ESM, securPharm Advance Project for Pharma Supply Chain

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 03-04-2014 12:12

The European Stakeholder Model (ESM), a pan European partnership of organizations involved in the pharmaceutical supply chain, and securPharm e.V., a cooperative effort of stakeholders involved in the manufacture and distribution of pharmaceuticals in Germany, will join forces in July 2014, by linking the securPharm German system to the ESM European Hub to demonstrate how European and national components of the European Medicines Verification System (EMVS) can be linked, according to a press release from the European Federation of Pharmaceutical Industries and Associations (EFPIA). ESM and securPharm presented their joint project during a workshop held in Brussels on February 26, 2014 for marketing authorization holders in Europe, reported EFPIA. 

The ESM partners have been working since 2010 to develop and test a single interoperable and scalable pan-European system verification system to combat falsified medicines. 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.

As part of a commitment to the European 
Falsified Medicines Directive, FMD (2011/62/EU), EFPIA 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. 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 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.

EFPIA Director General Richard Bergström said in a press statement: “We look forward to the start-up project as another opportunity to demonstrate the effectiveness of ESM's European Hub. The collaboration with securPharm is invaluable in demonstrating the Hub’s potential, furthering our efforts to fight falsified medicines in Europe as a whole. I encourage manufacturing authorization holders to join us in moving this initiative ahead.”

Reinhard Hoferichter, spokesman of securPharm, said in a press statement: “The securPharm system is already running under real-life conditions of the German pharmaceutical market. We welcome this opportunity to join forces with the ESM in the fight against falsified medicines. We are looking forward to demonstrate that a powerful European solution can be created by building upon national systems that have been tailored to the specific requirements of each country.”

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.

Both ESM’s Hub and securPharm's system are in accordance with the Falsified Medicines Directive, FMD (2011/62/EU). Also, they are in line with the outcomes of a recent related impact assessment on behalf of the European Commission that favors a stakeholder based end-to-end verification system under the supervision of competent authorities and using data matrix codes over alternative approaches that had been considered in the past, according to EFPIA.

The German participants of the securPharm system – drug manufacturers, wholesalers and pharmacies – will not have to alter their procedures when the systems are linked.



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