87R3238 MCF-D     By: Klick H.B. No. 1535       A BILL TO BE ENTITLED   AN ACT   relating to the medical use of low-THC cannabis by patients with   certain medical conditions and the establishment of   compassionate-use institutional review boards to evaluate and   approve proposed research programs to study the medical use of   low-THC cannabis in the treatment of certain patients.          BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:          SECTION 1.  Chapter 487, Health and Safety Code, is amended   by adding Subchapter F to read as follows:   SUBCHAPTER F.  COMPASSIONATE-USE RESEARCH AND REPORTING          Sec. 487.251.  DEFINITIONS. In this subchapter:                (1)  "Executive commissioner" means the executive   commissioner of the Health and Human Services Commission.                (2)  "Institutional review board" means a   compassionate-use institutional review board established under   Section 487.253.          Sec. 487.252.  RULES. (a)  Except as otherwise provided by   Subsection (b), the executive commissioner shall adopt all   necessary rules to implement this subchapter, including rules   designating the medical conditions for which a patient may be   treated with low-THC cannabis as part of an approved research   program conducted under this subchapter.          (b)  The Texas Medical Board may adopt rules regarding the   certification of a physician by an institutional review board.          Sec. 487.253.  COMPASSIONATE-USE INSTITUTIONAL REVIEW   BOARDS.  (a)  One or more compassionate-use institutional review   boards may be established to:                (1)  evaluate and approve proposed research programs to   study the medical use of low-THC cannabis in treating a medical   condition designated by rule of the executive commissioner under   Section 487.252(a); and                (2)  oversee patient treatment undertaken as part of an   approved research program, including the certification of treating   physicians.          (b)  An institutional review board must be affiliated with a   dispensing organization and meet one of the following conditions:                (1)  be affiliated with a medical school, as defined by   Section 61.501, Education Code;                (2)  be affiliated with a hospital licensed under   Chapter 241 that has at least 150 beds;                (3)  be accredited by the Association for the   Accreditation of Human Research Protection Programs;                (4)  be registered by the United States Department of   Health and Human Services, Office for Human Research Protections,   in accordance with 21 C.F.R. Part 56; or                (5)  be accredited by a national accreditation   organization acceptable to the Texas Medical Board.          Sec. 487.254.  REPORTS BY INSTITUTIONAL REVIEW BOARDS. Each   institutional review board shall submit written reports that   describe and assess the research findings of each approved research   program to:                (1)  the Health and Human Services Commission, not   later than October 1 of each year; and                (2)  the legislature, not later than October 1 of each   even-numbered year.          Sec. 487.255.  PATIENT TREATMENT. (a)  Patient treatment   provided as part of an approved research program under this   subchapter may be administered only by a physician certified by an   institutional review board to participate in the program.          (b)  A patient participating in a research program under this   subchapter must be a permanent resident of this state.          Sec. 487.256.  INFORMED CONSENT. (a)  Before receiving   treatment under an approved research program, each patient must   sign a written informed consent form.          (b)  If the 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)  An institutional review board overseeing a research   program under this subchapter may adopt a form to be used for the   informed consent required by this section.          SECTION 2.  Section 169.001, Occupations Code, is amended by   amending Subdivision (3) and adding Subdivision (7) to read as   follows:                (3)  "Low-THC cannabis" means the plant Cannabis sativa   L., and any part of that plant or any compound, manufacture, salt,   derivative, mixture, preparation, resin, or oil of that plant that   contains not more than five [0.5] percent by weight of   tetrahydrocannabinols.                (7)  "Veteran" means a person who has served in:                      (A)  the army, navy, air force, coast guard, or   marine corps of the United States;                      (B)  the state military forces as defined by   Section 431.001, Government Code; or                      (C)  an auxiliary service of one of those branches   of the armed forces.          SECTION 3.  Section 169.002, Occupations Code, is amended by   adding Subsection (c) to read as follows:          (c)  A physician is qualified to prescribe low-THC cannabis   for the treatment of a patient with a medical condition approved by   rule of the executive commissioner of the Health and Human Services   Commission for treatment in an approved research program conducted   under Subchapter F, Chapter 487, Health and Safety Code, if the   physician is:                (1)  licensed under this subtitle; and                (2)  certified by a compassionate-use institutional   review board created under Section 487.253, Health and Safety Code,   that oversees patient treatment undertaken as part of that approved   research program.          SECTION 4.  Section 169.003, Occupations Code, is amended to   read as follows:          Sec. 169.003.  PRESCRIPTION OF LOW-THC CANNABIS. (a) A   physician described by Section 169.002 may prescribe low-THC   cannabis to a patient if:                (1)  the patient is a permanent resident of the state;                (2)  the physician complies with the registration   requirements of Section 169.004; and                (3)  the physician certifies to the department that:                      (A)  the patient is diagnosed with:                            (i)  epilepsy;                            (ii)  a seizure disorder;                            (iii)  multiple sclerosis;                            (iv)  spasticity;                            (v)  amyotrophic lateral sclerosis;                            (vi)  autism;                            (vii)  [terminal] cancer; [or]                            (viii)  an incurable neurodegenerative   disease;                            (ix)  a condition that causes acute or   chronic pain, for which a physician would otherwise prescribe an   opioid;                            (x)  post-traumatic stress disorder and is a   veteran;                            (xi)  a medical condition that is approved   for a research program under Subchapter F, Chapter 487, Health and   Safety Code, and for which the patient is receiving treatment under   that program; or                            (xii)  a debilitating medical condition   designated by the Department of State Health Services under   Subsection (b); and                      (B)  the physician determines the risk of the   medical use of low-THC cannabis by the patient is reasonable in   light of the potential benefit for the patient.          (b)  The Department of State Health Services by rule may   designate debilitating medical conditions for which a physician may   prescribe low-THC cannabis under this section.          SECTION 5.  Section 169.001(6), Occupations Code, is   repealed.          SECTION 6.  (a)  Not later than December 1, 2021, the   executive commissioner of the Health and Human Services Commission   shall adopt rules as necessary under Section 487.252, Health and   Safety Code, as added by this Act.          (b)  Not later than December 1, 2021, the public safety   director of the Department of Public Safety shall adopt or amend   department rules regarding the cultivation, processing, and   dispensing of low-THC cannabis by a licensed dispensing   organization under Chapter 487, Health and Safety Code.          SECTION 7.  This Act takes effect September 1, 2021.