103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB3310 Introduced , by Rep. Joe C. Sosnowski SYNOPSIS AS INTRODUCED: New Act Creates the Canadian Prescription Drug Importation Act. Provides that the Department of Public Health shall establish the Canadian Prescription Drug Importation Program for the importation of safe and effective prescription drugs from Canada which have the highest potential for cost savings to the State. Provides that the Department shall contract with a vendor to provide services under the program. Provides that on or before December 1, 2023, and each year thereafter, the vendor shall develop a wholesale prescription drug importation list identifying the prescription drugs that have the highest potential for cost savings to the State. Provides that the vendor shall identify Canadian suppliers that are in full compliance with the provisions of the Act and contract with the Canadian suppliers to import drugs under the program. Provides for: a bond requirement; requirements for eligible prescription drugs; requirements for eligible Canadian suppliers; requirements for eligible importers; distribution requirements; federal approval; prescription drug supply chain documentation; immediate suspension of specified imported drug; requirements of an annual report; notification of federal approval. Provides that the Department shall adopt rules necessary to implement the Act. Effective immediately. LRB103 30128 CPF 56552 b A BILL FOR 103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB3310 Introduced , by Rep. Joe C. Sosnowski SYNOPSIS AS INTRODUCED: New Act New Act Creates the Canadian Prescription Drug Importation Act. Provides that the Department of Public Health shall establish the Canadian Prescription Drug Importation Program for the importation of safe and effective prescription drugs from Canada which have the highest potential for cost savings to the State. Provides that the Department shall contract with a vendor to provide services under the program. Provides that on or before December 1, 2023, and each year thereafter, the vendor shall develop a wholesale prescription drug importation list identifying the prescription drugs that have the highest potential for cost savings to the State. Provides that the vendor shall identify Canadian suppliers that are in full compliance with the provisions of the Act and contract with the Canadian suppliers to import drugs under the program. Provides for: a bond requirement; requirements for eligible prescription drugs; requirements for eligible Canadian suppliers; requirements for eligible importers; distribution requirements; federal approval; prescription drug supply chain documentation; immediate suspension of specified imported drug; requirements of an annual report; notification of federal approval. Provides that the Department shall adopt rules necessary to implement the Act. Effective immediately. LRB103 30128 CPF 56552 b LRB103 30128 CPF 56552 b A BILL FOR
103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB3310 Introduced , by Rep. Joe C. Sosnowski SYNOPSIS AS INTRODUCED:
New Act New Act
New Act
Creates the Canadian Prescription Drug Importation Act. Provides that the Department of Public Health shall establish the Canadian Prescription Drug Importation Program for the importation of safe and effective prescription drugs from Canada which have the highest potential for cost savings to the State. Provides that the Department shall contract with a vendor to provide services under the program. Provides that on or before December 1, 2023, and each year thereafter, the vendor shall develop a wholesale prescription drug importation list identifying the prescription drugs that have the highest potential for cost savings to the State. Provides that the vendor shall identify Canadian suppliers that are in full compliance with the provisions of the Act and contract with the Canadian suppliers to import drugs under the program. Provides for: a bond requirement; requirements for eligible prescription drugs; requirements for eligible Canadian suppliers; requirements for eligible importers; distribution requirements; federal approval; prescription drug supply chain documentation; immediate suspension of specified imported drug; requirements of an annual report; notification of federal approval. Provides that the Department shall adopt rules necessary to implement the Act. Effective immediately.
LRB103 30128 CPF 56552 b LRB103 30128 CPF 56552 b
LRB103 30128 CPF 56552 b
A BILL FOR
HB3310LRB103 30128 CPF 56552 b HB3310 LRB103 30128 CPF 56552 b
HB3310 LRB103 30128 CPF 56552 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 Canadian Prescription Drug Importation Act.
6 Section 3. Findings. The General Assembly finds:
7 (1) United States citizens pay some of the highest
8 prices for prescription drugs in the world, and the
9 Canadian government estimates that United States consumers
10 pay twice as much as Canadians for patented prescription
11 drugs and 20% more for generics.
12 (2) Under the United States Food and Drug
13 Administration's discretion not to enforce the law,
14 individual patients may import from Canada a 90-day supply
15 of prescription drugs that are less expensive than drugs
16 licensed by the Food and Drug Administration in the United
17 States.
18 (3) Individual importation via the Internet increases
19 consumer health and safety risks because many Internet
20 pharmacies are not licensed in Canada, and it is difficult
21 to verify the validity, reputation, actual identity, and
22 pharmacy practices of online pharmacies outside of the
23 United States.
103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB3310 Introduced , by Rep. Joe C. Sosnowski SYNOPSIS AS INTRODUCED:
New Act New Act
New Act
Creates the Canadian Prescription Drug Importation Act. Provides that the Department of Public Health shall establish the Canadian Prescription Drug Importation Program for the importation of safe and effective prescription drugs from Canada which have the highest potential for cost savings to the State. Provides that the Department shall contract with a vendor to provide services under the program. Provides that on or before December 1, 2023, and each year thereafter, the vendor shall develop a wholesale prescription drug importation list identifying the prescription drugs that have the highest potential for cost savings to the State. Provides that the vendor shall identify Canadian suppliers that are in full compliance with the provisions of the Act and contract with the Canadian suppliers to import drugs under the program. Provides for: a bond requirement; requirements for eligible prescription drugs; requirements for eligible Canadian suppliers; requirements for eligible importers; distribution requirements; federal approval; prescription drug supply chain documentation; immediate suspension of specified imported drug; requirements of an annual report; notification of federal approval. Provides that the Department shall adopt rules necessary to implement the Act. Effective immediately.
LRB103 30128 CPF 56552 b LRB103 30128 CPF 56552 b
LRB103 30128 CPF 56552 b
A BILL FOR
New Act
LRB103 30128 CPF 56552 b
HB3310 LRB103 30128 CPF 56552 b
HB3310- 2 -LRB103 30128 CPF 56552 b HB3310 - 2 - LRB103 30128 CPF 56552 b
HB3310 - 2 - LRB103 30128 CPF 56552 b
1 (4) The United States allows patients to travel to
2 other countries for surgeries and other high-risk medical
3 treatments without regulating that activity, and insurers
4 sometimes facilitate and pay for treatments outside of the
5 United States.
6 (5) The United States Food and Drug Administration
7 estimates that currently 40% of finished prescription drug
8 products are produced outside of the United States, and
9 80% of raw products for United States pharmaceutical
10 manufacturing come from outside the United States.
11 (6) The United States Food and Drug Administration
12 recently signed reciprocity agreements with European Union
13 regulators to accept the results of European Union
14 inspections of pharmaceutical manufacturing plants. Since
15 1973, the United States Food and Drug Administration has
16 had in place a Memorandum of Understanding for regulatory
17 cooperation around pharmaceuticals with the Canadian
18 regulatory authorities.
19 (7) Canada has a rigorous regulatory system to license
20 prescription drugs that is considered to be on par with
21 the United States licensing system.
22 (8) The enactment of Title II of the federal Drug
23 Quality and Security Act (P.L. 113-54) has resulted in
24 improvements in drug security and safety by implementing a
25 pharmaceutical track-and-trace system that could be
26 leveraged for the safe importation of pharmaceuticals.
HB3310 - 2 - LRB103 30128 CPF 56552 b
HB3310- 3 -LRB103 30128 CPF 56552 b HB3310 - 3 - LRB103 30128 CPF 56552 b
HB3310 - 3 - LRB103 30128 CPF 56552 b
1 (9) The Secretary of the United States Department of
2 Health and Human Services may certify a prescription drug
3 reimportation program that is safe and saves consumers
4 money.
5 (10) The State can ensure that wholesale importation
6 of prescription drugs from Canada into the State will be
7 safe and cost-effective for State consumers.
8 Section 5. Program established. The Department of Public
9 Health shall establish the Canadian Prescription Drug
10 Importation Program for the importation from Canada of safe
11 and effective prescription drugs that have the highest
12 potential for cost savings to the State.
13 Section 10. Definitions. As used in this Act:
14 "Canadian supplier" means a manufacturer, wholesale
15 distributor, or pharmacy appropriately licensed or permitted
16 under Canadian law to manufacture, distribute, or dispense
17 prescription drugs.
18 "County health department" means a health care facility
19 established under Division 5-25 of the Counties Code.
20 "Department" means the Department of Public Health.
21 "Drug" or "prescription drug" has the same meaning as
22 "drugs" in Section 1 of the Pharmacy Practice Act.
23 "Federal act" means the Federal Food, Drug, and Cosmetic
24 Act as amended by the federal Drug Quality and Security Act.
HB3310 - 3 - LRB103 30128 CPF 56552 b
HB3310- 4 -LRB103 30128 CPF 56552 b HB3310 - 4 - LRB103 30128 CPF 56552 b
HB3310 - 4 - LRB103 30128 CPF 56552 b
1 "Free clinic" means a free medical clinic as defined in
2 subsection (b) of Section 30 of the Good Samaritan Act.
3 "Medicaid pharmacy" means a pharmacy licensed under the
4 Pharmacy Practice Act that has a Medicaid provider agreement
5 in effect with the State and is in good standing with the
6 State.
7 "Pharmacist" means a person who holds an active and
8 unencumbered license to practice pharmacy under the Pharmacy
9 Practice Act.
10 "Program" means the Canadian Prescription Drug Importation
11 Program created under this Act.
12 "Track-and-trace" means the product-tracing process for
13 the components of the pharmaceutical distribution supply chain
14 as described in Title II of the federal Drug Quality and
15 Security Act.
16 "Vendor" means the entity contracted by the Department to
17 manage specified functions of the program.
18 Section 15. Importation process.
19 (a) The Department shall contract with a vendor to provide
20 services under the program.
21 (b) On or before December 1, 2023, and on or before
22 December 1 of each year thereafter, the vendor shall develop a
23 wholesale prescription drug importation list identifying the
24 prescription drugs that have the highest potential for cost
25 savings to the State. In developing the list, the vendor shall
HB3310 - 4 - LRB103 30128 CPF 56552 b
HB3310- 5 -LRB103 30128 CPF 56552 b HB3310 - 5 - LRB103 30128 CPF 56552 b
HB3310 - 5 - LRB103 30128 CPF 56552 b
1 consider, at a minimum, which prescription drugs will provide
2 the greatest cost savings to State programs, including
3 prescription drugs for which there are shortages, specialty
4 prescription drugs, and high-volume prescription drugs. The
5 Department, in consultation with the federal department, shall
6 review the wholesale prescription drug importation list every
7 3 months to ensure that it continues to meet the requirements
8 of the programs and may direct the vendor to revise the list as
9 necessary.
10 (c) The vendor shall identify Canadian suppliers that are
11 in full compliance with relevant Canadian federal and
12 provincial laws and regulations and the federal act and who
13 have agreed to export drugs identified on the list at prices
14 that will provide cost savings to the State. The vendor must
15 verify that such Canadian suppliers meet all of the
16 requirements of the program while meeting or exceeding the
17 federal and State track-and-trace laws and regulations.
18 (d) The vendor shall contract with such eligible Canadian
19 suppliers, or facilitate contracts between eligible importers
20 and Canadian suppliers, to import drugs under the program.
21 (e) The vendor shall maintain a list of all registered
22 importers that participate in the program.
23 (f) The vendor shall ensure compliance with Title II of
24 the federal Drug Quality and Security Act by all suppliers,
25 importers and other distributors, and participants in the
26 program.
HB3310 - 5 - LRB103 30128 CPF 56552 b
HB3310- 6 -LRB103 30128 CPF 56552 b HB3310 - 6 - LRB103 30128 CPF 56552 b
HB3310 - 6 - LRB103 30128 CPF 56552 b
1 (g) The vendor shall assist the Department in the
2 preparation of the annual report required by Section 60 of
3 this Act including the timely provision of any information
4 requested by the Department.
5 (h) The vendor shall provide an annual financial audit of
6 its operations to the Department as required by the
7 Department. The vendor shall also provide quarterly financial
8 reports specific to the program and shall include information
9 on the performance of its subcontractors and vendors. The
10 Department shall determine the format and contents of the
11 reports.
12 Section 20. Bond requirement. The Department shall require
13 a bond from the vendor to mitigate the financial consequences
14 of potential acts of malfeasance or misfeasance or fraudulent
15 or dishonest acts committed by the vendor, any employees of
16 the vendor, or its subcontractors.
17 Section 25. Eligible prescription drugs. Eligible
18 importers, as described in Section 35 of this Act, may import a
19 drug from an eligible Canadian supplier, as described in
20 Section 30 of this Act, if:
21 (1) the drug meets the United States Food and Drug
22 Administration's standards related to safety,
23 effectiveness, misbranding, and adulteration;
24 (2) importing the drug would not violate federal
HB3310 - 6 - LRB103 30128 CPF 56552 b
HB3310- 7 -LRB103 30128 CPF 56552 b HB3310 - 7 - LRB103 30128 CPF 56552 b
HB3310 - 7 - LRB103 30128 CPF 56552 b
1 patent laws;
2 (3) importing the drug is expected to generate cost
3 savings; and
4 (4) the drug is not:
5 (i) a controlled substance as defined in 21 U.S.C.
6 802;
7 (ii) a biological product as defined in 42 U.S.C.
8 262;
9 (iii) an infused drug;
10 (iv) an intravenously injected drug;
11 (v) a drug that is inhaled during surgery; or
12 (vi) a drug that is a parenteral drug, the
13 importation of which is determined by the United
14 States Secretary of Health and Human Services to pose
15 a threat to the public health.
16 Section 30. Eligible Canadian suppliers. A Canadian
17 supplier may export prescription drugs into this State under
18 the program if the supplier:
19 (1) is in full compliance with relevant Canadian
20 federal and provincial laws and regulations;
21 (2) is identified by the vendor as eligible to
22 participate in the program; and
23 (3) submits an attestation that the supplier has a
24 registered agent in the United States, including the name
25 and United States address of the registered agent.
HB3310 - 7 - LRB103 30128 CPF 56552 b
HB3310- 8 -LRB103 30128 CPF 56552 b HB3310 - 8 - LRB103 30128 CPF 56552 b
HB3310 - 8 - LRB103 30128 CPF 56552 b
1 Section 35. Eligible importers. The following entities may
2 import prescription drugs from an eligible Canadian supplier
3 under the program:
4 (1) a pharmacist or wholesaler employed by or under
5 contract with the Department's central pharmacy, for
6 distribution to a county health department or free clinic
7 for dispensing to clients treated in such department or
8 clinic;
9 (2) a pharmacist or wholesaler employed by or under
10 contract with a Medicaid pharmacy, for dispensing to the
11 pharmacy's Medicaid recipients;
12 (3) a pharmacist or wholesaler employed by or under
13 contract with the Department of Corrections, for
14 dispensing to inmates in the custody of the Department of
15 Corrections;
16 (4) a pharmacist or wholesaler employed by or under
17 contract with the Department of Juvenile Justice, for
18 dispensing to inmates in the custody of the Department of
19 Juvenile Justice;
20 (5) a pharmacist or wholesaler employed by or under
21 contract with a developmental disabilities center, as
22 defined in the Mental Health and Developmental
23 Disabilities Administrative Act, for dispensing to clients
24 treated in such center; and
25 (6) a pharmacist or wholesaler employed by or under
HB3310 - 8 - LRB103 30128 CPF 56552 b
HB3310- 9 -LRB103 30128 CPF 56552 b HB3310 - 9 - LRB103 30128 CPF 56552 b
HB3310 - 9 - LRB103 30128 CPF 56552 b
1 contract with a residential treatment facility, or
2 "facility" as defined in the Specialized Mental Health
3 Rehabilitation Act of 2013 for dispensing to patients
4 treated in such facility.
5 Section 40. Distribution requirements. Eligible Canadian
6 suppliers and eligible importers participating under the
7 program:
8 (1) must comply with the tracking and tracing
9 requirements of 21 U.S.C. 360; and
10 (2) may not distribute, dispense, or sell prescription
11 drugs imported under the program outside of the State.
12 Section 45. Federal approval. On or before July 1, 2023,
13 the Department shall submit a request to the United States
14 Secretary of Health and Human Services for approval of the
15 program under paragraph (1) of 21 U.S.C. 384. The Department
16 shall begin operating the program within 6 months after
17 receiving such approval. The request must, at a minimum:
18 (1) describe the Department's plan for operating the
19 program;
20 (2) demonstrate how the prescription drugs imported
21 into this State under the program will meet the applicable
22 federal and State standards for safety and effectiveness;
23 (3) demonstrate how the drugs imported into this State
24 under the program will comply with federal tracing
HB3310 - 9 - LRB103 30128 CPF 56552 b
HB3310- 10 -LRB103 30128 CPF 56552 b HB3310 - 10 - LRB103 30128 CPF 56552 b
HB3310 - 10 - LRB103 30128 CPF 56552 b
1 procedures;
2 (4) include a list of proposed prescription drugs that
3 have the highest potential for cost savings to the State
4 through importation at the time that the request is
5 submitted;
6 (5) estimate the total cost savings attributable to
7 the program;
8 (6) provide the costs of program implementation to the
9 State; and
10 (7) include a list of potential Canadian suppliers
11 from which the State would import drugs and demonstrate
12 that the suppliers are in full compliance with relevant
13 Canadian federal and provincial laws and regulations as
14 well as all applicable federal and State laws and
15 regulations.
16 Section 50. Prescription drug supply chain documentation.
17 (a) The vendor shall ensure the safety and quality of
18 drugs imported under the program. The vendor shall:
19 (1) for an initial imported shipment of a specific
20 drug by an importer, ensure that each batch of the drug in
21 the shipment is statistically sampled and tested for
22 authenticity and degradation in a manner consistent with
23 the federal act;
24 (2) for every subsequent imported shipment of that
25 drug by that importer, ensure that a statistically valid
HB3310 - 10 - LRB103 30128 CPF 56552 b
HB3310- 11 -LRB103 30128 CPF 56552 b HB3310 - 11 - LRB103 30128 CPF 56552 b
HB3310 - 11 - LRB103 30128 CPF 56552 b
1 sample of the shipment is tested for authenticity and
2 degradation in a manner consistent with the federal act;
3 (3) certify that the drug:
4 (i) is approved for marketing in the United States
5 and is not adulterated or misbranded; and
6 (ii) meets all of the labeling requirements under
7 21 U.S.C. 352;
8 (4) maintain qualified laboratory records, including
9 complete data derived from all tests necessary to ensure
10 that the drug is in compliance with the requirements of
11 this Section.
12 (5) maintain documentation demonstrating that the
13 testing required by this Section was conducted at a
14 qualified laboratory in accordance with the federal act
15 and any other applicable federal and State laws and
16 regulations governing laboratory qualifications.
17 (b) All testing required by this Section must be conducted
18 in a qualified laboratory that meets the standards under the
19 federal act and any other applicable federal and State laws
20 and regulations governing laboratory qualifications for drug
21 testing.
22 (c) The vendor shall maintain information and
23 documentation submitted under this Section for a period of at
24 least 7 years.
25 (d) A participating importer must submit all of the
26 following information to the vendor:
HB3310 - 11 - LRB103 30128 CPF 56552 b
HB3310- 12 -LRB103 30128 CPF 56552 b HB3310 - 12 - LRB103 30128 CPF 56552 b
HB3310 - 12 - LRB103 30128 CPF 56552 b
1 (1) the name and quantity of the active ingredient of
2 the drug;
3 (2) a description of the dosage form of the drug;
4 (3) the date on which the drug is received;
5 (4) the quantity of the drug that is received;
6 (5) the point of origin and destination of the drug;
7 and
8 (6) the price paid by the importer for the drug;
9 (e) A participating Canadian supplier must submit the
10 following information and documentation to the vendor
11 specifying all of the following:
12 (1) the original source of the drug, including:
13 (i) the name of the manufacturer of the drug;
14 (ii) the date on which the drug was manufactured;
15 and
16 (iii) the location including the country, state or
17 province, and city, where the drug was manufactured;
18 (2) the date on which the drug is shipped;
19 (3) the quantity of the drug that is shipped;
20 (4) the quantity of each lot of the drug originally
21 received and the source of the lot; and
22 (5) the lot or control number and the batch number
23 assigned to the drug by the manufacturer.
24 (f) The Department may require that the vendor collect any
25 other information necessary to ensure the protection of the
26 public health.
HB3310 - 12 - LRB103 30128 CPF 56552 b
HB3310- 13 -LRB103 30128 CPF 56552 b HB3310 - 13 - LRB103 30128 CPF 56552 b
HB3310 - 13 - LRB103 30128 CPF 56552 b
1 Section 55. Immediate suspension. The Department shall
2 immediately suspend the importation of a specific drug or the
3 importation of drugs by a specific importer if it discovers
4 that any drug or activity is in violation of this Section or
5 any federal or State law or regulation. The Department may
6 revoke the suspension if, after conducting an investigation,
7 it determines that the public is adequately protected from
8 counterfeit or unsafe drugs being imported into this State.
9 Section 60. Annual report. On or before December 1 of each
10 year, the Department shall submit a report to the Governor,
11 the President of the Senate, and the Speaker of the House of
12 Representatives on the operation of the program during the
13 previous fiscal year. The report must include, at a minimum:
14 (1) a list of the prescription drugs that were
15 imported under the program;
16 (2) the number of participating entities;
17 (3) the number of prescriptions dispensed through the
18 program;
19 (4) the estimated cost savings during the previous
20 fiscal year and to date attributable to the program;
21 (5) a description of the methodology used to determine
22 which drugs should be included on the wholesale
23 prescription drug importation list; and
24 (6) documentation as to how the program ensures the
HB3310 - 13 - LRB103 30128 CPF 56552 b
HB3310- 14 -LRB103 30128 CPF 56552 b HB3310 - 14 - LRB103 30128 CPF 56552 b
HB3310 - 14 - LRB103 30128 CPF 56552 b
1 following that:
2 (i) Canadian suppliers participating in the
3 program are of high quality, high performance, and in
4 full compliance with relevant Canadian federal and
5 provincial laws and regulations as well as all federal
6 laws and regulations and State laws and rules;
7 (ii) prescription drugs imported under the program
8 are not shipped, sold, or dispensed outside of this
9 State once in the possession of the importer;
10 (iii) prescription drugs imported under the
11 program are pure, unadulterated, potent, and safe;
12 (iv) the program does not put consumers at a
13 higher health and safety risk than if the consumer did
14 not participate; and
15 (v) the program provides cost savings to the State
16 on imported prescription drugs.
17 Section 65. Notification of federal approval. Upon receipt
18 of federal approval of the program, the Department shall
19 notify the President of the Senate, the Speaker of the House of
20 Representatives, and the relevant committees of the Senate and
21 the House of Representatives. After approval is received and
22 before the start of the next regular session of the General
23 Assembly in which the proposal could be funded, the Department
24 shall submit to all parties a proposal for program
25 implementation and program funding.
HB3310 - 14 - LRB103 30128 CPF 56552 b
HB3310- 15 -LRB103 30128 CPF 56552 b HB3310 - 15 - LRB103 30128 CPF 56552 b
HB3310 - 15 - LRB103 30128 CPF 56552 b
1 Section 70. Rulemaking. The Department shall adopt rules
2 necessary to implement this Act.
3 Section 99. Effective date. This Act takes effect upon
4 becoming law.
HB3310 - 15 - LRB103 30128 CPF 56552 b