Source: ANVISA, 08/12/2009

The implementation of a traceability system for medicines sold in Brazil was discussed on Tuesday (8), during the last Anvisa Debate of the year. About 200 people participated in the event, which was also broadcast over the internet.

Counterfeiting, the circulation of clandestine products and cargo theft are global problems, affecting several countries. In Brazil, whose specificity is the extensive territorial dimensions, the concern is even greater.

Tiago Lanius, specialist in regulation and health surveillance at Anvisa, spoke about the advances achieved in the last decade, in response to the circulation of clandestine and counterfeit products, which became evident in the years 1997 and 1998. “The inclusion of counterfeiting as a heinous crime, the increase in the penalties imposed for crimes and the very creation of the Agency in 1999 and the SNGPC, more recently, deserve mention ”, said the technician.

Lanius also recalled advances such as the publication of Ordinance 802/98 and RDC 320/02, which made it possible to regulate the drug production chain and include, in invoices, the numbers of batches of drugs purchased by pharmacies.

National control

In order to further improve the mechanisms of traceability and authenticity of medicines in the country and to provide an effective response to informality, the National Drug Control System was created in 2009, through law 11903/09.

"The lack of rules may even promote private development, but social development only occurs when there are rules," said the president of the Brazilian Institute of Ethics in Competition (Etco), André Franco Montoro, speaking of the importance of implementing the system in Brazil.

Etco is a civil society organization of public interest (Oscip) focused on combating competitive imbalances. Through an agreement with Anvisa, the Institute conducted pilot tests with 75 thousand packages in the country, using copies of the two-dimensional bar code, also called Datamatrix. The tests helped to subsidize the choice of this technology by Anvisa, as the main tool to guarantee the functioning of the system.

Unlike the common barcode, which is visible and contains only one number, the two-dimensional can store thousands of information at the same time, such as numbers, letters and other data

Safety labels

During the debate, the representative of the Etco Institute argued that the simple printing of the two-dimensional barcode on the medicine boxes would already be able to guarantee the smooth functioning of the system. "There is no need for an extra security mechanism, which could represent new costs", defended Montoro.

According to RDC 59/09, published in November, the two-dimensional bar code will be on labels or stamps that will act as an additional security mechanism. The Casa da Moeda should be the institution that supplies these security tags.

Tiago Lanius explained that Anvisa's board of directors opted for a model that could guarantee traceability, through the two-dimensional code and also authenticity, through the labels. “Simple printing could be multiplied in several packages, putting the system in check. In addition, consumers would have to access the databases to check product information and many could have difficulties to do so ”, explained the technician.

Still according to Lanius, Casa da Moeda has the knowledge to make modifications to the labels, introducing new safety components whenever necessary.

Rafael de Aguiar Barbosa, deputy director of the Agency, stated that the inclusion of the label will not bring new expenses to the industry and that, therefore, there is no reason to think about transferring costs to the consumer. "Studies carried out by Anvisa have shown that there will be savings in escort and insurance expenses, for example, and with the extinction of old security mechanisms such as scratch cards," pondered Barbosa.