Por: STJ

STJ – 18/08/2011

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 and similar medicines based on the active ingredient escitalopram (antidepressant). The decision suspends the effects of the Federal Court decision in the Federal District.

According to Minister Fischer, the suspension of the sentence is advisable "in order to avoid the risk of weakening the public policy of generic drugs in the country, which is undoubtedly valuable to the population, especially the portion of lower purchasing power."

Exclusivity

The judge of first instance had decided that Anvisa should refrain from granting registration to a third party not authorized by Lundbeck Brazil Ltda. – Producer of Lexapro, a reference drug – if they used the test results and data of the dossier sent by the company to receive the registration for the drug.

The first instance decision also determined 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., Manufacturers of similar drugs. According to the judge, the term of ten years to protect the rights of data exclusivity should be applied by analogy, which meant they would expire only in September 2012.

Health policy

But for the minister Felix Fischer, the decision affects the public health policy, since it prohibits, albeit on a temporary basis, the entry of other generic or similar drugs on the market.

According to the vice president, the decision of first instance "means, in addition to the risk of offering products ‘less effective, with treatment failure and delay’, the negative effect of erecting barriers to the participation of manufacturers interested in producing similar or generic drugs, whose prices are practiced at levels more accessible to the population. "

He also highlighted the risk of the multiplier effect from decisions with the same content, which could result in the stoppage of supply of generic and similar drugs "produced even from other chemical entities."