The pan-European medicines verification system uses an anti-tampering device together with 2D barcoding to verify the authenticity of medicinal products and is currently being implemented with all supply chain stakeholders in Europe.
It is being introduced in line with the requirements of the EU Falsified Medicines Directive (Directive 2011/62/EU).
Under the system, serial numbers corresponding to each package will be recorded. In the case of repackaging, a link between the originators’ serial numbers and the traders’ serial numbers at batch level will be secured in the system. EFPIA says this link will prevent any re-introduction of stolen medicines on any EU markets.
Last week, the problem of stolen drugs was highlighted again by the Italian Medicines Agency, AIFA, which reported on its ongoing investigation about stolen medicines in Italian hospitals. According to a 2014 report from Transcrime (Joint Research Centre on Transnational Crime, Milan University), between 2006 and 2013, one hospital in 10 in Italy registered thefts of pharmaceuticals.
However EFPIA is confident that these issues will be halted with the implementation of the pan-European verification system.
Under the ESM, manufacturers generate and apply an internationally recognised 2D data matrix barcode to authenticate medicines at the point of dispensing. The contents of the code are sent to a database before the product is released. When the barcode is scanned, the pharmacist will be alerted if the code is unregistered. The data matrix can also hold additional information such as national codes or other requirements from national authorities. The code contain four key elements: product number, batch number, expiry date and a random serial number.
In 2013 the ESM European Hub, which is designed to link national systems throughout Europe, was joined to the German national securPharm verification system and is gradually rolling out across the German healthcare system.
The ESM is overseen by the European Medicines Verification Organisation (EMVO) – a non-profit stakeholder organisation.
The ESM includes supply chain stakeholders GIRP (the European Association of Pharmaceutical Full-line Wholesalers), EAEPC (The European Association of Euro-Pharmaceutical Companies), and PGEU (Pharmaceutical Group of the European Union). The European Generics Association (EGA) is also expected to join soon.
Richard Bergström, director general EFPIA, stated: “The European Stakeholder Model is proof that, by joining together, we can best protect patients and their security in Europe. By joining the European Stakeholder Model all supply chain partners have shown their commitment to maintain the integrity of the legitimate supply chain in Europe.”