Texas 2015 - 84th Regular

Texas Senate Bill SB694 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New	Differences
1	1	84R27626 JSC-F
2	2	By: Bettencourt, et al. S.B. No. 694
3	3	(Kacal, King of Hemphill, Rodriguez of Travis, Parker,
4	4	Davis of Harris, et al.)
5	5
6	6
7	7	A BILL TO BE ENTITLED
8	8	AN ACT
9	9	relating to authorizing patients with certain terminal illnesses to
10	10	access certain investigational drugs, biological products, and
11	11	devices that are in clinical trials.
12	12	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
13	13	SECTION 1. (a) This Act shall be known as the Right To Try
14	14	Act.
15	15	(b) The legislature finds that:
16	16	(1) the process for the approval of investigational
17	17	drugs, biological products, and devices in the United States takes
18	18	many years;
19	19	(2) patients with a terminal illness do not have the
20	20	luxury of waiting until an investigational drug, biological
21	21	product, or device receives final approval from the United States
22	22	Food and Drug Administration;
23	23	(3) the standards of the United States Food and Drug
24	24	Administration for the use of investigational drugs, biological
25	25	products, and devices may deny the benefits of potentially
26	26	life-saving treatments to patients with a terminal illness;
27	27	(4) patients with a terminal illness have a
28	28	fundamental right to attempt to pursue the preservation of their
29	29	own lives by accessing available investigational drugs, biological
30	30	products, and devices;
31	31	(5) the use of available investigational drugs,
32	32	biological products, and devices is a decision that should be made
33	33	by the patient with a terminal illness in consultation with the
34	34	patient's physician and is not a decision to be made by the
35	35	government; and
36	36	(6) the decision to use an investigational drug,
37	37	biological product, or device should be made with full awareness of
38	38	the potential risks, benefits, and consequences to the patient with
39	39	a terminal illness and the patient's family.
40	40	(c) It is the intent of the legislature to allow patients
41	41	with a terminal illness to use potentially life-saving
42	42	investigational drugs, biological products, and devices.
43	43	SECTION 2. Subtitle C, Title 6, Health and Safety Code, is
44	44	amended by adding Chapter 489 to read as follows:
45	45	CHAPTER 489. ACCESS TO INVESTIGATIONAL TREATMENTS FOR PATIENTS
46	46	WITH TERMINAL ILLNESSES
47	47	SUBCHAPTER A. GENERAL PROVISIONS
48	48	Sec. 489.001. DEFINITIONS. In this chapter:
49	49	(1) "Investigational drug, biological product, or
50	50	device" means a drug, biological product, or device that has
51	51	successfully completed phase one of a clinical trial but has not yet
52	52	been approved for general use by the United States Food and Drug
53	53	Administration and remains under investigation in the clinical
54	54	trial.
55	55	(2) "Terminal illness" means an advanced stage of a
56	56	disease with an unfavorable prognosis that, without
57	57	life-sustaining procedures, will soon result in death or a state of
58	58	permanent unconsciousness from which recovery is unlikely.
59	59	SUBCHAPTER B. ACCESS TO INVESTIGATIONAL DRUGS, BIOLOGICAL
60	60	PRODUCTS, AND DEVICES FOR PATIENTS WITH TERMINAL ILLNESSES
61	61	Sec. 489.051. PATIENT ELIGIBILITY. A patient is eligible
62	62	to access and use an investigational drug, biological product, or
63	63	device under this chapter if:
64	64	(1) the patient has a terminal illness, attested to by
65	65	the patient's treating physician; and
66	66	(2) the patient's physician:
67	67	(A) in consultation with the patient, has
68	68	considered all other treatment options currently approved by the
69	69	United States Food and Drug Administration and determined that
70	70	those treatment options are unavailable or unlikely to prolong the
71	71	patient's life; and
72	72	(B) has recommended or prescribed in writing that
73	73	the patient use a specific class of investigational drug,
74	74	biological product, or device.
75	75	Sec. 489.052. INFORMED CONSENT. (a) Before receiving an
76	76	investigational drug, biological product, or device, an eligible
77	77	patient must sign a written informed consent described by this
78	78	section that is attested to by the patient's physician and a
79	79	witness.
80	80	(b) If the patient is a minor or lacks the mental capacity to
81	81	provide informed consent, a parent, guardian, or conservator may
82	82	provide informed consent on the patient's behalf.
83	83	(c) The executive commissioner of the Health and Human
84	84	Services Commission, in collaboration with the Texas Medical Board,
85	85	by rule shall adopt a form for the informed consent required under
86	86	this section.
87	87	Sec. 489.053. PROVISION OF INVESTIGATIONAL DRUG,
88	88	BIOLOGICAL PRODUCT, OR DEVICE BY MANUFACTURER. (a) A manufacturer
89	89	of an investigational drug, biological product, or device may make
90	90	available the manufacturer's investigational drug, biological
91	91	product, or device to eligible patients in accordance with this
92	92	chapter if the patient provides to the manufacturer the informed
93	93	consent required under Section 489.052.
94	94	(b) This chapter does not require that a manufacturer make
95	95	available an investigational drug, biological product, or device to
96	96	an eligible patient.
97	97	(c) A manufacturer may:
98	98	(1) provide an investigational drug, biological
99	99	product, or device to an eligible patient without receiving
100	100	compensation; or
101	101	(2) require an eligible patient to pay the costs of, or
102	102	the costs associated with, the manufacture of the investigational
103	103	drug, biological product, or device.
104	104	Sec. 489.054. NO CAUSE OF ACTION CREATED. This chapter does
105	105	not create a private or state cause of action against a manufacturer
106	106	of an investigational drug, biological product, or device or
107	107	against any other person or entity involved in the care of an
108	108	eligible patient using the investigational drug, biological
109	109	product, or device for any harm done to the eligible patient
110	110	resulting from the investigational drug, biological product, or
111	111	device.
112	112	Sec. 489.055. STATE MAY NOT INTERFERE WITH ACCESS TO
113	113	INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE. An official,
114	114	employee, or agent of this state may not block or attempt to block
115	115	an eligible patient's access to an investigational drug, biological
116	116	product, or device under this chapter.
117	117	Sec. 489.056. CORRECTIONAL MANAGED CARE. A person covered
118	118	by the correctional managed health care plan under Subchapter E,
119	119	Chapter 501, Government Code, is an eligible patient for purposes
120	120	of this chapter only to the extent that the correctional managed
121	121	health care Offender Health Services Plan and federal law governing
122	122	offender participation in biomedical research permit the
123	123	offender's access to and use of the investigational drug,
124	124	biological product, or device.
125	125	SUBCHAPTER C. HEALTH INSURANCE
126	126	Sec. 489.101. HEALTH BENEFIT PLANS. A health benefit plan
127	127	may, but is not required to, provide coverage for the cost of an
128	128	investigational drug, biological product, or device.
129	129	Sec. 489.102. EFFECT ON HEALTH CARE COVERAGE FOR CLINICAL
130	130	TRIAL ENROLLEES. This chapter does not affect the coverage of
131	131	enrollees in clinical trials under Chapter 1379, Insurance Code.
132	132	SUBCHAPTER D. PHYSICIANS
133	133	Sec. 489.151. ACTION AGAINST PHYSICIAN'S LICENSE
134	134	PROHIBITED. Notwithstanding any other law, the Texas Medical Board
135	135	may not revoke, fail to renew, suspend, or take any action against a
136	136	physician's license under Subchapter B, Chapter 164, Occupations
137	137	Code, based solely on the physician's recommendations to an
138	138	eligible patient regarding access to or treatment with an
139	139	investigational drug, biological product, or device, provided that
140	140	the care provided or recommendations made to the patient meet the
141	141	standard of care and the requirements of this chapter.
142	142	SECTION 3. The executive commissioner of the Health and
143	143	Human Services Commission by rule shall adopt the form for informed
144	144	consent as required by Section 489.052(c), Health and Safety Code,
145	145	as added by this Act, not later than the 30th day after the
146	146	effective date of this Act.
147	147	SECTION 4. This Act takes effect immediately if it receives
148	148	a vote of two-thirds of all the members elected to each house, as
149	149	provided by Section 39, Article III, Texas Constitution. If this
150	150	Act does not receive the vote necessary for immediate effect, this
151	151	Act takes effect September 1, 2015.