1 | 1 | | By: Garcia H.B. No. 4423 |
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2 | 2 | | |
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3 | 3 | | |
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4 | 4 | | A BILL TO BE ENTITLED |
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5 | 5 | | AN ACT |
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6 | 6 | | relating to the establishment of the Psilocybin Research Advisory |
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7 | 7 | | Council. |
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8 | 8 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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9 | 9 | | SECTION 1. Subtitle E, Title 2, Health and Safety Code, is |
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10 | 10 | | amended by adding Chapter 106 to read as follows: |
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11 | 11 | | CHAPTER 106. PSILOCYBIN RESEARCH ADVISORY COUNCIL |
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12 | 12 | | 106.001. DEFINITION. In this subchapter "advisory council" |
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13 | 13 | | means the Psilocybin Research Advisory Council established under |
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14 | 14 | | this chapter. |
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15 | 15 | | 106.002. ESTABLISHMENT OF ADVISORY COUNCIL. The commission |
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16 | 16 | | shall establish the Psilocybin Research Advisory Council to advise |
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17 | 17 | | the commission and the legislature on psilocybin research and |
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18 | 18 | | treatment. |
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19 | 19 | | 106.003. APPOINTMENT OF ADVISORY COUNCIL MEMBERS. (a) The |
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20 | 20 | | advisory council is composed of the members appointed by the |
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21 | 21 | | executive commissioner as provided by this section. |
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22 | 22 | | (b) The advisory council must include at least: |
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23 | 23 | | (1) one member who is a physician with a federal |
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24 | 24 | | license to study psychedelics; |
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25 | 25 | | (2) one member who is a military veteran; |
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26 | 26 | | (3) one member who is a law enforcement officer in this |
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27 | 27 | | state; |
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28 | 28 | | (4) one member who is a professor or researcher from a |
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29 | 29 | | university who specializes in clinical research or psychedelic |
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30 | 30 | | studies; and |
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31 | 31 | | (5) ex officio representatives of the commission or |
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32 | 32 | | another state agency as the executive commissioner determines |
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33 | 33 | | appropriate. |
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34 | 34 | | (c) Advisory council members serve at the pleasure of the |
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35 | 35 | | executive commissioner. |
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36 | 36 | | Sec. 106.004. TERMS; VACANCY. (a) An advisory council |
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37 | 37 | | member serves a four-year term. |
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38 | 38 | | (b) If a vacancy occurs on the advisory council, a person |
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39 | 39 | | shall be appointed to fill the vacancy for the unexpired term. |
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40 | 40 | | Sec. 118.005. OFFICERS. Advisory council members shall: |
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41 | 41 | | (1) elect a chair and a vice chair; and |
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42 | 42 | | (2) establish the duties of the chair and the vice |
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43 | 43 | | chair. |
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44 | 44 | | Sec. 106.006. MEETINGS. The executive commissioner shall |
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45 | 45 | | set a time and place for regular meetings, which must occur at least |
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46 | 46 | | twice each year. |
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47 | 47 | | Sec. 106.007. DUTIES. The advisory council shall: |
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48 | 48 | | (1) establish criteria for the clinical trials that |
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49 | 49 | | qualify to receive research grants; |
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50 | 50 | | (2) oversee the application process and review |
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51 | 51 | | applications for the clinical trial research grants to assist the |
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52 | 52 | | commission in selecting the most credible clinical trials to award |
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53 | 53 | | the research grants; |
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54 | 54 | | (3) on or before July 1 of each year, make |
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55 | 55 | | recommendations to the legislature on psychedelic-assisted |
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56 | 56 | | therapy. |
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57 | 57 | | 106.008. RESEARCH GRANTS. (a) The commission shall provide |
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58 | 58 | | from monies appropriated competitive research grants for whole |
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59 | 59 | | mushroom psilocybin phase one, phase two, and phase three clinical |
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60 | 60 | | trials that are capable of being approved by the United States Food |
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61 | 61 | | and Drug Administration to evaluate the effects of whole mushroom |
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62 | 62 | | psilocybin on treating any of the following: |
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63 | 63 | | (1) post-traumatic stress disorder; |
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64 | 64 | | (2) symptoms associated with long Covid-19; |
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65 | 65 | | (3) depression; |
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66 | 66 | | (4) anxiety disorders; |
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67 | 67 | | (5) symptoms associated with end-of-life distress; |
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68 | 68 | | (6) obsessive compulsive disorder; |
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69 | 69 | | (7) substance abuse and addiction disorders; |
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70 | 70 | | (8) eating disorders; |
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71 | 71 | | (9) chronic pain; |
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72 | 72 | | (10) inflammatory disorders; |
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73 | 73 | | (11) autoimmune disorders; |
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74 | 74 | | (12) seizure disorders; or |
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75 | 75 | | (13) other degenerative disorders. |
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76 | 76 | | (b) The commission shall announce the opening of the |
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77 | 77 | | application process at least thirty days before applications are |
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78 | 78 | | available and allow at least ninety days for applicants to complete |
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79 | 79 | | their submission. |
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80 | 80 | | (c) The research grants shall be awarded not later than July |
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81 | 81 | | 1 of each year for three years. If in any year there is not a |
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82 | 82 | | proposal that meets the criteria for a research grant to be awarded |
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83 | 83 | | for a whole mushroom psilocybin clinical trial, the commission |
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84 | 84 | | shall postpone the award to the following year. |
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85 | 85 | | (d) Clinical trials that are funded pursuant this section |
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86 | 86 | | shall prioritize: |
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87 | 87 | | (1) using whole mushroom psilocybin cultivated under a |
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88 | 88 | | schedule I license issued by the United States Drug Enforcement |
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89 | 89 | | Administration; and |
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90 | 90 | | (2) using veterans, first responders, frontline |
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91 | 91 | | health care workers and persons from underserved communities as the |
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92 | 92 | | research subjects. |
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93 | 93 | | (e) A person who receives a grant for a whole mushroom |
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94 | 94 | | psilocybin clinical trial pursuant to this section and any of the |
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95 | 95 | | person's employees working on the clinical trial may not be charged |
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96 | 96 | | with or prosecuted for possession of psilocybin when the person is |
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97 | 97 | | working on the clinical trial. |
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98 | 98 | | Sec. 106.009. COMPENSATION AND REIMBURSEMENT. A member of |
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99 | 99 | | the advisory council is not entitled to compensation or |
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100 | 100 | | reimbursement for expenses incurred in performing advisory council |
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101 | 101 | | duties. |
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102 | 102 | | Sec. 106.010. SUNSET PROVISION. The Psilocybin Research |
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103 | 103 | | Advisory Council is subject to Chapter 325, Government Code (Texas |
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104 | 104 | | Sunset Act). Unless continued in existence as provided by that |
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105 | 105 | | chapter, the advisory council is abolished and this chapter expires |
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106 | 106 | | September 1, 2035. |
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107 | 107 | | SECTION 2. Not later than December 31, 2023, the executive |
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108 | 108 | | commissioner of the Health and Human Services Commission shall |
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109 | 109 | | appoint the members to the Psilocybin Research Advisory Council as |
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110 | 110 | | required by Section 106.003, Health and Safety Code, as added by |
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111 | 111 | | this Act. |
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112 | 112 | | SECTION 16. This Act takes effect September 1, 2023. |
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