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