The Brazilian Health Regulatory Agency (Anvisa) has submitted for public consultation a draft resolution that establishes the guidelines to be observed in sanitary administrative proceedings (PAS) within Anvisa (Public Consultation 1,297/24).

The PAS is a proceeding initiated by health surveillance authorities based on an infraction notice that investigates potential irregularities and the responsibilities of the offender. In this proceeding, the offender is assured the right to a broad defense and adversarial process.

Currently, Anvisa's PAS is regulated by Law 9,784/99, which establishes the norms for administrative processes within the federal Public Administration (which includes, besides Anvisa, other federal agencies, autarchies, and entities).

Key aspects of the proposed resolution

To support the process of preparing the regulatory impact analysis report and drafting the resolution, the topic was widely discussed by several organizational units of Anvisa and the Federal Attorney's Office.

Among the main aspects brought by the proposed resolution, the following stand out:

• Responsive supervision: adoption of a risk-based approach, considering the company's compliance history and specific circumstances to determine the most appropriate response. Such administrative measures can be classified as:
  • Preliminary: Applied at Anvisa's discretion when the damages resulting from the infraction are of low or medium impact on public health. These measures aim to encourage a return to compliance with sanitary rules in a quickly and effectively manner, without constituting a penalty for the offender. They will be applied by the competent authority through a sanitary notification, which must contain: the description of the detected irregularity, the respective legal provision violated, and the deadline for correction or submission of a corrective action plan. The offending company must prove the correction of the infraction within the deadlines established in the sanitary notification or the corrective action plan, under penalty of adopting a sanctioning administrative measure. Preliminary administrative measures are not allowed in the following cases:
    • Another preliminary administrative measure has already been applied to the company for the same type of infraction in the last 12 months;
    • A sanctioning measure has already been applied for the same type of infraction in the last 3 years; or
    • The company acted with intent or bad faith.
  • Precautionary: adopted in case of imminent risk, without prior manifestation of the interested party. These measures aim to eliminate, reduce, or mitigate the sanitary risks associated with products or services and can be of two types:
    • Cautionary, which will last as long as the special circumstances of imminent health risk are present; or
    • Preventive, applied in cases where there are clear indications of product alteration or adulteration. These measures should not exceed 90 days. The company will be notified of the precautionary administrative measure through an express administrative act No suspensive effect is allowed in appeals against precautionary administrative measures. These measures will be revoked ex officio when the reasons for their application are demonstrated to be unfounded or ceased;
  • Sanctioning: involve the application of a sanction, as established in Law 6.437/77.
• Stages of PAS: The stages of the sanctioning PAS are:

• issuance of the sanitary infraction notice (AIS);
• presentation of defense of the AIS;
• manifestation of the acting area or server;
• first instance judgment;
• appeal;
• second instance judgment;
• appeal against the second instance decision;
• final instance judgment; and
• certification of the final decision.

• Double visit: the double visit criterion must be observed when very low, low, or medium sanitary risk infractions are detected, committed by individual micro-entrepreneurs, micro-enterprises, or small businesses that have no previous convictions for sanitary infractions.
• Prevalence of the competent authority: whenever the initiation of a PAS for the same fact and the same infraction is identified in different spheres of the National Health Surveillance System, the PAS later initiated by Anvisa will be archived.
• Conduct Adjustment Commitment Term (TCAC): possibility and criteria for entering into a TCAC – an instrument aimed at simplifying, adjusting, repairing, or compensating irregular conduct to legal and regulatory provisions, as well as remedying and ceasing the effects of the imputed infraction.
  • The use of TCAC in the context of sanitary supervision actions is already allowed by Law 14.671/23. Its application has been widely discussed both internally at Anvisa and the regulated sector (for example, through Public Consultation 1.282/24 – click here for more information).
• Economic capacity of the offender: the economic capacity of the offender will be assessed at the time of the first instance decision and considered in the penalty definition. Companies that do not keep their registration data updated may be automatically classified as large.
• PAS’ digitalization: full digitization of PAS’ proceedings and regulation through electronic proceedings to reduce costs and optimize human resources.
• Fine table: annex to the proposed resolution which sets out the amounts of the fines according to the economic capacity of the offender, the nature of the infraction, and the degree of sanitary risk. According to Anvisa, this annex aims to bring transparency to health authorities and offenders, to reduce the re-discussion of the parameters used to set the fine values in the appeal context. In cases of sanitary infractions where the conduct description contains more than one product, non-compliance with more than one notification item, or similar act or with the presence of mitigating factors, the values defined will be:
  • increased by 10% per product up to the maximum limit established for the fine range of the infraction;
  • increased by 10% per non-compliant item up to the maximum limit established for the fine range of the infraction; and
  • reduced by 10% per mitigating factor up to the minimum limit established for the fine range of the infraction.

The annex is composed of the following values:

TCU Determination

According to Anvisa, Public Consultation 1.297/24 aims to make the agency's oversight more efficient, cost-effective, and transparent.

their is also a result from a determination issued by the Federal Court of Accounts (TCU), within the scope of Decision 732/20 (Process 001.814/2019-2).

After conducting an audit of ongoing proceedings at Anvisa, TCU concluded that the agency is inefficient in investigating sanitary infractions and holding offenders accountable, requiring actions to resolve the problem. For this, it was recommended to Anvisa's Collegiate Board of Directors to:

• establish a unit responsible for managing the entire the PAS, encompassing instruction, infraction, judgment, and appeals, regardless of the object, to provide uniformity and legal security to the process;
• systematically regulate the PAS;
• establish an electronic system for complete management and processing of the PAS, entirely electronically;
• evaluate the possibility of issuing an internal jurisprudence bulletin, to help standardize understandings;
• evaluate the possibility of publishing consolidated information on an electronic site, in a Business Intelligence (BI) format;
• regulate the use of the Conduct Adjustment Term (TAC); and
• submit  a proposal to amend Law 6.437/77 (which defines infractions to federal sanitary legislation and establishes respective sanctions) to the National Congress.

Contributions to Public Consultation 1.297/24 can be made until February 3^rd, 2025. The Life Sciences & Health practice can provide more information on the topic.