102ND GENERAL ASSEMBLY
State of Illinois
2021 and 2022
HB3583

 

Introduced 2/22/2021, by Rep. Dagmara Avelar

 

SYNOPSIS AS INTRODUCED:
 
New Act
5 ILCS 140/7.5

    Creates the Affordable Drug Manufacturing Act. Provides that the Department of Public Health shall enter into partnerships to increase competition, lower prices, and address shortages in the market for generic prescription drugs, to reduce the cost of prescription drugs for public and private purchasers, taxpayers, and consumers, and to increase patient access to affordable drugs. Requires the partnerships to result in the production or distribution of generic prescription drugs with the intent that these drugs be made widely available to public and private purchasers, providers and suppliers, and pharmacies. Provides that the Department shall comply with specified requirements when entering into partnerships or setting prices for generic prescription drugs. Requires the Department to submit separate reports to the General Assembly that (1) assess the feasibility of directly manufacturing generic prescription drugs and selling generic prescription drugs at a fair price; and (2) describe the status of all drugs targeted under the Act and analyze how the activities of the Department may impact competition, access to targeted drugs, the costs of those drugs, and the costs of generic prescription drugs to public and private purchasers. Contains other provisions. Amends the Freedom of Information Act to exempt certain information disclosed under the Affordable Drug Manufacturing Act is exempt from disclosure under the Act. Contains a severability provision. Effective July 1, 2021.


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FISCAL NOTE ACT MAY APPLY

 

 

A BILL FOR

 

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1    AN ACT concerning health.
 
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
5Affordable Drug Manufacturing Act.
 
6    Section 5. Definitions. In this Act:
7    "Department" means the Department of Public Health.
8    "Generic drug" means a drug that is approved pursuant to
9subsection (j) of Section 355 of the federal Food, Drug, and
10Cosmetic Act (21 U.S.C. Sec. 301 et seq.) or a biosimilar, as
11defined under the federal Public Health Service Act (42 U.S.C.
12Sec. 262).
13    "Partnerships" include, but are not limited to, agreements
14for the procurement of generic prescription drugs by way of
15contracts or purchasing by a payer, State governmental agency,
16group purchasing organization, nonprofit organization, or
17other entity.
18    "Provider" means a hospital licensed under the Hospital
19Licensing Act or organized under the University of Illinois
20Hospital Act, a skilled nursing facility as that term is
21defined under Section 2 of the Comprehensive Health Insurance
22Plan Act, a comprehensive outpatient rehabilitation facility,
23a home health agency as that term is defined under Section 2.04

 

 

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1of the Home Health, Home Services, and Home Nursing Agency
2Licensing Act, a hospice as that term is defined under Section
32 of the Comprehensive Health Insurance Plan Act, a public
4health clinic as that term is defined under Section 6-101 of
5the Local Governmental and Governmental Employees Tort
6Immunity Act, or a rehabilitation agency.
7    "Supplier" means a physician and surgeon or other health
8care practitioner, or an entity that furnishes health care
9services other than a provider.
 
10    Section 10. Cost of prescription drugs; partnerships.
11    (a) The Department shall enter into partnerships
12consistent with subsection (b) of Section 15, in consultation
13with other State agencies as necessary, to increase
14competition, lower prices, and address shortages in the market
15for generic prescription drugs, reduce the cost of
16prescription drugs for public and private purchasers,
17taxpayers, and consumers, and increase patient access to
18affordable drugs.
19    (b) The Department may hire staff to oversee and
20project-manage the partnerships for manufacturing or
21distribution of generic prescription drugs, contingent upon an
22appropriation by the General Assembly for this purpose.
 
23    Section 15. Prescription drug prices.
24    (a) The Department shall enter into partnerships resulting

 

 

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1in the production or distribution of generic prescription
2drugs with the intent that these drugs be made widely
3available to public and private purchasers, providers and
4suppliers, and pharmacies licensed under the Pharmacy Practice
5Act, as appropriate. The generic prescription drugs shall be
6produced or distributed by a drug company or generic drug
7manufacturer that is registered with the United States Food
8and Drug Administration.
9    (b) The Department shall comply with the following
10requirements when entering into partnerships or setting prices
11for generic prescription drugs:
12        (1) The Department shall only enter into partnerships
13    pursuant to subsection (a) to produce a generic
14    prescription drug at a price that results in savings,
15    targets failures in the market for generic drugs, and
16    improves patient access to affordable medications.
17        (2) For top drugs identified pursuant to the criteria
18    listed in paragraph (5), the Department shall determine if
19    viable pathways exist for partnerships to manufacture or
20    distribute generic prescription drugs by examining the
21    relevant legal, market, policy, and regulatory factors.
22        (3) The Department shall consider the following, if
23    applicable, when setting the price of the generic
24    prescription drug:
25            (A) United States Food and Drug Administration
26        user fees.

 

 

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1            (B) Abbreviated new drug application acquisition
2        costs, amortized over a 5-year period.
3            (C) Mandatory rebates.
4            (D) Total contracting and production costs for the
5        drug, including a reasonable amount for
6        administrative, operating, and rate-of-return expenses
7        of the drug company or generic drug manufacturer.
8            (E) Research and development costs attributed to
9        the drug over a 5-year period.
10            (F) Other initial start-up costs amortized over a
11        5-year period.
12        (4) Each drug shall be made available to providers,
13    patients, and purchasers at a transparent price and
14    without rebates, other than federally required rebates.
15        (5) The Department shall prioritize the selection of
16    generic prescription drugs that have the greatest impact
17    on lowering drug costs to patients, increasing competition
18    and addressing shortages in the prescription drug market,
19    improving public health, or reducing the cost of
20    prescription drugs to public and private purchasers.
21    (c) In identifying generic prescription drugs to be
22produced, the Department shall consider pharmacy spending data
23from Medicaid and other entities for which the State pays the
24cost of generic prescription drugs.
25    The partnerships entered into pursuant to subsection (a)
26shall include the production of at least one form of insulin,

 

 

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1provided that a viable pathway for manufacturing a more
2affordable form of insulin exists.
3    The Department shall prioritize drugs for chronic and
4high-cost conditions and shall consider prioritizing those
5that can be delivered through mail order.
6    (d) The Department shall consult with all of the following
7public and private purchasers to assist in developing a list
8of generic prescription drugs to be manufactured or
9distributed through partnerships and to determine the volume
10of each generic prescription drug that can be procured over a
11multiyear period to support a market for a lower cost generic
12prescription drug:
13        (1) Any public agency that is a purchaser.
14        (2) Health insurers holding a valid outstanding
15    certificate of authority from the Director of Insurance.
16        (3) Hospitals.
17        (4) Pharmacy benefit managers.
18    (e) Before entering into a partnership pursuant to this
19Section, the Department shall determine minimum thresholds for
20procurement of an entity's expected volume of a targeted drug
21from the company or manufacturer over a multiyear period.
22    (f) The entities listed in paragraphs (2) through (5) of
23subsection (d) shall not be required to purchase prescription
24drugs from the Department or entities that contract or partner
25with the Department pursuant to this Act.
26    (g) The Department shall not be required to consult with

 

 

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1every entity listed in paragraphs (2) through (5) of
2subsection (d), so long as purchaser engagement includes a
3reasonable representation from these groups.
 
4    Section 20. Feasibility report.
5    (a) On or before July 1, 2023, the Department shall submit
6a report to the General Assembly that assesses the feasibility
7of directly manufacturing generic prescription drugs and
8selling generic prescription drugs at a fair price. The report
9shall include an analysis of governance structure options for
10manufacturing functions, including chartering a private
11organization, public-private partnership, or public board of
12directors.
13    (b) This Section is repealed on January 1, 2025.
 
14    Section 25. Status and analysis report.
15    (a) On or before July 1, 2022, the Department shall report
16to the General Assembly on both of the following:
17        (1) A description of the status of all drugs targeted
18    under this Act.
19        (2) An analysis of how the activities of the
20    Department may impact competition, access to targeted
21    drugs, the costs of those drugs, and the costs of generic
22    prescription drugs to public and private purchasers.
23    (b) This Section is repealed on January 1, 2026.
 

 

 

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1    Section 30. Nonpublic information; disclosure.
2Notwithstanding any other provision of law, all nonpublic
3information and documents obtained under this Act shall not be
4required to be disclosed pursuant to the Freedom of
5Information Act.
 
6    Section 35. The Freedom of Information Act is amended by
7changing Section 7.5 as follows:
 
8    (5 ILCS 140/7.5)
9    Sec. 7.5. Statutory exemptions. To the extent provided for
10by the statutes referenced below, the following shall be
11exempt from inspection and copying:
12        (a) All information determined to be confidential
13    under Section 4002 of the Technology Advancement and
14    Development Act.
15        (b) Library circulation and order records identifying
16    library users with specific materials under the Library
17    Records Confidentiality Act.
18        (c) Applications, related documents, and medical
19    records received by the Experimental Organ Transplantation
20    Procedures Board and any and all documents or other
21    records prepared by the Experimental Organ Transplantation
22    Procedures Board or its staff relating to applications it
23    has received.
24        (d) Information and records held by the Department of

 

 

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1    Public Health and its authorized representatives relating
2    to known or suspected cases of sexually transmissible
3    disease or any information the disclosure of which is
4    restricted under the Illinois Sexually Transmissible
5    Disease Control Act.
6        (e) Information the disclosure of which is exempted
7    under Section 30 of the Radon Industry Licensing Act.
8        (f) Firm performance evaluations under Section 55 of
9    the Architectural, Engineering, and Land Surveying
10    Qualifications Based Selection Act.
11        (g) Information the disclosure of which is restricted
12    and exempted under Section 50 of the Illinois Prepaid
13    Tuition Act.
14        (h) Information the disclosure of which is exempted
15    under the State Officials and Employees Ethics Act, and
16    records of any lawfully created State or local inspector
17    general's office that would be exempt if created or
18    obtained by an Executive Inspector General's office under
19    that Act.
20        (i) Information contained in a local emergency energy
21    plan submitted to a municipality in accordance with a
22    local emergency energy plan ordinance that is adopted
23    under Section 11-21.5-5 of the Illinois Municipal Code.
24        (j) Information and data concerning the distribution
25    of surcharge moneys collected and remitted by carriers
26    under the Emergency Telephone System Act.

 

 

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1        (k) Law enforcement officer identification information
2    or driver identification information compiled by a law
3    enforcement agency or the Department of Transportation
4    under Section 11-212 of the Illinois Vehicle Code.
5        (l) Records and information provided to a residential
6    health care facility resident sexual assault and death
7    review team or the Executive Council under the Abuse
8    Prevention Review Team Act.
9        (m) Information provided to the predatory lending
10    database created pursuant to Article 3 of the Residential
11    Real Property Disclosure Act, except to the extent
12    authorized under that Article.
13        (n) Defense budgets and petitions for certification of
14    compensation and expenses for court appointed trial
15    counsel as provided under Sections 10 and 15 of the
16    Capital Crimes Litigation Act. This subsection (n) shall
17    apply until the conclusion of the trial of the case, even
18    if the prosecution chooses not to pursue the death penalty
19    prior to trial or sentencing.
20        (o) Information that is prohibited from being
21    disclosed under Section 4 of the Illinois Health and
22    Hazardous Substances Registry Act.
23        (p) Security portions of system safety program plans,
24    investigation reports, surveys, schedules, lists, data, or
25    information compiled, collected, or prepared by or for the
26    Regional Transportation Authority under Section 2.11 of

 

 

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1    the Regional Transportation Authority Act or the St. Clair
2    County Transit District under the Bi-State Transit Safety
3    Act.
4        (q) Information prohibited from being disclosed by the
5    Personnel Record Review Act.
6        (r) Information prohibited from being disclosed by the
7    Illinois School Student Records Act.
8        (s) Information the disclosure of which is restricted
9    under Section 5-108 of the Public Utilities Act.
10        (t) All identified or deidentified health information
11    in the form of health data or medical records contained
12    in, stored in, submitted to, transferred by, or released
13    from the Illinois Health Information Exchange, and
14    identified or deidentified health information in the form
15    of health data and medical records of the Illinois Health
16    Information Exchange in the possession of the Illinois
17    Health Information Exchange Office due to its
18    administration of the Illinois Health Information
19    Exchange. The terms "identified" and "deidentified" shall
20    be given the same meaning as in the Health Insurance
21    Portability and Accountability Act of 1996, Public Law
22    104-191, or any subsequent amendments thereto, and any
23    regulations promulgated thereunder.
24        (u) Records and information provided to an independent
25    team of experts under the Developmental Disability and
26    Mental Health Safety Act (also known as Brian's Law).

 

 

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1        (v) Names and information of people who have applied
2    for or received Firearm Owner's Identification Cards under
3    the Firearm Owners Identification Card Act or applied for
4    or received a concealed carry license under the Firearm
5    Concealed Carry Act, unless otherwise authorized by the
6    Firearm Concealed Carry Act; and databases under the
7    Firearm Concealed Carry Act, records of the Concealed
8    Carry Licensing Review Board under the Firearm Concealed
9    Carry Act, and law enforcement agency objections under the
10    Firearm Concealed Carry Act.
11        (w) Personally identifiable information which is
12    exempted from disclosure under subsection (g) of Section
13    19.1 of the Toll Highway Act.
14        (x) Information which is exempted from disclosure
15    under Section 5-1014.3 of the Counties Code or Section
16    8-11-21 of the Illinois Municipal Code.
17        (y) Confidential information under the Adult
18    Protective Services Act and its predecessor enabling
19    statute, the Elder Abuse and Neglect Act, including
20    information about the identity and administrative finding
21    against any caregiver of a verified and substantiated
22    decision of abuse, neglect, or financial exploitation of
23    an eligible adult maintained in the Registry established
24    under Section 7.5 of the Adult Protective Services Act.
25        (z) Records and information provided to a fatality
26    review team or the Illinois Fatality Review Team Advisory

 

 

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1    Council under Section 15 of the Adult Protective Services
2    Act.
3        (aa) Information which is exempted from disclosure
4    under Section 2.37 of the Wildlife Code.
5        (bb) Information which is or was prohibited from
6    disclosure by the Juvenile Court Act of 1987.
7        (cc) Recordings made under the Law Enforcement
8    Officer-Worn Body Camera Act, except to the extent
9    authorized under that Act.
10        (dd) Information that is prohibited from being
11    disclosed under Section 45 of the Condominium and Common
12    Interest Community Ombudsperson Act.
13        (ee) Information that is exempted from disclosure
14    under Section 30.1 of the Pharmacy Practice Act.
15        (ff) Information that is exempted from disclosure
16    under the Revised Uniform Unclaimed Property Act.
17        (gg) Information that is prohibited from being
18    disclosed under Section 7-603.5 of the Illinois Vehicle
19    Code.
20        (hh) Records that are exempt from disclosure under
21    Section 1A-16.7 of the Election Code.
22        (ii) Information which is exempted from disclosure
23    under Section 2505-800 of the Department of Revenue Law of
24    the Civil Administrative Code of Illinois.
25        (jj) Information and reports that are required to be
26    submitted to the Department of Labor by registering day

 

 

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1    and temporary labor service agencies but are exempt from
2    disclosure under subsection (a-1) of Section 45 of the Day
3    and Temporary Labor Services Act.
4        (kk) Information prohibited from disclosure under the
5    Seizure and Forfeiture Reporting Act.
6        (ll) Information the disclosure of which is restricted
7    and exempted under Section 5-30.8 of the Illinois Public
8    Aid Code.
9        (mm) Records that are exempt from disclosure under
10    Section 4.2 of the Crime Victims Compensation Act.
11        (nn) Information that is exempt from disclosure under
12    Section 70 of the Higher Education Student Assistance Act.
13        (oo) Communications, notes, records, and reports
14    arising out of a peer support counseling session
15    prohibited from disclosure under the First Responders
16    Suicide Prevention Act.
17        (pp) Names and all identifying information relating to
18    an employee of an emergency services provider or law
19    enforcement agency under the First Responders Suicide
20    Prevention Act.
21        (qq) Information and records held by the Department of
22    Public Health and its authorized representatives collected
23    under the Reproductive Health Act.
24        (rr) Information that is exempt from disclosure under
25    the Cannabis Regulation and Tax Act.
26        (ss) Data reported by an employer to the Department of

 

 

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1    Human Rights pursuant to Section 2-108 of the Illinois
2    Human Rights Act.
3        (tt) Recordings made under the Children's Advocacy
4    Center Act, except to the extent authorized under that
5    Act.
6        (uu) Information that is exempt from disclosure under
7    Section 50 of the Sexual Assault Evidence Submission Act.
8        (vv) Information that is exempt from disclosure under
9    subsections (f) and (j) of Section 5-36 of the Illinois
10    Public Aid Code.
11        (ww) Information that is exempt from disclosure under
12    Section 16.8 of the State Treasurer Act.
13        (xx) Information that is exempt from disclosure or
14    information that shall not be made public under the
15    Illinois Insurance Code.
16        (yy) Information prohibited from being disclosed under
17    the Illinois Educational Labor Relations Act.
18        (zz) Information prohibited from being disclosed under
19    the Illinois Public Labor Relations Act.
20        (aaa) Information prohibited from being disclosed
21    under Section 1-167 of the Illinois Pension Code.
22        (bbb) Information prohibited from being disclosed
23    under Section 30 of the Affordable Drug Manufacturing Act.
24(Source: P.A. 100-20, eff. 7-1-17; 100-22, eff. 1-1-18;
25100-201, eff. 8-18-17; 100-373, eff. 1-1-18; 100-464, eff.
268-28-17; 100-465, eff. 8-31-17; 100-512, eff. 7-1-18; 100-517,

 

 

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1eff. 6-1-18; 100-646, eff. 7-27-18; 100-690, eff. 1-1-19;
2100-863, eff. 8-14-18; 100-887, eff. 8-14-18; 101-13, eff.
36-12-19; 101-27, eff. 6-25-19; 101-81, eff. 7-12-19; 101-221,
4eff. 1-1-20; 101-236, eff. 1-1-20; 101-375, eff. 8-16-19;
5101-377, eff. 8-16-19; 101-452, eff. 1-1-20; 101-466, eff.
61-1-20; 101-600, eff. 12-6-19; 101-620, eff 12-20-19; 101-649,
7eff. 7-7-20.)
 
8    Section 97. Severability. The provisions of this Act are
9severable under Section 1.31 of the Statute on Statutes.
 
10    Section 99. Effective date. This Act takes effect July 1,
112021.