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SECOND REGULAR SESSION
SENATE BILL NO. 1581
103RD GENERAL ASSEMBLY
INTRODUCED BY SENATOR BEAN.
6783S.01I KRISTINA MARTIN, Secretary
AN ACT
To amend chapter 191, RSMo, by adding thereto seven new sections relating to ibogaine treatment.
Be it enacted by the General Assembly of the State of Missouri, as follows:
Section A. Chapter 191, RSMo, is amended by adding thereto 1
seven new sections, to be known as sections 191.1610, 191.1613, 2
191.1616, 191.1619, 191.1622, 191.1625, and 191.1628, to read 3
as follows:4
191.1610. Sections 191.1610 to 191.1628 shall be known 1
and may be cited as the "Veterans Mental Health Innovation 2
Act". 3
191.1613. As used in sections 191.1610 to 191.1628, 1
the following terms mean: 2
(1) "Applicant", an entity that applies for a grant 3
under section 191.1616; 4
(2) "Consortium", a group created by law in another 5
state of the United States for the purpose of conducting 6
drug development clinical trials with ibogaine; 7
(3) "Department", the department of health and senior 8
services; 9
(4) "Ibogaine", ibogaine and ibogaine-based 10
therapeutics, including, but not limited to, ibogaine 11
analogs. 12
191.1616. 1. Subject to appropriation, the department 1
shall award grants to conduct certified clinical drug 2
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development trials overseen by the U.S. Food and Drug 3
Administration on the use of ibogaine for the treatment of 4
opioid use disorder, co-occurring substance use disorder, or 5
any other neurological or mental health condition for which 6
ibogaine demonstrates efficacy. The department shall award 7
grants only to an entity that satisfies all of the following: 8
(1) Is located within this state; 9
(2) Has a history of proven research and treatment of 10
neurological diseases and expertise in substance dependence, 11
emotional trauma, and physical or neurological trauma; 12
(3) Has a neurosurgery program with the requisite 13
clinical and research facilities and that is: 14
(a) Staffed by professionals having expertise in the 15
most challenging neurological and neurosurgical conditions; 16
and 17
(b) Capable of providing the necessary infrastructure 18
and expertise to deliver cardiac intensive care services; 19
(4) Has the ability to facilitate pioneering research 20
and innovation in diagnosis and treatment of neurological 21
conditions; 22
(5) Has demonstrated to the department that the entity 23
has a commitment for matching moneys of gifts, grants, and 24
donations from sources other than this state in an amount 25
equal to the amount to be awarded to conduct the certified 26
clinical research study on the use of ibogaine for the 27
treatment of neurological diseases; and 28
(6) Has signed an agreement with a consortium 29
established by the government of another state within the 30
United States, whether acting directly or through an agent 31
or joint venture, that satisfies all of the following: 32
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(a) Has submitted an investigational new drug (IND) 33
application to the U.S. Food and Drug Administration in 34
accordance with 21 CFR 312; and 35
(b) Has requested a breakthrough therapy designation 36
for ibogaine from the U.S. Food and Drug Administration 37
under 21 U.S.C. Section 356. 38
2. The department shall not disburse the funding 39
authorized in this section to an applicant until the 40
applicant receives, and the department verifies the receipt 41
of, matching funds from sources other than the state. 42
3. (1) There is hereby created in the state treasury 43
the "Ibogaine Study Fund", which shall consist of moneys 44
appropriated to it by the general assembly and any gifts, 45
contributions, grants, or bequests received from federal, 46
private, or other sources. The state treasurer shall be 47
custodian of the fund. In accordance with sections 30.170 48
and 30.180, the state treasurer may approve disbursements. 49
The fund shall be a dedicated fund and, upon appropriation, 50
moneys in this fund shall be used solely to award grants 51
under this section. 52
(2) Notwithstanding the provisions of section 33.080 53
to the contrary, any moneys remaining in the fund at the end 54
of the biennium shall not revert to the credit of the 55
general revenue fund. 56
(3) The state treasurer shall invest moneys in the 57
fund in the same manner as other funds are invested. Any 58
interest and moneys earned on such investments shall be 59
credited to the fund. 60
191.1619. 1. An applicant selected to conduct 1
ibogaine drug development clinical trials shall quarterly 2
prepare and submit to the department: 3
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(1) A report on the progress of the drug development 4
clinical trials conducted under sections 191.1616 to 5
191.1622; and 6
(2) A financial status report, including information 7
to verify expenditures of state funds and required matching 8
funds. 9
2. The department shall submit a report to the general 10
assembly on the progress of the drug development clinical 11
trials conducted under sections 191.1616 to 191.1622 and the 12
financial status of the trials before December first of each 13
year. 14
191.1622. 1. There is hereby created in the state 1
treasury the "Ibogaine Intellectual Property Fund", which 2
shall consist of all revenue attributable to all 3
intellectual property rights and other commercial rights 4
that may arise from drug development clinical trials 5
conducted by a multistate consortium under sections 191.1616 6
to 191.1622 during the period for which the trials are 7
funded and any following period of commercialization. The 8
state treasurer shall be custodian of the fund. In 9
accordance with sections 30.170 and 30.180, the state 10
treasurer may approve disbursements. The fund shall be a 11
dedicated fund and, upon appropriation, moneys in this fund 12
shall be used solely for programs that assist veterans or 13
other at-risk populations in this state. 14
2. Notwithstanding the provisions of section 33.080 to 15
the contrary, any moneys remaining in the fund at the end of 16
the biennium shall not revert to the credit of the general 17
revenue fund. 18
3. The state treasurer shall invest moneys in the fund 19
in the same manner as other funds are invested. Any 20
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interest and moneys earned on such investments shall be 21
credited to the fund. 22
4. For purposes of this section, intellectual property 23
rights and other commercial rights arising from the drug 24
development clinical trials conducted under sections 25
191.1616 to 191.1622 include any of the following as related 26
to the trials: 27
(1) Intellectual property, technology, and inventions; 28
(2) Patents, trademarks, and licenses; 29
(3) Proprietary and confidential information; 30
(4) Trade secrets, data, and databases; 31
(5) Tools, methods, and processes; 32
(6) Treatment models or techniques; 33
(7) Administration protocols; and 34
(8) Works of authorship. 35
191.1625. 1. The provisions of this section shall 1
apply only if ibogaine is approved by the U.S. Food and Drug 2
Administration to treat a medical condition. 3
2. No person shall prescribe ibogaine for a patient 4
except a physician licensed under chapter 334. 5
3. A physician licensed under chapter 334 shall 6
supervise the administration of ibogaine at a hospital or 7
other licensed health care facility to ensure the patient's 8
safety while the patient is under the influence of ibogaine. 9
4. The provisions of this section shall not preclude a 10
physician from administering ibogaine in accordance with 11
federal law. 12
191.1628. 1. If, before implementing any provision of 1
sections 191.1610 to 191.1628, a state agency determines 2
that a waiver or authorization from a federal agency is 3
necessary for implementation of that provision, the agency 4
affected by the provision shall request the waiver or 5
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authorization and may delay implementing that provision 6
until the waiver or authorization is granted. 7
2. The department shall begin accepting grant 8
applications under section 191.1616 before November 1, 2026. 9
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