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UNOFFICIAL COPY 26 RS SB 77/VO
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AN ACT relating to ibogaine research in the Commonwealth. 1
Be it enacted by the General Assembly of the Commonwealth of Kentucky: 2
SECTION 1. A NEW SECTION OF KRS CHAPTER 218A IS CREATED TO 3
READ AS FOLLOWS: 4
As used in Sections 1 to 5 of this Act: 5
(1) "Department" means the Department of Agriculture; 6
(2) "Drug developer" means a for -profit, nonprofit, or public benefit corporation 7
engaged in drug development and manufacturing that has established an 8
ibogaine drug development agreement with at least one (1) additional state with a 9
plan to conduct drug development clinical trials to obtain United States Food and 10
Drug Administration approval for use of ibogaine; and 11
(3) "Ibogaine": 12
(a) Means a crystalline alkaloid psychogenic compound obtained from the 13
Tabernanthe iboga plant; and 14
(b) Includes any of its derivatives or analogs in any form, whether existing or 15
as-yet to be developed. 16
SECTION 2. A NEW SE CTION OF KRS CHAPTER 218A IS CREATED TO 17
READ AS FOLLOWS: 18
(1) There is hereby established in the State Treasury a trust and agency fund entitled 19
the ibogaine research and intellectual property fund, to be administered by the 20
department for the purpose of al lowing the department to enter into a public -21
private partnership with a drug developer to conduct a clinical drug development 22
trial or trials related to the use of ibogaine for the treatment of opioid use 23
disorder, co -occurring substance use disorder, or a ny other neurological or 24
mental health condition for which ibogaine demonstrates efficacy. 25
(2) The fund may receive state appropriations, gifts, grants, federal funds, and any 26
other funds, both public and private. Moneys deposited in the fund are to be use d 27
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for the purposes set out in Sections 1 to 5 of this Act. 1
(3) Notwithstanding KRS 45.229, any unallocated or unencumbered balances in the 2
fund shall be invested as provided in KRS 42.500(9), and any interest or other 3
income earned from the investments, al ong with the unallotted or unencumbered 4
balances in the fund, shall not lapse but shall be carried forward into the next 5
fiscal year. 6
SECTION 3. A NEW SECTION OF KRS CHAPTER 218A IS CREATED TO 7
READ AS FOLLOWS: 8
(1) Before the department may contract with a drug developer, the drug developer 9
shall provide the department with: 10
(a) A detailed description of the drug developer’s strategy for obtaining 11
approval for the drug development clinical trials from the United States 12
Food and Drug Administration and a detailed drug development clinical 13
trial design, including a description of the composition of the consortium's 14
drug development clinical trial team and the expertise of the team members; 15
(b) Protocols for clinical trial par ticipant recruitment, patient screening 16
criteria, administration, after-care, and post-acute treatment support; 17
(c) A plan to seek a breakthrough therapy designation for ibogaine from the 18
United States Food and Drug Administration under 21 U.S.C. sec. 356; 19
(d) Financial disclosures necessary to verify that the drug developer is prepared 20
to meet its full obligations under this section; and 21
(e) Certification of an existing ibogaine drug development agreement with one 22
(1) or more other states or state-sponsored consortiums. 23
(2) Before the department may contract with a drug developer, the department shall 24
negotiate a contract requiring the drug developer to substantially agree to: 25
(a) Match the Commonwealth’s investment in drug development clinical trials 26
with ibogaine with an equal amount of additional funding and to devote this 27
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total amount in drug development clinical trials conducted within the 1
Commonwealth. These trials shall exclusively use in -state clinicians, 2
facilities, and study participants; 3
(b) Provide reports as specified under Section 4 of this Act; 4
(c) Establish a plan to ensure broad and accessible ibogaine treatment access to 5
patients within the Commonwealth following approval of ibogaine by the 6
United States Food and Drug Administration by diver se means, including 7
but not limited to: 8
1. Providing priority access to ibogaine treatment to residents of the 9
Commonwealth; 10
2. Seeking third-party payor approval for ibogaine treatment within the 11
Commonwealth; 12
3. Developing means of access to ibogaine tre atment within the 13
Commonwealth for uninsured and low-income individuals; and 14
4. Training and credentialing medical providers within the 15
Commonwealth to administer ibogaine treatment; and 16
(d) Provide a plan to recognize the Commonwealth’s economic interest in the 17
intellectual property generated over the course of the multistate drug 18
development clinical trials with ibogaine, consisting of a share of the 19
proceeds from said intellectual property which is proportional to the 20
Commonwealth’s contribution to the t otal cost of the multistate drug 21
development trials, and to deposit the state’s share of those proceeds in the 22
ibogaine research and intellectual property fund established in Section 2 of 23
this Act at agreed -upon intervals during the period for which the dr ug 24
development clinical trials are funded and during any subsequent period of 25
commercialization. 26
(3) In negotiating a contract with the drug developer, the department may agree to 27
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additional terms and make reasonable deviations from the requirements of thi s 1
section as long as the resulting contract is fair and creates substantially 2
equivalent value for the Commonwealth. 3
(4) For purposes of this section, intellectual property rights and other commercial 4
rights arising from multistate drug development clinica l trials with ibogaine 5
include any of the following as related to these trials: 6
(a) Intellectual property, technology, and inventions; 7
(b) Patents, trademarks, and licenses; 8
(c) Proprietary and confidential information; 9
(d) Trade secrets, data, and databases; 10
(e) Tools, methods, and processes; 11
(f) Treatment models or techniques; 12
(g) Administration protocols; and 13
(h) Works of authorship. 14
SECTION 4. A NEW SECTION OF KRS CHAPTER 218A IS CREATED TO 15
READ AS FOLLOWS: 16
(1) The drug developer shall quarterly prepare and submit to the department a: 17
(a) Report on the progress of any multistate drug development clinical trials 18
with ibogaine conducted pursuant to Sections 1 to 5 of this Act; and 19
(b) Financial status report, including information to verify expenditures of 20
Commonwealth funds and required matching funds. 21
(2) The department shall submit an annual report by December 1 each year to the 22
Legislative Research Commission for referral to the Interim Joint Committee on 23
Health Services on the progress of the drug development clinical trials and their 24
related financial status until the clinical trials are concluded. 25
SECTION 5. A NEW SECTION OF KRS CHAPTER 218A IS CREATED TO 26
READ AS FOLLOWS: 27
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All receipts from the proceeds from the commercialization of intellectual property 1
created through the public-private partnership created under Sections 1 to 5 of this Act 2
shall be deposited into the ibogaine research and intellectual property fund established 3
in Section 2 of this Act. Expenditures from the fund shall be used only for programs or 4
research benefitting at -risk populations that suffer from conditions treatable with 5
ibogaine, including but not limited to opioid use disorder, co -occurring substance use 6
disorder, post-traumatic stress disorder, traumatic brain injury, and other neurological 7
or mental health disorders. 8