Brazil and the antidepressant market : changing the mood
The vice-president of the Superior Court of Justice (STJ), Minister Felix Fischer, restored the power of the National Health Surveillance Agency (Anvisa) to grant registration of generic medicines and the like, based on the active ingredient escitalopram (antidepressant).
Background
The judge of first instance had decided that ANVISA refrain from granting registration to a third party not authorized by Lundbeck Brazil Ltda - producer of Lexapro, the reference medical product – to use test results and data of the dossier sent by the company for the registration of the drug.
Also, the court held the invalidity of any drug registration already granted based on this dossier, in particular those obtained by companies Aché Pharmaceutical Laboratories S/A and Biosintética Pharmaceuticals Ltd, which are manufacturers of similar drugs. The judge applied the term of ten years to protect the rights of data exclusivity – in this case due to expire in September 2012.
Final decision
According to Minister Fischer, the decision of first instance has a “negative effect of erecting barriers to the participation of manufacturers interested in producing similar or generic drugs”. Therefore, the suspension of the sentence is advisable "in order to avoid the risk of weakening the national policy of generic drugs in the country". To that effect, the Vice-President of the Supreme Court re-establishes the power of ANVISA to register generic antidepressants with the said ingredient.
Note that the Brazilian drug market is governed by technical regulations and is regulated by a National Health Sanitary Surveillance Agency (ANVISA), which is a financially autonomous regulatory agency linked to the Brazilian Ministry of Health under management contract. No drug can be produced, imported, put for sale, or distributed in Brazil without registering with ANVISA.
Process number SLS 1425. Full decision can be found here.
Background
The judge of first instance had decided that ANVISA refrain from granting registration to a third party not authorized by Lundbeck Brazil Ltda - producer of Lexapro, the reference medical product – to use test results and data of the dossier sent by the company for the registration of the drug.
Also, the court held the invalidity of any drug registration already granted based on this dossier, in particular those obtained by companies Aché Pharmaceutical Laboratories S/A and Biosintética Pharmaceuticals Ltd, which are manufacturers of similar drugs. The judge applied the term of ten years to protect the rights of data exclusivity – in this case due to expire in September 2012.
Final decision
According to Minister Fischer, the decision of first instance has a “negative effect of erecting barriers to the participation of manufacturers interested in producing similar or generic drugs”. Therefore, the suspension of the sentence is advisable "in order to avoid the risk of weakening the national policy of generic drugs in the country". To that effect, the Vice-President of the Supreme Court re-establishes the power of ANVISA to register generic antidepressants with the said ingredient.
Note that the Brazilian drug market is governed by technical regulations and is regulated by a National Health Sanitary Surveillance Agency (ANVISA), which is a financially autonomous regulatory agency linked to the Brazilian Ministry of Health under management contract. No drug can be produced, imported, put for sale, or distributed in Brazil without registering with ANVISA.
Process number SLS 1425. Full decision can be found here.
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