Author: Ceila Santos

Source: Decision Report - São Paulo / SP - HEALTH - 13/08/2010

The pharmaceutical industry is in the marathon in May to comply with Law 11.903 / 2009, sanctioned by President Luiz Inácio Lula da Silva, who instituted the creation of the National Drug Control System. There is no doubt that the deadline will be one of the challenges. According to the legislation, 2010 would be the year to put electronic tracking into practice in the medication production line. Detail: the deadline for implementation was January.

However, ANVISA (National Health Surveillance Agency) only succeeded in issuing the Resolution (RDC 59/09) that regulates the system at the end of November 2009. If, on the one hand, the industry may gain momentum for the Tracking race Medicines, on the other hand, will be obliged to invest more when printing the 2D code, since the Resolution imposes the use of paper money.

Márcio Moreti, managing partner of Active, explains that the seal is already used in the cigarette industry, which hires up to 30 employees to carry out such activity. Although the industry is against the use of paper money, everything indicates that there will be no changes in this decision. But these setbacks do not portray the main challenges of the new law for the pharmaceutical sector. It is on the factory floor that it will be necessary to transform the way of controlling medicines.

The pilot project carried out between January and July 2009 by the Brazilian Institute of Ethics in Competition (ETCO), which for 40 days put into practice the printing and reading of identification codes on the secondary packaging of seven industries, in addition to the transmission of all the information collected through the system, he showed that the challenge will be to adapt the production lines to new equipment such as barcode readers, antennas and printers.

Opportunity or compliance?

It is rare to find a health specialist who has a discourse that is contrary to the law. There is a worldwide consensus on the need for electronic tracking of various products as a monitoring mechanism. In the case of Brazil, the indicators further reinforce this awareness.

According to ANVISA, the seizure of 316 tons of counterfeit drugs in the first half of 2009 represents a 702% increase over 2008. In addition, the World Health Organization (WHO) points out that in regions such as Latin America , about 30% of the remedies consumed are of unproven origin.

That is why Jorge Froes de Aguilar, executive director of Abafarma (Brazilian Association of Wholesale Pharmaceuticals) explains that, in addition to being totally favorable to the new rule, the entity has been fighting since 2003 to implement the tracking system in the value chain. "Regardless of the impacts, the system is a guarantee for consumers and represents a leap in quality for the sector", he says.

During the presentation of the seven industries that participated in the Etco pilot project, however, the noise from the audience - filled with representatives of the industry - made clear the concern about the pace of production, the cost of the label and the necessary changes in the manufacturing architecture or contracting of human Resources. It is worth mentioning that, at that time, the use of paper money was not foreseen.

The new system, however, does not only bring improvements to inspection. For many specialists, the Tracking represents a unique opportunity for management of the production line and, in detail, a control closely linked to the Business Intelligence concepts for more strategic and competitive decision making.