(15 September 2014 - Brussels, Belgium): The pan-European medicines verification system that EFPIA, the European Federation of Pharmaceutical Industries and Associations, is currently implementing with all supply chain stakeholders in Europe, will put an end to the resale of stolen and counterfeit drugs in the legitimate supply chain.
Last week the Italian Medicines Agency, AIFA, reported on the latest results of its on-going investigation about stolen medicines in Italian hospitals. According to a 2014 report from Transcrime (Joint Research Centre on Transnational Crime, Milan University), between 2006 and 2013, one hospital out of ten in Italy registered thefts of pharmaceuticals. The full report is available here.
At multiple instances EFPIA emphasised the dangers of counterfeit medicines and demonstrated possible solutions in the frame of the European Stakeholder Model. EFPIA is setting up the European Stakeholder Model (ESM) in the context of the implementation of the EU Falsified Medicines Directive (Directive 2011/62/EU), together with all supply chain stakeholders including GIRP (the European Association of Pharmaceutical Full-line Wholesalers), EAEPC (The European Association of Euro-Pharmaceutical Companies), and PGEU (Pharmaceutical Group of the European Union). The European Generics Association (EGA) is also closely involved in the ESM work and is expected to formally join the other partners very shortly. The ESM offers a cost-effective technological solution using anti-tampering device together with 2D barcoding to verify the authenticity of medicinal products, combating the entry of falsified medicines in the EU supply chain and ensuring patient safety across Europe.
According to available information from AIFA and Transcrime, because of loopholes in traceability systems across jurisdictions, the stolen medicines are re-entering the legal trade in other EU countries through fictitious or corrupt brokers. This will not be permitted anymore with the implementation of the pan-European verification system. Serial numbers corresponding to each packaging will be recorded in the system. In case of repackaging a link between the originators' serial numbers and the traders' serial numbers at batch level will be secured in the system. This link will prevent any re-introduction of stolen medicines on any EU markets.
Richard Bergström, Director General EFPIA, stated: “The European Stakeholder Model is proof that, by joining together, we can best protect patients and their security in Europe. By joining the European Stakeholder Model all supply chain partners have shown their commitment to maintain the integrity of the legitimate supply chain in Europe.” Beyond the European Stakeholder Model EFPIA is also engaged in with other stakeholders in various initiatives in order to strengthen the integrity of the legitimate supply chain as well as to make buying medicines online safer.
EFPIA represents the pharmaceutical industry operating in Europe. Through its direct membership of 33 national associations and 40 leading pharmaceutical companies, EFPIA provides the voice of 1,900 companies committed to researching, developing and bringing new medicines to improve health and quality of life around the world. The pharmaceutical industry invests € 30.6 billion on research and development per year in Europe and directly employs 690,000 people including 115,000 in R&D units in Europe.
EFPIA members are committed to delivering innovative medicines to address unmet needs of patients and reducing the burden of chronic diseases for Europe’s ageing population. EFPIA believes in close cooperation with its stakeholders to help create sustainable healthcare systems and to develop prompt responses to health threats in Europe.
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