Regular Session 2021-2022 House Bill 2421 P.N. 2832

PRINTER'S NO. 2832

THE GENERAL ASSEMBLY OF PENNSYLVANIA

HOUSE BILL

No.

2421

Session of

2022

INTRODUCED BY PENNYCUICK, O'NEAL, RYAN, SCHLOSSBERG, SCHLEGEL

CULVER AND ROZZI, MARCH 16, 2022

REFERRED TO COMMITTEE ON HEALTH, MARCH 16, 2022

AN ACT

Providing for research and clinical studies of psilocybin and

psilocybin-assisted therapy.

The General Assembly of the Commonwealth of Pennsylvania

hereby enacts as follows:

Section 1. Short title.

This act shall be known and may be cited as the Psilocybin

Data Act.

Section 2. Declaration of purpose.

The General Assembly finds and declares as follows:

(1) Our nation is experiencing an unprecedented mental

health crisis.

(2) In 2021, more than 47,000,000 Americans were

suffering from a mental illness, including more than

1,800,000 adults in this Commonwealth, which represents 18%

of this Commonwealth's adult population.

(3) Of the 1,800,000 adults in this Commonwealth who

suffer from a mental illness, more than 727,000 suffered from

a substance use disorder and more than 416,000 suffered from

serious thoughts of suicide.

(4) For veterans in the United States, the nationwide

suicide rate is one and a half times greater than for

nonveterans.

(5) In the United States, 22 veterans die by suicide

each day.

(6) This Commonwealth ranks among the worst states in

the nation in treating mental health conditions with

approximately 480,000 adults in this Commonwealth reporting

an unmet need for their mental health conditions in 2021.

(7) Common barriers to entry for mental health treatment

include the lack of adequate health insurance, shortfalls in

psychiatrists and other mental health professionals, lack of

available treatment types and insufficient finances to cover

health care costs.

(8) While the full extent of the mental health

consequences of the COVID-19 pandemic are not yet fully

understood, a study conducted by Dartmouth University found

that since the onset of the pandemic, rates of depression and

anxiety have soared amongst college-age adults.

(9) Similarly, the United States Department of Health

and Human Services Centers for Disease Control and Prevention

has noted increases in the number of adults seeking mental

health care, dealing with anxiety and experiencing symptoms

of depressive episodes.

(10) Consequently, this Commonwealth is in desperate

need of innovative and cost-effective mental health treatment

to combat this significant public health crisis.

(11) A growing body of research suggests that

psilocybin, administered in a controlled setting, may be the

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most effective tool at our disposal to combat this public

health crisis.

(12) Studies conducted by world-renowned medical

institutions indicate that psilocybin has shown efficacy,

tolerability and safety in the treatment of mental health

conditions, including, but not limited to, addiction,

depression, anxiety disorders and end-of-life psychological

distress.

(13) The United States Food and Drug Administration,

based on the success of the studies on the efficacy of

psilocybin, has granted a "breakthrough therapy" designation

for use of psilocybin to treat depression.

(14) Numerous jurisdictions in the United States have

reformed their laws to decriminalize or further research the

full scope of the public health benefits of psilocybin.

(15) This Commonwealth, including this Commonwealth's

substantial veteran community, will benefit from establishing

a psilocybin regulatory system to combat the worsening mental

health crisis.

(16) Additional research is required to determine the

efficacy of psilocybin and how to maximize its public health

benefits at the lowest cost with the goal of making the

treatment broadly available if clinical studies prove

successful.

(17) Achieving the optimal public health benefit of

psilocybin requires the Commonwealth to invest in and

facilitate research using naturally grown psilocybin

mushrooms, which would be infeasible if conducted through

private funding.

(18) Our federalist system of government allows states

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to experiment and compete in the marketplace of ideas to

achieve the most efficient and practical solutions to the

problems of constituents.

(19) This act provides a framework for research in this

Commonwealth to discover innovative methods to optimize the

public health benefits of psilocybin.

Section 3. Definitions.

The following words and phrases when used in this act shall

have the meanings given to them in this section unless the

context clearly indicates otherwise:

"Academic research institution." An institution affiliated

with a hospital or an institution of higher education that

conducts health care research in this Commonwealth.

"Advisory committee." The Health Research Advisory Committee

established in section 903(b) of the act of June 26, 2001

(P.L.755, No.77), known as the Tobacco Settlement Act.

"Department." The Department of Health of the Commonwealth.

"Psilocybin." Psilocybin and other compounds that cause

nonordinary states of consciousness via serotonin 2A receptor

agonism.

"Psilocybin-assisted therapy." The use of a therapeutic

protocol involving one or more therapy sessions in which the

research subject who receives therapy does so after ingesting

psilocybin.

Section 4. Research and clinical studies of psilocybin and

psilocybin-assisted therapy.

The department, in collaboration with the advisory committee,

shall contract with at least one academic research institution

for the purpose of collecting and studying the efficacy and

cost-benefit optimization of psilocybin and psilocybin-assisted

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therapy in the treatment of mental health conditions and

traumatic brain injury as conducted in clinical studies by the

academic research institution. The data collected under this

section shall include a consideration for individual health

outcomes and public health outcomes, including methods to reduce

cost and increase scalability of treatment. In conducting the

clinical studies for the purposes of this section, the academic

research institution shall focus on all of the following

conditions:

(1) Post-traumatic stress disorders.

(2) Depression.

(3) Anxiety.

(4) Suicidal ideation.

(5) Eating disorders.

(6) Bipolar disorders.

(7) Chronic pain.

(8) Migraines.

(9) Substance use disorders.

(10) Traumatic brain injury.

(11) Any other necessary condition as determined by the

department, in collaboration with the advisory committee, or

the academic research institution.

Section 5. Reports.

(a) Reports.--The department, in collaboration with the

advisory committee, shall issue interim reports every 180 days

beginning 180 days after the effective date of this section on

the data collected from the academic research institution under

section 4 and a final report by December 31, 2025. The final

report shall contain all of the following:

(1) The results of the clinical studies of psilocybin

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conducted by the academic research institution.

(2) An analysis of the current state of available

research related to psilocybin and similar compounds.

(3) An overview of current Federal laws related to

psilocybin and similar compounds.

(4) An overview of laws in other states related to

psilocybin and similar compounds, including an analysis of

the successes and challenges of the laws in other states with

a particular focus on the regulatory framework for research

or the implementation of psilocybin-assisted therapy

developed in other states.

(5) An overview of proposed Federal, State, local and

other jurisdictional laws or ordinances, including proposed

laws or ordinances outside of the United States, related to

psilocybin and similar compounds.

(6) Recommendations for legislative actions or other

actions to enact a framework for further research of

psilocybin and similar compounds, including a consideration

of systems adopted by other states and the medical marijuana

research framework already established in this Commonwealth.

(7) Recommendations for legislative actions or other

actions for the implementation of a regulatory system

governing the use of psilocybin and psilocybin-assisted

therapy with the goal of minimizing cost and maximizing the

public health benefit of treatment.

(b) Submission.--The department, in collaboration with the

advisory committee, shall submit the interim reports and the

final report under subsection (a) to all of the following:

(1) The President pro tempore of the Senate.

(2) The Speaker of the House of Representatives.

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(3) The Majority Leader of the Senate.

(4) The Majority Leader of the House of Representatives.

(5) The Minority Leader of the Senate.

(6) The Minority Leader of the House of Representatives.

(7) The chair and minority chair of the Appropriations

Committee of the Senate.

(8) The chair and minority chair of the Appropriations

Committee of the House of Representatives.

(9) The chair and minority chair of the Health and Human

Services Committee of the Senate.

(10) The chair and minority chair of the Health

Committee of the House of Representatives.

(11) The chair and minority chair of the Human Services

Committee of the House of Representatives.

(12) The chair and minority chair of the Veterans

Affairs and Emergency Preparedness Committee of the Senate.

(13) The chair and minority chair of the Veterans

Affairs and Emergency Preparedness Committee of the House of

Representatives.

protected health data collected from the academic research

institution under section 4 remains confidential and does not

personally identify an individual in the interim reports and the

final report under subsection (a).

Section 6. Effective date.

This act shall take effect in 60 days.

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