RS 28:212     

  

§212. Drug development of ibogaine and psychedelic medication treatments

            A. An academic health center may enter into an agreement with a drug developer to establish a consortium for the purpose of conducting drug development clinical trials with ibogaine and psychedelic medication treatments and securing the United States Food and Drug Administration's approval of such treatments for the treatment of opioid use disorder, co-occurring substance use disorder, and any other neurological or mental health condition for which the treatments demonstrate efficacy.

            B. A consortium seeking to conduct a drug development clinical trial may do all of the following:

            (1) Submit an investigational new drug application to the United States Food and Drug Administration in accordance with 21 CFR Part 312.

            (2) Seek a breakthrough therapy designation from the United States Food and Drug Administration in accordance with 21 U.S.C. 356.

            (3) Enter into an agreement with a consortium established by the government of another state, whether acting through an agent or joint venture, that has taken both of the following actions:

            (a) Has submitted an investigational new drug application to the United States Food and Drug Administration in accordance with 21 CFR Part 312.

            (b) Has requested a breakthrough therapy designation for ibogaine from the United States Food and Drug Administration in accordance with 21 U.S.C. 356.

            (4) Work with the United States Food and Drug Administration to coordinate the drug development trial in Louisiana with drug development trials that are being conducted in other states.

            C.(1) Any revenue attributable to newly developed intellectual property and other commercial rights arising from trial-enabling and drug development clinical trial activity conducted by a consortium pursuant to this Section, during the period for which the trials are funded, and any following period of commercialization shall be allocated as follows:

            (a) Not less than a two and one-half percent of net sales running royalty to the state.

            (b) The remainder to the members of the consortium in the amounts specified by written agreement of the members.

            (2) Intellectual property and other commercial rights arising from the drug development clinical trials conducted pursuant to this Section shall include any of the following as related to the trials:

            (a) Intellectual property, technology, and inventions.

            (b) Patents, trademarks, and licenses.

            (c) Proprietary and confidential information.

            (d) Trade secrets, data, and databases.

            (e) Tools, methods, and processes.

            (f) Treatment models or techniques.

            (g) Administration protocols.

            (h) Works of authorship.

            Acts 2026, No. 956, §1.