Who we are
The European Stakeholder Model (ESM) is a partnership of organisations involved in the pharmaceutical supply chain. The ESM partners have joined forces to develop a safe, cost-effective and partnership based pan-European medicines verification system to combat falsified medicines and ensure patient safety.
The risk of falsified medicines entering the legitimate supply chain is now greater than ever before and has begun to raise concerns over the capabilities of the present supply chain system to deal with more sophisticated and structured criminal activities.
Ensuring the delivery of safe and genuine medicines to patients is the responsibility of the whole pharmaceutical supply chain. We have worked together since 2010 to develop and test a single interoperable and scalable pan-European system. This is to ensure that any medicine sold in the EU can be verified at point of dispensing using individual pack level serial numbers before being given to the patient. As the ESM has been developed by supply chain experts, it is a safe, cost-effective and partnership-based system that can meet the needs of all users during a time of austerity in EU Member States.
We welcome the 2011 EU Falsified Medicines Directive (FMD), which mandates pack-level safety features and outlines the important role that the industry should play in developing them. As the FMD legislation sets a tight deadline to develop a system, we are moving ahead with a phased implementation of the ESM to make sure that we deliver additional protection against falsified medicines on time. We are collaborating with end users including patients, public authorities and policy makers to ensure that all aspects of the system meet expectations.
The ESM is tried and tested
The technical approach was tested at national level through a successful pilot project in Sweden. This was conducted in partnership with Swedish retail pharmacy chain Apoteket AB and locally based wholesalers Tamro and Oriola KD from September 2009 to February 2010.
As part of a phased implementation of the ESM, work continues on the national interface with the ‘securPharm’ project in Germany in 2013.