Avery Dennison - Business-friendly compliance

Ricardo ten Velden, global segment director, pharma and healthcare, materials group, explains how Avery Dennison offers the technical support teams and breadth of product options needed to stay ahead of the counterfeiters while controlling costs.

The 'EU Directive on Falsified Medicines' (Directive 2011/62/EU) was published in July 2011. It reflects an increasingly complex distribution network for medicinal products, with many different players - and a pressing need to ensure reliability across the entire supply chain. As a result, harmonised safety features across the entire EU are on their way. The European Commission formally adopted the delegated act on safety features for medicinal products in the first week of October 2015. When the delegated act is published in the Official Journal of the European Union, it will become mandatory three years from that date - late 2018 or early 2019. Manufacturers and other stakeholders will then have to decide on and implement a range of different safety features. It means new responsibilities for wholesalers and brokers, with written confirmation needed for active pharmaceutical ingredients manufactured outside the EU and logos for legally operating online pharmacies.

Obviously, the more layers of security a brand-owner applies, the more resistant a product is to counterfeiting, pirating or diversion. A decision on appropriate measures will need to take into account commercial and regulatory requirements. Above all, due diligence to protect a brand is vital. Security is an investment that directly impacts the bottom line, safeguarding brand reputation and shielding a brand-owner from potential liabilities if a counterfeit product results in patient injury.

Layers of protection measures have to be designed with an awareness of the current capabilities of counterfeiters. The question of tampering is also very significant, and a properly designed labelling solution must show immediately whether or not a medicine's package has been interfered with.

Avery Dennison is an advocate of 'layering' when designing security measures. Self-adhesive labels and seals allow a very broad range of measures to be designed, often with several protection methods working simultaneously. Making use of low-level anti-counterfeit technology that is visible to the consumer and also high-level security features using a covert or forensic technology allows brand-owners to protect any medicine, no matter what its value or intended use.

For non-prescription drugs, the use of self-adhesive labelling allows strong visual messages to be communicated, including intricate designs and complex die-cuts. For prescription drugs, self-adhesive seals open up many possibilities for safety and brand protection. Such labels safeguard original products very effectively, in ways that are not available via folding box gluing, and show counterfeiters that there is no practicable way to create a fake. Indeed, self-adhesive technology offers much more flexibility in manufacturing as glue does not like stop and go, especially when the machine has to stop longer for a format changeover. Furthermore, the glue technology is a dirty process that requires more housekeeping. Beside manufacturing flexibility, self-adhesive offers a unique combination of tamper evidence and authentication features that no other technologies can deliver. Several anti-counterfeiting technologies employed by brand-owners are shown below.

Overt technology

This level of protection is visible to the naked eye and allows the brand to be authenticated without the need of a special inspection tool. Overt technology offers only basic protection.

Covert technology

Covert technology gives advanced protection with hard-to copy security features and some level of personalisation. These security devices are not visible to the naked eye, but can be detected using an inspection device such as a UV light, magnifying glass or plastic film overlay. The type of tool depends on the specific protection technology used.

Forensic technology

Forensic security devices are invisible to the naked eye. They require laboratory analysis for authentication. An example is the use of DNA taggants, which provide a forensic chain of evidence recognised by courts globally. To make the taggants, large botanical DNA is segmented, shuffled and reassembled to form a unique secure signature DNA marker. IR taggants are uniquely associated with the brand and cannot be counterfeited, digitally copied, scanned or re-engineered. There are potential pitfalls on the way, and effective deployment depends on cooperation between the brand-owner, the label converter and the materials supplier.

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