Bill Text: IL HB3583 | 2021-2022 | 102nd 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 under the Affordable Drug Manufacturing Act from disclosure. Contains a severability provision. Effective July 1, 2021.

Spectrum: Partisan Bill (Democrat 2-0)

Status: (Introduced - Dead) 2021-03-27 - House Committee Amendment No. 1 Rule 19(c) / Re-referred to Rules Committee [HB3583 Detail]

Download: Illinois-2021-HB3583-Introduced.html

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102ND GENERAL ASSEMBLY State of Illinois 2021 and 2022 HB3583 Introduced , 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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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.
"Generic drug" means a drug that is approved pursuant to
subsection (j) of Section 355 of the federal Food, Drug, and
Cosmetic Act (21 U.S.C. Sec. 301 et seq.) or a biosimilar, as
defined under the federal Public Health Service Act (42 U.S.C.
Sec. 262).
"Partnerships" include, but are not limited to, agreements
for the procurement of generic prescription drugs by way of
contracts or purchasing by a payer, 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
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

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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 and surgeon or other health
care practitioner, or an entity that furnishes health care
services other than a provider.
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
prescription drugs for public and private purchasers,
taxpayers, and consumers, and increase patient access to
affordable drugs.
(b) The Department may hire staff to oversee and
project-manage the partnerships for manufacturing or
distribution of generic prescription drugs, contingent upon an
appropriation by the General Assembly for this purpose.
Section 15. Prescription drug prices.
(a) The Department shall enter into partnerships resulting

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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 licensed under the Pharmacy Practice
Act, as appropriate. The generic prescription drugs shall be
produced or distributed by a drug company or generic 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
pursuant to subsection (a) to produce a generic
prescription drug at a price that results in savings,
targets failures in the market for generic drugs, and
improves patient access to affordable medications.
(2) For top drugs identified pursuant to 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, market, policy, and regulatory factors.
(3) The Department shall consider the following, if
applicable, when setting the price of the generic
prescription drug:
(A) United States Food and Drug Administration
user fees.

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(B) Abbreviated new drug application acquisition
costs, amortized over a 5-year period.
(C) Mandatory rebates.
(D) Total contracting and production costs for the
drug, including a reasonable amount for
administrative, operating, and rate-of-return expenses
of the drug company or generic drug manufacturer.
(E) Research and development costs attributed to
the drug over a 5-year period.
(F) Other initial start-up costs amortized over a
5-year period.
(4) Each 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,
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 pursuant to subsection (a)
shall include the production of at least one form of insulin,

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provided that a viable pathway for manufacturing a more
affordable form of insulin exists.
The Department shall prioritize 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 pursuant to this
Section, the Department shall determine minimum thresholds for
procurement of an entity's expected volume of a targeted 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 entities that contract or partner
with the Department pursuant to this Act.
(g) The Department shall not be required to consult with

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every entity listed in paragraphs (2) through (5) of
subsection (d), so long as purchaser engagement includes a
reasonable representation from these groups.
Section 20. Feasibility report.
(a) On or before July 1, 2023, the Department shall submit
a report to the General Assembly that assesses the feasibility
of 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, 2025.
Section 25. Status and analysis report.
(a) On or before July 1, 2022, the Department shall report
to the General Assembly on both of the following:
(1) A description of the status of all drugs targeted
under this Act.
(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 to public and private purchasers.
(b) This Section is repealed on January 1, 2026.

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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
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

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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
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.

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(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
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
Regional Transportation Authority under Section 2.11 of

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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
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).

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(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.
(w) Personally identifiable information which is
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

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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
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

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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
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

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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
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 prohibited from being disclosed
under Section 30 of the Affordable Drug Manufacturing Act.
(Source: P.A. 100-20, eff. 7-1-17; 100-22, eff. 1-1-18;
100-201, eff. 8-18-17; 100-373, eff. 1-1-18; 100-464, eff.
8-28-17; 100-465, eff. 8-31-17; 100-512, eff. 7-1-18; 100-517,

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eff. 6-1-18; 100-646, eff. 7-27-18; 100-690, eff. 1-1-19;
100-863, eff. 8-14-18; 100-887, eff. 8-14-18; 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.)
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,
2021.