ANVISA Sanctioning Administrative Proceedings – Regulatory Advances and Challenges

Health regulation in Brazil plays a central role in promoting public health and ensuring the safety of products and services. With the aim of strengthening this system, the Brazilian Health Regulatory Agency (“ANVISA”) has initiated a comprehensive review of its Sanctioning Administrative Proceedings (“PAS”), seeking to make them more efficient and effective.

This initiative was prompted by findings set out in Decision No. 732/2020 of the Brazilian Federal Court of Accounts (“TCU”), which identified shortcomings in the processing of these proceedings and in the application of health-related penalties, such as lengthy proceedings and the low rate of payment of fines imposed. According to the decision, the current health legislation, particularly Law No. 6,437/1977, has become “outdated and, in some cases, represents an obstacle to making PAS proceedings at ANVISA more efficient.” 

In addition, administrative proceedings still rely on physical formats, which compromises efficiency and increases operating costs. These factors have been further aggravated by the lack of uniformity in the criteria used for issuing notices of violation and adjudicating cases. 

The new regulatory proposal, presented to the public through Public Consultation No. 1,297/2024, aims to modernize PAS proceedings and make them more efficient and effective, ensuring that they are more responsive to current demands. Among the established objectives is the creation of a regulatory framework that harmonizes the criteria for imposing penalties, taking health risks into account. 

The full digitalization of proceedings and the regulation of PAS through electronic procedures are also key elements of the proposal, with the goal of reducing costs, optimizing human resources, and incorporating advanced technologies, such as artificial intelligence, to accelerate the analysis and adjudication of cases. 

ANVISA also proposes criteria for adopting precautionary and preventive measures, such as Terms of Conduct Adjustment (“TACs”), for low-risk violations, provided that the offender clearly demonstrates its willingness and ability to promptly remedy any impacts caused by the violation and return to compliant conduct. 

This approach seeks to replace punitive measures with educational and collaborative initiatives, in line with a regulatory model that prioritizes effective outcomes. 

In addition, the proposed resolution expressly provides that appeals against precautionary administrative measures will not have suspensive effect, as set forth in Article 8 of the draft, which reflects the rule currently in force. Article 32, in turn, establishes that appeals against decisions concerning the immediate enforceability of obligations will also not have suspensive effect, depending on the health risk involved; this represents a new provision. 

In our view, the draft lacks a clear and objective provision regarding suspensive effect which, by a contrario reasoning, remains applicable to appeals in general, subject to the aforementioned exceptions. 

These measures are expected to improve the efficiency of administrative proceedings and increase transparency in decision-making. The modernization of PAS proceedings promises not only to optimize the use of public resources, but also to strengthen public confidence in ANVISA’s regulatory actions. 

To ensure broad public participation, ANVISA established a 45-day period for submitting contributions. This period began on December 20, 2024, and ended on February 3, 2025, allowing citizens, regulated entities, and other interested parties to submit suggestions and comments. Public participation appears to be essential to ensure that the regulation gains support and adherence from the regulated sector. 

For further information, our Life Sciences team remains available to assist.