Estonia says drug verification system found no fakes last year

The organisation responsible for the European medicines verification system (EMVS) in Estonia says it found no falsified drugs last year out of almost 20m checks.

The non-profit REKS group says that around 2.5m packages are being scanned every month under the EMVS, which is part of the implementation of the Falsified medicines Directive, says a report in The Baltic Times.

The Estonian EMVS was connected to the EU hub in mid-2018, and is in the midst of a ‘soft’ implementation period until September 2020. During this phase, all products must be scanned and checked, and if that prompts an alert the decision to dispense or prescribe the drug is made on a case-by-case basis.

Estonia’s 495 pharmacies, 23 hospital pharmacies and 19 wholesalers are all participating in the EMVS, with 700,000 checks yielding around 2,000 false alerts every week at present, according to the update.

The false alerts are mainly caused by medicine packs that were released for distribution on the Estonian market ahead of the February 9, 2019 implementation of the FMD’s safety features requirements, says the report.

Along with serialised, unique 2D bar codes on medicine packs used to verify them at the point of dispensing, it also requires the use of tamper-evident seals.

There have been instances of falsified medicines being caught by the EMVS, including a counterfeit version of Roche’s cancer drug Avastin (bevacizumab) which was identified in the Netherlands a few months after the system came online last year.

Towards the end of last year REKS’ equivalent in the UK – securMed – said it had identified no counterfeits out of almost 45m packs dispensed in the first 10 months the FMD safety features system was in operation.

At the time, national regulator the Medicines and Healthcare products Regulatory Agency (MHRA) told The Pharmaceutical Journal that a small number of falsified medicines had been identified in the legal supply chain since the launch, but these were picked up using other means than the 2D bar code.

There are still big questions about the UK’s continued participation in the EMVS once the transition period following the UK’s departure from the UK comes to an end on December 31.

The MHRA has previously said it thinks the UK would not have access to the EU central data hub if the transition period ends without a deal, and has suggested that the UK may have to develop its own verification system that would sit in parallel to the EU’s platform.