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.