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SB3199
THE SENATE
S.B. NO.
3199
THIRTY-THIRD LEGISLATURE, 2026
STATE OF HAWAII
A BILL FOR AN ACT
relating
to mental health
.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:
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SECTION 1.
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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.
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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.
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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.
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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.
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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.
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Without similar action,
Hawaii risks falling behind and limiting access for residents and communities
most affected by trauma.
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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.
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SECTION 2.
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(a)
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There is established the
mental health emerging therapies task force within the department for
administrative purposes only.
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(b)
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The
task force shall consist of the following thirteen members:
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(1)
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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;
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(2)
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One
member representing the department of health's alcohol and drug abuse division;
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(3)
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One
member representing the department of health's adult mental health division;
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(4)
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One
member representing the department of the attorney general;
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(5)
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One
member representing the office of wellness and resilience;
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(6)
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One
member representing the John A. Burns school of medicine at the university of
Hawaii at Manoa; and
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(7)
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Seven
members to be invited by the chair, comprising:
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(A)
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One
member representing a veteran-serving institution;
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(B)
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One
member representing a Native Hawaiian health organization;
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(C)
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One member representing an expert in
controlled‑substances laws and regulations;
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(D)
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Two licensed psychiatrists or psychologists
with expertise in trauma and post-traumatic stress disorder; and
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(E)
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Two community members with lived experience as
veterans, first responders, or family caregivers.
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The chair may invite any other stakeholder
the chair deems appropriate to participate in the task force.
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(c)
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The task force shall:
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(1)
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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;
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(2)
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Identify
opportunities and requirements for expanding local clinical trials,
investigator-initiated research, and university-based research partnerships;
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(3)
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Develop
educational partnerships to help expand awareness of clinical research
opportunities for potential beneficiaries of breakthrough therapies;
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(4)
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Recommend
training, certification, and workforce development pathways for licensed
professionals who may administer or support emerging therapies;
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(5)
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Evaluate
best practices from other jurisdictions regarding patient safety, culturally-informed
care, equity, access, and harm reduction;
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(6)
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Develop
a statewide implementation roadmap for integrating emerging therapies pending
federal approval; and
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(7)
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Make
legislative, administrative, and other recommendations to support long-term
adoption of mental health emerging therapies in the State.
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(d)
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The department shall provide administrative, technical, and research
support to the task force.
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(e)
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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.
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(f)
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Members of the task force shall serve without compensation but may be
reimbursed for reasonable expenses, including travel expenses, necessary for
their duties.
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(g)
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The task force shall submit to the legislature:
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(1)
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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
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(2)
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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.
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(h)
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For the purposes of this section:
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"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.
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"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.
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"Department" means the department
of health.
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"Emerging therapy" means therapy
using any psychedelic or entactogenic compound therapy that:
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(1)
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Is
undergoing clinical trials regulated by the United States Food and Drug
Administration;
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(2)
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Has
been approved for marketing by the United States Food and Drug Administration;
or
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(3)
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Has
been rescheduled or authorized for medical use under state law.
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"Psychedelic" means a substance
that produces altered states of consciousness with potential therapeutic
benefit, including psilocybin, MDMA, and ibogaine.
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SECTION 3.
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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.
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SECTION 4.
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This Act shall take effect on July 1, 2026,
and shall be repealed on June 30, 2028.
INTRODUCED
BY:
_____________________________
Report Title:
DOH; Mental
Health; Emerging Therapies; Task Force; Reports
Description:
Establishes
the Mental Health Emerging Therapies Task Force to
prepare the State for
the integration of breakthrough therapies, expansion of pathways for clinical
trials and clinical research, and development of policy recommendations for safe,
ethical, and culturally informed implementation of emerging therapies.
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Requires reports to the Legislature.
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Sunsets 6/30/2028.
The summary description
of legislation appearing on this page is for informational purposes only and is
not legislation or evidence of legislative intent.