LRBa2531/1
KP:ahe
2017 - 2018 LEGISLATURE
SENATE AMENDMENT 1,
TO ASSEMBLY BILL 608
March 20, 2018 - Offered by Senators Hansen,
Larson, Schachtner, Vinehout,
Carpenter, Erpenbach, Risser, Ringhand, Miller, Shilling, Bewley and L.
Taylor.
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21. Page 1, line 2: delete “pharmacy and" and substitute “pharmacy, price
3restrictions for certain off-patent or generic drugs,".
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7“
Section 1e. 134.91 of the statutes is created to read:
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8134.91 Price gouging of certain drugs. (1) Definitions. In this section:
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(a) “Essential off-patent or generic drug” means any of the following:
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1. A prescription drug if all of the following apply:
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a. All exclusive marketing rights for the prescription drug, if any, have expired.
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1b. The prescription drug appears on the model list of essential medicines most
2recently adopted by the World Health Organization or is designated by the
3department of health services as an essential medicine under s. 250.04 (15).
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c. The prescription drug is actively manufactured and marketed for sale in the
5United States by 3 or fewer manufacturers.
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d. The prescription drug is made available for sale in this state.
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2. A drug-device combination product for which all exclusive marketing rights,
8if any, have expired and used for the delivery of an essential off-patent or generic
9drug defined under subd. 1.
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(b) “Exclusive marketing rights” means exclusive marketing rights granted
11under the federal act, the federal public health service act under
42 USC 262, or
12federal patent law.
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(c) “Federal act” means the federal food, drug, and cosmetic act,
21 USC 301 14et seq.
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(d) “Prescription drug” has the meaning given in s. 450.01 (20).
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(e) “Price gouging” means to unconscionably increase the price of an essential
17off-patent or generic drug.
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(f) “State public assistance program” means any of the following:
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1. The medical assistance program under subch. IV of ch. 49.
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2. A program for assisting victims of disease under ss. 49.68, 49.683, and
2149.685, and drug reimbursement under s. 49.686.
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3. The program for prescription drug assistance for the elderly under s. 49.688.
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(g) “Unconscionably increase” means to increase the price of an essential
24off-patent or generic drug if all of the following apply:
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11. The increase in price is excessive and not justified by the cost of producing
2the drug or the cost of appropriate expansion of access to the drug to promote public
3health.
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2. The increase in price results in a consumer for whom the essential off-patent
5or generic drug has been prescribed having no meaningful choice about whether to
6purchase the drug at an excessive price because any of the following applies:
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a. The essential off-patent or generic drug is important to the consumer's
8health.
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b. Insufficient competition exists in the market for the essential off-patent or
10generic drug.
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11(2) Price gouging of certain drugs prohibited. (a) Except as provided in par.
12(b), no manufacturer or wholesale distributor may sell or offer to sell an essential
13off-patent or generic drug at a price that results in price gouging.
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(b) A wholesale distributor does not violate par. (a) by increasing the price of
15an essential off-patent or generic drug if the price increase is directly attributable
16to additional costs for the drug imposed on the wholesale distributor by the
17manufacturer of the drug.
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18(3) Enforcement. (a) The attorney general may require a manufacturer or
19wholesale distributor of an essential off-patent or generic drug to provide the
20following information within 45 days:
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1. The components of the cost of producing the drug.
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2. The circumstances and timing of any increase in materials or manufacturing
23costs that caused any increase in the price of the drug within the one-year period
24preceding the date of the price increase.
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13. The circumstances and timing of any expenditures made by the
2manufacturer to expand access to the drug.
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4. An explanation of any improvement in public health associated with any
4expenditures described in subd. 3.
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5. Any other information that the manufacturer believes to be relevant to a
6determination of whether a violation of sub. (2) (a) has occurred.
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(b) The attorney general may require a manufacturer or wholesale distributor
8to produce any records or other documents that may be relevant to a determination
9of whether a violation of sub. (2) (a) has occurred.
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(c) On petition of the attorney general, a circuit court may issue an order doing
11any of the following:
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1. Compelling a manufacturer or wholesale distributor to do all of the following:
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a. Provide the information required under par. (a).
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b. Produce specific records or other documents requested by the attorney
15general under par. (b) that may be relevant to a determination of whether a violation
16of sub. (2) (a) has occurred.
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2. Restraining or enjoining a violation of sub. (2) (a).
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3. Restoring to any consumer, including a 3rd-party payer, any money acquired
19as a result of a price increase that violates sub. (2) (a).
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4. Requiring a manufacturer that has engaged in price gouging in the sale of
21an essential off-patent or generic drug to make the drug available to participants in
22any state public assistance program or state group health insurance program under
23s. 40.51 (6) for a period of up to one year at the price at which the drug was made
24available to participants in the state public assistance program or state group health
1insurance program under s. 40.51 (6) immediately prior to the manufacturer's
2violation of sub. (2) (a).
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5. Imposing a civil forfeiture of up to $10,000 for each violation of sub. (2) (a).
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(d) The attorney general may not bring an action for a remedy or penalty under
5par. (c) 2. to 5. unless the attorney general provides the manufacturer or wholesale
6distributor an opportunity to meet with the attorney general to offer a justification
7for the increase in the price of the essential off-patent or generic drug.
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(e) Any information provided by a manufacturer or a wholesale distributor to
9the attorney general under par. (a) or (b) is not subject to the right of public inspection
10and copying under s. 19.35 (1).
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(f) In an action brought by the attorney general under par. (c), a person who is
12alleged to have violated a requirement of this section may not assert as a defense that
13the person did not deal directly with a consumer residing in this state.