Mass visible serialization; i.e mass serialization with visible tags is not working for product authentication. Here we explain why.

Why serialization of medical products has been introduced?

According to the World Health Organization: over 920 Substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products have so far been reported.

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.

Two examples of a required visible serialized programs are:

  • The Falsified Medicines Directive (FMD) in Europe
  • Title II of the Drug Quality Security Act (DQSA), known as the Drug Supply Chain Security Act (DSCSA).

 

How the use of serialization evolved over recent decades

  • Operational efficiency

Traditionally, serialization has been used to “…improve the accuracy and efficiency of internal and/or business to-business (B2B) transactions.” This use was by no means intended to secure or help authenticate the products being bought or sold.

  • Product authentication

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.

Serialization is usually 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.

  • Customer engagement

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.” But some industry experts have voiced concerns over the promises and potential of this system.

 

Why visible serialization does not work for product authentication?

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,” that exchange runs the risk of falling into 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  (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, by no means 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.

 

5 main reasons why visible serialization does not work:

For Avi Chaudhuri and Jim Lee of Systech International, serialization is “failing” in the consumer products sector for 5 main reasons.

  1. Implementation
    • adding an additional visual element to product packaging impacts design work, the printing process, and cost.
  2. Adoption
    • the difficulty of educating consumers about the presence of the code, then getting them to interact with it.
  3. Customer involvement in the authentication process
    • 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.”
  4. Consumer engagement
    • Does the technology company responsible for the serialization also drive the digital marketing campaign? This duality may lead to conflict in roles, if these tasks are not executed by two separate vendors.
  5. Security
    • Like Marsh, Chaudhuri and Lee find that serialized barcodes can easily be replicated or take consumers to fake websites, which represent “an unacceptable risk9.”

 

Conclusions

Serialization with visible codes is clearly not sufficient to ensure product authentication. Mainly because tags such as RFID or barcode can easily be replicated. This brings risks which far outweigh the benefits of mass serialization with visible easy-to replicate tags. The value of deploying such technologies is simply not high enough to justify enabling item-level serialization, the additional cost, and the potential risk to the consumer.

In conclusion, product authentication requires more secure, multi-layered methods.

 

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