Italy leads Europe in the fight against pharmaceutical crime

Da oltre vent’anni il nostro Paese è impegnato nel contrasto ai reati che danneggiano la supply chain del pharma tanto da aver guidato un progetto per trasferire le proprie competenze alle altre nazioni UE

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Italy is at the highest levels in Europe for the effectiveness of combating pharmaceutical crime, so much so that Aifa was entrusted with the coordination of the project MEDI-THEFT with the aim of transferring the good practices that characterize our national system to other Member States. In fact, if the enforcement action is not carried out in parallel between all the countries, the risk is of obtaining limited results, which perhaps move the criminals from Italy to other member states, without however eradicating the phenomenon.

As Domenico Di Giorgio, manager of the Aifa product quality and fight against pharmaceutical crime office, explains, “closing sales channels is the best way to discourage criminals who dedicate themselves to the theft and laundering of medicines, but the mechanism can work only if all channels are closed, that is, if foreign markets can also be blocked with the same measures in use for years Italy”.

Theft and money laundering are the main crimes

In particular, the project, which concluded in October 2023 after two years of activity, aimed to increase the effectiveness of investigations, strategic analysis processes and international cooperation between public and private, thanks to a platform with a triple function: collecting and analyzing data relating to pharmaceutical crimes with a view to prevention, avoiding new access to the market for stolen medicines through the creation of timely risk indicators and improving international and public-private synergy.

Whether it is theft on commission or for the purpose of money laundering, sales on foreign markets, online or by word of mouth, the pharmaceutical supply chain offers several weak points. Support warehouses, contractors, pharmacies, means of transport: the drug distribution chain is an often very complex system, which can be sensitive to a type of crime that is dangerous for both companies and consumers.

Furthermore, as highlighted by the research The theft of medicines in the EU, conducted by the TRANSCRIME research center of the Catholic University of the Sacred Heart of Milan, the data collection in this regard is often incomplete and the real extent of the problem is in all likelihood underestimated.

The investigations coordinated by Aifa since 2014 for the so-called Operation Volcano have highlighted how the theft and laundering of medicines represent the main form of counterfeiting on the European market: medicines are stolen by criminals from our hospitals and from other countries, manipulated and stored in unsuitable conditions and cleaned through invoices that mask their illegal origin, generating danger for patients in all those countries where the supply chain is more permeable than the Italian one.

The Italian leadership

Over the years, Italy has convincingly and rapidly implemented the tools that allow timely and transparent collaboration between administrations and private stakeholders on these issues. Aifa has been dealing with the fight against pharmaceutical crime for almost twenty years, when it supported the foundation of “Impact”, the WHO anti-counterfeiting task force.

Already then there was a clear perception of the growing incidence also on the European markets of illegal phenomena of various kinds, such as falsification: the Falsified medicines directive published by the EC in 2011, in the negotiation of which Aifa actively participated , demonstrates how the institutions’ sensitivity to this type of danger has progressively grown.
The IMPACT Italia task force, operational since 2006, formally structured in 2007 and finally consolidated into the national anti-counterfeiting task force with the implementation of Directive 2011/62, has joined other thematic technical tables.

Examples are the fight against theft of medicines or the conference of services on illegal web sales, which allow systematic cooperation not only on training and information initiatives for the network and the public, but also on investigations and activities aimed at blocking developments criminals we see internationally.

The rapid sharing of signals and cases and the support for the activities that Aifa, Carabinieri NAS and the Ministry of Health carry out on the topic is guaranteed by these now consolidated tools: the actors in the supply chain can refer to their associations and the communication channels with AIFA to be able to participate in an operational manner in the fight against illicit trafficking.

In Italy we already have security systems that guarantee the network against infiltration. The traceability of the drug with a stamp system, which has been active for almost twenty years, the presence of a specialized police force that is unique in Europe, i.e. the Carabinieri NAS, and the consolidated and operational collaboration between institutions and private stakeholders on the topic are all part of a very reassuring overall picture.

The criminals who have dedicated themselves in recent years to the infiltration of illegal products have used our country at most as a source of products to steal in an attempt to access other markets and not as a market. This is precisely due to the solidity of our network, which is very less permeable to attempts to place unauthorized products on the market.

Domenico Di Giorgio, manager of the AIFA product quality and fight against pharmaceutical crime office.

A constantly evolving activity

The implementation work – explains Di Giorgio – must continue, because we are confronted with a counterpart that evolves to try to avoid the obstacles we build.

As explained in the publication on good practices, which we have also included in the State Bookshop thanks to the collaboration with Poligrafico, the theft of medicines is unfortunately a natural phenomenon given the high value of the products, their conservation in poorly protected structures and accessibility to recycling channels. Consequently, as we develop tools, criminal organizations symmetrically try to define new ways that protect their illegal market. For this reason, beyond the topics that we will explore further, it is important to keep in mind that this is a constantly evolving process.

But we are certain that the strengthening of international collaboration will allow us to build obstacles that are increasingly difficult to avoid.