Shown verbatim: the complete text as captured from the official PDF posted by the Kentucky General Assembly, fetched 2026-09-25. Page and line markers are part of the official record; nothing is edited or removed. This is the current version. The official bill page.
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1 AN ACT relating to ibogaine research in the Commonwealth.
2 Be it enacted by the General Assembly of the Commonwealth of Kentucky:
3 SECTION 1. A NEW SECTION OF KRS CHAPTER 218A IS CREATED TO
4 READ AS FOLLOWS:
5 As used in Sections 1 to 5 of this Act:
6 (1) "Department" means the Department of Agriculture;
7 (2) "Drug developer" means a for-profit, nonprofit, or public benefit corporation
8 engaged in drug development and manufacturing that has established an
9 ibogaine drug development agreement with at least one (1) additional state with a
10 plan to conduct drug development clinical trials to obtain United States Food and
11 Drug Administration approval for use of ibogaine; and
12 (3) "Ibogaine":
13 (a) Means a crystalline alkaloid psychogenic compound obtained from the
14 Tabernanthe iboga plant; and
15 (b) Includes any of its derivatives or analogs in any form, whether existing or
16 as-yet to be developed.
17 SECTION 2. A NEW SECTION OF KRS CHAPTER 218A IS CREATED TO
18 READ AS FOLLOWS:
19 (1) There is hereby established in the State Treasury a trust and agency fund entitled
20 the ibogaine research and intellectual property fund, to be administered by the
21 department for the purpose of allowing the department to enter into a public-
22 private partnership with a drug developer to conduct a clinical drug development
23 trial or trials related to the use of ibogaine for the treatment of opioid use
24 disorder, co-occurring substance use disorder, or any other neurological or
25 mental health condition for which ibogaine demonstrates efficacy.
26 (2) The fund may receive state appropriations, gifts, grants, federal funds, and any
27 other funds, both public and private. Moneys deposited in the fund are to be used
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1 for the purposes set out in Sections 1 to 5 of this Act.
2 (3) Notwithstanding KRS 45.229, any unallocated or unencumbered balances in the
3 fund shall be invested as provided in KRS 42.500(9), and any interest or other
4 income earned from the investments, along with the unallotted or unencumbered
5 balances in the fund, shall not lapse but shall be carried forward into the next
6 fiscal year.
7 SECTION 3. A NEW SECTION OF KRS CHAPTER 218A IS CREATED TO
8 READ AS FOLLOWS:
9 (1) Before the department may contract with a drug developer, the drug developer
10 shall provide the department with:
11 (a) A detailed description of the drug developer’s strategy for obtaining
12 approval for the drug development clinical trials from the United States
13 Food and Drug Administration and a detailed drug development clinical
14 trial design, including a description of the composition of the consortium's
15 drug development clinical trial team and the expertise of the team members;
16 (b) Protocols for clinical trial participant recruitment, patient screening
17 criteria, administration, after-care, and post-acute treatment support;
18 (c) A plan to seek a breakthrough therapy designation for ibogaine from the
19 United States Food and Drug Administration under 21 U.S.C. sec. 356;
20 (d) Financial disclosures necessary to verify that the drug developer is prepared
21 to meet its full obligations under this section; and
22 (e) Certification of an existing ibogaine drug development agreement with one
23 (1) or more other states or state-sponsored consortiums.
24 (2) Before the department may contract with a drug developer, the department shall
25 negotiate a contract requiring the drug developer to substantially agree to:
26 (a) Match the Commonwealth’s investment in drug development clinical trials
27 with ibogaine with an equal amount of additional funding and to devote this
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1 total amount in drug development clinical trials conducted within the
2 Commonwealth. These trials shall exclusively use in-state clinicians,
3 facilities, and study participants;
4 (b) Provide reports as specified under Section 4 of this Act;
5 (c) Establish a plan to ensure broad and accessible ibogaine treatment access to
6 patients within the Commonwealth following approval of ibogaine by the
7 United States Food and Drug Administration by diverse means, including
8 but not limited to:
9 1. Providing priority access to ibogaine treatment to residents of the
10 Commonwealth;
11 2. Seeking third-party payor approval for ibogaine treatment within the
12 Commonwealth;
13 3. Developing means of access to ibogaine treatment within the
14 Commonwealth for uninsured and low-income individuals; and
15 4. Training and credentialing medical providers within the
16 Commonwealth to administer ibogaine treatment; and
17 (d) Provide a plan to recognize the Commonwealth’s economic interest in the
18 intellectual property generated over the course of the multistate drug
19 development clinical trials with ibogaine, consisting of a share of the
20 proceeds from said intellectual property which is proportional to the
21 Commonwealth’s contribution to the total cost of the multistate drug
22 development trials, and to deposit the state’s share of those proceeds in the
23 ibogaine research and intellectual property fund established in Section 2 of
24 this Act at agreed-upon intervals during the period for which the drug
25 development clinical trials are funded and during any subsequent period of
26 commercialization.
27 (3) In negotiating a contract with the drug developer, the department may agree to
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1 additional terms and make reasonable deviations from the requirements of this
2 section as long as the resulting contract is fair and creates substantially
3 equivalent value for the Commonwealth.
4 (4) For purposes of this section, intellectual property rights and other commercial
5 rights arising from multistate drug development clinical trials with ibogaine
6 include any of the following as related to these trials:
7 (a) Intellectual property, technology, and inventions;
8 (b) Patents, trademarks, and licenses;
9 (c) Proprietary and confidential information;
10 (d) Trade secrets, data, and databases;
11 (e) Tools, methods, and processes;
12 (f) Treatment models or techniques;
13 (g) Administration protocols; and
14 (h) Works of authorship.
15 SECTION 4. A NEW SECTION OF KRS CHAPTER 218A IS CREATED TO
16 READ AS FOLLOWS:
17 (1) The drug developer shall quarterly prepare and submit to the department a:
18 (a) Report on the progress of any multistate drug development clinical trials
19 with ibogaine conducted pursuant to Sections 1 to 5 of this Act; and
20 (b) Financial status report, including information to verify expenditures of
21 Commonwealth funds and required matching funds.
22 (2) The department shall submit an annual report by December 1 each year to the
23 Legislative Research Commission for referral to the Interim Joint Committee on
24 Health Services on the progress of the drug development clinical trials and their
25 related financial status until the clinical trials are concluded.
26 SECTION 5. A NEW SECTION OF KRS CHAPTER 218A IS CREATED TO
27 READ AS FOLLOWS:
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1 All receipts from the proceeds from the commercialization of intellectual property
2 created through the public-private partnership created under Sections 1 to 5 of this Act
3 shall be deposited into the ibogaine research and intellectual property fund established
4 in Section 2 of this Act. Expenditures from the fund shall be used only for programs or
5 research benefitting at-risk populations that suffer from conditions treatable with
6 ibogaine, including but not limited to opioid use disorder, co-occurring substance use
7 disorder, post-traumatic stress disorder, traumatic brain injury, and other neurological
8 or mental health disorders.
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