The publication this week of the delegated Regulation 2016/161 associated with the EU Falsified Medicines Directive sets February 9, 2019 as the date by which the vast majority of prescription and some OTC (over-the-counter) medicines dispensed or sold within the 28 EU Member States must meet the requirements of the Acts. Failure to comply will render affected products illegal for sale.
Amongst these requirements and categorised under the seemingly innocuous heading of ‘safety features’ is the need for every pack to carry a unique identity in a standardised format that can be verified at any point from manufacture to patient. It is this requirement, item-level serialisation, more than any other that is exercising those responsible for compliance, in the wider supplier community as well as in the industry itself.
Enactment will ostensibly mark the culmination of a decade-long journey for many in the industry, a journey which began with the legal proposal put forward by the EU Commission in December 2008. At Domino, we have characterised item-level serialisation as the biggest challenge faced by the pharmaceutical industry in a generation and we believe that its ramifications will continue to be felt for some time beyond the compliance deadline. While manufacturers must become technically capable of producing serialised packs over the next three years, all the evidence suggests that productivity may be adversely impacted for some time beyond that.
There are steps that can be taken now to mitigate the ‘side effects’ of serialisation but the extent of the impact will only become apparent when producers begin serialised production in earnest: for many this is still some time away.
It would be foolish to underestimate the amount of work still to be done ahead of the compliance deadline and the occasional bout of serialisation fatigue can certainly be forgiven. But there are some real positives to be drawn from the journey so far.
First and foremost, the fundamental premise of the Falsified Medicines Directive is patient safety. Serialisation will be a significant line of defence in protecting all EU Citizens from the trade in illicit medicines, which, according to figures from Interpol’s Operation Pangea, is growing exponentially.
Secondly, it is enormously gratifying to see the industry pulling together to produce a cohesive response to the legislation. Manufacturers, suppliers and other stakeholders recognise that no organisation can provide a solution singlehandedly, prompting a sharing of knowledge and resource unlike anything we at Domino have experienced. This spirit of partnership bodes well for the sector as it addresses the challenge of serialisation and, we hope, far beyond that.
 The Directive introduces tougher rules to improve the protection of public health with new harmonised, pan-European measures to ensure that medicines are safe and that the trade in medicines is rigorously controlled. To this end, these new measures include:
- Obligatory safety features on the outer packaging of the medicines, to be detailed via a delegated act;
- A common, EU-wide logo to identify legal online pharmacies. This would make it easier to distinguish between legal and illegal online pharmacies throughout the European Union;
- Tougher rules on the controls and inspections of producers of active pharmaceutical ingredients; and
- Strengthened record-keeping requirements for wholesale distributors