103RD GENERAL ASSEMBLY
State of Illinois
2023 and 2024
HB4525

 

Introduced 1/31/2024, 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

 

HB4525LRB103 36423 RPS 66525 b

1    AN ACT concerning health.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 1. Short title. This Act may be cited as the
5Wholesale Prescription Drug Importation Program Act.
 
6    Section 5. Definitions. As used in this Act:
7    "Canadian supplier" means a manufacturer, wholesale
8distributor, or pharmacy that is appropriately licensed or
9permitted under Canadian federal or provincial laws and rules
10to 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
14licensed as a wholesale drug distributor under the Wholesale
15Drug Distribution Licensing Act, that contracts with this
16State to import prescription drugs under the program.
17    "Program" means the Wholesale Prescription Drug
18Importation Program.
 
19    Section 10. Wholesale Prescription Drug Importation
20Program.
21    (a) The Department shall establish the Wholesale
22Prescription Drug Importation Program to provide lower cost

 

 

HB4525- 2 -LRB103 36423 RPS 66525 b

1prescription drugs available outside of the United States to
2consumers 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- 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
5requirements of 21 U.S.C. 384.
6    (d) In developing the program, the Department may consult
7with interested parties.
 
8    Section 15. Eligible prescription drugs. A prescription
9drug may be imported into this State under the program only if
10the 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- 4 -LRB103 36423 RPS 66525 b

1    Section 20. Program expansion. In its discretion, the
2Department may by rule expand the Program to import
3prescription drugs from any other country that is allowed
4under federal law to import prescription drugs into the United
5States.
 
6    Section 25. Anticompetitive behavior monitoring. The
7Department, in consultation with the Attorney General, shall
8identify and monitor any potential anticompetitive activities
9in industries affected by the program.
 
10    Section 30. Program funding. In addition to money
11appropriated by the General Assembly, the Department may
12impose a fee on each prescription drug sold under the program
13or establish another funding method to administer the program.
 
14    Section 35. Audit procedures. The Director, by rule, shall
15develop procedures to effectively audit a prescription drug
16wholesaler participating in the program.
 
17    Section 40. Annual reporting. Not later than December 1,
182025, and each December 1 thereafter, the Department shall
19submit a report to the Governor and the General Assembly
20regarding the operation of the program during the preceding
21State fiscal year, including:

 

 

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
18effective date of this Act, the Director shall adopt any rules
19necessary to implement this Act.
 
20    Section 50. Federal waiver or authorization. If, before
21implementing any provision of this Act, a State agency
22determines that a waiver or authorization from a federal
23agency is necessary for implementation of that provision, the
24agency affected by the provision shall request the waiver or

 

 

HB4525- 6 -LRB103 36423 RPS 66525 b

1authorization and may delay implementing that provision until
2the waiver or authorization is granted.
 
3    Section 99. Effective date. This Act takes effect July 1,
42024.