By: Talarico H.B. No. 25
A BILL TO BE ENTITLED
AN ACT
relating to wholesale importation of prescription drugs for resale
to Texas residents.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. SHORT TITLE. This Act shall be known as the
"Wholesale Prescription Drug Importation Act."
SECTION 2. WHOLESALE PRESCRIPTION DRUG IMPORTATION
PROGRAM. Subtitle C, Title 2, Health and Safety Code is amended by
adding Chapter 66 to read as follows:
CHAPTER 66. WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM
SUBCHAPTER A. GENERAL PROVISIONS.
Sec. 66.001. DEFINITIONS. In this chapter:
(1) "Canadian supplier" means a manufacturer, wholesale
distributor or pharmacy that is appropriately licensed or permitted
under Canadian federal or provincial laws and rules to manufacture,
distribute or dispense prescription drugs.
(2) "Commission" means Health and Human Services
Commission.
(3) "Eligible prescription drug" means a drug eligible for
importation that:
(a) meets the United States federal food and drug
administration's standards related to safety, effectiveness,
misbranding and adulteration;
(b) does not violate federal patent laws;
(c) is expected to generate cost savings; and
(d) is not a controlled substance;
(4) "Program" means the wholesale prescription drug
importation program; and
(5) "State drug wholesaler" means a licensed wholesale drug
distributor that contracts with the state to import eligible
prescription drugs from a Canadian supplier.
Sec. 66.002. CONSTRUCTION OF CHAPTER; PURPOSE. (a) The
purpose of this chapter is to establish a program to make
prescription drugs that are available at lower costs outside the
United States available to consumers in Texas at those lower costs.
Sec. 66.003. ESTABLISHMENT OF WHOLESALE PRESCRIPTION DRUG
IMPORTATION PROGRAM. (a) The commission shall design a "wholesale
prescription drug importation program" that complies with the
applicable requirements of 21 U.S.C. Section 384, including the
requirements regarding safety and cost savings. The commission
shall explore all potential mechanisms, to the extent allowable
under law, for the importation of eligible prescription drugs. The
program design shall:
(1) contract with one or more state drug wholesalers
to seek federal certification and approval to import safe, eligible
prescription drugs from Canadian suppliers and provide significant
prescription drug cost savings to Texas consumers;
(2) allow the importation of eligible prescription
drugs sold by Canadian suppliers;
(3) ensure that only eligible prescription drugs
meeting the United States food and drug administration's safety,
effectiveness and other standards are imported by or on behalf of
the state;
(4) import only those eligible prescription drugs
expected to generate substantial savings for Texas consumers;
(5) ensure that, with respect to eligible prescription
drugs to be imported pursuant to the program, the program and the
state drug wholesaler comply with the tracking, tracing,
verification and identification requirements of 21 U.S.C. Sections
360eee and 360eee-1;
(6) prohibit the distribution, dispensing or sale of
eligible prescription drugs imported pursuant to the Wholesale
Prescription Drug Importation Act outside the exterior boundaries
of the state;
(7) recommend a charge per prescription or another
method of support to ensure that the program is funded adequately in
a manner that does not jeopardize significant consumer savings; and
(8) include an audit function.
Sec. 66.004. MONITORING FOR ANTI-COMPETITIVE
BEHAVIOR. (a) The commission shall consult with the attorney
general to identify the potential, and to monitor, for
anti-competitive behavior in industries that would be affected by
the program.
Sec. 66.005. FEDERAL COMPLIANCE. (a) The commission shall
submit a formal request to the secretary of the United States
department of health and human services for certification of the
state's program.
Sec. 66.006. IMPLEMENTATION. (a) Upon certification of
approval by the secretary of the United States department of health
and human services, the commission shall begin implementing the
program and begin operating the program within six months of that
approval. As part of the implementation process, the commission
shall:
(1) enter into contracts in accordance with the
Procurement Code with one or more state drug wholesalers and Texas
licensed drug distributors and contract with one or more approved
Canadian suppliers;
(2) consult with interested stakeholders, including
the committee, the legislature, health insurance plans, employers,
pharmacies, health care providers and consumers;
(3) develop a registration process for health
insurance plans, pharmacies and prescription drug administering
health care providers who choose to participate in the program;
(4) make a list of imported eligible prescription
drugs and their prices and make that list available to all
participating entities and the general public;
(5) create an outreach and marketing plan to generate
program awareness;
(6) create and staff a helpline to answer questions
and address the needs of consumers, employers, health insurance
plans, pharmacies, health care providers and other affected
sectors;
(7) require annual specific audits of the program; and
(8) carry out other duties in accordance with the
Wholesale Prescription Drug Importation Act that the commission
determines to be necessary for successful implementation of the
program.
Sec. 66.007. ANNUAL REPORTING. (a) Annually, after
implementation, the commission shall report to the governor and the
legislature regarding the operation of the program during the
previous year, including:
(1) which eligible prescription drugs and Canadian
suppliers are included in the program;
(2) the number of participating pharmacies, health
care providers and health insurance plans;
(3) the number of prescriptions dispensed through the
program;
(4) the estimated savings to consumers, health plans,
employers and the state during the previous year and to date;
(5) information regarding implementation of the audit
plan and the correction plans for audit findings; and
(6) any other information requested by the governor or
the legislature or state health authority deems relevant.
Sec. 66.008. COUNTRIES OTHER THAN CANADA ALLOWED BY FEDERAL
LAW. (a) The provisions of the Wholesale Prescription Drug
Importation Act may be extended to any other country allowed by
federal law to import prescription drugs into the United States, at
the discretion of the commission.
SECTION 3. As soon as practicable after the effective date
of this Act, the executive commissioner of the Health and Human
Services Commission and any other state agency designated by the
executive commissioner shall adopt rules necessary to implement
Chapter 66, Health and Safety Code, as added by this Act.
SECTION 4. This Act takes effect September 1, 2023.