Full Text of HB4900 100th General Assembly
HB4900eng 100TH GENERAL ASSEMBLY |
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| 1 | | AN ACT concerning regulation.
| 2 | | Be it enacted by the People of the State of Illinois,
| 3 | | represented in the General Assembly:
| 4 | | Section 1. Short title. This Act may be cited as the | 5 | | Illinois Generic Drug Pricing Fairness Act. | 6 | | Section 5. Definitions. As used in this Act: | 7 | | "Essential off-patent or generic drug" means any | 8 | | prescription 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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| 1 | | drug-device combination product used for the delivery of a drug | 2 | | for which all exclusive marketing rights, if any, granted under | 3 | | the Federal Food, Drug, and Cosmetic Act, Section 351 of the | 4 | | federal Public Health Service Act, and federal patent law have | 5 | | expired. | 6 | | "Manufacturer" has the meaning provided in Section 15 of | 7 | | the Wholesale Drug Distribution Licensing Act. | 8 | | "Price gouging" means an unconscionable increase in a | 9 | | prescription 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 | 20 | | be 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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| 1 | | under the State Employees Group Insurance Act of 1971. | 2 | | "Wholesale acquisition cost" has the meaning provided in 42 | 3 | | U.S.C. 1395w-3a. | 4 | | "Wholesale drug distributor" has the meaning provided in | 5 | | Section 15 of the Wholesale Drug Distribution Licensing Act. | 6 | | Section 10. Price gouging prohibited. | 7 | | (a) A manufacturer or wholesale drug distributor shall not | 8 | | engage in price gouging in the sale of an essential off-patent | 9 | | or generic drug. | 10 | | It is not a violation of this Act for a wholesale | 11 | | distributor to increase the price of an essential off-patent or | 12 | | generic drug if the price increase is directly attributable to | 13 | | additional costs for the essential off-patent or generic drug | 14 | | imposed on the wholesale drug distributor by the manufacturer | 15 | | of 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 | 2 | | manufacturer or wholesale drug distributor of an essential | 3 | | off-patent or generic drug has violated this Act, then the | 4 | | Attorney General shall send a notice to the manufacturer or the | 5 | | wholesale 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 | 23 | | manufacturer or wholesale drug distributor shall submit the | 24 | | statement to the Attorney General. | 25 | | To accomplish the objectives and carry out the duties | 26 | | prescribed in this Act, the Attorney General may issue |
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| 1 | | subpoenas or examine under oath any person to determine whether | 2 | | a manufacturer or wholesale drug distributor has violated this | 3 | | Act. | 4 | | (c) Upon petition of the Attorney General, a circuit court | 5 | | may 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 | 4 | | under this Section, a manufacturer or wholesale drug | 5 | | distributor who is alleged to have violated this Act may not | 6 | | assert as a defense that the manufacturer or wholesale drug | 7 | | distributor did not directly sell a product to a consumer | 8 | | residing in Illinois. | 9 | | (d) Any financial information provided by a manufacturer or | 10 | | a wholesale drug distributor to the Attorney General in | 11 | | accordance with this Section may not be disclosed to the public | 12 | | by the Attorney General. The financial information, while in | 13 | | the possession of the Attorney General, shall be exempt from | 14 | | disclosure by the Attorney General under the Freedom of | 15 | | Information Act. Notwithstanding the other provisions of this | 16 | | subsection, if it appears to the Attorney General that a | 17 | | manufacturer or wholesale drug distributor has engaged in or is | 18 | | engaging in any practice declared to be in violation of this | 19 | | Act and that legal proceedings would be in the public interest, | 20 | | then the Attorney General may disclose any financial | 21 | | information provided in accordance with this Section in support | 22 | | of the filing of an action in the circuit court. | 23 | | Section 99. Effective date. This Act takes effect January | 24 | | 1, 2019.
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