WHO Recommendations on Anti-Counterfeit Technologies

Some time ago, the World Health Organisation and its International Medical Products Anti-Counterfeiting Taskforce (IMPACT), which aims at combating counterfeit medicines, published a document titled "Anti-counterfeit Technologies for the Protection of Medicines". The author of this WHO document is Mr Geoff Power, former Director, Packaging Security Global Quality Assurance, GlaxoSmithKline.

Today, many technologies are available that can be used by pharmaceutical manufacturers to fight the counterfeiting of medicinal products -  from very simple to highly complex systems.

The WHO paper broadly divides the anti-counterfeit technologies into four groups:

  • Overt, or visible features
  • Covert, or hidden markers
  • Forensic techniques
  • Serialisation/Track and Trace

The WHO paper deals in detail with all 4 categories, but does not want to give specific recommendations for certain products or suppliers.

1. Overt features help the end user to recognise the authenticity of a package. A typical example for this is the application of a hologram.

2. The covert features are meant to enable the pharmaceutical manufacturer to identify counterfeit medicines as such. These measures are, of course, not intended for the common public. For this purpose e. g. invisible printings can be used that can only be read under certain circumstances (under UV or IR light), invisible images that can only be seen with the help of a special filter, or digital watermarks invisible to the human eye.

3. The forensic techniques are among the technically demanding solutions, since they require specific laboratory tests or special test kits for the proof of authenticity of a medicinal product. Strictly speaking, these measures are a subset of the covert features. Examples for forensic markers are chemical taggants, biological taggants or DNA taggants.

4. For the pharmaceutical area, a number of track-and-trace technologies are being developed. This means that, during production, each unit is assigned a single and unique identity that is retained throughout the whole supply chain until this unit is finally consumed. This usually includes information on product name, strength, batch number and expiry date. In this way authenticity of the product can be monitored throughout the entire supply chain. Under this item, the WHO publication lists serialisation, bar codes (2D datamatrix code) and RFID (Radio Frequency Identity Tagging).

The complete WHO paper can be found here.

The author of this WHO/IMPACT publication is also a speaker at the University of Würzburg's international conference "Strategies against Counterfeit Medicines" taking place in Würzburg near Frankfurt, Germany, from 3 to 5 November 2008. Details of the programme can be found here.

Dr. Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

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