With regards to serialisation projects, there will be a few trends emerging. I think 2014 will see much more formal collaboration between leading suppliers so that 'complete' compliance solutions can be offered.
As the industry starts to realise the full scope of the impact of emerging legislation, I predict that additional stakeholders such as the European Directorate for the Quality of Medicines (EDQM), the European Generics Association (EGA) and even non-EU organisations such as Brazil's ANVISA will align themselves more closely with the European Medicines Verification System (EMVS) group.
The EMVS will be up and running and stakeholders will connect and start 'practising' by actually connecting to the system. They will start to send data to the hub and see if it ends up in the right national system and if a connected pharmacist is able to scan and check the data correctly.
It is likely that? a European Medicines Verification Organization (EMVO) will also be set-up in Brussels, and it will be there to help users of the EMVS system and to manage, amongst other things, the so called "false positives" (about 7000 units a day when fully operational).
I also predict that a number of vendors will reach capacity and close their order books for a while. Lead times are becoming longer and longer: up to a year in some cases. I think by the end of 2014 we will have lead times of between one, two and three years and perhaps even longer.
Will this make companies look elsewhere and will new providers emerge? Perhaps. If so, manufacturers should be more careful than ever to choose suppliers with proven technology, long term solutions, validation and support.
In terms of manufacturers, I foresee them approaching serialisation in two ways. Some will grasp the opportunity and realise the potential benefits – greater patient adherence and brand protection, for example – and others will implement the absolute minimum to achieve regulatory compliance and get no added return.
Whichever strand they belong to, though, most manufacturers will implement serialisation on at least one pilot line, whether they are 'big pharma' or SME manufacturers. Serialisation will also be adopted in more and more parts of the world, especially in the US, South Americas and Asia, and the themes will be what we've come to expect: the 2D data matrix, aggregation and track and trace.
