SB2308

Who participates. A consortium must include at least one drug developer, one institution of higher education and one hospital. A member higher-education institution leads administration and contracting with the Health and Human Services Commission. Only a qualifying institution or hospital may be a trial site. The incorporated Education Code definition covers public higher-education institutions; the bill does not simply treat every private training business as an eligible university. “Ibogaine” expressly includes ibogaine-based therapeutics and analogs. Final law, sections 491.001 and 491.051–.057; Incorporated higher-education definition, subdivision (8).

Proposal and safeguards. The proposal must identify participants and expertise, recruitment and screening plans, cardiac-safety and administration protocols, aftercare, data integrity and the strategy for FDA review and breakthrough-therapy designation. It also must address Texas research/commercial operations, provider training, future payer coverage and uninsured access after approval, and financial capacity to match state funding. These are required plans—not guarantees that insurers already cover treatment or that uninsured patients already have access. Final law, section 491.053.

HHSC selects the consortium in its sole discretion and contracts with the lead institution, specifying goals, budget, timeline, collaborating entities and the state revenue percentage. It must notify the legislature of the contract. No state disbursement may occur until the consortium has received non-state matching funds and HHSC verifies receipt. Payments may be tied to documented milestones and spending. The consortium reports progress and finances quarterly; HHSC reports to the legislature by December 1 each year. HHSC had to begin accepting proposals within 60 days after the act took effect; that is not a deadline for FDA approval or completion of trials. Final law, sections 491.054–.059 and section 2.

Federal approval remains separate. A designated consortium member must submit an investigational-new-drug application and seek breakthrough-therapy designation. Federal rules require an effective IND before covered human trials and retain participant-protection, informed-consent, review-board and clinical-hold requirements. Breakthrough designation expedites development/review when the federal criteria are met; it is not marketing approval or a waiver of the evidence standard. The state act cannot establish a clinical result by declaring a research objective. Final law, section 491.056; Federal IND rules, sections 312.20, .40, .42, .60 and .66; Federal breakthrough-therapy law, subsections (a) and (e).

Revenue and later treatment. At least 20% of revenue attributable to the covered intellectual-property and commercial rights goes to the state, including during subsequent commercialization; the contract sets the percentage and members allocate the remainder by agreement. The covered rights extend beyond patents to such things as data, methods, protocols and treatment models. Receipts enter General Revenue, and 25% of the state’s receipts may be appropriated only to Texas veterans’ programs. That is not 25% of all consortium revenue or an automatic cash payment to veterans. The treatment-administration subchapter applies only if FDA approves ibogaine to treat a medical condition, then requiring the prescribing Texas-licensed physician to supervise administration in a hospital or other licensed health-care facility. It preserves administration consistent with federal law. Final law, sections 491.060–.061 and 491.101–.103.

The final law is not the earlier grant proposal. Introduced and Senate versions used a grant program and selection committee. The House committee removed the conditional post-approval treatment subchapter and added appropriated money to the proposed grant-funding clause. Harris’s sole indexed floor amendment, adopted May 12, added the definition covering ibogaine analogs; that definition survived. Conference replaced the grant/committee approach with the consortium, lead-institution contract, verified-match and revenue-sharing structure, restored the conditional treatment provisions and added the 60-day proposal-opening deadline. The Senate and House expressly authorized the broader conference changes through SR703 and HR1495, adopted May 31 and June 1 respectively. All versions and conference report; Harris amendment; Amendment disposition; Senate authorization; House authorization.

Conference also removed the earlier requirement that HHSC establish sites equipped and staffed for cardiac intensive care and select a Texas-based institutional review board. It retained proposal-level cardiac-safety requirements and the federal trial framework; deleting those particular state provisions did not eliminate all safety or ethics-review obligations. Agencies must request any federal waiver or authorization they determine necessary and may delay the affected provision until it is granted. Authorized deletions, item 13; Final law, sections 491.053 and 2; Federal trial protections.

Compare the published text versions in the official text index. A change is not attributed to a specific amendment here without a verified record.

The potential benefit is rigorously testing a possible treatment while building Texas research capacity and preserving a public revenue share if commercialization succeeds. The risks include uncertain clinical outcomes, participant safety, substantial research spending and revenue that may never materialize. The legislation requires screening and cardiac-safety planning; it does not establish that treatment is safe or effective for a particular person. No completed consortium award, successful trial, FDA approval or actual revenue payment is established by this briefing. Final law; Final fiscal note.

Funding is real, but not a guaranteed return. SB2308 itself states no dollar appropriation. The separate 2026–27 budget, SB1 Article IX section 18.74, appropriated $50 million in fiscal 2026 to HHSC contingent on this legislation, with unused first-year balances available for the second year. The governor’s SB1 line-item veto did not remove section 18.74. That appropriation is not proof the money has been disbursed, and SB2308’s verified non-state match condition still matters. SB1 budget, printed page IX-119; SB1 line-item veto; Final law, section 491.055(d).

The final May 30 fiscal note says total trial-funding needs, lead-institution staffing costs and possible state intellectual-property revenue cannot be determined; it anticipates no significant local-government impact. Earlier grant-version notes illustrated annual technical-support costs of $965,309, three additional state positions and related personnel/tracking costs, but those were not a final cost ceiling and excluded the unknown trial funding itself. The later $50 million budget appropriation does not turn the final note into a finding that all trials will cost exactly that amount or generate matching profits. Final conference estimate; Earlier grant-version estimate.