Leak reveals surprises in EU Delegated Act on safety features

Christoph Krähenbühl, 15-Aug-2014

Former AstraZeneca serialisation expert and member of the EFPIA-led European Stakeholder Model (ESM) technical experts working group, 3C Integrity’s Christoph Krähenbühl, examines the latest update on the ‘Safety Features’ Delegated Act, currently being examined by Member States’ expert teams and how some of the proposed provisions could have a significant impact on all stakeholders, in particular pharmaceutical manufacturers supplying products to the European Market.

"Tranquility Base here - the Delegated Act has landed" will be the message resounding across the European Pharma industry and beyond, when the long-expected 'Safety Features' Delegated Act (DA) is finally published later this autumn.

It remains to be seen, however, whether the prevailing feeling in the industry will be a mood of tranquility – or rather the opposite: The realisation even amongst the most recalcitrant manufacturers that they need to embark on their journey towards readiness, a journey not across the Sea of Tranquility but possibly into a perfect storm of challenging requirements, short timescales, and system vendors whose order books are rapidly filling up already.

The publication of the DA will put paid to the argument that it is not possible to take preparatory action because there is still too much uncertainty about the EU-FMD requirements. Not that the ‘wait and see’ attitude stands up to scrutiny even today because the provisions of the DA will not appear out of the blue; on the contrary, they will have been arrived at through extensive consultation and years of engagement with all stakeholders.

The trajectory of the journey – like that of an Lunar Lander – has been clear for all to see and, in fact, been set right at the start of the EU-FMD process; what we are now observing are simply the final course corrections that will ensure that the DA and its provisions land in the right place and do not hit a rock-strewn crater.

This is the context against which we should assess the latest update on the details of the DA that are beginning to leak out into the public domain. While this latest draft text, circulated amongst Member States’ experts only, is not currently available to stakeholders or the public, the document presents the best current view of what is to be expected once the Act is published later this year. It largely confirms the key elements of the EU-FMD provisions that have been consulted on before and should provide few major surprises.

However, drilling into the details reveals a few points that have the potential to affect stakeholders significantly and also challenge some of the assumptions that underlie, for example, the European Stakeholder Model (ESM) which is currently being rolled out to early adopters, such as the suggestion that parallel importers can continue to use the original unique identifier or the stipulation that the system should support the verification of a pack in a different market to the intended market. Both these suggestions transgress the design of the ESM concept and could prove to be quite a headache to the technical solution and the processes it supports.

[Additional commentary on the Delegated Act can be found in our exclusive white paper, which can be downloaded here - Ed]

Most eye-catching will be the proposal for a two-year transitional arrangement. This seems to offer, at first glance, a two-year period of grace, but on reading more carefully what the proposals entail, it becomes clear that expectations that manufactures will have two extra years to achieve compliance are misplaced.

But potentially the biggest bombshell is the stipulation that the UI barcode will take the place of all other visible barcodes on the packs: if this requirement stands, the pharma industry will need to undertake a massive artwork change programme affecting the vast majority of pharmaceutical packs supplied to the European Market in the next three years – the compliance burden on manufacturers that was already big has now become significantly bigger!

Christoph Krähenbühl is a respected serialisation expert and thought leader in coding and serialisation for the pharmaceutical industry. Along with partner Ian Haynes, he runs 3C Integrity, a specialist consulting firm which currently offers two-day training programs to fully prepare pharma companies of all sizes for implementation.

3C Integrity's next training will take place at the Vitra Campus in Basel, Switzerland, on September 23-24, 2014. To qualify for a 15 per cent discount use the code "SecuringIndustry", which is valid until August 31.