By: Garcia H.B. No. 4423
A BILL TO BE ENTITLED
AN ACT
relating to the establishment of the Psilocybin Research Advisory
Council.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subtitle E, Title 2, Health and Safety Code, is
amended by adding Chapter 106 to read as follows:
CHAPTER 106. PSILOCYBIN RESEARCH ADVISORY COUNCIL
106.001. DEFINITION. In this subchapter "advisory council"
means the Psilocybin Research Advisory Council established under
this chapter.
106.002. ESTABLISHMENT OF ADVISORY COUNCIL. The commission
shall establish the Psilocybin Research Advisory Council to advise
the commission and the legislature on psilocybin research and
treatment.
106.003. APPOINTMENT OF ADVISORY COUNCIL MEMBERS. (a) The
advisory council is composed of the members appointed by the
executive commissioner as provided by this section.
(b) The advisory council must include at least:
(1) one member who is a physician with a federal
license to study psychedelics;
(2) one member who is a military veteran;
(3) one member who is a law enforcement officer in this
state;
(4) one member who is a professor or researcher from a
university who specializes in clinical research or psychedelic
studies; and
(5) ex officio representatives of the commission or
another state agency as the executive commissioner determines
appropriate.
(c) Advisory council members serve at the pleasure of the
executive commissioner.
Sec. 106.004. TERMS; VACANCY. (a) An advisory council
member serves a four-year term.
(b) If a vacancy occurs on the advisory council, a person
shall be appointed to fill the vacancy for the unexpired term.
Sec. 118.005. OFFICERS. Advisory council members shall:
(1) elect a chair and a vice chair; and
(2) establish the duties of the chair and the vice
chair.
Sec. 106.006. MEETINGS. The executive commissioner shall
set a time and place for regular meetings, which must occur at least
twice each year.
Sec. 106.007. DUTIES. The advisory council shall:
(1) establish criteria for the clinical trials that
qualify to receive research grants;
(2) oversee the application process and review
applications for the clinical trial research grants to assist the
commission in selecting the most credible clinical trials to award
the research grants;
(3) on or before July 1 of each year, make
recommendations to the legislature on psychedelic-assisted
therapy.
106.008. RESEARCH GRANTS. (a) The commission shall provide
from monies appropriated competitive research grants for whole
mushroom psilocybin phase one, phase two, and phase three clinical
trials that are capable of being approved by the United States Food
and Drug Administration to evaluate the effects of whole mushroom
psilocybin on treating any of the following:
(1) post-traumatic stress disorder;
(2) symptoms associated with long Covid-19;
(3) depression;
(4) anxiety disorders;
(5) symptoms associated with end-of-life distress;
(6) obsessive compulsive disorder;
(7) substance abuse and addiction disorders;
(8) eating disorders;
(9) chronic pain;
(10) inflammatory disorders;
(11) autoimmune disorders;
(12) seizure disorders; or
(13) other degenerative disorders.
(b) The commission shall announce the opening of the
application process at least thirty days before applications are
available and allow at least ninety days for applicants to complete
their submission.
(c) The research grants shall be awarded not later than July
1 of each year for three years. If in any year there is not a
proposal that meets the criteria for a research grant to be awarded
for a whole mushroom psilocybin clinical trial, the commission
shall postpone the award to the following year.
(d) Clinical trials that are funded pursuant this section
shall prioritize:
(1) using whole mushroom psilocybin cultivated under a
schedule I license issued by the United States Drug Enforcement
Administration; and
(2) using veterans, first responders, frontline
health care workers and persons from underserved communities as the
research subjects.
(e) A person who receives a grant for a whole mushroom
psilocybin clinical trial pursuant to this section and any of the
person's employees working on the clinical trial may not be charged
with or prosecuted for possession of psilocybin when the person is
working on the clinical trial.
Sec. 106.009. COMPENSATION AND REIMBURSEMENT. A member of
the advisory council is not entitled to compensation or
reimbursement for expenses incurred in performing advisory council
duties.
Sec. 106.010. SUNSET PROVISION. The Psilocybin Research
Advisory Council is subject to Chapter 325, Government Code (Texas
Sunset Act). Unless continued in existence as provided by that
chapter, the advisory council is abolished and this chapter expires
September 1, 2035.
SECTION 2. Not later than December 31, 2023, the executive
commissioner of the Health and Human Services Commission shall
appoint the members to the Psilocybin Research Advisory Council as
required by Section 106.003, Health and Safety Code, as added by
this Act.
SECTION 16. This Act takes effect September 1, 2023.