Reliable traceability, the fight against counterfeiting, compliance with European regulations; for Jean-Marc Bobée, director of the industrial anti-counterfeiting strategy with Sanofi and a member of the EFPIA* working group on drug codification and identification in Europe, the serialisation of prescription drugs is inevitable.
Towards European harmonisation
By 2019, the entire pharmaceutical industry in Europe must comply with the 'falsified medicines' directive 2011/62/EU "a Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source". To comply with this regulation, and to facilitate the detection of falsified products in the European Union, "companies operating in the pharmaceutical industry of all European states need to introduce a serialisation system with a control at the point of dispensation," explains Jean-Marc Bobée, "This system must be associated with devices allowing the inviolability of the packaging of all prescription drugs."
Patient safety first and foremost
Beyond regulation, patient safety is the main concern. Recognised by all countries in the world and universally applicable, serialised Datamatrix can not only improve traceability and assist governments to combat refund fraud, but also help fight against counterfeiting, which has become a real scourge over the past ten years. "Technological advances and their increasing accessibility are making counterfeiting easier and easier," says Jean-Marc Bobée, recalling also that, for a long time, falsifying medicines was more lucrative and less dangerous than drug trafficking ... Ensuring product serialisation and the tracking of these serial numbers can secure the supply chain and make the flow of products more reliable, within Europe’s borders and beyond.
A collaborative and responsible chain
The solution proposed by Europe is the introduction of the serialisation of prescription drugs (by the manufacturer) with systematic control at the point of delivery (Pharmacy or Hospital). This approach offers a compromise between the pursued aim of efficiency (ensuring patient safety) and cost control "it avoids rolling out the aggregation process between the serial numbers of the different logistics units, a process that incurs very high investments, and greater complexity for the manufacturers and distributors. The setting up of equipment necessary for this serialisation measure does however come at a significant cost".
For manufacturers, integrating serialisation means equipping packaging lines with Datamatrix tagging and reading systems, driven by dedicated software feeding a centralised database. Distributors for their part must set up tools to read and call up data, allowing regular control of products (returns for example). Finally, the pharmacist must also be equipped with reading tools capable of interrogating the centralised database to check that a) the serial number of the product exists, b) that the product has not already been sold or c) is the subject of a batch recall.
A need for robust systems
Costs aside, the implementation can be complex, especially for the manufacturer. "On high speed lines, for example, it is difficult to introduce serialisation without impacting production. In addition, the new system must be able to adapt to existing lines, each with their specificities. A flexible, robust and adaptable solution that can be rolled out across the board is essential," says Jean-Marc Bobée. Serialisation certainly implies costs and constraints in its implementation phase, but ultimately, it allows greater efficiency and, more importantly, it ensures the safety of the patient, which is, after all, the primary objective.
* EFPIA: European Federation of Pharmaceutical Industries and Associations