Changes at Anvisa


Otto Licks and Ricardo Dutra Nunes

The Brazilian national health surveillance agency (Anvisa) is the equivalent of the US FDA and the EU’s EMEA. It was established in 1999.

Anvisa is an autonomous agency, which in theory makes it independently administered and financially autonomous, with security of tenure for its five directors. But it has been controversial and, some say, has resulted in a lack of enforcement of intellectual property legislation relating to the pharmaceutical industry.

However, this situation could be changing. Anvisa enacted Rule no. 136 in February, 2011. It promises a totally new procedure governing administrative appeals filed against the agency’s decisions, which might increase the enforcement of IP and food and drug laws along with transparency, due process and accountability.

The rule is being compared to the 1946 Administrative Procedure Act in the US. Administrative appeals regulated by Rule no. 136 automatically stay the effects of the appealed decision, as a matter of law.

Anvisa, IP rights