The responsive aspect of guiding supervision carried out by Anvisa

Resumen

[Purpose] The article has the scope of analyzing the existence of a responsive model to provide functionality to Anvisa's inspection and punishment, using the double visit criterion, consisting of an initially guiding and corrective inspection, to draw up infraction notices against Micro and Small Companies, except for risk situations incompatible with the procedure and the non-virtuous behavior of the regulated party.

[Methodology/approach/design] The method used is relational/comparative of theory with practice.  The opinion of the Federal Prosecutor's Office with Anvisa (Opinion 119), the Decision of the Anvisa collegiate (Vote 1576/2023) and the understanding of the Superior Court of Justice (Resp 1,952,610 and 2,024,779) regarding the topic will be analyzed, in order to verify whether Anvisa has been applying the rule in health investigations and whether it will do so it is aligned with the regulatory design of the Responsive Regulation Theory.

[Findings] The results of this analysis will point to cooperation, the pedagogical effect and the responsive aspect of the guidance inspection carried out through double visits, with emphasis on the non-application of the benefit in case of non-virtuous behavior of the regulated party (recidivism, fraud, resistance or embarrassment to oversight). On the other hand, it will be necessary to regulate and define activities considered high risk by Anvisa, as decided by the STJ. In the end, will be defended adoption of an innovative effort in regulatory techniques and strategies by Anvisa, in order to have a regulatory design that is more comprehensive to the theory.

[Practical implications] The present study has practical importance that is not restricted to Anvisa's activity, but also to the entire sector in which the standard is applied, from the agency to regulated companies and consumers, reflected in the quality of the result delivered to society as a practical implication of the study. Likewise, it is important to note the benefits of this incentive and its responsive aspect, so that other regulatory measures and strategies can be motivated to achieve responsive modeling intrinsic to the theory with the aim of maximizing utility delivery.