Texas 2021 - 87th Regular

Texas House Bill HB1535 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1		-	H.B. No. 1535
	1	+	By: Klick, et al. (Senate Sponsor - Schwertner) H.B. No. 1535
	2	+	(In the Senate - Received from the House May 3, 2021;
	3	+	May 20, 2021, read first time and referred to Committee on State
	4	+	Affairs; May 24, 2021, reported adversely, with favorable
	5	+	Committee Substitute by the following vote: Yeas 9, Nays 0;
	6	+	May 24, 2021, sent to printer.)
	7	+	Click here to see the committee vote
	8	+	COMMITTEE SUBSTITUTE FOR H.B. No. 1535 By: Schwertner
2	9
3	10
	11	+	A BILL TO BE ENTITLED
4	12		AN ACT
5	13		relating to the medical use of low-THC cannabis by patients with
6	14		certain medical conditions and the establishment of
7	15		compassionate-use institutional review boards to evaluate and
8	16		approve proposed research programs to study the medical use of
9	17		low-THC cannabis in the treatment of certain patients.
10	18		BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
11	19		SECTION 1. Chapter 487, Health and Safety Code, is amended
12	20		by adding Subchapter F to read as follows:
13	21		SUBCHAPTER F. COMPASSIONATE-USE RESEARCH AND REPORTING
14	22		Sec. 487.251. DEFINITIONS. In this subchapter:
15	23		(1) "Executive commissioner" means the executive
16	24		commissioner of the Health and Human Services Commission.
17	25		(2) "Institutional review board" means a
18	26		compassionate-use institutional review board established under
19	27		Section 487.253.
20	28		Sec. 487.252. RULES. (a) Except as otherwise provided by
21	29		Subsection (b), the executive commissioner shall adopt all
22	30		necessary rules to implement this subchapter, including rules
23	31		designating the medical conditions for which a patient may be
24	32		treated with low-THC cannabis as part of an approved research
25	33		program conducted under this subchapter.
26	34		(b) The Texas Medical Board may adopt rules regarding the
27	35		certification of a physician by an institutional review board.
28	36		Sec. 487.253. COMPASSIONATE-USE INSTITUTIONAL REVIEW
29	37		BOARDS. (a) One or more compassionate-use institutional review
30	38		boards may be established to:
31	39		(1) evaluate and approve proposed research programs to
32	40		study the medical use of low-THC cannabis in treating a medical
33	41		condition designated by rule of the executive commissioner under
34	42		Section 487.252(a); and
35	43		(2) oversee patient treatment undertaken as part of an
36	44		approved research program, including the certification of treating
37	45		physicians.
38	46		(b) An institutional review board must be affiliated with a
39	47		dispensing organization and meet one of the following conditions:
40	48		(1) be affiliated with a medical school, as defined by
41	49		Section 61.501, Education Code;
42	50		(2) be affiliated with a hospital licensed under
43	51		Chapter 241 that has at least 150 beds;
44	52		(3) be accredited by the Association for the
45	53		Accreditation of Human Research Protection Programs;
46	54		(4) be registered by the United States Department of
47	55		Health and Human Services, Office for Human Research Protections,
48	56		in accordance with 21 C.F.R. Part 56; or
49	57		(5) be accredited by a national accreditation
50	58		organization acceptable to the Texas Medical Board.
51	59		Sec. 487.254. REPORTS BY INSTITUTIONAL REVIEW BOARDS. Each
52	60		institutional review board shall submit written reports that
53	61		describe and assess the research findings of each approved research
54	62		program to:
55	63		(1) the Health and Human Services Commission, not
56	64		later than October 1 of each year; and
57	65		(2) the legislature, not later than October 1 of each
58	66		even-numbered year.
59	67		Sec. 487.255. PATIENT TREATMENT. (a) Patient treatment
60	68		provided as part of an approved research program under this
61	69		subchapter may be administered only by a physician certified by an
62	70		institutional review board to participate in the program.
63	71		(b) A patient participating in a research program under this
64	72		subchapter must be a permanent resident of this state.
65	73		Sec. 487.256. INFORMED CONSENT. (a) Before receiving
66	74		treatment under an approved research program, each patient must
67	75		sign a written informed consent form.
68	76		(b) If the patient is a minor or lacks the mental capacity to
69	77		provide informed consent, a parent, guardian, or conservator may
70	78		provide informed consent on the patient's behalf.
71	79		(c) An institutional review board overseeing a research
72	80		program under this subchapter may adopt a form to be used for the
73	81		informed consent required by this section.
74	82		SECTION 2. Section 169.001(3), Occupations Code, is amended
75	83		to read as follows:
76	84		(3) "Low-THC cannabis" means the plant Cannabis sativa
77	85		L., and any part of that plant or any compound, manufacture, salt,
78	86		derivative, mixture, preparation, resin, or oil of that plant that
79	87		contains not more than one [0.5] percent by weight of
80	88		tetrahydrocannabinols.
81	89		SECTION 3. Section 169.002, Occupations Code, is amended by
82	90		adding Subsection (c) to read as follows:
83	91		(c) A physician is qualified to prescribe low-THC cannabis
84	92		for the treatment of a patient with a medical condition approved by
85	93		rule of the executive commissioner of the Health and Human Services
86	94		Commission for treatment in an approved research program conducted
87	95		under Subchapter F, Chapter 487, Health and Safety Code, if the
88	96		physician is:
89	97		(1) licensed under this subtitle; and
90	98		(2) certified by a compassionate-use institutional
91	99		review board created under Section 487.253, Health and Safety Code,
92	100		that oversees patient treatment undertaken as part of that approved
93	101		research program.
94	102		SECTION 4. Section 169.003, Occupations Code, is amended to
95	103		read as follows:
96		-	Sec. 169.003. PRESCRIPTION OF LOW-THC CANNABIS. A
97		-	~~physician~~ described by Section 169.002 may prescribe low-THC
98		-	~~cannabis to a~~ patient if:
	104	+	Sec. 169.003. PRESCRIPTION OF LOW-THC CANNABIS. A physician
	105	+	described by Section 169.002 may prescribe low-THC cannabis to a
	106	+	patient if:
99	107		(1) the patient is a permanent resident of the state;
100	108		(2) the physician complies with the registration
101	109		requirements of Section 169.004; and
102	110		(3) the physician certifies to the department that:
103	111		(A) the patient is diagnosed with:
104	112		(i) epilepsy;
105	113		(ii) a seizure disorder;
106	114		(iii) multiple sclerosis;
107	115		(iv) spasticity;
108	116		(v) amyotrophic lateral sclerosis;
109	117		(vi) autism;
110	118		(vii) [terminal] cancer; [or]
111	119		(viii) an incurable neurodegenerative
112	120		disease;
113	121		(ix) post-traumatic stress disorder; or
114	122		(x) a medical condition that is approved
115	123		for a research program under Subchapter F, Chapter 487, Health and
116	124		Safety Code, and for which the patient is receiving treatment under
117	125		that program; and
118	126		(B) the physician determines the risk of the
119	127		medical use of low-THC cannabis by the patient is reasonable in
120	128		light of the potential benefit for the patient.
121	129		SECTION 5. Section 169.001(6), Occupations Code, is
122	130		repealed.
123	131		SECTION 6. (a) Not later than December 1, 2021, the
124	132		executive commissioner of the Health and Human Services Commission
125	133		shall adopt rules as necessary under Section 487.252, Health and
126	134		Safety Code, as added by this Act.
127	135		(b) Not later than December 1, 2021, the public safety
128	136		director of the Department of Public Safety shall adopt or amend
129	137		department rules regarding the cultivation, processing, and
130	138		dispensing of low-THC cannabis by a licensed dispensing
131	139		organization under Chapter 487, Health and Safety Code.
132	140		SECTION 7. This Act takes effect September 1, 2021.
133		-	______________________________ ______________________________
134		-	President of the Senate Speaker of the House
135		-	I certify that H.B. No. 1535 was passed by the House on April
136		-	29, 2021, by the following vote: Yeas 134, Nays 12, 1 present, not
137		-	voting; and that the House concurred in Senate amendments to H.B.
138		-	No. 1535 on May 28, 2021, by the following vote: Yeas 119, Nays 25,
139		-	1 present, not voting.
140		-	______________________________
141		-	Chief Clerk of the House
142		-	I certify that H.B. No. 1535 was passed by the Senate, with
143		-	amendments, on May 25, 2021, by the following vote: Yeas 31, Nays
144		-	0.
145		-	______________________________
146		-	Secretary of the Senate
147		-	APPROVED: __________________
148		-	Date
149		-	__________________
150		-	Governor
	141	+	* * * * *