Texas 2019 - 86th Regular

Texas House Bill HB805 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1		-	~~86R19298~~ KKR-F
	1	+	86R4635 KKR-F
2	2		By: Parker H.B. No. 805
3		-	Substitute the following for H.B. No. 805:
4		-	By: Sheffield C.S.H.B. No. 805
5	3
6	4
7	5		A BILL TO BE ENTITLED
8	6		AN ACT
9	7		relating to access to certain investigational drugs, biological
10	8		products, and devices that are in clinical trials by patients with
11	9		severe chronic diseases.
12	10		BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
13	11		SECTION 1. (a) This Act shall be known as the "Medical
14	12		Freedom Act."
15	13		(b) The legislature finds that:
16	14		(1) the Right To Try Act, as added by Chapter 502 (H.B.
17	15		21), Acts of the 84th Legislature, Regular Session, 2015, has had
18	16		tremendous success in saving the lives of many patients with a
19	17		terminal illness;
20	18		(2) the process for approving the use of
21	19		investigational drugs, biological products, and devices by
22	20		patients without a terminal illness who need access to the drugs,
23	21		products, or devices continues to take many years in the United
24	22		States;
25	23		(3) patients who are battling a severe chronic disease
26	24		that is debilitating or causes severe pain do not have the luxury of
27	25		waiting until an investigational drug, biological product, or
28	26		device receives final approval from the United States Food and Drug
29	27		Administration;
30	28		(4) the standards of the United States Food and Drug
31	29		Administration for the use of investigational drugs, biological
32	30		products, and devices may deny the benefits of potentially
33	31		life-altering treatment to patients with a severe chronic disease;
34	32		(5) patients with a severe chronic disease have a
35	33		fundamental right to attempt to pursue the preservation of their
36	34		state of life by accessing available investigational drugs,
37	35		biological products, and devices;
38	36		(6) the use of available investigational drugs,
39	37		biological products, and devices is a decision that should be made
40	38		by a patient with a severe chronic disease in consultation with the
41	39		patient's physician and is not a decision to be made by the
42	40		government; and
43	41		(7) the decision to use an investigational drug,
44	42		biological product, or device should be made with full awareness of
45	43		the potential risks, benefits, and consequences to a patient with a
46	44		severe chronic disease and the patient's family.
47	45		(c) It is the intent of the legislature to allow patients
48	46		with a severe chronic disease to use potentially life-altering
49	47		investigational drugs, biological products, and devices.
50	48		SECTION 2. Subtitle C, Title 6, Health and Safety Code, is
51	49		amended by adding Chapter 490 to read as follows:
52	50		CHAPTER 490. ACCESS TO INVESTIGATIONAL TREATMENTS FOR PATIENTS
53	51		WITH SEVERE CHRONIC DISEASES
54	52		SUBCHAPTER A. GENERAL PROVISIONS
55	53		Sec. 490.001. DEFINITIONS. In this chapter:
56		-	(1) "Commissioner" means the commissioner of state
57		-	health services.
58		-	(2) "Executive commissioner" means the executive
	54	+	(1) "Executive commissioner" means the executive
59	55		commissioner of the Health and Human Services Commission.
60		-	(3) "Investigational drug, biological product, or
	56	+	(2) "Investigational drug, biological product, or
61	57		device" means a drug, biological product, or device that has
62	58		successfully completed phase one of a clinical trial but has not yet
63	59		been approved for general use by the United States Food and Drug
64	60		Administration or its international equivalent and remains under
65		-	investigation in the clinical trial. The term does not include
66		-	low-THC cannabis, as defined by Section 169.001, Occupations Code,
67		-	or a product containing marihuana, as defined by Section 481.002,
68		-	regardless of whether the cannabis or product has successfully
69		-	completed phase one of a clinical trial.
70		-	(4) "Severe chronic disease" means a condition,
	61	+	investigation in the clinical trial.
	62	+	(3) "Severe chronic disease" means a condition,
71	63		injury, or illness that:
72		-	(A) ~~may be treated~~;
73		-	(B) ~~may not be cured or eliminated~~; and
	64	+	(A) lasts for at least one year;
	65	+	(B) requires ongoing medical attention; and
74	66		(C) entails significant functional impairment or
75		-	severe pain.
	67	+	severe pain that limits a person's activities of daily life.
76	68		Sec. 490.002. DESIGNATION OF SEVERE CHRONIC DISEASES. The
77		-	commissioner shall designate the medical conditions considered to
78		-	be severe chronic diseases under this chapter.
79		-	Sec. 490.003. RULES. The executive commissioner shall
80		-	adopt rules necessary to administer this chapter.
	69	+	executive commissioner by rule shall designate the medical
	70	+	conditions that are considered severe chronic diseases under this
	71	+	chapter.
81	72		SUBCHAPTER B. ACCESS TO INVESTIGATIONAL DRUGS, BIOLOGICAL
82	73		PRODUCTS, AND DEVICES FOR PATIENTS WITH SEVERE CHRONIC DISEASES
83	74		Sec. 490.051. PATIENT ELIGIBILITY. A patient is eligible
84	75		to access and use an investigational drug, biological product, or
85	76		device under this chapter if:
86	77		(1) the patient has a severe chronic disease
87		-	designated by the commissioner under Section 490.002 and ~~attested~~
88		-	to by the patient's treating physician;
	78	+	designated by the executive commissioner under Section 490.002 and
	79	+	attested to by the patient's treating physician;
89	80		(2) the use of the investigational drug, biological
90	81		product, or device is consistent with this chapter and rules
91	82		adopted under this chapter; and
92	83		(3) the patient's physician:
93		-	(A) in consultation with the patient, ~~considers~~
94		-	all other treatment options currently approved by the ~~United States~~
95		-	Food and Drug Administration and ~~determines those treatment options~~
96		-	are unavailable or unlikely to provide ~~relief for the significant~~
97		-	impairment or severe pain associated ~~with the patient's severe~~
98		-	chronic disease; and
99		-	(B) ~~recommends~~ or ~~prescribes~~ in writing ~~the~~
100		-	patient's use of a specific class of investigational drug,
	84	+	(A) in consultation with the patient, has
	85	+	considered all other treatment options currently approved by the
	86	+	United States Food and Drug Administration and determined that
	87	+	those treatment options are unavailable or unlikely to provide
	88	+	relief for the significant impairment or severe pain associated
	89	+	with the patient's severe chronic disease; and
	90	+	(B) has recommended or prescribed in writing that
	91	+	the patient use a specific class of investigational drug,
101	92		biological product, or device.
102	93		Sec. 490.052. INFORMED CONSENT. (a) Before receiving an
103	94		investigational drug, biological product, or device, an eligible
104	95		patient must sign a written informed consent. If the patient is a
105	96		minor or lacks the mental capacity to provide informed consent, a
106	97		parent, guardian, or conservator may provide informed consent on
107	98		the patient's behalf.
108		-	(b) The commissioner may ~~prescribe~~ a form for ~~the informed~~
109		-	consent required under this section.
	99	+	(b) The executive commissioner by rule may adopt a form for
	100	+	the informed consent required under this section.
110	101		Sec. 490.053. NO CAUSE OF ACTION CREATED. This chapter does
111	102		not create a private or state cause of action against a manufacturer
112	103		of an investigational drug, biological product, or device or
113	104		against any other person or entity involved in the care of an
114	105		eligible patient using the investigational drug, biological
115		-	product, or device for any harm to the eligible patient resulting
116		-	from the investigational drug, biological product, or device.
	106	+	product, or device for any harm done to the eligible patient
	107	+	resulting from the investigational drug, biological product, or
	108	+	device.
117	109		Sec. 490.054. STATE MAY NOT INTERFERE WITH ACCESS TO
118	110		INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT, OR DEVICE. An official,
119	111		employee, or agent of this state may not block or attempt to block
120	112		an eligible patient's access to an investigational drug, biological
121		-	product, or device under this chapter unless the drug, biological
122		-	product, or device is considered adulterated or misbranded under
123		-	Chapter 431. For purposes of this section, a governmental entity
124		-	may not consider the drug, biological product, or device to be
125		-	adulterated or misbranded solely on the basis that the United
126		-	States Food and Drug Administration has not approved the drug,
127		-	biological product, or device.
	113	+	product, or device under this chapter.
128	114		SUBCHAPTER C. HEALTH INSURANCE
129	115		Sec. 490.101. EFFECT ON HEALTH CARE COVERAGE FOR CLINICAL
130	116		TRIAL ENROLLEES. This chapter does not affect the coverage of
131	117		enrollees in clinical trials under Chapter 1379, Insurance Code.
132	118		SUBCHAPTER D. PHYSICIANS
133	119		Sec. 490.151. ACTION AGAINST PHYSICIAN'S LICENSE
134	120		PROHIBITED. Notwithstanding any other law, the Texas Medical Board
135	121		may not revoke, fail to renew, suspend, or take any action against
136	122		a physician's license under Subchapter B, Chapter 164, Occupations
137	123		Code, based solely on the physician's recommendations to an
138	124		eligible patient regarding access to or treatment with an
139	125		investigational drug, biological product, or device, provided that
140		-	the recommendations meet the medical standard of care and the
141		-	requirements of this chapter.
142		-	SECTION 3. (a) As soon as practicable after the effective
143		-	date of this Act, the commissioner of state health services shall
144		-	designate the medical conditions considered to be severe chronic
145		-	diseases as required by Section 490.002, Health and Safety Code, as
146		-	added by this Act.
147		-	(b) As soon as practicable after the effective date of this
148		-	Act, the executive commissioner of the Health and Human Services
149		-	Commission shall adopt the rules required by Section 490.003,
	126	+	the recommendations made to the patient meet the medical standard
	127	+	of care and the requirements of this chapter.
	128	+	SECTION 3. As soon as practicable after the effective date
	129	+	of this Act, the executive commissioner of the Health and Human
	130	+	Services Commission by rule shall designate the medical conditions
	131	+	that are severe chronic diseases as required by Section 490.002,
150	132		Health and Safety Code, as added by this Act. The executive
151		-	commissioner may adopt initial rules in the manner provided by ~~law~~
152		-	for emergency rules.
	133	+	commissioner may adopt the initial rules in the manner provided by
	134	+	law for emergency rules.
153	135		SECTION 4. This Act takes effect immediately if it receives
154	136		a vote of two-thirds of all the members elected to each house, as
155	137		provided by Section 39, Article III, Texas Constitution. If this
156	138		Act does not receive the vote necessary for immediate effect, this
157	139		Act takes effect September 1, 2019.