According to the World Health Organization, over 920 Substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products have so far been reported.I These products are manufactured in all regions of the world. In response, regulation in many different countries has led to the adoption of serialization as a means to track and trace pharmaceutical packaging through the supply chain from manufacturing to the point of dispense. The Falsified Medicines Directive (FMD) in Europe and Title II of the Drug Quality Security Act (DQSA), known as the Drug Supply Chain Security Act (DSCSA), are two examples of a required serialized program.
Traditionally, serialization has been used to “…improve the accuracy and efficiency of internal and/or business to-business (B2B) transactions.”II This use was by no means intended to secure or help authenticate the products being bought or sold. However, because most large-scale pharmaceutical companies already used this tool to store and transfer product data, creating item-level identification or mass serialization was viewed as a solution to securing, then tracking those items through the supply chain.
This process is generally accomplished through radio-frequency identification (RFID) or a two-dimensional (2D) barcode. This means that serialization is not only used to transfer and inventory goods, but also to verify their authenticity in order to remedy product integrity issues and protect patient safety.
This technology is also being increasingly used to foster consumer engagement. In this respect, the unique, serialized identifier on pharmaceutical packaging allows brand owners to not only verify the authenticity of pharmaceutical packaging, but also to interact with consumers to drive brand loyalty.
According to a recent whitepaper, “…there are now over forty countries that have issued guidelines for the pharmaceutical industry whereby a serialized barcode is either currently mandated or soon will be on individual medicinal products.”III But some industry experts have voiced concerns over the promises and potential of this system.
Tim Marsh of Supply Chain Security Partners questions the security of the data and data carrier (RFID, 2D barcode) on the individual item. Because the transaction of information requires using “open and globally interoperable standards,”IV that exchange runs the risk of falling in unauthorized hands or being improperly disclosed. Moreover, because the data carrier is visible, it is also inevitably more vulnerable to forging and hacking.
Marsh also raises questions about the reliability of the verification database as it is often in proprietary hands and therefore susceptible to HaaS, or Hacking as a Service. In this scenario, anyone with a computer and the right skills could potentially break into the system.
By contrast, Marsh views serialization as a “component” of the anti-counterfeiting strategy, not a cure-all. He takes on a more layered approach to security, preferring combining multiple anti-counterfeiting measures to preserve packaging integrity and patient safety.
For Avi Chaudhuri and Jim Lee of Systech International, serialization is “failing” in the consumer products sector specifically for five reasons. To start, there are issues with implementation.V Adding an additional visual element to product packaging impacts design work, the printing process, and cost.
Another issue raised is that of adoptionVI, the difficulty of educating consumers about the presence of the code, then getting them to interact with it. This issue leads to a larger question of whether or not consumers should in fact authenticate products, as this type of interaction “leads brand owners into unknown waters.”VII
If the serialized program is adopted, who then owns the consumer engagement?VIII Does the technology company responsible for the serialization also drive the digital marketing campaign? This duality may lead to role conflict, if these tasks are not executed by two separate vendors.
The most common issue raised however is that of security. Like Marsh, Chaudhuri and Lee find that serialized barcodes can easily be replicated or take consumers to fake websites, which represent “an unacceptable risk.”IX
The risks outlined above therefore far outweigh the benefits of mass serialization. The valueX of deploying serialized products is simply not high enough to justify enabling item-level serialization, the additional cost, and the potential risk to the consumer.
I Substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products, World Health Organization, Retrieved 10 April 2017
II Marsh, Tim (25 September 2015). Product serialization: The ease of falsifying serialized codes, SecuringIndustry.com, Retrieved 5 March 2017
III Chaudhuri, Avi; Lee, Jim (2016). Serialization Reality Check: Where are all the numbers? Systech International, Retrieved 5 March 2017, p. 3
IV See Reference 2
V See Reference 3, p. 4
VI See Reference 3, p. 5
VII Inspector-Led Authentication is Here to Stay (and Better Than Ever), Authentix, 2017, p. 4
VIII See Reference 3, p. 6
IX See Reference 3, p. 8
X See Reference 3, p. 8