Regulatory Focus™ > News Articles > Brazil Revises Patent Prior Consent Rules

Brazil Revises Patent Prior Consent Rules

Posted 15 April 2013 | By Louise Zornoza

The board of Brazil's National Health Surveillance Agency (Anvisa) has approved updated rules for the agency's prior consent assessment of patent applications for medicines.

The new rules establish a process for prioritizing patent reviews to ensure that the focus is on pharmaceutical products of interest to the public health policies of the country's Unified Health System (SUS).

The list of products of interest to the SUS will be published by the Ministry of Health, which will also require Anvisa to deny patent applications dealing with products prohibited in Brazil.  According to Anvisa's director, Dirceu Barbano, the main advance in the updated rules is to define what is in the public interest and to allow the Agency to take a more strategic approach to products.


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