| 47 | | - | SECTION 1. The legislature finds that addressing the mental health crisis affecting the residents of Hawaii, particularly veterans who face disproportionately high rates of suicide and post-traumatic stress disorder (PTSD), is of the utmost importance. Suicide is a leading cause of death among veterans, with studies indicating that veterans are at a significantly higher risk of suicide compared to the general population, underscoring the urgent need for innovative and effective mental health interventions. The legislature further finds that the United States Food and Drug Administration has granted breakthrough therapy designation to emerging treatments, such as MDMA-assisted therapy for PTSD and psilocybin therapy for treatment-resistant depression, recognizing their potential to offer rapid and substantial improvements over existing treatments. These therapies, when administered in clinical settings with the proper safeguards, have demonstrated promising results in reducing symptoms of PTSD and suicidal ideation, particularly among veterans who have not responded to conventional treatments. The legislature also finds that establishing a mental health emerging therapies pilot project within the office of wellness and resilience, using private moneys to match state funds, will enable the State to assess the feasibility, effectiveness, and accessibility of these cutting-edge therapies for individuals in Hawaii who could stand to benefit the most. By investing in evidence-based emerging therapies through the pilot project, the State can lead the way in expanding mental health care options, improving health outcomes, and reducing veteran suicide rates. Accordingly, the purpose of this Act is to establish and appropriate funds for a two-year mental health emerging therapies pilot program within the office of wellness and resilience. SECTION 2. (a) There is established a two-year mental health emerging therapies pilot program within the office of wellness and resilience to support clinical research and the development of emerging therapies for the treatment of mental health and behavioral health disorders. (b) The pilot program may: (1) Establish partnerships with public and private stakeholders, such as public agencies, academic institutions, health care providers, or any other as the office of wellness and resilience may deem appropriate; (2) Fund phase three clinical trials of treatments or therapies that have received a breakthrough-therapy designation from the United States Food and Drug Administration, investor-initiated clinical trails, or other clinical trials, including trials to: (A) Inform optimal methods of treatment delivery; (B) Inform transdiagnostic safety and efficacy; and (C) Inform patient access, patient support services, and real world data collection and analysis; (3) Fund education and training opportunities for mental health professionals; (4) Support public education and harm reduction; (5) Fund implementation studies, including research and analyses of best practices, cost effectiveness, and methods to reduce treatment costs; and (6) Provide recommendations for expanding patient access, patient support services, and other means by which those with mental health and behavioral health needs may access emerging therapies. (c) The office of wellness and resilience may contract with a third party to administer funding under the mental health emerging therapies pilot program. (d) The office of wellness and resilience may adopt rules without regard to chapter 91, Hawaii Revised Statutes, to administer the pilot program. (e) The office of wellness and resilience shall submit a report of its activities to the legislature no later than twenty days prior to the convening of the regular sessions of 2026 and 2027. Each report shall include but not be limited to: (1) The studies funded and efforts supported by the mental health emerging therapies pilot program in the previous year; (2) Any findings and recommendations; and (3) Any proposed legislation. (f) The mental health emerging therapies pilot program shall cease to exist on June 30, 2027. (g) For the purposes of this Act, "emerging therapies" means any psychedelic or entactogenic compound or mixture that is: (1) Undergoing clinical trials regulated by the United States Food and Drug Administration for the treatment of mental health or behavioral health conditions; (2) Approved by the United States Food and Drug administration for marketing in interstate commerce; or (3) Approved for medical use under state law. SECTION 3. There is appropriated out of the general revenues of the State of Hawaii the sum of $ or so much thereof as may be necessary for fiscal year 2025-2026 and the same sum or so much thereof as may be necessary for fiscal year 2026-2027 for the mental health emerging therapies pilot program. The sums appropriated shall be expended by the office of wellness and resilience for the purposes of this Act. SECTION 4. This Act shall take effect on July 1, 3000. |
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| 47 | + | SECTION 1. Chapter 321, Hawaii Revised Statutes, is amended by adding a new section to part I to be appropriately designated and to read as follows: "§321- Mental health emerging therapies special fund. (a) There is established in the state treasury the mental health emerging therapies special fund to be administered by the department of health. The following moneys shall be deposited into the fund: (1) Appropriations by the legislature to the special fund; and (2) Gifts, donations, and grants from public agencies and private persons. All interest earned or accrued on moneys deposited into the special fund shall become part of the special fund. (b) Moneys in the special fund shall be expended to support clinical research and the development of emerging therapies for the treatment of mental health and behavioral health disorders. Among other purposes, the moneys may be used for: (1) Establishing public-private partnerships to jointly fund phase three clinical trials of United States Food and Drug Administration breakthrough therapies; (2) Funding investor-initiated clinical trials, including trials to: (A) Inform optimal methods of treatment delivery; and (B) Inform transdiagnostic safety and efficacy; (3) Establishing compassionate use programs, including data collection and analysis; (4) Funding education and training opportunities for mental health professionals; (5) Supporting public education and harm reduction; (6) Developing patient access pilot programs, including real-world data collection and analysis; (7) Establishing community programs to provide long-term patient support services; and (8) Funding implementation studies, including research and analyses of best practices, cost effectiveness, and methods to reduce treatment costs. (c) The department shall adopt rules pursuant to chapter 91 for the administration of the mental health emerging therapies special fund. (d) The department shall submit to the legislature no later than twenty days prior to the convening of each regular session, beginning with the regular session of 2026, a report of: (1) The studies funded and efforts supported by the mental health emerging therapies special fund in the previous year; (2) The department's findings and recommendations; and (3) Any proposed legislation. (e) For the purposes of this section: "Compassionate use" means treating patients suffering from terminal or life-threatening conditions, including treatment‑resistant mental health conditions under either the federal Right to Try Act, Public Law 115-176, or the Food and Drug Administration Expanded Access program (21 U.S.C. 360bbb(b)). "Emerging therapies" means any psychedelic or entactogenic compound or mixture that is either: (1) Undergoing clinical trials regulated by the United States Food and Drug Administration for the treatment of a mental or behavioral health condition; (2) Approved by the United States Food and Drug Administration for marketing in interstate commerce; or (3) Approved for medical use under Hawaii law. "United States Food and Drug Administration breakthrough therapies" means investigational drugs that have been granted breakthrough therapy designation by the United States Food and Drug Administration under section 506(a) of the Food, Drug, and Cosmetic Act (21 U.S.C. 356(a))." SECTION 2. There is appropriated out of the general revenues of the State of Hawaii the sum of $ or so much thereof as may be necessary for fiscal year 2025-2026 and the same sum or so much thereof as may be necessary for fiscal year 2026-2027 for deposit into the mental health emerging therapies special fund. SECTION 3. There is appropriated out of the mental health emerging therapies special fund the sum of $ or so much thereof as may be necessary for fiscal year 2025-2026 and the same sum or so much thereof as may be necessary for fiscal year 2026-2027 for supporting clinical research and the use of emerging therapies for treating mental and behavioral health disorders. The sums appropriated shall be expended by the department of health for the purposes of this Act. SECTION 4. New statutory material is underscored. SECTION 5. This Act shall take effect on December 31, 2050. |
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