2023 -- H 5430

========

LC000377

========

     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2023

____________

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:

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

amended by adding thereto the following chapter:

CHAPTER 38

WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM

     21-38-1. Authorization.

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

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

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

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

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

and Human Services.

     21-38-2. Design of program.

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

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

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

regarding safety and cost savings. The program design shall:

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

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

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

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

or more Canadian provinces, or both;

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

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

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

consumers in the state;

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

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

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

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

licensed drug wholesaler;

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

collaboration with other states;

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

the state;

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

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

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

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

     (10) Include an audit function.

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

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

of this section no later than January 1, 2024.

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

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

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

     21-38-3. Implementation.

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

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

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

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

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

the program pursuant to this chapter shall:

LC000377 - Page 2 of 5

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

wholesaler in the state;

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

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

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

providers and consumers;

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

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

in the program;

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

imported under the program;

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

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

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

program;

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

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

operate the program.

     21-38-4. Annual reporting.

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

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

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

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

     (1) The prescription drugs included in the program;

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

carriers;

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

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

state during the previous calendar year and to date;

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

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

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

LC000377 - Page 3 of 5

     SECTION 2. This act shall take effect upon passage.

========

LC000377

========

LC000377 - Page 4 of 5

EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO FOOD AND DRUGS -- WHOLESALE PRESCRIPTION DRUG

IMPORTATION PROGRAM

***

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

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

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

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

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

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

drugs outside of Rhode Island.

     This act would take effect upon passage.

========

LC000377

========

LC000377 - Page 5 of 5