BILL ANALYSIS

Senate Research Center	S.B. 265
88R2337 KKR-D	By: Perry
	Health & Human Services
	3/20/2023
	As Filed

AUTHOR'S / SPONSOR'S STATEMENT OF INTENT

According to the United States Health and Human Services VAERS Website:

The Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system, meaning it relies on individuals to send in reports of their experiences. Anyone can submit a report to VAERS, including parents and patients.

Healthcare providers are required by law to report to VAERS if:

Any adverse event listed in the VAERS Table of Reportable Events Following Vaccination that occurs within the specified time period after vaccinations

An adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine

Healthcare providers are strongly encouraged to report to VAERS if:

Any adverse event that occurs after the administration of a vaccine licensed in the United States, whether it is or is not clear that a vaccine caused the adverse event

Vaccine administration errors

There is currently no requirement that adverse reactions to the COVID vaccine are to be reported.

S.B. 265 requires by statute, a physician report any adverse reaction that is caused by or potentially caused by an experimental or investigational, or administered under emergency use authorization by the United States Food and Drug Administration.

By requiring this reporting, it would help identify possible side effects or reactions which would help better inform the patient while helping health care workers and policy makers work toward solutions in preventing or treating diseases.

As proposed, S.B. 265 amends current law relating to required reports of certain vaccine-related or drug-related injuries and adverse events.

RULEMAKING AUTHORITY

Rulemaking authority is expressly granted to the executive commissioner of the Health and Human Services Commission in SECTION 1 (Section 161.0103, Health and Safety Code) and SECTION 2 (Section 431.1145, Health and Safety Code) of this bill.

SECTION BY SECTION ANALYSIS

SECTION 1. Amends Subchapter A, Chapter 161, Health and Safety Code, by adding Section 161.0103, as follows:

Sec. 161.0103. REQUIRED REPORT OF CERTAIN VACCINE-RELATED INJURIES AND ADVERSE EVENTS. (a) Provides that this section applies only to a vaccine that is experimental or investigational or is approved or authorized for emergency use by the United States Food and Drug Administration.

(b) Requires a physician, notwithstanding any other law, for a vaccine to which this section applies, to report to the federal Vaccine Adverse Event Reporting System each potential vaccine-related injury of a patient the physician treats and any adverse event following the patient's vaccination.

(c) Provides that a physician who violates this section is subject to disciplinary action by the Texas Medical Board (TMB) as if the physician violated Subtitle B (Physicians), Title 3, Occupations Code.

(d) Requires the executive commissioner of the Health and Human Services Commission (executive commissioner) to adopt rules necessary to implement this section.

SECTION 2. Amends Subchapter E, Chapter 431, Health and Safety Code, by adding Section 431.1145, as follows:

Sec. 431.1145. REQUIRED REPORT OF CERTAIN DRUG-RELATED INJURIES AND ADVERSE EVENTS. (a) Provides that this section applies only to a drug that is experimental or investigational or is approved or authorized for emergency use by the United States Food and Drug Administration.

(b) Requires a physician, notwithstanding any other law, for a drug to which this section applies, to report to the United States Food and Drug Administration through the MedWatch Reporting System each potential drug-related injury of a patient the physician treats and any adverse event following the administration or use of the drug.

(c) Provides that a physician who violates this section is subject to disciplinary action by TMB as if the physician violated Subtitle B, Title 3, Occupations Code.

(d) Requires the executive commissioner to adopt rules necessary to implement this section.

SECTION 3. Requires the executive commissioner, as soon as practicable after the effective date of this Act, to adopt rules necessary to implement the changes in law made by this Act.

SECTION 4. Effective date: September 1, 2023.