A bill for an act
relating to health; establishing a prescription drug affordability board and
prescription drug affordability advisory council; providing for prescription drug
cost reviews and remedies; requiring a report; appropriating money; proposing
coding for new law in Minnesota Statutes, chapter 62J.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
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Sections 62J.85 to 62J.95 may be cited as the "Prescription Drug Affordability Act."
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For the purposes of sections 62J.85 to 62J.95, the following
terms have the meanings given them.
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"Advisory council" means the Prescription Drug Affordability
Advisory Council established under section 62J.88.
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"Biologic" means a drug that is produced or distributed in accordance
with a biologics license application approved under Code of Federal Regulations, title 42,
section 447.502.
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"Biosimilar" has the meaning provided in section 62J.84, subdivision
2, paragraph (b).
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"Board" means the Prescription Drug Affordability Board established
under section 62J.87.
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"Brand name drug" has the meaning provided in section
62J.84, subdivision 2, paragraph (c).
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"Generic drug" has the meaning provided in section 62J.84,
subdivision 2, paragraph (e).
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"Group purchaser" has the meaning given in section 62J.03,
subdivision 6, and includes pharmacy benefit managers as defined in section 62W.02,
subdivision 15.
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"Manufacturer" means an entity that:
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(1) engages in the manufacture of a prescription drug product or enters into a lease with
another manufacturer to market and distribute a prescription drug product under the entity's
own name; and
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(2) sets or changes the wholesale acquisition cost of the prescription drug product it
manufacturers or markets.
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"Prescription drug product" means a brand name
drug, a generic drug, a biologic, or a biosimilar.
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"Wholesale acquisition cost" or "WAC"
has the meaning given in United States Code, title 42, section 1395W-3a(c)(6)(B).
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The Prescription Drug Affordability Board is created as
a board under section 15.012, paragraph (a), to protect consumers, state and local
governments, health plan companies, providers, pharmacies, and other health care system
stakeholders from unaffordable costs of certain prescription drugs.
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(a) The Prescription Drug Affordability Board consists of seven
members appointed as follows:
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(1) three members appointed by the governor;
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(2) one member appointed by the majority leader of the senate;
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(3) one member appointed by the minority leader of the senate;
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(4) one member appointed by the speaker of the house; and
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(5) one member appointed by the minority leader of the house of representatives.
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(b) All members appointed must have knowledge and demonstrated expertise in
pharmaceutical economics and finance or health care economics and finance. A member
must not be an employee of, a board member of, or a consultant to a manufacturer or trade
association for manufacturers or a pharmacy benefit manager or trade association for
pharmacy benefit managers.
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(c) Initial appointments shall be made by January 1, 2022.
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(a) Board appointees shall serve four-year terms, except that initial
appointees shall serve staggered terms of two, three, or four years as determined by lot by
the secretary of state. A board member shall serve no more than two consecutive terms.
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(b) A board member may resign at any time by giving written notice to the board.
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(a) The governor shall designate an acting chair from
the members appointed by the governor.
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(b) The board shall elect a chair to replace the acting chair at the first meeting of the
board by a majority of the members. The chair shall serve for one year.
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(c) The board shall elect a vice-chair and other officers from its membership as it deems
necessary.
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(a) The board shall hire an executive director and
other staff, who shall serve in the unclassified service. The executive director must have
knowledge and demonstrated expertise in pharmacoeconomics, pharmacology, health policy,
health services research, medicine, or a related field or discipline. The board may employ
or contract for professional and technical assistance as the board deems necessary to perform
the board's duties.
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(b) The attorney general shall provide legal services to the board.
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