January 9, 2025
The Brazilian FDA (“ANVISA”) has opened the Public Consultation #1,297/2024 until February 3, 2025, to receive contributions to the proposal for a new Board of Directors Rule (“RDC”) that provides for the systematic standardization of Administrative Sanctioning Proceedings (“PAS”) within the scope of ANVISA1.
The proposed RDC aims to harmonize the guidelines of this category of administrative proceedings into a single regulation, currently jointly based on Law #6,437/1977 and Law #9,784/1999, as well as on RDC #266/2019 (applicable to appeals). In this sense, the text under Public Consultation does not introduce any new procedures or deadlines, but rather consolidates them into a specific rule.
Moreover, the proposed RDC is based on the implementation of a responsive surveillance model, which, based on the concept included in the text subject to Public Consultation, consists of providing criteria to guide the health authorities in the selection of administrative measures and penalties that consider: (i) the potential health risks associated with the infraction; (ii) the compliance history of the company; and (iii) the need to prevent or mitigate identified risks more quickly. This regulatory model focuses on the virtuous behavior of regulated agents, encouraging them to voluntarily comply with regulatory requirements as an alternative to a regulatory model that is strictly based on punishments.
ANVISA has been discussing the drafting of this regulation since December 2020, through the Term of Process Opening (“TAP”) #134/2020, and it stems from an audit carried out by the Brazilian Court of Auditors (“TCU”) on ANVISA’s surveillance activities, which concluded that the agency was inefficient in its processes for investigating infractions and imposing penalties. Through Decision #732/2020, the TCU determined that ANVISA should “standardize the Sanitary Administrative Process in a systemic manner (...)” (free translation)2 among other measures intended to make the agency's inspection processes more efficient and effective.
Furthermore, the text incorporates and regulates, within the scope of the PAS, the application of prior measures (in cases of risk of damage or actual damage of low or medium impact on health), precautionary measures (in cases of imminent risk), and sanctions.
In this regard, the penalty application system may be intensified to the detriment of the violator when there are: (i) concurrent infractions resulting from the same fact and/or (ii) a continuous infraction. In the case of concurrent infractions (when there is more than one infraction in the same health infraction notice), for instance, the regulation draft proposes that the maximum value limits may no longer consider the penalty amount in the PAS, but rather each individual infraction. On the other cases, when a continuous infraction is found3, an increase to the base penalty for the most serious conduct (or for the identical conduct practiced continuously) from 1/6 (one sixth) to 2/3 (two thirds) is proposed, in addition to an increase of up to three times the base penalty when an aggravating circumstance is characterized.
This could represent an excessive burden, for example, to the medical devices industry, whose routine activity is carrying out field actions, should ANVISA continue to fine these companies for each issued notification, despite recognizing voluntary recall actions as a mitigating circumstance.
The text also proposes requirements and guidelines for the execution of a Conduct Adjustment Commitment Agreement ("TCAC"), in addition to those already provided for in Law #6,437/1977 (included by Law #14,671, of 2023). Unlike what is provided for in the legislation, among the proposed guidelines, a TCAC could only be entered into sua sponte by the health authority, with no possibility of request by the violator. In practice, the decision to accept the TCAC would be made by the health authority but, under the terms of the text submitted to the CP, the health authority would not even evaluate the grounds of the violator if they intended to propose the TCAC.
It is worth noting that the RDC proposal innovates on the topic of communication of administrative acts. Beyond the ordinary means (in person, by mail, public notice or by electronic system), it proposes the inclusion of communication by messaging applications with the individual violator or their legal representative. In this case, identification would be authenticated by three means: telephone number, written confirmation, and photo of the summoned individual. Should this type of communication fail, the text suggests communication by public notice.
Finally, the regulation draft proposes that the application of the new PAS guidelines shall already occur in the processes in progress at the time of publication of the RDC.
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