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EFPIA agrees Europe-wide plans to tackle counterfeit medicines

Harmonisation of data between Member States fits with EU’s Falsified Medicines Directive says pharma trade body

Richard Bergstom - director general, EFPIA

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published plans to improve the verification of medicines in Europe.

Developed jointly with groups representing different aspects of the supply chain, the paper presents ways to use new technologies and harmonised, internationally-recognised standards to ensure pharmaceutical products sold in Europe are what they claim to be.

At the heart of these plans would be the European Stakeholder Model (ESM), which involves having a series of national data repositories in EU Member States that pharmacies could use to verify product information.

These would be linked via a European hub and involve standardised systems to detect counterfeit products, forming what EFPIA describes as the European Medicines Verification System (EMVS).

The European hub would be run by the European Medicines Verification Organization (EMVO), which would provide a centralised location for the storage of product master data and a central point from which product recall actions can be initiated.

Such a model has been successful in a pilot project in Sweden, and EFPIA has estimated the annual cost of a model covering the EU would be between €120m and €205m covering all prescription and generics products.

“The costs have been established through the use of actual real life examples rather than theoretical estimates,” said the Federations' director general, Richard Bergström.

He added: “The EFPIA Board endorsement illustrates the strong commitment of the industry in setting up a harmonised system across the EU based on international standards that provides a high level of security for patients while being cost-effective and integrating into existing structures in the distribution chain.”

EFPIA said this model meets the requirements of the EU's Falsified Medicines Directive, which aims to introduce new measures to prevent counterfeit medicines from reaching patients.

Other methods to improve the verification of medicines in Europe suggested by EFPIA include incorporating batch number and expiry dates into a medicine's 'serialised product code'.

This would be a cost-effective way for wholesale distributors and pharmacists to obtain relevant information enhancing patient safety and improving product recall procedures, according to the EFPIA.

Pharmacy level verification of medicines at the point of dispensing is also featured in the plans, with verification software to be integrated with existing pharmacy software to ensure products are verified in one scanning action to avoid delays.

Fellow contributors to the paper were the Pharmaceutical Group of the European union (PGEU), the European Association of Pharmaceutical Wholesalers (GIRP) and the European Association of Euro-Pharmaceutical Companies (EAEPC).


3rd May 2012


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