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.