the purpose of administering the
28Cancer Clinical Trials Grant Program to increase patient access
29to cancer clinical trials.

30(c) The board shall use no more than 20 percent of funds made
31available for the Cancer Clinical Trials Grant Program for
32administrative costs.

33

begin insert101994.end insert  

(a) Upon contribution of an unspecified amount of
34moneys to the foundation, the board shall establish the Cancer
35Clinical Trials Grant Program to increase patient access to cancer
36clinical trials in underserved or disadvantaged communities and
37populations, including among women and patients from racial
38and ethnic minority communities. The board shall determine the
39criteria to award grants, and may award grants to either or both
40of the following:

P5    1(1) Public and private research institutions and hospitals that
2conduct cancer clinical trials approved by the federal Food and
3Drug Administration.

4(2) Nonprofit organizations described in Section 501(c)(3) of
5the Internal Revenue Code of 1954 that are exempt from income
6tax under Section 501(a) of that code and that specialize in direct
7patient support for improved clinical trial enrollment and retention.

8(b) Grants awarded pursuant to subdivision (a) shall be used
9for activities to increase patient access to cancer clinical trials,
10including, but not limited to, any of the following:

11(1) Patient navigator services or programs.

12(2) Education and community outreach.

13(3) Patient-friendly technical tools to assist patients in
14identifying available clinical trials.

15(4) Translation and interpretation services of clinical trial
16information.

17(5) Counseling services for clinical trial participants.

18(6) Well-being services for clinical trial participants, including,
19but not limited to, physical therapy, pain management, stress
20management, and nutrition management.

21(7) Payment of ancillary costs for patients and caregivers,
22including, but not limited to:

23(A) Airfare during the clinical trial.

24(B) Lodging during the clinical trial.

25(C) Rental cars during the clinical trial.

26(D) Fuel during the clinical trial.

27(E) Local transportation via bus, train, or other public
28transportation during the clinical trial.

29(F) Meals during the clinical trial.

30(G) Child care costs during the clinical trial.

31

begin insert101995.end insert  

(a) Grant recipients shall report to the board to ensure
32the appropriate use of funds within one year of receiving a grant.

33(b) (1) The board shall report to the Legislature to ensure the
34appropriate use of the funds. The report shall include
35accountability measures, including, but not limited to, a description
36of how the funds were used, an evaluation of the grant program,
37and recommendations for the program. This report shall be
38submitted by January 1, 2020.

P6    1(2) The requirement for submitting a report imposed under
2paragraph (1) is inoperative on January, 1, 2024, pursuant to
3Section 10231.5 of the Government Code.

end insert
begin delete4

SECTION 1.  

Section 491 of the Business and Professions Code
5 is amended to read:

6

491.  

(a) Upon suspension or revocation of a license by a board
7on one or more of the grounds specified in Section 490, the board
8shall:

9(1) Send a copy of the provisions of Section 11522 of the
10Government Code to the ex-licensee.

11(2) Send a copy of the criteria relating to rehabilitation
12formulated under Section 482 to the ex-licensee.

13(b) Subdivision (a) shall be satisfied through first-class mail
14and by email if the board has an email address on file for the
15ex-licensee.

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