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An Act
ENROLLED HOUSE
BILL NO. 3834 By: May and Pae of the House
and
Frix of the Senate
An Act relating to ibogaine clinical trials; creating
the Oklahoma Breakthrough Therapy Act; providing
short title; defining terms; directing the State
Department of Health to enter into certain contracts
subject to specified conditions; establishing
requirements for drug developers; providing
contractual terms; providing for intellectual
property rights; requiring submission of certain
reports; creating the Ibogaine Development Revolving
Fund; specifying type of fund and sources of monies;
providing for budgeting and expenditure of monies for
specified purpose; granting certain professional
immunity to medical professionals; providing for
codification; and providing an effective date.
SUBJECT: Ibogaine clinical trials
BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
SECTION 1. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 2-806.1 of Title 63, unless
there is created a duplication in numbering, reads as follows:
This act shall be known and may be cited as the “Oklahoma
Breakthrough Therapy Act”.
SECTION 2. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 2-806.2 of Title 63, unless
there is created a duplication in numbering, reads as follows:
As used in this act:
ENR. H. B. NO. 3834 Page 2
1. “Department” means the State Department of Health;
2. “Drug developer” means a public-private partnership, for-
profit, nonprofit, or public benefits corporation engaged in drug
development and manufacturing that has established an ibogaine drug
development agreement with at least one additional state with a plan
to conduct drug development clinical trials to obtain United States
Food and Drug Administration approval for the use of ibogaine; and
3. “Ibogaine” means ibogaine and ibogaine-based therapeutics,
including ibogaine analogs.
SECTION 3. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 2-806.3 of Title 63, unless
there is created a duplication in numbering, reads as follows:
A. The State Department of Health shall, subject to the
availability of funds and in accordance with the provisions of this
act, contract with a drug developer to support multistate drug
development clinical trials to obtain United States Food and Drug
Administration approval for the use of ibogaine.
B. Before the State Department of Health may contract with the
drug developer, the drug developer shall provide to the Department:
1. A detailed description of the drug developer’s strategy for
obtaining approval for ibogaine from the United States Food and Drug
Administration through sanctioned drug development clinical trials,
including a detailed clinical trial design, a description of the
composition of the consortium’s drug development clinical trial team
and the expertise of the team members, its plan to submit an
investigational new drug application, if it has not already done so,
and to seek a breakthrough therapy designation under 21 U.S.C.,
Section 356 to expedite the trials;
2. Protocols for clinical trial participant recruitment,
patient screening criteria administration, aftercare, and post-acute
treatment support;
3. Certification of an existing ibogaine drug development
agreement with one or more other states or state-sponsored
consortia; and
ENR. H. B. NO. 3834 Page 3
4. Financial disclosures sufficient to verify the drug
developer is prepared to meet its full obligations under this
section.
C. Before the Department may contract with the drug developer,
the Department shall negotiate a contract requiring the drug
developer to substantially agree to the following:
1. To match the state’s investment in drug development clinical
trials with ibogaine with an equal amount of additional funding and
to devote this total amount to drug development clinical trials
conducted within this state. These trials shall, to the maximum
extent possible, use in-state clinicians, facilities, and study
participants;
2. To provide reporting as specified under Section 4 of this
act;
3. To establish a plan to ensure broad and accessible ibogaine
treatment access to patients within the state following approval of
ibogaine by the United States Food and Drug Administration by
diverse means including, but not limited to:
a. providing priority access to ibogaine treatment to
residents of the state,
b. seeking third-party payor approval for ibogaine
treatment within the state,
c. developing means of access to ibogaine treatment
within the state for uninsured and low-income
individuals, and
d. training and credentialing medical providers within
the state to administer ibogaine treatment; and
4. To provide a plan to recognize the state’s economic interest
in the intellectual property generated over the course of the
multistate drug development clinical trials with ibogaine,
consisting of the share of the proceeds from such intellectual
property that is proportional to the state’s contribution to the
total cost of the multistate drug development trials, and to remit
the state’s share of those proceeds to the Department at agreed-upon
intervals during the period for which the drug development clinical
trials are funded and during any following period of
ENR. H. B. NO. 3834 Page 4
commercialization. The Department shall deposit all remitted
proceeds in the Ibogaine Development Revolving Fund created in
Section 5 of this act.
D. In negotiating a contract with the drug developer, the
Department may agree to additional terms and make reasonable
deviations from the requirements of this section if the resulting
contract is fair and creates at least substantially equivalent value
for the state.
E. For purposes of this section, intellectual property rights
and other economic rights accruing to the State of Oklahoma arising
from multistate drug development clinical trials with ibogaine shall
include any and all of the following as related to these trials:
1. Intellectual property, technology, and inventions;
2. Patents, trademarks, and licenses;
3. Proprietary and confidential information;
4. Trade secrets, data, and databases;
5. Tools, methods, and processes;
6. Treatment models or techniques;
7. Administration protocols; and
8. Works of authorship.
SECTION 4. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 2-806.4 of Title 63, unless
there is created a duplication in numbering, reads as follows:
A. The drug developer shall quarterly prepare and
electronically submit to the State Department of Health:
1. A report on the progress of the multistate drug development
clinical trials with ibogaine conducted pursuant to this act; and
2. A financial status report, including information to verify
expenditures of state funds and required matching funds.
ENR. H. B. NO. 3834 Page 5
B. The Department shall electronically submit a report to the
Governor, the President Pro Tempore of the Senate, and the Speaker
of the House of Representatives on the progress of the drug
development clinical trials and its related financial status by
December 1 of each year until the clinical trials are concluded.
SECTION 5. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 2-806.5 of Title 63, unless
there is created a duplication in numbering, reads as follows:
There is hereby created in the State Treasury a revolving fund
for the State Department of Health to be designated the “Ibogaine
Development Revolving Fund”. The fund shall be a continuing fund,
not subject to fiscal year limitations, and shall consist of all
monies received by the Department from:
1. Remittance of the state share of proceeds from intellectual
property generated over the course of the multistate drug
development clinical trials as provided in paragraph 4 of subsection
C of Section 3 of this act; and
2. Any other source when provided for the purpose described in
this section including, but not limited to:
a. legislative appropriations,
b. private gifts and donations, and
c. public and private grants.
All monies accruing to the credit of the fund are hereby
appropriated and may be budgeted and expended by the Department for
the purpose of supporting programs or research benefiting at-risk
populations that suffer from conditions treatable with ibogaine
including, but not limited to, traumatic brain injury, opioid use
disorder, co-occurring substance use disorder, and other
neurological or mental health disorders. Expenditures from the fund
shall be made upon warrants issued by the State Treasurer against
claims filed as prescribed by law with the Director of the Office of
Management and Enterprise Services for approval and payment.
SECTION 6. NEW LAW A new section of law to be codified
in the Oklahoma Statutes as Section 2-806.6 of Title 63, unless
there is created a duplication in numbering, reads as follows:
ENR. H. B. NO. 3834 Page 6
Medical professionals licensed by the State of Oklahoma shall
not be subject to professional disciplinary action solely for
recommending participation in clinical trials of ibogaine.
SECTION 7. This act shall become effective November 1, 2026.
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Passed the House of Representatives the 6th day of May, 2026.
Presiding Officer of the House
of Representatives
Passed the Senate the 29th day of April, 2026.
Presiding Officer of the Senate
OFFICE OF THE GOVERNOR
Received by the Office of the Governor this ____________________
day of ___________________, 20_______, at _______ o'clock _______ M.
By: _________________________________
Approved by the Governor of the State of Oklahoma this _________
day of ___________________, 20_______, at _______ o'clock _______ M.
_________________________________
Governor of the State of Oklahoma
OFFICE OF THE SECRETARY OF STATE
Received by the Office of the Secretary of State this __________
day of ___________________, 20_______, at _______ o'clock _______ M.
By: _________________________________