The inspection bodies of the National Health Surveillance System may execute commitment agreements with private parties

by | Sep 15, 2023 | Client Alert, Patent

Law 14671/2023 was published today in the Federal Official Gazette (DOU), amending Law 6437/1977, which deals with violations of federal health legislation and establishes corresponding sanctions. With this change, there is now a specific legal provision for the control and inspection bodies of the National Health Surveillance System to enter into commitment agreements with private individuals. Although compliance agreements had already been made, these were joint actions with the Federal or State Public Prosecutors Offices. The commitment agreement is a mechanism that the legislator has implemented to encourage regulated industries to rectify their shortcomings, thereby preventing harm to public health and, at the same time, reducing the need for severe administrative actions or legal interventions.

The application must provide a detailed description of its subject matter and contain the necessary data for the technical and legal feasibility analysis, under penalty of rejection, and must be analyzed within a 90-day period. The law also establishes requirements, such as the identification and qualification of the parties involved, the duration of the commitment to be determined according to the complexity of the obligations set forth therein, and penalties in case of termination or non-compliance, among others.

During its validity, this instrument suspends the imposition of administrative sanctions related to the events that prompted it, except for preventive and precautionary measures. However, it is important to note that the celebration of the agreement does not prevent the enforcement of sancctions imposed prior to the filing of its application. Termination of the agreement occurs if any of its clauses are not fulfilled, except in cases of fortuitous events or force majeure.


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