Georgia 2025-2026 Regular Session

Georgia Senate Bill SB72 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1		-	25 ~~SB 72/AP~~
	1	+	25 LC 52 0746S (SCS)
2	2		Senate Bill 72
3	3		By: Senators Brass of the 6th, Kirkpatrick of the 32nd, Dolezal of the 27th, Strickland of the
4	4		42nd, Walker III of the 20th and others
5		-	AS PASSED
	5	+	AS PASSED SENATE
6	6		A BILL TO BE ENTITLED
7	7		AN ACT
8	8		To amend Chapter 52 of Title 31 of the Official Code of Georgia Annotated, relating to
9	9		1
10	10		terminally ill patient's right to try investigational drugs, biological products, and devices, so2
11	11		as to expand access to individualized investigational treatments to patients who have 3
12	12		severely debilitating or life-threatening illnesses; to provide for definitions; to provide for4
13	13		eligibility criteria; to provide for written informed consent; to allow certain manufacturers5
14	14		or eligible facilities to make available individualized investigational treatments; to provide6
15	15		that coverage is not mandatory; to prohibit the sanctions against a physician's license; to7
16	16		provide exemption to liability for certain charges; to provide for statutory construction; to8
17	17		provide for related matters; to provide for a short title; to repeal conflicting laws; and for9
18	18		other purposes.10
19	19		BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:11
20	20		SECTION 1.12
21	21		This Act shall be known and may be cited as the "Hope for Georgia Patients Act."13
22	22		S. B. 72
23		-	- 1 - 25 ~~SB 72/AP~~
	23	+	- 1 - 25 LC 52 0746S (SCS)
24	24		SECTION 2.
25	25		14
26	26		Chapter 52 of Title 31 of the Official Code of Georgia Annotated, relating to terminally ill15
27	27		patient's right to try investigational drugs, biological products, and devices, is amended by16
28	28		designating Code Sections 31-52-1 through 31-52-10, the "Georgia Right to Try Act," as17
29	29		Article 1.18
30	30		SECTION 3.19
31	31		Said chapter is further amended by replacing "chapter" with "article" wherever the former20
32	32		appears in:21
33	33		(1) Code Section 31-52-1, relating to short title;22
34	34		(2) Code Section 31-52-4, relating to eligibility criteria; 23
35	35		(3) Code Section 31-52-6, relating to manufacturers permitted to make investigational24
36	36		drugs, biological products, or devices available;25
37	37		(4) Code Section 31-52-7, relating to coverage under health benefit plan permitted but not26
38	38		required;27
39	39		(5) Code Section 31-52-8, relating to physician immunity from sanction for28
40	40		recommending, prescribing, or treating with investigational drugs, biological products, or29
41	41		devices; and30
42	42		(6) Code Section 31-52-10, relating to statutory construction.31
43	43		SECTION 4.32
44	44		Said chapter is further amended by revising Code Section 31-52-3, relating to definitions, as33
45	45		follows:34
46	46		"31-52-3.35
47	47		As used in this chapter
48	48		article, the term:36
49	49		(1) 'Eligible patient' means a person who meets the requirements of Code37
50	50		Section 31-52-4.38
51	51		S. B. 72
52		-	- 2 - 25 ~~SB 72/AP~~
	52	+	- 2 - 25 LC 52 0746S (SCS)
53	53		(2) 'Investigational drug, biological product, or device' means a drug, biological product,
54	54		39
55	55		or device which has successfully completed Phase I of a federal Food and Drug40
56	56		Administration approved clinical trial but has not yet been approved for general use by41
57	57		the federal Food and Drug Administration and currently remains under investigation in42
58	58		a federal Food and Drug Administration approved clinical trial.43
59	59		(3) 'Physician' means a person licensed to practice medicine pursuant to Article 2 of44
60	60		Chapter 34 of Title 43.45
61	61		(4) 'Terminal illness' means a disease that, without life-sustaining procedures, will result46
62	62		in death in the near future and is not considered by a treating physician to be reversible47
63	63		even with administration of current federal Food and Drug Administration approved and48
64	64		available treatments.49
65	65		(5) 'Written informed consent' means a written document that:50
66	66		(A) Is signed by the patient; parent, if the patient is a minor; legal guardian; or health
67	67		51
68	68		care healthcare agent designated by the patient in an advance directive for health care52
69	69		healthcare executed pursuant to Chapter 32 of Title 31 this title;53
70	70		(B) Is attested to by the patient's physician and a witness; and54
71	71		(C) Meets the requirements of Code Section 31-52-5."55
72	72		SECTION 5.56
73	73		Said chapter is further amended by adding a new article to read as follows:57
74	74		"ARTICLE 258
75	75		31-52-20.59
76	76		As used in this article, the term:60
77	77		(1) 'Eligible facility' means an institution that is currently operating under the61
78	78		Federalwide Assurance for the Protection of Human Subjects under 42 U.S.C.62
79	79		S. B. 72
80		-	- 3 - 25 ~~SB 72/AP~~
	80	+	- 3 - 25 LC 52 0746S (SCS)
81	81		Section 289(a) and 45 C.F.R. Part 46 and is subject to federal laws, regulations, policies,63
82	82		and guidelines, including renewals and updates.64
83	83		(2) 'Eligible patient' means a person who meets the requirements of Code65
84	84		Section 31-52-21.66
85	85		(3) 'Individualized investigational treatment' means a drug, biological product, or device67
86	86		that is unique to and produced exclusively for an individual patient based on his or her68
87	87		own genetic profile. Such term includes, but is not limited to, individualized gene69
88	88		therapy, individualized investigational antisense oligonucleotides, and individualized70
89	89		neoantigen vaccines or individualized neoantigen therapy. Such term includes any drug,71
90	90		biological product, or device derived from human perinatal tissues, cells, and secreted72
91	91		factors, provided that such substances are not obtained from an abortion. Such term does73
92	92		not include any drug, biological product, or device derived from human primary or74
93	93		secondary embryonic stem cells or cell lines.75
94	94		(4) 'Life-threatening illness' means a disease or condition where the likelihood of death76
95	95		is high unless the course of the disease is interrupted or a disease or condition with a77
96	96		potentially fatal outcome, where the end point of clinical trial analysis is survival. Such78
97	97		term shall not include the natural process of aging.79
98	98		(5) 'Manufacturer' means a person or entity engaged in the manufacturing of80
99	99		individualized investigational treatments in an eligible facility.81
100	100		(6) 'Physician' means a person licensed to practice medicine pursuant to Article 2 of82
101	101		Chapter 34 of Title 43.83
102	102		(7) 'Severely debilitating illness' means a disease or condition that causes major84
103	103		irreversible morbidity.85
104	104		(8) 'Written informed consent' means a written document that:86
105	105		(A) Is signed by the patient; parent, if the patient is a minor; legal guardian; or87
106	106		healthcare agent designated by the patient in an advance directive for healthcare88
107	107		executed pursuant to Chapter 32 of this title;89
108	108		S. B. 72
109		-	- 4 - 25 ~~SB 72/AP~~
	109	+	- 4 - 25 LC 52 0746S (SCS)
110	110		(B) Is attested to by the patient's physician and a witness; and90
111	111		(C) Meets the requirements of Code Section 31-52-22.91
112	112		31-52-21.92
113	113		In order for a person to be considered an eligible patient to access an individualized93
114	114		investigational treatment pursuant to this article, a physician must document in writing that94
115	115		the person:95
116	116		(1) Has a life-threatening or severely debilitating illness;96
117	117		(2) Has, in consultation with the physician, considered all other treatment options97
118	118		currently approved by the United States Food and Drug Administration;98
119	119		(3) Has been given a recommendation by the physician for an individualized99
120	120		investigational treatment based on an analysis of such patient's genomic sequence, human100
121	121		chromosomes, deoxyribonucleic acid, ribonucleic acid, genes, gene products such as101
122	122		enzymes and other types of proteins, or metabolites; and102
123	123		(4) Has given written informed consent for the use of the individualized investigational103
124	124		treatment.104
125	125		31-52-22.105
126	126		Written informed consent shall, at a minimum, include the following:106
127	127		(1) A description of the currently approved products and treatments for the 107
128	128		life-threatening or severely debilitating illness from which the patient suffers;108
129	129		(2) An attestation that the patient concurs with his or her physician in believing that all109
130	130		currently approved and conventionally recognized treatments are unlikely to prolong the110
131	131		patient's life, and the known risks of the individualized investigational treatment are not111
132	132		greater than the probable outcome of the patient's illness;112
133	133		(3) Clear identification of the specific proposed individualized investigational treatment113
134	134		that the patient is seeking to use;114
135	135		S. B. 72
136		-	- 5 - 25 ~~SB 72/AP~~
	136	+	- 5 - 25 LC 52 0746S (SCS)
137	137		(4) A description of the potential best and worst outcomes of using the individualized115
138	138		investigational treatment and a realistic description of the most likely outcome. The116
139	139		description shall include the possibility that new, unanticipated, different, or worse117
140	140		symptoms might result and that death could be hastened by the proposed treatment. The118
141	141		description shall be based on the physician's knowledge of the proposed treatment in119
142	142		conjunction with an awareness of the patient's condition;120
143	143		(5) A statement that the patient understands that his or her health benefit plan or121
144	144		third-party administrator is not obligated to pay for the individualized investigational122
145	145		treatment, or any care or treatment consequent to the use of such treatment, unless such123
146	146		health benefit plan or third-party administrator is specifically required to do so by law or124
147	147		contract;125
148	148		(6) A statement that the patient understands that his or her eligibility for hospice care126
149	149		may be withdrawn if he or she begins treatment with the individualized investigational127
150	150		treatment but that such hospice care may be reinstated if such treatment ends and he or128
151	151		she meets hospice eligibility requirements; and129
152	152		(7) A statement that the patient understands that he or she is liable for all expenses130
153	153		consequent to the use of the individualized investigational treatment and that such131
154	154		liability extends to the patient's estate, unless a contract between the patient and the132
155	155		manufacturer of the individualized investigational treatment states otherwise, except as133
156	156		provided for in Code Section 31-52-27.134
157	157		31-52-23.135
158	158		(a) A manufacturer or an eligible entity may make available an individualized136
159	159		investigational treatment to an eligible patient, and an eligible patient may request such137
160	160		treatment from such manufacturer or facility pursuant to this article; provided, however,138
161	161		that nothing in this article shall be construed to require that such manufacturer or facility139
162	162		make available such treatment to such patient.140
163	163		S. B. 72
164		-	- 6 - 25 ~~SB 72/AP~~
	164	+	- 6 - 25 LC 52 0746S (SCS)
165	165		(b) A manufacturer or an eligible facility may provide an individualized investigational141
166	166		treatment to an eligible patient:142
167	167		(1) Without receiving compensation; or143
168	168		(2) With the requirement that the eligible patient pays the costs of or the costs associated144
169	169		with the manufacture of the individualized investigational treatment.145
170	170		31-52-24.146
171	171		(a) A health benefit plan or governmental agency may provide coverage for the cost of any147
172	172		individualized investigational treatment pursuant to this article; provided, however, that148
173	173		nothing in this article shall be construed to require a health benefit plan or governmental149
174	174		agency to provide coverage for the cost of any individualized investigational treatment or150
175	175		related cost of services associated with the use, care, or treatment of an eligible patient151
176	176		associated with such individualized investigational treatment pursuant to this article.152
177	177		(b) A hospital or other healthcare facility is not required to provide new or additional153
178	178		services associated with any individualized investigational treatment unless approved by154
179	179		such hospital or facility.155
180	180		31-52-25.156
181	181		(a) The Georgia Composite Medical Board shall not revoke, suspend, sanction, fail to157
182	182		renew, or take any other action against a physician's license solely based on such158
183	183		physician's recommendation, prescription, or treatment of an eligible patient with an159
184	184		individualized investigational treatment pursuant to this article.160
185	185		(b) The Department of Community Health shall not take action against a healthcare161
186	186		provider's Medicare certification based solely on such provider's recommendation that an162
187	187		eligible patient have access to an individualized investigational treatment.163
188	188		S. B. 72
189		-	- 7 - 25 ~~SB 72/AP~~
	189	+	- 7 - 25 LC 52 0746S (SCS)
190	190		31-52-26.164
191	191		No official, employee, or agent of the state shall block or attempt to block an eligible165
192	192		patient's access to an individualized investigational treatment. Counseling, advice, or a166
193	193		recommendation for treatment consistent with medical standards of care shall not be167
194	194		construed as a violation of this Code section.168
195	195		31-52-27.169
196	196		(a) This article shall not be construed to create a private cause of action against a170
197	197		manufacturer, eligible facility, or any other person or entity involved in the care of an171
198	198		eligible patient using any individualized investigational treatment for any harm done to172
199	199		such patient resulting from the individualized investigational treatment if such173
200	200		manufacturer, facility, person, or entity complied in good faith with the terms of this article174
201	201		and exercised reasonable care.175
202	202		(b) This article shall not be construed to create a private cause of action against a physician176
203	203		who refuses to recommend an individualized investigational treatment for any otherwise177
204	204		eligible patient.178
205	205		(c) Any person or entity involved in the care of an eligible patient using an individualized179
206	206		investigational treatment shall not be liable for injury or death to such patient as a result of180
207	207		such treatment under Code Section 51-1-27 or Chapter 4 of Title 51, unless it is shown that181
208	208		the person or entity failed to obtain written informed consent in compliance with Code182
209	209		Section 31-52-22.183
210	210		(d) This article shall not be construed to affect any required healthcare coverage under184
211	211		Title 33 for patients in clinical trials.185
212	212		(e) If an eligible patient's death is proximately caused by an individualized investigational186
213	213		treatment, such patient's estate, heirs, or devisees are not liable for any debt remaining after187
214	214		payment by insurance for charges directly incurred for such treatment; provided, however,188
215	215		that this subsection does not provide an exemption to liability for charges for189
216	216		S. B. 72
217		-	- 8 - 25 ~~SB 72/AP~~
	217	+	- 8 - 25 LC 52 0746S (SCS)
218	218		nonexperimental treatments provided to the patient, including nonexperimental treatments190
219	219		rendered to the patient due to complications or consequences of the individualized191
220	220		investigational treatment."192
221	221		SECTION 6.193
222	222		All laws and parts of laws in conflict with this Act are repealed.194
223	223		S. B. 72
224	224		- 9 -