For over a year, the European Federation of Pharmaceutical Industries and Associations (EFPIA; Brussels) has been touting a demonstration project that it is sponsoring to establish the feasibility of item-level production identification inside the European Union. At the upcoming May annual meeting of the organization, the wraps will be taken off the project. But EFPIA representatives are already describing the general parameters of it in some detail.
The project has considerable significance for the European pharma industry (as well as wholesalers, retailers and payors—who tend to be national governments). At the time that EFPIA settled on using 2D Datamatrix barcode as the identifier, the US was still tentatively moving forward with product identification based on RFID technology. Last fall, a commission within the EU released a “Pharmaceutical Package” that, among other things, called for industry to address the growing problem of counterfeit products circulating within the EU. In addition, a longstanding bone of contention between the industry and the national governments has been the allowance for parallel trade—permitting the importation of lower-priced products from one nation in the EU into other nations where prices are often higher.
Use of product identification technologies doesn’t itself prevent or enhance parallel trade, which the EU, as a supranational organization, is emphatically in support of. But it does create the possibility of a greater degree of control over how products are distributed, which in turn might give the industry some leverage in dealing with parallel trade.
At another level, the EFPIA project is simply “where it’s at” for the vendors, system integrators and trading partners concerned with anticounterfeiting technology and track-and-trace systems. Since US track-and-trace regulations have been postponed to 2015, only a few organizations (but there are a few!) are still working on track-and-trace implementations. Winning vendors could have a leg up on future project work; for sure, how the demonstration project actually operates with set some of the technological features of future systems.
Let’s go to Sweden
But the vendor selection is not yet publicly announced by EFPIA. According to EFPIA sources, what is known is that the demonstration project will take place in Sweden, involving some 50 Swedish pharmacies that already make use of a form of barcode-reading technology for order processing. The pharmacy order-management systems there make use of an IT system from Apoteket AB, a Stockholm distributor, called ApoDos, that manages prescription deliveries to patients.
The specific 2D barcode standard that will be used is the ECC200 standard, which is “derived from” GS1 EAN 128 standards. The system will operate with what has been called a “book ends” approach, in that products will be coded at the manufacturer (or, potentially, recoded by repackagers) and then authenticated at the point of dispensing. This is contrasted with the US approach involving pedigree information that gets passed from one trading partner to the next, and in theory protects against diversion or counterfeiting up and down the supply chain.
Initial implementation steps of the demonstration project are already being undertaken, and the project is scheduled to start up during Q3 of this year. Some 100,000 packages will be run through the system, and then it will shut down and an assessment performed. PC