STAND. COM. REP. NO. 2551

Honolulu, Hawaii

RE: S.B. No. 3199

S.D. 1

Honorable Ronald D. Kouchi

President of the Senate

Thirty-Third State Legislature

Regular Session of 2026

State of Hawaii

Sir:

Your Committee on Health and Human Services, to which was referred S.B. No. 3199 entitled:

"A BILL FOR AN ACT RELATING TO MENTAL HEALTH,"

begs leave to report as follows:

The purpose and intent of this measure is to:

(1) Establish the Mental Health Emerging Therapies Task Force within the Department of Health to prepare the State for the:

(A) Integration of breakthrough therapies;

(B) Expansion of pathways for clinical trials and clinical research; and

(C) Development of policy recommendations for safe, ethical, and culturally informed implementation of emerging therapies; and

(2) Require reports to the Legislature.

Your Committee received testimony in support of this measure from the Department of Health, Office of Wellness and Resilience, State Council on Mental Health, Clarity Project, MindWave Medicine, Veterans Exploring Treatment Solutions, Hawaiʻi Health & Harm Reduction Center, Drug Policy Forum of Hawaii, Reason for Hope, Veteran Mental Health Leadership Coalition, Hawaii Radiant Health, and forty individuals.

Your Committee received testimony in opposition to this measure from one individual.

Your Committee received comments on this measure from the Hawaiʻi Psychiatric Medical Association and Hawaii Medical Association.

Your Committee finds that there is an urgent need to address the mental health crisis affecting the residents of the State, particularly among veterans, first responders, and trauma survivors. Your Committee further 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. This measure establishes a responsible and evidence-based process that prepares the State for emerging therapies for individuals with serious mental illness.

Your Committee notes the concerns raised in the testimony of the Department of Health that breakthrough therapies involving psychedelic or entactogenic compounds require sophisticated research design, strict adherence to human participant protections, comprehensive informed consent protocols, secure pharmaceutical handling and storage procedures, data safety monitoring processes, and institutional legal review for liability and compliance. To this end, an existing entity with qualified research investigators, experienced clinical trial personnel, and established compliance frameworks is better positioned to ensure safe and effective outcomes rather than the Department of Health. Therefore, amendments to this measure are necessary to address this concern.

Your Committee has amended this measure by:

(1) Changing the administrative placement of the Mental Health Emerging Therapies from within the Department of Health to an entity with demonstrated expertise in primary scientific research and pharmaceutical or medical education and requiring that entity to provide administrative technical and research support to the task force;

(2) Inserting language to clarify that:

(A) Administrative placement of the task force within an entity with demonstrated expertise in primary scientific research and pharmaceutical or medical education shall not be construed to transfer, delegate, diminish, expand, or otherwise modify any regulatory, enforcement, licensing, scheduling, or rulemaking authority vested in the Department of Health, Board of Pharmacy, or any other state agency; and

(B) All statutory authority relating to controlled substances, professional licensure, and public health regulation shall remain with the appropriate executive branch agencies as provided by law;

(3) Amending section 1 to reflect its amended purpose;

(4) Inserting an effective date of January 30, 2050, to encourage further discussion; and

(5) Making a technical, nonsubstantive amendment for the purposes of clarity and consistency.

As affirmed by the record of votes of the members of your Committee on Health and Human Services that is attached to this report, your Committee is in accord with the intent and purpose of S.B. No. 3199, as amended herein, and recommends that it pass Second Reading in the form attached hereto as S.B. No. 3199, S.D. 1, and be referred to your Committee on Ways and Means.

Respectfully submitted on behalf of the members of the Committee on Health and Human Services,

________________________________

JOY A. SAN BUENAVENTURA, Chair