Author: André Franco Montoro Filho

Source: Correio Braziliense - DF - OPINION - 19/10/2009

Recent information released by the National Council for Combating Piracy (CNCP) and the National Health Surveillance Agency (Anvisa) from operations by the Federal Police and the Federal Highway Police indicate the great extent of the illegal drug trade. According to these data, in the first half of 2009 alone, more than 316 tons of irregular medicines were seized. The irregularities range from counterfeiting, adulteration and smuggling of medicines to the production of drugs not authorized by Anvisa, including theft and diversion of medicines, as we recently witnessed with the discovery of a gang that diverted cancer products from public hospitals.

The sheer volume of these transgressions and the enormous risks to which consumers are exposed is worrying. At best, the product is harmless. The consumer does not receive the proper treatment, but does not eat anything harmful. However, in most cases, there is a high probability that the patient will pay to consume something harmful to health.

This threat to public health has drawn the attention of authorities, non-governmental entities and companies in the pharmaceutical sector and has encouraged them to look for mechanisms to prevent or minimize these illegalities. One of the most effective tools to treat the problem is an electronic medication tracking system, created in Brazil by Law No. 11.903 / 2009, which was initiated by deputy Vanessa Grazziotin. It should be noted that this is not just a national concern. In the United States and the European Union, governmental and non-governmental entities have been seeking solutions to similar problems. And the consensus moves to a drug tracking system.

The basic design of the system is extremely simple. It is similar to that used for motor vehicles. Each vehicle leaves the factory with a unique identification on the chassis, stored in a data center. This code informs the main characteristics of the vehicle and is associated with other information, such as ownership. The information is available to authorized stakeholders.

In the case of the pharmaceutical sector, product packaging would leave laboratories with a unique drug identifier (IUM) that would be stored in a central database. This number would be read by the medication distributor (wholesaler) and transmitted electronically to the database. The same process would be carried out at the final point of sale (pharmacies). Once the system is implemented, this number can be accessed at any time by interested parties, inspectors, police and consumers, to check and guarantee the authenticity of the products.

To collaborate with Anvisa in the implementation of the system provided for in Law No. 11903/2009, the Brazilian Institute of Ethics in Competition (ETCO) coordinated a pilot test of a tracking system. Seven laboratories participated, each with a product, three distributors and four retail chains that sent the medicines to 11 pharmacies and drugstores, located in Belo Horizonte, Fortaleza, Rio de Janeiro and São Paulo. In total, 75.733 drugs passed the test.

The results obtained were auspicious. The operational impact of the procedures required for the implementation of the system was small and the additional costs were shown to be proportional to the complexity of the existing production lines. It was possible to print and read the unique identifiers (Data Matrix codes) with equipment available on the market and, therefore, freely accessible to all companies, whether large, medium or small.

The pilot test demonstrated the feasibility of implementing a system for tracking and authenticating medicines in Brazil. However, it was clear that extending the system to the entire market is an extremely complex task, either due to the large number of products traded, or because of the thousands of existing commercial establishments. A task of this magnitude will require the collaboration of all participants in the pharmaceutical chain. It is a firm conduct of the process by Anvisa, in the philosophy of an authentic public-private partnership, since this is a situation in which legitimate private business interests correspond to a public interest: the defense of the health of the Brazilian population.

André Franco Montoro Filho
Economist, Ph.D. in economics from Yale University, full professor at USP, president of the Brazilian Institute of Competitive Ethics