European Medicines Verification System – is it worth it?

When it comes to patient safety, what level of risk are you willing to accept? What number is an acceptable number?
With the Falsified Medicines Directive coming into force on 9 February 2019 stakeholders have received many questions around “how much does it cost?” and “is it worth it, considering that falsified medicines in the legal supply chain are not really a problem in the developed world?”.
The impact assessment published by the European Commission acknowledges that concrete numbers of falsified medicines in the legal supply chain are hard to come by. Nonetheless, the European Commission attempts to make a rough estimate based on past evidence of falsified medicines confiscated in various Member States.
The impact assessment arrives at an estimate of approx. 0,005 %, which does not sound like a big number. It does not really sound like “it’s worth it”. But with around 15 billion (that is 15 000 000 000) prescriptions medicines circulating on the EU market in any given year, that small percentage translates into a significant number in absolute terms (whispers it means 750 thousands medicinal packs).
No matter the number you chose to focus on (0,005% or 750 thousands), we believe that any number higher than 0 is too high when it comes to patient safety. 
And when it comes to the cost of the overall medicines verification system, is the guarantee of a 100% secure supply chain, at a cost of about 3 eurocents per pack, even debatable for any respectable supply chain stakeholder?
For us, here at EFPIA, it’s a no-brainer: the European Medicines Verification System is definitively worth it.

Mihai Rotaru

Mihai Rotaru is Project Manager Market Access in the Economic and Social Affairs team, responsible, among others,...
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