On February 9, 2019, the EU Falsified Medicines Directive will come into force. From this point forward, all prescription pharmaceuticals must be verified by pharmacies before delivery to the customer. This applies to both the member states of the Eurpean Union and the states of the European Economic Area.
In Germany alone, more than 700 million pharmaceutical packages are expected to be affected by the new safety measures each year and around 10.5 billion across Europe, explains Andreas Walter, Managing Director of the European Medicines Verification Organization (EMVO) under whose auspices the EU directive is being implemented.
The ultimate goal is to connect more than 2,300 pharmaceutical manufacturers and many thousands of pharmacies in 29 countries to the so-called European Medicines Verification System (EMVS). In Germany, securPharm e. V. is already successfully establishing the authentication system.
In order to check the authenticity of prescription medicines in the future, two new safety features are implemented on the packaging. On one hand, a special seal can be used to determine whether a product has already been opened and possibly falsified. The other is an individual serial number in the form of a data matrix code. Pharmacies can scan and compare these codes with an independent, EU-wide database, the so-called European Hub.
In Germany, the verification of the code is facilitated via two independent servers, between which the data is anonymously exchanged and compared. “In order to ensure the greatest possible data protection for all system users, securPharm works with a system of separate databases for manufacturers and drug suppliers,” according to an information letter by the Federal Association of German Pharmacist Associations (ABDA). “Pharmaceutical manufacturers and suppliers upload their product-related data to the appropriate industry database system. All drug dispensers such as pharmacies, hospitals or wholesalers use the pharmacy system to check and deactivate products subject to verification.”
In addition to Germany, eight other countries have joined the European Hub so far and are testing the new counterfeit protection mechanisms: Bulgaria, the Czech Republic, Denmark, Iceland, Ireland, Lithuania, Slovenia, and Sweden.
The Federal Institute for Drugs and Medical Devices (BfArM) has just recently pointed out the great significance of the new counterfeit protection for pharmaceuticals. “Counterfeit medicines can entail severe consequences for the patients’ health. Counterfeiters accept that seriously ill patients may be treated with adulterated or ineffective substances,” criticizes Karl Broich, President of BfArM.