André Franco Montoro Filho: Drug tracking system

By ETCO
19/10/2010

Source: Agência Senado - Brasília / DF - 19/10/2010

The illegal sale of medicines not properly registered has posed a serious threat to public health. It is alarming the volume of products without registration and, therefore, without the necessary phytosanitary guarantees, which are traded in the country, putting users' lives at risk.

To face this serious problem, on January 14, 2009, after approval by the National Congress, Law 11.903 was enacted, which created the National Drug Control System. This control would be carried out by means of a unique product identification system and with the use of technologies for the capture, storage and electronic transmission of data.

To collaborate with the National Health Surveillance Agency (Anvisa), the sector's regulatory agency, the Brazilian Institute of Ethical Competition (ETCO) signed a protocol of technical cooperation with that entity, to conduct a pilot test of a drug tracking system . With the collaboration of companies and entities in the sector and monitoring by Anvisa, the test was carried out during 2009 with total success.

The pilot test consisted of the printing of a two-dimensional unit code, internationally accepted, on the cartridges (packaging) of medicines and monitoring the movement of these products throughout the distribution chain, from laboratories to pharmacies and drugstores, through an electronic data capture, storage and transmission system.

The test involved 75 thousand cartridges, which is an adequate volume of drugs for the evaluation of processes and systems. In order to simplify and facilitate the implementation of the system and for companies not to be tied to a single equipment or technology supplier, open and public domain technologies were adopted, with characteristics and flexibility to be implemented by laboratories of any size or sophistication. technological.

The main conclusions of this test were that performing drug tracking by printing a code on the drug packaging is feasible with the technologies available on the market and that direct and indirect costs (possible impacts on production lines) are reduced and proportionate the sophistication or speed of the production lines.

It is reported, however, that Anvisa decided to adopt a different procedure to carry out drug screening. This would be done through the use of adhesive labels (stamps) to be provided by the Casa da Moeda, with a security technology owned by a multinational company. The stamp would cost R $ 0,07 per unit. In Brazil, approximately 4 billion units are sold, which would result in a total cost of R $ 280 million per year.

This procedure is, in our view, wrong for a basic reason. The use of this seal is not provided for in Law No. 11.903 / 2009, which established the mandatory systems for drug tracking as of January 2010, as it provides for the “use of technologies for the capture, storage and economic transmission of data”. This seal in no way contributes to the tracking system.

In view of these considerations, it is necessary for Anvisa to review its position so that it is possible to start with the utmost urgency, as we are already behind schedule in the law, the implementation of an authentic drug tracking system in Brazil.

André Franco Montoro Filho

Ph.D in economics (Yale University), he is a professor at USP and executive president of the Brazilian Institute of Ethics in Competition (ETCO)