Bill Text: IL HB1441 | 2019-2020 | 101st General Assembly | Introduced

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Bill Title: Creates the Wholesale Importation of Prescription Drugs Act. Requires the Department of Public Health to design an importation program where the State is the licensed wholesaler of imported drugs from licensed, regulated Canadian suppliers. Requires the program to address specified issues, including billing issues, cost savings issues, and safety and regulatory issues. Contains auditing and reporting requirements. Provides that the Department shall enlist the assistance of the Attorney General to identify the potential for anti-competitive behavior in industries that would be affected by an importation program. Requires the Department to submit a formal request to the Secretary of the United States Department of Health and Human Services for certification of the importation program. Requires the Department to have the program operational within 6 months after receiving the certification. Contains provisions concerning implementation requirements.

Spectrum: Partisan Bill (Democrat 9-0)

Status: (Introduced - Dead) 2020-02-26 - Added Co-Sponsor Rep. Debbie Meyers-Martin [HB1441 Detail]

Download: Illinois-2019-HB1441-Introduced.html

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101ST GENERAL ASSEMBLY State of Illinois 2019 and 2020 HB1441 Introduced , by Rep. Anna Moeller SYNOPSIS AS INTRODUCED:
New Act
Creates the Wholesale Importation of Prescription Drugs Act. Requires the Department of Public Health to design an importation program where the State is the licensed wholesaler of imported drugs from licensed, regulated Canadian suppliers. Requires the program to address specified issues, including billing issues, cost savings issues, and safety and regulatory issues. Contains auditing and reporting requirements. Provides that the Department shall enlist the assistance of the Attorney General to identify the potential for anti-competitive behavior in industries that would be affected by an importation program. Requires the Department to submit a formal request to the Secretary of the United States Department of Health and Human Services for certification of the importation program. Requires the Department to have the program operational within 6 months after receiving the certification. Contains provisions concerning implementation requirements.
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FISCAL NOTE ACT MAY APPLY
A BILL FOR
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AN ACT concerning regulation.
WHEREAS, United States citizens pay some of the highest
prices for prescription drugs in the world, and the Canadian
government estimated that United States consumers pay twice as
much as Canadians for patented prescription drugs and 20% more
for generics; and
WHEREAS, Under the Food and Drug Administration's
discretion not to enforce the law, individual patients may
import a 90-day supply of prescription drugs from Canada that
are less expensive than drugs licensed by the Food and Drug
Administration in the United States; and
WHEREAS, Individual importation via the Internet increases
consumer health and safety risks because many Internet
pharmacies are not licensed in Canada and it is difficult to
verify the validity, reputation, actual identity, and pharmacy
practices of online pharmacies outside the United States; and
WHEREAS, The United States allows patients to go to other
countries for surgeries and other high-risk medical treatments
without regulating that consumer purchasing activity, and
insurers sometimes facilitate and pay for treatments outside
the United States; and
WHEREAS, The Food and Drug Administration estimates that
currently 40% of finished prescription drug products are
produced outside the United States and 80% of raw products for
United States pharmaceutical manufacturing come from outside
the United States; and

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WHEREAS, The Food and Drug Administration recently signed
reciprocity agreements with European Union regulators to
accept the results of European Union inspections of
pharmaceutical manufacturing plants. The Food and Drug
Administration has a Memorandum of Understanding for
regulatory cooperation around pharmaceuticals with the
Canadian regulatory authorities since 1973; and
WHEREAS, Canada has a rigorous regulatory system to license
prescription drugs that is considered to be on par with the
United States licensing system; and
WHEREAS, Title II of the federal Drug Quality and Security
Act (P.L. 113-54), Drug Supply Chain Security, has resulted in
improvements in drug security and safety through a system of
pharmaceutical track and trace that can be leveraged for safe
importation; and
WHEREAS, The Secretary of the United States Department of
Health and Human Services may certify a prescription drug
reimportation program that is safe and saves consumers money;
and
WHEREAS, The State can ensure that wholesale importation of
prescription drugs from Canada into the State will be safe and
cost-saving for State consumers; therefore
Be it enacted by the People of the State of Illinois,
represented in the General Assembly:

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Section 1. Short title. This Act may be cited as the
Wholesale Importation of Prescription Drugs Act.
Section 5. Definitions. As used in this Act:
"Department" means the Department of Public Health.
"Importation program" means a State-administered wholesale
importation program where the State is the licensed wholesaler
importing drugs from a licensed, regulated Canadian supplier,
solely for distribution to voluntarily participating,
State-licensed, and in-state pharmacies and administering
providers for the exclusive purpose of dispensing to State
residents with a valid prescription.
Section 10. Importation program. The Department shall
design an importation program in consultation with relevant
State stakeholders and federal offices and agencies that meets
the relevant requirements of 21 U.S.C. 384, including
requirements concerning safety and cost savings. In developing
an importation program for federal certification, the
Department shall address the following issues:
(1) That the program requires the Department to become
a licensed wholesaler for the purpose of seeking federal
certification and approval to import safe prescription
drugs that will provide savings to State consumers.
(2) That the program uses Canadian suppliers regulated
under the appropriate Canadian and provincial laws.

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(3) That the program has a process to sample the
purity, chemical composition, and potency of imported
products.
(4) That the program only imports those prescription
pharmaceuticals expected to generate substantial savings
for State consumers.
(5) That the program ensures imported products will not
be distributed, dispensed, or sold outside of this State's
borders.
(6) That the program ensures that voluntary
participants, State-licensed pharmacies, and administering
providers charge individual consumers and health plans the
actual acquisition cost of the imported, dispensed
product.
(7) That the program ensures health plan payment of the
product component of pharmacy and provider billing
reimburses no more than the actual acquisition cost of the
dispensed, imported product.
(8) That the program ensures participating health
plans keep their formularies and claims payment systems up
to date with the prescription drugs provided through the
importation program.
(9) That the program ensures participating health
plans base patient cost sharing on no more than the actual
acquisition cost of the dispensed, imported product.
(10) That the program require participating health

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plans to demonstrate to the Department how savings on
imported drugs are reflected in premiums.
(11) That the profit margin of any participating
wholesaler or distributor of imported pharmaceutical
products is limited to a specified amount established by
the Department.
(12) That the program does not import generic products
that would violate United States patent laws on United
States branded products.
(13) That the program complies with the requirements of
21 U.S.C. 581 through 21 U.S.C. 582 pertaining to the track
and trace requirements as enacted in Title II of the Drug
Security and Quality Act (P.L. 113-54) to the extent
practical and feasible before imported drugs come into
possession of the State wholesaler and complies fully after
imported drugs are in the possession of the State
wholesaler.
(14) That the program is adequately financed through a
fee on each prescription or other appropriate approach, but
the amount of the fee may not jeopardize significant
consumer savings.
(15) That the program includes an audit function to
ensure that:
(A) the Department has a sound methodology by which
to determine the most cost-effective products to
include in the importation program on an ongoing basis;

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(B) the Department has processes in place to select
Canadian suppliers of high quality, of high
performance, and in full compliance with Canadian law
and regulation and State pharmacy or wholesaler laws;
(C) imported drugs under the importation program
are not shipped, sold, or dispensed outside the State
once in the possession of the State;
(D) imported products are pure, unadulterated,
potent, and safe;
(E) participating pharmacies and administering
providers are not charging more than the actual
acquisition cost to any consumer or any participating
health plan;
(F) participating health plan formularies and
claims processing systems remain up to date with all
relevant aspects of the importation program;
(G) participating health plans base patient
coinsurance and other cost sharing on the actual
acquisition cost of covered, imported drugs;
(H) participating health plans reimburse
participating pharmacies and administering providers
the actual acquisition cost for imported, dispensed
product;
(I) the program is adequately financed to support
all administrative functions while generating
significant consumer savings;

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(J) the program does not put consumers at higher
risk than if the program did not exist; and
(K) the program continues to provide State
consumers with substantial savings on prescription
drugs.
Section 15. Monitoring for anti-competitive behavior. The
Department shall enlist the assistance of the Attorney General
to identify the potential for anti-competitive behavior in
industries that would be affected by an importation program.
Section 20. Report to the General Assembly. The Department
shall report to the General Assembly no later than 6 months
after the effective date of this Act on the final importation
program design that takes into consideration at least the items
in Section 10. The report to the General Assembly shall be
filed with the Clerk of the House of Representatives and the
Secretary of the Senate in electronic form only, in the manner
that the Clerk and the Secretary shall direct.
Section 25. Submission of request for federal
certification and approval. No later than 2 weeks after the
Department submits the report required under Section 20, the
Department shall submit a formal request to the Secretary of
the United States Department of Health and Human Services for
certification of the importation program.

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Section 30. Implementation and additional administrative
requirements. Upon certification and approval by the Secretary
of the United States Department of Health and Human Services,
the Department shall begin implementation of the importation
program and have the program operational within 6 months after
the date of the Secretary's certification. As part of the
implementation process, the Department shall, in accordance
with State procurement and contracting laws and rules as
appropriate:
(1) Become licensed as a wholesaler.
(2) Contract with a State-licensed distributor or
distributors.
(3) Contract with licensed, regulated Canadian
suppliers.
(4) Engage health plans, employers, pharmacies,
providers, and consumers.
(5) Develop a registration process for health plans,
pharmacies, and administering providers that are willing
to participate.
(6) Create a publicly available source for listing
prices of imported products that shall be available to all
participating entities and consumers.
(7) Create an outreach and marketing plan to generate
program awareness.
(8) Create and staff a hotline to answer questions from

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any affected sector starting in the weeks before the
program becomes operational that can address the needs and
questions of consumers, employers, plans, pharmacies, and
providers, among others.
(9) Establish the audit function and a 2-year audit
work plan cycle.
(10) Conduct any other activities determined to be
important to successful implementation, as determined by
the Department.
Section 35. Ongoing oversight of program administration.
The Department shall report to the General Assembly every 6
months, commencing with either the first June or December after
implementation, whichever is the nearest date to the date that
is 6 months after implementation of the importation program.
The report to the General Assembly shall include the following:
(1) The drugs covered in the importation program.
(2) The number of participating pharmacies, providers,
and health plans.
(3) The number of prescriptions dispensed under the
program in the period.
(4) The estimated savings to consumers, health plans,
and employers that resulted from the program in the
reporting period and to date.
(5) In the first 3 reporting periods, information on
the implementation of the audit plan and, on an ongoing

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basis, audit findings for the reporting period.
(6) Any other information of importance, as determined
by the Department.
The report to the General Assembly shall be filed with the
Clerk of the House of Representatives and the Secretary of the
Senate in electronic form only, in the manner that the Clerk
and the Secretary shall direct.