EU Falsified Medicine Directive

Getting ready for EU Directive 2011/62
The forthcoming EU directive on falsified medicines is prompting action across the entire pharma industry. Gabriela Gregor, product manager Pharma at Avery Dennison, explains how the directive affects medical packaging and explores some of the ways in which pharma companies can comply.

What the European Commission identifies as ‘falsified medicines’ have become a familiar and growing threat over recent years. That threat extends far beyond intellectual property violations – and the use of the word ‘falsified’ (rather than the alternative ‘counterfeit’) reflects the seriousness of the issue. Not only are brand reputations and profits at stake, but patients are exposed to unacceptable risks. Falsified medicines can contain poor quality ingredients and/or incorrect doses, and can either fail to treat a condition or actively damage patient wellbeing.

The full scale of illegal trade is hard to assess, but the global value is estimated at around £1 billion in 2017, with a potential annual death toll of something like a hundred thousand people.* Responses to the challenge posed by falsified medicines have therefore been growing too. 

In Europe, an original legal proposal was put forward by the European Commission in 2008. Directive EU 2011/62 was established to ensure that patients could be confident that they were receiving authentic products. The directive reinforced an existing trend in the pharma segment: for many years, brand owners and converters have paid increasing attention to safeguarding both customers and brand reputations. However, the new formal regulations now in place mean that brand owners and packaging converters must now offer solutions that are fully compliant. Around eight thousand packaging lines are currently being upgraded as a result.*

Directive EU 2011/62 requirements
EU Directive 2011/62/EU, article 54(o), applies to all prescription and some over-the-counter medicinal products.  It requires outer packaging to reveal any tampering, from February 2019. The directive mandates a number of requirements, with Article 54a relating particularly to safety features in packaging. There are obligations on wholesale distributors, and on people who are authorised or entitled to supply medicinal products to the public. Manufacturers and other stakeholders must implement the requirements in most European countries. The European Economic Area (EEA) members and Switzerland are also implementing the directive. Belgium, Italy and Greece have a delay until 2025, due to ongoing current implementation of a similar serialization requirement. 

For medicines subject to prescription, those in the supply chain must ensure:

  • Product authentication: verify authenticity by assessing overt, covert or forensic devices

  • Product identification: identify individual packs

  • Product integrity: verify whether the outer packaging has been tampered with. For non-prescription medicines, individual packs must be identifiable.

The Commission left open the precise nature of authentication/anti-tamper measures to be employed. It required that delegated Acts implemented in 2015 should set out characteristics and technical specifications of all measures, with due consideration to cost effectiveness. The Acts also set out lists of affected medicines.

Finding the right solution
Protection measures must take into account the current capabilities of counterfeiters. Many fake medicines are now very difficult to distinguish from the real thing, and resisting the falsified medicines threat depends on two key factors: creating something what will be difficult for a counterfeiter to reproduce; and making sure that the solution will be easy to understand and use for wholesalers, retailers and patients/consumers of medicines. The question of tampering is also very significant. A properly designed labelling solution must show immediately whether or not a medicine’s package has been opened or interfered with.

Finding the right solution for a particular product has to reflect a range of issues including product type, product value and production volumes. Avery Dennison is an advocate of ‘layering’ when designing security measures, with measures that complement each other and achieve the desired level of protection. Self-adhesive labels and seals are an especially flexible option, because they allow a very broad range of measures to be designed, often with several protection methods working simultaneously. Low-level anti-counterfeit technology can be made visible to the patient/consumer, and high-level security features can employ a covert or forensic technology, so brand owners can protect any medicine, no matter what its value or intended use.

Any measures for non-prescription drugs must not reduce shelf impact, and the use of self-adhesive labelling allows strong visual messages to be communicated including intricate designs and complex die-cuts. For prescription drugs, subject to much more stringent directive requirements, self-adhesive seals open up many possibilities for safety and brand protection. Such labels safeguard original products very effectively, and show counterfeiters that there is no practicable way to create a fake.

Protection for every product
The range of brand protection label technologies offered by Avery Dennison is extremely versatile, including overt, covert and forensic security solutions:

  • Entry-level security features use security papers, holograms, threads, tamper-evident labels and VOID labels

  • More advanced protection uses custom solutions such as holograms, UV fluorescent prints, and microprint.  Options also include threads with microprint, colour shift inks and UV print

  • Ultimate high-end protection employs personalized security features, such as infrared detection and forensics. Unique components are incorporated into a label, allowing products to be identified and tracked.

A new Tamper-evident Seal range has also been designed to reduce packaging falsification in the pharmaceutical industry. Newly formulated adhesive S779P performs well on most varnished cardboards, making it more difficult to interfere with cartons and enabling easier compliance with the EU directive.

Click here to download the Pharma Security product overview.

* Source: Euromonitor International and internal assumptions.

The information in this article is for guidance purposes only and should not be regarded as a substitute for taking legal advice on the “EU Directive on Falsified Medicines” (Directive 2011/62/EU).