ESM seeks ties with securPharm for serialisation initiative

The stakeholders involved in European Stakeholder Model (ESM) for medicine serialisation are in discussion with the group behind Germany's national securPharm scheme to demonstrate how the two systems can work alongside each other.

The ESM - which grew out of a pilot project set up by the European Federation of Pharmaceutical Industries & Associations (EFPIA) - is based on the application of unique and random serial numbers on each pack of medicine at the point of manufacture, and the verification of that number in the pharmacy at the point the pack is dispensed to the patient.

The implementation of machine-readable codes is now thought to be inevitable in the context of the Falsified Medicines Directive (FMD) which is due to come into effect in the EU next year, but the nature of the system to be implemented is still being determined.

EFPIA and its partners in the ESM project - representing Europe's pharmaceutical manufacturers, pharmacists, wholesalers and parallel importers - are building a case for their end-to-end verification system as the detail of the FMD's safety feature requirements are being thrashed out via the EU delegated acts procedure.

At a seminar* on Europe's Falsified Medicines Directive (FMD) earlier this month run by coding specialist Domino, GlaxoSmithKline serialisation and security manager Grant Courtney - representing EFPIA - updated delegates on progress with the ESM and disclosed the plan to start working with securPharm.

The securPharm traceability pilot is due to get underway on January 1 2013 and - much like EFPIA's earlier Swedish pilot - will involve placing unique, serialised GS1-compliant codes on medicines at the point of manufacture, in order to allow them to be scanned and authenticated by pharmacists at the point of dispensing.

The ESM's aim is that national initiatives of this type should be fully interoperable with its model, which relies on the use of a European hub - or medicines verification repository - that will handle the transactions between databases operated by stakeholders in the supply chain.

The stakeholder group recently launched a tender process for the information technology underlying the hub, and is currently shortlisting vendors and expects to have an operational system in place by the second quarter of 2013.

Courtney told SecuringIndustry.com that the next step will be to plug the hub into national systems. To that end, the ESM and securPharm are now discussing setting up a project to show how the national database system created in the securPharm project can interface with the hub.

Once the proof-of-principle has been demonstrated in Germany the ESM will then try to replicate that with other national systems, he added.

"The ESM partners want to deliver an effective system on time," said Courtney, noting that current projections are that compliance with the FMD will become mandatory in 2017.

* Domino is planning to run a series of additional seminars in Paris, Barcelona and Frankfurt in the months leading up to the FMD's implementation in 2013. To register your interest in attending the next FMD Conference, please email fmdevents@domino-uk.com.