AN ACT to enact the healing through evidence‑based access to lifesaving care act.

The General Assembly of North Carolina enacts:

SECTION 1.(a)  Establishment of Fund. – The Breakthrough Therapies Research (BTR) Grant Fund is established as a nonreverting special fund in the Department of Health and Human Services, Division of Mental Health, Developmental Disabilities, and Substance Use Services (Division). Funds shall be used to award two competitive BTR Grants to recipients for eligible research projects or studies, as outlined in this section. The funds shall be used by the recipient to pay for costs associated with an eligible research project or study, which is intended to last three years.

For the purposes of this act, the term breakthrough therapies shall mean any drug that has been designated as a Breakthrough Therapy for which an expedited approval pathway has been granted by the United States Food and Drug Administration (FDA).

SECTION 1.(b)  Eligible Research Projects or Studies. – The Division shall accept applications in a timely fashion for the grant awards to be made no later than August 1, 2027. Applications are limited to federal medical or research entities and academic institutions located in this State with infrastructure and staff experience to support the research being funded under this act. All research must be conducted within this State and participants must be age 21 or older. To be eligible for a BTR Grant, the recipient must attest that the grant funds will be used to conduct research in this State on the use of psychedelic drugs, including ibogaine, MDMA, and psilocybin, and that the research will adhere to all FDA protocols and all applicable federal laws, including President Trump's April 18, 2026, Executive Order on Accelerating Medical Treatments for Serious Mental Illness. The research shall be concentrated on treating the mental health of any of the following populations that are disproportionately impacted by trauma:

(1)        Military veterans.

(2)        Active or former first responders, specifically individuals with specialized training who are among the first to arrive and aid or provide incident resolution at the scene of an emergency or natural disaster. This population includes, but is not limited to, law enforcement officers, paramedics, emergency medical technicians, and firefighters.

(3)        Frontline healthcare personnel, specifically individuals with specialized training to provide direct healthcare services to members of the community. These healthcare services include preventing, detecting, and treating diseases or other public health issues. Frontline healthcare personnel includes licensed doctors, physician assistants, nurses, pharmacists, and community health workers.

(4)        Individuals who have experienced domestic violence or sexual assault.

The research study involving psilocybin shall be concentrated on the treatment of anxiety disorder, depressive disorder, or both. All research studies awarded a grant must measure participant baseline pain levels and any changes to the pain levels that may be related to the breakthrough therapies.

Each grant recipient shall be required to submit a report on the research findings and recommendations to the Division and the Breakthrough Therapies Task Force, established under Section 2 of this act, no later than January 15, 2031. The grant amount is intended to fund three years worth of research study.

SECTION 1.(c)  Grant Awards. – Upon the recommendation of the Breakthrough Therapies Task Force, established under Section 2 of this act, and no later than July 1, 2027, the Division shall award up to five competitive grants of no less than one million dollars ($1,000,000) each. No later than July 1, 2027, the Division shall announce the recipients of the competitive grant awards authorized under this section and report to the Joint Legislative Oversight Committee on Health and Human Services on the following information related to the research project or studies to be conducted by each eligible competitive grant recipient:

(1)        The scope and purpose.

(2)        The anticipated number of people participating and a description of the participating targeted population.

(3)        The geographic area to be served.

(4)        The anticipated time frame for completion.

SECTION 1.(d)  Rules. – The Division may adopt any rules, emergency, temporary, or otherwise, for the purposes of this act. The Division shall determine the method and manner by which applicants may apply for the competitive grant, including what information the Division requires of the applicants.

SECTION 2.(a)  Establishment of Task Force. – There is established within the Department of Health and Human Services, Division of Mental Health, Developmental Disabilities, and Substance Use Services (Division), the Breakthrough Therapies Task Force (Task Force). This Task Force shall consist of the following members:

(1)        The Secretary of the Department of Health and Human Services, or the Secretary's designee.

(2)        The Secretary of the Department of Military and Veterans Affairs, or the Secretary's designee.

(3)        The Secretary of the Department of Commerce, or the Secretary's designee.

(4)        One member representing mental health issues in the State, selected by the State chapter of the national alliance focused on mental health and mental illness.

(5)        Two members representing healthcare needs of North Carolina Native communities, one selected by the tribal council of the Eastern Band of Cherokee Indians and one selected by the tribal council of the Lumbee Tribe of North Carolina.

(6)        One member representing the healthcare needs of survivors of domestic violence and sexual assault, selected by the NC Domestic Violence Commission.

(7)        One member representing the psychiatric profession, selected by the governing body of the North Carolina Psychiatric Association.

(8)        One member of the faculty of the University of North Carolina School of Medicine, selected by the dean of the University of North Carolina School of Medicine.

(9)        One member of the faculty of the East Carolina University Brody School of Medicine, selected by the dean of the Brody School of Medicine.

(10)      Two members of the Senate, one appointed by the President Pro Tempore of the Senate and one appointed by the Senate Minority Leader.

(11)      Two members of the House of Representatives, one appointed by the Speaker of the House of Representatives and one appointed by the House Minority Leader.

(12)      Up to three members selected by the Task Force, once assembled, that the Task Force determines would serve the purpose of the Task Force, including, but not limited to, members of veterans advocacy groups, disabled veterans groups, first responders associations, anti‑human trafficking advocacy organizations, law enforcement advocacy organizations, and victims' rights groups. The Task Force is not required to make an appointment under this subdivision.

The initial task force shall be appointed no later than December 1, 2026. On or after December 1, 2026, any vacancies shall be filled in the manner appointed.

SECTION 2.(b)  Duties of the Task Force. – The Breakthrough Therapies Task Force shall have the following duties:

(1)        Assess the potential use of psychedelic medicine in treating trauma‑related mental health conditions.

(2)        Identify barriers to access and affordable implementation.

(3)        Recommend licensing and insurance requirements for practitioners in the State in the event that psychedelic medicines are federally reclassified and approved by the United States Food and Drug Administration.

(4)        Consider legal and regulatory pathways to the legalization of psychedelic medicines in the State and the potential effects of the medicines on public health.

(5)        Make recommendations to the Division regarding the method and manner by which applicants may apply for the competitive BTR Grant, including what information the Division requires of the applicants. Preference for grant applications focusing on implementation research shall be given.

(6)        Review grant applications and make recommendations to the Division regarding research projects or studies to be funded.

(7)        Monitor research projects or studies conducted by recipients of the BTR Grant.

(8)        No later than December 1, 2027, and annually thereafter for three additional years, report to the Division regarding any updates based upon the monitoring of the BTR Grant research projects or studies, in accordance with subdivision (7) of this subsection.

(9)        Evaluate the research findings and recommendations submitted by the BTR Grant recipients and include this evaluation in the report due to the Division no later than December 1, 2031, along with any recommendations for the continuation of the Breakthrough Therapies Research Grant Pilot Program and any recommended changes to the pilot program.

SECTION 2.(c)  This section shall expire December 31, 2031.

SECTION 3.  Effective July 1, 2026, there is appropriated from the General Fund to the Department of Health and Human Services, Division of Mental Health, Developmental Disabilities, and Substance Use Services, the sum of five million four hundred thousand dollars ($5,400,000) in nonrecurring funds for the 2026‑2027 fiscal year. Of those funds, five million dollars ($5,000,000) in nonrecurring funds shall be deposited into the BTR Grant Fund, as established under Section 1(a) of this act. The remaining four hundred thousand dollars ($400,000) in nonrecurring funds shall be used by the Division for administrative costs related to the BTR Grants established under Section 1 of this act, including costs of the Breakthrough Therapies Task Force, established under Section 2 of this act.

SECTION 4.  The Department of Health and Human Services, Division of Mental Health, Developmental Disabilities, and Substance Use Services (the Division), shall identify opportunities for the State to leverage federal funding of the BTR Grants established under Section 1 of this act, including opportunities under Section 3 of President Trump's April 18, 2026, Executive Order on Accelerating Medical Treatments for Serious Mental Illness. The Division shall take all necessary actions to leverage those opportunities to secure maximum federal funding under this section.

SECTION 5.  Except as otherwise provided, this act is effective when it becomes law.