HB 2075

This bill authorizes a cohort established and selected by the department of mental health and substance abuse services ("department"") to conduct drug development clinical trials with ibogaine for the purpose of obtaining approval from the United States fo od and drug administration (""FDA"") for ibogaine as a medication to treat opioid use disorder, co-occurring substance use disorder, and other neurological or mental health conditions for which ibogaine demonstrates efficacy. A cohort must include one or m or e drug developers, one or more research institutions, which may be an institution of higher education, and one or more hospitals. This bill requires a cohort to select a project lead from among the cohort's members to represent the cohort and perform administrative functions, including contracting with and reporting to the department. A project lead selected by the department is a uthorized to employ clinical, administrative, and data management personnel necessary to support cohort activities, which may include participation in the Texas consortium for clinical trial collaboration. The cohort project lead must submit a proposal a nd request for funding to the department. The proposal must provide:  The identity of all cohort members.  A detailed strategy for obtaining FDA approval for drug development clinical trials.  A clinical trial design including team composition, participant recruitment plans, cardiac safety protocols, administration protocols, aftercare plans, and data integrity plans.  A plan to seek a breakthrough therapy designation for ibogaine from the FDA under federal law aimed at expedited approval of drugs for serious or life-threatening diseases or conditions.  A proposal to recognize the state's commercial interest in all intellectual property generated during the trials, including treatments, protocols, treatment models and techniques, and technology.  Plans for a state corporate presence and the promotion of ibogaine-related research, manufacturing, and distribution within the state.  Plans to secure third-party payor approval, such as private insurers, medicare, medicaid, and the TRICARE program, and ensure access for uninsured individuals following FDA approval.  Plans to ensure ibogaine treatment access to uninsured individuals following approval by the FDA;  A plan to train and credential medical providers.  Financial disclosures verifying the capacity to match state funding with non-state sources. This bill grants the department sole discretion to select a cohort for the purpose of conducting clinical trials. After making a selection, the department must enter into an interagency agreement with the project lead to provide funding. The contract must specify goals, objectives, proposed budgets, timelines, collaborating entities, the percentage of revenue arising from the trials to be paid to the state, and any other information requested by the department. After entering into the interagency contract, the department must report the existence of the contract to the chief clerks of the senate and the house of representatives. The department is prohibited from disbursing funds until it verifies the cohort's receipt of matching funds from non-state sources. OPERATIONAL REQUIREMENTS AND REPORTING This bill requires the selected cohort to submit an investigational new drug application to the FDA and seek breakthrough therapy designation as soon as practicable. However, only research institutions or hospitals are permitted to serve as a trial site. This bill authorizes the department and cohort members to solicit and accept gifts, grants, and donations from non-state sources. Disbursements by the department may be made incrementally based on the completion of defined objectives as negotiated in the interagency contract. This bill requires selected cohorts to submit quarterly reports to the department regarding trial progress and financial status, including verification of expenditures for state and matching funds. The department must submit an annual progress report to the general assembly no later than December 1 of each year. REVENUE ALLOCATION This bill requires that revenue attributable to intellectual property and commercial rights arising from the trials, including (i) intellectual property, technology, and inventions; (ii) patents, trademarks, and licenses; (iii) proprietary and confidential information; (iv) trade secrets, data, and databases; (v) tools, methods, and processes; (vi) treatment models or techniques; (vii) administration protocols; and (viii) works of authorship, to be allocated as follows:  No less than 5% to the state.  The remainder to cohort members in amounts specified by written agreement. TENNESSEE MENTAL HEALTH INNOVATION FUND This bill establishes the Tennessee mental health innovation fund as a special account within the general fund. The fund is primarily capitalized through moneys realized from intellectual property and other commercial rights arising from ibogaine clinic al trials and appropriations made specifically to the fund by the general assembly. Funds must only be expended in accordance with this bill and pursuant to appropriations made by the general assembly. In order to ensure accountability, all expenditures a re subject to review via an annual report submitted by the commissioner of mental health and substance abuse services (""commissioner"") to the general assembly. State revenue from the trials must be deposited as follows:  No less than 50% into the innovation fund.  The remainder into the general fund. This bill requires the commissioner to administer the fund to support proposals from behavioral health providers to train and support staff in best practices for patients undergoing ibogaine therapy. APPLICABILITY AND MEDICAL OVERSIGHT This bill requires a licensed physician who has prescribed ibogaine to supervise its administration at a hospital or other licensed healthcare facility to ensure patient safety. However, this bill does not preclude a physician from administering ibogain e in accordance with federal law. Further, this bill applies only if ibogaine is approved by the FDA to treat a medical condition. If the department determines a federal waiver is necessary for implementation, then the department must request the waiver and may delay implementation of t his bill until the waiver is granted. However, the department must begin accepting cohort proposals no later than September 1, 2026. ON APRIL 15, 2026, THE SENATE ADOPTED AMENDMENT #2 AND PASSED SENATE BILL 2149, AS AMENDED. AMENDMENT #2 rewrites the bill to, instead, establish the council on emerging behavioral health treatments (""council"") to oversee this state's participation in emerging behavioral health treatment research. The council must be composed of the following 11 members:  The chair of the committee of the house of representatives having jurisdiction over health.  The chair of the health and welfare committee of the senate.  One person appointed by the governor.  One person appointed by the speaker of the house of representatives.  One person appointed by the speaker of the senate.  One non-voting representative from the department of mental health and substance abuse services.  One non-voting representative from the department of health.  Two non-voting representatives of nonprofit advocacy-focused organizations, selected by majority vote of the voting members of the council pursuant to a published selection process.  Two non-voting representatives of licensed mental health providers, selected by majority vote of the voting members of the council pursuant to a published selection process. This amendment requires appointments to the council to be made by September 1, 2026. The organizational meeting of the council must occur within 30 days after all five voting members are appointed. The non-voting members must be selected within 90 days of the organizational meeting. Three voting members constitute a quorum and official actions require an affirmative vote of a majority of voting members present. Conflicts of Interest This amendment requires a voting member of the council to disclose, in writing, any financial interest in an entity that has applied for or received authorization for funding under this amendment. Such a member is required to recuse themselves from any deliberation or vote involving an entity in which they have a financial interest. Further, an entity in which a voting member holds a board position, employment relationship, or ownershi p interest is not eligible to receive authorization or funding under this chapter during that member's tenure on the council. MULTISTATE IBOGAINE RESEARCH CONSORTIUM This amendment permits the council to authorize one or more qualified institutions in this state to participate in a multistate ibogaine drug development clinical trial consortium. However, this authorization must not require the formation of a Tennesse e-specific cohort or consortium. A qualified institution in this state may participate individually or jointly with other institutions in this state as a member of an existing multistate consortium. The council may provide funding to a participating ins ti tution. This amendment requires an institution seeking authorization to participate in a multistate consortium to submit an application to the council that includes all of the following:  The identity of the institution and its proposed role within the multistate consortium.  Evidence of the institution's eligibility for membership in the multistate consortium, including a letter of intent, invitation, or executed agreement from the consortium.  A description of clinical trial activities proposed to be conducted in this state, including patient recruitment, trial sites, and safety protocols.  Cardiac safety protocols and patient screening criteria consistent with current United States federal food and drug administration (FDA) guidance on ibogaine research.  An aftercare and post-acute treatment support plan.  Documentation of FDA investigational new drug authorization or evidence of a pending application.  A plan to serve populations of this state disproportionately impacted by opioid use disorder, including veterans and rural residents.  Financial disclosures demonstrating the institution's capacity to manage state funds and fulfill any matching requirements imposed by the council. However, this amendment authorizes the council to waive or modify application requirements upon a finding that the multistate consortium's existing documentation satisfies the relevant requirements. In order to participate in a multistate ibogaine drug development clinical trial consortium, this amendment requires a participating institution to (i) execute a participation agreement required by the multistate consortium and provide a copy to the coun cil; (ii) agree to report to the council on a quarterly basis; and (iii) ensure that any clinical trial activity conducted in this state complies with applicable state and federal law. If two or more institutions in this state participate in a multistate c onsortium, the council must designate one institution as the coordinating institution for the purposes of contracting with and reporting to the council. Such a coordinating institution may employ personnel necessary to support the activities of participa ting institutions in this state. This amendment authorizes the council and participating institutions to solicit and accept gifts, grants, and donations of any kind received from sources other than the state for purposes of funding drug developmental clinical trials for ibogaine. The c ouncil may disburse funds incrementally, based on the completion of clearly defined objectives as negotiated in the contract with a coordinating institution. Contracting with the Coordinating Institution This amendment requires the council to enter into an interagency contract with the coordinating institution to provide funding to implement the authorized ibogaine drug development clinical trials as soon as practicable after authorizing a participating institution. Such an interagency contract must specify (i) the goals and objectives of the proposed ibogaine drug development clinical trials; (ii) the proposed budget; (iii) the timeline for completing the proposed objectives; (iv) the for-profit, nonpr of it, or public benefit corporate entities collaborating with the participating institutions in this state in the drug development clinical trials, including any multistate consortiums that the participating institutions in this state are members; (v) the s tate's financial interest or monetary return on any FDA-approved medication that is developed by the drug development clinical trials; and (vi) any other information required by the council. The council must report the existence of an interagency contrac t to the general assembly. This amendment prohibits the council from disbursing funds to or for a participating institution under the interagency contract until the institution receives and the council verifies the receipt of matching funds from sources other than the state. However, the council may waive this requirement upon a finding, adopted by majority vote, that extraordinary circumstances make compliance impracticable. INVESTIGATIONAL NEW DRUG APPLICATION This amendment requires a participating institution that is conducting clinical trials in this state to ensure that such activities are conducted pursuant to a valid investigational new drug (IND) application submitted to the United States food and drug administration in accordance with federal regulations. If a participating institution joins a multistate consortium that holds or is pursuing a consortium-level IND, compliance with that IND satisfies this requirement. This amendment clarifies that it does not authorize the administration of ibogaine to human subjects in this state except in the context of a clinical trial conducted pursuant to a valid FDA investigational new drug authorization. CLINICAL TRIAL SITES This amendment provides that a drug development clinical trial site for an ibogaine clinical trial must be either a research institution, institution of higher education with clinical research capacity, or a hospital. REPORTING REQUIREMENTS This amendment requires a participating institution to prepare and submit to the council a quarterly report on the progress of the drug development clinical trials for ibogaine. Further, a participating institution must submit a quarterly financial stat us report. This amendment requires the council to submit a report to the general assembly on the progress of the drug development clinical trials conducted on ibogaine by December 1st of each year. The council must include in its report a projection of the anticip ated revenue attributable to the state's financial interest or monetary return for the succeeding fiscal year. ALLOCATION OF REVENUE This amendment requires the revenue attributable to the state's financial interest o monetary return on any FDA-approved medication that is developed by the drug developmental clinical to be allocated as follows:  At least 2% of the state's financial interest or monetary return to the state as specified in the interagency contract.  The remained to the members of the participating institutions in the amounts specified by written agreement of the members. State Revenue This amendment requires at least 50% of any revenue allocated to the state must be deposited into the emerging behavioral health treatment innovation fund. The remainder of the revenue must be deposited into the state general fund. EMERGING BEHAVIORAL HEALTH TREATMENT INNOVATION FUND This amendment establishes the emerging behavioral health treatment innovation fund and requires the moneys realized from the state's financial interest or monetary return on any FDA-approved medication that is developed by the drug development clinical trials to be deposited into the fund. The council may accept other funds, public or private, to the fund. The state treasurer must invest money s in the fund, investments and deposits of the fund must be credited to and remain part of the fun. Unencumbered and unexpended moneys must be carried forward until expended. This amendment requires that moneys in the fund be expended only for the following purposes:  Fund research by behavioral health providers and institutions into emerging and innovative behavioral health treatments, including ibogaine and other psychedelic-assisted therapies.  Support training and credentialing of clinical and supportive care staff in evidence-based and emerging behavioral health treatment modalities.  Fund grants to nonprofit organizations providing direct behavioral health services, patient navigation, and recovery support to residents of this state.  Support public education and provider outreach regarding emerging behavioral health treatments authorized under this amendments.  Fund community education and public policy education efforts by nonprofit organizations working to expand access to emerging behavioral health treatments for citizens of this state. This amendment provides that all expenditures from the fund are subject to review in the form of an annual report submitted to the general assembly. MISCELLANEOUS REQUIREMENTS This amendment requires a physician that has prescribed ibogaine to a patient to supervise the administration of ibogaine at a hospital or other licensed healthcare facility participating in an ibogaine clinical trial. Federal Law This amendment clarifies that it does not preclude a physician from administering ibogaine in accordance with federal law. This amendment requires the council, or another entity of state government, to request a waiver or authorization from a federal agency if necessary to effectuate this amendment. Further, implementation of a provision of this amendment may be delayed unt il the necessary waiver or authorization is granted. Exemption from Controlled Substances Liability This amendment clarifies that a physician, researcher, or institution participating in an ibogaine clinical trial authorized by the council is not subject to criminal liability under this state's controlled substances laws solely on the basis of possessi on, administration, or use of ibogaine in furtherance of participation in such a trial. However, all activities must be conducted in compliance with this amendment, the terms of the council's authorization, and applicable federal law ON APRIL 22, 2026, THE HOUSE SUBSTITUTED SENATE BILL 2149 FOR HOUSE BILL 2075, ADOPTED AMENDMENT #3, AND PASSED SENATE BILL 2149, AS AMENDED. AMENDMENT #3 rewrites this bill to enact the ""HOPE Treatment Act"" to authorize a research institution to participate in one or more clinical trials involving ibogaine, so long as the trial complies with a valid United States FDA investigational new drug (IND) authorization, when such authorization is required by federal law. This amendment specifies that ibogaine may only be administered in Tennessee: (1) As part of a clinical trial conducted at a hospital or qualified research facility; and (2) Under the medical direction of a physician licensed in Tennessee. A research institution that is conducting or participating in a federally authorized clinical trial for ibogaine shall implement appropriate patient screening and safety protocols consistent with federal law, rule, and guidance. This amendment provides immunity from criminal liability to a healthcare provider, researcher, patient, or research institution participating in a clinical trial involving ibogaine in compliance with this bill and applicable federal law for conduct that occurs as part of such clinical trial, if such conduct is authorized by federal law. ON APRIL 23, 2026, THE SENATE CONCURRED IN HOUSE AMENDMENT # 3 ."