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SENATE BILL 2149
By Walley
HOUSE BILL 2075
By Terry
HB2075
010579
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AN ACT to amend Tennessee Code Annotated, Title 9;
Title 33; Title 53; Title 63 and Title 68, relative to
clinical trials.
WHEREAS, ibogaine is a naturally occurring psychoactive compound that has
demonstrated promise in treating a wide range of mental health and neurological conditions,
including opioid use disorder, post-traumatic stress disorder (PTSD), traumatic brain injury,
depression, anxiety, multiple sclerosis, and more; and
WHEREAS, ibogaine is classified as a Schedule I drug by the federal government,
making research and access difficult, and forcing patients to seek unregulated treatment
abroad; and
WHEREAS, multiple states have authorized and funded research into ibogaine, and
Texas has launched a research consortium facilitating a multistate effort to conduct clinical trials
on ibogaine as a medical treatment; and
WHEREAS, recent studies demonstrate ibogaine's ability to significantly reduce
symptoms of substance use addiction, PTSD, depression, and anxiety after one treatment; and
WHEREAS, ibogaine treatment has been associated with marked improvements in
patients with traumatic brain injury, with results that include significant improvements in
concentration, information processing, memory, and impulse control; and
WHEREAS, Stanford University has studied the impact of treatment on veterans who
have been supported by nonprofit organizations that facilitate veterans traveling to ibogaine
retreats abroad with reported substantial improvements in depression scores, PTSD symptoms,
anxiety, sleep, quality of life, substance abuse, and emotional well-being; and
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WHEREAS, trusted institutions, including the federal Food and Drug Administration and
Department of Veterans Affairs, are actively supporting and investing in research on
psychedelic-assisted therapies for PTSD and related mental health conditions; and
WHEREAS, expediting research into the medical potential of ibogaine is an effective and
safe way to ensure patients have access to a potentially groundbreaking treatment; now,
therefore,
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF TENNESSEE:
SECTION 1. Tennessee Code Annotated, Title 33, is amended by adding the following
as a new chapter:
33-12-101. Short title.
This chapter is known and may be cited as the "Helping Open Pathways to
Effective (HOPE) Treatment Act."
33-12-102. Chapter definitions.
As used in this chapter:
(1) "Commissioner" means the commissioner of mental health and
substance abuse services;
(2) "Department" means the department of mental health and substance
abuse services;
(3) "Drug developer" means a pharmaceutical company, biotechnology
company, or contract development and manufacturing organization engaged in
drug development and manufacturing;
(4) "Hospital" means any institution, place, building, or agency
represented and held out to the general public as ready, willing, and able to
furnish care, accommodations, facilities, and equipment for the use, in
connection with the services of a physician or dentist, of one (1) or more
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nonrelated persons who may be suffering from deformity, injury, or disease or
from any other condition for which nursing, medical, or surgical services would be
appropriate for care, diagnosis, or treatment;
(5) "Ibogaine" means ibogaine and ibogaine-based therapeutics,
including ibogaine analogs; and
(6) "Institution of higher education" means any postsecondary institution
operated by the board of trustees for the University of Tennessee system, the
board of regents, or a state university board that offers courses of instruction
leading to a certificate or degree.
33-12-103. Establishment of cohort.
(a) A cohort may be established under this section and apply for department
selection under this chapter to conduct drug development clinical trials with ibogaine and
secure the United States food and drug administration's approval of ibogaine as a
medication for the treatment of:
(1) Opioid use disorder;
(2) Co-occurring substance use disorder; and
(3) Any other neurological or mental health condition for which ibogaine
demonstrates efficacy.
(b) A cohort established under this section must include one (1) or more of each
of the following entities:
(1) A drug developer;
(2) A research institution, which may be an institution of higher
education; and
(3) A hospital.
33-12-104. Lead institution - Administration - Personnel.
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(a) A cohort established under this chapter shall select a project lead from
among the cohort's members to represent the cohort and perform administrative
functions under this chapter, including contracting with and reporting to the department
as required by this chapter. It is the intent of the general assembly that the research
institution be selected as project lead.
(b) A project lead selected by the department under this chapter may employ
personnel, including clinical, administrative, and data management personnel, necessary
to support any cohort member's activities related to drug development clinical trials
conducted under this chapter. Such activities may include participation in the Texas
consortium for the purpose of clinical trial collaboration.
33-12-105. Cohort proposal.
(a) The cohort project lead shall submit to the department a proposal and
request for funding on behalf of the cohort for purposes of conducting ibogaine drug
development clinical trials in accordance with this chapter.
(b) A proposal submitted under subsection (a) must provide:
(1) The identity of all cohort members;
(2) A detailed description of the planned strategy for obtaining approval
for the drug development clinical trials from the United States food and drug
administration;
(3) A detailed drug development clinical trial design that includes:
(A) A description of the composition of the cohort's drug
development clinical trial team and the expertise of the team members;
(B) A drug development clinical trial participant recruitment plan;
(C) Patient screening criteria and cardiac safety protocols;
(D) Administration protocols;
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(E) An aftercare and post-acute treatment support plan; and
(F) A data integrity plan;
(4) A detailed plan to seek a breakthrough therapy designation for
ibogaine from the United States food and drug administration under 21 U.S.C. §
356;
(5) A proposal to recognize this state's commercial interest in all
intellectual property that may be generated over the course of the drug
development clinical trials, including:
(A) The treatment that is the subject of the trials;
(B) Administration protocols;
(C) Treatment models or techniques; and
(D) Technology used in the trials;
(6) A plan to establish a corporate presence in this state and to promote
and maintain ibogaine-related biomedical research, development, treatment,
manufacturing, and distribution in this state;
(7) A plan to secure third-party payor approval for ibogaine treatment
following approval by the United States food and drug administration through:
(A) Private insurers;
(B) Medicare;
(C) Medicaid; and
(D) The TRICARE program of the United States department of
defense;
(8) A plan to ensure ibogaine treatment access to uninsured individuals
following approval by the United States food and drug administration;
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(9) A plan to train and credential medical providers to administer ibogaine
treatment according to developed clinical standards; and
(10) Financial disclosures that verify the cohort's capacity to fully match
state funding with funds received from non-state sources.
33-12-106. Department selection.
The department, in the department's sole discretion, shall select a cohort
established in accordance with § 33-12-103 for the purpose of conducting ibogaine drug
development clinical trials under this chapter.
33-12-107. Contract with lead institution.
(a) As soon as practicable after selecting a cohort to conduct ibogaine drug
development clinical trials under § 33-12-106, the department shall enter into an
interagency agreement with the project lead of the selected cohort to provide funding to
implement the cohort's proposed ibogaine drug development clinical trials.
(b) The interagency contract described by subsection (a) must specify:
(1) The goals and objectives of the proposed ibogaine drug development
clinical trials;
(2) The proposed budget;
(3) The timeline for completing the proposed objectives;
(4) The for-profit, nonprofit, or public benefit corporate entities
collaborating with the cohort in the drug development clinical trials under this
chapter or a clinical trial initiated in another state, including the clinical trial
conducted by the Texas consortium;
(5) The percentage of the revenue arising from the drug development
clinical trials to be paid to the state; and
(6) Any other information required by the department.
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(c) As soon as practicable after entering into an interagency contract under
subsection (a), the department shall report the existence of the contract to the general
assembly by sending notice to the chief clerks of the senate and house of
representatives.
(d) The department shall not disburse funds to or for a selected cohort under the
interagency contract described by subsection (a) until the cohort receives and the
department verifies the receipt of matching funds from sources other than the state.
33-12-108. Investigational new drug application.
On the department's notification that a cohort is selected to conduct the drug
development clinical trials under this chapter, a drug developer or hospital member of
the selected cohort or the project lead of the cohort, as specified by written agreement of
the cohort members, shall, as soon as practicable:
(1) Submit an investigational new drug application to the United States
food and drug administration in accordance with 21 CFR Part 312; and
(2) Seek a breakthrough therapy designation for ibogaine from the United
States food and drug administration under 21 U.S.C. § 356.
33-12-109. Drug development clinical trial sites.
For purposes of conducting a drug development clinical trial under this chapter,
only a research institution or a hospital shall serve as a trial site.
33-12-110. Funding - Disbursement by department.
(a) The department and cohort members may solicit and accept gifts, grants,
and donations of any kind received from sources other than the state for purposes of
funding drug development clinical trials under this chapter.
(b) Disbursements of funds by the department may be made incrementally
based on the completion of clearly defined objectives as negotiated in the contract
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described by § 33-12-107, including verifiable documentation demonstrating the efficient
expenditure of both state and matching funds.
33-12-111. Reporting requirements.
(a) A cohort selected to conduct ibogaine drug development clinical trials shall
prepare and submit to the department quarterly:
(1) A report on the progress of the drug development clinical trials
conducted under this chapter; and
(2) A financial status report, including information to verify expenditures
of state funds and required matching funds.
(b) The department shall submit a report to the general assembly on the
progress of the drug development clinical trials conducted under this chapter no later
than December 1 of each year. The report must be submitted to the chief clerk of the
senate, the chief clerk of the house of representatives, and the legislative librarian, and
may be submitted by electronic means.
33-12-112. Allocation of revenue attributable to intellectual property and other
rights.
(a) The revenue attributable to all intellectual property rights and other
commercial rights arising from drug development clinical trials conducted by a cohort
under this chapter during the period for which the trials are funded and any following
period of commercialization shall be allocated as follows:
(1) No less than five percent (5%) to the state as specified in the contract
under § 33-12-107; and
(2) The remainder to the members of the cohort in the amounts specified
by written agreement of the members.
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(b) For purposes of this section, intellectual property rights and other commercial
rights arising from the drug development clinical trials conducted under this chapter
include any of the following as related to the trials:
(1) Intellectual property, technology, and inventions;
(2) Patents, trademarks, and licenses;
(3) Proprietary and confidential information;
(4) Trade secrets, data, and databases;
(5) Tools, methods, and processes;
(6) Treatment models or techniques;
(7) Administration protocols; and
(8) Works of authorship.
33-12-113. Use of state revenue.
(a) The state treasurer shall deposit the revenue received under § 33-12-
112(a)(1) as follows:
(1) No less than fifty percent (50%) into the Tennessee mental health
innovation fund, created by § 33-12-114; and
(2) The remainder into the general fund.
(b) The state treasurer shall develop accounting procedures for the purpose of
implementing this section.
33-12-114. Creation of innovation fund - Purpose.
(a) There is created within the state general fund a special account to be known
as the Tennessee mental health innovation fund.
(b) Unless otherwise specified in this part, moneys realized from intellectual
property and other commercial rights pursuant to § 33-12-112(a)(1) and allocated
pursuant to § 33-12-113(a)(1) must be deposited in the fund and used only to implement
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and administer the purposes set forth in subsection (f). In addition to appropriations
made to the fund, the commissioner may accept other funds, public or private, by way of
gift or grant to the fund. Any such gift or grant must be deposited into the fund to be
expended in accordance with this part.
(c) The state treasurer shall invest moneys in the fund for the benefit of the fund
in accordance with § 9-4-603. Interest accruing on investments and deposits of the fund
must be credited to and remain part of the fund.
(d) Any unencumbered moneys and any unexpended balance of the fund
remaining at the end of a fiscal year do not revert to the general fund, but must be
carried forward until expended in accordance with this part. No part of the fund shall be
diverted to the general fund or any other public fund.
(e) The commissioner shall administer the fund, and moneys in the fund must be
expended and obligated only in accordance with this part and in accordance with
appropriations made by the general assembly. All expenditures from the fund are
subject to review in the form of an annual report submitted by the commissioner to the
general assembly.
(f) The purpose of the Tennessee mental health innovation fund is to fund
proposals from behavioral health providers to train and support clinical and supportive
care staff in best practices for supporting patients who have undergone ibogaine
therapy.
33-12-115. Applicability of chapter.
This chapter applies only if ibogaine is approved by the United States food and
drug administration to treat a medical condition.
33-12-116. Medical supervision.
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A physician licensed under title 63, chapter 6 or 9, who has prescribed ibogaine
for a patient shall supervise the administration of ibogaine at a hospital or other licensed
healthcare facility to ensure the patient's safety while the patient is undergoing ibogaine
treatment.
33-12-117. Administration under federal law.
This chapter does not preclude a physician from administering ibogaine in
accordance with federal law.
33-12-118. Waiver authority - Deadline to begin accepting proposals.
(a) If the department, or another department of state government involved in the
administration of this chapter, determines that a waiver or authorization from a federal
agency is necessary to implement a provision of this chapter, then the department
responsible for implementing such provision shall request the waiver or authorization
and may delay implementing that provision until the waiver or authorization is granted.
(b) The department shall begin accepting proposals from cohorts under this
chapter no later than September 1, 2026.
SECTION 2. The headings in this act are for reference purposes only and do not
constitute a part of the law enacted by this act. However, the Tennessee Code Commission is
requested to include the headings in any compilation or publication containing this act.
SECTION 3. This act takes effect July 1, 2026, the public welfare requiring it.