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SECOND REGULAR SESSION
HOUSE COMMITTEE SUBSTITUTE FOR
HOUSE BILL NOS. 2817 & 2961
103RD GENERAL ASSEMBL Y
6391H.02C JOSEPH ENGLER, Chief Clerk
AN ACT
T o 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 seven new sections, to
2 be known as sections 191.1610, 191.1613, 191.1616, 191.1619, 191.1622, 191.1625, and
3 191.1628, to read as follows:
191.1610. Sections 191.1610 to 191.1628 shall be known and may be cited as the
2 "V eterans Mental Health Innovation Act".
191.1613. As used in sections 191.1610 to 191.1628, the following terms mean:
2 (1) "Applicant", an entity that applies for a grant under section 191.1616;
3 (2) "Consortium", a gr oup creat ed by law in another state of the United States
4 for the purpose of conducting drug development clinical trials with ibogaine;
5 (3) "Department", the department of health and senior services;
6 (4) "Ibogaine", ibogaine and ibogaine-based therapeutics including, but not
7 limited to, ibogaine analogs.
191.1616. 1. Subject to appr opriation, the department shall award grants to
2 conduct certified clinical drug development trials overseen by the United States Food
3 and Drug Administration on the use of ibogaine for the tr eatment of opioid use disorder ,
4 co-occurring substance use disorder , or any other neur ological or mental health
5 condition for which ibogaine demonstrates efficacy . The department shall award grants
6 only to an entity that satisfies all of the following:
7 (1) Is located within this state;
EXPLANA TION — Matter enclosed in bold-faced brackets [thus] in the above bill is not enacted and is
intended to be omitted from the law . Matter in bold-face type in the above bill is proposed language.
8 (2) Has a history of prove n r esear ch and tr eatment of neur ological diseases and
9 expertise in substance dependence, emotional trauma, and physical or neur ological
10 trauma;
11 (3) Has a neur osurgery pr ogram with the req uisite clinical and rese arch facilities
12 and that is:
13 (a) Staffed by pr ofessionals having expertise in the most challenging neur ological
14 and neur osurgical conditions; and
15 (b) Capable of pr oviding the necessary infrastructure and expertise to deliver
16 cardiac intensive care services;
17 (4) Has the ability to facilitate pioneering res earch and innovation in diagnosis
18 and tre atment of neur ological conditions;
19 (5) Has demonstrated to the department that the entity has a commitment for
20 matching moneys of gifts, grants, and donations fro m sources other than this state in an
21 amount equal to the amount to be awarded to conduct the certified clinical r esear ch
22 study on the use of ibogaine for the tr eatment of neur ological diseases; and
23 (6) Has signed an agreement with a consortium established by the government of
24 another state within the United States, whether acting dir ectly or thr ough an agent or
25 joint venture, that satisfies all of the following:
26 (a) Has submitted an investigational new drug (IND) application to the United
27 States Food and Drug Administration in accordance with 21 CFR Part 312; and
28 (b) Has req uested a brea kthroug h therapy designation for ibogaine fr om the
29 United States Food and Drug Administration under 21 U.S.C. Section 356.
30 2. The department shall not disburse the funding authorized in this section to an
31 applicant until the applicant re ceives and the department verifies the receip t of
32 matching funds fr om sources other than the state.
33 3. (1) There is her eby cr eated in the state tr easury the "Ibogaine Study Fund",
34 which shall consist of moneys appr opriated to it by the general assembly and any gifts,
35 contributions, grants, or bequests received from federal, private, or other sources . The
36 state tr easur er shall be custodian of the fund. In accordance with sections 30.170 and
37 30.180, the state tr easur er may appr ove disbursements. The fund shall be a dedicated
38 fund and, upon appr opriation, moneys in this fund shall be used solely to award grants
39 under this section.
40 (2) Notwithstanding the pro visions of section 33.080 to the contrary , any moneys
41 r emaining in the fund at the end of the biennium shall not r evert to the credit of the
42 general reven ue fund.
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43 (3) The state tre asurer shall invest moneys in the fund in the same manner as
44 other funds ar e invested. Any interes t and moneys earned on such investments shall be
45 cr edited to the fund.
191.1619. 1. An applicant selected to conduct ibogaine drug development
2 clinical trials shall quarterly prep are and submit to the department:
3 (1) A r eport on the pr ogr ess of the drug development clinical trials conducted
4 under sections 191.1616 to 191.1622; and
5 (2) A financial status rep ort, including information to verify expenditures of
6 state funds and r equir ed matching funds.
7 2. The department shall submit a r eport to the general assembly on the pr ogr ess
8 of the drug development clinical trials conducted under sections 191.1616 to 191.1622
9 and the financial status of the trials befor e December first of each year .
191.1622. 1. Ther e is her eby cre ated in the state tr easury the "Ibogaine
2 Intellectual Pr operty Fund", which shall consist of all revenu e attributable to all
3 intellectual prop erty rights and other commer cial rights that may arise fr om drug
4 development clinical trials conducted by a multistate consortium under sections
5 191.1616 to 191.1622 during the period for which the trials ar e funded and any following
6 period of commerci alization. The state tr easure r shall be custodian of the fund. In
7 accordance with sections 30.170 and 30.180, the state tre asure r may appr ove
8 disbursements. The fund shall be a dedicated fund and, upon appr opriation, moneys
9 in this fund shall be used solely for pr ograms that assist veterans or other at-risk
10 populations in this state.
11 2. Notwithstanding the prov isions of section 33.080 to the contrary , any moneys
12 r emaining in the fund at the end of the biennium shall not r evert to the credit of the
13 general reven ue fund.
14 3. The state tr easure r shall invest moneys in the fund in the same manner as
15 other funds ar e invested. Any interes t and moneys earned on such investments shall be
16 cr edited to the fund.
17 4. For purposes of this section, intellectual pr operty rights and other commer cial
18 rights arising fr om the drug development clinical trials conducted under sections
19 191.1616 to 191.1622 include any of the following as rel ated to the trials:
20 (1) Intellectual pr operty , technology , and inventions;
21 (2) Patents, trademarks, and licenses;
22 (3) Pr oprietary and confidential information;
23 (4) T rade secr ets, data, and databases;
24 (5) T ools, methods, and pr ocesses;
25 (6) T reat ment models or techniques;
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26 (7) Administration pr otocols; and
27 (8) W orks of authorship.
191.1625. 1. This section applies only if ibogaine is appr oved by the United
2 States Food and Drug Administration to tr eat a medical condition.
3 2. No person shall pre scribe ibogaine for a patient except a physician licensed
4 under chapter 334.
5 3. A physician licensed under chapter 334 shall supervise the administration of
6 ibogaine at a hospital or other licensed health care facility to ensur e the patient's safety
7 while the patient is under the influence of ibogaine.
8 4. This section shall not pr eclude a physician fr om administering ibogaine in
9 accordance with federal law .
191.1628. 1. If befor e implementing any pr ovision of sections 191.1610 to
2 191.1628 a state agency determines that a waiver or authorization fr om a federal agency
3 is necessary for implementation of that pr ovision, the agency affected by the provi sion
4 shall r equest the waiver or authorization and may delay implementing that prov ision
5 until the waiver or authorization is granted.
6 2. The department shall begin accepting grant applications under section
7 191.1616 before November 1, 2026.
✔
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