Tex. Health and Safety Code § 491.053: CONSORTIUM PROPOSAL.

(a) The lead institution of higher education of a consortium shall submit to the commission a proposal and request for funding on behalf of the consortium for purposes of conducting ibogaine drug development clinical trials in accordance with this subchapter.

(b) A proposal submitted under Subsection (a) must provide:

(1) the identity of all consortium members;

(2) a detailed description of the planned strategy for obtaining approval for the drug development clinical trials from the United States Food and Drug Administration;

(3) a detailed drug development clinical trial design that includes:

(A) a description of the composition of the consortium's drug development clinical trial team and the expertise of the team members;

(B) a drug development clinical trial participant recruitment plan;

(C) patient screening criteria and cardiac safety protocols;

(D) administration protocols;

(E) an aftercare and post-acute treatment support plan; and

(F) a data integrity plan;

(4) a detailed plan to seek a breakthrough therapy designation for ibogaine from the United States Food and Drug Administration under 21 U.S.C. Section 356;

(5) a proposal to recognize this state's commercial interest in all intellectual property that may be generated over the course of the drug development clinical trials, including:

(A) the treatment that is the subject of the trials;

(B) administration protocols;

(C) treatment models or techniques; and

(D) technology used in the trials;

(6) a plan to establish a corporate presence in this state and to promote and maintain ibogaine-related biomedical research, development, treatment, manufacturing, and distribution in this state;

(7) a plan to secure third-party payor approval for ibogaine treatment following approval by the United States Food and Drug Administration through:

(A) private insurers;

(B) Medicare;

(C) Medicaid; and

(D) the TRICARE program of the United States Department of Defense;

(8) a plan to ensure ibogaine treatment access to uninsured individuals following approval by the United States Food and Drug Administration;

(9) a plan to train and credential medical providers to administer ibogaine treatment according to developed clinical standards; and

(10) financial disclosures that verify the consortium's capacity to fully match state funding with funds received from non-state sources.

Added by Acts 2025, 89th Leg., R.S., Ch. 333 (S.B. 2308), Sec. 1, eff. June 11, 2025.