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