HOUSE BILL NO. 2817 103RD GENERAL ASSEMBLY
INTRODUCED BY REPRESENTATIVE OVERCAST.
6391H.01I JOSEPH ENGLER, Chief Clerk
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 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 "Veterans 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 group created 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 appropriation, 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 treatment of opioid use disorder, 4 co-occurring substance use disorder, or any other neurological 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;
EXPLANATION — 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. HB 2817 2
8 (2) Has a history of proven research and treatment of neurological diseases and 9 expertise in substance dependence, emotional trauma, and physical or neurological 10 trauma; 11 (3) Has a neurosurgery program with the requisite clinical and research facilities 12 and that is: 13 (a) Staffed by professionals having expertise in the most challenging neurological 14 and neurosurgical conditions; and 15 (b) Capable of providing the necessary infrastructure and expertise to deliver 16 cardiac intensive care services; 17 (4) Has the ability to facilitate pioneering research and innovation in diagnosis 18 and treatment of neurological conditions; 19 (5) Has demonstrated to the department that the entity has a commitment for 20 matching moneys of gifts, grants, and donations from sources other than this state in an 21 amount equal to the amount to be awarded to conduct the certified clinical research 22 study on the use of ibogaine for the treatment of neurological 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 directly or through 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 requested a breakthrough therapy designation for ibogaine from 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 receives and the department verifies the receipt of 32 matching funds from sources other than the state. 33 3. (1) There is hereby created in the state treasury the "Ibogaine Study Fund", 34 which shall consist of moneys appropriated to it by the general assembly and any gifts, 35 contributions, grants, or bequests received from federal, private, or other sources. The 36 state treasurer shall be custodian of the fund. In accordance with sections 30.170 and 37 30.180, the state treasurer may approve disbursements. The fund shall be a dedicated 38 fund and, upon appropriation, moneys in this fund shall be used solely to award grants 39 under this section. 40 (2) Notwithstanding the provisions of section 33.080 to the contrary, any moneys 41 remaining in the fund at the end of the biennium shall not revert to the credit of the 42 general revenue fund. HB 2817 3
43 (3) The state treasurer shall invest moneys in the fund in the same manner as 44 other funds are invested. Any interest and moneys earned on such investments shall be 45 credited to the fund. 191.1619. 1. An applicant selected to conduct ibogaine drug development 2 clinical trials shall quarterly prepare and submit to the department: 3 (1) A report on the progress of the drug development clinical trials conducted 4 under sections 191.1616 to 191.1622; and 5 (2) A financial status report, including information to verify expenditures of 6 state funds and required matching funds. 7 2. The department shall submit a report to the general assembly on the progress 8 of the drug development clinical trials conducted under sections 191.1616 to 191.1622 9 and the financial status of the trials before December first of each year. 191.1622. 1. There is hereby created in the state treasury the "Ibogaine 2 Intellectual Property Fund", which shall consist of all revenue attributable to all 3 intellectual property rights and other commercial rights that may arise from 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 are funded and any following 6 period of commercialization. The state treasurer shall be custodian of the fund. In 7 accordance with sections 30.170 and 30.180, the state treasurer may approve 8 disbursements. The fund shall be a dedicated fund and, upon appropriation, moneys 9 in this fund shall be used solely for programs that assist veterans or other at-risk 10 populations in this state. 11 2. Notwithstanding the provisions of section 33.080 to the contrary, any moneys 12 remaining in the fund at the end of the biennium shall not revert to the credit of the 13 general revenue fund. 14 3. The state treasurer shall invest moneys in the fund in the same manner as 15 other funds are invested. Any interest and moneys earned on such investments shall be 16 credited to the fund. 17 4. For purposes of this section, intellectual property rights and other commercial 18 rights arising from the drug development clinical trials conducted under sections 19 191.1616 to 191.1622 include any of the following as related to the trials: 20 (1) Intellectual property, technology, and inventions; 21 (2) Patents, trademarks, and licenses; 22 (3) Proprietary and confidential information; 23 (4) Trade secrets, data, and databases; 24 (5) Tools, methods, and processes; 25 (6) Treatment models or techniques; HB 2817 4
26 (7) Administration protocols; and 27 (8) Works of authorship. 191.1625. 1. This section applies only if ibogaine is approved by the United 2 States Food and Drug Administration to treat a medical condition. 3 2. No person shall prescribe 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 ensure the patient's safety 7 while the patient is under the influence of ibogaine. 8 4. This section shall not preclude a physician from administering ibogaine in 9 accordance with federal law. 191.1628. 1. If before implementing any provision of sections 191.1610 to 2 191.1628 a state agency determines that a waiver or authorization from a federal agency 3 is necessary for implementation of that provision, the agency affected by the provision 4 shall request the waiver or authorization and may delay implementing that provision 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. ✔
Statutes affected: