103RD GENERAL ASSEMBLY
State of Illinois
2023 and 2024
SB3727

 

Introduced 2/9/2024, by Sen. Ann Gillespie

 

SYNOPSIS AS INTRODUCED:
 
New Act

    Creates the Patient Access to Pharmacy Protection Act. Defines terms. Provides that no person, including a pharmaceutical manufacturer, may deny, restrict, prohibit, condition, or otherwise interfere with, either directly or indirectly, the acquisition of a 340B drug by, or delivery of a 340B drug to, a 340B covered entity or a 340B contract pharmacy authorized to receive 340B drugs on behalf of the 340B covered entity unless such receipt is prohibited by federal law. Provides that no person, including a pharmaceutical manufacturer, may impose any restriction on the ability of a 340B covered entity to contract with or designate a 340B contract pharmacy including restrictions relating to the number, location, ownership, or type of 340B contract pharmacy. Provides that no person, including a pharmaceutical manufacturer, may require or compel a 340B covered entity or 340B contract pharmacy to submit or otherwise provide ingredient cost or pricing data pertinent to 340B drugs; institute requirements in any way relating to how a 340B covered entity manages its inventory of 340B drugs that are not required by a State or federal agency, including requirements relating to the frequency or scope of audits of inventory management systems of a 340B covered entity or a 340B contract pharmacy; or require a 340B covered entity or its 340B contract pharmacy to submit or otherwise provide data or information that is not required by State or federal law. Sets forth provisions concerning enforcement of this Act; preemption of this Act; and severability of this Act. Effective immediately.


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A BILL FOR

 

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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
5Patient Access to Pharmacy Protection Act.
 
6    Section 5. Findings. The General Assembly finds that:
7    (a) It is within the traditional authority of the State to
8regulate the acquisition and delivery of drugs to pharmacies
9and providers.
10    (b) Drug manufacturers are impeding access to lifesaving
11drugs to Illinois residents, especially those in rural and
12medically underserved communities, by limiting or placing
13conditions on acquisition and delivery of drugs purchased
14through the federal 340B drug discount program by 340B covered
15entities that utilize contract pharmacies to distribute 340B
16drugs.
17    (c) The federal 340B statute is silent on distribution of
18340B-acquired drugs to 340B covered entities and their
19contract pharmacy partners.
20    (d) The State's compelling interest in preserving and
21improving access to health care services for the People of the
22State of Illinois requires it to ensure that 340B covered
23entities continue to be allowed to contract with one or more

 

 

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1pharmacies to receive 340B drugs and dispense them to the
2patients of 340B covered entities.
3    (e) That addressing accessibility of these life-saving
4medications is a matter of health, safety, and welfare for the
5people of the State of Illinois.
 
6    Section 10. Definitions. As used in this Act:
7    "340B drug discount program" means the program established
8under Section 340B of the federal Public Health Service Act,
942 U.S.C. 256b.
10    "340B contract pharmacy" means any pharmacy that is under
11contract with a 340B covered entity to dispense 340B drugs on
12behalf of the 340B covered entity and is either (i) located in
13Illinois and qualifies as a pharmacy under Section 3 of the
14Pharmacy Practice Act; or (ii) is located in a state,
15commonwealth, or territory of the United States, other than
16Illinois, and dispenses 340B drugs on behalf of the 340B
17covered entity.
18    "340B covered entity" means an entity in Illinois that
19qualifies as a covered entity under Section 340B of the
20federal Public Health Service Act, 42 U.S.C. 256b(a)(4).
21    "340B drug" means a drug that has been subject to any offer
22for reduced prices by a manufacturer pursuant to 42 U.S.C.
23256b and is purchased by a 340B covered entity.
24    "Department" means the Department of Financial and
25Professional Regulation.

 

 

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1    "Manufacturer" has the meaning given to that term in the
2Wholesale Drug Distribution Licensing Act.
3    "Person" means and includes a natural person, partnership,
4association, corporation, or any other legal business entity,
5but does not include any federal or state government entity or
6body.
7    "Secretary" means the Secretary of Financial and
8Professional Regulation.
 
9    Section 15. Protection of patient access to pharmacy.
10    (a) No person, including a pharmaceutical manufacturer,
11may deny, restrict, prohibit, condition, or otherwise
12interfere with, either directly or indirectly, the acquisition
13of a 340B drug by, or delivery of a 340B drug to, a 340B
14covered entity or a 340B contract pharmacy authorized to
15receive 340B drugs on behalf of the 340B covered entity unless
16such receipt is prohibited by federal law.
17    (b) No person, including a pharmaceutical manufacturer,
18may impose any restriction on the ability of a 340B covered
19entity to contract with or designate a 340B contract pharmacy
20including restrictions relating to the number, location,
21ownership, or type of 340B contract pharmacy.
22    (c) No person, including a pharmaceutical manufacturer,
23may require or compel a 340B covered entity or 340B contract
24pharmacy to:
25        (1) submit or otherwise provide ingredient cost or

 

 

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1    pricing data pertinent to 340B drugs;
2        (2) institute requirements in any way relating to how
3    a 340B covered entity manages its inventory of 340B drugs
4    that are not required by a state or federal agency,
5    including requirements relating to the frequency or scope
6    of audits of inventory management systems of a 340B
7    covered entity or a 340B contract pharmacy; or
8        (3) require a 340B covered entity or its 340B contract
9    pharmacy to submit or otherwise provide data or
10    information that is not required by State or federal law.
11    (d) Each individual saleable unit, as such term is defined
12in 21 U.S.C. 360eee-11, of 340B drugs that is subject to a
13prohibited act in subsections (a) and (b) shall constitute a
14separate violation of this Act. Each communication received by
15a 340B covered entity or 340B contract pharmacy in violation
16of subsection (c) shall constitute a separate violation of
17this Act.
 
18    Section 20. Enforcement.
19    (a) The Department is authorized to enforce this Act and
20investigate possible violations of this Act by any person,
21including a pharmaceutical manufacturer, including, but not
22limited to, the issuance of subpoenas to:
23        (1) require the person, including a pharmaceutical
24    manufacturer, to file a statement or report or answer
25    interrogatories in writing as to all information relevant

 

 

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1    to the alleged violations;
2        (2) examine under oath any person, including a
3    pharmaceutical manufacturer, who possesses knowledge or
4    information directly related to the alleged violations; or
5        (3) examine any record, book, document, account, or
6    paper necessary to investigate the alleged violation.
7    (b) If the Department determines that there is a reason to
8believe that any person, including a pharmaceutical
9manufacturer, has violated this Act, the Secretary may, in the
10name of the People of the State of Illinois, through the
11Attorney General of the State of Illinois or the State's
12Attorney of a county in which the action is brought, bring an
13action to obtain, and a court may order:
14        (1) temporary, preliminary, or permanent injunctive
15    relief for any act, policy, or practice that violates this
16    Act;
17        (2) money damages to be paid to the 340B covered
18    entity as a result of the violation of this Section;
19        (3) the assessment of a civil penalty of up to $10,000
20    for each violation of Section 15; or
21        (4) any other relief.
22        
23    (c) Whenever a 340B covered entity or 340B contract
24pharmacy has reason to believe that any person, including a
25pharmaceutical manufacturer, has violated Section 15, a 340B
26covered entity or 340B contract pharmacy may bring a civil

 

 

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1action to obtain, and a court may order:
2        (1) temporary, preliminary, or permanent injunctive
3    relief for any act, policy, or practice that violates this
4    Act;
5        (2) money damages to be paid to the 340B covered
6    entity as a result of the violation of this Section;
7        (3) the assessment of a civil penalty of up to $10,000
8    for each violation of Section 15;
9        (4) reimbursement for the costs and reasonable
10    attorney's fees incurred in bringing the action; or
11        (5) any other relief.
12    (d) The actions described in subsections (b) and (c) may
13be consolidated or combined if a court believes that an action
14in such form is in the best interests of judicial economy. If
15an action brought under subsection (b) involves the same or
16similar allegations as an action brought under subsection (c),
17then the actions may be combined.
 
18    Section 25. Preemption.
19    (a) Nothing in this Act shall be construed or applied to be
20less restrictive than federal law for a person regulated by
21this Act.
22    (b) Nothing in this Act shall be construed or applied in a
23manner that would conflict with:
24        (1) applicable federal law; or
25        (2) other laws of this State if the State law is

 

 

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1    compatible with applicable federal law.
2    (c) Limited distribution of a drug required under 21
3U.S.C. 355-1 may not to be construed as a violation of this
4Act.
 
5    Section 90. Severability. If any provision of this Act or
6its application to any person or circumstance is held invalid,
7the invalidity of that provision or application does not
8affect other provisions or applications of this Act that can
9be given effect without the invalid provision or application.
10Each paragraph defining "340B contract pharmacy" in Section 10
11is severable.
 
12    Section 99. Effective date. This Act takes effect upon
13becoming law.