Counterfeit Medicines: EFPIA Position Paper on the European Commission's Draft

In October 2009, the EFPIA published a position paper in which it gives its opinion on the European Commission's proposal for fighting counterfeit medicines.

Recently, a number of counterfeit medicinal products have been placed on the European market and have also reached patients. Therefore, the EFPIA demands zero tolerance for counterfeit medicines and calls for strict measures to be taken in order to ensure patient safety.

From the EFPIA's point of view, the introduction of counterfeit medicines into the supply chain can only be prevented if the integrity of the original packaging is maintained throughout the entire supply chain, from the time when a medicinal product leaves the manufacturing site to the time it reaches the patient.

There are three core elements for an efficient technological strategy against counterfeit medicines based on the integrity of the packaging:

  • The use of safety packaging or tamper-proof closures
  • The use of overt, covert and forensic features for authentication
  • Strengthening of the product identification for each package through a harmonised coding standard

If products are now repackaged by firms other than the original manufacturer, the effectiveness of any anti-counterfeit measure integrated into the original packaging is seriously put at risk. For this reason, repackaging should be banned as such.

Furthermore, in the passage on safety measures, the draft by the European Commission points out that these measures enable wholesalers and pharmacists to check a medicinal product's authenticity by assessing overt, covert or forensic features. From the EFPIA's point of view, it is essential that such features remain secret. In case the pharmaceutical manufacturers were forced to disclose these features, the latter would thereby become useless for guaranteeing safety. For this reason, the EFPIA states that there should be no requirement to disclose safety features.

Summed up, EFPIA's opinion on the draft by the European Commission is: It's a step in the right direction, but not enough in order to guarantee patient safety.

The complete position paper by EFPIA with all further points can be found here.

EFPIA's project for coding and identification with the 2D Data Matrix Code and the experiences from the related pilot project in Sweden are highlighted by Dr Stephan Schwarze, Bayer Schering Pharma AG and member of EFPIA's Anti-Counterfeiting ad hoc working group, at the University of Würzburg's conference "Strategies against Counterfeit Medicines" on 26-28 April 2010. All information on this programme with 16 speakers from university, authorities (FDA, MHRA, WHO, RIVM) and pharmaceutical industry can be found here.

Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

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