The use and exemption of Regulatory Impact Assessment by the National Health Surveillance Agency

Por: Natasha Schmitt Caccia Salinas, Lucas Thevenard Gomes

Regulatory impact assessment—RIA—is increasingly important for Brazilian Administrative Law, especially after the ‘Economic Freedom Act’ (Lei de Liberdade Econômica) extended its scope of implementation to all  public  bodies  and  federal  administration  entities.  This  work  analyses  the  evolution  of  RIA  under  the  purview  of  the  National  Health  Surveillance  Agency  (Anvisa),  a  federal  agency  that  stands  out  for  being  at  the  forefront  of  RIA  implementation  in  Brazil.  To  this  end,  data  published  on  the  legislation  section  of  the  agency’s  website  about  the  use  of  RIA  to  substantiate  Directors’  Collegiate  Regulations  (Resoluções de  Diretoria  Colegiada)  and  Normative  Instructions  (Instruções  Normativas)  between  2011  and  2020  were collected. The total number and proportion of cases in which the Directors’ Collegiate approved the realization or dispensation of RIA, based on relevant normative acts collected in this period, are presented. It  was  found  that,  in  most  cases,  there  were  exemptions  from  RIA,  and  this  proportion  was  not  reduced  over  time.  Furthermore,  in  cases  of  exemption,  it  was  observed  that  the  urgency/severity  of  the  process  was used as justification in a high proportion of cases. Finally, it was also observed that the use of RIA and exemption justifications vary according to the subject of the regulatory norm in question. The results of this study advance the existing knowledge about the implementation of RIA in Brazil and suggest new avenues of qualitative research on the factors that influenced the use and exemption of RIA by Anvisa.