Counterfeit GoodsCustoms and TradeNews

Fake medicines worth EUR 64 million off EU markets

Between April and October 2023, Europol coordinated the fourth edition of Operation SHIELD. Law enforcement, judicial, customs, medical and anti-doping authorities from 30 countries across 3 continents joined forces in this global effort targeting the trafficking of counterfeit and misused medicines and illicit doping substances. The operation was also supported by the European Anti-Fraud Office (OLAF), the European Union Intellectual Property Office (EUIPO), Frontex, the World Anti-Doping Agency (WADA) and national medicine agencies.

Europol supported this wide-reaching operation with several operational meetings and the deployment of specialists with mobile offices offering analytical and forensic support. Operation SHIELD’s 2023 edition was led by a steering group composed of Italian, French, Greek and Spanish law enforcement authorities.

The trafficking of pharmaceuticals is a growing issue in the European Union and beyond. The investigations under SHIELD IV have highlighted a pattern of large scale trafficking which is highly lucrative for organised crime, which in turn incentivises more criminal groups to enter the trade. This crime area inflicts significant costs for the health and social care systems of EU Member States, as well as alarming effects on public health.

Illegal vendors continue to advertise doping substances on social media, mostly targeting non-professional athletes and members of restricted or private sport groups. Along with performance-enhancing products, medicines for erectile dysfunction are offered via dubious channels online and remain among the most seized counterfeits by law enforcement. Unregulated use of medicines and doping substances, especially of counterfeit products, can cause serious and irreversible bodily harm.

Results of Operation SHIELD IV:
1 284 individuals charged (296 arrests and 988 under prosecution)
52 organised crime groups investigated
Total seizures worth above EUR 64 million, including:
636 263 illegal packages of illegal pharmaceuticals
69 255 kilograms of powders and raw material
11 551 litres of active ingredient
121 503 vials and ampoules
over 12 million tablets and pills
4 underground labs dismantled
92 websites shut down
3 935 inspections carried out
4 321 anti-doping “in competition” controls carried out
3 659 anti-doping “out competition” controls carried out

Highlights of Operation SHIELD IV

Trafficking of unauthorised pharmaceuticals and medical devices targeted in Greece
Greek authorities dismantled a criminal network which had been trafficking unauthorised pharmaceuticals and medical devices since 2019. The products included counterfeit botox and vitamin acid preparations used in cosmetic surgery. The criminals’ customer base of these counterfeits covered various regions of the country. The seized products were imported via couriers or transported by a member of the group from Turkey and Poland.

San Marino underground lab uncovered by Italian authorities
The Italian authorities searched the logistical base of a criminal group operating from San Marino. Investigators identified a rural underground lab set up for the production, labelling and packaging of doping products. Police seized vast quantities of doping substances in the form of vials, tablets, capsules, bottles and packaging, all intended for sale in Italy as well as around EUR 180 000 in cash. The suspect allegedly imported pure Nandronole, an anabolic steroid classified as a narcotic drug in Italy. His trafficking routes spanned all over Europe and as far as China.

Misuses of medicines

The consumption of medications beyond medical oversight remains a persistent social issue. The reasons for use vary from psychotropic and recreational purposes to performance-enhancing effects. Some users disregard medical prescriptions and inject non-injectable products (such as sublingual pills, patch contents, or eye drops) or resell medicines prescribed for medical treatment.

The excessive consumption of medications nurtures a demand that cannot be satisfied through legal means, leads to diversion from the regulated supply chain. Counterfeit medicines are circulated among those diverted from the legitimate chain. Authorities have seen these counterfeit medications re-enter the legal supply chain through the parallel market. One increasing trend is the traffic of sedatives and the use of counterfeit or illegal medicines for diabetes.

Medicines are often counterfeited in underground laboratories without any regulation or safety measures in place. Counterfeit products created under such circumstances do not produce the desired effect; in the best case scenario the patient remains untreated, however such products can cause serious health issues or be potentially lethal.

Operation SHIELD IV Steering Group:
Italian Carabinieri Anti-Adulteration and Public Health Units (Nuclei Antisofisticazione e Sanità dell’Arma dei Carabinieri)
French Law Enforcement Directorate for Environment and Public Health (Commandement pour l’Environnement et la Santé – CESAN)
Hellenic Police – Financial Police Division (oικονομική υπηρεσία της ελληνικής αστυνομίας)
Spanish Civil Guard (Guardia Civil)