AB1046,2,55 a. All exclusive marketing rights for the prescription drug, if any, have expired.
AB1046,2,86 b. The prescription drug appears on the model list of essential medicines most
7recently adopted by the World Health Organization or is designated by the
8department of health services as an essential medicine under s. 250.04 (15).
AB1046,2,109 c. The prescription drug is actively manufactured and marketed for sale in the
10United States by 3 or fewer manufacturers.
AB1046,3,1
1d. The prescription drug is made available for sale in this state.
AB1046,3,42 2. A drug-device combination product for which all exclusive marketing rights,
3if any, have expired and used for the delivery of an essential off-patent or generic
4drug defined under subd. 1.
AB1046,3,75 (b) “Exclusive marketing rights” means exclusive marketing rights granted
6under the federal act, the federal public health service act under 42 USC 262, or
7federal patent law.
AB1046,3,98 (c) “Federal act” means the federal food, drug, and cosmetic act, 21 USC 301
9et seq.
AB1046,3,1010 (d) “Prescription drug” has the meaning given in s. 450.01 (20).
AB1046,3,1211 (e) “Price gouging” means to unconscionably increase the price of an essential
12off-patent or generic drug.
AB1046,3,1313 (f) “State public assistance program” means any of the following:
AB1046,3,1414 1. The medical assistance program under subch. IV of ch. 49.
AB1046,3,1615 2. A program for assisting victims of disease under ss. 49.68, 49.683, and
1649.685, and drug reimbursement under s. 49.686.
AB1046,3,1717 3. The program for prescription drug assistance for the elderly under s. 49.688.
AB1046,3,1918 (g) “Unconscionably increase” means to increase the price of an essential
19off-patent or generic drug if all of the following apply:
AB1046,3,2220 1. The increase in price is excessive and not justified by the cost of producing
21the drug or the cost of appropriate expansion of access to the drug to promote public
22health.
AB1046,3,2523 2. The increase in price results in a consumer for whom the essential off-patent
24or generic drug has been prescribed having no meaningful choice about whether to
25purchase the drug at an excessive price because any of the following applies:
AB1046,4,2
1a. The essential off-patent or generic drug is important to the consumer's
2health.
AB1046,4,43 b. Insufficient competition exists in the market for the essential off-patent or
4generic drug.
AB1046,4,7 5(2) Price gouging of certain drugs prohibited. (a) Except as provided in par.
6(b), no manufacturer or wholesale distributor may sell or offer to sell an essential
7off-patent or generic drug at a price that results in price gouging.
AB1046,4,118 (b) A wholesale distributor does not violate par. (a) by increasing the price of
9an essential off-patent or generic drug if the price increase is directly attributable
10to additional costs for the drug imposed on the wholesale distributor by the
11manufacturer of the drug.
AB1046,4,14 12(3) Enforcement. (a) The attorney general may require a manufacturer or
13wholesale distributor of an essential off-patent or generic drug to provide the
14following information within 45 days:
AB1046,4,1515 1. The components of the cost of producing the drug.
AB1046,4,1816 2. The circumstances and timing of any increase in materials or manufacturing
17costs that caused any increase in the price of the drug within the one-year period
18preceding the date of the price increase.
AB1046,4,2019 3. The circumstances and timing of any expenditures made by the
20manufacturer to expand access to the drug.
AB1046,4,2221 4. An explanation of any improvement in public health associated with any
22expenditures described in subd. 3.
AB1046,4,2423 5. Any other information that the manufacturer believes to be relevant to a
24determination of whether a violation of sub. (2) (a) has occurred.
AB1046,5,3
1(b) The attorney general may require a manufacturer or wholesale distributor
2to produce any records or other documents that may be relevant to a determination
3of whether a violation of sub. (2) (a) has occurred.
AB1046,5,54 (c) On petition of the attorney general, a circuit court may issue an order doing
5any of the following:
AB1046,5,66 1. Compelling a manufacturer or wholesale distributor to do all of the following:
AB1046,5,77 a. Provide the information required under par. (a).
AB1046,5,108 b. Produce specific records or other documents requested by the attorney
9general under par. (b) that may be relevant to a determination of whether a violation
10of sub. (2) (a) has occurred.
AB1046,5,1111 2. Restraining or enjoining a violation of sub. (2) (a).
AB1046,5,1312 3. Restoring to any consumer, including a 3rd-party payer, any money acquired
13as a result of a price increase that violates sub. (2) (a).
AB1046,5,2014 4. Requiring a manufacturer that has engaged in price gouging in the sale of
15an essential off-patent or generic drug to make the drug available to participants in
16any state public assistance program or state group health insurance program under
17s. 40.51 (6) for a period of up to one year at the price at which the drug was made
18available to participants in the state public assistance program or state group health
19insurance program under s. 40.51 (6) immediately prior to the manufacturer's
20violation of sub. (2) (a).
AB1046,5,2121 5. Imposing a civil forfeiture of up to $10,000 for each violation of sub. (2) (a).
AB1046,5,2522 (d) The attorney general may not bring an action for a remedy or penalty under
23par. (c) 2. to 5. unless the attorney general provides the manufacturer or wholesale
24distributor an opportunity to meet with the attorney general to offer a justification
25for the increase in the price of the essential off-patent or generic drug.
AB1046,6,3
1(e) Any information provided by a manufacturer or a wholesale distributor to
2the attorney general under par. (a) or (b) is not subject to the right of public inspection
3and copying under s. 19.35 (1).
AB1046,6,64 (f) In an action brought by the attorney general under par. (c), a person who is
5alleged to have violated a requirement of this section may not assert as a defense that
6the person did not deal directly with a consumer residing in this state.
AB1046,2 7Section 2. 250.04 (15) of the statutes is created to read:
AB1046,6,128 250.04 (15) The department may designate a prescription drug, as defined in
9s. 450.01 (20), as an essential medicine for purposes of s. 134.91 (1) (a) 1. b. if it is
10effective in treating a life-threatening health condition or a chronic health condition
11that substantially impairs an individual's ability to engage in activities of daily
12living.
AB1046,6,1313 (End)
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