Texas 2019 - 86th Regular

Texas House Bill HB3148 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1		-	H.B. No. 3148
	1	+	By: Parker, et al. (Senate Sponsor - Bettencourt) H.B. No. 3148
	2	+	(In the Senate - Received from the House May 9, 2019;
	3	+	May 10, 2019, read first time and referred to Committee on Health &
	4	+	Human Services; May 20, 2019, reported adversely, with favorable
	5	+	Committee Substitute by the following vote: Yeas 9, Nays 0;
	6	+	May 20, 2019, sent to printer.)
	7	+	Click here to see the committee vote
	8	+	COMMITTEE SUBSTITUTE FOR H.B. No. 3148 By: Perry
2	9
3	10
	11	+	A BILL TO BE ENTITLED
4	12		AN ACT
5	13		relating to the administration and oversight of investigational
6	14		adult stem cell treatments administered to certain patients.
7	15		BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
8	16		SECTION 1. Subchapter B, Chapter 1003, Health and Safety
9	17		Code, is amended by adding Sections 1003.0525 and 1003.0526 to read
10	18		as follows:
11	19		Sec. 1003.0525. ADMINISTRATION OF SUBCHAPTER. The
12	20		department shall administer this subchapter.
13	21		Sec. 1003.0526. INVESTIGATIONAL STEM CELL REGISTRY. The
14	22		department shall establish and maintain an investigational stem
15	23		cell registry that lists each physician who administers an
16	24		investigational stem cell treatment under this subchapter.
17	25		SECTION 2. Section 1003.054(c), Health and Safety Code, is
18	26		amended to read as follows:
19	27		(c) The executive commissioner by rule shall [may] adopt a
20	28		form for the informed consent under this section. The form must
21	29		provide notice that the department administers this subchapter.
22	30		SECTION 3. Section 1003.055(d), Health and Safety Code, is
23	31		amended to read as follows:
24	32		(d) An institutional review board that oversees
25	33		investigational stem cell treatments administered under this
26	34		subchapter must meet one of the following conditions [be affiliated
27	35		with]:
28	36		(1) be affiliated with a medical school, as defined by
29	37		Section 61.501, Education Code; [or]
30	38		(2) be affiliated with a hospital licensed under
31	39		Chapter 241 that has at least 150 beds;
32	40		(3) be accredited by the Association for the
33	41		Accreditation of Human Research Protection Programs;
34	42		(4) be registered by the United States Department of
35	43		Health and Human Services, Office for Human Research Protections,
36	44		in accordance with 21 C.F.R. Part 56; or
37	45		(5) be accredited by a national accreditation
38	46		organization acceptable to the Texas Medical Board.
39	47		SECTION 4. Section 1003.058(b), Health and Safety Code, is
40	48		amended to read as follows:
41	49		(b) A governmental entity or an officer, employee, or agent
42	50		of a governmental entity may not interfere with an eligible
43	51		patient's access to or use of an investigational [a] stem cell
44	52		treatment authorized under this subchapter unless the treatment
45	53		uses an adult stem cell product that is considered an adulterated or
46	54		misbranded drug under Chapter 431. For purposes of this subsection,
47	55		a governmental entity may not consider the adult stem cell product
48	56		to be an adulterated or misbranded drug solely on the basis that the
49	57		United States Food and Drug Administration has not approved the
50	58		adult stem cell product.
51	59		SECTION 5. Subchapter B, Chapter 1003, Health and Safety
52	60		Code, is amended by adding Section 1003.060 to read as follows:
53	61		Sec. 1003.060. CONSTRUCTION OF SUBCHAPTER. This subchapter
54	62		may not be construed to:
55	63		(1) prohibit a physician from using adult stem cells
56	64		for their intended homologous use if the stem cells are:
57	65		(A) produced by a manufacturer registered by the
58	66		United States Food and Drug Administration; and
59	67		(B) commercially available; or
60	68		(2) require an institutional review board to oversee
61	69		treatment using adult stem cells registered by the United States
62	70		Food and Drug Administration for their intended homologous use.
63		-	SECTION 6. The Department of State Health Services ~~may~~ not
64		-	establish the investigational stem cell registry ~~described by~~
65		-	Section 1003.0526, Health and Safety Code, as added by ~~this Act,~~
66		-	until September 1, 2027.
	71	+	SECTION 6. The Department of State Health Services is not
	72	+	required to establish the investigational stem cell registry
	73	+	described by Section 1003.0526, Health and Safety Code, as added by
	74	+	this Act, until September 1, 2027.
67	75		SECTION 7. This Act takes effect September 1, 2019.
68		-	______________________________ ______________________________
69		-	President of the Senate Speaker of the House
70		-	I certify that H.B. No. 3148 was passed by the House on May 9,
71		-	2019, by the following vote: Yeas 141, Nays 0, 2 present, not
72		-	voting; that the House refused to concur in Senate amendments to
73		-	H.B. No. 3148 on May 23, 2019, and requested the appointment of a
74		-	conference committee to consider the differences between the two
75		-	houses; and that the House adopted the conference committee report
76		-	on H.B. No. 3148 on May 26, 2019, by the following vote: Yeas 141,
77		-	Nays 0, 3 present, not voting.
78		-	______________________________
79		-	Chief Clerk of the House
80		-	I certify that H.B. No. 3148 was passed by the Senate, with
81		-	amendments, on May 21, 2019, by the following vote: Yeas 31, Nays
82		-	0; at the request of the House, the Senate appointed a conference
83		-	committee to consider the differences between the two houses; and
84		-	that the Senate adopted the conference committee report on H.B. No.
85		-	3148 on May 26, 2019, by the following vote: Yeas 31, Nays 0.
86		-	______________________________
87		-	Secretary of the Senate
88		-	APPROVED: __________________
89		-	Date
90		-	__________________
91		-	Governor
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