On the other hand, I proposed a track and trace system three years ago that relied on third-party repositories and subscriber contracts that specified things like high availability, disaster recovery and service level agreements. At that time, no one really liked the idea because the concept of a distributed pedigree that relied on something like discovery services still had a lot of appeal to most people.

I think the concept could work with the right kind of contracts, but I’m suspicious that the cost would be prohibitive because of the high cost of a major data loss or connectivity problems.

Dirk.

Thank you for another thought provoking article. I have been thinking over the pedigree law and the point that pedigree information is actually part of the product itself. This reminded of the Electronic Funds Transfer (EFT) Act, which requires “banks” to respond and resolve consumer issues within a defined timeframe and quality.

http://en.wikipedia.org/wiki/Electronic_Funds_Transfer_Act

Initially when PayPal started up, it ran into some difficulties in being compliant with the act. Since it had to overcome some hurdles that the traditional players had a good handle on. But overcoming those challenges enabled it to be the de-facto online financial transaction facility.

How about if traceability solution providers guaranteed access to Traceability information, under an act similar to EFT? For example, there can be Availability Certification programs that service providers can subscribe to and would ensure that their solution is in compliance with the EFT.

So each supply chain participant would host the entire pedigree that it is holding over their own EPCIS and the industry Discovery Services. Access control to this information is made possible thru standard interfaces and in compliance with the regulation.

This approach would enable traceability further down the chain beyond the packaged products [, while protecting trade secrets via auxiliary services such as identifier anonymizers.] As well as having the ability to be extended up the stream to consumers, via smart medicine cabinets, which can participate and assist in performing surgical recalls.

Are there cases where the pedigree information owner is not known when the goods leave the custody of the shipper? For example with distribution channels and 3rd party service providers. I am asking this since the product itself and its e-pedigree information could travel on different channels.

Best Regards,
Ali

Thanks.
Dirk.

Daniel

There are quite a few manufacturers who appear to be interested in applying RFID tags on their cases and pallets, but there are still a sizable number who appear to be planning to use only barcodes due to the cost difference. This makes it logistically impractical to track cases through non-owner points.

Also, the owners of drugs in the supply chain (and regulators too, for that matter) will resist providing non-owner handlers of the product with any of the item-level details of the container contents, including aggregation information. For this reason, non-owner handlers (couriers, delivery companies, trucking companies, etc.) would not be able to perform the practice of item-level inference and that will seriously complicate the ability to track drugs through these points. Remember, pedigree regulations focus on tracing the items, not the containers.

So, to me, what you are suggesting may be true in theory, it is probably impractical.

Would you agree?

Dirk.

But “Track” is not mandated by any law so it can have wide variation in the adoption model. No company is compelled to participate in “Track”. In fact, most of the data needed to properly track drugs through the supply chain will be owned by wholesalers. A workable adoption model for “Track” in a serialized pharma supply chain will have to acknowledge that ownership. There is no guarantee that such an adoption model will be developed or widely deployed because “Track” is fully voluntary. Therefore there is no guarantee that GS1 Discovery Services will actually result in the potential benefits of Track that I listed, including diversion detection.

Dirk.