Rhode Island 2023 Regular Session

Rhode Island Senate Bill S0099 Compare Versions

Only one version of the bill is available at this time.

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5	5	2023 -- S 0099
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7	7	LC000312
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9	9	S TATE OF RHODE IS LAND
10	10	IN GENERAL ASSEMBLY
11	11	JANUARY SESSION, A.D. 2023
12	12	____________
13	13
14	14	A N A C T
15	15	RELATING TO FOOD AND DRUGS -- WHOLESALE PRESCRIPTION DRUG
16	16	IMPORTATION PROGRAM
17	17	Introduced By: Senators DiPalma, Miller, Pearson, DiMario, Valverde, and Goodwin
18	18	Date Introduced: February 01, 2023
19	19	Referred To: Senate Health & Human Services
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22	22	It is enacted by the General Assembly as follows:
23	23	SECTION 1. Title 21 of the General Laws entitled "FOOD AND DRUGS" is hereby 1
24	24	amended by adding thereto the following chapter: 2
25	25	CHAPTER 38 3
26	26	WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM 4
27	27	21-38-1. Authorization. 5
28	28	The wholesale prescription drug importation program, referred to in this chapter as the 6
29	29	("program,") is established to provide for the wholesale importation of prescription drugs from 7
30	30	Canada by or on behalf of the state. The program shall be designed in accordance with the 8
31	31	requirements of this chapter. The program may not be implemented unless the state obtains 9
32	32	approval and certification, pursuant to § 21-38-2(c), from the United States Department of Health 10
33	33	and Human Services. 11
34	34	21-38-2. Design of program. 12
35	35	(a) Design requirements. The executive office of health and human services, in consultation 13
36	36	with appropriate federal and other state agencies, other states and interested parties, shall design 14
37	37	the program to comply with the applicable requirements of 21 U.S.C. § 384, including requirements 15
38	38	regarding safety and cost savings. The program design shall: 16
39	39	(1) Designate a state agency to become a licensed drug wholesaler or to contract with a 17
40	40	licensed drug wholesaler in order to seek federal certification and approval, pursuant to § 21-38-18
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44	44	2(c), to import safe prescription drugs and provide cost savings to consumers in the state; 1
45	45	(2) Use prescription drug suppliers in Canada regulated under the laws of Canada or of one 2
46	46	or more Canadian provinces, or both; 3
47	47	(3) Ensure that only prescription drugs meeting the federal Food and Drug Administration's 4
48	48	safety, effectiveness and other standards are imported by or on behalf of the state; 5
49	49	(4) Import only those prescription drugs expected to generate substantial cost savings for 6
50	50	consumers in the state; 7
51	51	(5) Ensure that the program complies with the transaction and tracing requirements of 21 8
52	52	U.S.C. §§ 360eee and 360eee-1 to the extent feasible and practical prior to imported prescription 9
53	53	drugs coming into the possession of the licensed drug wholesaler and that the program complies 10
54	54	fully with those federal requirements after imported prescription drugs are in the possession of the 11
55	55	licensed drug wholesaler; 12
56	56	(6) Consider whether the program may be developed on a multistate basis through 13
57	57	collaboration with other states; 14
58	58	(7) Prohibit the distribution, dispensing or sale of imported prescription drugs outside of 15
59	59	the state; 16
60	60	(8) Recommend a charge per prescription or another method of financing to ensure that the 17
61	61	program is adequately funded in a manner that does not jeopardize significant cost savings to 18
62	62	consumers, including adequate funding for the initial start-up costs of the program; 19
63	63	(9) Apply for and receive funds, grants or contracts from public and private sources; and 20
64	64	(10) Include an audit function. 21
65	65	(b) Rules. The executive office of health and human services shall adopt and promulgate 22
66	66	rules and regulations to design the program in accordance with the requirements of subsection (a) 23
67	67	of this section no later than January 1, 2024. 24
68	68	(c) Request for federal approval and certification. The executive office of health and human 25
69	69	services shall submit a request for approval and certification of the program to the United States 26
70	70	Department of Health and Human Services no later than May 1, 2024. 27
71	71	21-38-3. Implementation. 28
72	72	(a) Implementation of operation. Upon receipt of federal approval and certification under 29
73	73	§ 21-38-2(c), the state agency designated to oversee the program pursuant to this chapter shall 30
74	74	implement the program as required in subsection (b) of this section. The program shall begin 31
75	75	operating no later than six (6) months following receipt of federal approval and certification. 32
76	76	(b) Requirements. Prior to operating the program, the state agency designated to oversee 33
77	77	the program pursuant to this chapter shall: 34
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81	81	(1) Become a licensed drug wholesaler or enter into a contract with a licensed drug 1
82	82	wholesaler in the state; 2
83	83	(2) Contract with one or more distributors licensed in the state; 3
84	84	(3) Contract with one or more licensed and regulated prescription drug suppliers in Canada; 4
85	85	(4) Consult with health insurance carriers, employers, pharmacies, pharmacists, health care 5
86	86	providers and consumers; 6
87	87	(5) Develop a registration process for health insurance carriers, pharmacies and health care 7
88	88	providers authorized to prescribe and administer prescription drugs that are willing to participate 8
89	89	in the program; 9
90	90	(6) Create a publicly accessible website for listing the prices of prescription drugs to be 10
91	91	imported under the program; 11
92	92	(7) Create an outreach and marketing plan to generate public awareness of the program; 12
93	93	(8) Provide a telephone hotline to answer questions and address needs of consumers, 13
94	94	employers, health insurance carriers, pharmacies, health care providers and others affected by the 14
95	95	program; 15
96	96	(9) Develop a two (2) year audit work plan; and 16
97	97	(10) Conduct any other activity determined necessary to successfully implement and 17
98	98	operate the program. 18
99	99	21-38-4. Annual reporting. 19
100	100	Beginning January 2025, and annually thereafter, the executive office of health and human 20
101	101	services, or other state agency designated to oversee the program pursuant to this chapter, shall 21
102	102	report to the speaker of the house and president of the senate regarding the implementation and 22
103	103	operation of the program during the previous calendar year, including: 23
104	104	(1) The prescription drugs included in the program; 24
105	105	(2) The number of participating pharmacies, health care providers and health insurance 25
106	106	carriers; 26
107	107	(3) The number of prescription drugs dispensed through the program; 27
108	108	(4) The estimated cost savings to consumers, health insurance carriers, employers and the 28
109	109	state during the previous calendar year and to date; 29
110	110	(5) Information regarding implementation of the audit work plan and audit findings; and 30
111	111	(6) Any other information the executive office of health and human services, or other state 31
112	112	agency designated to oversee the program pursuant to this chapter, considers relevant. 32
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116	116	SECTION 2. This act shall take effect upon passage. 1
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123	123	EXPLANATION
124	124	BY THE LEGISLATIVE COUNCIL
125	125	OF
126	126	A N A C T
127	127	RELATING TO FOOD AND DRUGS -- WHOLESALE PRESCRIPTION DRUG
128	128	IMPORTATION PROGRAM
129	129	***
130	130	This act would establish the Wholesale Prescription Drug Importation Program for the 1
131	131	importation of wholesale prescription drugs from Canada to provide savings to Rhode Island 2
132	132	consumers. The program would require the designation of a state agency to become a licensed drug 3
133	133	wholesaler, or to contract with a licensed drug wholesaler, use of prescription drug suppliers in 4
134	134	Canada; ensure that only drugs approved by the US Food and Drug Administration are imported; 5
135	135	and import only drugs expected to generate savings; and prohibit the distribution or sale of these 6
136	136	drugs outside of Rhode Island. 7
137	137	This act would take effect upon passage. 8
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