Thanks to ExLPharma and the presenters for organising the serialisation conference last week in Philidelpia and “hi” to all those who attended.
For those that did not attend, I thought I would share some headlines which resonated for me as someone who had been involved in serialisation for the last 5+ years…
Some Key Messages
Although not new, I think it is particularly notable that EFPIA, and therefore a good number of Rx Manufacturers are setting up a serialisation system as we speak in the hope that this will be adopted as the European solution to meet the recent Falsified Medicinal Products Legislation. This is not a watered down version of the European legislative requirements, but what I believe is a full implementation based on international GS1 standards. This represents a significant change in position for the manufacturers and other supply chain partners (excluding Generics manufacturers) when compared to only a few years ago and appears to demonstrate their belief that serialisation is here to stay and has significant value.
The fact that serialisation is happening and companies need to establish their own strategy and plans to manage it was also evidenced by other legislative information presented at the event and the experience of implementation activities that was shared by large and small companies alike.
A “serialise and authenticate”, or “book-ending” model, as legislated for in Europe and elsewhere is significantly simpler than the “track and trace” models currently in legislation such as California’s and others. However, it is clear that Legislators in certain jurisdictions such as California feel that they must have “track and trace” in order to be able to stop illegal activity.
There is a great deal of behind the scenes activity going on at present to agree a US Federal Bill on the subject of serialisation. Theoretically, this will pre-empt California’s legislation.
Understanding the emerging legislation and translating this into timely implementation action continues to be a challenge for all companies.
As many speakers demonstrated, learning how to implement efficiently and effectively is a journey for all organisations and takes many years. Whilst it is developing, the supply base is not mature, standards are not embedded and therefore solutions need to pieced together from a number of component parts. All of this adds to the complexity, cost and risk of implementing solutions.
We are heading towards another Y2K if we are not careful. Therefore companies need to understand how they are going to avoid becoming victims of the almost inevitable lack of capacity in the market place to provide expertise and solutions as we approach the enforcement dates of the major pieces of legislation across the globe.
Some other highlights
California Board of Pharmacy
CBOP’s Virginia Herold made it very clear that the dates for the California Legislation are holding and reminded a list of manufacturers that the reason the dates had been delayed previously was that they had signed up to the new dates. This is all subject to a Federal level pre-emption of course.
Camilla Kent Hanson from EFPIA gave a great presentation emphasising three key messages from EFPIA:
- EFPIA is building a system to meet the European legislation
- Any system needs to be governed by the stakeholders
- Any solution needs to be cost effective
We were also reminded of the learning from the EFPIA pilot which was completed in Sweden a couple of years ago and is the foundation for their proposed solution.
Other European solution activity
We were reminded that EDQM and securePharma are both planning pilots in Europe as well.
Bob Celeste of GS1 US announced or reminded us of the following information which will be available from them.
- Various pilot/implementation learning reports – available now
- Paper on inference – available now
- Stanford University/GS1 methodology for sampling to ensure adequate accuracy of aggregation – available later this year
- US implementation guide – available in the summer
Aerospace are apparently looking to Pharma to help them prevent counterfeit parts activity.
I hope you found this useful and please feel free to contact me at Stephen.firstname.lastname@example.org to discuss any questions serialisation you may have or issues you may be facing.