Source: Valor Econômico - São Paulo / SP - 25/11/2010

The pharmaceutical industries will go to court in the coming days against the decision of Anvisa (Health Surveillance Agency) that requires the use of a security seal on the packaging of medicines. “Our lawyers are defining the best judicial strategy. We intend to take action in the first week of December, ”Nelson Mussolini, executive vice president of Sindusfarma (Pharmaceutical Products Industry Union in the State of São Paulo) told Valor.

The mandatory nature of this stamp costs R $ 400 million per year to the sector and the expense goes to the consumer's account, according to Mussolini. "The discount margin for drugs in retail chains will be much lower and SUS [Unified Health System] will pay more," he argued. It is estimated that drug prices will rise between 6% and 10%, on average.

On Monday, lawyers consulted by the pharmaceutical industries will give their opinion on the best judicial path to be adopted by the sector.

The laboratories installed in the country sell about 4 billion packages of medicines per year. Anvisa published, in early November, Normative Instruction No. 11, which formalizes the adoption of the self-adhesive security label on the medicine boxes. The laboratories will have to implement the new requirement during 2011, since the requirement becomes effective from 2012.

The security seal will be distributed by the Casa da Moeda do Brasil, which has an exclusive supplier - the French Arjo Wiggins, a company that owns a paper money factory in Salto (SP). Anvisa's goal is to combat the smuggling and counterfeiting of medicines in the country. This seal will work in the same way as used in cigarette packs.

The pharmaceutical companies argue that this measure does not prevent piracy and should still affect the consumer's pocket. "These discussions have been taking place since 2006 and we have spent the past few months pointing out alternatives to strengthen traceability," said Mussolini. SUS buys medicines for about R $ 0,30, on average, for packaging. The cost of each label is estimated at about R $ 0,10, increasing your costs with acquisitions by more than 30%.

One of the suggestions presented by the sector was the use of the 2D barcode (Datamatrix), printed on the packaging, to do this tracking. Mussolini said that this system has the same efficiency as the seal and has a cost ten times lower than the R $ 400 million per year that Anvisa is imposing through the self-adhesive seal. "We discussed the efficiency of this system, which is used in medicines on the international market, last year together with Anvisa itself."

To Valor, Pedro Ivo Sebba Ramalho, deputy to the CEO of Anvisa, said that he already expected a reaction from the industries. Ramalho countered the sector, stating that the self-adhesive seal combines the two technologies - authenticity and traceability - and, therefore, is more effective. "We never stopped listening to the industries and we did several public consultations."

According to Ramalho, Anvisa discussed in contract with Casa da Moeda the costs of implementing the seal - R $ 0,07 excluding taxes, an average of R $ 0,10, including fees -, and the annual price adjustment index by the IPCA. The guarantee of supply of the product was also discussed, since the industries point this factor as a risk.

From the date of IN's publication, on November 3, pharmacists have two months to register with the Casa da Moeda, another six months to label medicines and another six months for medicines to be in accordance with Anvisa's requirements. Penalties range from warning to fines, ranging from R $ 2 to R $ 1,5 million for an infraction, in addition to the closure of the establishment.

Anvisa data show that the seizures of counterfeit and smuggled drugs rose from 620 units in 2007 to 53.535 thousand, last year. Until September this year, there were 53.575 thousand units. The seizures of controlled drugs increased from 61.495 thousand units in 2009 to 155.817 thousand, from January to September this year.