Bill Text: IL HB3256 | 2023-2024 | 103rd General Assembly | Introduced

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Bill Title: 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. Contains a severability provision. Effective July 1, 2023.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Introduced) 2024-04-05 - Rule 19(a) / Re-referred to Rules Committee [HB3256 Detail]

Download: Illinois-2023-HB3256-Introduced.html

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103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB3256 Introduced , 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
HB3256 LRB103 27492 CPF 53866 b
AN ACT concerning health.
Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
Section 1. Short title. This Act may be cited as the
Affordable Drug Manufacturing Act.
Section 5. Definitions. In this Act:
"Department" means the Department of Public Health.
"Eligible prescription drug" means a prescription drug
that is not under patent or a biological product, as defined in
42 U.S.C. 262(i), that is not under patent.
"Generic prescription drug" means a drug that is approved
pursuant to an application referencing an eligible
prescription drug that is submitted under subsection (j) of
Section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)) or under subsection (k) of Section 351 of the
federal Public Health Service Act (42 U.S.C. 262(k)).
"Partnerships" include, but are not limited to, agreements
for the procurement of generic prescription drugs by way of
contracts or purchasing by a payor, State governmental agency,
group purchasing organization, nonprofit organization, or
other entity.
"Provider" means a hospital licensed under the Hospital
Licensing Act or organized under the University of Illinois

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

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

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

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

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

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a report to the General Assembly with:
(1) a description of the status of all drugs targeted
under this Act; and
(2) an analysis of 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 for public and private purchasers.
(b) This Section is repealed on January 1, 2028.
Section 30. Nonpublic information; disclosure.
Notwithstanding any other provision of law, all nonpublic
information and documents obtained under this Act shall not be
required to be disclosed pursuant to the Freedom of
Information Act.
Section 35. The Freedom of Information Act is amended by
changing Section 7.5 as follows:
(5 ILCS 140/7.5)
Sec. 7.5. Statutory exemptions. To the extent provided for
by the statutes referenced below, the following shall be
exempt from inspection and copying:
(a) All information determined to be confidential
under Section 4002 of the Technology Advancement and
Development Act.
(b) Library circulation and order records identifying

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

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

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

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

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

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Interest Community Ombudsperson Act.
(ee) Information that is exempted from disclosure
under Section 30.1 of the Pharmacy Practice Act.
(ff) Information that is exempted from disclosure
under the Revised Uniform Unclaimed Property Act.
(gg) Information that is prohibited from being
disclosed under Section 7-603.5 of the Illinois Vehicle
Code.
(hh) Records that are exempt from disclosure under
Section 1A-16.7 of the Election Code.
(ii) Information which is exempted from disclosure
under Section 2505-800 of the Department of Revenue Law of
the Civil Administrative Code of Illinois.
(jj) Information and reports that are required to be
submitted to the Department of Labor by registering day
and temporary labor service agencies but are exempt from
disclosure under subsection (a-1) of Section 45 of the Day
and Temporary Labor Services Act.
(kk) Information prohibited from disclosure under the
Seizure and Forfeiture Reporting Act.
(ll) Information the disclosure of which is restricted
and exempted under Section 5-30.8 of the Illinois Public
Aid Code.
(mm) Records that are exempt from disclosure under
Section 4.2 of the Crime Victims Compensation Act.
(nn) Information that is exempt from disclosure under

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

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Section 16.8 of the State Treasurer Act.
(xx) Information that is exempt from disclosure or
information that shall not be made public under the
Illinois Insurance Code.
(yy) Information prohibited from being disclosed under
the Illinois Educational Labor Relations Act.
(zz) Information prohibited from being disclosed under
the Illinois Public Labor Relations Act.
(aaa) Information prohibited from being disclosed
under Section 1-167 of the Illinois Pension Code.
(bbb) Information that is prohibited from disclosure
by the Illinois Police Training Act and the Illinois State
Police Act.
(ccc) Records exempt from disclosure under Section
2605-304 of the Illinois State Police Law of the Civil
Administrative Code of Illinois.
(ddd) Information prohibited from being disclosed
under Section 35 of the Address Confidentiality for
Victims of Domestic Violence, Sexual Assault, Human
Trafficking, or Stalking Act.
(eee) Information prohibited from being disclosed
under subsection (b) of Section 75 of the Domestic
Violence Fatality Review Act.
(fff) Images from cameras under the Expressway Camera
Act. This subsection (fff) is inoperative on and after
July 1, 2023.

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(ggg) Information prohibited from disclosure under
paragraph (3) of subsection (a) of Section 14 of the Nurse
Agency Licensing Act.
(hhh) Information submitted to the Department of State
Police in an affidavit or application for an assault
weapon endorsement, assault weapon attachment endorsement,
.50 caliber rifle endorsement, or .50 caliber cartridge
endorsement under the Firearm Owners Identification Card
Act.
(iii) Information prohibited from being disclosed
under Section 30 of the Affordable Drug Manufacturing Act.
(Source: P.A. 101-13, eff. 6-12-19; 101-27, eff. 6-25-19;
101-81, eff. 7-12-19; 101-221, eff. 1-1-20; 101-236, eff.
1-1-20; 101-375, eff. 8-16-19; 101-377, eff. 8-16-19; 101-452,
eff. 1-1-20; 101-466, eff. 1-1-20; 101-600, eff. 12-6-19;
101-620, eff 12-20-19; 101-649, eff. 7-7-20; 101-652, eff.
1-1-22; 101-656, eff. 3-23-21; 102-36, eff. 6-25-21; 102-237,
eff. 1-1-22; 102-292, eff. 1-1-22; 102-520, eff. 8-20-21;
102-559, eff. 8-20-21; 102-813, eff. 5-13-22; 102-946, eff.
7-1-22; 102-1042, eff. 6-3-22; 102-1116, eff. 1-10-23.)
Section 97. Severability. The provisions of this Act are
severable under Section 1.31 of the Statute on Statutes.
Section 99. Effective date. This Act takes effect July 1,
2023.