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Security Implementing security solutions to keep consumers safe

riven by increasingly complex supply chains, a lack of enforcement capacity, the

Serialisation is the system of tracking,

expansion of ecommerce and more sophisticated counterfeiters and counterfeiting methods, the US Food & Drug Administration estimates that approximately 10 per cent of all pharmaceuticals currently sold globally are illicit and this figure is continuing to grow. To address this threat, a number of anti-counterfeiting measures have been identified by pharmaceutical companies and governments alike, and are now being implemented around the world. In 2011 the European Parliament and

Council of the European Union created the Falsified Medicines Directive (FMD) which formally recognised the public health threat posed by counterfeit pharmaceutical products. The Directive raised the profile of counterfeiting in the industry and explicitly stated that solutions such as tamper verification and serialisation were to become mandatory - requiring changes throughout the supply chain, from data management to packaging. These changes must be implemented by February 9, 2019, as required by the Delegated Regulation. As a leading global provider of packaging

and authentication solutions, Essentra advocates applying multiple measures to provide enhanced security; these include tamper verification solutions, security features, and serialisation measures. Tamper verification solutions are vital to instantly allow the consumer to identify if the drug they are going to consume has been previously opened or interfered with, providing a first layer of security. This could take the form of a label that leaves a void message or a carton that has glued locks. Security features can provide an

additional layer of protection and, while may not be mandated by governments, can help brands further protect themselves from counterfeiters. Such features are often classed into three categories. Overt technologies enable instant authentication through visual inspection, and most commonly feature holographic devices and colour-shift inks. Covert solutions, such as microtext and microscopic tagging, rely on technologies such as infra-red and ultra- violet inks and are dificult to detect without specialist equipment. Finally, forensic features, which include molecular markers and biological tracers, offer a further layer of authentication and can be identified only with laboratory equipment.

34 November 2016

tracing and verifying products via unique identification codes. These codes reveal a complete history of the drug and can take the form of a linear barcode, 2D barcode or a combination of numbers. Irrespective of the format, the code will convey key information about the drug contained in the box: for example, the FMD states that manufacturers are required to print the drug’s product code and serial code of the unique identifier on the packaging in human-readable format. Furthermore, if required by the Member State where the product is intended to be sold, the outer packaging must state the national reimbursement number or national number identifying the medicinal product. These data elements allow for confirmation of the integrity of the medicine and ensuring that the patient’s product is reliable.

THE ABILITY TO IMPLEMENT CHANGES However there still remain a number of challenges for pharmaceuticals to overcome in order to implement an eficient serialisation system. Firstly, a uniform system must be put in place that meets the requirements at each level of the supply chain. This may require existing suppliers within the supply chain to invest in new IT systems, databases and business structures, which can be both expensive and administratively challenging. Plus the creation of the required serial codes themselves will call for significant expenditure, particularly when additional

elements are included. The more complex the structure of the serial codes, the more dificult standardisation will be across all companies across the supply chain.

TRACK AND TRACE SYSTEMS ARE KEY With so many different codes and suppliers to manage, Essentra believes that the key to the implementation of a successful serialisation system is data management and the control of data integrity. The process of track and trace will mean that every point within the manufacturing chain will have to carry out a ‘stop-check’, resulting in the collection of a large amount of data. Each individual unit will have a unique identifying code and, once printed, this code must be recorded and tracked from supplier to consumer. The monitoring and organisation of this vast amount of information can be demanding, so companies and governments must work together to create an effective data management system. It is clear that pharmaceutical companies

and governments must collaborate to protect consumers from the threat of counterfeiters. Implementing various levels of solutions, including both track and trace serialisation and tamper verification features, pharmaceutical companies can confirm that their products are authentic and have not been altered by counterfeiters. Though introducing these solutions will be costly, the benefits to the consumer are great.

Protection against counterfeit products: D

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