Who approves? RDC 21 stirs the pot


Otto Licks

The Brazilian food and drug administration (ANVISA) regulation RDC 21 of 2013, effective from April 16, 2013, covering pharmaceutical patents, caught the IP and the investment community by surprise.

It bluntly violates the World Trade Organization TRIPS Agreement, the Paris Convention, the Brazilian patent law and the country’s 1988 Constitution. Regulation RDC 21 of 2013 amends regulation RDC 48 of 2008, which established ANVISA’s procedures for the prior approval for the grant of pharmaceutical applications claiming pharmaceutical products or processes under the statutory authority of Article 229-C of the Brazilian patent statute.

Under RDC 21, ANVISA may deny prior approval under Article 229-C for patent applications considered of interest under the Brazilian public policy of access to medicines or the public healthcare system (SUS). This covers patent applications for products and therapeutic indications listed in several regulations published by the Ministry of Health.

RDC 21 is immediately applicable to all pending applications. It is not settled at this time whether applications already being examined by the Brazilian patent office (INPI) will be sent to ANVISA before the end of the examination.

RDC 21, pharmaceuticals, ANVISA