Source: Exame - Print Edition - 25/06/2009

Claudio Rossi Biolab Factory, in São Paulo: adapting production to
include the tracking system

The National Health Surveillance Agency (Anvisa) seized 170 tons
of medicines only in the first three months of this year. Thousands of
counterfeit, stolen or unregistered medicine boxes. Seizures
represented a jump of almost nine times over the 2008 total. But the enormous
illegal drug market, which reaches between 5 billion and 8 billion
of reais per year, may be close to being nipped in the bud - with the support of
digital technology. A monitoring system capable of tracking the entire chain
production of medicines sold in Brazil, from manufacturers to the
retail, starts to be tested this year. Each box will have a digital code that
contain the following information: who manufactured the medicine, when, what was the
date of dispatch from the factory and which is the destination distributor. All
information will be stored in a single database controlled by Anvisa,
a large central repository of the origin of legally produced remedies
and sold in Brazil. “It will be a true RG of the medicine. Through it, it will be
It is possible to know all the way the medicine has gone and even to identify if
it was stolen, ”says Dirceu Raposo de Mello, president of the agency.

Along with counterfeiting, cargo theft brings great damage to
laboratories. Together, the losses exceed 10 billion reais per year, compared to a
turnover of 23 billion reais. Criminals' favorites are
medicines for erectile dysfunction, cancer, HIV, abortion and anabolic steroids,
according to Marcelo Liebhardt, from the Pharmaceutical Research Industry Association
(Interfarma). Tracking will help to prevent cargo theft especially
because the central database controlled by Anvisa will receive the information
distributors - intermediaries between manufacturers and pharmacies - and
also from retail. The project foresees that pharmacies have readers of the new
medicine codes available to customers. When scanning a remedy by
equipment, the consumer will have the guarantee that it is a product of
legitimate origin. The measure is also a way to inhibit counterfeiting.
Even if the boxes are defrauded, there will be no information recorded in the
digital code engraved on the medicine box. “The system will represent
zero tolerance against theft, counterfeiting and tax evasion ”, says
Liebhardt.

The project is the result of a federal law, and its official debut must take place
only at the beginning of next year. But the laboratories are already starting to prepare their
infrastructure for the deployment of tracking technology. The preference
unanimous on Anvisa's board is the two-dimensional (2D) code, also called
QR Code. Usually in the form of a square with several black and white dots,
this code has great capacity for storing data that will be recorded
in the medication box by a laser printer. It is estimated that the
total investment to put the system into operation reaches 150 million
of reais. Each laboratory must invest, on average, 180 reais so that each
one of its production lines can also print the digital code on the
packaging. The Aché laboratory, for example, has 30 lines, which would generate costs
more than R $ 5 million. Biolab Farmacêutica has already adapted production to
2D printing on your packaging. “Investments are high, but the siege
to the illegal market pays off, ”says Márcio Lopes, IT manager at Biolab. The networks
pharmacists start thinking about the adoption of two-dimensional code readers - which
cost about 2 000 reais. Drogaria Onofre, with 34 stores in the South and
Southeast, you will need at least 140 devices, in addition to creating the software for
supply the Anvisa database. Those who celebrate the opportunities are
software companies, such as São Paulo Active, from automation systems for
laboratories. The company earned 4 million reais last year and projects
revenues of 9 million reais from traceability projects.

In the third stage of the control system, scheduled for 2012, even the
doctors must be involved. The idea is that the medicines prescribed to patients
also be inserted into the database. In this way, Anvisa can
identify, for example, any discrepancies between the number of prescriptions
and the sales volume of a particular drug - which may indicate that the
pharmacies are not requiring the presentation of prescriptions. But if, on the one hand,
preparation for this technological advance in tracking has begun, a challenge
still needs to be overcome. “The weak point is consumer education”, says
Mello, from Anvisa. The challenge will be to communicate the possibility of consulting the
code, under the risk of falling into the same situation as the “scratch card”,
anti-counterfeiting that displays a watermark proving the authenticity of the
medicine. Although it has existed for seven years, few consumers know of this
system.