48 | 44 | | Shading denotes HOUSE amendment. Double underlining denotes SENATE amendment. |
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49 | 45 | | Capital letters or bold & italic numbers indicate new material to be added to existing law. |
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50 | 46 | | Dashes through the words or numbers indicate deletions from existing law. protection of human subjects. An eligible patient is an individual who |
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51 | 47 | | has: |
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52 | 48 | | ! A life-threatening or severely debilitating illness, as |
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53 | 49 | | attested to by the patient's treating physician; |
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54 | 50 | | ! Considered all other treatment options currently approved |
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55 | 51 | | by the United States food and drug administration; |
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56 | 52 | | ! Received a recommendation from the patient's treating |
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57 | 53 | | physician; |
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58 | 54 | | ! Given written, informed consent for the use of the |
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59 | 55 | | individualized investigational drug, biological product, or |
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60 | 56 | | device; and |
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61 | 57 | | ! Documentation from the treating physician that the |
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62 | 58 | | individual meets the definition of "eligible patient". |
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63 | 59 | | The bill authorizes, but does not require, a manufacturer to make |
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64 | 60 | | the individualized investigational drug, biological product, or device |
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65 | 61 | | available to an eligible patient at no charge, but the manufacturer may |
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66 | 62 | | require payment to cover the cost. |
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67 | 63 | | If any harm is caused to the eligible patient resulting from the use |
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68 | 64 | | of the individualized investigational drug, biological product, or device, |
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69 | 65 | | a private right of action cannot be brought against the manufacturer or |
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70 | 66 | | against any other individual or entity involved in the care of the eligible |
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71 | 67 | | patient with regard to the eligible patient's use of the individualized |
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72 | 68 | | investigational drug, biological product, or device, so long as the |
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73 | 69 | | manufacturer, individual, or entity complied with the law and exercised |
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74 | 70 | | reasonable care. |
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75 | 71 | | The bill prohibits any action against a health-care provider's |
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76 | 72 | | license based on the health-care provider's recommendations regarding |
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77 | 73 | | the use of the individualized investigational drug, biological product, or |
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78 | 74 | | device. |
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79 | 75 | | Nothing in the bill affects a health-care insurer's obligation under |
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80 | 76 | | current law relating to coverage for an insured's participation in a clinical |
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81 | 77 | | trial. |
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82 | 78 | | Be it enacted by the General Assembly of the State of Colorado:1 |
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83 | 79 | | SECTION 1. In Colorado Revised Statutes, 25-45-102, amend2 |
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84 | 80 | | (1) introductory portion and (2) as follows:3 |
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85 | 81 | | 25-45-102. Legislative declaration. (1) F |
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86 | 82 | | OR PURPOSES OF THIS4 |
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87 | 83 | | PART 1, the general assembly finds and declares that:5 |
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88 | 84 | | (2) It is the intent of the general assembly |
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89 | 85 | | FOR THIS PART 1 to6 |
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90 | 86 | | allow for terminally ill patients to use potentially life-saving7 |
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91 | 87 | | 1270-2- investigational drugs, biological products, and devices.1 |
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92 | 88 | | SECTION 2. In Colorado Revised Statutes, 25-45-103, amend2 |
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93 | 89 | | the introductory portion as follows:3 |
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94 | 90 | | 25-45-103. Definitions. As used in this article PART 1, unless the4 |
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95 | 91 | | context otherwise requires:5 |
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96 | 92 | | SECTION 3. In Colorado Revised Statutes, 25-45-104, amend6 |
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97 | 93 | | (1) and (3)(a) as follows:7 |
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98 | 94 | | 25-45-104. Drug manufacturers - availability of investigational8 |
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99 | 95 | | drugs, biological products, or devices - costs - insurance coverage.9 |
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100 | 96 | | (1) A manufacturer of an investigational drug, biological product, or10 |
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101 | 97 | | device may make available the manufacturer's investigational drug,11 |
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102 | 98 | | biological product, or device to eligible patients pursuant to this article12 |
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103 | 99 | | PART 1. This article PART 1 does not require that a manufacturer make13 |
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104 | 100 | | available an investigational drug, biological product, or device to an14 |
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105 | 101 | | eligible patient.15 |
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106 | 102 | | (3) (a) Nothing in this article PART 1 expands the coverage16 |
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107 | 103 | | provided in sections SECTION 10-16-104 (20) or 10-16-104.6. C.R.S.17 |
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108 | 104 | | SECTION 4. In Colorado Revised Statutes, amend 25-45-107 as18 |
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109 | 105 | | follows:19 |
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110 | 106 | | 25-45-107. No cause of action created. This article PART 1 does20 |
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111 | 107 | | not create a private cause of action against a manufacturer of an21 |
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112 | 108 | | investigational drug, biological product, or device, or against any other22 |
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113 | 109 | | person or entity involved in the care of an eligible patient using the23 |
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114 | 110 | | investigational drug, biological product, or device, for any harm done to24 |
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115 | 111 | | the eligible patient resulting from the investigational drug, biological25 |
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116 | 112 | | product, or device, so long as the manufacturer or other person or entity26 |
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117 | 113 | | is complying in good faith with the terms of this article PART 1, unless27 |
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118 | 114 | | 1270 |
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119 | 115 | | -3- there was a failure to exercise reasonable care.1 |
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120 | 116 | | SECTION 5. In Colorado Revised Statutes, add part 2 to article2 |
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121 | 117 | | 45 of title 25 as follows:3 |
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122 | 118 | | PART 24 |
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123 | 119 | | INDIVIDUALIZED TREATMENTS5 |
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124 | 120 | | 25-45-201. Legislative declaration. (1) F |
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125 | 121 | | OR PURPOSES OF THIS6 |
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126 | 122 | | PART 2, THE GENERAL ASSEMBLY FINDS AND DETERMINES THAT :7 |
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127 | 123 | | (a) S |
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128 | 124 | | OME PUBLIC AND PRIVATE ENTITIES OPERATING UNDER8 |
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129 | 125 | | FEDERAL STANDARDS FOR THE PROTECTION OF HUMAN SUBJECTS IN9 |
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130 | 126 | | RESEARCH DEVELOP INDIVIDUALIZED INVESTIGATIONAL DRUGS ,10 |
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131 | 127 | | BIOLOGICAL PRODUCTS, AND DEVICES THAT ARE UNIQUE AND PRODUCED11 |
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132 | 128 | | EXCLUSIVELY FOR USE BY AN INDIVIDUAL PATIENT BASED ON THE12 |
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133 | 129 | | PATIENT'S GENETIC PROFILE, INCLUDING INDIVIDUAL GENE THERAPY ,13 |
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134 | 130 | | ANTISENSE OLIGONUCLEOTIDES , AND INDIVIDUALIZED NEOANTIGEN14 |
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135 | 131 | | VACCINES; AND15 |
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136 | 132 | | (b) A |
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137 | 133 | | PATIENT WHO HAS A LIFE-THREATENING OR SEVERELY16 |
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138 | 134 | | DEBILITATING ILLNESS MAY BENEFIT FROM THESE INDIVIDUALIZED17 |
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139 | 135 | | TREATMENTS.18 |
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140 | 136 | | (2) T |
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141 | 137 | | HEREFORE, THE GENERAL ASSEMBLY DECLARES THAT , IN19 |
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142 | 138 | | ACCORDANCE WITH THE RECOMMENDATION OF THE PATIENT 'S TREATING20 |
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143 | 139 | | PHYSICIAN AND WITH THE SAFEGUARDS DESCRIBED IN THIS PART 2, A21 |
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144 | 140 | | PATIENT SHOULD HAVE THE RIGHT TO TRY AN INDIVIDUALIZED22 |
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145 | 141 | | INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE, AND THE23 |
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146 | 142 | | TREATING PHYSICIAN AND MANUFACTURER THAT PROVIDES THE24 |
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147 | 143 | | INDIVIDUALIZED INVESTIGATIONAL DRUG , BIOLOGICAL PRODUCT, OR25 |
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148 | 144 | | DEVICE, ACTING IN ACCORDANCE WITH THIS PART 2, SHOULD BE26 |
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149 | 145 | | PROTECTED FROM ADVERSE CONSEQUENCES RESULTING FROM THE27 |
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150 | 146 | | 1270 |
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151 | 147 | | -4- PATIENT'S DECISION TO TRY THE INDIVIDUALIZED INVESTIGATIONAL DRUG ,1 |
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152 | 148 | | BIOLOGICAL PRODUCT, OR DEVICE.2 |
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153 | 149 | | 25-45-202. Definitions. A |
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154 | 150 | | S USED IN THIS PART 2, UNLESS THE3 |
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155 | 151 | | CONTEXT OTHERWISE REQUIRES :4 |
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156 | 152 | | (1) "E |
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157 | 153 | | LIGIBLE FACILITY" MEANS AN INSTITUTION OPERATING5 |
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158 | 154 | | UNDER THE FEDERALWIDE ASSURANCE FOR THE PROTECTION OF HUMAN6 |
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159 | 155 | | SUBJECTS IN ACCORDANCE WITH 45 CFR 46 AND 42 U.S.C. SEC. 289a.7 |
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160 | 156 | | (2) "E |
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161 | 157 | | LIGIBLE PATIENT" MEANS AN INDIVIDUAL WHO HAS:8 |
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162 | 158 | | (a) A |
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163 | 159 | | LIFE-THREATENING OR SEVERELY DEBILITATING ILLNESS , AS9 |
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164 | 160 | | ATTESTED TO BY THE PATIENT'S TREATING PHYSICIAN;10 |
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165 | 161 | | (b) I |
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166 | 162 | | N CONSULTATION WITH THE TREATING PHYSICIAN ,11 |
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167 | 163 | | CONSIDERED ALL OTHER TREATMENT OPTIONS CURRENTLY APPROVED BY12 |
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168 | 164 | | THE UNITED STATES FOOD AND DRUG ADMINISTRATION ;13 |
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169 | 165 | | (c) R |
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170 | 166 | | ECEIVED A RECOMMENDATION FROM THE TREATING14 |
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171 | 167 | | PHYSICIAN FOR USE OF AN INDIVIDUALIZED INVESTIGATIONAL DRUG ,15 |
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172 | 168 | | BIOLOGICAL PRODUCT , OR DEVICE FOR TREATMENT OF THE16 |
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173 | 169 | | LIFE-THREATENING OR SEVERELY DEBILITATING ILLNESS ;17 |
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174 | 170 | | (d) G |
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175 | 171 | | IVEN WRITTEN, INFORMED CONSENT FOR THE USE OF THE18 |
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176 | 172 | | INDIVIDUALIZED INVESTIGATIONAL DRUG , BIOLOGICAL PRODUCT, OR19 |
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177 | 173 | | DEVICE, OR, IF THE PATIENT IS A MINOR OR LACKS THE MENTAL CAPACITY20 |
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178 | 174 | | TO PROVIDE INFORMED CONSENT , A PARENT OR LEGAL GUARDIAN HAS21 |
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179 | 175 | | GIVEN WRITTEN, INFORMED CONSENT ON THE PATIENT 'S BEHALF; AND22 |
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180 | 176 | | (e) D |
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181 | 177 | | OCUMENTATION FROM THE TREATING PHYSICIAN THAT THE23 |
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182 | 178 | | PATIENT MEETS THE REQUIREMENTS OF THIS SUBSECTION (2), INCLUDING24 |
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183 | 179 | | ATTESTATION FROM THE TREATING PHYSICIAN THAT THE TREATING25 |
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184 | 180 | | PHYSICIAN WAS CONSULTED IN THE CREATION OF THE WRITTEN , INFORMED26 |
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185 | 181 | | CONSENT GIVEN UNDER THIS PART 2.27 |
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186 | 182 | | 1270 |
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187 | 183 | | -5- (3) "INDIVIDUALIZED INVESTIGATIONAL DRUG , BIOLOGICAL1 |
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188 | 184 | | PRODUCT, OR DEVICE" MEANS A DRUG, BIOLOGICAL PRODUCT, OR DEVICE2 |
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189 | 185 | | THAT IS UNIQUE AND PRODUCED EXCLUSIVELY FOR USE BY AN ELIGIBLE3 |
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190 | 186 | | PATIENT, BASED ON THE PATIENT'S OWN GENETIC PROFILE, INCLUDING4 |
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191 | 187 | | INDIVIDUALIZED GENE THERAPY , ANTISENSE OLIGONUCLEOTIDES , AND5 |
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192 | 188 | | INDIVIDUALIZED NEOANTIGEN VACCINES .6 |
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193 | 189 | | (4) "I |
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194 | 190 | | NSTITUTION" HAS THE MEANING SET FORTH IN 45 CFR 46.1027 |
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195 | 191 | | (f).8 |
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196 | 192 | | (5) "L |
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197 | 193 | | IFE-THREATENING OR SEVERELY DEBILITATING ILLNESS " HAS9 |
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198 | 194 | | THE MEANING SET FORTH IN 21 CFR 312.81.10 |
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199 | 195 | | (6) "M |
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200 | 196 | | INOR" MEANS AN INDIVIDUAL WHO IS UNDER EIGHTEEN11 |
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201 | 197 | | YEARS OF AGE.12 |
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202 | 198 | | (7) "W |
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203 | 199 | | RITTEN, INFORMED CONSENT " MEANS A WRITTEN13 |
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204 | 200 | | DOCUMENT SIGNED BY AN ELIGIBLE PATIENT ; BY A PARENT OR LEGAL14 |
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205 | 201 | | GUARDIAN, IF THE PATIENT IS A MINOR ; OR BY A DESIGNATED15 |
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206 | 202 | | HEALTH-CARE AGENT PURSUANT TO A HEALTH -CARE POWER OF16 |
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207 | 203 | | ATTORNEY, IF THE PATIENT IS INCAPACITATED, THAT, AT A MINIMUM:17 |
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208 | 204 | | (a) E |
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209 | 205 | | XPLAINS THE CURRENTLY APPROVED PRODUCTS AND18 |
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210 | 206 | | TREATMENTS FOR THE LIFE-THREATENING OR SEVERELY DEBILITATING19 |
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211 | 207 | | ILLNESS FROM WHICH THE ELIGIBLE PATIENT SUFFERS ;20 |
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212 | 208 | | (b) A |
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213 | 209 | | TTESTS THAT THE ELIGIBLE PATIENT CONCURS WITH THE21 |
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214 | 210 | | TREATING PHYSICIAN'S BELIEF THAT ALL CURRENTLY APPROVED22 |
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215 | 211 | | TREATMENTS ARE UNLIKELY TO PROLONG THE PATIENT 'S LIFE;23 |
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216 | 212 | | (c) C |
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217 | 213 | | LEARLY IDENTIFIES THE SPECIFIC INDIVIDUALIZED24 |
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218 | 214 | | INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE PROPOSED FOR25 |
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219 | 215 | | TREATMENT OF THE ELIGIBLE PATIENT'S LIFE-THREATENING OR SEVERELY26 |
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220 | 216 | | DEBILITATING ILLNESS;27 |
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221 | 217 | | 1270 |
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222 | 218 | | -6- (d) DESCRIBES THE POTENTIAL BEST AND WORST OUTCOMES1 |
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223 | 219 | | RESULTING FROM USE OF THE INDIVIDUALIZED INVESTIGATIONAL DRUG ,2 |
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224 | 220 | | BIOLOGICAL PRODUCT, OR DEVICE, WITH A REALISTIC DESCRIPTION OF THE3 |
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225 | 221 | | MOST LIKELY OUTCOME , INCLUDING THE POSSIBILITY THAT NEW ,4 |
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226 | 222 | | UNANTICIPATED, DIFFERENT, OR WORSE SYMPTOMS MIGHT RESULT AND5 |
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227 | 223 | | THAT DEATH COULD BE HASTENED BY THE PROPOSED TREATMENT , BASED6 |
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228 | 224 | | ON THE PHYSICIAN'S KNOWLEDGE OF THE PROPOSED TREATMENT IN7 |
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229 | 225 | | CONJUNCTION WITH AN AWARENESS OF THE ELIGIBLE PATIENT 'S8 |
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230 | 226 | | CONDITION;9 |
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231 | 227 | | (e) M |
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232 | 228 | | AKES CLEAR THAT THE PATIENT'S ELIGIBILITY FOR HOSPICE10 |
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233 | 229 | | CARE MAY BE WITHDRAWN IF THE ELIGIBLE PATIENT BEGINS TREATMENT11 |
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234 | 230 | | OF THE LIFE-THREATENING OR SEVERELY DEBILITATING ILLNESS WITH AN12 |
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235 | 231 | | INDIVIDUALIZED INVESTIGATIONAL DRUG , BIOLOGICAL PRODUCT, OR13 |
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236 | 232 | | DEVICE AND THAT HOSPICE CARE MAY BE REINSTATED IF SUCH TREATMENT14 |
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237 | 233 | | ENDS AND THE PATIENT AGAIN MEETS HOSPICE CARE ELIGIBILITY15 |
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238 | 234 | | REQUIREMENTS;16 |
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239 | 235 | | (f) M |
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240 | 236 | | AKES CLEAR THAT IN-HOME HEALTH CARE MAY BE DENIED IF17 |
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241 | 237 | | TREATMENT BEGINS;18 |
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242 | 238 | | (g) M |
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243 | 239 | | AKES CLEAR THAT THE ELIGIBLE PATIENT 'S HEALTH19 |
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244 | 240 | | INSURANCE PROVIDER OR HEALTH -CARE PROVIDER IS NOT OBLIGATED TO20 |
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245 | 241 | | PAY FOR ANY CARE OR TREATMENTS CONSEQUENT TO THE USE OF THE21 |
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246 | 242 | | INDIVIDUALIZED INVESTIGATIONAL DRUG , BIOLOGICAL PRODUCT, OR22 |
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247 | 243 | | DEVICE UNLESS SPECIFICALLY REQUIRED BY LAW OR CONTRACT ;23 |
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248 | 244 | | (h) S |
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249 | 245 | | TATES THAT THE PATIENT UNDERSTANDS THAT THEY ARE24 |
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250 | 246 | | LIABLE FOR ALL EXPENSES CONSEQUENT TO THE USE OF THE25 |
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251 | 247 | | INDIVIDUALIZED INVESTIGATIONAL DRUG , BIOLOGICAL PRODUCT, OR26 |
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252 | 248 | | DEVICE, AND THAT THIS LIABILITY EXTENDS TO THE PATIENT 'S ESTATE,27 |
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253 | 249 | | 1270 |
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254 | 250 | | -7- UNLESS A CONTRACT BETWEEN THE PATIENT AND THE MANUFACTURER OF1 |
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255 | 251 | | THE INDIVIDUALIZED INVESTIGATIONAL DRUG , BIOLOGICAL PRODUCT, OR2 |
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256 | 252 | | DEVICE STATES OTHERWISE; AND3 |
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257 | 253 | | (i) S |
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258 | 254 | | TATES THAT THE ELIGIBLE PATIENT , OR, FOR AN ELIGIBLE4 |
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259 | 255 | | PATIENT WHO IS A MINOR OR WHO LACKS CAPACITY TO PROVIDE INFORMED5 |
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260 | 256 | | CONSENT, THE PARENT OR LEGAL GUARDIAN , CONSENTS TO THE USE OF6 |
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261 | 257 | | THE INDIVIDUALIZED INVESTIGATIONAL DRUG , BIOLOGICAL PRODUCT, OR7 |
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262 | 258 | | DEVICE FOR TREATMENT OF THE LIFE -THREATENING OR SEVERELY8 |
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263 | 259 | | DEBILITATING ILLNESS.9 |
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264 | 260 | | 25-45-203. Drug manufacturers - authorized access to and use10 |
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265 | 261 | | of individualized investigational drugs, biological products, or devices11 |
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266 | 262 | | - costs. (1) A |
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267 | 263 | | MANUFACTURER OPERATING WITHIN AN ELIGIBLE FACILITY12 |
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268 | 264 | | AND IN ACCORDANCE WITH APPLICABLE FEDERAL LAW MAY MAKE13 |
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269 | 265 | | AVAILABLE TO AN ELIGIBLE PATIENT , AND AN ELIGIBLE PATIENT MAY14 |
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270 | 266 | | REQUEST, THE MANUFACTURER 'S INDIVIDUALIZED INVESTIGATIONAL15 |
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271 | 267 | | DRUG, BIOLOGICAL PRODUCT, OR DEVICE FROM THE ELIGIBLE FACILITY OR16 |
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272 | 268 | | MANUFACTURER OPERATING WITHIN THE ELIGIBLE FACILITY .17 |
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273 | 269 | | (2) A |
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274 | 270 | | MANUFACTURER OF AN INDIVIDUALIZED INVESTIGATIONAL18 |
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275 | 271 | | DRUG, BIOLOGICAL PRODUCT, OR DEVICE MAY:19 |
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276 | 272 | | (a) P |
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277 | 273 | | ROVIDE THE INDIVIDUALIZED INVESTIGATIONAL DRUG ,20 |
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278 | 274 | | BIOLOGICAL PRODUCT, OR DEVICE TO AN ELIGIBLE PATIENT WITHOUT21 |
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279 | 275 | | RECEIVING COMPENSATION; OR22 |
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280 | 276 | | (b) R |
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281 | 277 | | EQUIRE AN ELIGIBLE PATIENT TO PAY THE COSTS OF, OR THE23 |
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282 | 278 | | COSTS ASSOCIATED WITH, THE MANUFACTURE OF THE INDIVI DUALIZED24 |
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283 | 279 | | INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE.25 |
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284 | 280 | | (3) N |
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285 | 281 | | OTHING IN THIS PART 2 REQUIRES A MANUFACTURER OF AN26 |
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286 | 282 | | INDIVIDUALIZED INVESTIGATIONAL DRUG , BIOLOGICAL PRODUCT, OR27 |
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287 | 283 | | 1270 |
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288 | 284 | | -8- DEVICE TO MAKE THE INDIVIDUALIZED INVESTIGATIONAL DRUG ,1 |
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289 | 285 | | BIOLOGICAL PRODUCT, OR DEVICE AVAILABLE TO AN ELIGIBLE PATIENT.2 |
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290 | 286 | | (4) I |
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291 | 287 | | F A PATIENT DIES WHILE BEING TREATED WITH AN3 |
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292 | 288 | | INDIVIDUALIZED INVESTIGATIONAL DRUG , BIOLOGICAL PRODUCT, OR4 |
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293 | 289 | | DEVICE, THE PATIENT'S HEIRS ARE NOT LIABLE FOR OUTSTANDING DEBT5 |
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294 | 290 | | RELATED TO THE TREATMENT, INCLUDING COSTS ATTRIBUTED TO LACK OF6 |
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295 | 291 | | INSURANCE COVERAGE FOR THE TREATMENT .7 |
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296 | 292 | | 25-45-204. Action against health-care provider's license or8 |
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297 | 293 | | medicare certification prohibited. N |
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298 | 294 | | OTWITHSTANDING ANY OTHER LAW ,9 |
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299 | 295 | | A LICENSING BOARD SHALL NOT REVOKE , FAIL TO RENEW, SUSPEND, OR10 |
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300 | 296 | | TAKE OTHER ACTION AGAINST A HEALTH -CARE PROVIDER'S LICENSE11 |
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301 | 297 | | ISSUED PURSUANT TO TITLE 12 BASED SOLELY ON THE HEALTH -CARE12 |
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302 | 298 | | PROVIDER'S RECOMMENDATION TO AN ELIGIBLE PATIENT REGARDING13 |
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303 | 299 | | ACCESS TO OR TREATMENT WITH AN INDIVIDUALIZED INVESTIGATIONAL14 |
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304 | 300 | | DRUG, BIOLOGICAL PRODUCT , OR DEVICE, SO LONG AS THE15 |
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305 | 301 | | RECOMMENDATION IS CONSISTENT WITH MEDICAL STANDARDS OF CARE .16 |
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306 | 302 | | A |
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307 | 303 | | CTION AGAINST A HEALTH-CARE PROVIDER'S MEDICARE CERTIFICATION17 |
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308 | 304 | | BASED SOLELY ON THE HEALTH -CARE PROVIDER'S RECOMMENDATION18 |
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309 | 305 | | THAT AN ELIGIBLE PATIENT HAVE ACCESS TO AN INDIVIDUALIZED19 |
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310 | 306 | | INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE IS PROHIBITED.20 |
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311 | 307 | | 25-45-205. Access to individualized investigational drugs,21 |
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312 | 308 | | biological products, and devices - prohibition on state action. A |
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313 | 309 | | N22 |
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314 | 310 | | OFFICIAL, EMPLOYEE, OR AGENT OF THIS STATE SHALL NOT BLOCK OR23 |
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315 | 311 | | ATTEMPT TO BLOCK AN ELIGIBLE PATIENT'S ACCESS TO AN INDIVIDUALIZED24 |
---|
316 | 312 | | INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE. COUNSELING,25 |
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317 | 313 | | ADVICE, OR A RECOMMENDATION CONSISTENT WITH MEDICAL ST ANDARDS26 |
---|
318 | 314 | | OF CARE FROM A LICENSED HEALTH-CARE PROVIDER IS NOT A VIOLATION27 |
---|
319 | 315 | | 1270 |
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320 | 316 | | -9- OF THIS SECTION.1 |
---|
321 | 317 | | 25-45-206. No cause of action created. T |
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322 | 318 | | HIS PART 2 DOES NOT2 |
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323 | 319 | | CREATE A PRIVATE RIGHT OF ACTION AGAINST A MANUFACTURER OF AN3 |
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324 | 320 | | INDIVIDUALIZED INVESTIGATIONAL DRUG , BIOLOGICAL PRODUCT, OR4 |
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325 | 321 | | DEVICE, OR AGAINST AN INDIVIDUAL OR ENTITY INVOLVED IN THE CARE OF5 |
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326 | 322 | | AN ELIGIBLE PATIENT USING AN INDIVIDUALIZED INVESTIGATIONAL DRUG ,6 |
---|
327 | 323 | | BIOLOGICAL PRODUCT, OR DEVICE, FOR ANY HARM CAUSED TO THE7 |
---|
328 | 324 | | ELIGIBLE PATIENT RESULTING FROM USE OF THE INDIVIDUALIZED8 |
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329 | 325 | | INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE, SO LONG AS9 |
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330 | 326 | | THE MANUFACTURER OR INDIVIDUAL OR ENTITY HAS MADE A GOOD FAITH10 |
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331 | 327 | | EFFORT TO COMPLY WITH THE PROVISIONS OF THIS PART 2 AND HAS11 |
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332 | 328 | | EXERCISED REASONABLE CARE IN ACTIONS TAKEN PURS UANT TO THIS PART12 |
---|
333 | 329 | | 2.13 |
---|
334 | 330 | | 25-45-207. Effect on health-care coverage. N |
---|
335 | 331 | | OTHING IN THIS14 |
---|
336 | 332 | | PART 2 AFFECTS A HEALTH INSURANCE PROVIDER 'S OBLIGATION TO15 |
---|
337 | 333 | | PROVIDE COVERAGE FOR AN INSURED 'S PARTICIPATION IN A CLINICAL16 |
---|
338 | 334 | | TRIAL PURSUANT TO SECTION 10-16-104 (20).17 |
---|
339 | 335 | | SECTION 6. Safety clause. The general assembly finds,18 |
---|
340 | 336 | | determines, and declares that this act is necessary for the immediate19 |
---|
341 | 337 | | preservation of the public peace, health, or safety or for appropriations for20 |
---|
342 | 338 | | the support and maintenance of the departments of the state and state21 |
---|
343 | 339 | | institutions.22 |
---|
344 | 340 | | 1270 |
---|
345 | 341 | | -10- |
---|