The California Emerging Therapies Research Partnership Act.

Existing law, the California Uniform Controlled Substances Act, classifies controlled substances into 5 schedules and places the greatest restrictions and penalties on the use of substances placed in Schedule I. Existing law classifies, among others, psilocybin, ibogaine, and dimethyltryptamine as Schedule I substances, classifies ketamine as a Schedule III substance, and prohibits various actions related to those substances, including their sale, possession, transportation, manufacture, or cultivation. Existing law authorizes a person who is lawfully entitled to use specified controlled substances under applicable federal laws or regulations to obtain and use those substances for approved purposes in bona fide research, instruction, or analysis. This bill, the California Emerging Therapies Research Partnership Act, would establish the California Emerging Therapies Research Partnership Fund, a continuously appropriated fund, within the State Treasury, to be administered by the State Department of Health Care Services (department) and the Department of Veterans Affairs, to, among other things, issue grants to a University of California campus to serve as an anchor institution for a federally registered emerging therapies clinical trial. The bill would define "emerging therapies" for these purposes to mean psilocybin, ibogaine, 3,4-methylenedioxymethamphetamine, dimethyltryptamine, and ketamine when used in the context of a federally registered clinical trial, as specified. The bill would prohibit General Fund moneys from being deposited into the fund and would authorize the fund to receive federal grants, awards, and partnership payments and gifts, bequests, and philanthropic contributions made to the state, upon appropriation by the Legislature. The bill would prohibit the use of fund moneys for, among other things, purchasing, distributing, or administering a controlled substance. By creating a continuously appropriated fund, this bill would make an appropriation. This bill would require the California Health and Human Services Agency (agency) , in coordination with the department, the Department of Veterans Affairs, and the office of the President of the University of California, to submit a complete application for partnership designation to the federal Advanced Research Projects Agency for Health (ARPA-H) , as specified. The bill would require the department, within 90 days of receiving ARPA-H partnership designation, to execute a data-sharing memorandum of understanding with specified federal agencies to establish protocols for the sharing of deidentified, aggregated clinical trial outcome data. The bill would authorize specified legislative committees to request interim briefings from the agency on the status of the ARPA-H partnership application and would require the agency to respond to a request for briefing within 30 days. The bill would require the department to request that the University of California participate in specific activities. This bill would require the office of the President of the University of California to submit a readiness certification to the agency, the Department of Finance, and the Legislature, as specified. The bill would require the Department of Veterans Affairs to convene the California Veteran Emerging Therapies Research Advisory Council, with specified membership, to, among other things, serve as the primary advisory body to the department, the Department of Veterans Affairs, and the agency on matters relating to emerging therapies research for veterans and other priority populations. The bill would require the council to submit a needs assessment to the Department of Veterans Affairs, the agency, and the Legislature, as specified. The bill would require the agency to submit a federal readiness report to the Legislature and the Department of Finance, no later than January 1, 2028, that addresses, among other things, the status of California's ARPA-H partnership designation and the total amount of federal moneys received, as specified. This bill would provide that its provisions are severable.