New law allows agreements between offenders and health authorities to avoid sanctions

On September 12, Brazilian Law 14,671/2023 was enacted, amending Law No. 6,437/1977, commonly known as the Sanitary Infractions Law. Now, health surveillance agencies are allowed to enter into agreements with private entities in breach of sanitary regulations, aiming to make corrections and adjustments to comply with sanitary legislation requirements.

How It Works

To enter into an agreement, the offender must submit a request to the respective health surveillance agency, providing information for assessment of technical and legal feasibility of the agreement.

The health surveillance agency will have 90 days, counted from the date of the filing, to review the request. If the agreement is authorized, the agreement signed by the parties is treated as an extrajudicial enforceable instrument. However, this does not prevent the enforcement of sanctions applied prior to the filing of the request by the offender.

What Must Be Included in the Commitment Agreement

The commitment agreement must, at a minimum, include the following points:

• Identification of the parties;
• Agreement term;
• Detailed description of the agreement’s subject matter;
• Penalties that may be applied and situations that lead to termination in case of non-compliance by the offender; and
• Venue for resolving disputes between the parties.

Benefit

If the commitment agreement is entered into by the parties, the imposing of administrative penalties related to the agreement’s subject matter will be suspended, except for preventive and provisional measures.

Additional Information

Agreements of this kind were already being signed by some health authorities, although there was no express legal provision authorizing it under Brazilian laws.

The new Law lacks specific regulation that will provide further details on the applicable procedure and any possible required criteria.

Our Life Sciences team is available to assist you with this matter and to provide any necessary clarifications to your company.