EU Medicines Verfication System Formed To Close Supply Chain Loopholes
By Lori Clapper
With recent supply chain breeches in the EU, including the counterfeit vials of Roche’s lymphoma drug MabThera discovered in Germany last week, along with the €10 million in seized fakes across eight EU countries earlier in the month, the European Federation of Pharmaceutical Industries and Associations (EFPIA) holds high hopes that its pan-European medicines verification system will deter thieves and counterfeiters in Europe’s pharma supply chain.
The Italian Medicines Agency, AIFA, just released data from its investigation about stolen medicines in Italian hospitals. According to the 2014 report from Transcrime (Joint Research Centre on Transnational Crime, Milan University), one out of ten Italian hospitals announced pharmaceutical theft, with several reporting multiple incidences between 2006 and 2013.
Because there are serious serialization loopholes as pharmaceuticals cross borders within the EU, stolen or fake medicines can “re-enter 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,” according to the EFPIA.
EFPIA is highly concerned with the obvious danger of counterfeit drugs and has offered possible solutions within the framework of the European Stakeholder Model (ESM), a group of European organizations involved in the pharma supply chain that have partnered to end counterfeiting and keep patients safe. The ESM was created specifically for the implementation of the EU Falsified Medicines Directive and includes organizations like the European Association of Euro-Pharmaceutical Companies (EAEPC), the Pharmaceutical Group of the European Union (PGEU), among others. Richard Bergström, director general EFPIA, added the organization is also in talks with other stakeholders, outside of those in the ESM. The European Generics Association (EGA) also plans to join in the near future.
The ESM serialization solution will use anti-tampering devices with 2D barcodes that will verify the authenticity of medical products. Product serial numbers that correspond to each package will be recorded in a central system. If drugs are re-packaged, a link between the originators' serial numbers and the traders' serial numbers at batch level will also be recorded to keep stolen medicines from re-entering the market.