state drug importation adds European Union suppliers to Canadian ones

The text as introduced · 780 words

By: Schoolcraft
H.B. No. 1319

A BILL TO BE ENTITLED

AN ACT

relating to wholesale importation of prescription drugs in this

state.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:

SECTION1. Subtitle A, Title 6, Chapter 444 Health and Safety Code,

is amended as follows:

CHAPTER 444. WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM

Sec. 444.001. 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) "European Union supplier" " means a manufacturer,

wholesale distributor, or pharmacy that is appropriately licensed

or permitted under European Union or laws and rules, or the national

laws and rules of a European Union member nation, to manufacture,

distribute, or dispense prescription drugs.

( 2 3 ) "Commission" means the Health and Human Services

Commission.

( 3 4 ) "Prescription drug wholesaler" means a person

licensed as a wholesale distributor under Subchapter N, Chapter

431, that contracts with this state to import prescription drugs

under the program.

( 4 5 ) "Program" means the wholesale prescription drug

importation program established under this chapter.

Sec. 444.002. ESTABLISHMENT OF WHOLESALE PRESCRIPTION DRUG

IMPORTATION PROGRAM. (a) The commission shall establish the

wholesale prescription drug importation program to provide lower

cost prescription drugs available outside of the United States to

consumers in this state at the lower cost.

(b) The commission shall implement the program by:

(1) contracting with one or more prescription drug

wholesalers and Canadian or European Union suppliers to import

prescription drugs and provide prescription drug cost savings to

consumers in this state;

(2) developing a registration process for health

benefit plan issuers, health care providers, and pharmacies to

obtain and dispense prescription drugs imported under the program;

(3) developing a list of prescription drugs, including

the prices of those drugs, that meet the requirements of Section

444.003 and publishing the list on the commission's Internet

website;

(4) establishing an outreach and marketing plan to

generate program awareness;

(5) establishing and administering a telephone call

center or electronic portal to provide information about the

program;

(6) ensuring the program and the prescription drug

wholesalers that contract with this state under Subdivision (1)

comply with the tracking, tracing, verification, and

identification requirements of 21 U.S.C. Section 360eee-1;

(7) prohibiting the distribution, dispensing, or sale

of prescription drugs imported under this chapter outside the

boundaries of this state; and

(8) performing any other duties the executive

commissioner determines necessary to implement the program.

(c) The commission shall ensure that the program meets the

requirements of 21 U.S.C. Section 384.

(d) In developing the program, the commission may consult

with interested parties.

Sec. 444.003. ELIGIBLE PRESCRIPTION DRUGS. A prescription

drug may be imported into this state under the program only if the

drug:

(1) meets the United States Food and Drug

Administration's standards related to prescription drug safety,

effectiveness, misbranding, and adulteration;

(2) does not violate any federal patent laws through

its importation;

(3) is expected to generate cost savings for

consumers; and

(4) is not:

(A) listed as a controlled substance under state

or federal law;

(B) a biological product;

(C) an infused drug;

(D) an intravenously injected drug;

(E) a drug that is inhaled during surgery; or

(F) a parenteral drug.

Sec. 444.004. ANTICOMPETITIVE BEHAVIOR MONITORING. The

commission, in consultation with the attorney general, shall

identify and monitor any potential anticompetitive activities in

industries affected by the program.

Sec. 444.005. PROGRAM FUNDING. In addition to money

appropriated by the legislature, the commission may impose a fee on

each prescription drug sold under the program or establish another

funding method to administer the program.

Sec. 444.006. AUDIT PROCEDURES. The executive commissioner

by rule shall develop procedures to effectively audit a

prescription drug wholesaler participating in the program.

Sec. 444.007. ANNUAL REPORTING. Not later than December 1

of each year, the commission shall submit a report to the governor

and the legislature regarding the operation of the program during

the preceding state fiscal year, including:

(1) which prescription drugs and Canadian or European

Union suppliers are included in the program;

(2) the number of health benefit plan issuers, health

care providers, and pharmacies participating in the program;

(3) the number of prescriptions dispensed through the

program;

(4) the estimated cost savings to consumers, health

plans, employers, and this state since the establishment of the

program and during the preceding state fiscal year;

(5) information regarding the implementation of the

audit procedures under Section 444.006; and

(6) any other information:

(A) the governor or the legislature requests; or

(B) the commission considers necessary.

SECTION 3. This Act takes effect September 1, 2025.