Bill > SB2149

This bill, known as the "Helping Open Pathways to Effective (HOPE) Treatment Act," establishes a framework for conducting clinical trials of ibogaine, a substance and its related therapeutics, for treating opioid use disorder, co-occurring substance use disorders, and other neurological or mental health conditions, contingent on its approval by the U.S. Food and Drug Administration (FDA). The act allows for the creation of "cohorts," which are groups composed of a drug developer (a company involved in creating medications), a research institution (like a university), and a hospital, to apply for state selection to conduct these trials. If selected, the cohort will designate a lead institution, typically the research institution, to manage administrative functions and contract with the Department of Mental Health and Substance Abuse Services (DMHAS) for funding. The cohort must submit a detailed proposal to the DMHAS outlining their strategy for FDA approval, trial design, participant recruitment, safety protocols, aftercare plans, and plans to secure third-party payor approval and ensure access for uninsured individuals. The state will receive a percentage of revenue generated from intellectual property and commercial rights stemming from these trials, with a portion of that revenue directed to a new "Tennessee Mental Health Innovation Fund" to support training for behavioral health providers in best practices for patients who have undergone ibogaine therapy. The bill also outlines reporting requirements for the cohort and the DMHAS, and specifies that clinical trials can only be conducted at research institutions or hospitals.

Budget and Finance, Health and Social Services

https://wapp.capitol.tn.gov/apps/Billinfo/Default?BillNumber=SB2149&ga=114