Business worth billions

Drug counterfeiting more lucrative than drug trafficking

(Bild: Schlierner)

The sick expect to be cured and receive ineffective to toxic counterfeit drugs at horrendous prices. Worldwide, the unscrupulous producers and traders of fake drugs already generate annual sales of between 200 and 400 billion US dollars (up to around 3.8 billion euros).

"According to the World Health Organization, between two and 30 percent of medicines sold are counterfeits, depending on the region of the world. When perpetrators are convicted, there are often only lenient sentences. These matters are often only classified as a fraud offense. The risk of a drug trafficker is much greater," said Stephanie Beer, an employee of MSD's Forensic Lab in Schachen near Lucerne, during a background discussion on Monday.

They fill saline solution into vials and sell them for 1500 US dollars, if not more.

Mitarbeiter von Pharmakonzernen über die üblen Praktiken

Basically, there is hardly a more criminally lucrative activity than counterfeiting medicines. "You fill saline solution into vials and sell them for 1,500 US dollars, if not more," was one of the statements made in Lucerne. The range is huge: it extends from completely ineffective "preparations" and "stretched" fakes to toxic, even infectious contents.

Forensic laboratories set up
A few years ago, MSD, one of the largest pharmaceutical companies in the world (USA), literally had enough: in 2017, the first forensic laboratory was established in West Point (USA) to investigate possible drug fakes. This was followed in 2018 by a laboratory for Europe, Russia and Central Asia in Schachen near Lucerne, and the third such facility for the Far East was established in Singapore the following year.

Stephanie Beer: "In 2022, our team (MSD Product Integrity; note) handled 2102 cases related to product safety in 90 countries. This led to 166 arrests and the seizure of 11,009 units of counterfeit or illegal versions of our products."

Exact procedure for suspected cases
Suspicious cases are investigated from the outside in. Photo documentation of the possible counterfeit is taken. Then the packaging is meticulously examined under a microscope and compared with the MSD original. Finally, tablets, for example, are measured using a 3D scanner, followed by a chemical analysis of the contents. We move from non-destructive procedures to destructive methods.

Stephanie Beer: "The analysis of biotech products is even more complicated than that of small (synthetic; note) molecules." With pembrolizumab, for example, the US company has a globally used checkpoint inhibitor for the highly effective treatment of many cancers. The active ingredient, a monoclonal antibody, can be identified as a genuine MSD product by the composition of a sugar side chain, for example - or as an expensive counterfeit with no value.

Guidelines to put the brakes on counterfeiting
Ultimately, the Group wants to use the laboratories to create a tighter line between counterfeits and legal supply and distribution channels for medicines. Around five years ago, the serialization of every single pack of prescription medicines established in the EU and Switzerland, which is entered into the EU-wide system by the manufacturer using a QR code, serial number and seal and then removed again by the service provider - primarily pharmacies and hospitals - was a significant step forward. This is intended to prevent the influx of counterfeits.

However, consumers must be advised: Medicines are best obtained through pharmacies.

Nicolas Florin vom Schweizer Verband für die Verifizierung von Arzneimitteln

"Counterfeit medicines should not be a business model in Europe. Safety has been increased. But consumers must be advised: Medicines are best obtained from pharmacies. The risk of counterfeiting is low in Europe," said Nicolas Florin from the Swiss Association for the Verification of Medicines.