According to Directive 2011/62/EU, the majority of EU member states have to implement serialisation legislation before February 9, 2019.
The only exceptions are Belgium, Greece and Italy – where verification and identification systems for medicinal products are already in place – which have been granted until February 9, 2025 to enforce the legislation.
However at serialisation-focused conference Nexus 17 in Barcelona last month, Biogen’s Bjoern Rosner said these exceptions could undermine the overall aim of the Falsified Medicines Directive’s (FMD) initiative.
European Commission on drug fraud
Falsified Medicines are fake medicines that pass themselves off as real, authorised medicines.
Counterfeit medicines are medicines that do not comply with EU law on intellectual and industrial property rights, such as registered trademarks or patent rights.
Further, Rosner said he thought this security threat would take years to resolve.
The Associate Director of Biogen’s Serialization Program said ‘holes in the system’ could encourage the fraudulent drug market, explaining “If I were a counterfeiter, I would concentrate on Greek or Italian product and trade it into the rest of the countries.”
“Usually, you reap the full benefit of legislation only after a few years of operation, when all the old data has been flushed out,” he said.
“In the transition phase, of a serialisation requirement, you always have gaps.”
Falsified drug threat
European Commission spokesperson Anca Paduraru disagreed with the idea that, as a result of the implementation extension, fraudsters would be able to use Belgium, Greece and Italy as bases from which to feed falsified drugs into the rest of the European Union.
She told us: “We do not envisage the additional time allowed to Greece and Italy will cause a significant problem in those member states who will have a system in place by February 2019, as all manufacturers and marketing authorisation holders must put the data on the unique identifier for their product into the national database of the Member State(s) where the product is intended to be placed on the market.”
However, she agreed there is a risk of falsified drugs circulating in Greece and Italy during the transition phase until the directive is implemented.
“The risk of falsification of products to be placed on both the Italian and Greek markets remains until such time as they implement Directive 2016/161,” Paduraru told us.