1 | 1 | | By: Larson H.B. No. 3137 |
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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 a medical cannabis research program. |
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7 | 7 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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8 | 8 | | SECTION 1. Section 481.062(a), Health and Safety Code, is |
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9 | 9 | | amended to read as follows: |
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10 | 10 | | (a) The following persons may possess a controlled |
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11 | 11 | | substance under this chapter without registering with the Federal |
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12 | 12 | | Drug Enforcement Administration: |
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13 | 13 | | (1) an agent or employee of a manufacturer, |
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14 | 14 | | distributor, analyzer, or dispenser of the controlled substance who |
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15 | 15 | | is registered with the Federal Drug Enforcement Administration and |
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16 | 16 | | acting in the usual course of business or employment; |
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17 | 17 | | (2) a common or contract carrier, a warehouseman, or |
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18 | 18 | | an employee of a carrier or warehouseman whose possession of the |
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19 | 19 | | controlled substance is in the usual course of business or |
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20 | 20 | | employment; |
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21 | 21 | | (3) an ultimate user or a person in possession of the |
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22 | 22 | | controlled substance under a lawful order of a practitioner or in |
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23 | 23 | | lawful possession of the controlled substance if it is listed in |
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24 | 24 | | Schedule V; |
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25 | 25 | | (4) an officer or employee of this state, another |
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26 | 26 | | state, a political subdivision of this state or another state, or |
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27 | 27 | | the United States who is lawfully engaged in the enforcement of a |
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28 | 28 | | law relating to a controlled substance or drug or to a customs law |
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29 | 29 | | and authorized to possess the controlled substance in the discharge |
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30 | 30 | | of the person's official duties; |
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31 | 31 | | (5) if the substance is tetrahydrocannabinol or one of |
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32 | 32 | | its derivatives: |
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33 | 33 | | (A) a Department of State Health Services |
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34 | 34 | | official, a medical school researcher, or a research program |
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35 | 35 | | participant possessing the substance as authorized under |
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36 | 36 | | Subchapter G or G-1, including all persons permitted or otherwise |
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37 | 37 | | authorized to possess cannabis under Subchapter G-1; or |
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38 | 38 | | (B) a practitioner or an ultimate user possessing |
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39 | 39 | | the substance as a participant in a federally approved therapeutic |
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40 | 40 | | research program that the commissioner has reviewed and found, in |
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41 | 41 | | writing, to contain a medically responsible research protocol; or |
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42 | 42 | | (6) a dispensing organization licensed under Chapter |
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43 | 43 | | 487 that possesses low-THC cannabis. |
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44 | 44 | | SECTION 2. Chapter 481, Health and Safety Code, is amended |
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45 | 45 | | by adding Subchapter G-1 to read as follows: |
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46 | 46 | | SUBCHAPTER G-1. MEDICAL CANNABIS RESEARCH PROGRAM |
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47 | 47 | | Sec. 481.251. DEFINITION. In this subchapter, "commission" |
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48 | 48 | | means the Health and Human Services Commission. |
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49 | 49 | | Sec. 481.252. MEDICAL CANNABIS RESEARCH PROGRAM. (a) Not |
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50 | 50 | | later than January 31, 2022, the executive commissioner by rule |
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51 | 51 | | shall establish a medical cannabis research program to be conducted |
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52 | 52 | | by health-related institutions of higher education in this state. |
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53 | 53 | | (b) In adopting rules under this section, the executive |
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54 | 54 | | commissioner may provide: |
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55 | 55 | | (1) procedures for a health-related institution of |
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56 | 56 | | higher education in this state to apply to the commission for a |
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57 | 57 | | permit to conduct medical cannabis research under the program |
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58 | 58 | | established by this subchapter; and |
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59 | 59 | | (2) criteria for granting a permit to a health-related |
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60 | 60 | | institution of higher education to conduct medical cannabis |
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61 | 61 | | research. |
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62 | 62 | | Sec. 481.253. INSTITUTIONAL REVIEW BOARD. (a) Before |
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63 | 63 | | applying for a permit under this subchapter, a health-related |
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64 | 64 | | institution of higher education shall establish an institutional |
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65 | 65 | | review board to review or approve the initiation of and conduct |
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66 | 66 | | periodic review of research programs to ensure the legal protection |
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67 | 67 | | of the rights and welfare of human research subjects. |
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68 | 68 | | (b) The institution may designate an existing board, |
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69 | 69 | | committee, or other group as the institutional review board |
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70 | 70 | | required under this section. |
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71 | 71 | | Sec. 481.254. COMPASSIONATE-USE RESEARCH. (a) A |
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72 | 72 | | health-related institution of higher education may apply for a |
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73 | 73 | | permit to research: |
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74 | 74 | | (1) the efficacy of medical cannabis product |
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75 | 75 | | formulations and product forms; |
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76 | 76 | | (2) medical conditions that might benefit from |
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77 | 77 | | treatment with medical cannabis and are approved by the |
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78 | 78 | | health-related institution's institutional review board, including |
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79 | 79 | | those not listed in Section 169.003, Occupations Code; and |
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80 | 80 | | (3) any other research matter approved by the |
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81 | 81 | | institution's institutional review board. |
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82 | 82 | | (b) In applying for a permit, the health-related |
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83 | 83 | | institution of higher education shall disclose any private sector |
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84 | 84 | | organization contractors under Section 481.255 and shall disclose |
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85 | 85 | | additional contractors as additional contractors are formed. |
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86 | 86 | | Sec. 481.255. CONTRACTORS. (a) A health-related |
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87 | 87 | | institution of higher education granted a permit under this |
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88 | 88 | | subchapter shall be authorized to contract with one or more private |
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89 | 89 | | sector organizations to fulfill the terms of the permit, including |
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90 | 90 | | contracting for the production and distribution of medical |
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91 | 91 | | cannabis. |
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92 | 92 | | (b) A private sector organization is eligible to contract |
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93 | 93 | | with a health-related institution of higher education under this |
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94 | 94 | | subchapter if the organization: |
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95 | 95 | | (1) meets all requirements for a dispensing |
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96 | 96 | | organization under Chapter 487, except that the participant is not |
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97 | 97 | | required to pay a licensing or application fee; |
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98 | 98 | | (2) demonstrates capability to provide funding to |
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99 | 99 | | support medical cannabis research activities at a health-related |
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100 | 100 | | institution of higher education; |
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101 | 101 | | (3) demonstrates capability to establish and operate a |
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102 | 102 | | production and distribution system sufficient to support research |
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103 | 103 | | program needs; and |
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104 | 104 | | (4) is not a dispensing organization licensed under |
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105 | 105 | | Chapter 487, owned or controlled by any direct or indirect owner of |
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106 | 106 | | a licensed dispensing organization, or otherwise affiliated with a |
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107 | 107 | | licensed dispensing organization. |
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108 | 108 | | (c) The commission shall approve contractors between |
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109 | 109 | | health-related institutions of higher education and private sector |
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110 | 110 | | organizations authorized under this subchapter. |
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111 | 111 | | Sec. 481.256. PATIENT TREATMENT. (a) Patient treatment |
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112 | 112 | | provided as part of an approved research program under this |
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113 | 113 | | subchapter may be administered only by a medical practitioner |
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114 | 114 | | meeting standards approved by the institution's institutional |
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115 | 115 | | review board. |
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116 | 116 | | (b) A patient participating in a research program under this |
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117 | 117 | | subchapter must be a permanent resident of this state. |
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118 | 118 | | Sec. 481.257. INFORMED CONSENT. (a) Before receiving |
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119 | 119 | | treatment under an approved research program, each patient must |
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120 | 120 | | sign a written informed consent form. |
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121 | 121 | | (b) If a patient is a minor or lacks the mental capacity to |
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122 | 122 | | provide informed consent, a parent, guardian, or conservator may |
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123 | 123 | | provide informed consent on the patient's behalf. |
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124 | 124 | | (c) The executive commissioner shall adopt a form to be used |
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125 | 125 | | for the informed consent required by this section. |
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126 | 126 | | Sec. 481.258. LICENSURE AS DISPENSING ORGANIZATION. A |
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127 | 127 | | private sector organization contracting with a health-related |
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128 | 128 | | institution of higher education under this subchapter shall be |
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129 | 129 | | eligible for licensure as a dispensing organization under Chapter |
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130 | 130 | | 487, or any other law that authorizes cultivating, processing, and |
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131 | 131 | | dispensing cannabis, on or after the second anniversary of the date |
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132 | 132 | | the organization entered into a contract with a health-related |
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133 | 133 | | institution of higher education related to a research program |
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134 | 134 | | authorized under this subchapter, provided that the organization's |
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135 | 135 | | operations comply with applicable state law. |
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136 | 136 | | SECTION 3. This Act takes effect September 1, 2021. |
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