EFPIA Emphasizes European Stakeholder Model to Combat Counterfeit Medicines

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 09-16-2014 04:03

The European Federation of Pharmaceutical Industries and Associations (EFPIA) is emphasizing the importance of a pan-European medicines verification system as a means to address counterfeit medicines entering the European supply chain. 

EFPIA is setting up the European Stakeholder Model (ESM) in the context of the implementation of the EU Falsified Medicines Directive (Directive 2011/62/EU), together with all supply-chain stakeholders, including 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 involved in the ESM work and is expected to formally join the other partners very shortly, according to EFPIA. The ESM offers a technological solution using anti-tampering devices, together with 2D barcoding, to verify the authenticity of medicinal products to combat the entry of falsified medicines in the EU supply chain.  

Richard Bergström, Director General EFPIA, said in an EFPIA press statement: “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.”  Beyond the European Stakeholder Model, EFPIA is also engaged in with other stakeholders in various initiatives in order to strengthen the integrity of the legitimate supply chain as well as to make buying medicines online safer

Last week,  the Italian Medicines Agenc (AIFA) reported on the latest results of 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 out of ten in Italy registered thefts of pharmaceuticals. According to available information from AIFA and Transcrime, because of loopholes in traceability systems across jurisdictions, the stolen medicines are re-entering the legal trade in other EU countries through fictitious or corrupt brokers.

The pan-European verification system seeks to address that problem. Serial numbers corresponding to each packaging will be recorded in the system. In case of repackaging, a link between the originators' serial numbers and the traders' serial numbers at batch level will be secured in the system. This link will prevent any re-introduction of stolen medicines on any EU markets, said EFPIA.

Source: EFPIA



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