Senate Bill 631
By: Senators Halpern of the 39th, Anderson of the 43rd, Wicks of the 34th, Jackson of the
41st and Parent of the 44th
A BILL TO BE ENTITLED
AN ACT
To amend Article 1 of Chapter 2A Title 31 of the Official Code of Georgia Annotated,
relating to general provisions of the Department of Public Health, so as to authorize the
department to award grants to eligible entities to conduct clinical trials approved by the
United States Food and Drug Administration as a part of a multistate consortium using
ibogaine as an investigational new drug for the treatment of opioid use disorder, co-occurring
substance use disorder, and any other neurological or mental health conditions as related to
veterans for which ibogaine demonstrates efficacy; to provide for waiver; to provide for
definitions; to provide for revenue attributable to intellectual property rights and other
commercial rights relative to clinical trials; to provide for the awarding of grants by the
Department of Public Health; to provide for certain eligibility requirements; to provide for
certain verifications; to provide for certain limitations on disbursement; to provide for
reporting; to provide for construction; to provide for related matters; to provide for a short
title; to provide for an effective date; to provide for contingencies; to repeal conflicting laws;
and for other purposes.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:
SECTION 1.
This Act shall be known and may be cited as the "Veterans Mental Health Innovations Act."
SECTION 2.
Article 1 of Chapter 2A Title 31 of the Official Code of Georgia Annotated, relating to
general provisions of the Department of Public Health, is amended by adding a new Code
section to read as follows:
"31-2A-21.
(a) As used in this Code section, the term:
(1) 'Armed forces' means the United States army, navy, marine corps, space force, coast
guard, air force, Georgia National Guard, or other reserve unit of the United States
military.
(2) 'Clinical trial' means a clinical trial program approved by the federal Food and Drug
Administration and conducted in this state as part of a multistate consortium for the
investigational use of ibogaine for the treatment of opioid use disorder, co-occurring
substance use disorder, and any other neurological or mental health conditions as related
to veterans for which ibogaine demonstrates efficacy.
(3) 'Ibogaine' means ibogaine and ibogaine based therapeutics, including ibogaine
analogs.
(4) 'Multistate consortium' means a collection of state, research institutions or state
agencies from different states collaborating or associating for the purpose of conducting
clinical trials concerning the medicinal use of ibogaine.
(5) 'Veteran' means a former member of the armed forces who received an honorable
discharge.
(b) Subject to appropriations by the General Assembly for such purpose, the department
shall be authorized to award grants to entities to participate in clinical trials, provided that
the department has obtained a waiver or authorization from the federal government if such
department determines that such waiver or authorization is required under federal law for
the implementation of any provision of this Code section. The department shall only award
a grant pursuant to this Code section to an applicant that:
(1) Is located within this state;
(2) Has a history of proven research and treatment of neurological conditions and
expertise in substance dependence and emotional, physical or neurological trauma as
related to veterans;
(3) Has a neurosurgery program with clinical and research facilities authorized to enter
into a multistate consortium agreement and is:
(A) Staffed by professionals with expertise in neurological and neurosurgical
conditions; and
(B) Capable of providing the necessary infrastructure and expertise to deliver cardiac
intensive care services;
(4) Has the ability to facilitate research and innovation in the diagnosis and treatment of
neurological conditions as related to veterans;
(5) Has demonstrated to the department that the entity has the financial capability to
match moneys from gifts, grants, and donations from sources other than this state in the
amount of at least $7 million to conduct the clinical trials described in this Code section;
and
(6) Has agreed to enter into an agreement with a multistate consortium by which the
applicant or an agent or joint venture thereof has agreed to:
(A) Submit an investigational new drug application to the United States Food and Drug
Administration in accordance with 21 C.F.R. Part 312; and
(B) Request a breakthrough therapy designation for ibogaine from the United States
Food and Drug Administration under 21 U.S.C. Section 356.
(c) An applicant selected to conduct clinical trials shall quarterly, prepare and submit to the
department:
(1) A report on the progress of the clinical trials conducted under this Code section; and
(2) A financial status report, including information verifying expenditures of state funds
and required matching funds.
(d) All revenue attributable to all intellectual property rights and other commercial rights
that may arise from the clinical trials conducted by the entity receiving the grant described
in subsection (b) of this Code section during the period for which trials are funded shall be
deposited into the state general fund. For purposes of this subsection, intellectual property
rights and other commercial rights arising from the clinical trials conducted under this
Code section shall include any of the following as related to such trials:
(1) Intellectual property, technology, and inventions;
(2) Patents, trademarks, and licenses;
(3) Proprietary and confidential information;
(4) Trade secrets, data, and databases;
(5) Tools, methods, and processes;
(6) Treatment models or techniques;
(7) Administration protocols; and
(8) Works of authorship.
(e) The commissioner shall prepare an accounting of the funds expended pursuant to this
Code section during the most recently completed fiscal year to be reported to the Office of
Planning and Budget, the House Budget and Research Office, and the Senate Budget and
Evaluation Office by January 1 of each year.
(f) The department shall submit to the General Assembly a report on the progress of the
clinical trials and their related financial status conducted under this Code section not later
than December 1 of each year. Such report shall include information verifying
expenditures of state funds and required matching funds.
(g) Nothing in this Code section shall be construed to preclude a physician from
administering ibogaine in accordance with federal law and state law."
SECTION 3.
(a) This Act shall become effective only if funds are specifically appropriated for purposes
of this Act in an appropriations Act enacted by the General Assembly.
(b) If funds are so appropriated, then this Act shall become effective on the later of:
(1) The date on which such appropriations Act becomes effective; or
(2) The beginning date of the fiscal year for which such appropriations are made.
(c) If funds are not appropriated by July 1, 2029, as described in this section, this Act shall
stand repealed.
SECTION 4.
All laws and parts of laws in conflict with this Act are repealed.