Urgency for drug tracking
Author: André Montoro *
Source: Correio Braziliense, 06/09/2007
Consensus is forming in Brazil and in the world around
the need to track various products. Recent episodes with
goods exported by China generated great concern in public opinion,
to the point that proposals have emerged in the United States and the European Union
prohibit importation or at least establish strict quality controls for
Chinese products.
In the case of meat, both in the control of foot-and-mouth disease and in that of cow disease
crazy, certification and tracking mechanisms of origin are adopted in almost
all countries in the world. This problem also appears in other products, such as
in the recent case of toys. But there is a sector in which the need for
tracking to certify the origin and authenticity of the products presents itself
as fundamental and priority: the medicines sector.
As
reasons for such concern can be grouped into two groups. The first and
most important is related to public health. The dangers and losses
resulting from medicines not manufactured in accordance with the standards and
procedures adopted by Organs controlling agencies, Anvisa in Brazil, are of
incalculable dimensions. Medicines manufactured without proper control, instead of
healing can even kill. Even if the extreme case does not occur, this type
medication can become ineffective, delaying and increasing the costs of
treatments.
The second group of concerns has to do with the fact that the problem
really exists and assumes great proportions, as the documents and
statements made by the Parliamentary Committee of Inquiry (CPI) of the Chamber of
Deputies on medicines in 1999/2000 and at the Piracy CPI, which discussed the
issue in the pharmaceutical sector, among others, in 2004. It is not today that the
sector authorities and companies are looking for mechanisms that can curb these
illegal practices.
On July 2, 1998, the National Congress classified the counterfeits of
pharmaceutical products and raw materials as heinous crimes against health
public. Still in 1998, the Ministry of Health determined the inclusion of the
product identification bars and scratch card, which consists of a
symbol printed with reactive ink containing the company logo and the
mandatory seal on packaging. Another important measure was the
inclusion of the batch number in the invoices of distributors.
From the implementation of these measures, data from Anvisa show that in 1997
and 1998, 197 counterfeiting cases were confirmed. From 1999 to the end of 2006,
only 18 cases were recorded. However, studies carried out by
McKinsey consultancy in 2005 showed that the level of informality in the sector
of drugs is alarming. According to the study 23% of taxes due are
evaded, 40% of the use of labor in the sector is informal and 27% of sales
of drugs in the researched therapeutic classes are made through the exchange of
illegal product.
To combat these practices, the Brazilian Institute of Ethics in Competition
(ETCO), which brings together an important portion of the pharmaceutical industry, has been working
in the search for an electronic tracking and authenticity system. Our
purpose is to find systems that are easy to apply, with the least
possible cost, which guarantees security for all links in the chain and is of
easy identification by the consumer.
On August 8, the seminar “Tracking and authenticity of
medicines in the Brazilian market ”, organized by Anvisa with the participation of
representatives from the entire pharmaceutical sector. The objective was to know and discuss
solutions for an efficient traceability system. It was about meeting
open and participatory, where technology supply companies had
opportunity to present their projects and discuss with representatives of Anvisa
and associations representing the pharmaceutical sector, effective and
cheap for such a system.
The continuity of this process, in a transparent manner and with continuous dialogue
between pharmaceutical companies and government officials, it is essential
to achieve a solution that best meets the interests of public health
national. Ensuring safety on the path that leads to medicines
laboratories to pharmacies and consumers is an objective that goes beyond
industry and government, as it reaches the entire population. The implementation of a
modern system that brings us security in this monitoring will be a lesson to the
world of how public health policies can be implemented, with the aim of
engagement of everyone involved in the process.
* Executive President of the Brazilian Institute of Competition Ethics
(ETCO)