1| HOUSE OF REPRESENTATIVES - FLOOR VERSION | | | 2| STATE OF OKLAHOMA | | | 3| 2nd Session of the 60th Legislature (2026) | | | 4|HOUSE BILL 3834 By: May and Pae of the House | | | 5| and | | | 6| Frix of the Senate | | | 7| | | | 8| | | | 9| AS INTRODUCED | | | 10| An Act relating to ibogaine clinical trials; creating | | the Oklahoma Breakthrough Therapy Act; defining | 11| terms; establishing requirements for drug developers; | | providing contractual terms; providing for | 12| intellectual property rights; requiring submission of | | reports; creating an intellectual property account in | 13| the Office of the State Treasurer; prohibiting | | adverse licensing action towards medical | 14| professionals; providing funding for trials; | | providing for noncodification; providing for | 15| codification; and providing an effective date. | | | 16| | | | 17| | | | 18|BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA: | | | 19| SECTION 1. NEW LAW A new section of law not to be | | | 20|codified in the Oklahoma Statutes reads as follows: | | | 21| This act shall be known and may be cited as the "Oklahoma | | | 22|Breakthrough Therapy Act". | | | 23| | | | 24| | | | arsid4211350 HB3834 HFLR Page 1 ___________________________________________________________________________
1| SECTION 2. NEW LAW A new section of law to be codified | | | 2|in the Oklahoma Statutes as Section 2-806 of Title 63, unless there | | | 3|is created a duplication in numbering, reads as follows: | | | 4| As used in this act: | | | 5| 1. "Department" means the State Department of Health; | | | 6| 2. "Drug developer" means a public-private partnership, | | | 7|for-profit, nonprofit, or public benefits corporation engaged in | | | 8|drug development and manufacturing that has established an ibogaine | | | 9|drug development agreement with at least one additional state with a | | | 10|plan to conduct drug development clinical trials to obtain United | | | 11|States Food and Drug Administration approval for use of ibogaine; | | | 12|and | | | 13| 3. "Ibogaine" means ibogaine and ibogaine-based therapeutics, | | | 14|including ibogaine analogs. | | | 15| SECTION 3. NEW LAW A new section of law to be codified | | | 16|in the Oklahoma Statutes as Section 2-807 of Title 63, unless there | | | 17|is created a duplication in numbering, reads as follows: | | | 18| A. Before the State Department of Health may contract with the | | | 19|drug developer, the drug developer shall provide to the Department: | | | 20| 1. A detailed description of the drug developer's strategy for | | | 21|obtaining approval for ibogaine from the United States Food and Drug | | | 22|Administration through sanctioned drug development clinical trials, | | | 23|including a detailed clinical trial design, a description of the | | | 24|composition of the consortium's drug development clinical trial team | | | arsid4211350 HB3834 HFLR Page 2 ___________________________________________________________________________
1|and the expertise of the team members, its plan to submit an | | | 2|investigational new drug application, if it has not already done so, | | | 3|and to seek a breakthrough therapy designation under 21 U.S.C., | | | 4|Section 356, to expedite the trials; | | | 5| 2. Protocols for clinical trial participant recruitment, | | | 6|patient screening criteria administration, aftercare, and post-acute | | | 7|treatment support; | | | 8| 3. Certification of an existing ibogaine drug development | | | 9|agreement with one or more other states or state-sponsored | | | 10|consortia; and | | | 11| 4. Financial disclosures sufficient to verify the drug | | | 12|developer is prepared to meet its full obligations under this | | | 13|section. | | | 14| B. Before the Department may contract with the drug developer, | | | 15|the Department shall negotiate a contract requiring the drug | | | 16|developer to substantially agree to the following: | | | 17| 1. To match the state's investment in drug development clinical | | | 18|trials with ibogaine with an equal amount of additional funding and | | | 19|to devote this total amount to drug development clinical trials | | | 20|conducted within the State of Oklahoma. These trials shall, to the | | | 21|maximum extent possible, use in-state clinicians, facilities, and | | | 22|study participants; | | | 23| 2. To provide reporting as specified under Section 4 of this | | | 24|act; | | | arsid4211350 HB3834 HFLR Page 3 ___________________________________________________________________________
1| 3. To establish a plan to ensure broad and accessible ibogaine | | | 2|treatment access to patients within the state following approval of | | | 3|ibogaine by the United States Food and Drug Administration by | | | 4|diverse means including, but not limited to: | | | 5| a. providing priority access to ibogaine treatment to | | | 6| residents of the state, | | | 7| b. seeking third-party payor approval for ibogaine | | | 8| treatment within the state, | | | 9| c. developing means of access to ibogaine treatment | | | 10| within the state for uninsured and low-income | | | 11| individuals, and | | | 12| d. training and credentialing medical providers within | | | 13| the state to administer ibogaine treatment; and | | | 14| 4. To provide a plan to recognize the state's economic interest | | | 15|in the intellectual property generated over the course of the | | | 16|multistate drug development clinical trials with ibogaine, | | | 17|consisting of share of the proceeds from said intellectual property | | | 18|which is proportional to the state's contribution to the total cost | | | 19|of the multistate drug development trials, and to deposit the | | | 20|state's share of those proceeds in the Ibogaine Intellectual | | | 21|Property Account established under Section 5 of this act at agreed | | | 22|upon intervals during the period for which the drug development | | | 23|clinical trials are funded and during any following period of | | | 24|commercialization. | | | arsid4211350 HB3834 HFLR Page 4 ___________________________________________________________________________
1| C. In negotiating a contract with the drug developer, the | | | 2|Department may agree to additional terms and make reasonable | | | 3|deviations from the requirements of this section as long as the | | | 4|resulting contract is fair and creates at least substantially | | | 5|equivalent value for the state. | | | 6| D. For purposes of this section, intellectual property rights | | | 7|and other economic rights accruing to the State of Oklahoma arising | | | 8|from multistate drug development clinical trials with ibogaine shall | | | 9|include any and all of the following as related to these trials: | | | 10| 1. Intellectual property, technology, and inventions; | | | 11| 2. Patents, trademarks, and licenses; | | | 12| 3. Proprietary and confidential information; | | | 13| 4. Trade secrets, data, and databases; | | | 14| 5. Tools, methods, and processes; | | | 15| 6. Treatment models or techniques; | | | 16| 7. Administration protocols; and | | | 17| 8. Works of authorship. | | | 18| SECTION 4. NEW LAW A new section of law to be codified | | | 19|in the Oklahoma Statutes as Section 2-808 of Title 63, unless there | | | 20|is created a duplication in numbering, reads as follows: | | | 21| A. The drug developer shall quarterly, prepare and submit to | | | 22|the State Department of Health: | | | 23| 1. A report on the progress of the multistate drug development | | | 24|clinical trials with ibogaine conducted pursuant to this act; and | | | arsid4211350 HB3834 HFLR Page 5 ___________________________________________________________________________
1| 2. A financial status report, including information to verify | | | 2|expenditures of state funds and required matching funds. | | | 3| B. The State Department of Health shall submit a report to the | | | 4|Legislature on the progress of the drug development clinical trials | | | 5|and its related financial status by December 1 of each year until | | | 6|the clinical trials are concluded. | | | 7| SECTION 5. NEW LAW A new section of law to be codified | | | 8|in the Oklahoma Statutes as Section 2-809 of Title 63, unless there | | | 9|is created a duplication in numbering, reads as follows: | | | 10| The ibogaine intellectual property account shall be created in | | | 11|the Office of the State Treasurer. All receipts from the proceeds | | | 12|from the commercialization of intellectual property created through | | | 13|the public-private partnership created pursuant to Section 3 of this | | | 14|act shall be deposited into the account. Monies in the account | | | 15|shall be spent only after appropriation. Expenditures from this | | | 16|account shall be used only for programs or research benefitting | | | 17|at-risk populations that suffer from conditions treatable with | | | 18|ibogaine, including but not limited to traumatic brain injury, | | | 19|opioid use disorder, co-occurring substance use disorder, and other | | | 20|neurological or mental health disorders. | | | 21| SECTION 6. NEW LAW A new section of law to be codified | | | 22|in the Oklahoma Statutes as Section 2-810 of Title 63, unless there | | | 23|is created a duplication in numbering, reads as follows: | | | 24| | | | arsid4211350 HB3834 HFLR Page 6 ___________________________________________________________________________
1| Medical professionals licensed by the State of Oklahoma shall | | | 2|not be subject to adverse licensing action for recommending | | | 3|psilocybin or ibogaine therapy services. | | | 4| SECTION 7. This act shall become effective November 1, 2026. | | | 5| | | | 6|COMMITTEE REPORT BY: COMMITTEE ON HEALTH AND HUMAN SERVICES | |OVERSIGHT, dated 02/19/2026 - DO PASS. | 7| | | | 8| | | | 9| | | | 10| | | | 11| | | | 12| | | | 13| | | | 14| | | | 15| | | | 16| | | | 17| | | | 18| | | | 19| | | | 20| | | | 21| | | | 22| | | | 23| | | | 24| | | | arsid4211350 HB3834 HFLR Page 7