The bill would establish a consortium to apply for Health and Human Services Commission (HHSC) selection to conduct drug development trials with ibogaine to secure the United States Food and Drug Administration's (USDA) approval of ibogaine as a medication for treatment of opioid use disorder, co-occurring substance use disorder, and any other neurological or mental health condition for which ibogaine demonstrates efficacy. The consortium would be required to select a lead institution of higher education from the consortium's members to represent the consortium and perform administrative functions. The lead institution of higher education selected would also be required submit a proposal and request for funding to HHSC to conduct the ibogaine drug development clinical trials. The proposal must verify that the consortium has capacity to contribute toward the cost of developing ibogaine treatment at an amount of funding to fully match state funding with funds received from non-state sources. HHSC would be required to select a consortium to conduct the clinical trials and enter into an interagency contract to provide funding to implement the clinical trials. The bill would allocate revenue attributable to all intellectual property rights and other commercial rights arising from the drug development trials at an amount of not less than 20.0 percent to the state and the remainder to the consortium members.
HHSC would require appropriations to fund the consortium's clinical trials, but the cost of such funding is unknown at this time. It is also unknown what the cost would be
at the selected institution of higher education related to employing administrative, clinical, and data management personnel.
Revenue received from intellectual property rights that would be allocated to the state is indeterminate and would be dependent on the drug development trials.
No significant fiscal implication to units of local government is anticipated.