Kentucky allows a dedicated fund to support ibogaine drug trials

Kentucky’s Department of Agriculture can use a dedicated fund to partner with a drug developer on ibogaine trials. Trials concern opioid addiction, substance use disorders that occur alongside it, and other brain or mental health conditions for which ibogaine shows effectiveness. The fund can receive state funding, gifts, grants, federal money, and other public or private money. The law provides no specific funding amount. Unused money and investment earnings stay in the fund for the next fiscal year.

Before signing a research contract, the Department of Agriculture must review developer plans and negotiate funding and trial requirements. Eligible developers already have an ibogaine development agreement with another state. State money and matching money support trials using only Kentucky clinicians, facilities, and participants. Developers must provide trial and patient-care plans, federal approval plans, financial disclosures, and proof of another state partnership. Contracts must require developers to substantially agree to the safeguards. Officials may allow reasonable departures if the contract stays fair and gives Kentucky substantially equivalent value. Developers report progress and finances quarterly. The Department of Agriculture reports to lawmakers by December 1 each year until trials conclude.

Research contracts must call for a plan to make ibogaine treatment broadly accessible in Kentucky after federal approval. The plan concerns treatment access for patients within Kentucky. The plan includes priority for Kentucky residents, efforts to secure insurance coverage, access for uninsured and low-income patients, and training and credentials for Kentucky medical providers. Officials may allow reasonable contract departures if the agreement stays fair and gives Kentucky substantially equivalent value. The access plan concerns treatment following approval by the United States Food and Drug Administration.

Research contracts must call for a plan to share income from research discoveries and related commercial rights with Kentucky. Covered commercial rights include patents, research data, and treatment methods developed through the multistate trials. Kentucky’s planned share follows its contribution to the total cost of the multistate trials. Officials may allow reasonable contract departures if the agreement stays fair and gives Kentucky substantially equivalent value. All fund spending must support programs or research benefiting at-risk people with conditions treatable with ibogaine. Kentucky’s share returns to the fund at agreed intervals during funded trials and any later commercial use of the research.