Sweden will host EFPIA serialisation project

The European Federation of Pharmaceutical Industry Associations (EFPIA) has selected Sweden as the location for its much-anticipated pilot project aimed at verifying the identity of pharmaceuticals at the point of dispensing.

EFPIA’s plan is to add a 2D data matrix code carrying the product code, batch number and expiry date, as well as a unique serial number, onto each medicine pack which will be read automatically at the pharmacy counter using a simple optical scanner.

By identifying any duplication of data on packs at the point of dispensing, the pharmacist will be immediately alerted to the possible existence of a counterfeit product, according to Dr. Jean-Marc Bobée (pictured), director of anti-counterfeiting strategy at Sanofi-Aventis, who chairs the project.

Other benefits will include fighting reimbursement fraud, making sure patients receive correct product which is still within shelf-life, and making recalls more efficient, he told delegates at the Logipharma Europe 2009 meeting in Geneva recently.

Bobée said the pilot project will include 30-50 Swedish pharmacies and get underway in August, taking three to four months to complete. It is expected that around 100,000 coded packs will be dispensed over the course of the pilot, with the code carried on a adhesive label and containing the data matrix as well as a serial number in human-readable form.

EFPIA is launching the project in part to try to bring some sort of conformity into the use of mass serialisation for medicines, particularly with regard to the codes used across Europe. Some form of international standardisation within Europe will be required to avoid wasted investment in backing the ‘wrong’ standard.

That is no easy feat. At the moment there are at least 10 different codes in use across Europe, Bobée pointed out, with the most widespread at the moment being the 13-digit GTIN (Global Trade Item Number) code structure developed by standards company GS1 (see map).



Moreover, four countries in Europe – Belgium, Italy, Greece and Turkey – have already launched mass serialisation of medicines with the addition of their own unique identifier numbers in addition to the national product code, while a further two countries – Spain and Serbia – are working on legislation that will bring this in.

“The picture is very fragmented,” said Bobée. “That increases manufacturing cost, complexity and supply chain differentiation across the European market.”

To try to harmonise efforts, EFPIA is putting its weight behind the GS1 GTIN code carried within a standard serialised data matrix (ECC200), a variant of the GS1 EAN 128 standard that is already adopted in 17 EU countries. A further 10 countries use an EAN-compatible code structure.

Meanwhile, for a number of countries such as France which have adopted their own serialisation code it may be possible to create a so-called ‘pseudo-GTIN’, in which the various national codes are incorporated within the GTIN code (see below).



The 2D data matrix including the GTIN code will be affixed to each item-level pack in the pilot programme at the time of manufacture. The codes will then be read at the pharmacy in a verification step prior to handover of the medicine to the patient.

No need for e-pedigree

EFPIA has stopped short of implementing a full track-and-trace or electronic pedigree (e-pedigree) project, with packs scanned at each point in the supply chain (e.g. at distributors and wholesalers).

Bobée said EFPIA decided rather to implement an end-to-end verification model because a full e-pedigree was much more complex and expensive to implement, largely because of the multitude of logistical practices and software systems being currently used between EU member states, and “is not necessary to adequately protect patient safety.”

In fact, EFPIA is pushing the European Commission to amend the text of its proposed legislation on counterfeit medicinal products - part of the ‘pharmaceutical package’ announced last December, and do away with what it refers to as ‘uninterrupted traceability’ as this could imply that an e-pedigree is required.

To make an e-pedigree system workable will probably require the combination of 2D data matrix codes with RFID tagging, which Bobée believes is “unreliable and very expensive,” at 20 to 40 euro cents per tag versus 0.1-0.3 cents for a data matrix code.

RFID has its own standards problems, he pointed out. Interference with metals and liquids means that the effective read rate is less than 100 per cent and there are also concerns about RFID's compatibility with biologic drugs and vaccines.

However, Bobée conceded that RFID could have a role at the case or pallet level, rather than at the pack level, and in this setting RFID brings additional logistical benefits such as inventory management. For now though the use of 2D data matrix provides an easy route to traceability and verification of product without precluding the later adoption of RFID.

[Ed: This dual approach has been used with some success in the EU-funded BRIDGE project, which will be covered in detail in a future article on SecuringPharma.com.]

The relative uniformity of healthcare delivery in Sweden was one of the reasons behind the selection of that country for the pilot, said Bobée. All pharmacies in Sweden use 2D barcode readers, although not all are compatible with the ECC200 format selected for the pilot at the moment and EFPIA will have to fund the supply of some scanners. Moreover, Swedish pharmacies all use the same software - called ApoDos - for handling stock and inventory, and this will make implementation easier.

Looking to the future, Bobée said the next step is to work with national governments and the European Commission to agree on harmonisation of product codes across Europe, promote the adoption of 2D data matrix and bring into place a commitment that pharmaceutical companies adopt data matrix and mass serialisation within a specified timeframe.

He also reiterated EFPIA’s call for a blanket ban on repackaging medicines, something which was expected to be included in the pharmaceutical package but was left out of the December draft.

EFPIA will make an official presentation of the pilot project at its upcoming annual meeting on 13 to 15 May, at which it is expected that the vendor partners for the project will be announced.