Source: ETCO Magazine, No.12

An important achievement to assist in combating illegal practices in the medication sector was the approval of Law No. 11.903 / 2009, sanctioned by President Luiz Inácio Lula da Silva, which created the National Medicines Control System. The draft of this law initially passed in the Chamber of Deputies as PL 6.672 / 2002 and followed in the form of the Bill of Law (PLC) 24/2007, proposed by deputy Vanessa Grazziotin, of the B-AM PC. After being processed in the Chamber, the project was discussed in the Constitution, Justice and Citizenship Committee and in the Social Affairs Committee (CAS) of the Federal Senate, where it received favorable opinions, being then forwarded to the Presidency of the Republic.

Like what is already happening in some countries of the world, such as Turkey, the system intends to track medicines from their production to the final consumer. Each product will have a unique identification code, which will facilitate, among other features, proof of falsification or theft of medicines. The control will be carried out through technologies of capture, storage and electronic transmission of data.

The law provides that the complete system will have to be implemented in three years. At the end of this period, the system should contain all information related to the drug, such as the manufacturer, supplier, buyer, transport or logistics units, the name of the patient and the doctor who prescribed the product. Grazziotin, author of the bill, "the system aims to track a drug within the production, distribution and consumption network, with a view to ensuring product safety and effectiveness". In any part of the commercialization chain it will be possible to verify if the medicine is genuine or not. For example, the consumer himself will be able to verify the authenticity of the medicine he is purchasing. In case of any suspicion of irregularity, the consumer will be able to access the system to check the authenticity of the product.

The national system for tracking and authenticity of medicines will assist in the inspection of actions, such as the “banknote tour” between States on account of tax benefits, since inspection agents, through applied technology, will be able to know if the route and the State of destination informed are being complied with. Cargo theft, diversion of medicines, accidents or incidents in cargo transportation can also be detected, which will increase the quality assurance of the marketed medicine.

Thus, the main objective of creating the National Drug Control System is fulfilled: to establish greater control over the drugs sold and dispensed in the country. Stricter control at all stages of the chain will provide consumers with greater security. In order to help Anvisa (National Health Surveillance Agency) in the implementation of the system, in December 2008, a cooperation agreement was signed with ETCO that foresees the realization of a pilot project for the system of tracking and authenticity of medicines.

"The system will allow greater efficiency in the inspection of medicines marketed in Brazil, which is extremely important for the improvement of national public health", explains ETCO's executive president, professor André Franco Montoro Filho.