Table 1.

Elements in Brazil’s priority-setting legal instruments

Transparency	The priority-setting process and the way in which decision makers are chosen are described in Portaria No. 2009.24 All decisions regarding priority setting must be made public.25
Relevance	The Ministry of Health and several health-related agencies are part of CONITEC.26 Additionally, all decisions are subject to a public consultation in which regular citizens can participate.27 Cost-effectiveness and clinical effectiveness studies are considered.28 Equity is part of the universality mandate, which CONITEC must consider in its process.29 Solidarity is present in the Protocols and Guidelines for the Comprehensive Care of Rare Diseases.30 There is no mention of copayments or shared payments as criteria for priority setting or of the patient’s ability to choose the treatment he or she wants.
Review and revision	The Protocols and Guidelines for the Comprehensive Care of Rare Diseases and RENAME can be modified whenever necessary. RENAME and RENASES are updated every two years.31
Oversight and supervision	The Health Surveillance Secretariat and the National Health Surveillance Agency are part of CONITEC, but there is no mention of their specific roles in oversight and supervision activities with regard to priority setting.32