Source: The State of S. Paulo - São Paulo / SP - OPINION - 02/04/2010

The system that allowed the recording of abuses in the prescription of appetite moderators and the identification of doctors who prescribed these drugs the most, and for that reason will be investigated by the Federal Council of Medicine, will be extended to all remedies. As of 2011, each of the more than 2 billion boxes of medicine that the country consumes annually will have to contain information about manufacturer, distributor, date of manufacture, expiration date, among others. At least that is what the legislation that creates the National Drug Control System provides. But the questioning made by manufacturers to decisions taken by the National Health Surveillance Agency (Anvisa) is delaying the completion of the first stage of the System.

Called a unique medicine identifier, the brand to be affixed to each box will be a kind of product identity card, through which you can trace the entire production chain, from the factory to the sale to the consumer, which will allow a combat counterfeiting and theft more effectively and give authorities a more effective tool for withdrawing drugs from the market, when appropriate.

According to the Brazilian Institute of Ethics in Competition, the illegal trade of medicines moves up to R $ 8 billion per year in Brazil. Anvisa, in partnership with the Federal Police and Federal Highway Police, has been fighting this trade and, in the first ten months of 2009, seized 329 tons of unregistered, counterfeit, smuggled or expired drugs.

If it works the way the authorities think, the System will provide more guarantees to the consumer and prevent fraud and crimes involving drugs, in addition to assisting the logistics of companies that manufacture, distribute and sell medicines.

Created by law in January 2009, the System must be put into practice in three years, and some of its stages should already be concluded. Since January, the packaging should have a seal identifying manufacturers, distributors or importers, but only two days before the deadline for that, Anvisa published essential decisions on the process that should be adopted. Pharmaceutical companies now question decisions.

In November, Anvisa's Board of Directors approved a resolution defining the technology that will be adopted in the identification of medicines. The seal was chosen, similar to that used in alcoholic beverages and cigarette packs. In January, by means of a normative instruction aimed at regulating the resolution, Anvisa decided that the Casa da Moeda would be responsible for the production and distribution control of the self-adhesive security labels for the Drug Tracking System. It will also be up to the Casa da Moeda to decide on the technology of data capture and transmission, as well as on the specifications of the labels.

The Ministry of Health defined, among the requirements for the medication identification system, the low cost, capacity to replace equipment, the reduced possibility of fraud and the ease of identification by the consumer. The industry argues that Anvisa's decision disregards at least some of these criteria. Would an alternative system, the barcode printed on the packaging, contain the information required by law, would it cost much less for the industry? about R $ 40 million per year, against R $ 300 million for the label, according to the president of the Pharmaceutical Research Industry Association, Antônio Britto? and would offer greater security against fraud.

The industry warns of the fact that in the country there is only one supplier of the raw material for the manufacture of the seal, which leaves the Mint dependent on it. Finally, it disputes the excessive power given to the Casa da Moeda in the management of information and suggests the creation of a specific company to manage the database that will be constituted with the tracking.

These are arguments that must be taken into account.