New law authorizes signing of commitment term between offender and health authority before penalties are applied

On September 12, 2023, Law No. 14,671/2023 was published, amending Law No. 6,437, of August 20, 1977 (also known as the “Health Violations Law”) to provide for the signing of a commitment term in order to promote corrections and adjustments to the requirements of health legislation.

The new Law includes a provision in the Sanitary Violations Law aimed at authorizing oversight and inspection bodies that are part of the National Health Regulatory System (SNVS) to sign commitment terms with offenders. Such terms have already been used by some health authorities, but until the publication of the new Law, there was no express legal provision in federal legislation.

The respective health authority must analyze the request within 90 days from the filing date. The request must contain the necessary information to verify its technical and legal feasibility, under penalty of rejection, and must contain at least the following information:

1. the identification, qualification, and address of the parties involved and their legal representatives;
2. the term of validity of the commitment, defined according to the complexity of the obligations set out therein;
3. the detailed description of its purpose;
4. the penalties that may be applied and the cases in which termination can occur because of failure to comply with the obligations of the term;
5. the competent jurisdiction to settle disputes between the parties.

With the signing of the commitment term, the application of administrative sanctions, except those of a preventive and precautionary nature, must be suspended, in relation to the facts that gave rise to the signing of the instrument.

The commitment term will have enforceability as an extrajudicial title for execution but does not prevent the penalties that have been applied before the application is filed.

Finally, if there is a breach of clauses of the term, it will be considered terminated, except in the case of unforeseeable circumstances and force majeure.

Demarest’s Life Sciences team is available to provide any further clarifications that may be necessary.