Viewpoint: Pay the Falsified Medicines Directive its due

An earlier version of this article incorrectly stated that Ireland had also not transposed the FMD. Apologies for the error and many thanks to the Irish Medicines Board for drawing it to our attention - Ed.

Bart VansteenkisteThe news that Italy, Poland and Slovenia have not yet transposed the Falsified Medicines Directive (FMD 2011/62/EU) into law is alarming. The deadline to comply with the FMD is almost certainly going to be January 2017.

This is less than three years away and with the consensus of industry opinion being that it takes between four and five years to implement a successful serialisation scheme, manufacturers need all the support they can get. If governments are seen not to be enacting the Directive, manufacturers might well be forgiven for relaxing their approach to implementation.

The FMD is being introduced to help stem the flow of counterfeit drugs infiltrating the European market (11 billion counterfeit articles were intercepted at EU borders in 2011).  It is taking the matter so seriously that if companies do not comply they will be unable to sell their product in any EU territory. The potential impact this has on businesses, and economies, is huge.
Creating a unique, non-predictive number, the cornerstone of serialisation, is difficult, especially when no one knows yet who is issuing the numbers. Is it government, the brand owner, global standards body such as GS1, or all three? At present, effective solutions are few and far between and invariably involve multiple suppliers. Before long, order books will be full and demand even higher. To the uninitiated, three years may seem a lifetime away but for those in the know, the governments of Italy, Slovenia and Poland, together with all producers supplying the EU, need to act now. Taking an active approach will protect business efficiency, profitability, brand image and, most importantly, patients.

Many believe that serialisation is 'just' an engineering challenge. That may be the first step, but a critical success factor is senior stakeholder buy-in to earmark the funds, time and training necessary to implement it. These industry leaders will almost certainly take their lead from government, which doesn't bode well for FMD-readiness in Italy, Poland and Slovenia.

Governments must recognise the consequences of delaying the transposing of legislation into law.  They need to be taking a forward thinking approach to protect their business interests, their customers and in turn the public, which needs to be safe in the knowledge that in January 2017 their medicines will still be available.

Bart Vansteenkiste is European life sciences sector manager at Domino Printing Sciences

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