Domino Life Sciences’ latest serialisation survey has exposed sharp differences in levels of preparedness for the enactment of the EU Falsified Medicines Directive (FMD) in January 2018, raising fresh concerns about the complexities of compliance. Conducted throughout June and during ACHEMA, Domino’s survey drew responses from small to large research-based manufacturers, device manufacturers, generics and contract packers.
Key findings include:
- 20% of respondents are either unsure or do not think that their company’s serialisation strategy is robust
- A quarter estimate it will take longer than three years to be fully compliant – beyond the available timeline before the FMD is enforced
- 44% of respondents state that integration of serialisation solutions into current systems is their biggest concern; other issues raised include long term robustness of printed codes and software, the impact of serialisation on revenue, cross-business participation and the maintenance of Overall Equipment Effectiveness (OEE)
Cutting it fine
With fewer than three years before the industry implements item-level serialisation as part of the FMD, manufacturers are now effecting radical changes to their processes. However, while more than three quarters of those asked by Domino believe their company’s current progress is in line with industry developments, 20% of them are either in the earliest planning stages of serialisation or looking for solutions providers in order to start implementing a pilot roll out.
Craig Stobie, head – global Life Sciences team at Domino, thinks it is understandable why some manufacturers are holding back. 'While it is clear that the Directive will comprise 2D data matrix codes, an end-to-end verification system and a central data repository system, the Commission is yet to formally publicise the Delegated Acts, so investing in a programme before the definitive announcement is a real concern for manufacturers with smaller budgets,' he explains. 'The fundamentals are unlikely to change when the acts are announced, however, so starting early on a solution with an element of flexibility will give invaluable operational experience.'
A complex solution in evolving legislative landscape
While just under half of manufacturers shared the view that integration of serialisation solutions into current systems was the most pressing issue, there are a number of other considerations. 'A major concern for me is a robust and sustainable compliance model in a changing legislative environment,' says one manufacturer. 'Keeping systems and processes compliant with continual changing global legislation is a major challenge, as is the overall cost and impact on revenue,' comments another.
One recurring theme is the need for clarity around the specifics of the Directive and more overall industry support. 'The attitude from some is that serialisation is a nuisance, because there is not much awareness of the individual requirements,' says one respondent. 'We don’t feel there is much support to push individual sites to implement the projects.'
Keeping systems and processes compliant with continual changing global legislation is a major challenge, as is the overall cost and impact on revenue
'The vast range of opinions our survey has uncovered re-enforces just how multifaceted an FMD-compliant serialisation solution is and there is no "one size fits all" solution,' comments Stobie. 'Each company has different requirements, from the choice of printing technology to how software systems will be deployed and it’s clear that manufacturers are looking for support from the supplier community in terms of understanding the specifics of the Directive and what is the most appropriate infrastructure for their needs.
'Manufacturers who are still looking for the right solutions providers will benefit from the knowledge of vendors who not only offer counsel in these areas, but have also partnered with other OEMs and integrators to offer flexible and innovative solutions in response to emerging legislation.
'FMD compliance is complex and individual to every company and the right suppliers understand this - the trick here is not to leave it too late,' Stobie concludes.
