Bill Text: TX HB1535 | 2021-2022 | 87th Legislature | Enrolled


Bill Title: 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.

Spectrum: Slight Partisan Bill (Democrat 50-33)

Status: (Passed) 2021-06-15 - Effective on 9/1/21 [HB1535 Detail]

Download: Texas-2021-HB1535-Enrolled.html
 
 
  H.B. No. 1535
 
 
 
 
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(3), Occupations Code, is amended
  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 one [0.5] percent by weight of
  tetrahydrocannabinols.
         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
  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)  post-traumatic stress disorder; or
                           (x)  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; 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.
         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.
 
 
  ______________________________ ______________________________
     President of the Senate Speaker of the House     
 
 
         I certify that H.B. No. 1535 was passed by the House on April
  29, 2021, by the following vote:  Yeas 134, Nays 12, 1 present, not
  voting; and that the House concurred in Senate amendments to H.B.
  No. 1535 on May 28, 2021, by the following vote:  Yeas 119, Nays 25,
  1 present, not voting.
 
  ______________________________
  Chief Clerk of the House   
 
         I certify that H.B. No. 1535 was passed by the Senate, with
  amendments, on May 25, 2021, by the following vote:  Yeas 31, Nays
  0.
 
  ______________________________
  Secretary of the Senate   
  APPROVED: __________________
                  Date       
   
           __________________
                Governor       
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