Europe - International hologram body welcomes New EU Directive

International Journal of Health Care Quality Assurance

ISSN: 0952-6862

Article publication date: 19 July 2011




(2011), "Europe - International hologram body welcomes New EU Directive", International Journal of Health Care Quality Assurance, Vol. 24 No. 6.



Emerald Group Publishing Limited

Copyright © 2011, Emerald Group Publishing Limited

Europe - International hologram body welcomes New EU Directive

Article Type: News and views From: International Journal of Health Care Quality Assurance, Volume 24, Issue 6

Keywords: Pharmaceutical counterfeiting, Healthcare quality improvement, Patient safety

The International Hologram Manufacturers Assn. (IHMA) welcomes directive to strengthen pan-European anti counterfeiting laws.

The EU Falsified Medicines Directive is set to become law this year, ensuring that a definition of “falsified medicinal product” is provided to clearly distinguish falsified medicinal products from other illegal products, as well as from infringements of intellectual property rights.

Furthermore, it will distinguish those products with unintentional quality defects resulting from manufacturing or distribution errors from ones that have been deliberately falsified.

The IHMA says that statistics paint an alarming picture when it comes to pharmaceutical counterfeiting, not only in developing markets, but also in mature ones.

The World Health Organisation estimates that up to 25 per cent of the medicines consumed in some developing countries are counterfeit or substandard and that annual earnings from the global sales of fake and substandard medicines exceed $32bn.

Glenn Wood, US media representative for the IHMA, said any move to tackle the global rise in pharmaceutical counterfeiting has to be seen as positive. “This is a critical time for those involved in tackling counterfeit pharmaceuticals. Counterfeits are on the increase with confiscation at borders or during enforcement raids on the rise not only in developing countries but also in the US and in other developed nations.

“The EU Falsified Medicines Directive has to be seen as a welcome move and, along with other global initiatives, will undoubtedly play a vital part in the constant battle to stem the flood of counterfeit drugs and help producers stay one step ahead of the criminals”.

Holograms can now combine authentication overt features with covert elements and forensic and track-and-trace elements to provide a weapon in the fight against illicit products, said Wood. And they can be used as seals, labels, or as the foil in a blister pack.

He added that there are examples of how holograms provide a successful and vital detection function in pharmaceutical anti-counterfeiting strategies.

Many branded medicines have a hologram on the pack or in the blister pack, and a few years ago Malaysia introduced its Meditag® serialised hologram label to be found on all registered medicines – traditional and Western – that has helped the Ministry of Health inspectors to detect unauthorised and counterfeit product.

“The evolving anti-counterfeiting role of holograms lies in their ability to combine authentication with detection”, said Wood. “And sometimes pack enhancement, as Rodotex GmbH has shown with its packaging for Vitamin C+Kollagen in Indonesia. This is why enlightened pharmaceutical companies and enforcement agencies continue to make them an integral part of modern anti-counterfeiting strategies”.

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