During the last decade, the European Union approved directives and regulations with the aim to counteract the illegal markets in the pharmaceutical and tobacco product sectors. The two regulatory frameworks emerging from the European Commission activity are deeply different.
For tobacco products, the EC established a clear distinction between traceability systems and anti-counterfeiting features (codes and databases on one side, security printing technologies on the other), while the medicines’ traceability system defined in the European Regulation 2016/161 considers the coding system and traceability database strong enough, in itself, to guarantee the pharmaceutical product anti-counterfeiting.
The Italian experience in the control of the pharmaceutical market, based on the Bollino Farmaceutico security stamp, is the combination of a traceability system managed by the Italian institutions, and the security printing features of Bollino Farmaceutico.
The Italian system is the most effective anti-counterfeiting and traceability system for the pharmaceutical market in Europe. It traces every packet of medicine sold in Italy, in every stage of the packet lifecyle (from production to the pharmacy, in an e-pedigree monitoring model), with the complete integration of traceability, anti-counterfeiting and national medicine reimbursement systems.
The paper will show the effectiveness demonstrated by the Bollino system in Italy and in other European countries (with real investigation cases and evidence) with the explanation of why security printing is still the only way to distinguish the original from the fake.