Who approves? RDC 21 stirs the pot
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.
According to Article 2 of RDC 21, prior approval is an administrative decision that takes into account compliance regarding Article 229-C, in which ANVISA must verify if ‘the subject’ of the patent application is against public health.
Article 3 states that the prior approval procedure will take place after the INPI sends the application to ANVISA, but before substantive examination of the application at the INPI. After receiving the patent application, ANVISA will perform its examination in the light of public health, through a decision produced by the Office of Coordination of IP (COOPI), the ANVISA department located in Rio de Janeiro.
