2021 -- H 5249

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2021

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A N   A C T

RELATING TO HEALTH AND SAFETY -- WHOLESALE PRESCRIPTION DRUG

IMPORTATION PROGRAM

     Introduced By: Representatives Williams, Vella-Wilkinson, Alzate, Morales, Biah,
Giraldo, Noret, and Casimiro

     Date Introduced: January 29, 2021

     Referred To: House Health & Human Services

     It is enacted by the General Assembly as follows:

     SECTION 1. Title 23 of the General Laws entitled "HEALTH AND SAFETY" is hereby

amended by adding thereto the following chapter:

CHAPTER 95

WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM

     23-95-1. Short title.

     This chapter shall be known and may be cited as the "Wholesale Prescription Drug

Importation Program."

     23-95-2. Establishment of program.

     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 must 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 § 23-95-3(c), from the U.S. Department of Health and

Human Services.

     23-95-3. Design of program.

     (a) The department of health, 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 must:

     (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 subsection

(c) of this section, 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 U.S. 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 startup 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 and regulations. The department of health shall promulgate rules and regulations

to design the program in accordance with the requirements of subsection (a) of this section no later

than January 1, 2022.

     (c) Request for federal approval and certification. The department of health shall submit a

request for approval and certification of the Program to the U.S. Department of Health and Human

Services no later than May 1, 2022.

     23-95-4. Implementation and operation.

     (a) Upon receipt of federal approval and certification under § 23-95-3(c), the state agency

designated to oversee the program pursuant to this chapter shall implement the program as required

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in subsection (b) of this section. The program must 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:

     (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 drug 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.

     23-95-5. Annual reporting.

     Beginning January 2023, and annually. thereafter, the department of health, or other state

agency designated to oversee the program pursuant to this chapter, shall report to the speaker of

the house of representatives and the 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 finding; and

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     (6) Any other information the department of health, or other state agency designated to

oversee the program pursuant to this chapter, considers relevant.

     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 HEALTH AND SAFETY -- WHOLESALE PRESCRIPTION DRUG

IMPORTATION PROGRAM

***

     This act would establish a program for the importation of wholesale prescription drugs

from Canada to provide cost savings to Rhode Island consumers.

     This act would take effect upon passage.

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