A1526

An Act concerning a pilot program for psilocybin research and making an appropriation.

Be It Enacted by the Senate and General Assembly of the State of New Jersey:

1. The Legislature finds and declares that:

a. New Jersey has a high prevalence of adults living with behavioral health conditions.

b. Studies conducted by nationally and internationally recognized medical institutions indicate that psilocybin has shown efficacy, tolerability, and safety in the treatment of a variety of behavioral health conditions, including, but not limited to, substance use disorders, depression, anxiety disorders, and end-of-life psychological distress.

c. The United States Food and Drug Administration has determined that preliminary clinical evidence indicates psilocybin may demonstrate substantial improvement over available therapies for treatment-resistant depression, and has granted a breakthrough therapy designation for the use of psilocybin as a therapy for treatment-resistant depression.

d. The Legislature intends to establish a psilocybin pilot program to support hospitals to advance psilocybin research in a manner compliant with United States Food and Drug Administration and United States Drug Enforcement Administration regulations, and as a means for the State to evaluate the establishment of a safe, legal, and affordable Statewide medical psilocybin care delivery system.

e. It is the intent of the Legislature that research funded and conducted pursuant to this act will be compliant with United States Food and Drug Administration and United States Drug Enforcement Administration regulations, and that the State will work to facilitate and support the research.

f. In establishing this pilot program, the Legislature seeks to improve the physical, mental, and social well-being of the residents of New Jersey, and to prevent and reduce the prevalence of behavioral health disorders in adults.

g. It is necessary and appropriate to assess whether a comprehensive Statewide delivery scheme can be developed and implemented in the future that ensures that psilocybin can be accessed in safe, controlled environments that are designed to foster improvements in behavioral health for adult patients.

2. As used in this act:

“Board” means the Psychedelic Therapy and Research Advisory Board established pursuant to section 4 of this act.

“Central region” means Middlesex, Monmouth, Mercer, and Union counties.

“Commissioner” means the Commissioner of Health.

“Department” means the Department of Health.

“Hospital” means a health care facility licensed pursuant to P.L.1971, c.136 (C.26:2H-1 et seq.) or a community-based organization with a formal partnership with a healthcare facility licensed pursuant to P.L.1971, c.136 (C.26:2H-1 et seq.).

“Northern region” means Bergen, Essex, Hudson, Hunterdon, Morris, Passaic, Somerset, Sussex, and Warren counties.

“Participating hospital” means a hospital that has been selected by the department to participate in the pilot program.

“Pilot program” means the Psilocybin Behavioral Health Access and Therapy Pilot Program established pursuant to section 3 of this act.

“Psilocybin” means psilocybin or psilocin.

“Psychedelic substance” means a psychoactive substance that produces changes in a person’s perception, mood, and cognitive processes, including but not limited to psilocybin.

“Psychedelic therapy” means a method of mental health care treatment provided by a qualified health care professional that combines psychedelic substances and psychotherapy.

“Southern region” means Atlantic, Burlington, Camden, Cape May, Cumberland, Gloucester, Ocean, and Salem counties.

3. a. There is established in the department a “Psilocybin Behavioral Health Access and Therapy Pilot Program.”

b. The pilot program shall be overseen by the department and the Psychedelic Therapy and Research Advisory Board, established pursuant to section 4 of this act, in accordance with the provisions of this act.

c. The pilot program shall commence upon the selection of hospitals by the department pursuant to subsection a. of section 5 of this act.

4. a. There is established in the department the Psychedelic Therapy and Research Advisory Board.

b. The board shall comprise 11 members, as follows:

(1) the Commissioner and the Deputy Commissioner for Public Health Services, or their designees, who shall serve as ex officio, nonvoting members; and

(2) nine public members, three to be appointed by the Governor, two to be appointed by the President of the Senate, two to be appointed by the Speaker of the General Assembly, one to be appointed by the Minority Leader of the Senate, and one to be appointed by the Minority Leader of the General Assembly. Each public member shall represent at least one of the following categories:

(a) a behavioral healthcare provider who is a physician licensed pursuant to Title 45 of the Revised Statutes;

(b) a facilitator, or trainer or supervisor of a facilitator, with experience in United States Food and Drug Administration-approved clinical trials involving psychedelics;

(d) a health care access expert focused on ensuring affordable access to psychedelic therapy, particularly for underserved or historically marginalized communities;

(e) a scientist with experience in conducting clinical trials with psychedelics;

(f) an individual with expertise or experience in traditional or Indigenous uses of natural medicines;

(g) a licensed behavioral health care provider with experience providing mental health care to veterans or first responders;

(h) an attorney or legal expert specializing in drug policy and regulation; or

(i) a professional focused on researching ethical practices in psychedelic therapy.

c. The public members of the board shall serve from the date of appointment through the duration of the pilot program.

d. Members shall be appointed to the board no later than 60 days after the effective date of this act. Vacancies in the board shall be filled in the same manner as is provided for the initial appointment. The board shall organize upon the appointment of the public members and shall select a chairperson and a vice-chairperson from among the membership. The chairperson shall appoint a secretary, who need not be a member of the board.

e. A majority of the public members of the board shall constitute a quorum for the purpose of conducting official board business. The official adoption of guidelines by the board shall require the approval of a majority of the public members.

f. The board shall meet at least quarterly at a time and place designated by the chairperson. The board shall meet at any time at the call of the chairperson or at the call of a majority of the public members.

g. The members of the board shall serve without compensation but may be reimbursed for reasonable expenses incurred in the performance of their official duties, within the limits of funds made available to the board for this purpose.

h. The board may establish committees and subcommittees as may be necessary for the board’s operation. The department shall provide such stenographic, clerical, and other administrative assistants and such professional staff as the board requires to carry out its work. The board shall be entitled to call to its assistance and avail itself of the services of the employees of any State, county, or municipal department, board, bureau, commission, or agency as it may require and as may be available for its purposes.

i. The responsibilities of the board shall include:

(1) researching and gathering available medical, psychological, and scientific studies, social scientific research, and other information relating to the safety of psilocybin and any other psychedelic substances and their efficacy in ameliorating behavioral health conditions, including, but not limited to, clinical dependence disorders, depression, anxiety disorders, and end-of-life psychological distress, and the potential for psilocybin and any other psychedelic substances to promote community, address trauma, and enhance physical and mental wellness;

(2) evaluating outcomes of the pilot program and any research, pilot programs, and access programs related to psilocybin or other psychedelic substances under the laws of other states; and

(3) making recommendations, in collaboration with the department, to the Legislature that consider efficacy, safety, and affordability for the development and implementation of a comprehensive plan to provide therapeutic access to psilocybin in New Jersey for individuals who could benefit.

5. a. With input from the board established pursuant to section 4 of this act, the department shall administer the pilot program in accordance with this act. Under no circumstance shall the department establish, implement, or enforce a requirement, specification, or guideline under the pilot program that conflicts with protocols and guidelines from the United States Food and Drug Administration related to clinical trials for psychedelic substances.

b. No later than 180 days after the effective date of this act, the department shall establish and implement a process and issue a request for proposals by which hospitals may submit applications for participation in the pilot program. The department shall develop a set of criteria by which applying hospitals shall be evaluated for participation in the pilot program and perform selections no later than 60 days after the release of the request for proposals.

c. The department shall select one qualified hospital from the northern region, one from the central region, and one from the southern region of the State, provided that an applicant from each of these regions meets the criteria developed pursuant to subsection b. of this section.

d. The department shall require each participating hospital to collect and report data and information related to the pilot program and patient outcomes, except that nothing in this section shall be construed to require any participating hospital to disclose to any personal identifying information for any individual patient.

e. The department shall assess participation by the pilot program in national data-sharing programs, data sharing programs established by other states, or practice-based research networks for psychedelic research and participating in such programs if the programs are operational and consistent with the quality standards for similar collaborative research networks in other health fields.

6. a. Following the completion of year two of the pilot program, the department shall prepare and submit a report to the Governor, and to the Legislature, pursuant to section 2 of P.L.1991, c.164 (C.52:14-19.1), outlining the department’s implementation and administration of this act and its findings and recommendations concerning the continuation or expansion of the pilot program. The report shall include, at a minimum, the total number of participants in each completed operating year of the pilot program organized by: participating hospitals; the types of behavioral health conditions researched; and outcomes.

b. Following the completion of year two of the pilot program, the board shall prepare and submit a report to the Governor, and to the Legislature, pursuant to section 2 of P.L.1991, c.164 (C.52:14-19.1), with the board’s findings and recommendations as to the development and implementation of a comprehensive plan for State and local regulation of psilocybin to provide access in New Jersey for individuals who could benefit and that considers efficacy, safety, and affordability.

7. The Department of the Treasury shall establish a non-lapsing, restricted fund to be referred as the “Psychedelic Therapy and Research Fund.” In addition to funds appropriated, credited, or transferred by the Legislature, the department may seek and apply for any available federal funds, and solicit and accept private gifts, grants, or donations from any source, public or private, as necessary to ensure the effective implementation of the pilot program.

8. There is appropriated $6,000,000 from the General Fund to the Psychedelic Therapy and Research Fund, which shall be administered by the Department of Health to implement the provisions of this act. From the total amount herein appropriated to the fund, the department shall allocate $2,000,000 to each of the three hospitals selected by the department to participate in the Psilocybin Behavioral Health Services Pilot Program.

9. This act shall take effect immediately and shall expire upon the submission of the reports submitted pursuant to section 6 of this act.

STATEMENT

This bill establishes Psilocybin Behavioral Health Access and Therapy Pilot Program (pilot program), and appropriates $6 million to fulfill the bill’s purposes.

Under the bill, the pilot program is to be overseen by the Department of Health (department) and the Psychedelic Therapy and Research Advisory Board (board), which is to comprise of 11 members as provided for in the bill. The responsibilities of the board are to include: (1) researching and gathering available medical, psychological, and scientific studies, social scientific research, and other information relating to the safety of psilocybin and any other psychedelic substances and their efficacy in ameliorating behavioral health conditions; (2) evaluating outcomes of the pilot program and any research, pilot programs, and access programs related to psilocybin or other psychedelic substances under the laws of other states; and (3) making recommendations, in collaboration with the department, to the Legislature that consider efficacy, safety, and affordability for the development and implementation of a comprehensive plan to provide therapeutic access to psilocybin.

The bill provides that the department is not to establish, implement, or enforce a requirement, specification, or guideline under the pilot program that conflicts with protocols and guidelines from the United States Food and Drug Administration related to clinical trials for psychedelic substances.

No later than 180 days after the bill’s effective date, the department is to establish and implement a process and issue a request for proposals by which hospitals may submit applications for participation in the pilot program. The department is to develop a set of criteria by which applying hospitals are to be evaluated for participation in the pilot program and perform selections no later than 60 days after the release of the request for proposals. The department is to select one qualified hospital from each of the northern, central, and southern regions of the State, provided that an applicant from each of these regions meets the department’s criteria. The department is to require each participating hospital to collect and report data and information related to the pilot program and patient outcomes.

Following the completion of year two of the pilot program, the department and board are to prepare and submit reports to the Governor and Legislature with findings and recommendations, as provided in the bill.