By: Larson H.B. No. 3137
A BILL TO BE ENTITLED
AN ACT
relating to a medical cannabis research program.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Section 481.062(a), Health and Safety Code, is
amended to read as follows:
(a) The following persons may possess a controlled
substance under this chapter without registering with the Federal
Drug Enforcement Administration:
(1) an agent or employee of a manufacturer,
distributor, analyzer, or dispenser of the controlled substance who
is registered with the Federal Drug Enforcement Administration and
acting in the usual course of business or employment;
(2) a common or contract carrier, a warehouseman, or
an employee of a carrier or warehouseman whose possession of the
controlled substance is in the usual course of business or
employment;
(3) an ultimate user or a person in possession of the
controlled substance under a lawful order of a practitioner or in
lawful possession of the controlled substance if it is listed in
Schedule V;
(4) an officer or employee of this state, another
state, a political subdivision of this state or another state, or
the United States who is lawfully engaged in the enforcement of a
law relating to a controlled substance or drug or to a customs law
and authorized to possess the controlled substance in the discharge
of the person's official duties;
(5) if the substance is tetrahydrocannabinol or one of
its derivatives:
(A) a Department of State Health Services
official, a medical school researcher, or a research program
participant possessing the substance as authorized under
Subchapter G or G-1, including all persons permitted or otherwise
authorized to possess cannabis under Subchapter G-1; or
(B) a practitioner or an ultimate user possessing
the substance as a participant in a federally approved therapeutic
research program that the commissioner has reviewed and found, in
writing, to contain a medically responsible research protocol; or
(6) a dispensing organization licensed under Chapter
487 that possesses low-THC cannabis.
SECTION 2. Chapter 481, Health and Safety Code, is amended
by adding Subchapter G-1 to read as follows:
SUBCHAPTER G-1. MEDICAL CANNABIS RESEARCH PROGRAM
Sec. 481.251. DEFINITION. In this subchapter, "commission"
means the Health and Human Services Commission.
Sec. 481.252. MEDICAL CANNABIS RESEARCH PROGRAM. (a) Not
later than January 31, 2022, the executive commissioner by rule
shall establish a medical cannabis research program to be conducted
by health-related institutions of higher education in this state.
(b) In adopting rules under this section, the executive
commissioner may provide:
(1) procedures for a health-related institution of
higher education in this state to apply to the commission for a
permit to conduct medical cannabis research under the program
established by this subchapter; and
(2) criteria for granting a permit to a health-related
institution of higher education to conduct medical cannabis
research.
Sec. 481.253. INSTITUTIONAL REVIEW BOARD. (a) Before
applying for a permit under this subchapter, a health-related
institution of higher education shall establish an institutional
review board to review or approve the initiation of and conduct
periodic review of research programs to ensure the legal protection
of the rights and welfare of human research subjects.
(b) The institution may designate an existing board,
committee, or other group as the institutional review board
required under this section.
Sec. 481.254. COMPASSIONATE-USE RESEARCH. (a) A
health-related institution of higher education may apply for a
permit to research:
(1) the efficacy of medical cannabis product
formulations and product forms;
(2) medical conditions that might benefit from
treatment with medical cannabis and are approved by the
health-related institution's institutional review board, including
those not listed in Section 169.003, Occupations Code; and
(3) any other research matter approved by the
institution's institutional review board.
(b) In applying for a permit, the health-related
institution of higher education shall disclose any private sector
organization contractors under Section 481.255 and shall disclose
additional contractors as additional contractors are formed.
Sec. 481.255. CONTRACTORS. (a) A health-related
institution of higher education granted a permit under this
subchapter shall be authorized to contract with one or more private
sector organizations to fulfill the terms of the permit, including
contracting for the production and distribution of medical
cannabis.
(b) A private sector organization is eligible to contract
with a health-related institution of higher education under this
subchapter if the organization:
(1) meets all requirements for a dispensing
organization under Chapter 487, except that the participant is not
required to pay a licensing or application fee;
(2) demonstrates capability to provide funding to
support medical cannabis research activities at a health-related
institution of higher education;
(3) demonstrates capability to establish and operate a
production and distribution system sufficient to support research
program needs; and
(4) is not a dispensing organization licensed under
Chapter 487, owned or controlled by any direct or indirect owner of
a licensed dispensing organization, or otherwise affiliated with a
licensed dispensing organization.
(c) The commission shall approve contractors between
health-related institutions of higher education and private sector
organizations authorized under this subchapter.
Sec. 481.256. PATIENT TREATMENT. (a) Patient treatment
provided as part of an approved research program under this
subchapter may be administered only by a medical practitioner
meeting standards approved by the institution's institutional
review board.
(b) A patient participating in a research program under this
subchapter must be a permanent resident of this state.
Sec. 481.257. INFORMED CONSENT. (a) Before receiving
treatment under an approved research program, each patient must
sign a written informed consent form.
(b) If a patient is a minor or lacks the mental capacity to
provide informed consent, a parent, guardian, or conservator may
provide informed consent on the patient's behalf.
(c) The executive commissioner shall adopt a form to be used
for the informed consent required by this section.
Sec. 481.258. LICENSURE AS DISPENSING ORGANIZATION. A
private sector organization contracting with a health-related
institution of higher education under this subchapter shall be
eligible for licensure as a dispensing organization under Chapter
487, or any other law that authorizes cultivating, processing, and
dispensing cannabis, on or after the second anniversary of the date
the organization entered into a contract with a health-related
institution of higher education related to a research program
authorized under this subchapter, provided that the organization's
operations comply with applicable state law.
SECTION 3. This Act takes effect September 1, 2021.