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A BILL TO BE ENTITLED
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AN ACT
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relating to patient authorization to access certain |
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investigational sun protection products. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. (a) The legislature finds that: |
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(1) the process for the approval of investigational |
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sun protection products in the United States takes many years; |
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(2) some patients do not have the luxury of waiting |
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until an investigational sun protection product receives final |
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approval from the United States Food and Drug Administration; |
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(3) the standards of the United States Food and Drug |
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Administration for the use of investigational sun protection |
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products may deny patients the benefits of potentially life-saving |
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products; |
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(4) patients have a fundamental right to attempt to |
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preserve their health and lives by accessing available |
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investigational sun protection products; |
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(5) the use of available investigational sun |
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protection products is a decision the patient in consultation with |
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the patient's physician should make to preserve the patient's |
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health or life and is not a decision the government should make; and |
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(6) the decision to use an investigational sun |
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protection product should be made with full awareness of the |
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potential risks, benefits, and consequences to the patient. |
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(b) It is the intent of the legislature to allow patients |
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the option of using investigational sun protection products. |
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SECTION 2. Subtitle C, Title 6, Health and Safety Code, is |
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amended by adding Chapter 491 to read as follows: |
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CHAPTER 491. PATIENT ACCESS TO INVESTIGATIONAL SUN PROTECTION |
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PRODUCTS |
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SUBCHAPTER A. GENERAL PROVISIONS |
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Sec. 491.001. DEFINITION. In this chapter, |
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"investigational sun protection product" means a sun protection |
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product containing an ingredient that has successfully completed |
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phase one of a clinical trial but has not yet been approved for |
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general use by the United States Food and Drug Administration and |
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remains under investigation in the clinical trial. |
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SUBCHAPTER B. ELIGIBLE PATIENT ACCESS TO INVESTIGATIONAL SUN |
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PROTECTION PRODUCTS |
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Sec. 491.051. PATIENT ELIGIBILITY. A patient is eligible |
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to access and use an investigational sun protection product if the |
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patient's physician: |
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(1) in consultation with the patient, has considered |
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all other sun protection products currently approved by the United |
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States Food and Drug Administration and determined those products |
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are less effective in comparison to an investigational sun |
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protection product; and |
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(2) recommends or prescribes in writing an |
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investigational sun protection product for the patient. |
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Sec. 491.052. INFORMED CONSENT. (a) Before recommending |
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or prescribing an investigational sun protection product, a |
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physician must require an eligible patient to sign a written |
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informed consent form. |
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(b) If the patient is a minor or lacks the mental capacity to |
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provide informed consent, a parent or legal guardian may provide |
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informed consent on the patient's behalf. |
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(c) The Texas Medical Board by rule may adopt a form for the |
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informed consent required under this section. |
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Sec. 491.053. PROVISION OF INVESTIGATIONAL SUN PROTECTION |
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PRODUCT. (a) A manufacturer of an investigational sun protection |
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product may make available in accordance with this chapter and any |
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rules adopted under this chapter the manufacturer's product to |
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eligible patients who provide to the manufacturer the informed |
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consent required under Section 491.052. |
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(b) This chapter does not require a manufacturer to make |
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available an investigational sun protection product to an eligible |
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patient. |
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(c) A manufacturer may: |
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(1) provide an investigational sun protection product |
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to an eligible patient without receiving compensation; or |
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(2) require an eligible patient to pay the |
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manufacturer's costs of, or costs associated with, the manufacture |
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of the product. |
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Sec. 491.054. NO CAUSE OF ACTION CREATED. This chapter does |
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not create a private or state cause of action against a manufacturer |
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of an investigational sun protection product or against any other |
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person or entity involved in the care of an eligible patient using |
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the product for any harm to the eligible patient resulting from the |
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product. |
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Sec. 491.055. STATE MAY NOT INTERFERE WITH ACCESS TO |
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INVESTIGATIONAL SUN PROTECTION PRODUCTS. An official, employee, or |
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agent of this state may not block or attempt to block an eligible |
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patient's access to an investigational sun protection product under |
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this chapter. |
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SUBCHAPTER C. HEALTH INSURANCE |
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Sec. 491.101. EFFECT ON HEALTH CARE COVERAGE FOR CLINICAL |
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TRIAL ENROLLEES. This chapter does not affect the coverage of |
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enrollees in clinical trials under Chapter 1379, Insurance Code. |
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SUBCHAPTER D. PHYSICIANS |
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Sec. 491.151. PROHIBITED ACTION AGAINST PHYSICIAN'S |
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LICENSE. Notwithstanding any other law, the Texas Medical Board |
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may not revoke, fail to renew, suspend, or take any action against a |
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physician's license under Subchapter B, Chapter 164, Occupations |
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Code, based solely on the physician's recommendation to or |
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prescription for an eligible patient regarding access to an |
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investigational sun protection product, provided the |
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recommendation or prescription for the patient meets the medical |
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standard of care and the requirements of this chapter. |
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SECTION 3. This Act takes effect immediately if it receives |
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a vote of two-thirds of all the members elected to each house, as |
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provided by Section 39, Article III, Texas Constitution. If this |
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Act does not receive the vote necessary for immediate effect, this |
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Act takes effect September 1, 2025. |