103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB4525 Introduced , by Rep. Maurice A. West, II SYNOPSIS AS INTRODUCED: New Act Creates the Wholesale Prescription Drug Importation Program Act. Requires the Department of Public Health to establish the Wholesale Prescription Drug Importation Program. Provides that the Department shall implement the program by: contracting with one or more prescription drug wholesalers and Canadian suppliers to import prescription drugs and provide prescription drug cost savings to consumers in this State; developing a registration process for health benefit plan issuers, health care providers, and pharmacies to obtain and dispense prescription drugs imported under the program; developing a list of prescription drugs, including the prices of those drugs, that meet certain requirements set forth under the Act and publishing the list on the Department's website; establishing an outreach and marketing plan to generate program awareness; ensuring the program and the prescription drug wholesalers that contract with this State comply with certain federal tracking, tracing, verification, and identification requirements; and other actions. Sets forth eligibility criteria for prescription drugs that may be imported into the State under the program. Contains provisions concerning anticompetitive behavior monitoring; program funding; program expansion; audit procedures; annual reporting requirements; the adoption of rules to implement the Act; and federal waiver or authorization requirements. Effective July 1, 2024. LRB103 36423 RPS 66525 b A BILL FOR 103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB4525 Introduced , by Rep. Maurice A. West, II SYNOPSIS AS INTRODUCED: New Act New Act Creates the Wholesale Prescription Drug Importation Program Act. Requires the Department of Public Health to establish the Wholesale Prescription Drug Importation Program. Provides that the Department shall implement the program by: contracting with one or more prescription drug wholesalers and Canadian suppliers to import prescription drugs and provide prescription drug cost savings to consumers in this State; developing a registration process for health benefit plan issuers, health care providers, and pharmacies to obtain and dispense prescription drugs imported under the program; developing a list of prescription drugs, including the prices of those drugs, that meet certain requirements set forth under the Act and publishing the list on the Department's website; establishing an outreach and marketing plan to generate program awareness; ensuring the program and the prescription drug wholesalers that contract with this State comply with certain federal tracking, tracing, verification, and identification requirements; and other actions. Sets forth eligibility criteria for prescription drugs that may be imported into the State under the program. Contains provisions concerning anticompetitive behavior monitoring; program funding; program expansion; audit procedures; annual reporting requirements; the adoption of rules to implement the Act; and federal waiver or authorization requirements. Effective July 1, 2024. LRB103 36423 RPS 66525 b LRB103 36423 RPS 66525 b A BILL FOR
103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB4525 Introduced , by Rep. Maurice A. West, II SYNOPSIS AS INTRODUCED:
New Act New Act
New Act
Creates the Wholesale Prescription Drug Importation Program Act. Requires the Department of Public Health to establish the Wholesale Prescription Drug Importation Program. Provides that the Department shall implement the program by: contracting with one or more prescription drug wholesalers and Canadian suppliers to import prescription drugs and provide prescription drug cost savings to consumers in this State; developing a registration process for health benefit plan issuers, health care providers, and pharmacies to obtain and dispense prescription drugs imported under the program; developing a list of prescription drugs, including the prices of those drugs, that meet certain requirements set forth under the Act and publishing the list on the Department's website; establishing an outreach and marketing plan to generate program awareness; ensuring the program and the prescription drug wholesalers that contract with this State comply with certain federal tracking, tracing, verification, and identification requirements; and other actions. Sets forth eligibility criteria for prescription drugs that may be imported into the State under the program. Contains provisions concerning anticompetitive behavior monitoring; program funding; program expansion; audit procedures; annual reporting requirements; the adoption of rules to implement the Act; and federal waiver or authorization requirements. Effective July 1, 2024.
LRB103 36423 RPS 66525 b LRB103 36423 RPS 66525 b
LRB103 36423 RPS 66525 b
A BILL FOR
HB4525LRB103 36423 RPS 66525 b HB4525 LRB103 36423 RPS 66525 b
HB4525 LRB103 36423 RPS 66525 b
1 AN ACT concerning health.
2 Be it enacted by the People of the State of Illinois,
3 represented in the General Assembly:
4 Section 1. Short title. This Act may be cited as the
5 Wholesale Prescription Drug Importation Program Act.
6 Section 5. Definitions. As used in this Act:
7 "Canadian supplier" means a manufacturer, wholesale
8 distributor, or pharmacy that is appropriately licensed or
9 permitted under Canadian federal or provincial laws and rules
10 to manufacture, distribute, or dispense prescription drugs.
11 "Department" means the Department of Public Health.
12 "Director" means the Director of Public Health.
13 "Prescription drug wholesaler" means a person or entity
14 licensed as a wholesale drug distributor under the Wholesale
15 Drug Distribution Licensing Act, that contracts with this
16 State to import prescription drugs under the program.
17 "Program" means the Wholesale Prescription Drug
18 Importation Program.
19 Section 10. Wholesale Prescription Drug Importation
20 Program.
21 (a) The Department shall establish the Wholesale
22 Prescription Drug Importation Program to provide lower cost
103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB4525 Introduced , by Rep. Maurice A. West, II SYNOPSIS AS INTRODUCED:
New Act New Act
New Act
Creates the Wholesale Prescription Drug Importation Program Act. Requires the Department of Public Health to establish the Wholesale Prescription Drug Importation Program. Provides that the Department shall implement the program by: contracting with one or more prescription drug wholesalers and Canadian suppliers to import prescription drugs and provide prescription drug cost savings to consumers in this State; developing a registration process for health benefit plan issuers, health care providers, and pharmacies to obtain and dispense prescription drugs imported under the program; developing a list of prescription drugs, including the prices of those drugs, that meet certain requirements set forth under the Act and publishing the list on the Department's website; establishing an outreach and marketing plan to generate program awareness; ensuring the program and the prescription drug wholesalers that contract with this State comply with certain federal tracking, tracing, verification, and identification requirements; and other actions. Sets forth eligibility criteria for prescription drugs that may be imported into the State under the program. Contains provisions concerning anticompetitive behavior monitoring; program funding; program expansion; audit procedures; annual reporting requirements; the adoption of rules to implement the Act; and federal waiver or authorization requirements. Effective July 1, 2024.
LRB103 36423 RPS 66525 b LRB103 36423 RPS 66525 b
LRB103 36423 RPS 66525 b
A BILL FOR
New Act
LRB103 36423 RPS 66525 b
HB4525 LRB103 36423 RPS 66525 b
HB4525- 2 -LRB103 36423 RPS 66525 b HB4525 - 2 - LRB103 36423 RPS 66525 b
HB4525 - 2 - LRB103 36423 RPS 66525 b
1 prescription drugs available outside of the United States to
2 consumers in this State at the lower cost.
3 (b) The Department shall implement the program by:
4 (1) contracting with one or more prescription drug
5 wholesalers and Canadian suppliers to import prescription
6 drugs and provide prescription drug cost savings to
7 consumers in this State;
8 (2) developing a registration process for health
9 benefit plan issuers, health care providers, and
10 pharmacies to obtain and dispense prescription drugs
11 imported under the program;
12 (3) developing a list of prescription drugs, including
13 the prices of those drugs, that meet the requirements of
14 Section 15 and publishing the list on the Department's
15 website;
16 (4) establishing an outreach and marketing plan to
17 generate program awareness;
18 (5) establishing and administering a telephone call
19 center or electronic portal to provide information about
20 the program;
21 (6) ensuring the program and the prescription drug
22 wholesalers that contract with this State under paragraph
23 (1) comply with the tracking, tracing, verification, and
24 identification requirements of 21 U.S.C. 360eee-1;
25 (7) prohibiting the distribution, dispensing, or sale
26 of prescription drugs imported under this Act outside the
HB4525 - 2 - LRB103 36423 RPS 66525 b
HB4525- 3 -LRB103 36423 RPS 66525 b HB4525 - 3 - LRB103 36423 RPS 66525 b
HB4525 - 3 - LRB103 36423 RPS 66525 b
1 boundaries of this State; and
2 (8) performing any other duties the Director
3 determines necessary to implement the program.
4 (c) The Department shall ensure that the program meets the
5 requirements of 21 U.S.C. 384.
6 (d) In developing the program, the Department may consult
7 with interested parties.
8 Section 15. Eligible prescription drugs. A prescription
9 drug may be imported into this State under the program only if
10 the drug:
11 (1) meets the United States Food and Drug
12 Administration's standards related to prescription drug
13 safety, effectiveness, misbranding, and adulteration;
14 (2) does not violate any federal patent laws through
15 its importation;
16 (3) is expected to generate cost savings for
17 consumers; and
18 (4) is not:
19 (A) listed as a controlled substance under State
20 or federal law;
21 (B) a biological product;
22 (C) an infused drug;
23 (D) an intravenously injected drug;
24 (E) a drug that is inhaled during surgery; or
25 (F) a parenteral drug.
HB4525 - 3 - LRB103 36423 RPS 66525 b
HB4525- 4 -LRB103 36423 RPS 66525 b HB4525 - 4 - LRB103 36423 RPS 66525 b
HB4525 - 4 - LRB103 36423 RPS 66525 b
1 Section 20. Program expansion. In its discretion, the
2 Department may by rule expand the Program to import
3 prescription drugs from any other country that is allowed
4 under federal law to import prescription drugs into the United
5 States.
6 Section 25. Anticompetitive behavior monitoring. The
7 Department, in consultation with the Attorney General, shall
8 identify and monitor any potential anticompetitive activities
9 in industries affected by the program.
10 Section 30. Program funding. In addition to money
11 appropriated by the General Assembly, the Department may
12 impose a fee on each prescription drug sold under the program
13 or establish another funding method to administer the program.
14 Section 35. Audit procedures. The Director, by rule, shall
15 develop procedures to effectively audit a prescription drug
16 wholesaler participating in the program.
17 Section 40. Annual reporting. Not later than December 1,
18 2025, and each December 1 thereafter, the Department shall
19 submit a report to the Governor and the General Assembly
20 regarding the operation of the program during the preceding
21 State fiscal year, including:
HB4525 - 4 - LRB103 36423 RPS 66525 b
HB4525- 5 -LRB103 36423 RPS 66525 b HB4525 - 5 - LRB103 36423 RPS 66525 b
HB4525 - 5 - LRB103 36423 RPS 66525 b
1 (1) which prescription drugs and Canadian suppliers
2 are included in the program;
3 (2) the number of health benefit plan issuers, health
4 care providers, and pharmacies participating in the
5 program;
6 (3) the number of prescriptions dispensed through the
7 program;
8 (4) the estimated cost savings to consumers, health
9 plans, employers, and this State since the establishment
10 of the program and during the preceding State fiscal year;
11 (5) information regarding the implementation of the
12 audit procedures under Section 35; and
13 (6) any other information:
14 (A) the Governor or the General Assembly requests;
15 or
16 (B) the Department considers necessary.
17 Section 45. Rules. As soon as practicable after the
18 effective date of this Act, the Director shall adopt any rules
19 necessary to implement this Act.
20 Section 50. Federal waiver or authorization. If, before
21 implementing any provision of this Act, a State agency
22 determines that a waiver or authorization from a federal
23 agency is necessary for implementation of that provision, the
24 agency affected by the provision shall request the waiver or
HB4525 - 5 - LRB103 36423 RPS 66525 b
HB4525- 6 -LRB103 36423 RPS 66525 b HB4525 - 6 - LRB103 36423 RPS 66525 b
HB4525 - 6 - LRB103 36423 RPS 66525 b
1 authorization and may delay implementing that provision until
2 the waiver or authorization is granted.
HB4525 - 6 - LRB103 36423 RPS 66525 b