C.R.S. § 27-60-207: Ibogaine research pilot program - creation - federal approval - fund - rules - reporting - definitions - repeal.

(1) As used in this section, unless the context otherwise requires:

(a) "Benefit-sharing plan" means an arrangement with Indigenous communities traditionally connected to the use of ibogaine or iboga that is intended to share in the benefits that arise from the research, therapeutic use, or commercialization of ibogaine or iboga. Benefits may include:

(I) Financial benefit sharing;

(II) Collaborative research or data sharing;

(III) Conservation support for plant species and habitats;

(IV) Community-identified development priorities;

(V) Cultural or educational exchanges; and

(VI) Utilizing a source for ibogaine that engages in benefit-sharing and ethical and sustainable cultivation practices.

(b) "Fund" means the ibogaine research pilot program cash fund created in subsection (10) of this section.

(c) "Ibogaine pilot site" means a facilitation site selected and authorized by the BHA to administer the pilot program.

(d) "Pilot program" means the ibogaine research pilot program established in subsection (2) of this section.

(2) There is established in the BHA the ibogaine research pilot program for the purpose of supporting research on the safety and effectiveness of using ibogaine to treat mental health conditions and substance use disorders.

(3) The BHA shall operate the pilot program. In operating the pilot program, the BHA:

(a) May approve up to five ibogaine pilot sites;

(b) May require a memorandum of understanding with each pilot site to ensure proper administration of the pilot program;

(c) In partnership with the ibogaine pilot sites, and in coordination with other appropriate state agencies, may seek federal authorization pursuant to 21 U.S.C. sec. 872(e) or other applicable federal law for purposes of expanding or advancing ibogaine research efforts;

(d) Shall assist the ibogaine pilot sites to complete and submit an investigational new drug application or revise and expand upon an existing investigational new drug application with the United States food and drug administration in accordance with 21 CFR part 312;

(e) Shall consider whether to obtain federal research program status under 21 U.S.C. sec. 872 or other applicable federal law for the purposes of expanding or advancing research efforts of the pilot sites;

(f) May negotiate a memorandum of understanding with the United States drug enforcement administration, United States department of health and human services, United States food and drug administration, United States attorney general, or any other appropriate federal agency, as necessary to ensure federal compliance and proper administration of the pilot program;

(g) May contract with individuals with expertise in behavioral health, nursing, researching a schedule I controlled substance, drug development, institutional review board and United States food and drug administration regulatory compliance, and physician consultation services to assist in the administration of the pilot program;

(h) May assist ibogaine pilot sites with funding opportunities, including identifying and applying for state, federal, or private grants;

(i) May award grants to selected ibogaine pilot sites to assist with operational costs; and

(j) May collaborate and enter into agreements with other states, state agencies, federally recognized tribes, and public or private entities to participate in multi-state consortia or similar efforts, including the sharing of data, funding, research, clinical protocols, and regulatory best practices related to ibogaine and ibogaine-related therapies.

(4) (a) The BHA shall establish a process to solicit and select ibogaine pilot sites.

(b) The BHA shall establish a pilot proposal review committee to review applications received from the solicitation process required by subsection (4)(a) of this section and make a recommendation to the BHA on the selection or denial of each application. The BHA shall notify each applicant of the selection decision within ninety days after the application deadline set by the BHA.

(5) To be eligible as an ibogaine pilot site, an applicant must:

(a) Demonstrate an intent to pursue the federal approval to operate an ibogaine pilot site to study safety and treatment effectiveness of the use of ibogaine to treat mental health conditions and substance use disorders; and

(b) Establish a benefit-sharing plan, which may be developed in consultation with Indigenous communities or their recognized governing institutions traditionally connected to ibogaine or iboga, that directly benefits those communities and shares in the benefits arising from research, therapeutic use, or commercialization of ibogaine or iboga. The benefit-sharing plan must include documentation of the sourcing of ibogaine or iboga.

(c) In developing a benefit-sharing plan pursuant to this subsection (5), applicants may consider internationally recognized principles related to equitable benefit sharing that may arise from the use of resources and traditional knowledge.

(6) (a) The commissioner shall adopt rules that are necessary to establish and administer the ibogaine pilot program. At a minimum, the commissioner shall adopt rules on the following:

(I) The application process for prospective ibogaine pilot site applicants;

(II) Criteria for awarding grants to ibogaine pilot sites to assist the ibogaine pilot site with funding;

(III) Data and research collection by the ibogaine pilot sites on the use and effectiveness of ibogaine in treating mental health conditions and substance use disorders;

(IV) Information sharing between the ibogaine pilot sites and the BHA;

(V) Adverse event reporting; and

(VI) Other rules that are necessary for the safe and effective operation of the ibogaine pilot sites and administration of the ibogaine research pilot program established by this section.

(b) With the exception of the requirements of subsection (6)(a) of this section, the commissioner shall not adopt rules that are duplicative of federal law.

(7) On or before a date set by the BHA and annually thereafter that the pilot program is operational, each ibogaine pilot site must submit the data and research as required pursuant to subsection (6)(a)(III) of this section for the proceeding year to the BHA.

(8) At least annually, but not more than quarterly, beginning one month after the date set by the BHA described in subsection (7) of this section while the pilot program is operational, the BHA must review the data and research submitted by the ibogaine pilot sites, as required by subsection (7) of this section, and post a report detailing the ibogaine pilot site findings on the BHA's website.

(9) The BHA may seek, accept, and expend gifts, grants, or donations received from private or public sources for the purposes of this section. The BHA shall transmit all money received through gifts, grants, or donations to the state treasurer, who shall credit the money to the ibogaine research pilot program cash fund created in subsection (10) of this section. The BHA may accept donations of in-kind services for purposes of this section.

(10) The ibogaine research pilot program cash fund is created in the state treasury. The fund consists of gifts, grants, and donations credited to the fund pursuant to subsection (9) of this section and any other money that the general assembly may appropriate or transfer to the fund. The state treasurer shall credit all interest and income derived from the deposit and investment of money in the fund to the fund. Money in the fund is continuously appropriated to the BHA for the purpose of administering the ibogaine research pilot program and awarding grants to selected ibogaine pilot sites.

(11) The operation of an ibogaine pilot site in accordance with this section is contingent on federal approval.

(12) This section does not preclude a person from administering ibogaine outside of the pilot program in compliance with federal law or as permitted pursuant to the "Natural Medicine Health Act of 2022", article 170 of title 12, and the "Colorado Natural Medicine Code", article 50 of title 44.

(13) An individual or entity participating in the pilot program must not be prosecuted or otherwise disciplined for actions or conduct permitted pursuant to this section.

(14) (a) A physician or health-care professional administering ibogaine to participants as part of the pilot program, or an ibogaine pilot site, is not liable for money damages in a civil malpractice action, a physical or psychological injury that a participant may experience as a result of being administered ibogaine as a participant in the pilot program, unless the injury was the direct result of the physician's or health-care professional's intentional misconduct, gross negligence, or a deviation from the generally accepted standards of practice.

(b) This subsection (14) does not apply to administrative proceedings.

(15) The BHA shall work to secure federal research and development funding available through the advanced research projects agency for health within the federal department of health and human services, or other available federal funding, in order to advance research efforts on the use of ibogaine as a treatment for serious mental illnesses.

(16) Subsections (1), (2), (3), (4), (5), (6), (7), (8), (11), (12), (13), (14), and (15) of this section take effect if the BHA receives one hundred fifty thousand dollars in gifts, grants, or donations, or if the BHA receives in-kind donations for which the value is equal to one hundred fifty thousand dollars, before January 1, 2028, for the purpose of implementing this section. The commissioner of the BHA shall notify the revisor of statutes in writing of the date on which the condition specified in this subsection (16) has occurred by emailing the notice to revisorofstatutes.ga@coleg.gov. Subsections (1), (2), (3), (4), (5), (6), (7), (8), (11), (12), (13), (14), and (15) of this section take effect on the date identified in the notice to the revisor of statutes that the BHA has received one hundred fifty thousand dollars in gifts, grants, or donations, or an in-kind donation for which the value is equal to one hundred fifty thousand dollars, for the purpose of this section, or, if the notice to the revisor of statutes does not specify that date, on the date of the notice to the revisor of statutes.

(17) (a) The BHA must receive additional gifts, grants, or donations in the amount necessary to cover the total remaining cost of operating the pilot program for the duration of the pilot program, or in-kind donations for which the value is equal to the amount necessary to cover the total remaining cost of operating the pilot program for the duration of the pilot program, within three hundred sixty-five days following the date on which subsections (1), (2), (3), (4), (5), (6), (7), (8), (11), (12), (13), (14), and (15) of this section take effect.

(b) This section is repealed if the BHA does not receive additional gifts, grants, or donations in the amount necessary to cover the total remaining cost of operating the pilot program for the duration of the pilot program, or in-kind donations for which the value is equal to the amount necessary to cover the total remaining cost of operating the pilot program for the duration of the pilot program, within three hundred sixty-five days following the date on which the revisor of statutes receives notice pursuant to subsection (16) of this section. The commissioner of the BHA shall notify the revisor of statutes of the date on which the condition specified in this subsection (17)(b) has occurred by emailing the notice to revisorofstatutes.ga@coleg.gov.

(18) (a) If, on or before January 1, 2028, the money in the fund has never reached or exceeded one hundred fifty thousand dollars, or additional gifts, grants, or donations in the amount necessary to cover the total remaining cost of the pilot program are not received within three hundred sixty-five days following the date on which the revisor of statutes receives notice pursuant to subsection (16) of this section, the state treasurer shall return from the fund to the grantor or donor the amount of the grantor's or donor's gifts, grants, or donations and, notwithstanding subsection (17) of this section, the BHA shall not accept additional gifts, grants, or donations for the purposes of this section.

(b) If any money remains in the fund after the state treasurer returns money to donors or grantors pursuant to subsection (18)(a) of this section, as applicable, the state treasurer shall, prior to the repeal of the fund, transfer all unexpended and unencumbered money in the fund to the regulated natural medicine cash fund created in section 44-50-601.