103RD GENERAL ASSEMBLY
State of Illinois
2023 and 2024
HB3490

 

Introduced 2/17/2023, by Rep. Hoan Huynh

 

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 by 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.


LRB103 27325 CPF 53696 b

 

 

A BILL FOR

 

HB3490LRB103 27325 CPF 53696 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
5Canadian Prescription Drug Importation Act.
 
6    Section 5. Legislative findings. The General Assembly
7finds:
8    (1) United States consumers pay some of the highest
9prescription drug prices in the world, and it is estimated
10that United States consumers pay twice as much as the amount
11Canadian consumers pay for patented prescription drugs and 20%
12more for generic drugs.
13    (2) Federal law, as codified in 21 U.S.C. 384, authorizes
14the Secretary of the United States Department of Health and
15Human Services to allow wholesale importation of prescription
16drugs from Canada if such importation is shown to be both safe
17and less costly for United States consumers.
18    (3) Although importing prescription drugs would be less
19costly, there may be risks posed to consumer health and safety
20if the source, quality, and purity of prescription drugs sold
21by online pharmacies cannot be verified.
22    (4) Canada has a rigorous regulatory system to license
23prescription drugs, equivalent to the licensing system in the

 

 

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1United States.
2    (5) In the United States, Title II of the federal Drug
3Quality and Security Act, referred to as the Drug Supply Chain
4Security Act, has significantly improved drug security and
5safety through a system of pharmaceutical product
6track-and-trace procedures.
7    (6) A wholesale drug importation program for the exclusive
8benefit of residents of the State should be designed and
9implemented to provide consumers of the State access to safe
10and less expensive prescription drugs.
 
11    Section 10. Definitions. As used in this Act:
12    "Canadian supplier means a manufacturer, wholesale
13distributor, or pharmacy that is appropriately licensed or
14permitted under Canadian federal and provincial laws and
15regulations to manufacturer, distribute, or dispense
16prescription drugs.
17    "Department" means the Department of Public Health.
18    "Drug" or prescription drug" has has the same meaning as
19"drugs" in Section 1 of the Pharmacy Practice Act.
20    "Eligible importer" means an importer that is:
21        (1) a pharmacist or wholesaler employed by or under
22    contract with a medicaid pharmacy, for dispensing to the
23    pharmacy's medicaid recipients;
24        (2) a pharmacist or wholesaler employed by or under
25    contract with the Department of Corrections, for

 

 

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1    dispensing to inmates in the custody of the Department of
2    Corrections;
3        (3) a commercial plan, as defined by rules adopted by
4    the Department and as approved by the federal government;
5    and
6        (4) a licensed pharmacist under the Pharmacy Practice
7    Act or registered wholesaler approved by the Department.
8    "Federal act" means the federal Food, Drug, and Cosmetic
9Act.
10    "Medicaid pharmacy means a pharmacy licensed under the
11Pharmacy Practice Act that has a Medicaid provider agreement
12in effect with the State and is in good standing with the
13State.
14    "Pharmacist" means a person who holds and active and
15unencumbered license to practice pharmacy under the Pharmacy
16Practice Act.
17    "Program" means the Canadian prescription drug importation
18program created in this Act.
19    "Vendor" means a vendor with which the State who contracts
20for the provision of services under the program pursuant to
21subsection (a) of Section 15.
 
22    Section 15. Canadian prescription drug importation
23program; importation process; contract with vendor; vendor
24duties.
25    (a) The Canadian prescription drug importation program is

 

 

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1created in the Department. Upon receiving approval of the
2program as described in Section 25, the Department shall
3contract with one or more vendors to provide services under
4the program. For 3 years following the effective date of this
5Act, the selection of any vendor pursuant to this subsection
6is exempt from the requirements of the Illinois Procurement
7Code.
8    (b) Each vendor, in consultation with the Department and
9any other vendors, shall establish a wholesale prescription
10drug importation list that identifies the prescription drugs
11that have the highest potential for cost savings to the State.
12In developing the list, each vendor shall consider, at a
13minimum, which prescription drugs will provide the greatest
14cost savings to the State, including prescription drugs for
15which there are shortages, specialty prescription drugs, and
16high-volume prescription drugs. Each vendor shall revise the
17list at least annually and at the direction of the State
18department pursuant to this subsection. The Department shall
19review the wholesale prescription drug importation list at
20least every 3 months to ensure that it continues to meet the
21requirements of the program. The Department may direct a
22vendor to revise the list, as necessary. Each vendor, in
23consultation with the Department, shall identify Canadian
24suppliers who are in full compliance with relevant Canadian
25federal and provincial laws and regulations and who have
26agreed to export prescription drugs identified on the

 

 

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1wholesale prescription drug importation list. Each vendor
2shall verify that such Canadian suppliers meet all of the
3requirements of the program and will export prescription drugs
4at prices that will provide cost savings to the State. Each
5vendor shall contract with such eligible Canadian suppliers,
6or facilitate contracts between eligible importers and
7Canadian suppliers, to import prescription drugs under the
8program. Each vendor shall assist the Department in developing
9and administering a distribution program within the program.
10Each vendor shall assist the Department with the annual report
11described in this Act and provide any information requested by
12the Department for the report. Each vendor shall ensure the
13safety and quality of drugs imported under the program, as
14follows:
15        (1) for an initial imported shipment, ensure that each
16    batch of the drug in the shipment is statistically sampled
17    and tested for authenticity and degradation in a manner
18    consistent with the federal act, and for any subsequent
19    imported shipment, ensure that a statistically valid
20    sample of the shipment is tested for authenticity and
21    degradation in a manner consistent with the federal act;
22        (2) certify that each drug: (i) is approved for
23    marketing in the United States and is not adulterated or
24    misbranded; and (ii) meets all of the labeling
25    requirements under 21 U.S.C. 352;
26        (3) maintain qualified laboratory records, including

 

 

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1    complete data derived from all tests necessary to ensure
2    that the drug is in compliance with the requirements of
3    this Section; and
4        (4) maintain documentation demonstrating that the
5    testing required by this Section was conducted at a
6    qualified laboratory in accordance with the Federal Act
7    and any other applicable federal and State laws and
8    regulations governing laboratory qualifications.
9    (c) All testing required by this section must be conducted
10in a qualified laboratory that meets the standards under the
11Federal Act and any other applicable federal and State laws
12and regulations governing laboratory qualifications for drug
13testing.
14    (d) Each vendor shall maintain a list of all eligible
15importers that participate in the program.
16    (e) Each vendor shall ensure compliance with Title II of
17the federal Drug Quality and Security Act by all Canadian
18suppliers, eligible importers, distributors, and other
19participants in the program.
20    (f) Each vendor shall provide an annual financial audit of
21its operations to the Department. Each vendor shall also
22provide quarterly financial reports specific to the program
23and shall include information concerning the performance of
24its subcontractors and vendors. The Department shall determine
25the format and contents of the reports.
26    (g) Each vendor shall submit evidence of a surety bond

 

 

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1with any bid or initial contract negotiation documents and
2shall maintain documentation of evidence of such a bond with
3the Department throughout the contract term. The surety bond
4may be from this State or any other State in the United States
5and must be in an amount of at least $25,000. The surety bond
6or comparable security arrangement must include the State as a
7beneficiary. In lieu of the surety bond, a vendor may provide a
8comparable security agreement, such as an irrevocable letter
9of credit or a deposit into a trust account or financial
10institution that includes the State as a beneficiary, payable
11to the State. The purposes of the bond or other security
12arrangement are to:
13        (1) ensure participation of the vendor in any civil or
14    criminal legal action by the State department, any other
15    State agency, or private individuals or entities against
16    the vendor because of the vendor's failure to perform
17    under the contract, including, but not limited to, causes
18    of actions for personal injury, negligence, and wrongful
19    death;
20        (2) ensure payment by the vendor through the use of a
21    bond or other comparable security arrangement of any legal
22    judgments and claims that are awarded to the State, other
23    entities acting on behalf of the State, individuals, or
24    organizations if the vendor is assessed a final judgment
25    or other monetary penalty in a court of law for a civil or
26    criminal action under the program. The bond or comparable

 

 

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1    security arrangement may be accessed if the vendor fails
2    to pay any judgment or claim within 60 days after final
3    judgment; and
4        (3) allow for civil and criminal litigation claims to
5    be made against the bond or other comparable security
6    arrangements for up to one year after the vendor's
7    contract under the program has ended with the Department,
8    the vendor's license is no longer valid, or the program
9    has ended, whichever occurs last.
10    (8) Each vendor shall maintain information and
11documentation submitted under this Section for a period of at
12least 7 years.
13    (9) The Department may require each vendor to collect any
14other information necessary to ensure the protection of the
15public health.
 
16    Section 20. Eligible prescription drugs; eligible Canadian
17suppliers; eligible importers; distribution requirements.
18    (a) An eligible importer may import a prescription drug
19from a Canadian supplier if:
20        (1) the drug meets the United States Food and Drug
21    Administration's standards related to safety,
22    effectiveness, misbranding, and adulteration;
23        (2) importing the drug would not violate federal
24    patent laws;
25        (3) importing the drug is expected to generate cost

 

 

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1    savings; and
2        (4) the drug is not:
3            (i) a controlled substance as defined in 21 U.S.C.
4        802;
5            (ii) a biological product as defined in 42 U.S.C.
6        262;
7            (iii) an infused drug;
8            (iv) an intravenously injected drug;
9            (v) a drug that is inhaled during surgery; or
10            (vi) a drug that is a parenteral drug, the
11        importation of which is determined by the United
12        States Secretary of Health and Human Services to pose
13        a threat to the public health.
14    (b) A Canadian supplier may export prescription drugs into
15the State under the program if the supplier:
16        (1) is in full compliance with relevant Canadian
17    federal and provincial laws and regulations;
18        (2) is identified by the vendor as eligible to
19    participate in the program; and
20        (3) submits an attestation that the supplier has a
21    registered agent in the United States, including the name
22    and United States address of the registered agent.
23    (c) The following entities are eligible importers and may
24obtain imported prescription drugs:
25        (1) a pharmacist or wholesaler employed by or under
26    contract with a Medicaid pharmacy, for dispensing to the

 

 

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1    pharmacy's Medicaid recipients;
2        (2) a pharmacist or wholesaler employed by or under
3    contract with the Department of Corrections, for
4    dispensing to inmates in the custody of the Department of
5    Corrections;
6        (3) commercial plans, as defined by rules promulgated
7    by the State Board and as approved by the federal
8    government; and
9        (4) a licensed pharmacist or wholesaler approved by
10    the Department under the Pharmacy Practice Act.
11    (d) The Department shall designate an office or division
12that must be a licensed pharmaceutical wholesaler or that
13shall contract with a licensed pharmaceutical wholesaler
14licensed pursuant to Part 3 of Article 42.5 of Title 12. The
15office or division designated by the Department shall:
16        (1) set a maximum profit margin so that a wholesaler,
17    distributor, pharmacy, or other licensed provider
18    participating in the program maintains a profit margin
19    that is no greater than the profit margin that the
20    wholesaler, distributor, pharmacy, or other licensed
21    provider whole have earned on the equivalent nonimported
22    drug;
23        (2) exclude generic products if the importation of the
24    products would violate United States patent laws
25    applicable to United States-branded products;
26        (3) comply with the requirements of 21 U.S.C. 360eee

 

 

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1    through 360eee-4 as enacted in Title II of the federal
2    Drug Quality and Security Act; and
3        (4) determine a method for covering the administrative
4    costs of the program, which method may include a fee
5    imposed on each prescription pharmaceutical product sold
6    through the program or any other appropriate method as
7    determined by the Department, but the Department shall not
8    require a fee in an amount the Department determines would
9    significantly reduce consumer savings.
10    (e) Canadian suppliers and eligible importers
11participating under the program:
12        (1) shall comply with the tracking and tracing
13    requirements of 21 U.S.C. 360; and
14        (2) shall not distribute, dispense, or sell
15    prescription drugs imported under the program outside of
16    the State.
17    (f) A participating eligible importer shall submit to the
18vendor all of the following information about each drug to be
19acquired by the importer under the program:
20        (1) the name and quantity of the active ingredient of
21    the drug;
22        (2) a description of the dosage form of the drug;
23        (3) the date on which the drug is received;
24        (4) the quantity of the drug that is received;
25        (5) the point of origin and destination of the drug;
26    and

 

 

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1        (6) the price paid by the importer for the drug.
2    (g) A participating Canadian supplier shall submit to the
3vender the following information about each drug to be
4supplied by the Canadian supplier under the program:
5        (1) the original source of the drug, including:
6            (i) the name of the manufacturer of the drug;
7            (ii) the date on which the drug was manufactured;
8        and
9            (iii) the location including the country, state or
10        province, and city, where the drug was manufactured;
11        (2) the date on which the drug is shipped;
12        (3) the quantity of the drug that is shipped;
13        (4) the quantity of each lot of the drug originally
14    received and the source of the lot; and
15        (5) the lot or control number and the batch number
16    assigned to the drug by the manufacturer.
17    (h) The Department shall immediately suspend the
18importation of a specific drug or the importation of drugs by a
19specific eligible importer if it discovers that any drug or
20activity is in violation of this Section or any federal or
21State law or regulation. The Department may revoke the
22suspension if, after conducting an investigation, it
23determines that the public is adequately protected from
24counterfeit or unsafe drugs being imported into this State.
 
25    Section 25. Federal approval.

 

 

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1    (a) On or before September 1, 2023, the Department shall
2submit a request to the United States Secretary of Health and
3Human Services for approval of the program under 21 U.S.C.
4384. The Department shall begin operating the program within 6
5months after receiving such approval. The request must, at a
6minimum:
7        (1) describe the Department's plan for operating the
8    program;
9        (2) demonstrate how the prescription drugs imported
10    into this State under the program will meet the applicable
11    federal and State standards for safety, effectiveness,
12    misbranding, and adulteration;
13        (3) include a list of proposed prescription drugs that
14    have the highest potential for cost savings to the State
15    through importation at the time that the request is
16    submitted;
17        (4) estimate the total cost savings attributable to
18    the program;
19        (5) include a list of potential Canadian suppliers
20    from which the State would import drugs and demonstrate
21    that the suppliers are in full compliance with relevant
22    Canadian federal and provincial laws and regulations.
23    (b) Notwithstanding any provision of this subsection to
24the contrary, the Department may expend money for the purpose
25of requesting approval of the program as described in
26subsection (a), but the Department shall not spend any other

 

 

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1money to implement the program until the Department receives
2approval of the program as described in subsection (a).
3    (c) Upon receipt of federal approval of the program, the
4Department shall notify the President of the Senate and the
5Speaker of the House of Representatives, as well as the Health
6and Human Services Committee of the Senate and the Health and
7Insurance Committee of the House of Representatives, or any
8successor committees. After approval is received and before
9the start of the next regular session of the General Assembly
10in which the proposal could be funded, the Department shall
11submit to all parties specified in this subsection a proposal
12for program implementation and program funding.
 
13    Section 30. Reports. On or before December 1, 2024, and on
14or before December 1 each year thereafter, the Department
15shall submit a report to the Governor, the President of the
16Senate, and the Speaker of the House of Representatives on the
17operation of the program during the previous fiscal year. The
18report must include, at a minimum:
19        (1) a list of the prescription drugs that were
20    imported under the program;
21        (2) the number of participating Canadian suppliers and
22    eligible importers;
23        (3) the number of prescriptions dispensed through the
24    program;
25        (4) the estimated cost savings during the previous

 

 

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1    fiscal year and to date attributable to the program;
2        (5) a description of the methodology used to determine
3    which drugs should be included on the wholesale
4    prescription drug importation list; and
5        (6) documentation as to how the program ensures the
6    following that:
7            (i) Canadian suppliers participating in the
8        program are in full compliance with relevant Canadian
9        federal and provincial laws;
10            (ii) prescription drugs imported under the program
11        are not shipped, sold, or dispensed outside of this
12        State once in the possession of the eligible importer;
13            (iii) prescription drugs imported under the
14        program are pure, unadulterated, potent, and safe;
15            (iv) the program does not put consumers at a
16        higher health and safety risk than if the program did
17        not exist; and
18            (v) the program provides cost savings to the State
19        on imported prescription drugs.
 
20    Section 35. Importation program authorized; rulemaking.
21    (a) Upon approval by the Secretary, in accordance with
22Section 30, the Department shall administer an importation
23program.
24    (b) The Department shall approve a method of financing and
25administrative costs of the importation program, which method

 

 

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1may include imposing a fee on each prescription pharmaceutical
2product sold through the importation program or any other
3appropriate method determined by the Department to finance
4administrative costs. The Department shall not require a fee
5in an amount that the Department determines would
6significantly reduce consumer savings.
7    (c) The Department shall adopt rules necessary to
8implement this Act.