Full Text of HB3957 103rd General Assembly
HB3957ham001 103RD GENERAL ASSEMBLY | Rep. Nabeela Syed Filed: 3/20/2023
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| 1 | | AMENDMENT TO HOUSE BILL 3957
| 2 | | AMENDMENT NO. ______. Amend House Bill 3957 by replacing | 3 | | everything after the enacting clause with the following:
| 4 | | "Section 1. Short title. This Act may be cited as the | 5 | | Pharmaceutical and Health Affordability: Restrictions on | 6 | | Manufacturers' Amoral Behavior through Reasonable Oversight | 7 | | Act. | 8 | | Section 2. Legislative Findings. | 9 | | (a) The General Assembly finds that public reports by | 10 | | Congress and the news media have
demonstrated the devastating | 11 | | impact that increasing drug prices can have on the
60% of | 12 | | Americans and 90% of seniors that take prescription drugs. | 13 | | (b) The General Assembly further finds that public reports | 14 | | describe a repeated pattern and practice
of price gouging by | 15 | | certain prescription drug manufacturers once they acquire the | 16 | | ownership rights for a
new generic drug. |
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| 1 | | (c) The General Assembly further finds that price gouging | 2 | | has forced patients to choose between
copayments exceeding | 3 | | tens of thousands of dollars per year and risking their health | 4 | | to find a more
affordable drug. | 5 | | (d) The General Assembly further finds that this choice | 6 | | has led patients to
delay or forgo necessary medications | 7 | | creating greater health risks and complications. | 8 | | (e) The General Assembly concludes that addressing | 9 | | accessibility of these life-saving medications
is a matter of | 10 | | health, safety, and welfare for the People of the State of | 11 | | Illinois. | 12 | | Section 5. Definitions. As used in this Act: | 13 | | "Essential off-patent or generic drug" means any | 14 | | prescription drug sold within the State: | 15 | | (1) for which all exclusive marketing rights, if any, | 16 | | granted under the Federal Food, Drug, and Cosmetic Act, | 17 | | Section 351 of the federal Public Health Service Act, and | 18 | | federal patent law have expired; | 19 | | (2) that appears on the model list of essential | 20 | | medicines most recently adopted by the World Health | 21 | | Organization or that has been designated by the United | 22 | | States Secretary of Health and Human Services as an | 23 | | essential medicine due to its efficacy in treating a | 24 | | life-threatening health condition or a chronic health | 25 | | condition that substantially impairs an individual's |
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| 1 | | ability to engage in activities of daily living; and | 2 | | (3) that is actively manufactured and marketed for | 3 | | sale in the United States by 3 or fewer manufacturers. | 4 | | "Essential off-patent or generic drug" includes any | 5 | | drug-device combination product used for the delivery of a | 6 | | drug for which all exclusive marketing rights, if any, granted | 7 | | under the Federal Food, Drug, and Cosmetic Act, Section 351 of | 8 | | the federal Public Health Service Act, and federal patent law | 9 | | have expired. | 10 | | "Manufacturer" has the meaning provided in Section 15 of | 11 | | the Wholesale Drug Distribution Licensing Act. Manufacturer" | 12 | | does not include an entity operating as a wholesale drug | 13 | | distributor as defined in Section 15 of the Wholesale Drug | 14 | | Distribution Licensing Act. | 15 | | "Price gouging" means an unconscionable increase in a | 16 | | prescription drug's price that: | 17 | | (1) would result in the wholesale acquisition cost of | 18 | | a 30-day supply of the essential off-patent or generic | 19 | | drug exceeding $20 and would result in an increase in the | 20 | | wholesale acquisition cost of the essential off-patent or | 21 | | generic drug of: | 22 | | (A) 30% or more within the preceding year; | 23 | | (B) 50% or more within the preceding 3 years; or | 24 | | (C) 75% or more within the preceding 5 years; | 25 | | (2) is otherwise excessive and unduly burdens | 26 | | consumers because of the importance of the essential |
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| 1 | | off-patent or generic drug to their health and because of | 2 | | insufficient competition in the marketplace. | 3 | | "Price gouging" does not include a price increase that can | 4 | | be reasonably justified by: | 5 | | (1) an increase in the cost of producing the essential | 6 | | off-patent or generic drug; or | 7 | | (2) the cost of appropriate expansion of access to the | 8 | | essential off-patent or generic drug to promote public | 9 | | health. | 10 | | "State health plan" means the program of health benefits | 11 | | under the State Employees Group Insurance Act of 1971. | 12 | | "Wholesale acquisition cost" has the meaning provided in | 13 | | 42 U.S.C. 1395w-3a. | 14 | | "Wholesale drug distributor" has the meaning provided in | 15 | | Section 15 of the Wholesale Drug Distribution Licensing Act. | 16 | | Section 10. Price gouging prohibited. | 17 | | (a) A manufacturer or wholesale drug distributor shall not | 18 | | engage in price gouging in the sale of an essential off-patent | 19 | | or generic drug that is ultimately sold in Illinois. | 20 | | It is not a violation of this Act for a wholesale | 21 | | distributor to increase the price of an essential off-patent | 22 | | or generic drug if the price increase is directly attributable | 23 | | to an increase in the wholesale acquisition cost for the | 24 | | essential off-patent or generic drug imposed on the wholesale | 25 | | drug distributor by the manufacturer of the drug. |
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| 1 | | For the purpose of the enforcement of this Act: | 2 | | (1) the Director of Healthcare and Family Services | 3 | | shall notify the Attorney General of any increase in the | 4 | | price of any essential off-patent or generic drug under | 5 | | the Medical Assistance Program under Section V of the | 6 | | Illinois Public Aid Code that amounts to price gouging; | 7 | | and | 8 | | (2) the Director of Central Management Services shall | 9 | | notify the Attorney General of any increase in the price | 10 | | of any essential off-patent or generic drug under the | 11 | | State health plan that amounts to price gouging. | 12 | | (b) If the Attorney General has reason to believe that a | 13 | | manufacturer or wholesale drug distributor of an essential | 14 | | off-patent or generic drug has violated this Act, then the | 15 | | Attorney General shall send a notice to the manufacturer or | 16 | | the wholesale drug distributor requesting a statement: | 17 | | (1) itemizing the components of the cost of producing | 18 | | the essential off-patent or generic drug; | 19 | | (2) identifying the circumstances and timing of an | 20 | | increase in materials or manufacturing costs that caused | 21 | | an increase in the wholesale acquisition cost of the | 22 | | essential off-patent or generic drug within the 5-year | 23 | | period preceding the date of the price increase; | 24 | | (3) identifying the circumstances and timing of any | 25 | | expenditures made by the manufacturer to expand access to | 26 | | the essential off-patent or generic drug and explaining |
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| 1 | | any improvement in public health associated with those | 2 | | expenditures; | 3 | | (4) identifying any communications with competitors of | 4 | | distributors about that drug and any price
changes; the | 5 | | request for a statement shall serve as a litigation hold | 6 | | regarding documents and communications
about that drug; | 7 | | and | 8 | | (5) providing any other information that the | 9 | | manufacturer or wholesale drug distributor believes to be | 10 | | relevant to a determination of whether a violation of this | 11 | | Act has occurred. | 12 | | Within 45 days after receipt of the request, the | 13 | | manufacturer or wholesale drug distributor shall submit the | 14 | | statement to the Attorney General. | 15 | | To accomplish the objectives and carry out the duties | 16 | | prescribed in this Act, the Attorney General may issue | 17 | | subpoenas or examine under oath any person to determine | 18 | | whether a manufacturer or wholesale drug distributor has | 19 | | violated this Act. | 20 | | (c) Upon petition of the Attorney General, a circuit court | 21 | | may issue an order: | 22 | | (1) compelling a manufacturer or a wholesale drug | 23 | | distributor: | 24 | | (A) to provide a statement required under | 25 | | subsection (b); or | 26 | | (B) to produce specific records or other documents |
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| 1 | | requested by the Attorney General that may be relevant | 2 | | to a determination of whether a violation of this Act | 3 | | has occurred; | 4 | | (2) restraining or enjoining a violation of this Act; | 5 | | (3) restoring to any consumer, including a third-party | 6 | | payor, any money acquired as a result of a price increase | 7 | | that violates this Act; | 8 | | (4) requiring a manufacturer or wholesale drug | 9 | | distributor that has engaged in price gouging in the sale | 10 | | of an essential off-patent or generic drug to make the | 11 | | drug available to participants in the State health plan or | 12 | | Medical Assistance Program under Section V of the Illinois | 13 | | Public Aid Code for a period of up to one year at the price | 14 | | at which the drug was made available to participants in | 15 | | Illinois immediately before the violation of this Act; | 16 | | (5) imposing a civil penalty of up to $10,000 per day | 17 | | for each violation of this Act; | 18 | | (6) providing for the Attorney General's recovery of | 19 | | costs and disbursements incurred in
bringing an action | 20 | | against a manufacturer found to be in violation of this | 21 | | Act, including the costs of
investigation and reasonable | 22 | | attorney's fees; or | 23 | | (7) granting any other relief. | 24 | | In response to any petition brought by the Attorney | 25 | | General under this Section, a manufacturer or wholesale drug | 26 | | distributor who is alleged to have violated this Act may not |
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| 1 | | assert as a defense that the manufacturer or wholesale drug | 2 | | distributor did not directly sell a product to a consumer | 3 | | residing in Illinois. | 4 | | (d) Any financial information provided by a manufacturer | 5 | | or a wholesale drug distributor to the Attorney General in | 6 | | accordance with this Section may not be disclosed to the | 7 | | public by the Attorney General. The financial information, | 8 | | while in the possession of the Attorney General, shall be | 9 | | exempt from disclosure by the Attorney General under the | 10 | | Freedom of Information Act. Notwithstanding the other | 11 | | provisions of this subsection, if it appears to the Attorney | 12 | | General that a manufacturer or wholesale drug distributor has | 13 | | engaged in or is engaging in any practice declared to be in | 14 | | violation of this Act and that legal proceedings would be in | 15 | | the public interest, then the Attorney General may disclose | 16 | | any financial information provided in accordance with this | 17 | | Section in support of the filing of an action in the circuit | 18 | | court. | 19 | | Section 99. Effective date. This Act takes effect January | 20 | | 1, 2024.".
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