The US has been struggling to establish a workable pedigree system since as early as 1988 and yet despite numerous efforts a functional pedigree system remains years away.

In contrast, in Europe – EFPIA has laid the ground work for a simpler approach based on mass serialisation utilising 2D barcoding. A single country pilot is planned for 2009, whilst individual European nations such as Turkey, France, Belgium, Italy and Greece are all pursuing variations on this theme.

Ironically, it is this fragmented regional approach that threatens the implementation of a clear strategy and effective protection programmes.

• Regional initiatives requiring pharmaceutical product to be serialised has exposed a lack of experience relevant to high- speed coding in the healthcare sector.
• The ‘dash’ to serialise has provided a false sense of security. Barcodes can still copied or cloned and product authentication is still a critical factor which must be incorporated to fully protect the patient from counterfeit product.
• The need to print a barcode on each pack, however, provides an excellent vehicle for authentication technologies.
• Fully functional pilot projects are still very scarce.
• The alignment of SecureTrace with EFPIA requirements will provide valuable feedback and experience.
• Independently authenticating product in the field will demonstrate the viability of the system without the need to deploy new equipment at pharmacies
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