Brazilian drug approval considerations

Gustavo de Freitas Morais
Rodrigo Augusto Oliveira Rocci
and Vyctor Taddeucci de Araújo

Introduction

The Brazilian patent system is ruled by Brazilian Patent Office created by Federal Law nº 5.648/70 and its authority is defined by Brazilian Industrial Property Law (no. 9.279/96). On the Brazilian health regulatory system introduced by Act no 6.360/76, any drug may be marketed only if it has been previously registered with the pertinent authority of the Ministry of Health; such competence was
attributed to Brazilian Agency of Sanitary Surveillance (“ANVISA”) by Law no 9.782/99.

As can be noticed, pharmaceuticals in Brazil are governed by a comprehensive and complex regime of legislation and regulations spanning many different areas of law. The legislative and regulatory landscapes are very dynamic, as patent laws are constantly under review and government authorities constantly update regulatory processes and policies.

This chapter provides an overview of each element in this complex Brazilian regime together with insights into the issues that might arise and how they might be navigated.

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