EFPIA says verification scheme 'will end resale of stolen drugs'

The medicines verification system developed by Europe's drug industry, pharmacists and wholesalers will stop illicit medicines entering the legitimate supply chain, says an industry body.

The European Federation of Pharmaceutical Industries & Associations (EFPIA) said the scheme - known as the European Stakeholder Model (ESM) - "will put an end to the resale of stolen and counterfeit drugs" via usual distribution channels, although it will not protect consumers who purchase medicines over the Internet.

The trade body representing Europe's pharmaceutical manufacturers makes the assertions in the wake of the publication of an investigation in Italy which found that around one in 10 hospitals had been affected by thefts of pharmaceuticals, with each incident valued at round €330,000.

The Italian Medicines Agency (AIFA) said earlier this year that medicines theft in the country had been linked to the activities of the Camorra organised crime syndicate.

"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," according to EFPIA. "This will not be permitted anymore with the implementation of the pan-European verification system."

The ESM is a partial tracking system for medicines which will involve marking each medicine pack with a unique code - at the point of manufacturer - which will then be verified in the pharmacy at the point of dispensing to the patient. It also covers the secure replacement of codes if medicines are repackaged.

Along with the use of tamper-evident packaging, the scheme seems to satisfy many of the requirements that are expected to be in the delegated act - a piece of legislation currently being drawn up to implement the safety features requirements of the EU's Falsified Medicines Directive (FMD).

There are a couple of areas where the ESM model as it stands may not fully meet the delegated act requirements however, such as such suggestion that parallel importers can continue to use the original unique identifier or a stipulation that the system should support the verification of a pack in a different market to the intended market.

Generic drugmakers

EFPIA also said that the European Generics Association (EGA) - a group that has been conspicuous by its absence from the ESM to date - is expected to formally join the other partners "very shortly".

The other partners in the initiative alongside EFPIA are GIRP (the European Association of Pharmaceutical Full-line Wholesalers), parallel imorter body the EAEPC (European Association of Euro-Pharmaceutical Companies), and the PGEU (Pharmaceutical Group of the European Union) represting pharmacists.

Beyond the ESM, 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," it added.