By: Perry, Hall  S.B. No. 265
         (In the Senate - Filed December 6, 2022; February 15, 2023,
  read first time and referred to Committee on Health & Human
  Services; April 17, 2023, reported adversely, with favorable
  Committee Substitute by the following vote:  Yeas 9, Nays 0;
  April 17, 2023, sent to printer.)
Click here to see the committee vote
 
  COMMITTEE SUBSTITUTE FOR S.B. No. 265 By:  Perry
 
 
A BILL TO BE ENTITLED
 
AN ACT
 
  relating to required reports of certain vaccine-related or
  drug-related adverse events.
         BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
         SECTION 1.  Subchapter A, Chapter 161, Health and Safety
  Code, is amended by adding Section 161.0103 to read as follows:
         Sec. 161.0103.  REQUIRED REPORT OF CERTAIN VACCINE-RELATED
  ADVERSE EVENTS.  (a)  In this section, "serious adverse event" means
  an event that:
               (1)  results in death;
               (2)  is considered life-threatening;
               (3)  results in inpatient hospitalization or an
  extension of the duration of an existing hospitalization;
               (4)  results in a persistent or significant incapacity
  or substantial disruption of a person's ability to perform normal
  life functions;
               (5)  results in a congenital anomaly or birth defect;
  or
               (6)  results in a medically important condition that,
  based on the physician's reasonable medical judgment, may require
  medical or surgical intervention to prevent an outcome described by
  Subdivisions (1) through (5).
         (b)  This section applies only to a vaccine that is:
               (1)  experimental or investigational; or
               (2)  approved or authorized for emergency use by the
  United States Food and Drug Administration.
         (c)  Notwithstanding Subsection (b), this section does not
  apply to a vaccine administered as part of a clinical trial.
         (d)  Notwithstanding any other law, a physician shall report
  to the federal Vaccine Adverse Event Reporting System any serious
  adverse event the physician's patient suffers if:
               (1)  the physician: 
                     (A)  diagnoses the patient with a condition
  related to the serious adverse event; and
                     (B)  knows the patient received a vaccination to
  which this section applies; and
               (2)  the patient suffers the serious adverse event
  before the first anniversary of the date the patient was
  vaccinated.
         (e)  A physician who violates this section is subject to:
               (1)  for an initial violation, non-disciplinary
  corrective action by the Texas Medical Board; and
               (2)  for each subsequent violation, disciplinary
  action by the Texas Medical Board as if the physician violated
  Subtitle B, Title 3, Occupations Code.
         (f)  For purposes of non-disciplinary corrective action or
  disciplinary action imposed under Subsection (e), a violation of
  this section may not be considered after the third anniversary of
  the date of the violation.  However, the Texas Medical Board must
  retain information on each violation in the physician's permanent
  record.
         (g)  The executive commissioner shall adopt rules necessary
  to implement this section.
         SECTION 2.  Subchapter E, Chapter 431, Health and Safety
  Code, is amended by adding Section 431.1145 to read as follows:
         Sec. 431.1145.  REQUIRED REPORT OF CERTAIN DRUG-RELATED
  ADVERSE EVENTS. (a)  In this section, "serious adverse event" means
  an event that:
               (1)  results in death;
               (2)  is considered life-threatening;
               (3)  results in inpatient hospitalization or an
  extension of the duration of an existing hospitalization;
               (4)  results in a persistent or significant incapacity
  or substantial disruption of the person's ability to perform normal
  life functions;
               (5)  results in a congenital anomaly or birth defect;
  or
               (6)  results in a medically important medical condition
  that, based on the physician's reasonable medical judgment, may
  require medical or surgical intervention to prevent an outcome
  described by Subdivisions (1) through (5).
         (b)  This section applies only to a drug that is:
               (1)  experimental or investigational; or
               (2)  approved or authorized for emergency use by the
  United States Food and Drug Administration.
         (c)  Notwithstanding Subsection (b), this section does not
  apply to a drug that is administered or used as part of a clinical
  trial.
         (d)  Notwithstanding any other law, a physician shall report
  to the United States Food and Drug Administration through the
  MedWatch Reporting System any serious adverse event the physician's
  patient suffers if:
               (1)  the physician:
                     (A)  diagnoses the patient with a condition
  related to the serious adverse event; and
                     (B)  knows the patient was administered or used a
  drug to which this section applies; and
               (2)  the patient suffers the serious adverse event
  before the first anniversary of the date the patient was
  administered or used the drug.
         (e)  A physician who violates this section is subject to:
               (1)  for an initial violation, non-disciplinary
  corrective action by the Texas Medical Board; and
               (2)  for each subsequent violation, disciplinary
  action by the Texas Medical Board as if the physician violated
  Subtitle B, Title 3, Occupations Code.
         (f)  For purposes of non-disciplinary corrective action or
  disciplinary action imposed under Subsection (e), a violation is
  not considered after the third anniversary of the date of the
  violation.  However, the Texas Medical Board must retain
  information on each violation in the physician's permanent record.
         (g)  The executive commissioner shall adopt rules necessary
  to implement this section.
         SECTION 3.  As soon as practicable after the effective date
  of this Act, the executive commissioner of the Health and Human
  Services Commission shall adopt rules necessary to implement the
  changes in law made by this Act.
         SECTION 4.  This Act takes effect September 1, 2023.
 
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