BILL ANALYSIS Ó AB 1823 Page 1 Date of Hearing: April 27, 2016 ASSEMBLY COMMITTEE ON APPROPRIATIONS Lorena Gonzalez, Chair AB 1823 (Bonilla) - As Amended April 12, 2016 ----------------------------------------------------------------- |Policy |Health |Vote:|17 - 0 | |Committee: | | | | | | | | | | | | | | |-------------+-------------------------------+-----+-------------| | |Higher Education | |13 - 0 | | | | | | | | | | | ----------------------------------------------------------------- Urgency: No State Mandated Local Program: NoReimbursable: No SUMMARY: This bill requests the University of California (UC) establish and designate a nonprofit public benefit corporation with the authority to solicit and receive funds from business, industry, foundations, and other private and public sources for the purpose of administering the Cancer Clinical Trials Program (the program) to increase patient access to cancer clinical trials. Specifically, this bill: AB 1823 Page 2 1)Allows the program administrator to solicit and receive funds from business, industry, foundations, research organizations, government agencies, individuals, and other private and public sources, to be deposited in a fund established by the program administrator for these purposes. 2)Requires that the UC be reimbursed from the fund for any money allocated by the UC to establish and operate the program. 3)Requires a board, upon receipt of $500,000 funding, to establish the 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. 4)Requires the board to determine the criteria to award grants, and authorize grants to be awarded to either research institutions or nonprofits. 5)Requires grants to be used for activities to increase patient access to cancer clinical trials, including, but not limited to: patient navigator services or programs; education and community outreach; translation and interpretation services of clinical trial information; patient-friendly technical tools to assist patients in identifying available clinical trials; payment of ancillary costs for patients and caregivers. 6)Authorizes the UC to terminate the program if it determines that moneys in the fund are insufficient to establish or sustain the program. Specifies that all moneys in the fund AB 1823 Page 3 (after repayment of expenses) must be distributed to appropriate organizations before such dissolution. 7)Requires that if the fund has not received $500,000 by January 1, 2021, then all moneys (after repayment of startup expenses) shall be returned to the donors on a pro rata basis. FISCAL EFFECT: 1)One-time costs in the range of $500,000 to establish the nonprofit foundation, develop grant guidelines, provide initial administrative support to the foundation, and begin the program (GF or other unknown public and private funds). Any costs to UC would be reimbursed by the fund specified in the bill. 2)Unknown annual cost pressure to award grants and provide administrative support to the new foundation (GF or other unknown public and private funds). The amount of grant funding the foundation will be able to award will depend on future donations, as will the level of administrative support needed to award the grants and manage the foundation. Given the types of direct services that the grants are expected to fund, it is reasonable to assume the level of funding required to make this a meaningful program would be in the millions annually. COMMENTS: 1)Purpose. This bill is intended to improve the diversity of patients participating in FDA-approved cancer clinical trials. AB 1823 Page 4 The author asserts underrepresentation of certain ethnic and socioeconomic groups will be addressed by creating a privately funded state grant program to help patients pay for the ancillary costs associated with participation in these trials. The bill is supported by oncologists, the California Chronic Care Coalition, Health Access California, and other groups, and has no opposition. 2)Background. Clinical trials are a critical step in the discovery of new prevention, diagnostic, and treatment methods for cancer. Racial and ethnic minorities, older adults, rural residents, and individuals of lower socioeconomic status are underrepresented among participants in cancer-related trials. Without adequate representation of these populations in clinical trials, researchers cannot learn about potential difference among groups and cannot ensure the generalization of results. In addition, participation in clinical trials increases access to state-of-the-art cancer care. Barriers to participation include lack of awareness, language/linguistic differences, mistrust, practical obstacles, public misconception, and physician lack of awareness. 3)Prior legislation. AB 1060 (Bonilla) of 2015, was similar to this bill, but housed the program within the California Health and Human Services Agency (CHHSA). It was vetoed by Governor Brown, stating "[n]umerous private organizations already perform this fundraising function. While I support eliminating barriers to take part in clinical trials, I am hesitant to place this new burden on the [CHHSA] which is managing a huge expansion of our health care system." This bill establishes the program in the UC instead of within a state agency. 4)Staff Comments. It appears the intent of the bill is that the program be privately funded through donations. The author may AB 1823 Page 5 wish to clarify that the program is not envisioned to be funded by the state. Analysis Prepared by:Lisa Murawski / APPR. / (916) 319-2081