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SF 3596

as introduced - 91st Legislature (2019 - 2020) Posted on 02/25/2020 09:47am

KEY: stricken = removed, old language.
underscored = added, new language.

Current Version - as introduced

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A bill for an act
relating to health care; designing a wholesale drug importation program.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1. new text beginWHOLESALE IMPORTATION PROGRAM FOR PRESCRIPTION
DRUGS.
new text end

new text begin Subdivision 1. new text end

new text begin Program design. new text end

new text begin The commissioner of health in consultation with the
commissioners of human services and commerce, interested stakeholders, and federal
officials shall design a wholesale prescription drug importation program that complies with
the requirements of United States Code, title 21, section 384, including safety and cost
savings requirements. The program design shall:
new text end

new text begin (1) designate a state agency that shall either become a licensed drug wholesaler or
contract with a licensed drug wholesaler in order to seek federal certification and approval
to import safe prescription drugs that will provide significant cost savings to Minnesota
consumers;
new text end

new text begin (2) use Canadian prescription drug suppliers that are regulated under the laws of Canada
or one or more Canadian provinces or both;
new text end

new text begin (3) ensure that only prescription drugs meeting United States Food and Drug
Administration safety, effectiveness, and other standards shall be imported by or on behalf
of the state;
new text end

new text begin (4) import only those prescription drugs expected to generate substantial savings for
Minnesota consumers;
new text end

new text begin (5) comply with the tracking and tracing requirements of United States Code, title 21,
sections 360eee and 360eee-1, to the extent feasible and practical prior to imported drugs
coming into the possession of the state wholesaler and comply fully after imported drugs
are in the possession of the state wholesaler;
new text end

new text begin (6) prohibit the distribution, dispensing, or sale of imported drug products outside
Minnesota;
new text end

new text begin (7) recommend a charge per prescription or another method of financial support to ensure
that the program is funded adequately in a manner that does not jeopardize significant
consumer savings;
new text end

new text begin (8) include thorough audit functions; and
new text end

new text begin (9) develop provisions to identify and monitor the potential for anticompetitive behavior
in industries that would be affected by a wholesale prescription drug importation program.
new text end

new text begin Subd. 2. new text end

new text begin Report. new text end

new text begin On or before January 1, 2021, the commissioner of health shall submit
the program design and recommendations for a wholesale prescription drug importation
program to the legislative committees with jurisdiction over health care policy and finance.
new text end

new text begin Subd. 3. new text end

new text begin Federal compliance. new text end

new text begin (a) Upon adoption of legislation establishing the wholesale
importation program for prescription drugs, the commissioner shall submit a formal request
to the secretary of the United States Department of Health and Human Services for
certification of the state's wholesale prescription drug importation program.
new text end

new text begin (b) The commissioner of health shall seek the appropriate federal approvals, waivers,
exemptions, or agreements needed to enable all covered entities enrolled in or eligible for
the federal 340B Drug Pricing Program to participate in the state's wholesale prescription
drug importation program to the fullest extent possible without jeopardizing their eligibility
for the 340B Drug Pricing Program.
new text end