IAA welcomes new law’s focus on authentication features

Moves to promote the benefit of the latest anti-counterfeiting safety features and more vigilant inspection of pharmaceutical packaging to check for evidence of tampering have been welcomed by the International Authentication Association (IAA).  

The IAA was commenting on the European Parliament’s adoption of the Falsified Medicines Directive, which is set to become law later this year after the EP vote on February 16. 

The Directive is a major step in the right direction, says the IAA, which is particularly encouraged to see its mandate for the use of authentication and safety features hand-in-hand with improvements in inspection of packaging throughout the supply chain. 

The IAA is concerned at the increasing incidence of counterfeit or falsified medicines and says the Directive will provide greater clarity in the definition of falsified medicinal products, specifically distinguishing them from other illegal products and infringements of intellectual property rights.  

In particular, the Directive’s emphasis on the incorporation of ‘safety features’ to verify the authenticity of medicines and to identify individual packs is an encouraging move, as is the requirements for features which will show whether the outer packaging has been tampered with.  

The IAA advocates increased pressure on those distributing or handling medicines to examine the safety features more closely to determine whether the medicine is genuine or has been tampered with. 

Its own guidance to users of authentication products – the ‘safety features’ mentioned by the Directive – recommends that users adopt a more holistic and strategic approach to the selection, application and examination of authentication features.  

Co-chair of the IAA, David Howard, who is also global director of product protection at Johnson & Johnson, says the new law will be important in the battle against pharmaceutical counterfeiting, which is on the increase around the world. ‘Historically, some users have simply adopted an authentication feature without paying adequate attention to how and by whom it will be examined. 

‘Now, the Directive is particularly welcome as it recognizes the importance of not only having a safety feature but ensuring that it is correctly examined. 

‘IAA members are experts in the authentication field. Many are already supplying authentication methods for medicines, and they are the best resource for national agencies and pharmaceutical companies to turn to as they seek to comply with the ‘safety feature’ requirements of this proposed EU Directive.’  

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