12 Months, 12 Solutions: The Countdown to the EU Falsified Medicines Directive

On February 9, 2019, EU Directive 2011/62/EU will come into effect. It aims to stop illegal trade in falsified medicines. From then onwards, pharmaceutical manufacturers will have to provide secondary packaging of all medicines placed on the market with an individual serial number as a 2D code for identification as well as an anti-tampering device to prove the integrity of the medicinal packaging. However, this does not yet guarantee reliable counterfeiting protection, which can only be achieved by customized integration of additional authenticity features—in overt, semi-covert, covert or digital form. We want patients to be protected against falsified medicines and pharmaceutical manufacturers to find the best solution for compliance with the legislative directive. In Schreiner MediPharm’s blog series over the next twelve months, we will present twelve selected security features that can be used to make medicinal packaging counterfeit-proof. The countdown is on!

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.

Product pirates often use a simple but perilous method to put falsified medicines on the market: They open the product pack and exchange the contents. If the medicine pack is sealed with a conventional label, product counterfeiters simply cut through it and reapply the seal – this will often go unnoticed by patients. The Cut-Through-Indicator Seal, however, thwarts such tampering attempts.

When it comes to securing the supply chain, digital technologies are playing an increasingly important part in the anti-counterfeiting strategies of pharmaceutical companies. Pharmaceutical manufacturers, distributors/retailers and inspectors must be able to clearly determine on-site.