Regular Session 2021-2022 House Bill 0833 P.N. 0815

PRINTER'S NO. 815

THE GENERAL ASSEMBLY OF PENNSYLVANIA

HOUSE BILL

No.

833

Session of

2021

INTRODUCED BY KINKEAD, PASHINSKI, CIRESI, A. DAVIS, DELLOSO,

FREEMAN, HILL-EVANS, ISAACSON, KINSEY, MADDEN, PARKER, ROZZI,

SANCHEZ, SCHLOSSBERG, SCHWEYER, SOLOMON AND ZABEL,

MARCH 8, 2021

REFERRED TO COMMITTEE ON HEALTH, MARCH 8, 2021

AN ACT

Providing for the study and design of a program for importing

prescription drugs.

The General Assembly of the Commonwealth of Pennsylvania

hereby enacts as follows:

Section 1. Short title.

This act shall be known and may be cited as the Wholesale

Prescription Drug Importation Program Design Act.

Section 2. Definitions.

The following words and phrases when used in this act shall

have the meanings given to them in this section unless the

context clearly indicates otherwise:

"Department." The Department of Health of the Commonwealth.

"Prescription drug." As defined in section 384(a)(3) of the

Federal Food, Drug, and Cosmetic Act (52 Stat. 1040, 21 U.S.C. §

384(a)(3)).

"Program." The wholesale prescription drug importation

program designed under section 4.

"Secretary." The Secretary of Health of the Commonwealth.

"Wholesale distributor of prescription drugs." As defined

under section 3 of the act of December 14, 1992 (P.L.1116,

No.145), known as the Wholesale Prescription Drug Distributors

License Act.

Section 3. Study on wholesale importation of prescription

drugs.

(a) General rule.--The department shall conduct a study and

issue a report regarding the wholesale importation of

prescription drugs from Canada into this Commonwealth.

(b) Report.--At a minimum, the report shall:

(1) Identify prescription drugs with the highest

potential for consumer savings if imported through a program.

(2) Estimate savings to consumers and the Commonwealth

if a program were to be established.

(3) Evaluate the likelihood of participation in a

program by consumers, pharmacies, health care providers,

health insurance companies and other relevant stakeholders.

(4) Identify the extent to which prescription drugs

imported through a program could comply with the tracking and

tracing requirements of sections 360eee and 360eee-1 of the

Federal Food, Drug, and Cosmetic Act (52 Stat. 1040, 21

U.S.C. §§ 360eee and 360eee-1) prior to the importation of

the drugs into this Commonwealth.

(5) Estimate the costs of operating a program.

(6) Identify a method of financial support for a

program, including, but not limited to, a charge or fee per

prescription drug.

(7) Assess, in consultation with the Office of Attorney

General, the potential for anticompetitive behavior.

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(8) Provide legislative recommendations regarding the

establishment of a program.

report to the following no later than one year after the

effective date of this section:

(1) The Governor.

(2) The President pro tempore of the Senate.

(3) The Speaker of the House of Representatives.

(4) The Majority Leader of the Senate.

(5) The Majority Leader of the House of Representatives.

(6) The Minority Leader of the Senate.

(7) The Minority Leader of the House of Representatives.

(8) The chairperson and minority chairperson of the

Appropriations Committee of the Senate.

(9) The chairperson and minority chairperson of the

Appropriations Committee of the House of Representatives.

(10) The chairperson and minority chairperson of the

Health and Human Services Committee of the Senate.

(11) The chairperson and minority chairperson of the

Health Committee of the House of Representatives.

Section 4. Wholesale prescription drug importation program.

(a) Design.--The department, in consultation with interested

stakeholders and appropriate Federal officials, shall design a

wholesale prescription drug importation program.

(b) Program.--The program shall:

(1) Identify methods to ensure that imported

prescription drugs meet the safety, effectiveness and other

standards of the United States Food and Drug Administration.

(2) Identify methods of:

(i) procuring prescription drugs from Canadian

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prescription drug suppliers identified under paragraph

(4); and

(ii) distributing prescription drugs procured under

subparagraph (i) throughout this Commonwealth.

(3) Evaluate the benefits and disadvantages of

designating and licensing an agency within the department as

a wholesale distributor of prescription drugs for the

purposes of this act.

(4) Identify Canadian prescription drug suppliers

regulated under the laws of Canada or under one or more

Canadian provinces.

(5) Identify ways to ensure that only prescription drugs

expected to generate substantial savings are imported into

this Commonwealth.

(6) Identify an efficient way of administering and

marketing the program.

transmit a copy of the program design to the following within

one year after the submission of the report under section 3(c):

(1) The Governor.

(2) The President pro tempore of the Senate.

(3) The Speaker of the House of Representatives.

(4) The Majority Leader of the Senate.

(5) The Majority Leader of the House of Representatives.

(6) The Minority Leader of the Senate.

(7) The Minority Leader of the House of Representatives.

(8) The chairperson and minority chairperson of the

Appropriations Committee of the Senate.

(9) The chairperson and minority chairperson of the

Appropriations Committee of the House of Representatives.

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(10) The chairperson and minority chairperson of the

Health and Human Services Committee of the Senate.

(11) The chairperson and minority chairperson of the

Health Committee of the House of Representatives.

(d) Construction.--Nothing in this section shall be

construed as establishing a program or giving the department the

authority to establish a program.

Section 5. Effective date.

This act shall take effect immediately.

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