HB4900 EngrossedLRB100 20493 MJP 35855 b

1    AN ACT concerning regulation.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 1. Short title. This Act may be cited as the
5Illinois Generic Drug Pricing Fairness Act.
 
6    Section 5. Definitions. As used in this Act:
7    "Essential off-patent or generic drug" means any
8prescription drug sold within the State:
9        (1) for which all exclusive marketing rights, if any,
10    granted under the Federal Food, Drug, and Cosmetic Act,
11    Section 351 of the federal Public Health Service Act, and
12    federal patent law have expired;
13        (2) that appears on the model list of essential
14    medicines most recently adopted by the World Health
15    Organization or that has been designated by the United
16    States Secretary of Health and Human Services as an
17    essential medicine due to its efficacy in treating a
18    life-threatening health condition or a chronic health
19    condition that substantially impairs an individual's
20    ability to engage in activities of daily living; and
21        (3) that is actively manufactured and marketed for sale
22    in the United States by 3 or fewer manufacturers.
23    "Essential off-patent or generic drug" includes any

 

 

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1drug-device combination product used for the delivery of a drug
2for which all exclusive marketing rights, if any, granted under
3the Federal Food, Drug, and Cosmetic Act, Section 351 of the
4federal Public Health Service Act, and federal patent law have
5expired.
6    "Manufacturer" has the meaning provided in Section 15 of
7the Wholesale Drug Distribution Licensing Act.
8    "Price gouging" means an unconscionable increase in a
9prescription drug's price that:
10        (1) would result in an increase in the wholesale
11    acquisition cost of the essential off-patent or generic
12    drug of 30% or more within the preceding year, 50% or more
13    within the preceding 3 years, or 75% or more within the
14    preceding 5 years; or
15        (2) is otherwise excessive and unduly burdens
16    consumers because of the importance of the essential
17    off-patent or generic drug to their health and because of
18    insufficient competition in the marketplace.
19    "Price gouging" does not include a price increase that can
20be reasonably justified by:
21        (1) an increase in the cost of producing the essential
22    off-patent or generic drug; or
23        (2) the cost of appropriate expansion of access to the
24    essential off-patent or generic drug to promote public
25    health.
26    "State health plan" means the program of health benefits

 

 

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1under the State Employees Group Insurance Act of 1971.
2    "Wholesale acquisition cost" has the meaning provided in 42
3U.S.C. 1395w-3a.
4    "Wholesale drug distributor" has the meaning provided in
5Section 15 of the Wholesale Drug Distribution Licensing Act.
 
6    Section 10. Price gouging prohibited.
7    (a) A manufacturer or wholesale drug distributor shall not
8engage in price gouging in the sale of an essential off-patent
9or generic drug.
10    It is not a violation of this Act for a wholesale
11distributor to increase the price of an essential off-patent or
12generic drug if the price increase is directly attributable to
13additional costs for the essential off-patent or generic drug
14imposed on the wholesale drug distributor by the manufacturer
15of the drug.
16    For the purpose of the enforcement of this Act:
17        (1) the Director of Healthcare and Family Services may
18    notify the Attorney General of any increase in the price of
19    any essential off-patent or generic drug under the Medical
20    Assistance Program under Section V of the Illinois Public
21    Aid Code that amounts to price gouging; and
22        (2) the Director of Central Management Services may
23    notify the Attorney General of any increase in the price of
24    any essential off-patent or generic drug under the State
25    health plan that amounts to price gouging.

 

 

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1    (b) If the Attorney General has reason to believe that a
2manufacturer or wholesale drug distributor of an essential
3off-patent or generic drug has violated this Act, then the
4Attorney General shall send a notice to the manufacturer or the
5wholesale drug distributor requesting a statement:
6        (1) itemizing the components of the cost of producing
7    the essential off-patent or generic drug;
8        (2) identifying the circumstances and timing of an
9    increase in materials or manufacturing costs that caused an
10    increase in the price of the essential off-patent or
11    generic drug within the 5-year period preceding the date of
12    the price increase;
13        (3) identifying the circumstances and timing of any
14    expenditures made by the manufacturer to expand access to
15    the essential off-patent or generic drug and explaining any
16    improvement in public health associated with those
17    expenditures; and
18        (4) providing any other information that the
19    manufacturer or wholesale drug distributor believes to be
20    relevant to a determination of whether a violation of this
21    Act has occurred.
22    Within 45 days after receipt of the request, the
23manufacturer or wholesale drug distributor shall submit the
24statement to the Attorney General.
25    To accomplish the objectives and carry out the duties
26prescribed in this Act, the Attorney General may issue

 

 

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1subpoenas or examine under oath any person to determine whether
2a manufacturer or wholesale drug distributor has violated this
3Act.
4    (c) Upon petition of the Attorney General, a circuit court
5may issue an order:
6        (1) compelling a manufacturer or a wholesale drug
7    distributor:
8            (A) to provide a statement required under
9        subsection (b); or
10            (B) to produce specific records or other documents
11        requested by the Attorney General that may be relevant
12        to a determination of whether a violation of this Act
13        has occurred;
14        (2) restraining or enjoining a violation of this Act;
15        (3) restoring to any consumer, including a third-party
16    payor, any money acquired as a result of a price increase
17    that violates this Act;
18        (4) requiring a manufacturer or wholesale drug
19    distributor that has engaged in price gouging in the sale
20    of an essential off-patent or generic drug to make the drug
21    available to participants in the State health plan or
22    Medical Assistance Program under Section V of the Illinois
23    Public Aid Code for a period of up to one year at the price
24    at which the drug was made available to participants in
25    Illinois immediately before the violation of this Act;
26        (5) imposing a civil penalty of up to $10,000 for each

 

 

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1    violation of this Act; or
2        (6) granting any other relief.
3    In response to any petition brought by the Attorney General
4under this Section, a manufacturer or wholesale drug
5distributor who is alleged to have violated this Act may not
6assert as a defense that the manufacturer or wholesale drug
7distributor did not directly sell a product to a consumer
8residing in Illinois.
9    (d) Any financial information provided by a manufacturer or
10a wholesale drug distributor to the Attorney General in
11accordance with this Section may not be disclosed to the public
12by the Attorney General. The financial information, while in
13the possession of the Attorney General, shall be exempt from
14disclosure by the Attorney General under the Freedom of
15Information Act. Notwithstanding the other provisions of this
16subsection, if it appears to the Attorney General that a
17manufacturer or wholesale drug distributor has engaged in or is
18engaging in any practice declared to be in violation of this
19Act and that legal proceedings would be in the public interest,
20then the Attorney General may disclose any financial
21information provided in accordance with this Section in support
22of the filing of an action in the circuit court.
 
23    Section 99. Effective date. This Act takes effect January
241, 2019.