Draft
Veterans Mental Health Innovations Act
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF _________:
Section 1. LEGISLATIVE FINDINGS.
- Ibogaine is a naturally-occurring psychoactive compound that has demonstrated promise in treating a wide range of mental health and neurological conditions, including opioid use disorder (OUD), post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), depression, anxiety, multiple sclerosis (MS), and more.
- Ibogaine is classified as a Schedule I drug by the federal government, making research and access difficult, and forcing patients to seek unregulated treatment abroad.
- Multiple states have authorized and funded research into ibogaine, and Texas has launched a research consortium facilitating a multistate effort to conduct clinical trials on ibogaine as a medical treatment.
- Recent studies demonstrate ibogaine’s ability to significantly reduce symptoms of PTSD, depression, and anxiety after one treatment.
- Ibogaine treatment has been associated with marked improvements in patients with TBI; results include significant improvements in concentration, information processing, memory, and impulse control.
- Nonprofit organizations that facilitate veterans traveling to ibogaine retreats abroad study the impact of treatment and report substantial improvements in depression scores, PTSD symptoms, anxiety, sleep, quality of life, and emotional well-being.
- Trusted institutions, including the Food and Drug Administration and Department of Veterans Affairs, are actively supporting and investing in research on psychedelic-assisted therapies for PTSD and related mental health conditions.
- Expediting research into the medical potential of ibogaine is an effective and safe way to ensure patients have access to a potentially groundbreaking treatment.
Section 2. SHORT TITLE.
This act may be cited as the “Veterans Mental Health Innovation Act.”
Section 3. PURPOSE.
The purpose of the Veterans Mental Health Innovation Act is to allow states/commonwealths to join a multistate consortium to advance research on ibogaine as medical treatment.
Section 4. IBOGAINE TREATMENT.
Subchapter A. General Provisions.
1. Definitions.
In this chapter:
(a) [“Comptroller,” “Controller,” or “Treasurer”] means the comptroller of public accounts.
(b) “Consortium” means a group created by law in another state of the United States for the purpose of conducting drug development clinical trials with ibogaine.
(c) “Department” means the [State Health Department].
(d) “Ibogaine” means ibogaine and ibogaine-based therapeutics, including ibogaine analogs.
Subchapter B. Participation in Multistate Ibogaine Clinical Research Trials Consortium.
1. Funding.
(a) The sum of $[Amount] is appropriated from the state general fund in fiscal year [Year] to the [State Health Department] to award a grant to conduct a certified clinical drug development trial overseen by the United States Food and Drug Administration on the use of ibogaine for the treatment of opioid use disorder, co-occurring substance use disorder, or any other neurological or mental health condition for which ibogaine demonstrates efficacy. The department may award grants only to an entity that satisfies all of the following:
- Is located within the [State].
- Has a history of proven research and treatment of neurological diseases and expertise in substance dependence, emotional, and physical/neurological trauma.
- Has a neurosurgery program with the requisite clinical and research facilities and that is:
- (i) Staffed by professionals having expertise in the most challenging neurological and neurosurgical conditions; and
- (ii) Capable of providing the necessary infrastructure and expertise to deliver cardiac intensive care services.
- Has the ability to facilitate pioneering research and innovation in diagnosis and treatment of neurological conditions.
- Has demonstrated to the department that the entity has a commitment for matching monies of gifts, grants and donations from sources other than this state in the amount of at least $[Amount] to conduct the certified clinical research study on the use of ibogaine for the treatment of neurological diseases.
- Has signed an agreement with a consortium established by the government of another state within the United States of America, whether acting directly or through an agent or joint venture, that satisfies all of the following:
- (i) Has submitted an investigational new drug (IND) application to the United States Food and Drug Administration in accordance with 21 C.F.R. Part 312; and
- (ii) Has requested a breakthrough therapy designation for ibogaine from the United States Food and Drug Administration under 21 U.S.C. Section 356.
(b) The appropriation made in subchapter (a) of this section is exempt from the provisions of [Statutory Section Defining the Lapsing of Appropriated Funds].
(c) The department may not disburse the funding authorized in subchapter (a) until the applicant receives and the department verifies the receipt of matching funds from sources other than the state.
2. Reporting Requirements.
(a) An applicant selected to conduct ibogaine drug development clinical trials shall quarterly prepare and submit to the department:
- A report on the progress of the drug development clinical trials conducted under this subchapter; and
- A financial status report, including information to verify expenditures of state funds and required matching funds.
(b) The department shall submit a report to the legislature on the progress of the drug development clinical trials and their related financial status conducted under this subchapter not later than December 1 of each year.
3. Intellectual Property and Other Rights; Permanent Fund and Allocation of Revenue Attributable to Intellectual Property.
(a) There is hereby created an Ibogaine Intellectual Property Fund within the accounts of the [State] into which all revenue attributable to all intellectual property rights and other commercial rights that may arise from drug development clinical trials conducted by a multistate consortium under this subchapter during the period for which the trials are funded and any following period of commercialization shall be deposited.
(b) Such Funds shall be a permanent fund and the revenues accruing thereto shall not be spent, except that the earnings on its principal shall be distributed quarterly to programs that assist veterans or other at-risk populations in this state.
(c) The [“Comptroller,” “Controller,” or “Treasurer”] shall manage the fund and may invest its principal in high-grade securities. Examples of eligible investments include obligations issued or guaranteed by the United States, bonds or other evidences of indebtedness of this State or its political subdivisions, commercial paper from entities with investment-grade ratings, banker’s acceptances, negotiable certificates of deposit, and certain bonds or debentures denominated in United States dollars with investment-grade ratings.
(d) For purposes of this section, intellectual property rights and other commercial rights arising from the drug development clinical trials conducted under this subchapter include any of the following as related to the trials:
- Intellectual property, technology, and inventions;
- Patents, trademarks, and licenses;
- Proprietary and confidential information;
- Trade secrets, data, and databases;
- Tools, methods, and processes;
- Treatment models or techniques;
- Administration protocols; and
- Works of authorship.
Subchapter C. Ibogaine Treatment Administration.
1.Applicability.
This subchapter applies only if ibogaine is approved by the United States Food and Drug Administration to treat a medical condition.
2.Medical Supervision.
(a) A physician licensed under [Statutory Section Reference] shall prescribe ibogaine for a patient; and
(b) A physician licensed under [Statutory Section Reference] shall supervise the administration of ibogaine at a hospital or other licensed health care facility to ensure the patient’s safety while the patient is under the influence of ibogaine.
3.Administration Under Federal Law.
This subchapter does not preclude a physician from administering ibogaine in accordance with federal law.
Section 5.
(a) If before implementing any provision of this Act a state agency determines that a waiver or authorization from a federal agency is necessary for implementation of that provision, the agency affected by the provision shall request the waiver or authorization and may delay implementing that provision until the waiver or authorization is granted.
(b) The department shall begin accepting proposals under [Reference Section 4], not later than the 60th day after the effective date of this Act.
Section 6. (OPTIONAL IMMEDIATE EFFECT PROVISION).
This Act takes effect immediately if it receives a vote of [Vote Threshold] of all the members elected to each house, as provided by [Constitutional Reference to Immediate Effect Provisions].