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A BILL TO BE ENTITLED
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AN ACT
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relating to required reports of certain vaccine-related or |
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drug-related adverse events. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Subchapter A, Chapter 161, Health and Safety |
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Code, is amended by adding Section 161.0103 to read as follows: |
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Sec. 161.0103. REQUIRED REPORT OF CERTAIN VACCINE-RELATED |
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ADVERSE EVENTS. (a) In this section, "serious adverse event" means |
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an event that: |
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(1) results in death; |
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(2) is considered life-threatening; |
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(3) results in inpatient hospitalization or an |
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extension of the duration of an existing hospitalization; |
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(4) results in a persistent or significant incapacity |
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or substantial disruption of a person's ability to perform normal |
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life functions; |
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(5) results in a congenital anomaly or birth defect; |
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or |
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(6) results in a medically important condition that, |
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based on the physician's reasonable medical judgment, may require |
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medical or surgical intervention to prevent an outcome described by |
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Subdivisions (1) through (5). |
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(b) This section applies only to a vaccine that is: |
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(1) experimental or investigational; or |
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(2) approved or authorized for emergency use by the |
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United States Food and Drug Administration. |
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(c) Notwithstanding Subsection (b), this section does not |
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apply to a vaccine administered as part of a clinical trial. |
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(d) Notwithstanding any other law, a physician shall report |
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to the federal Vaccine Adverse Event Reporting System any serious |
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adverse event the physician's patient suffers if: |
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(1) the physician: |
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(A) diagnoses the patient with a condition |
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related to the serious adverse event; and |
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(B) knows the patient received a vaccination to |
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which this section applies; and |
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(2) the patient suffers the serious adverse event |
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before the first anniversary of the date the patient was |
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vaccinated. |
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(e) A physician who violates this section is subject to: |
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(1) for an initial violation, non-disciplinary |
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corrective action by the Texas Medical Board; and |
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(2) for each subsequent violation, disciplinary |
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action by the Texas Medical Board as if the physician violated |
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Subtitle B, Title 3, Occupations Code. |
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(f) For purposes of non-disciplinary corrective action or |
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disciplinary action imposed under Subsection (e), a violation of |
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this section may not be considered after the third anniversary of |
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the date of the violation. However, the Texas Medical Board must |
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retain information on each violation in the physician's permanent |
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record. |
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(g) The executive commissioner shall adopt rules necessary |
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to implement this section. |
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SECTION 2. Subchapter E, Chapter 431, Health and Safety |
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Code, is amended by adding Section 431.1145 to read as follows: |
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Sec. 431.1145. REQUIRED REPORT OF CERTAIN DRUG-RELATED |
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ADVERSE EVENTS. (a) In this section, "serious adverse event" means |
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an event that: |
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(1) results in death; |
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|
(2) is considered life-threatening; |
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(3) results in inpatient hospitalization or an |
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extension of the duration of an existing hospitalization; |
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(4) results in a persistent or significant incapacity |
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or substantial disruption of the person's ability to perform normal |
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life functions; |
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(5) results in a congenital anomaly or birth defect; |
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or |
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(6) results in a medically important medical condition |
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that, based on the physician's reasonable medical judgment, may |
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require medical or surgical intervention to prevent an outcome |
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described by Subdivisions (1) through (5). |
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(b) This section applies only to a drug that is: |
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(1) experimental or investigational; or |
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(2) approved or authorized for emergency use by the |
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United States Food and Drug Administration. |
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(c) Notwithstanding Subsection (b), this section does not |
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apply to a drug that is administered or used as part of a clinical |
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trial. |
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(d) Notwithstanding any other law, a physician shall report |
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to the United States Food and Drug Administration through the |
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MedWatch Reporting System any serious adverse event the physician's |
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patient suffers if: |
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(1) the physician: |
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(A) diagnoses the patient with a condition |
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related to the serious adverse event; and |
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(B) knows the patient was administered or used a |
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drug to which this section applies; and |
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(2) the patient suffers the serious adverse event |
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before the first anniversary of the date the patient was |
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administered or used the drug. |
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(e) A physician who violates this section is subject to: |
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(1) for an initial violation, non-disciplinary |
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corrective action by the Texas Medical Board; and |
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(2) for each subsequent violation, disciplinary |
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|
action by the Texas Medical Board as if the physician violated |
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|
Subtitle B, Title 3, Occupations Code. |
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(f) For purposes of non-disciplinary corrective action or |
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|
disciplinary action imposed under Subsection (e), a violation is |
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not considered after the third anniversary of the date of the |
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|
violation. However, the Texas Medical Board must retain |
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information on each violation in the physician's permanent record. |
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(g) The executive commissioner shall adopt rules necessary |
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to implement this section. |
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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 rules necessary to implement the |
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changes in law made by this Act. |
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SECTION 4. This Act takes effect September 1, 2023. |
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* * * * * |