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.

(a) The Legislature finds and declares all of the following:

(1) California is home to the largest concentration of federally registered emerging psychedelic therapies clinical trials in the United States, anchored at the University of California campuses at San Francisco, San Diego, Los Angeles, Berkeley, and Davis.

(2) On April 18, 2026, the President of the United States issued an executive order directing the Advanced Research Projects Agency for Health (ARPA-H) to allocate a minimum of $50,000,000 in federal research partnership funds to states that establish qualifying emerging therapies research programs.

(3) The State of Texas has committed more than $100,000,000 in state funds to ibogaine and psilocybin clinical research and is actively applying for ARPA-H federal partnership designation, which creates competitive urgency for California.

(4) More than 6,000 veterans die by suicide in the United States each year, at a rate approximately twice that of the civilian population. Emerging psychedelic-assisted therapies show significant clinical promise in treating post-traumatic stress disorder, treatment-resistant depression, and opioid use disorder in veteran populations.

(5) In 2023, Governor Gavin Newsom vetoed Senate Bill 58, citing the need for a regulated therapeutic framework before California expanded access to psychedelic substances. The California Emerging Therapies Research Partnership Act is that framework. It is a research infrastructure and federal funding capture strategy that does not alter California’s controlled substances law, does not create a therapeutic access program, and does not authorize personal use.

(6) Assembly Bill 1103, enacted in 2025, establishes California’s procedural foundation for expedited psychedelic research approvals. This act, the California Emerging Therapies Research Partnership Act, builds upon that foundation by creating the institutional structure and federal partnership mandate necessary to make California a qualifying ARPA-H partner state.

(b) It is the intent of the Legislature to authorize California to receive federal emerging therapies research funds through the University of California system, to direct the relevant state agencies to apply for such funds without delay, and to establish accountability mechanisms to report progress to the Legislature.

Division 10.3. California Emerging Therapies Research Partnership Act

11730.

This division shall be known, and may be cited, as the California Emerging Therapies Research Partnership Act.

11730.5.

For purposes of this division, the following definitions apply:

(a) “Agency” means the California Health and Human Services Agency.

(b) “ARPA-H” means the Advanced Research Projects Agency for Health within the United States Department of Health and Human Services.

(c) “Emerging therapies” means psilocybin, ibogaine, 3,4-methylenedioxymethamphetamine, dimethyltryptamine, and ketamine when used in the context of a federally registered clinical trial conducted under an investigational new drug application that is approved by the United States Food and Drug Administration.

(d) “Federally registered clinical trial” means a clinical research study registered with ClinicalTrials.gov conducted pursuant to a United States Food and Drug Administration-approved investigational new drug, a research exemption pursuant to Section 56.104 of Subpart A of Part 56 of Subchapter A of Chapter I of Title 21 of the Code of Federal Regulations, or an equivalent federal authorization.

(e) “Fund” means the California Emerging Therapies Research Partnership Fund established pursuant to Section 11731.

11730.9.

The State Department of Health Care Services shall request that the University of California participate in the activities described in this division.

11731.

(a) The California Emerging Therapies Research Partnership Fund, a special deposit fund, is hereby established within the State Treasury.

(1) Notwithstanding Section 13340 of the Government Code, moneys in the fund are continuously appropriated to the State Department of Health Care Services and the Department of Veterans Affairs without regard to fiscal year and shall be used for the purposes set forth in this division.

(2) Moneys in the fund are not General Fund revenues and are not subject to appropriation in the annual Budget Act.

(b) The fund may receive any of the following:

(1) Federal grants, awards, and partnership payments received pursuant to a ARPA-H partnership designation or a substantially similar federal emerging therapies research program.

(2) Federal grants or research awards received from the United States Department of Veterans Affairs, the National Institutes of Health, or another federal agency in connection with emerging therapies clinical research.

(3) Gifts, bequests, and philanthropic contributions made to the state for emerging therapies research purposes, upon appropriation by the Legislature.

(c) General Fund moneys shall not be deposited into the fund. The existence of the fund does not constitute a commitment of state funds or a General Fund obligation of any kind.

11731.5.

(a) Moneys in the fund shall be used only for the following purposes:

(1) Issue grants to a University of California campus to serve as an anchor institution for a federally registered emerging therapies clinical trial, including direct costs of trial operations, patient recruitment infrastructure, and data reporting.

(2) Costs incurred by the State Department of Health Care Services in executing and maintaining data-sharing memoranda of understanding with the United States Department of Health and Human Services, the United States Food and Drug Administration, and the United States Department of Veterans Affairs.

(3) Costs incurred by the Department of Veterans Affairs in convening and staffing the California Veteran Emerging Therapies Research Advisory Council convened pursuant to Section 11735.

(4) Administrative costs of the State Department of Health Care Services and the office of the President of the University of California in implementing this division, not to exceed 5 percent of funds received in a fiscal year.

(b) Moneys in the fund shall not be used to do any of the following:

(1) Purchase, distribute, or administer a controlled substance.

(2) Establish a therapeutic access program.

(3) Support an activity that is not specifically authorized in this division.

11732.

(a) No later than 60 days after the operative date of the act that added this division, the agency, in coordination with the State Department of Health Care Services, the Department of Veterans Affairs, and the office of the President of the University of California, shall submit a complete application for partnership designation pursuant to the April 18, 2026, executive order or any substantially equivalent federal program to ARPA-H for the purpose of making California eligible to receive federal emerging therapies research moneys.

(b) The application submitted pursuant to subdivision (a) shall include, at minimum, all of the following:

(1) The University of California System Research Readiness Certification submitted by the office of the President of the University of California pursuant to Section 11734.

(2) A description of the California Emerging Therapies Research Partnership Fund and its legal authority to receive federal awards.

(3) A description of the California Veteran Emerging Therapies Research Advisory Council convened pursuant to Section 11735.

(4) A data-sharing framework demonstrating California’s capacity to share deidentified clinical trial outcome data with federal partner agencies in compliance with applicable federal privacy law.

(5) Within 90 days of partnership designation, a proposed schedule for execution of data-sharing memoranda of understanding with the United States Department of Health and Human Services, the United States Food and Drug Administration, and the United States Department of Veterans Affairs.

(c) If ARPA-H or a substantially similar federal program issues supplemental guidance, an amendment to application requirements, or an alternative funding vehicle after the effective date of this division, the agency shall amend or supplement California’s application, as necessary, to maintain eligibility and notify the Legislature within 30 days of a material change to the federal program requirements.

11732.5.

(a) The Joint Legislative Budget Committee, the Assembly Committee on Health, the Senate Committee on Health, the Assembly Committee on Military and Veterans Affairs, and the Senate Committee on Military and Veterans Affairs may request an interim briefing from the agency on the status of the ARPA-H partnership application at any time following its submission.

(b) The agency shall respond to a request submitted pursuant to subdivision (a) within 30 days.

11733.

(a) Within 90 days of receiving ARPA-H partnership designation, the State Department of Health Care Services shall execute a data-sharing memorandum of understanding with each of the following federal agencies:

(1) The United States Department of Health and Human Services.

(2) The United States Food and Drug Administration.

(3) The United States Department of Veterans Affairs.

(b) Each memorandum of understanding shall establish protocols for the sharing of deidentified, aggregated clinical trial outcome data generated by a University of California anchor institution with the relevant federal agency for the purposes of advancing emerging therapies research and supporting federal regulatory review.

(c) A memorandum of understanding executed pursuant to this section shall not require the disclosure of personally identifiable patient information or individually identifiable health information in a manner inconsistent with the federal Health Insurance Portability and Accountability Act of 1996 (Public Law 104-191) or the Confidentiality of Medical Information Act (Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code).

11734.

(a) No later than 45 days after the operative date of the act that added this division, the office of the President of the University of California shall submit a University of California System Research Readiness Certification identifying the emerging therapies research capacity of the University of California system to the agency, the Department of Finance, and the Legislature.

(b) The certification shall include, for each relevant University of California campus, including, at a minimum, University of California San Francisco, University of California San Diego, University of California Los Angeles, University of California Berkeley, and University of California Davis, all of the following:

(1) A list of all active or pending federally registered clinical trials in emerging therapies, including the applicable investigational new drug or protocol number, the sponsoring faculty investigator, the trial phase, current enrollment status, and estimated completion date.

(2) A description of the campus institutional review board infrastructure, including the review board’s experience with Schedule I substance research protocols.

(3) An assessment of the campus’s patient recruitment infrastructure and capacity to enroll veterans, first responders, and other priority populations in emerging therapies clinical trials.

(4) An identification of existing research partnerships with United States Department of Veterans Affairs medical centers affiliated with, or proximate to, the campus.

(5) An assessment of data infrastructure capacity to support deidentified outcome data sharing with state and federal agencies pursuant to Section 11733.

(c) The office of the President of the University of California shall consult with University of California campus research administrations, the University of California Academic Senate, and the University of California Health system in preparing the certification.

(d) The certification shall be transmitted to the agency and incorporated by reference into California’s ARPA-H partnership application submitted pursuant to Section 11732.

11735.

(a) The Department of Veterans Affairs shall convene the California Veteran Emerging Therapies Research Advisory Council no later than 90 days after the operative date of the act that added this division.

(b) The council shall include, at minimum, all of the following members:

(1) The Secretary of Veterans Affairs, or their designee, who shall serve as cochair.

(2) A University of California faculty researcher with active emerging therapies clinical trial experience, appointed by the office of the President of the University of California, who shall serve as cochair.

(3) One representative from each of at least three California-based veterans service organizations, appointed by the Secretary of Veterans Affairs.

(4) A licensed physician with clinical experience in psychedelic-assisted therapy, appointed by the Director of Health Care Services.

(5) A representative of the United States Department of Veterans Affairs Northern California Health Care System or the United States Department of Veterans Affairs Southern California Health Care System, appointed by the Department of Veterans Affairs in coordination with the United States Department of Veterans Affairs.

(6) A representative of the State Department of Health Care Services.

(7) A representative of the State Department of Public Health.

(8) At least two members with lived experience as veterans who have accessed emerging therapies treatment, appointed by the Secretary of Veterans Affairs.

(c) Council members shall serve without compensation.

(d) The Department of Veterans Affairs shall provide administrative staffing for the council from existing appropriations.

11735.5.

(a) The council shall do all of the following:

(1) Serve as the primary advisory body to the Department of Veterans Affairs, the State Department of Health Care Services, and the agency on matters relating to emerging therapies research for veterans and other priority populations.

(2) Advise on veteran patient recruitment strategies and enrollment pipelines for University of California-anchored clinical trials.

(3) Develop guidance on culturally appropriate and trauma-informed protocols for veteran participation in emerging therapies research.

(4) Recommend priority conditions and populations for emerging therapies research, including post-traumatic stress disorder, treatment-resistant depression, opioid use disorder, and traumatic brain injury.

(5) Advise on the content of the federal readiness report required pursuant to Section 11736.

(b) (1) No later than 180 days after the operative date of the act that added this division, the council shall submit a California Veteran Emerging Therapies Research Needs Assessment to the Department of Veterans Affairs, the agency, and the Legislature.

(2) The assessment shall identify veteran mental health and substance use treatment gaps addressable through emerging therapies research and shall serve as a supporting document for California’s federal partnership application.

11736.

(a) No later than January 1, 2028, the agency shall submit a federal readiness report to the Legislature and the Department of Finance that addresses, at minimum, all of the following:

(1) The status of California’s ARPA-H partnership designation application, including the date of submission, a federal agency response, if any, and the current designation status.

(2) The status of each data-sharing memorandum of understanding required pursuant to Section 11733, including execution date and scope.

(3) The total amount of federal moneys received by the state or directly by University of California campuses pursuant to this division.

(4) The number of active federally registered emerging therapies clinical trials at University of California campuses, the total enrolled participants, and the number of enrolled veteran participants.

(5) Recommendations for statutory or regulatory changes necessary to maintain or expand California’s federal partnership eligibility.

(b) The report required by subdivision (a) shall be submitted in compliance with Section 9795 of the Government Code.

11737.

This division does not do any of the following:

(a) Appropriate General Fund moneys. The California Emerging Therapies Research Partnership Fund established pursuant to Section 11731 shall not receive General Fund moneys and does not create a state obligation or liability against the General Fund.

(b) Amend, repeal, or supersede any provision of the California Uniform Controlled Substances Act (Division 10 (commencing with Section 11000)). The possession, cultivation, distribution, or administration of a controlled substance outside of a federally registered clinical trial remains subject to applicable state and federal law.

(c) Create a therapeutic access program, a personal use exemption, or a regulatory licensing framework for the provision of emerging therapies to the general public.

(d) Guarantee federal partnership designation or the receipt of federal moneys. The mandates in this division are obligations of state agencies to apply and to act and do not create entitlements to federal awards.

11738.

The provisions of this division are severable. If any provision of this division or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.