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  • 19 September 2023

Law authorizing agreements with the Health Surveillance before the imposition of fines is sanctioned

On September 12, 2023, Law No. 14,671/2023 came into force, authorizing the signing of terms of commitment between control and inspection bodies that are part of the Brazilian Health Surveillance System (“SNVS”) and violators of the sector’s rules, changing Law No. 6,437/1977, which establishes violations of federal health legislation and their sanctions.

The terms of commitment are instruments aimed at the negotiated resolution of conflicts through agreements signed with public entities, in order to prevent the continuation of illegal acts and repair the damage caused.

In this sense, the initiative aims to make the control and inspection of services and products of interest to health more effective, by using a corrective instrument that represents an alternative to the repression of illegal acts in the health sector.

The new law originates from Bill of Law (“PL”) No. 4,573/2019, authored by former Senator José Serra, who justified the proposal with the intention of filling a legislative gap on the subject, given the lack of express legal provision for the use of such instrument in the health sector.

After the sanction has been imposed by one of the bodies of the SNVS, the offender may submit a request to enter into a term of commitment, which must contain the information necessary for its technical and legal viability, including at least: (i) the identification, qualification and address of the parties, as well as their respective legal representatives, (ii) the duration of the commitment, which will be determined according to the complexity of the obligations contained therein, (iii) a detailed description of its purpose, (iv) the applicable penalties and cases of termination as a result of non-compliance with the agreed obligations, and (v) the competent forum for resolving disputes between the parties.

The rule stipulates that, once a written request has been submitted and filed with the SNVS bodies, it will be analyzed within 90 days.

Once the agreement has been signed and published by the competent bodies of the SNVS, the application of administrative sanctions (such as fines, cancellation of licenses, interventions in the establishment and others) will be suspended – except for those of a preventive and cautionary nature.

However, it should be noted that the signing of the agreement does not prevent the enforcement of any sanctions applied in a period prior to the filing of the request.

In addition, the agreement will be terminated in the event of non-compliance with any of its provisions, except in cases of unforeseeable circumstances or force majeure, which will be analyzed by the competent bodies of the SNVS.

Our Life Sciences & Healthcare team is closely monitoring the changes affecting the Brazilian market. For more information on this or any other topic that may interest you, please contact our professionals.

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