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 th e United States f ood and d rug a dministration ( "" FDA "" ) for ibogaine as a medication to treat opioid use disorder, co-occurring substance use disorder, and other neurological or mental health condition s for which ibogaine demonstrates efficacy . A cohort must include one or more drug developer s, one or mor e research institution s, 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 authorized 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 and 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 e xpedited 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, m edicare, m edicaid, 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 institution s or hospital s 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 ) i ntellectual property, technology, and inventions; ( ii ) p atents, trademarks, and licenses; ( iii ) p roprietary and confidential information; ( iv ) t rade secrets, data, and databases; ( v ) t ools, methods, and processes; ( vi ) t reatment models or techniques; ( vii ) a dministration protocols; and ( viii ) w orks 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 m oneys realized from intellectual property and other commercial rights arising from ibogaine clinical trials and a ppropriations made specifically to the fund by the general assembly . Funds m ust only be expended in accordance with this bill and pursuant to appropriations made by the general assembly . In order t o 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 t he 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, t his bill does not preclude a physician from administering ibogaine in accordance with federal law. Further, t his 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 this bill until the waiver is granted . However, t he department must begin accepting cohort proposals no later than September 1, 2026."