Safety Features & Drug Authentication: Which System will prevail?

To implement the requirements laid down in the new EU Counterfeit Directive and especially according to § 54 of the EU Directive, each company concerned must set safety features on medicinal product packaging to ensure the authenticity of every single prescription drugs' packaging. The question on how concrete implementation of these requirements should be performed hasn't been detailed yet. That is the reason why different systems are currently being developed.

In a new position paper issued in January 2012, the European Pharma Federation (EFPIA), the Organisation of pharmaceutical manufacturers (GIRP), the European licensed parallel distribution industry (EAEPC) together with the Pharmaceutical Group of the European Union (PGEU) have contested the "eTACT" system for drugs traceability proposed by the "European Directorate for the Quality of Medicines and Healthcare" (EDQM).

The organisations basically welcome EDQM's involvement in the fight against counterfeit medicines. However, they see many more efficiencies in the European Stakeholder Model ("ESM") which is under development by the 4 organisations implicated in the creation of the position paper.

According to them, a respective system should be designed and run by those who will use it day-to-day. The decentralised ESM structure will enable very flexible implementation at national level within a structure that guarantees security and data protection. The writing refers to the fact that the ESM model has been tested by the EFPIA in Sweden between 2009 and 2010 and revealed to be a great success. A further pilot project should be conducted in Germany in 2013. According to the organisations who issued the concept paper, the ESM model is a robust and cost-effective means of implementing the requirements of the new directive.

In Germany, pharmaceutical industry, wholesalers and pharmacist associations have started another model -  the so-called "securPharm" model. Because of the participation of leading pharmaceutical companies like for example Sanofi, the "securPharm" model is likely to be admitted too.

EDQM's eTACT system relies on a much broader Track & Trace approach. Contrary to the end-to-end solutions cited which only involve manufacturers and pharmacies actively; the EDQM's model should enable a control of the medicinal product at any time of the delivery stage. This should ensure better monitoring of the Supply Chain.

At the Anti-Counterfeit Conference from the University of Würzburg (7-8 May in Würzburg, Germany), decision-makers will have the possibility to concretely compare the different systems. During the conference, EDQM's eTACT system will be presented by Dr Hans-Joachim Bigalke. On the other side, the German "securPharm" model will be introduced by Dr Stephan Schwarze from Bayer AG. Please visit the conference website to get more information about the Anti-Counterfeit Conference.

You will find the complete position paper as appendix to the press release "EAEPC-EFPIA-GIRP-PGEU working for better Patient Safety".

Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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