Texas 2017 - 85th Regular

Texas House Bill HB661 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1	1		85R21273 KKR-F
2		-	By: Parker, et al. H.B. No. 661
3		-	Substitute the following for H.B. No. 661:
4		-	By: Price C.S.H.B. No. 661
	2	+	By: Parker, Guerra, Price, Fallon, Guillen, H.B. No. 661
	3	+	et al.
5	4
6	5
7	6		A BILL TO BE ENTITLED
8	7		AN ACT
9	8		relating to access to certain investigational drugs, biological
10	9		products, and devices that are in clinical trials by patients with
11	10		severe chronic diseases.
12	11		BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
13	12		SECTION 1. (a) This Act shall be known as the "Medical
14	13		Freedom Act."
15	14		(b) The legislature finds that:
16	15		(1) the Right To Try Act, as added by Chapter 502 (H.B.
17	16		21), Acts of the 84th Legislature, Regular Session, 2015, has had
18	17		tremendous success in saving the lives of many patients with a
19	18		terminal illness;
20	19		(2) the process for approving the use of
21	20		investigational drugs, biological products, and devices by
22	21		patients without a terminal illness who need access to the drugs,
23	22		products, or devices continues to take many years in the United
24	23		States;
25	24		(3) patients who are battling a severe chronic disease
26	25		that is debilitating or causes severe pain do not have the luxury of
27	26		waiting until an investigational drug, biological product, or
28	27		device receives final approval from the United States Food and Drug
29	28		Administration;
30	29		(4) the standards of the United States Food and Drug
31	30		Administration for the use of investigational drugs, biological
32	31		products, and devices may deny the benefits of potentially
33	32		life-altering treatment to patients with a severe chronic disease;
34	33		(5) patients with a severe chronic disease have a
35	34		fundamental right to attempt to pursue the preservation of their
36	35		state of life by accessing available investigational drugs,
37	36		biological products, and devices;
38	37		(6) the use of available investigational drugs,
39	38		biological products, and devices is a decision that should be made
40	39		by a patient with a severe chronic disease in consultation with the
41	40		patient's physician and is not a decision to be made by the
42	41		government; and
43	42		(7) the decision to use an investigational drug,
44	43		biological product, or device should be made with full awareness of
45	44		the potential risks, benefits, and consequences to a patient with a
46	45		severe chronic disease and the patient's family.
47	46		(c) It is the intent of the legislature to allow patients
48	47		with a severe chronic disease to use potentially life-altering
49	48		investigational drugs, biological products, and devices.
50	49		SECTION 2. Subtitle C, Title 6, Health and Safety Code, is
51	50		amended by adding Chapter 490 to read as follows:
52	51		CHAPTER 490. ACCESS TO INVESTIGATIONAL TREATMENTS FOR PATIENTS
53	52		WITH SEVERE CHRONIC DISEASES
54	53		SUBCHAPTER A. GENERAL PROVISIONS
55	54		Sec. 490.001. DEFINITIONS. In this chapter:
56	55		(1) "Executive commissioner" means the executive
57	56		commissioner of the Health and Human Services Commission.
58	57		(2) "Investigational drug, biological product, or
59	58		device" means a drug, biological product, or device that has
60	59		successfully completed phase one of a clinical trial but has not yet
61	60		been approved for general use by the United States Food and Drug
62	61		Administration or its international equivalent and remains under
63	62		investigation in the clinical trial.
64	63		(3) "Severe chronic disease" means a condition,
65	64		injury, or illness that:
66	65		(A) lasts for at least one year;
67	66		(B) requires ongoing medical attention; and
68	67		(C) entails significant functional impairment or
69	68		severe pain that limits a person's activities of daily life.
70	69		Sec. 490.002. DESIGNATION OF SEVERE CHRONIC DISEASES. The
71	70		executive commissioner by rule shall designate the medical
72	71		conditions that are considered severe chronic diseases under this
73	72		chapter.
74	73		SUBCHAPTER B. ACCESS TO INVESTIGATIONAL DRUGS, BIOLOGICAL
75	74		PRODUCTS, AND DEVICES FOR PATIENTS WITH SEVERE CHRONIC DISEASES
76	75		Sec. 490.051. PATIENT ELIGIBILITY. A patient is eligible
77	76		to access and use an investigational drug, biological product, or
78	77		device under this chapter if:
79	78		(1) the patient has a severe chronic disease
80	79		designated by the executive commissioner under Section 490.002 and
81	80		attested to by the patient's treating physician;
82	81		(2) the use of the investigational drug, biological
83	82		product, or device is consistent with this chapter and rules
84	83		adopted under this chapter; and
85	84		(3) the patient's physician:
86	85		(A) in consultation with the patient, has
87	86		considered all other treatment options currently approved by the
88	87		United States Food and Drug Administration and determined that
89	88		those treatment options are unavailable or unlikely to provide
90	89		relief for the significant impairment or severe pain associated
91	90		with the patient's severe chronic disease; and
92	91		(B) has recommended or prescribed in writing that
93	92		the patient use a specific class of investigational drug,
94	93		biological product, or device.
95	94		Sec. 490.052. INFORMED CONSENT. (a) Before receiving an
96	95		investigational drug, biological product, or device, an eligible
97	96		patient must sign a written informed consent. If the patient is a
98	97		minor or lacks the mental capacity to provide informed consent, a
99	98		parent, guardian, or conservator may provide informed consent on
100	99		the patient's behalf.
101	100		(b) The executive commissioner by rule may adopt a form for
102	101		the informed consent required under this section.
103	102		Sec. 490.053. NO CAUSE OF ACTION CREATED. This chapter does
104	103		not create a private or state cause of action against a manufacturer
105	104		of an investigational drug, biological product, or device or
106	105		against any other person or entity involved in the care of an
107	106		eligible patient using the investigational drug, biological
108	107		product, or device for any harm done to the eligible patient
109	108		resulting from the investigational drug, biological product, or
110	109		device.
111	110		Sec. 490.054. STATE MAY NOT INTERFERE WITH ACCESS TO
112	111		INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE. An official,
113	112		employee, or agent of this state may not block or attempt to block
114	113		an eligible patient's access to an investigational drug, biological
115	114		product, or device under this chapter.
116	115		SUBCHAPTER C. HEALTH INSURANCE
117	116		Sec. 490.101. EFFECT ON HEALTH CARE COVERAGE FOR CLINICAL
118	117		TRIAL ENROLLEES. This chapter does not affect the coverage of
119	118		enrollees in clinical trials under Chapter 1379, Insurance Code.
120	119		SUBCHAPTER D. PHYSICIANS
121	120		Sec. 490.151. ACTION AGAINST PHYSICIAN'S LICENSE
122	121		PROHIBITED. Notwithstanding any other law, the Texas Medical Board
123	122		may not revoke, fail to renew, suspend, or take any action against
124	123		a physician's license under Subchapter B, Chapter 164, Occupations
125	124		Code, based solely on the physician's recommendations to an
126	125		eligible patient regarding access to or treatment with an
127	126		investigational drug, biological product, or device, provided that
128	127		the recommendations made to the patient meet the medical standard
129	128		of care.
130	129		SECTION 3. As soon as practicable after the effective date
131	130		of this Act, the executive commissioner of the Health and Human
132	131		Services Commission by rule shall designate the medical conditions
133	132		that are severe chronic diseases as required by Section 490.002,
134	133		Health and Safety Code, as added by this Act.
135	134		SECTION 4. This Act takes effect immediately if it receives
136	135		a vote of two-thirds of all the members elected to each house, as
137	136		provided by Section 39, Article III, Texas Constitution. If this
138	137		Act does not receive the vote necessary for immediate effect, this
139	138		Act takes effect September 1, 2017.