29 February 2012
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.
You will find the complete position paper as appendix to the press release "EAEPC-EFPIA-GIRP-PGEU working for better Patient Safety".
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