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In this paper, we investigate whether the normative power of the National Health Surveillance Agency - Anvisa has violated the law, attracting the jurisdiction of the Judiciary, or whether there is a limitation of its regulatory competence, when compared to other federal autonomous agencies, due to political influence of the government (President of the Republic and National Congress) and the regulated industries. In this perspective, we understand that it is up to this Agency, having established the discussion about its differentiated normative capacity and considering the laws edited by the National Congress on its limit of competence, to fit into state regulation that establishes harmony in the regulatory sector. The controversy over the limitation of ANVISA's regulatory function includes the diagnosis of the elements of technical regulation - which involves technical-legal regulation and political regulation - that takes into account the conflicting interests of the regulated market.
Über den Autor / die Autorin
Master in Diritto presso il Centro Universitario di Brasília - UniCEUB con specializzazione in Diritto Sanitario presso la Fondazione Oswaldo Cruz - Fiocruz Brasília. È un funzionario dell'Agenzia Nazionale di Sorveglianza Sanitaria - Anvisa, assegnato alla consulenza della Direzione Generale dei Medicinali e dei Prodotti Biologici.
