Representative Brad M. Daw proposes the following substitute bill:


1     
MEDICAL CANNABIS POLICY

2     
2018 GENERAL SESSION

3     
STATE OF UTAH

4     
Chief Sponsor: Brad M. Daw

5     
Senate Sponsor: Evan J. Vickers

6     

7     LONG TITLE
8     General Description:
9          This bill creates a "right to try" cannabis-based treatment for terminally ill patients.
10     Highlighted Provisions:
11          This bill:
12          ▸     defines terms;
13          ▸     provides that an individual who possesses or uses cannabis in a medicinal dosage
14     form in compliance with Title 58, Chapter 85, Utah Right to Try Act, is not subject
15     to the penalties described in Title 58, Chapter 37, Utah Controlled Substances Act;
16     and
17          ▸     describes the procedure for a terminally ill patient to receive a recommendation for
18     a cannabis-based treatment from the terminally ill patient's physician.
19     Money Appropriated in this Bill:
20          None
21     Other Special Clauses:
22          None
23     Utah Code Sections Affected:
24     AMENDS:
25          58-37-3.6, as enacted by Laws of Utah 2017, Chapter 398

26          58-85-102, as enacted by Laws of Utah 2015, Chapter 110
27          58-85-104, as last amended by Laws of Utah 2016, Chapter 348
28          58-85-105, as enacted by Laws of Utah 2015, Chapter 110
29     ENACTS:
30          58-85-103.5, Utah Code Annotated 1953
31     

32     Be it enacted by the Legislature of the state of Utah:
33          Section 1. Section 58-37-3.6 is amended to read:
34          58-37-3.6. Exemption for possession or distribution of a cannabinoid product or
35     expanded cannabinoid product pursuant to an approved study.
36          (1) As used in this section:
37          (a) "Cannabinoid product" means a product intended for human ingestion that:
38          (i) contains an extract or concentrate that is obtained from cannabis;
39          (ii) is prepared in a medicinal dosage form; and
40          (iii) contains at least 10 units of cannabidiol for every one unit of tetrahydrocannabinol.
41          (b) "Cannabis" means any part of the plant cannabis sativa, whether growing or not.
42          (c) "Drug paraphernalia" means the same as that term is defined in Section 58-37a-3.
43          (d) "Expanded cannabinoid product" means a product intended for human ingestion
44     that:
45          (i) contains an extract or concentrate that is obtained from cannabis;
46          (ii) is prepared in a medicinal dosage form; and
47          (iii) contains less than 10 units of cannabidiol for every one unit of
48     tetrahydrocannabinol.
49          (e) "Medicinal dosage form" means:
50          (i) a tablet;
51          (ii) a capsule;
52          (iii) a concentrated oil;
53          (iv) a liquid suspension;
54          (v) a transdermal preparation; or
55          (vi) a sublingual preparation.
56          (f) "Tetrahydrocannabinol" means a substance derived from cannabis that meets the

57     description in Subsection 58-37-4(2)(a)(iii)(AA).
58          (2) Notwithstanding any other provision of this chapter, an individual who possesses or
59     distributes a cannabinoid product or an expanded cannabinoid product is not subject to the
60     penalties described in this title for the possession or distribution of marijuana or
61     tetrahydrocannabinol to the extent that the individual's possession or distribution of the
62     cannabinoid product or expanded cannabinoid product complies with Title 26, Chapter 61,
63     Cannabinoid Research Act.
64          (3) Notwithstanding any other provision of this chapter, an individual who possesses or
65     uses cannabis in a medicinal dosage form is not subject to the penalties described in this title
66     for the possession or use of marijuana or tetrahydrocannabinol to the extent that the individual's
67     possession or use of the cannabis complies with Title 58, Chapter 85, Utah Right to Try Act.
68          Section 2. Section 58-85-102 is amended to read:
69          58-85-102. Definitions.
70          As used in this chapter:
71          (1) "Cannabis" means cannabis that has been grown by a state-approved grower and
72     processed into a medicinal dosage form.
73          (2) "Cannabis-based treatment" means a course of treatment involving cannabis.
74          [(1)] (3) "Eligible patient" means an individual who has been diagnosed with a
75     terminal illness by a physician.
76          (4) "Health care facility" means the same as that term is defined in Section 26-55-102.
77          [(2)] (5) "Insurer" means the same as that term is defined in Section 31A-1-301.
78          [(3)] (6) "Investigational device" means a device that:
79          (a) meets the definition of "investigational device" in 21 C.F.R. Sec. 812.3; and
80          (b) has successfully completed the United States Food and Drug Administration Phase
81     1 testing for an investigational device described in 21 C.F.R. Part 812.
82          [(4)] (7) "Investigational drug" means a drug that:
83          (a) meets the definition of "investigational new drug" in 21 C.F.R. Sec. 312.3; and
84          (b) has successfully completed the United States Food and Drug Administration Phase
85     1 testing for an investigational new drug described in 21 C.F.R. Part 312.
86          (8) "Medicinal dosage form" means the same as that term is defined in Section
87     58-37-3.6.

88          [(5)] (9) "Physician" means an individual who is licensed under:
89          (a) Title 58, Chapter 67, Utah Medical Practice Act; or
90          (b) Title 58, Chapter 68, Utah Osteopathic Medical Practice Act.
91          (10) "State-approved grower and processor" means a person who grows cannabis
92     pursuant to state law and processes the cannabis into a medicinal dosage form.
93          [(6)] (11) "Terminal illness" means a condition of a patient that:
94          (a) as determined by a physician:
95          (i) is likely to pose a greater risk to the patient than the risk posed to the patient by
96     treatment with an investigational drug or investigational device; and
97          (ii) will inevitably lead to the patient's death; and
98          (b) presents the patient, after the patient has explored conventional therapy options,
99     with no treatment option that is satisfactory or comparable to treatment with an investigational
100     drug or device.
101          Section 3. Section 58-85-103.5 is enacted to read:
102          58-85-103.5. Right to request a recommendation for a cannabis-based treatment.
103          (1) As used in this section, "terminally ill patient" means a patient who has an
104     incurable and irreversible disease that has been medically confirmed and will, within
105     reasonable medical judgment, produce death within six months.
106          (2) A terminally ill patient's physician may give the eligible patient a recommendation
107     to try a cannabis-based treatment if:
108          (a) the physician believes, in the physician's professional judgment, that the
109     cannabis-based treatment may provide some benefit to the terminally ill patient; and
110          (b) the physician recommends a cannabis-based treatment to no more than 25
111     terminally ill patients at any given time.
112          (3) (a) A recommendation may be for up to a one-month supply of cannabis.
113          (b) Once a terminally ill patient has exhausted a one-month supply of cannabis, the
114     terminally ill patient's physician may renew the original recommendation for an additional
115     one-month supply of cannabis, so long as the terminally ill patient's physician continues to
116     believe, in the physician's professional judgment, that the cannabis-based treatment may
117     provide some benefit to the terminally ill patient.
118          (4) A terminally ill patient may possess and use cannabis if the terminally ill patient:

119          (a) has a recommendation from the terminally ill patient's physician as described in this
120     section; and
121          (b) procures cannabis from a state-approved source.
122          (5) The physician shall provide a terminally ill patient with a recommendation to use a
123     cannabis-based treatment with an informed consent document that, based on the physician's
124     knowledge of the cannabis-based treatment:
125          (a) describes the possible positive and negative outcomes the terminally ill patient
126     could experience;
127          (b) states that an insurer is not required to cover the cost of providing cannabis to the
128     terminally ill patient; and
129          (c) states that, subject to Section 58-85-105, an insurer may deny coverage for the
130     terminally ill patient.
131          Section 4. Section 58-85-104 is amended to read:
132          58-85-104. Standard of care -- Medical practitioners not liable -- No private right
133     of action.
134          (1) (a) It is not a breach of the applicable standard of care for a physician, other
135     licensed health care provider, or hospital to treat an eligible patient with an investigational drug
136     or investigational device under this chapter.
137          (b) It is not a breach of the applicable standard of care for a physician to recommend a
138     cannabis-based treatment to a terminally ill patient under this chapter, or a health care facility
139     to aid or assist in any way a terminally ill patient's use of cannabis.
140          (2) A physician, other licensed health care provider, or hospital that treats an eligible
141     patient with an investigational drug or investigational device under this chapter, or a physician
142     who recommends a cannabis-based treatment to a terminally ill patient or a health care facility
143     that facilitates a terminally ill patient's recommended use of a cannabis-based treatment under
144     this chapter, may not, for any harm done to the eligible patient by the investigational drug or
145     device, or for any harm done to the terminally ill patient by the cannabis-based treatment, be
146     subject to:
147          (a) civil liability;
148          (b) criminal liability; or
149          (c) licensure sanctions under:

150          (i) for a physician:
151          (A) Title 58, Chapter 67, Utah Medical Practice Act; or
152          (B) Title 58, Chapter 68, Utah Osteopathic Medical Practice Act;
153          (ii) for the other licensed health care provider, the act governing the other licensed
154     health care provider's license; or
155          (iii) for the hospital or health care facility, Title 26, Chapter 21, Health Care Facility
156     Licensing and Inspection Act.
157          (3) This chapter does not:
158          (a) require a manufacturer of an investigational drug or investigational device to agree
159     to make an investigational drug or investigational device available to an eligible patient or an
160     eligible patient's physician;
161          (b) require a physician to agree to:
162          (i) administer an investigational drug to an eligible patient under this chapter; [or]
163          (ii) treat an eligible patient with an investigational device under this chapter; or
164          (iii) recommend a cannabis-based treatment to a terminally ill patient; or
165          (c) create a private right of action for an eligible patient:
166          (i) against a physician or hospital, for the physician's or hospital's refusal to:
167          (A) administer an investigational drug to an eligible patient under this chapter; [or]
168          (B) treat an eligible patient with an investigational device under this chapter; or
169          (C) recommend a cannabis-based treatment to the terminally ill patient; or
170          (ii) against a manufacturer, for the manufacturer's refusal to provide an eligible patient
171     with an investigational drug or an investigational device under this chapter.
172          Section 5. Section 58-85-105 is amended to read:
173          58-85-105. Insurance coverage.
174          (1) This chapter does not:
175          (a) require an insurer to cover the cost of:
176          (i) administering an investigational drug under this chapter; [or]
177          (ii) treating a patient with an investigational device under this chapter; or
178          (iii) a cannabis-based treatment; or
179          (b) prohibit an insurer from covering the cost of:
180          (i) administering an investigational drug under this chapter; [or]

181          (ii) treating a patient with an investigational device under this chapter[.]; or
182          (iii) a cannabis-based treatment.
183          (2) Except as described in Subsection (3), an insurer may deny coverage to an eligible
184     patient who is treated with an investigational drug or investigational device, for harm to the
185     eligible patient caused by the investigational drug or investigational device.
186          (3) An insurer may not deny coverage to an eligible patient under Subsection (2) for:
187          (a) the eligible patient's preexisting condition;
188          (b) benefits that commenced before the day on which the eligible patient is treated with
189     the investigational drug or investigational device; or
190          (c) palliative or hospice care for an eligible patient that has been treated with an
191     investigational drug or device, but is no longer receiving curative treatment with the
192     investigational drug or device.