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1 New Chapter; State Participation in Ibogaine Clinical Research Trials Consortium. Amend RSA by inserting after chapter 126-Z the following new chapter:
CHAPTER 126-ZZ
STATE PARTICIPATION IN IBOGAINE CLINICAL RESEARCH TRIALS CONSORTIUM
126-ZZ:1 Definitions. In this chapter:
I. "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.
II. "Department" means the department of health and human services.
III. "Ibogaine" means ibogaine and ibogaine-based therapeutics, including ibogaine analogs.
126-ZZ:2 Participation In Multistate Ibogaine Clinical Research Trials Consortium.
I. The department of health and human services shall establish and administer a grant program 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 bogan demonstrates efficacy.
II. The department may award grants only to an entity that satisfies all of the following:
(a) Is located within the state.
(b) Has a history of proven research and treatment of neurological diseases and expertise in substance dependence, emotional, and physical/neurological trauma.
(c) Has a neurosurgery program with the requisite clinical and research facilities and that is:
(1) Staffed by professionals having expertise in the most challenging neurological and neurosurgical conditions; and
(2) Capable of providing the necessary infrastructure and expertise to deliver cardiac intensive care services.
(d) Has the ability to facilitate pioneering research and innovation in diagnosis and treatment of neurological conditions.
(e) Has demonstrated to the department that the entity has a commitment for matching moneys of gifts, grants, and donations from sources other than this state in the amount of specified by the department to conduct the certified clinical research study on the use of ibogaine for the treatment of neurological diseases.
(f) 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:
(1) 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
(2) Has requested a breakthrough therapy designation for ibogaine from the United States Food and Drug Administration under 21 U.S.C. section 356.
II. The department shall not disburse the grant funding awarded under this section until the applicant receives and the department verifies the receipt of matching funds from sources other than the state.
126-ZZ:3 Reporting Requirements.
I. An applicant selected to conduct ibogaine drug development clinical trials shall quarterly prepare and submit to the department:
(a) A report on the progress of the drug development clinical trials conducted under this chapter; and
(b) A financial status report, including information to verify expenditures of state funds and required matching funds.
II. 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 chapter not later than December 1 of each year. The report shall be submitted to the speaker of the house of representatives, the senate president, the house clerk, and the senate clerk.
126-ZZ:4 Ibogaine Clinical Research Trial Fund. There is established in the state treasury the ibogaine clinical research trial fund, which shall be kept separate and distinct from all other funds. The fund shall be nonlapsing and continually appropriated to the department for purposes of administering the ibogaine clinical research trial grant program established under this chapter. The department is authorized to accept funds from any source, including state appropriations, federal funds, gifts, grants, and donations, for the purpose of administering the grant program and participating in the multistate ibogaine clinical research trials consortium.
126-ZZ:5 Ibogaine Intellectual Property Fund.
I. There is established in the state treasury the ibogaine intellectual property fund, which shall be kept separate and distinct from all other funds and 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 chapter during the period for which the trials are funded and any following period of commercialization shall be deposited.
II. The fund shall be nonlapsing 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. The fund shall be continually appropriated to the department for this purpose.
III. The 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.
IV. For purposes of this section, intellectual property rights and other commercial rights arising from the drug development clinical trials conducted under this chapter 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; and
(h) Works of authorship.
126-ZZ:6 Ibogaine Treatment Administration.
I. This section applies only if ibogaine is approved by the United States Food and Drug Administration to treat a medical condition.
II.(a) A physician licensed under RSA 329 shall prescribe ibogaine for a patient; and
(b) A physician licensed under RSA 329 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.
III. This chapter shall not preclude a physician from administering ibogaine in accordance with federal law.
126-ZZ:7 Applicability; Waiver Request Prior to Implementation.
I. If before implementing any provision of this chapter, the department determines that a waiver or authorization from a federal agency is necessary for implementation of that provision, the department shall request the waiver or authorization and may delay implementing that provision until the waiver or authorization is granted.
II. The department shall begin accepting proposals under this chapter not later than the sixtieth day after the effective date of this chapter.
2 New Subparagraph; Dedicated Funds. Amend RSA 6:12, I(b) by inserting after subparagraph (410) the following new subparagraph:
(411) Moneys deposited in the ibogaine clinical research trial fund, under RSA 126-ZZ:4, and the ibogaine intellectual property fund, under RSA 126-ZZ:5.
3 Appropriation; Department of Health and Human Services; Ibogaine Clinical Research Trials Consortium. The sum of $1 for the fiscal year ending June 30, 2027, is appropriated to the department of health and human services for the purpose of state participation in the ibogaine clinical research trials consortium and implementation of section 1 of this act. The governor is authorized to draw a warrant for said sum out of any money in the treasury not otherwise appropriated.
4 Effective Date.
I. Section 3 of this act shall take effect July 1, 2026.
II. The remainder of this act shall take effect 60 days after its passage.
Text to be added highlighted in green.
1 New Chapter; State Participation in Ibogaine Clinical Research Trials Consortium. Amend RSA by inserting after chapter 126-Z the following new chapter:
CHAPTER 126-ZZ
STATE PARTICIPATION IN IBOGAINE CLINICAL RESEARCH TRIALS CONSORTIUM
126-ZZ:1 Definitions. In this chapter:
I. "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.
II. "Department" means the department of health and human services.
III. "Ibogaine" means ibogaine and ibogaine-based therapeutics, including ibogaine analogs.
126-ZZ:2 Participation In Multistate Ibogaine Clinical Research Trials Consortium.
I. The department of health and human services shall establish and administer a grant program 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 bogan demonstrates efficacy.
II. The department may award grants only to an entity that satisfies all of the following:
(a) Is located within the state.
(b) Has a history of proven research and treatment of neurological diseases and expertise in substance dependence, emotional, and physical/neurological trauma.
(c) Has a neurosurgery program with the requisite clinical and research facilities and that is:
(1) Staffed by professionals having expertise in the most challenging neurological and neurosurgical conditions; and
(2) Capable of providing the necessary infrastructure and expertise to deliver cardiac intensive care services.
(d) Has the ability to facilitate pioneering research and innovation in diagnosis and treatment of neurological conditions.
(e) Has demonstrated to the department that the entity has a commitment for matching moneys of gifts, grants, and donations from sources other than this state in the amount of specified by the department to conduct the certified clinical research study on the use of ibogaine for the treatment of neurological diseases.
(f) 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:
(1) 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
(2) Has requested a breakthrough therapy designation for ibogaine from the United States Food and Drug Administration under 21 U.S.C. section 356.
II. The department shall not disburse the grant funding awarded under this section until the applicant receives and the department verifies the receipt of matching funds from sources other than the state.
126-ZZ:3 Reporting Requirements.
I. An applicant selected to conduct ibogaine drug development clinical trials shall quarterly prepare and submit to the department:
(a) A report on the progress of the drug development clinical trials conducted under this chapter; and
(b) A financial status report, including information to verify expenditures of state funds and required matching funds.
II. 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 chapter not later than December 1 of each year. The report shall be submitted to the speaker of the house of representatives, the senate president, the house clerk, and the senate clerk.
126-ZZ:4 Ibogaine Clinical Research Trial Fund. There is established in the state treasury the ibogaine clinical research trial fund, which shall be kept separate and distinct from all other funds. The fund shall be nonlapsing and continually appropriated to the department for purposes of administering the ibogaine clinical research trial grant program established under this chapter. The department is authorized to accept funds from any source, including state appropriations, federal funds, gifts, grants, and donations, for the purpose of administering the grant program and participating in the multistate ibogaine clinical research trials consortium.
126-ZZ:5 Ibogaine Intellectual Property Fund.
I. There is established in the state treasury the ibogaine intellectual property fund, which shall be kept separate and distinct from all other funds and 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 chapter during the period for which the trials are funded and any following period of commercialization shall be deposited.
II. The fund shall be nonlapsing 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. The fund shall be continually appropriated to the department for this purpose.
III. The 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.
IV. For purposes of this section, intellectual property rights and other commercial rights arising from the drug development clinical trials conducted under this chapter 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; and
(h) Works of authorship.
126-ZZ:6 Ibogaine Treatment Administration.
I. This section applies only if ibogaine is approved by the United States Food and Drug Administration to treat a medical condition.
II.(a) A physician licensed under RSA 329 shall prescribe ibogaine for a patient; and
(b) A physician licensed under RSA 329 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.
III. This chapter shall not preclude a physician from administering ibogaine in accordance with federal law.
126-ZZ:7 Applicability; Waiver Request Prior to Implementation.
I. If before implementing any provision of this chapter, the department determines that a waiver or authorization from a federal agency is necessary for implementation of that provision, the department shall request the waiver or authorization and may delay implementing that provision until the waiver or authorization is granted.
II. The department shall begin accepting proposals under this chapter not later than the sixtieth day after the effective date of this chapter.
2 New Subparagraph; Dedicated Funds. Amend RSA 6:12, I(b) by inserting after subparagraph (410) the following new subparagraph:
(411) Moneys deposited in the ibogaine clinical research trial fund, under RSA 126-ZZ:4, and the ibogaine intellectual property fund, under RSA 126-ZZ:5.
3 Appropriation; Department of Health and Human Services; Ibogaine Clinical Research Trials Consortium. The sum of $1 for the fiscal year ending June 30, 2027, is appropriated to the department of health and human services for the purpose of state participation in the ibogaine clinical research trials consortium and implementation of section 1 of this act. The governor is authorized to draw a warrant for said sum out of any money in the treasury not otherwise appropriated.
4 Effective Date.
I. Section 3 of this act shall take effect July 1, 2026.
II. The remainder of this act shall take effect 60 days after its passage.