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A BILL TO BE ENTITLED
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AN ACT
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relating to wholesale importation of prescription drugs in this |
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state; authorizing a fee. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. This Act may be cited as the Wholesale |
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Prescription Drug Importation Act. |
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SECTION 2. Subtitle A, Title 6, Health and Safety Code, is |
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amended by adding Chapter 444 to read as follows: |
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CHAPTER 444. WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM |
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Sec. 444.001. DEFINITIONS. In this chapter: |
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(1) "Canadian supplier" means a manufacturer, |
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wholesale distributor, or pharmacy that is appropriately licensed |
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or permitted under Canadian federal or provincial laws and rules to |
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manufacture, distribute, or dispense prescription drugs. |
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(2) "Commission" means the Health and Human Services |
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Commission. |
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(3) "Prescription drug wholesaler" means a person |
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licensed as a wholesale distributor under Subchapter N, Chapter |
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431, that contracts with this state to import prescription drugs |
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under the program. |
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(4) "Program" means the wholesale prescription drug |
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importation program established under this chapter. |
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Sec. 444.002. ESTABLISHMENT OF WHOLESALE PRESCRIPTION DRUG |
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IMPORTATION PROGRAM. (a) The commission shall establish the |
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wholesale prescription drug importation program to provide lower |
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cost prescription drugs available outside of the United States to |
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consumers in this state at the lower cost. |
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(b) The commission shall implement the program by: |
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(1) contracting with one or more prescription drug |
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wholesalers and Canadian suppliers to import prescription drugs and |
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provide prescription drug cost savings to consumers in this state; |
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(2) developing a registration process for health |
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benefit plan issuers, health care providers, and pharmacies to |
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obtain and dispense prescription drugs imported under the program; |
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(3) developing a list of prescription drugs, including |
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the prices of those drugs, that meet the requirements of Section |
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444.003 and publishing the list on the commission's Internet |
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website; |
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(4) establishing an outreach and marketing plan to |
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generate program awareness; |
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(5) establishing and administering a telephone call |
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center or electronic portal to provide information about the |
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program; |
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(6) ensuring the program and the prescription drug |
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wholesalers that contract with this state under Subdivision (1) |
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comply with the tracking, tracing, verification, and |
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identification requirements of 21 U.S.C. Section 360eee-1; |
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(7) prohibiting the distribution, dispensing, or sale |
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of prescription drugs imported under this chapter outside the |
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boundaries of this state; and |
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(8) performing any other duties the executive |
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commissioner determines necessary to implement the program. |
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(c) The commission shall ensure that the program meets the |
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requirements of 21 U.S.C. Section 384. |
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(d) In developing the program, the commission may consult |
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with interested parties. |
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Sec. 444.003. ELIGIBLE PRESCRIPTION DRUGS. A prescription |
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drug may be imported into this state under the program only if the |
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drug: |
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(1) meets the United States Food and Drug |
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Administration's standards related to prescription drug safety, |
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effectiveness, misbranding, and adulteration; |
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(2) does not violate any federal patent laws through |
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its importation; |
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(3) is expected to generate cost savings for |
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consumers; and |
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(4) is not: |
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(A) listed as a controlled substance under state |
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or federal law; |
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(B) a biological product; |
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(C) an infused drug; |
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(D) an intravenously injected drug; |
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(E) a drug that is inhaled during surgery; or |
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(F) a parenteral drug. |
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Sec. 444.004. ANTICOMPETITIVE BEHAVIOR MONITORING. The |
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commission, in consultation with the attorney general, shall |
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identify and monitor any potential anticompetitive activities in |
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industries affected by the program. |
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Sec. 444.005. PROGRAM FUNDING. In addition to money |
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appropriated by the legislature, the commission may impose a fee on |
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each prescription drug sold under the program or establish another |
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funding method to administer the program. |
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Sec. 444.006. AUDIT PROCEDURES. The executive commissioner |
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by rule shall develop procedures to effectively audit a |
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prescription drug wholesaler participating in the program. |
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Sec. 444.007. ANNUAL REPORTING. Not later than December 1 |
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of each year, the commission shall submit a report to the governor |
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and the legislature regarding the operation of the program during |
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the preceding state fiscal year, including: |
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(1) which prescription drugs and Canadian suppliers |
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are included in the program; |
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(2) the number of health benefit plan issuers, health |
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care providers, and pharmacies participating in the program; |
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(3) the number of prescriptions dispensed through the |
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program; |
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(4) the estimated cost savings to consumers, health |
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plans, employers, and this state since the establishment of the |
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program and during the preceding state fiscal year; |
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(5) information regarding the implementation of the |
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audit procedures under Section 444.006; and |
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(6) any other information: |
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(A) the governor or the legislature requests; or |
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(B) the commission considers necessary. |
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SECTION 3. As soon as practicable after the effective date |
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of this Act, the executive commissioner of the Health and Human |
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Services Commission shall adopt any rules necessary to implement |
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Chapter 444, Health and Safety Code, as added by this Act. |
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SECTION 4. If before implementing any provision of this Act |
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a state agency determines that a waiver or authorization from a |
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federal agency is necessary for implementation of that provision, |
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the agency affected by the provision shall request the waiver or |
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authorization and may delay implementing that provision until the |
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waiver or authorization is granted. |
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SECTION 5. This Act takes effect September 1, 2023. |
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* * * * * |