103RD GENERAL ASSEMBLY
State of Illinois
2023 and 2024
HB3256

 

Introduced 2/17/2023, by Rep. Nabeela Syed

 

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 from inspection and copying under the Act. Contains a severability provision. Effective July 1, 2023.


LRB103 27492 CPF 53866 b

 

 

A BILL FOR

 

HB3256LRB103 27492 CPF 53866 b

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    "Eligible prescription drug" means a prescription drug
9that is not under patent or a biological product, as defined in
1042 U.S.C. 262(i), that is not under patent.
11    "Generic prescription drug" means a drug that is approved
12pursuant to an application referencing an eligible
13prescription drug that is submitted under subsection (j) of
14Section 505 of the Federal Food, Drug, and Cosmetic Act (21
15U.S.C. 355(j)) or under subsection (k) of Section 351 of the
16federal Public Health Service Act (42 U.S.C. 262(k)).
17    "Partnerships" include, but are not limited to, agreements
18for the procurement of generic prescription drugs by way of
19contracts or purchasing by a payor, State governmental agency,
20group purchasing organization, nonprofit organization, or
21other entity.
22    "Provider" means a hospital licensed under the Hospital
23Licensing Act or organized under the University of Illinois

 

 

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1Hospital Act, a skilled nursing facility as that term is
2defined under Section 2 of the Comprehensive Health Insurance
3Plan Act, a comprehensive outpatient rehabilitation facility,
4a home health agency as that term is defined under Section 2.04
5of the Home Health, Home Services, and Home Nursing Agency
6Licensing Act, a hospice as that term is defined under Section
72 of the Comprehensive Health Insurance Plan Act, a public
8health clinic as that term is defined under Section 6-101 of
9the Local Governmental and Governmental Employees Tort
10Immunity Act, or a rehabilitation agency.
11    "Supplier" means a physician, surgeon, or other health
12care practitioner or an entity other than a provider that
13furnishes health care services.
 
14    Section 10. Cost of prescription drugs; partnerships.
15    (a) The Department shall enter into partnerships
16consistent with subsection (b) of Section 15, in consultation
17with other State agencies as necessary, to increase
18competition, lower prices, and address shortages in the market
19for generic prescription drugs, reduce the cost of generic
20prescription drugs for public and private purchasers,
21taxpayers, and consumers, and increase patient access to
22affordable generic prescription drugs.
23    (b) Subject appropriation by the General Assembly for this
24purpose, the Department may hire staff to oversee and
25project-manage the partnerships for manufacturing or

 

 

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

 

 

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1    market, policy, and regulatory factors.
2        (3) The Department shall consider the following, if
3    applicable, when setting the price of a generic
4    prescription drug under this Section:
5            (A) United States Food and Drug Administration
6        user fees.
7            (B) Abbreviated new drug application acquisition
8        costs, amortized over a 5-year period.
9            (C) Mandatory rebates.
10            (D) Total contracting and production costs for the
11        generic prescription drug, including a reasonable
12        amount for administrative, operating, and
13        rate-of-return expenses of the drug company or generic
14        prescription drug manufacturer.
15            (E) Research and development costs attributed to
16        the generic prescription drug over a 5-year period.
17            (F) Other initial start-up costs, amortized over a
18        5-year period.
19        (4) Each generic prescription drug shall be made
20    available to providers, patients, and purchasers at a
21    transparent price and without rebates, other than
22    federally required rebates.
23        (5) The Department shall prioritize the selection of
24    generic prescription drugs that have the greatest impact
25    on lowering drug costs to patients, increasing competition
26    and addressing shortages in the prescription drug market,

 

 

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1    improving public health, or reducing the cost of
2    prescription drugs to public and private purchasers.
3    (c) In identifying generic prescription drugs to be
4produced, the Department shall consider pharmacy spending data
5from Medicaid and other entities for which the State pays the
6cost of generic prescription drugs.
7    The partnerships entered into under subsection (a) shall
8include the production of at least one form of insulin,
9provided that a viable pathway for manufacturing a more
10affordable form of insulin exists.
11    The Department shall prioritize generic prescription drugs
12for chronic and high-cost conditions and shall consider
13prioritizing those that can be delivered through mail order.
14    (d) The Department shall consult with all of the following
15public and private purchasers to assist in developing a list
16of generic prescription drugs to be manufactured or
17distributed through partnerships and to determine the volume
18of each generic prescription drug that can be procured over a
19multiyear period to support a market for a lower-cost generic
20prescription drug:
21        (1) Any public agency that is a purchaser.
22        (2) Health insurers holding a valid outstanding
23    certificate of authority from the Director of Insurance.
24        (3) Hospitals.
25        (4) Pharmacy benefit managers.
26    (e) Before entering into a partnership under subsection

 

 

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1(a), the Department shall determine minimum thresholds for
2procurement of an entity's expected volume of a targeted
3generic prescription drug from the company or manufacturer
4over a multiyear period.
5    (f) The entities listed in paragraphs (2) through (5) of
6subsection (d) shall not be required to purchase prescription
7drugs from the Department or from entities that contract or
8partner with the Department under this Act.
9    (g) The Department is not required to consult with every
10entity listed in paragraphs (2) through (5) of subsection (d)
11so long as purchaser engagement includes a reasonable
12representation from those groups.
 
13    Section 20. Feasibility report.
14    (a) On or before July 1, 2025, the Department shall submit
15a report to the General Assembly that assesses the feasibility
16of the Department directly manufacturing generic prescription
17drugs and selling generic prescription drugs at a fair price.
18The report shall include an analysis of governance structure
19options for manufacturing functions, including chartering a
20private organization, public-private partnership, or public
21board of directors.
22    (b) This Section is repealed on January 1, 2027.
 
23    Section 25. Status and analysis report.
24    (a) On or before July 1, 2024, the Department shall submit

 

 

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1a report to the General Assembly with:
2        (1) a description of the status of all drugs targeted
3    under this Act; and
4        (2) an analysis of how the activities of the
5    Department may impact competition, access to targeted
6    drugs, the costs of those drugs, and the costs of generic
7    prescription drugs for public and private purchasers.
8    (b) This Section is repealed on January 1, 2028.
 
9    Section 30. Nonpublic information; disclosure.
10Notwithstanding any other provision of law, all nonpublic
11information and documents obtained under this Act shall not be
12required to be disclosed pursuant to the Freedom of
13Information Act.
 
14    Section 35. The Freedom of Information Act is amended by
15changing Section 7.5 as follows:
 
16    (5 ILCS 140/7.5)
17    Sec. 7.5. Statutory exemptions. To the extent provided for
18by the statutes referenced below, the following shall be
19exempt from inspection and copying:
20        (a) All information determined to be confidential
21    under Section 4002 of the Technology Advancement and
22    Development Act.
23        (b) Library circulation and order records identifying

 

 

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1    library users with specific materials under the Library
2    Records Confidentiality Act.
3        (c) Applications, related documents, and medical
4    records received by the Experimental Organ Transplantation
5    Procedures Board and any and all documents or other
6    records prepared by the Experimental Organ Transplantation
7    Procedures Board or its staff relating to applications it
8    has received.
9        (d) Information and records held by the Department of
10    Public Health and its authorized representatives relating
11    to known or suspected cases of sexually transmissible
12    disease or any information the disclosure of which is
13    restricted under the Illinois Sexually Transmissible
14    Disease Control Act.
15        (e) Information the disclosure of which is exempted
16    under Section 30 of the Radon Industry Licensing Act.
17        (f) Firm performance evaluations under Section 55 of
18    the Architectural, Engineering, and Land Surveying
19    Qualifications Based Selection Act.
20        (g) Information the disclosure of which is restricted
21    and exempted under Section 50 of the Illinois Prepaid
22    Tuition Act.
23        (h) Information the disclosure of which is exempted
24    under the State Officials and Employees Ethics Act, and
25    records of any lawfully created State or local inspector
26    general's office that would be exempt if created or

 

 

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1    obtained by an Executive Inspector General's office under
2    that Act.
3        (i) Information contained in a local emergency energy
4    plan submitted to a municipality in accordance with a
5    local emergency energy plan ordinance that is adopted
6    under Section 11-21.5-5 of the Illinois Municipal Code.
7        (j) Information and data concerning the distribution
8    of surcharge moneys collected and remitted by carriers
9    under the Emergency Telephone System Act.
10        (k) Law enforcement officer identification information
11    or driver identification information compiled by a law
12    enforcement agency or the Department of Transportation
13    under Section 11-212 of the Illinois Vehicle Code.
14        (l) Records and information provided to a residential
15    health care facility resident sexual assault and death
16    review team or the Executive Council under the Abuse
17    Prevention Review Team Act.
18        (m) Information provided to the predatory lending
19    database created pursuant to Article 3 of the Residential
20    Real Property Disclosure Act, except to the extent
21    authorized under that Article.
22        (n) Defense budgets and petitions for certification of
23    compensation and expenses for court appointed trial
24    counsel as provided under Sections 10 and 15 of the
25    Capital Crimes Litigation Act. This subsection (n) shall
26    apply until the conclusion of the trial of the case, even

 

 

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1    if the prosecution chooses not to pursue the death penalty
2    prior to trial or sentencing.
3        (o) Information that is prohibited from being
4    disclosed under Section 4 of the Illinois Health and
5    Hazardous Substances Registry Act.
6        (p) Security portions of system safety program plans,
7    investigation reports, surveys, schedules, lists, data, or
8    information compiled, collected, or prepared by or for the
9    Department of Transportation under Sections 2705-300 and
10    2705-616 of the Department of Transportation Law of the
11    Civil Administrative Code of Illinois, the Regional
12    Transportation Authority under Section 2.11 of the
13    Regional Transportation Authority Act, or the St. Clair
14    County Transit District under the Bi-State Transit Safety
15    Act.
16        (q) Information prohibited from being disclosed by the
17    Personnel Record Review Act.
18        (r) Information prohibited from being disclosed by the
19    Illinois School Student Records Act.
20        (s) Information the disclosure of which is restricted
21    under Section 5-108 of the Public Utilities Act.
22        (t) All identified or deidentified health information
23    in the form of health data or medical records contained
24    in, stored in, submitted to, transferred by, or released
25    from the Illinois Health Information Exchange, and
26    identified or deidentified health information in the form

 

 

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1    of health data and medical records of the Illinois Health
2    Information Exchange in the possession of the Illinois
3    Health Information Exchange Office due to its
4    administration of the Illinois Health Information
5    Exchange. The terms "identified" and "deidentified" shall
6    be given the same meaning as in the Health Insurance
7    Portability and Accountability Act of 1996, Public Law
8    104-191, or any subsequent amendments thereto, and any
9    regulations promulgated thereunder.
10        (u) Records and information provided to an independent
11    team of experts under the Developmental Disability and
12    Mental Health Safety Act (also known as Brian's Law).
13        (v) Names and information of people who have applied
14    for or received Firearm Owner's Identification Cards under
15    the Firearm Owners Identification Card Act or applied for
16    or received a concealed carry license under the Firearm
17    Concealed Carry Act, unless otherwise authorized by the
18    Firearm Concealed Carry Act; and databases under the
19    Firearm Concealed Carry Act, records of the Concealed
20    Carry Licensing Review Board under the Firearm Concealed
21    Carry Act, and law enforcement agency objections under the
22    Firearm Concealed Carry Act.
23        (v-5) Records of the Firearm Owner's Identification
24    Card Review Board that are exempted from disclosure under
25    Section 10 of the Firearm Owners Identification Card Act.
26        (w) Personally identifiable information which is

 

 

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1    exempted from disclosure under subsection (g) of Section
2    19.1 of the Toll Highway Act.
3        (x) Information which is exempted from disclosure
4    under Section 5-1014.3 of the Counties Code or Section
5    8-11-21 of the Illinois Municipal Code.
6        (y) Confidential information under the Adult
7    Protective Services Act and its predecessor enabling
8    statute, the Elder Abuse and Neglect Act, including
9    information about the identity and administrative finding
10    against any caregiver of a verified and substantiated
11    decision of abuse, neglect, or financial exploitation of
12    an eligible adult maintained in the Registry established
13    under Section 7.5 of the Adult Protective Services Act.
14        (z) Records and information provided to a fatality
15    review team or the Illinois Fatality Review Team Advisory
16    Council under Section 15 of the Adult Protective Services
17    Act.
18        (aa) Information which is exempted from disclosure
19    under Section 2.37 of the Wildlife Code.
20        (bb) Information which is or was prohibited from
21    disclosure by the Juvenile Court Act of 1987.
22        (cc) Recordings made under the Law Enforcement
23    Officer-Worn Body Camera Act, except to the extent
24    authorized under that Act.
25        (dd) Information that is prohibited from being
26    disclosed under Section 45 of the Condominium and Common

 

 

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1    Interest Community Ombudsperson Act.
2        (ee) Information that is exempted from disclosure
3    under Section 30.1 of the Pharmacy Practice Act.
4        (ff) Information that is exempted from disclosure
5    under the Revised Uniform Unclaimed Property Act.
6        (gg) Information that is prohibited from being
7    disclosed under Section 7-603.5 of the Illinois Vehicle
8    Code.
9        (hh) Records that are exempt from disclosure under
10    Section 1A-16.7 of the Election Code.
11        (ii) Information which is exempted from disclosure
12    under Section 2505-800 of the Department of Revenue Law of
13    the Civil Administrative Code of Illinois.
14        (jj) Information and reports that are required to be
15    submitted to the Department of Labor by registering day
16    and temporary labor service agencies but are exempt from
17    disclosure under subsection (a-1) of Section 45 of the Day
18    and Temporary Labor Services Act.
19        (kk) Information prohibited from disclosure under the
20    Seizure and Forfeiture Reporting Act.
21        (ll) Information the disclosure of which is restricted
22    and exempted under Section 5-30.8 of the Illinois Public
23    Aid Code.
24        (mm) Records that are exempt from disclosure under
25    Section 4.2 of the Crime Victims Compensation Act.
26        (nn) Information that is exempt from disclosure under

 

 

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1    Section 70 of the Higher Education Student Assistance Act.
2        (oo) Communications, notes, records, and reports
3    arising out of a peer support counseling session
4    prohibited from disclosure under the First Responders
5    Suicide Prevention Act.
6        (pp) Names and all identifying information relating to
7    an employee of an emergency services provider or law
8    enforcement agency under the First Responders Suicide
9    Prevention Act.
10        (qq) Information and records held by the Department of
11    Public Health and its authorized representatives collected
12    under the Reproductive Health Act.
13        (rr) Information that is exempt from disclosure under
14    the Cannabis Regulation and Tax Act.
15        (ss) Data reported by an employer to the Department of
16    Human Rights pursuant to Section 2-108 of the Illinois
17    Human Rights Act.
18        (tt) Recordings made under the Children's Advocacy
19    Center Act, except to the extent authorized under that
20    Act.
21        (uu) Information that is exempt from disclosure under
22    Section 50 of the Sexual Assault Evidence Submission Act.
23        (vv) Information that is exempt from disclosure under
24    subsections (f) and (j) of Section 5-36 of the Illinois
25    Public Aid Code.
26        (ww) Information that is exempt from disclosure under

 

 

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1    Section 16.8 of the State Treasurer Act.
2        (xx) Information that is exempt from disclosure or
3    information that shall not be made public under the
4    Illinois Insurance Code.
5        (yy) Information prohibited from being disclosed under
6    the Illinois Educational Labor Relations Act.
7        (zz) Information prohibited from being disclosed under
8    the Illinois Public Labor Relations Act.
9        (aaa) Information prohibited from being disclosed
10    under Section 1-167 of the Illinois Pension Code.
11        (bbb) Information that is prohibited from disclosure
12    by the Illinois Police Training Act and the Illinois State
13    Police Act.
14        (ccc) Records exempt from disclosure under Section
15    2605-304 of the Illinois State Police Law of the Civil
16    Administrative Code of Illinois.
17        (ddd) Information prohibited from being disclosed
18    under Section 35 of the Address Confidentiality for
19    Victims of Domestic Violence, Sexual Assault, Human
20    Trafficking, or Stalking Act.
21        (eee) Information prohibited from being disclosed
22    under subsection (b) of Section 75 of the Domestic
23    Violence Fatality Review Act.
24        (fff) Images from cameras under the Expressway Camera
25    Act. This subsection (fff) is inoperative on and after
26    July 1, 2023.

 

 

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1        (ggg) Information prohibited from disclosure under
2    paragraph (3) of subsection (a) of Section 14 of the Nurse
3    Agency Licensing Act.
4        (hhh) Information submitted to the Department of State
5    Police in an affidavit or application for an assault
6    weapon endorsement, assault weapon attachment endorsement,
7    .50 caliber rifle endorsement, or .50 caliber cartridge
8    endorsement under the Firearm Owners Identification Card
9    Act.
10        (iii) Information prohibited from being disclosed
11    under Section 30 of the Affordable Drug Manufacturing Act.
12(Source: P.A. 101-13, eff. 6-12-19; 101-27, eff. 6-25-19;
13101-81, eff. 7-12-19; 101-221, eff. 1-1-20; 101-236, eff.
141-1-20; 101-375, eff. 8-16-19; 101-377, eff. 8-16-19; 101-452,
15eff. 1-1-20; 101-466, eff. 1-1-20; 101-600, eff. 12-6-19;
16101-620, eff 12-20-19; 101-649, eff. 7-7-20; 101-652, eff.
171-1-22; 101-656, eff. 3-23-21; 102-36, eff. 6-25-21; 102-237,
18eff. 1-1-22; 102-292, eff. 1-1-22; 102-520, eff. 8-20-21;
19102-559, eff. 8-20-21; 102-813, eff. 5-13-22; 102-946, eff.
207-1-22; 102-1042, eff. 6-3-22; 102-1116, eff. 1-10-23.)
 
21    Section 97. Severability. The provisions of this Act are
22severable under Section 1.31 of the Statute on Statutes.
 
23    Section 99. Effective date. This Act takes effect July 1,
242023.