PRINTER'S NO. 3166
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
2225
Session of
2020
INTRODUCED BY McCARTER, PASHINSKI, SCHLOSSBERG, KINSEY, HILL-
EVANS, FREEMAN, YOUNGBLOOD, DeLUCA, HOWARD, MACKENZIE,
McNEILL, MERSKI, CIRESI, CALTAGIRONE, SCHWEYER, McCLINTON AND
FRANKEL, JANUARY 17, 2020
REFERRED TO COMMITTEE ON HEALTH, JANUARY 17, 2020
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 21 U.S.C. § 384(a)(3)
(relating to importation of prescription drugs).
"Program." The wholesale prescription drug importation
program designed under section 4.
"Secretary." The Secretary of Health of the Commonwealth.
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"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 21 U.S.C. §§ 360eee (relating to
definitions) and 360eee-1 (relating to agreements) 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.
(8) Provide legislative recommendations regarding the
establishment of a program.
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(c) Report submission.--The secretary shall submit the
report to the following no later than one year after the
effective date of this act:
(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 Appropriations Committee of the Senate.
(9) The Appropriations Committee of the House of
Representatives.
(10) The Health and Human Services Committee of the
Senate.
(11) 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
prescription drug suppliers identified under paragraph
(4); and
(ii) distributing prescription drugs procured under
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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.
(c) Transmission of program design.--The secretary shall
transmit a copy of the program design to the following within
one year after the promulgation of regulations by the Federal
Government regarding the importation of prescription drugs from
Canada into the United States or from the submission of the
report under section 3(c), whichever is later:
(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 Appropriations Committee of the Senate.
(9) The Appropriations Committee of the House of
Representatives.
(10) The Health and Human Services Committee of the
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Senate.
(11) 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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