2023 -- H 5430

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LC000377

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2023

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A N   A C T

RELATING TO FOOD AND DRUGS -- WHOLESALE PRESCRIPTION DRUG

IMPORTATION PROGRAM

     

     Introduced By: Representatives Tanzi, Cortvriend, McGaw, and Henries

     Date Introduced: February 08, 2023

     Referred To: House Health & Human Services

     It is enacted by the General Assembly as follows:

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     SECTION 1. Title 21 of the General Laws entitled "FOOD AND DRUGS" is hereby

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amended by adding thereto the following chapter:

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CHAPTER 38

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WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM

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     21-38-1. Authorization.

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     The wholesale prescription drug importation program, referred to in this chapter as the

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("program,") is established to provide for the wholesale importation of prescription drugs from

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Canada by or on behalf of the state. The program shall be designed in accordance with the

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requirements of this chapter. The program may not be implemented unless the state obtains

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approval and certification, pursuant to § 21-38-2(c), from the United States Department of Health

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and Human Services.

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     21-38-2. Design of program.

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     (a) Design requirements. The executive office of health and human services, in consultation

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with appropriate federal and other state agencies, other states and interested parties, shall design

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the program to comply with the applicable requirements of 21 U.S.C. § 384, including requirements

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regarding safety and cost savings. The program design shall:

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     (1) Designate a state agency to become a licensed drug wholesaler or to contract with a

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licensed drug wholesaler in order to seek federal certification and approval, pursuant to § 21-38-

 

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2(c), to import safe prescription drugs and provide cost savings to consumers in the state;

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     (2) Use prescription drug suppliers in Canada regulated under the laws of Canada or of one

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or more Canadian provinces, or both;

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     (3) Ensure that only prescription drugs meeting the federal Food and Drug Administration's

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safety, effectiveness and other standards are imported by or on behalf of the state;

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     (4) Import only those prescription drugs expected to generate substantial cost savings for

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consumers in the state;

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     (5) Ensure that the program complies with the transaction and tracing requirements of 21

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U.S.C. §§ 360eee and 360eee-1 to the extent feasible and practical prior to imported prescription

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drugs coming into the possession of the licensed drug wholesaler and that the program complies

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fully with those federal requirements after imported prescription drugs are in the possession of the

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licensed drug wholesaler;

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     (6) Consider whether the program may be developed on a multistate basis through

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collaboration with other states;

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     (7) Prohibit the distribution, dispensing or sale of imported prescription drugs outside of

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the state;

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     (8) Recommend a charge per prescription or another method of financing to ensure that the

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program is adequately funded in a manner that does not jeopardize significant cost savings to

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consumers, including adequate funding for the initial start-up costs of the program;

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     (9) Apply for and receive funds, grants or contracts from public and private sources; and

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     (10) Include an audit function.

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     (b) Rules. The executive office of health and human services shall adopt and promulgate

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rules and regulations to design the program in accordance with the requirements of subsection (a)

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of this section no later than January 1, 2024.

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     (c) Request for federal approval and certification. The executive office of health and human

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services shall submit a request for approval and certification of the program to the United States

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Department of Health and Human Services no later than May 1, 2024.

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     21-38-3. Implementation.

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     (a) Implementation of operation. Upon receipt of federal approval and certification under

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§ 21-38-2(c), the state agency designated to oversee the program pursuant to this chapter shall

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implement the program as required in subsection (b) of this section. The program shall begin

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operating no later than six (6) months following receipt of federal approval and certification.

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      (b) Requirements. Prior to operating the program, the state agency designated to oversee

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the program pursuant to this chapter shall:

 

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     (1) Become a licensed drug wholesaler or enter into a contract with a licensed drug

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wholesaler in the state;

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     (2) Contract with one or more distributors licensed in the state;

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     (3) Contract with one or more licensed and regulated prescription drug suppliers in Canada;

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     (4) Consult with health insurance carriers, employers, pharmacies, pharmacists, health care

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providers and consumers;

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     (5) Develop a registration process for health insurance carriers, pharmacies and health care

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providers authorized to prescribe and administer prescription drugs that are willing to participate

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in the program;

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     (6) Create a publicly accessible website for listing the prices of prescription drugs to be

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imported under the program;

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     (7) Create an outreach and marketing plan to generate public awareness of the program;

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     (8) Provide a telephone hotline to answer questions and address needs of consumers,

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employers, health insurance carriers, pharmacies, health care providers and others affected by the

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program;

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     (9) Develop a two (2) year audit work plan; and

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     (10) Conduct any other activity determined necessary to successfully implement and

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operate the program.

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     21-38-4. Annual reporting.

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     Beginning January 2025, and annually thereafter, the executive office of health and human

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services, or other state agency designated to oversee the program pursuant to this chapter, shall

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report to the speaker of the house and president of the senate regarding the implementation and

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operation of the program during the previous calendar year, including:

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     (1) The prescription drugs included in the program;

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     (2) The number of participating pharmacies, health care providers and health insurance

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carriers;

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     (3) The number of prescription drugs dispensed through the program;

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     (4) The estimated cost savings to consumers, health insurance carriers, employers and the

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state during the previous calendar year and to date;

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     (5) Information regarding implementation of the audit work plan and audit findings; and

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     (6) Any other information the executive office of health and human services, or other state

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agency designated to oversee the program pursuant to this chapter, considers relevant.

 

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     SECTION 2. This act shall take effect upon passage.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO FOOD AND DRUGS -- WHOLESALE PRESCRIPTION DRUG

IMPORTATION PROGRAM

***

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     This act would establish the Wholesale Prescription Drug Importation Program for the

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importation of wholesale prescription drugs from Canada to provide savings to Rhode Island

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consumers. The program would require the designation of a state agency to become a licensed drug

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wholesaler, or to contract with a licensed drug wholesaler, use of prescription drug suppliers in

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Canada; ensure that only drugs approved by the US Food and Drug Administration are imported;

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and import only drugs expected to generate savings; and prohibit the distribution or sale of these

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drugs outside of Rhode Island.

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     This act would take effect upon passage.

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