The European Federation of Pharmaceutical Industries and Associations (EFPIA) has formally adopted a memorandum of understanding (MoU) with key partners for a harmonized, European system for medicines verification. The approach, which makes use of verification technology at the point of dispensing, could help combat the occurrence of falsified medicines in the EU.
Stakeholders in the project, known as the European Stakeholder Model (ESM), include supply chain partners representing pharmacists (Pharmaceutical Group of the European Union), wholesalers (GIRP - the European Association of Pharmaceutical Wholesalers) and parallel traders (European Association of Euro-Pharmaceutical Companies). The MoU establishes provisions for establishing a verification system that is cost effective, scalable, and that meets the requirements of the EU’s Falsified Medicines Directive. The verification system involves marking medicine packs with a unique code at the point of manufacture, which is then verified in the pharmacy prior to release of the pack to the patient. It is believed that the system will provide end users with more confidence in the pharmaceutical supply chain and its products.
According to a statement from EFPIA, the system could be beneficial in light of the European Commission’s upcoming Delegated Act on safety features, which is connected to the Falsified Medicines Directive and expected in 2014. In the public consultation on the Act, EFPIA and the other stakeholders of ESM specified the technical features of the verification system and highlighted its cost effectiveness. The system is expected to cost the EU around 120 million to 205 million Euros annually, with the cost per pack estimated at 1.3 to 2.2 Euro cents. Richard Bergström, Director General of EFPIA, added that the estimates were based on real-life usage rather than theoretical estimates.
As well as establishing whether a medicine is authentic, the system may provide further benefits in the future. For instance, the system could be used to automatically check information such as expiry date or whether the batch has been affected by a recall. EFPIA says it will work with governments to make sure that benefits are realized and that all medicines bear the necessary safety features.
“It seems outdated to sustain that only high-priced products should be protected,” Bergström said in a statement. “Indeed, the cost of manufacturing falsified medicines is close to zero, therefore any medicinal product, no matter its price, is likely to generate a profit for the counterfeiter.”