12 Months, 12 Solutions: The Blog Series on the EU Falsified Medicines Directive 2011/62/EU

Since February 9, 2019 the EU Falsified Medicines Directive 2011/62/EU has been in effect throughout Europe. It requires pharmaceutical manufacturers to provide secondary packaging of prescription medicines with an individual serial number as a 2D code for identification, plus a tamper-evident feature proving that the packaging is intact. This requirement is intended to stop illegal trading of falsified medicines. However, a serialization number alone does not ensure reliable counterfeiting protection, which is only achieved by integrating additional authenticity features – in overt, semi-covert or digital form. In our blog series “12 Months, 12 Solutions: The Countdown to the EU Falsified Medicines Directive” from February 2018 to January 2019, we presented twelve selected security features pharmaceutical manufacturers can use to make their medicine packaging tamper-proof.

Falsified medicines are a lucrative business for criminals. According to the “Pharmaceutical Crime: A Growth Market” research report published by the German Federal Criminal Police Office (BKA) in October 2016, one kilogram of the counterfeit version of a well-known potency-enhancing drug sells for 90,000 euros on average, whereas the price of cocaine is estimated at “merely” 65,000 euros. The serialization of packaging, complemented by anti-counterfeiting labels, helps stop this illegal trade.

Incidents of medicine counterfeiting increasingly often make the headlines – particularly when customs authorities achieve a major coup. In September 2017, German customs confiscated 950 parcels with 68,000 falsified pills and vials at only three parcel centers within a single week. An anonymized survey revealed that one in eight physicians has at one time or another held a counterfeit in his/her hand, and even six in 500 pharmacists have. One in seven counterfeits comes from a pharmacy in another EU country.

Mid-October, some 500 tons of fake medicines were confiscated in international raids. They included ineffective potency-enhancing drugs, pain killers and dietary supplements as well as counterfeit cancer drugs. According to Interpol, 116 countries were involved in the operation and 850 suspects arrested. This again shows the importance of tamper-proof packaging. An EU Directive-compliant closure seal provides an effective solution.

Treatment by self-medication with autoinjectors: a growing trend. For patients, the ease and safety of handling are particularly important. For pharmaceutical manufacturers, the protection of patients against fake medicines and security of the supply chain are crucial. The EU FMD, besides serialization, requires tamper protection of secondary packaging, however without considering first-opening indication for injection devices. That is exactly what the NFC-Label for autoinjectors is offering.

Often the less conspicuous a closure seal appears on medicinal packaging the more sophisticated the security technology it contains. Effects that are both conspicuous and unequivocal will only emerge when an informed expert authenticates the seal, like in the case of LumiSecure: Illumination by a special light makes colors on the label visible that can be clearly verified and thus indicate the authenticity of the packaged medicine.

Dumpster diving – this means sifting through containers, typically in search for food. However, medicine counterfeiters have long discovered this “source” as well: They look for empty medicine containers in order to fill them with fake substances. While the mandatory EU Directive makes tampering with secondary packaging more difficult, the risk with primary containers remains – and here first-opening indication would be particularly important: a security gap that Flexi-Cap can effectively close.

Stolen, repackaged, illegally refilled and relabeled: Whether or not a medicine is a copy is often not readily visible. Many counterfeiters have perfected their skills so that even customs and police officers can be deceived. The inconspicuous Covert-Hologram Seal seems to be easy to fake – but when it is opened an effect emerges that no counterfeiter expects.

Trade in counterfeit medicines is booming. The reasons: High profit margins, low risk of detection and relatively low penalties in some countries that prosecute the production of fake medicines as a patent infringement instead of what it really is: the endangerment of human life. Thus, for highly counterfeit-prone medicines, covert features such as microparticles provide particularly reliable proof of authenticity.

The World Health Organization (WHO) estimates that in Europe up to one percent of medicines in the market are counterfeit (WHO Report 2011). All dosage forms are affected. This does not only pose a risk to patient safety but may also jeopardize the pharmaceutical manufacturer’s reputation. Therefore, it is of vital importance to detect counterfeit products and withdraw them from circulation. Label-integrated thermochromatic inks enable exactly this: efficient authentication of medicines.

In September 2017, “Operation PANGEA” was run for the tenth time – an annual activity coordinated by Interpol to combat the sale of counterfeit and illegal medicines on the internet in which more than 100 countries participated. 25 million illegal and counterfeit medicines worth more than 50 million U.S. dollars were confiscated: a record number that shows how important fast and reliable authentication of an original product is. For customs officials, physicians, pharmacists and consumers.