As manufacturers await the implementation of the falsified medicines directive, Nadine Lampka product manager, pharma-security at Schreiner MediPharm examines the state of play.
Counterfeiting
The countdown has started: The EU requirements for protecting medicines against counterfeiting will become mandatory in three years’ time. Consequently, pharmaceutical manufacturers are preparing to meet these requirements with variable marking and sealing of their sales packs, and seeking innovative solutions to safeguard the pharmaceutical supply chain. But beware of misunderstandings: product marking is only secure if, in addition to a 2D code, products have counterfeit-proof authenticity features. Only a combination of DataMatrix code and anti-counterfeiting technologies can comprehensively protect a product against fraud, misuse and counterfeiting. Ideally, authenticity features should be selected so that both consumers and specialists are involved in the authentication process.
Counterfeit medicines are a common threat and an international challenge to all stakeholders involved in the pharmaceutical supply chain. The World Health Organisation (WHO) estimates that in industrialised countries up to 7% and in developing countries 30-70% of all medicines are fakes. As the profit margins are clearly higher than those generated with drugs such as heroin or cocaine, global counterfeiting syndicates are increasingly involved as well. All forms of administration are affected, such as tablets, infusions, injections, ointments and solutions, whether or not they require medical prescription. This poses a major risk to the safety of patients. Counterfeits are particularly wide-spread in developing countries in Africa and Asia, as a result of the growing number of internet pharmacies. Using diverse methods, fraudsters either circumvent the legal distribution chain or take advantage of its complexity to channel in products that have been falsified in terms of their identity, ingredients or origin.
Large number of unreported cases likely to exist
For instance, counterfeiters using increasingly professional methods produce detailed copies of medicine packs and fill them with ineffective, harmful and even toxic imitations. More than a million people around the world die of the consequences every year, according to Interpol. In 2015, for example, German customs investigators confiscated 150,166 counterfeit medicines worth €1.01 million, equating to a 26% increase compared to the year before, although German customs authorities actually check only 2% of all goods at the time of being imported. Counterfeiting affects the entire product range of the manufacturers and all forms of sale, from online and wholesale distribution all the way to the pharmacy. Thus, effective actions for counterfeiting protection should always be based on a holistic approach to product and patient safety. This requires strategic security management on company level in the respective pharmaceutical manufacturer’s operation.
Enhancing security of the supply chain
By means of EU Directive 2001/62/EC, the so-called Falsified Medicine Directive (FMD), legislators and pharmaceutical manufacturers intend to safeguard the supply chain in Europe. Since February 9, 2016, a three-year transition period has been in effect to implement EU Regulation 2016/161, which concerns protecting medicines from counterfeiting. The delegated act from Brussels supplements the Falsified Medicines Directive 2011/62/ EU by technical and organisational details pertaining to the required security features. Effective February 9, 2019, every manufacturer must provide prescription medicine packs with an individual serial number in the form of a 2D code (DataMatrix) and a tamper protection feature. Thus, patients shall be protected against falsified medicines. As the requirements set out in the valid version have been known since October 2 2015, the roadmap for those who need to take action is clear. The level of the counterfeiting risk determines whether or not a medicine has to be provided with these security features.
Serialisation plus authenticity feature
Serialisation by means of 2D codes, as required by the EU Directive, opens up additional opportunities to the industry. It controls internal logistics processes more efficiently and offers clear identification of every individual medicine pack. However, further actions are necessary to convert an easy-to-copy serialisation code into an authenticity feature for effective verification. Deep industry knowledge combined with specialised know-how in materials and printing technologies are prerequisites for developing tamper protection and anti-counterfeiting solutions for the pharmaceutical industry. Effective security solutions for diverse threat scenarios can be divided into three categories: Firstly, a label may clearly indicate first-opening and tampering. Secondly, integrated technologies of various security and detection levels provide effective protection against counterfeiting. Last but not least, track and trace system solutions serve to identify and trace products, and thus indicate gray market activities. All functional components can be customised and combined with each other. This results in complex security labels that effectively put a stop to the counterfeiters’ game and offer a wide range of added value to the pharmaceutical company.
Overt features for intuitive checks
Overt features enable fast authentication by sellers, pharmacists and consumers without any extra tools. Optically variable holograms, for instance, are based on microscopically small, diffractive structures in the film layers, which make the feature unique and thus achieve a high level of counterfeiting protection. Pharmaceutical manufacturers increasingly complement this feature by security colour-shifting inks. Providers of professional solutions rely on specialty inks that may only be used by security printing companies. Manufacturers achieve a particularly high protection level by combining these colour effects with special printing techniques, “latent images” or thermo-reactive inks. Overt features are typically used for allowing laypersons to perform intuitive checks, but require detailed knowledge of the authenticity features. Here interactive, digital technologies can be helpful as well and make information about the security feature’s properties accessible to the end user for verification.
Creating a fingerprint
Ideally, holistic counterfeiting protection should always consist of a combination of overt security features with digital and covert technologies.
Covert features from high-security printing are suitable for checking customs inquiries, for pharmacovigilance or for complaints. For this purpose, manufacturers integrate specialty pigments into the packaging or label. Only a special detector can prove the presence of these pigments during authentication. These robust and colourless markers can be invisibly incorporated into any design and implemented using diverse techniques. A customised formulation with an invisible “fingerprint” represents the highest level of counterfeiting protection, as it can neither be copied nor seen.
Digital security features use computer-generated and highly encrypted encodings as human-readable numbers, 2D codes or special random patterns to enable Internet-based authentication in the pharmaceutical supply chain all the way to the end user. In addition, digital technologies offer direct interaction between the product and the person performing the check, and can thus serve to provide information and to support promotional activities. However, due to the possibility of copying them, numbers and encodings alone are not counterfeit-proof. Companies should therefore always combine them with additional features. Copy protection patterns, for instance, provide clear proof of authenticity with a high-resolution, cloud-like printed image. Its delicate details are not discernible by the naked eye and, for technical reasons, a reproduction by counterfeiters is impossible at this level of resolution and will automatically result in a loss of printing quality. These variations can be clearly identified with handheld readers or smartphones and respective software, exposing them as a copy.
Qualification and implementation process
The requirements of the EU Directive to enhance the security of medicine packs meet with proven technologies on the manufacturers’ side. An analysis of the threat scenario and the product to be protected, as well as the development of an appropriately adapted security strategy, provide an important basis for selecting the security technology best suited for the respective task. However, the subsequent qualification and implementation process should not be underestimated. In addition to the high complexity involved in the system integration of code printing, checking and acquisition, administration and transfer to a database, solution providers have to rely on established know-how of integrating anti-counterfeiting and tamper protection. The experts not only consider the technical requirements and the particularly high quality criteria of the pharmaceutical industry, but also the demands made on security manufacturing, warehousing and distribution. Tamper protection and anti-counterfeiting measures are tasks requiring comprehensive, in-depth security management. Thus, effective measures to protect products against counterfeiting should always be based on a holistic approach to product and patient safety.