The EU Falsified Medicines Directive (FMD) Delegated Act states that wholesalers must verify the unique authenticity of products purchased from parties unrelated to the manufacturer, whether by scanning individual boxes or employing aggregation.
As a result, Santen Pharmaceuticals’ Frank Binder said implementing aggregation can increase shipment value, and speed up logistic processes.
For sales between such wholesalers, “that means opening all the boxes and scanning every pack. That is a lot of effort, and therefore money,” said Binder.
“Therefore, I conclude that a non-aggregated shipment is worth less than an aggregated one,” he said.
“We should get ready for the option of aggregation, because some important supply chain players may ask for it with a very loud voice,” he added.
Serialisation service provider TraceLink explained aggregation - which creates a digital relationship between case serial numbers and those of saleable units - tracks the outer container identifier, the identifiers of the inner units, and the quantity of those units.
“Having aggregation in place lets you scan a case’s bar code to get its serial number, and then use the aggregation relationship to infer the identity of all the contents,” which the firm said saves workers manually opening up and scanning every unit in a case.
Despite aggregation’s logistic and cost advantages, Binder said the method is complex.
“Serialisation is complex enough, but aggregation adds a whole new dimension,” said Binder, who said it begs the question: “Can we get around it? Or should we get ready?”
Complexity vs benefits
According to CEO of packaging services provider Tjoapack, Erik Tjoa, the advantages aggregation offers firms, such as improved speed and efficiency, outweighs outlay costs.
“While it’s true that introducing aggregation does increase the complexity and the cost of implementation, the resulting benefits such as faster passage through to market, longer term cost savings and additional supply chain security – for both patient safety and company reputation – should far outweigh the initial investment,” he told us.
Who is on board?
A poll held at Nexus 17 revealed many industry representatives were undecided as to whether their firms would adopt aggregation methods.
While 59% of guests said they planned to aggregate, 31% were undecided and 19% had made the decision not to aggregate.
These statistics were confirmed by delegates, who said the rate of aggregation adoption was so far unexpectedly low.
“Surprisingly few companies are requesting aggregation,” said Recipharm’s Erik Haeffler.
“Personally, I would have expected more,” he added.