Texas 2015 - 84th Regular

Texas House Bill HB2908 Compare Versions

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Version 2 (New)

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1	1	84R27503 JSC-F
2	2	By: Parker H.B. No. 2908
3	3	Substitute the following for H.B. No. 2908:
4	4	By: Crownover C.S.H.B. No. 2908
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
10	10	and severe chronic diseases to access certain investigational
11	11	drugs, biological products, and devices that are in clinical
12	12	trials.
13	13	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
14	14	SECTION 1. (a) This Act shall be known as the "Medical
15	15	Freedom Act."
16	16	(b) The legislature finds that:
17	17	(1) the process for approval of investigational drugs,
18	18	biological products, and devices in the United States takes many
19	19	years;
20	20	(2) patients with a terminal illness or severe chronic
21	21	disease do not have the luxury of waiting until an investigational
22	22	drug, biological product, or device receives final approval from
23	23	the United States Food and Drug Administration;
24	24	(3) the standards of the United States Food and Drug
25	25	Administration for the use of investigational drugs, biological
26	26	products, and devices may deny the benefits of potentially
27	27	life-saving treatment to patients with a terminal illness or severe
28	28	chronic disease;
29	29	(4) patients with a terminal illness or severe chronic
30	30	disease have a fundamental right to attempt to pursue the
31	31	preservation of their own lives by accessing available
32	32	investigational drugs, biological products, and devices;
33	33	(5) the use of available investigational drugs,
34	34	biological products, and devices is a decision that should be made
35	35	by the patient with a terminal illness or severe chronic disease in
36	36	consultation with the patient's physician and is not a decision to
37	37	be made by the government; and
38	38	(6) the decision to use an investigational drug,
39	39	biological product, or device should be made with full awareness of
40	40	the potential risks, benefits, and consequences to the patient with
41	41	a terminal illness or severe chronic disease and the patient's
42	42	family.
43	43	(c) It is the intent of the legislature to allow for
44	44	patients with a terminal illness or severe chronic disease to use
45	45	potentially life-saving investigational drugs, biological
46	46	products, and devices.
47	47	SECTION 2. Subtitle C, Title 6, Health and Safety Code, is
48	48	amended by adding Chapter 489 to read as follows:
49	49	CHAPTER 489. ACCESS TO INVESTIGATIONAL TREATMENTS FOR PATIENTS
50	50	WITH TERMINAL ILLNESSES OR SEVERE CHRONIC DISEASES
51	51	SUBCHAPTER A. GENERAL PROVISIONS
52	52	Sec. 489.001. DEFINITIONS. In this chapter:
53	53	(1) "Executive commissioner" means the executive
54	54	commissioner of the Health and Human Services Commission.
55	55	(2) "Investigational drug, biological product, or
56	56	device" means a drug, biological product, or device that is being
57	57	studied and administered to human participants in a clinical trial
58	58	but has not yet been approved for general use by the United States
59	59	Food and Drug Administration. The term may include a treatment
60	60	using stem cells other than embryonic stem cells.
61	61	(3) "Severe chronic disease" means a condition,
62	62	injury, or illness that:
63	63	(A) may be treated;
64	64	(B) is never cured or eliminated; and
65	65	(C) entails significant functional impairment or
66	66	severe pain.
67	67	(4) "Terminal illness" means an advanced stage of a
68	68	disease with an unfavorable prognosis and that, without
69	69	life-sustaining procedures, will soon result in death or a state of
70	70	permanent unconsciousness from which recovery is unlikely.
71	71	Sec. 489.002. RULES. (a) The executive commissioner by
72	72	rule may designate a condition as a terminal illness or a severe
73	73	chronic disease.
74	74	(b) The executive commissioner shall adopt rules specifying
75	75	which treatments may be accessed by patients under this chapter and
76	76	the manner in which those treatments may be accessed.
77	77	(c) The executive commissioner may approve for treatment an
78	78	investigational drug, biological product, or device that has
79	79	completed or is in the appropriate phase of a clinical trial in
80	80	another country, provided that the executive commissioner
81	81	determines that the benefit of authorizing the treatment outweighs
82	82	the potential risk.
83	83	(d) For any treatment approved under this section, the
84	84	executive commissioner shall specify the safety parameters and
85	85	protocols the executive commissioner considers necessary for
86	86	patient use of the drug, product, or device.
87	87	Sec. 489.003. EXCLUSION OF CERTAIN TREATMENTS. This
88	88	chapter does not authorize the use of cannabis to treat patients
89	89	with terminal illnesses or severe chronic diseases.
90	90	SUBCHAPTER B. ACCESS TO INVESTIGATIONAL DRUGS, BIOLOGICAL
91	91	PRODUCTS, AND DEVICES FOR PATIENTS WITH TERMINAL ILLNESSES OR
92	92	SEVERE CHRONIC DISEASES
93	93	Sec. 489.051. PATIENT ELIGIBILITY. A patient is eligible
94	94	to access and use an investigational drug, biological product, or
95	95	device under this chapter if:
96	96	(1) the patient has a terminal illness or severe
97	97	chronic disease, attested to by the patient's treating physician;
98	98	(2) the use of the investigational drug, biological
99	99	product, or device is consistent with rules adopted under Section
100	100	489.002; and
101	101	(3) the patient's physician:
102	102	(A) in consultation with the patient, has
103	103	considered all other treatment options currently approved by the
104	104	United States Food and Drug Administration and determined that
105	105	those treatment options are unavailable or unlikely to prolong the
106	106	patient's life; and
107	107	(B) has recommended or prescribed in writing that
108	108	the patient use a specific class of investigational drug,
109	109	biological product, or device.
110	110	Sec. 489.052. INFORMED CONSENT. (a) Before receiving an
111	111	investigational drug, biological product, or device, an eligible
112	112	patient must sign a written informed consent.
113	113	(b) If the patient is a minor or lacks the mental capacity to
114	114	provide informed consent, a parent, guardian, or conservator may
115	115	provide informed consent on the patient's behalf.
116	116	(c) The executive commissioner, in collaboration with the
117	117	Texas Medical Board, by rule shall adopt a form for the informed
118	118	consent under this section.
119	119	Sec. 489.053. PROVISION OF INVESTIGATIONAL DRUG,
120	120	BIOLOGICAL PRODUCT, OR DEVICE BY MANUFACTURER. (a) A manufacturer
121	121	of an investigational drug, biological product, or device may make
122	122	available the manufacturer's investigational drug, biological
123	123	product, or device to eligible patients in accordance with this
124	124	chapter if the patient provides to the manufacturer the informed
125	125	consent required under Section 489.052.
126	126	(b) This chapter does not require that a manufacturer make
127	127	available an investigational drug, biological product, or device to
128	128	an eligible patient.
129	129	(c) A manufacturer may:
130	130	(1) provide an investigational drug, biological
131	131	product, or device to an eligible patient without receiving
132	132	compensation; or
133	133	(2) require an eligible patient to pay the costs of, or
134	134	the costs associated with, the manufacture of the investigational
135	135	drug, biological product, or device.
136	136	Sec. 489.054. NO CAUSE OF ACTION CREATED. This chapter does
137	137	not create a private or state cause of action against a manufacturer
138	138	of an investigational drug, biological product, or device or
139	139	against any other person or entity involved in the care of an
140	140	eligible patient using the investigational drug, biological
141	141	product, or device for any harm done to the eligible patient
142	142	resulting from the investigational drug, biological product, or
143	143	device.
144	144	SUBCHAPTER C. HEALTH INSURANCE
145	145	Sec. 489.101. HEALTH BENEFIT PLANS. A health benefit plan
146	146	may, but is not required to, provide coverage for the cost of an
147	147	investigational drug, biological product, or device.
148	148	Sec. 489.102. EFFECT ON HEALTH CARE COVERAGE FOR CLINICAL
149	149	TRIAL ENROLLEES. This chapter does not affect the coverage of
150	150	enrollees in clinical trials under Chapter 1379, Insurance Code.
151	151	SUBCHAPTER D. PHYSICIANS
152	152	Sec. 489.151. ACTION AGAINST PHYSICIAN'S LICENSE
153	153	PROHIBITED. Notwithstanding any other law, the Texas Medical Board
154	154	may not revoke, fail to renew, suspend, or take any action against
155	155	a physician's license under Subchapter B, Chapter 164, Occupations
156	156	Code, based solely on the physician's recommendations to an
157	157	eligible patient regarding access to or treatment with an
158	158	investigational drug, biological product, or device, provided that
159	159	the care provided or recommendations made to the patient meet the
160	160	standard of care and the requirements of this chapter.
161	161	SECTION 3. This Act takes effect immediately if it receives
162	162	a vote of two-thirds of all the members elected to each house, as
163	163	provided by Section 39, Article III, Texas Constitution. If this
164	164	Act does not receive the vote necessary for immediate effect, this
165	165	Act takes effect September 1, 2015.