European Stakeholder Model (ESM) and securPharm e.V. - a pan European and a German organisation, respectively, of stakeholders involved in the manufacturing and distribution of pharmaceuticals - will join forces: In July 2014, they will link securPharm’s German system to ESMs European Hub.
In this way they want to demonstrate for the first time how European and national components of the European Medicines Verification System (EMVS) can be linked. This will pave the way for other country verification systems to be linked. A fully integrated supply chain protection – rather than multiple incompatible national systems – will be the result. This is good news for patients who will be protected from falsified medicines and for drug manufacturers that deliver goods to Europe’s complex supranational supply web. ESM and securPharm presented their joint project during during a workshop held in Brussels on 26 February 2014 for marketing authorization holders.
In Europe, the Falsified Medicines Directive, FMD (2011/62/EU) is an important step in better protecting patients from counterfeit medicines. Towards this end, EFPIA has joined together with PGEU (Pharmaceutical Group of the European Union), GIRP (Groupement International de la Repartition Pharmaceutique) and EAEPC (the European Association of the Euro-Pharmaceutical Companies) to develop the ESM (European Stakeholder Model). These partners came together with the aim of developing a system that will provide a high level of security for patients while being cost-effective, pan-European and interoperable – and capable of being effectively integrated into existing national structures and practices in the distribution chain. The result is the European Medicines Verification System (EMVS), a system designed to ensure the medicines are making it safely from the point of manufacture to the point of sale – to the patient.
Both the Hub and the securPharm system are run by stakeholders of the drug supply chain – drug manufacturers, wholesalers and pharmacies, and their respective business associations. Both are based on the concept of end-to-end verification: Drug companies generate a unique randomized serialization number for each package they supply. This number is not only printed on the package (as part of a Data Matrix Code) but also uploaded to a protected data base. In the pharmacies the code is being scanned and checked for authenticity before the packages are handed out to the patients.
The European Stakeholder Model (ESM) is a partnership of organisations involved in the pharmaceutical supply chain. The ESM partners have joined forces to develop a safe, cost-effective and partnership based pan-European medicines verification system to combat falsified medicines and ensure patient safety. Ensuring the delivery of safe and genuine medicines to patients is the responsibility of the whole pharmaceutical supply chain. We have worked together since 2010 to develop and test a single interoperable and scalable pan-European system.
securPharm e.V. is a cooperative effort of stakeholders involved in the manufacture and distribution of pharmaceuticals in Germany. Its partners include the pharmaceutical manufacturers’ associations BAH (Bundesverband der Arzneimittelhersteller), BPI (Bundesverband der Pharmazeutischen Industrie) and vfa (Verband der forschenden Pharma-Unternehmen); the wholesalers’ association PHAGRO (Bundesverband des pharmazeutischen Großhandels); and ADBA (Bundesvereinigung Deutscher Apothekerverbände), the umbrella organization of German pharmacists.