SB3199

SECTION 1. The legislature finds that addressing the mental health crisis affecting the residents of the State, particularly among veterans, first responders, and trauma survivors, is urgent. Suicide continues to be a leading cause of preventable death, and the State must explore all safe and effective treatment options supported by scientific evidence.

The legislature furthers finds that the United States Food and Drug Administration has granted breakthrough therapy designation to several emerging treatments, including 3,4‑methylenedioxymethamphetamine (MDMA)-assisted therapy for post-traumatic stress disorder and psilocybin-assisted therapy for treatment‑resistant depression, in recognition of their potential to provide significant improvements over existing interventions. As federal rescheduling and approval of these therapies are anticipated, the State must proactively prepare public health, clinical, and research systems for safe and equitable implementation.

The legislature also finds that several states, including New Mexico, Texas, Oregon, and Connecticut, have already taken meaningful steps toward establishing frameworks for clinical research, pilot programs, or medical access pathways for emerging mental health therapies. Without similar action, Hawaii risks falling behind and limiting access for residents and communities most affected by trauma.

Accordingly, the purpose of this Act is to establish a two‑year mental health emerging therapies task force within the department of health, charged with preparing the State for the integration of federally rescheduled breakthrough therapies, expanding pathways for clinical trials and clinical research in the State, and developing policy recommendations for safe, ethical, and culturally-informed implementation.

SECTION 2. (a) There is established the mental health emerging therapies task force within the department for administrative purposes only.

(b) The task force shall consist of the following thirteen members:

(1) One member representing the Thompson school of social work and public health at the university of Hawaii at Manoa with demonstrated history and expertise in breakthrough and emerging therapies for therapeutic applications, who shall serve as the chair of the taskforce;

(2) One member representing the department of health's alcohol and drug abuse division;

(3) One member representing the department of health's adult mental health division;

(4) One member representing the department of the attorney general;

(5) One member representing the office of wellness and resilience;

(6) One member representing the John A. Burns school of medicine at the university of Hawaii at Manoa; and

(7) Seven members to be invited by the chair, comprising:

(A) One member representing a veteran-serving institution;

(B) One member representing a Native Hawaiian health organization;

(D) Two licensed psychiatrists or psychologists with expertise in trauma and post-traumatic stress disorder; and

(E) Two community members with lived experience as veterans, first responders, or family caregivers.

The chair may invite any other stakeholder the chair deems appropriate to participate in the task force.

(1) Prepare the State for federal rescheduling and medical approval of 3,4‑methylenedioxymethamphetamine (MDMA), psilocybin, and other drugs or treatments designated as breakthrough therapies by the United States Food and Drug Administration;

(2) Identify opportunities and requirements for expanding local clinical trials, investigator-initiated research, and university-based research partnerships;

(3) Develop educational partnerships to help expand awareness of clinical research opportunities for potential beneficiaries of breakthrough therapies;

(4) Recommend training, certification, and workforce development pathways for licensed professionals who may administer or support emerging therapies;

(5) Evaluate best practices from other jurisdictions regarding patient safety, culturally-informed care, equity, access, and harm reduction;

(6) Develop a statewide implementation roadmap for integrating emerging therapies pending federal approval; and

(7) Make legislative, administrative, and other recommendations to support long-term adoption of mental health emerging therapies in the State.

(d) The department shall provide administrative, technical, and research support to the task force.

(e) The task force may form working groups, invite subject matter experts, and contract with third-party organizations to carry out its duties under this section.

(f) Members of the task force shall serve without compensation but may be reimbursed for reasonable expenses, including travel expenses, necessary for their duties.

(g) The task force shall submit to the legislature:

(1) An interim report of its findings and recommendations, including any proposed legislation, no later than twenty days prior to the convening of the regular session of 2027; and

(2) A final report of its findings and recommendations, including any proposed legislation, no later than twenty days prior to the convening of the regular session of 2028.

(h) For the purposes of this section:

"Breakthrough therapy" means any drug or treatment that has received breakthrough therapy designation by the United States Food and Drug Administration for a mental health or behavioral health condition.

"Clinical trial" means any phase II or phase III trials regulated by the United States Food and Drug Administration, investigator-initiated trials, or state-authorized research studies designed to evaluate safety, efficacy, treatment delivery, or implementation models.

"Department" means the department of health.

"Emerging therapy" means therapy using any psychedelic or entactogenic compound therapy that:

(1) Is undergoing clinical trials regulated by the United States Food and Drug Administration;

(2) Has been approved for marketing by the United States Food and Drug Administration; or

(3) Has been rescheduled or authorized for medical use under state law.

"Psychedelic" means a substance that produces altered states of consciousness with potential therapeutic benefit, including psilocybin, MDMA, and ibogaine.

SECTION 3. If any drug or treatment designated as a breakthrough therapy by the United States Food and Drug Administration is scheduled, rescheduled, or descheduled as a controlled substance under federal law, the board of pharmacy shall similarly control, reschedule, or deschedule the drug or treatment in accordance with section 329-11, Hawaii Revised Statutes, within ninety days after publication of the applicable notice in the Federal Register or interim final order.

SECTION 4. This Act shall take effect on July 1, 2026, and shall be repealed on June 30, 2028.

INTRODUCED BY:	_____________________________

THE SENATE	S.B. NO.	3199
THIRTY-THIRD LEGISLATURE, 2026
STATE OF HAWAII