Thanks to the ongoing collaboration between Fondazione SAFE and the Law Department of the University of Verona, a research activity in the context of the MEDI-THEFT project was carried out. Specifically, the fruitful collaboration resulted in the drafting of a research paper aimed at providing an overview of the Italian and European legislation against the illicit trafficking and counterfeiting of medicines. The study has been carried out by Miriana Strippoli, a student and researcher, supported by Prof. Matteo Nicolini at the University of Verona and the SAFE team.
In line with the scope of the analysis, the researcher conducted an interview with the Director of the MEDI-THEFT project Domenico Di Giorgio – Head of the Inspection & Certification Department and of the Pharmaceutical Crime Counteracting Office at the Italian Medicines Agency (AIFA).
The interview – an extract of which is presented below – provides an overview of the Italian legislation on the matters as well as features the role of AIFA in the fight against the organized crime of trafficking of medicines.
Interviewer: What are the main features of the illicit trafficking and counterfeiting of medicines in Europe and Italy?
Domenico Di Giorgio: The illicit trafficking of medicines is a problem both at the national as well as international levels. Considering the international level, this crime is relevant, especially for countries that have a strong channel of entry due to the advantageous prices that are highly attractive for criminal organizations. For example, Germany and the United Kingdom are attractive countries due to the high demand for this kind of pharmaceutical product.
Moreover, the pandemic two years ago clearly accelerated computer literacy and e-commerce. Notably, most of the online market of medical products is illegal. Despite this, the legal offer of medical products on the web is limited especially in Italy. On the other side, in other countries, the online market of medical products is very broad. In those countries, big actors such as Amazon, are involved in the legal online selling of medical products. Thus, by offering a legally online market of medicines the illicit infiltration of organized criminal groups may disappear.
Interviewer: Could you please provide an overview of the involvement and the role of AIFA in Operation VOLCANO?
Domenico Di Giorgio: Operation VOLCANO is a police operation, which occurred at a time when there were numerous cases of illicit trafficking of medicines, including several attacks on hospital pharmacies in Italy. The Police Force was operating at the local level, while AIFA was expected to contribute strategically. The results of Operation Volcano were very significant also in terms of operational results which have been exceptional. Basically, the Italian branch of a very structured criminal organization was dismantled. However, we noted that these activities and operations have limitations because if they are not carried out at the European level, and if there is no awareness of the issue at the international level, those criminal offences may be considered less serious at the national level. In fact, in this case, what has happened is that criminal activities have been moved from Italy to other MS – for instance, the illegal product of the Lunapharm case (2018) arrived in Germany from Greece.
Interviewer: With regard to Italian legislation, the Penal Code shows a lack or gaps in the level of sanctions, due to the fact that there are no ad hoc articles focusing on prevention or sanctions.
Domenico Di Giorgio: In the Italian Penal Code, there is a need to include new provisions penalizing illicit conduct. At the moment, the provisions apply only in the case of damage. However, determining the existence of damage is very difficult. Thus, overall, the Italian legislation seems to be difficult to apply.
On the other side, The European Falsified Medicines Directive 2011/62 implicitly provides that counterfeit products are always a danger. Thus, it does not require to prove the existence of damage. Indeed, the legislator at the European level tells us that counterfeiting is dangerous and must be prosecuted. This provision does not exist in the Italian Criminal code.
In Italy, we have a Police Force specialized in the protection of public health, namely, the Italian Carabinieri – NAS unit. In addition, AIFA has an office delegated to fighting and preventing pharmaceutical crime.
Moreover, in regard to procedure, in Italy, there is traceability system for medicines in place since 2001, and it is definitely a mature system, while in Europe it only arrived in 2019 and it is still in the implementation phase. We have, for over 15 years, a collaboration between different agencies that makes it natural for us to cooperate with customs and police, the laboratories of institutions, and anyone else, including private individuals, when we have to execute an investigation. So, even if there is a need to improve it, the Italian model is certainly virtuous.
Taking all of this into consideration, it’s clear that the fight against illicit trafficking and counterfeiting of medicines should be conducted in a collaborative and European manner.
Lastly, in relation to the MEDICRIME Convention, it has not been ratified by Italy.
Indeed, countries like Italy, which has signed the document, did not implement it. Nevertheless, In Italy, we already implement the most part of the measures that are envisaged in the MEDICRIME Convention. However, we should include more severe sanctions for those who perpetrate this crime.
Interviewer: How important do you think culture is, especially among citizens in the fight against this organized crime? What role the citizens could play in preventing and combating drug trafficking?
Domenico Di Giorgio: We, as AIFA, undertake a lot of activities to prevent and fight this organized crime. The activities are also linked with communication. It is clear that the illegal supply comes from the fact that there is an unmet demand for some kind of products. What we see on a daily basis is that when there is a gap between supply and demand, criminal organizations try to fill the gap with illicit offers.
A very obvious example is the selling of products related to the sexual sphere, the sale of which on the Internet through illicit markets is clearly prevalent. When we do operations like PANGEA, 70-80% of what we find is from the Viagra family. The type of non-therapeutic, recreational supply of certain products is largely via illegal channels. In addition to sexual medicines, sports performance products are often purchased illegally. For example, doping products, and steroids, especially for the male audience. While, for the female audience, there is an unsatisfied demand for products such as botulinum or slimming products, including those with sibutramine, or with dinitrophenol, then active products that are no longer used, because they are risky. Indeed, we need to do a lot in terms of communication in order to raise awareness of the risks this kind of illegal product could have to health.
Speaking of communication, at the end of last year, we did several campaigns, training and raising awareness initiatives. Several communication spots were tailored to teenagers, which represents a large audience of buyers. Indeed, the communication campaign involved a well-known Youtuber. The campaign resulted to succeed, gaining a few million views. The campaign also came on Instagram, in order to reach young people.
We’d like to sincerely thank Dr. Di Giorgio for his contribution, and Ms. Strippoli and Prof. Nicolini, for the valuable research and cooperation for MEDI-THEFT project.