Achema Messeguide 2012

A few industries have already set up organizations to combat product counterfeiting. The pharmaceutical industry is one of them. Few counterfeit products can have such serious consequences for consumers as imitation pharmaceuticals. Quite apart from the financial losses incurred by the companies involved, counterfeit drugs represent a danger to consumer health. The list of risks includes inefficacy, harmful substances and over or under dosage of the active ingredients. A few years ago in Africa, anti-freeze instead of glycerin was added to cough medicine, causing the deaths of several hundred people.

The World Health Organization (WHO) has created the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) which is attempting to bring nations together in an effort to stop the production, trade and sales of imitation pharmaceuticals. IMPACT is sponsored by international organizations, NGOs, law enforcement agencies, pharmaceutical trade associations, drug agencies and regulatory bodies. The list includes the Food and Drug Administration (FDA), WTO, the World Customs Organization (WCO), the World Intellectual Property Organization (WIPO), the European Commission and OECD. Taskforce Working Groups are addressing the legal framework, implementation and enforcement of regulations and anti-counterfeiting and traceability technology for pharmaceutical products, but no standardized worldwide solution is currently in place. One Working Group is looking specifically at international standardization of product marking. Until uniform worldwide standards are in place, marking technology suppliers are being asked to come up with anti-counterfeiting strategies.

Existing Identification Techniques

As is the case with any other commercial item, identification features on pharmaceuticals are used for product authentication and to deter counterfeiters. Identification methods which are difficult to reproduce create enormous difficulties for imitators, and the costs involved in making copies are considerable.

There is a wide range of identification techniques to choose from, ranging from very simple to high-tech. Identification features can be added in different places including various parts of the packaging or on the product itself.

Anti-counterfeit identification technology is divided into three main categories:

  • Overt (open/visible) technologies
  • Covert (hidden) technologies
  • Forensic techniques

Overt marking provides basic product identification information for consumers, knowledgeable professionals and customs agents. It is generally highly visible on the product. In the case of pharmaceuticals, the marking is applied to the vial or folding carton, and imitating it is difficult and costly. Examples include holograms which may contain customer-specific designs. Optional hidden features which are admissible as evidence in court provide added counterfeit protection. Color shift ink as well as security ink and foil which change color depending on the viewing angle belong in this category. The ink and pigments are only available from certain manufacturers, which is an additional security aspect. Marking on the product itself, for example a tablet, is an overt technique. It provides a certain level of security, because imitating tablet dies is costly and time consuming. In addition, color shift ink can be applied directly to products such as coated tablets to produce changing colors. This provides protection against product substitution later on. Slanted corners or similar features can be added to the packaging to differentiate it from standard versions.

Security graphics created by printing fine lines, micro text or images similar to what you see on banknotes combine overt and covert design features such as guilloches, grids and line embossing. Printed using standard offset lithography, they may be used as a background or placed in a less conspicuous location. Overt features only provide protection, however, if dealers or consumers are aware of their significance.

Partially hidden markings straddle the boundary between overt and covert technologies. Examples include thermo-reactive printing which changes color as a function of temperature. Pressing a finger on the color field is sufficient for immediate authentication.

Knowing Where – Hidden Product Validation Identification

Hidden markers are used among other things to enable brand owners to identify counterfeit products and remove them from circulation. Only the manufacturer should actually know the exact details of the markings. Consumers either do not notice them or are unable to verify their authenticity.

This marking category includes such things as printing with invisible ink which can be applied to virtually any product or packaging. The printing is visible under UV or infrared light and may fluoresce at different wavelengths and in different colors. Invisible images, which only appear when a special filter is used, can also be produced. Other options include the use of special fluorescent fibers, watermarks, metal threads, scents or chemical reagents in the product packaging.

The printing can also be designed in such a way that it cannot be copied. Background patterns made of very fine lines look like plain color surfaces, but an image that was not previously visible appears when the patterns are copied or scanned.

Application of digital watermarks is one of the more complex methods. To verify authenticity, readers and special software are used to recover data which is digitally encoded in the watermarks. Laser coding is also complex and cost intensive, but that is precisely what makes it a very secure type of anti-counterfeit identification.

High-tech Methods Provide Almost Total Security

Strictly speaking, forensic identification belongs to the covert category. Special equipment is needed to detect the markers which are not visible to the naked eye and cannot be found using simple analysis techniques.

This category includes various types of taggants. Chemical taggants and marking with isotopes in defined ratios, which can only be detected with highly specialized reaction and analysis techniques, are one example. Biological and DNA taggants are another possibility. Minute amounts added to the product formulation or packaging are sufficient for identification. Highly sophisticated analysis equipment is needed to detect these substances. Forensic markers such as micro taggants made of microscopic particles or threads which contain encoded information require an equal amount of effort to detect.

These markers are very effective, but they are also very expensive and consumers are not aware of them. They are primarily intended for extremely expensive pharmaceuticals and high-end products which counterfeiters often target. When imitators are at work, an effective method is needed to remove imitations from circulation.

Rather than relying on just one type of identification, a combination of different overt and covert technologies is often used. To make life as difficult as possible for counterfeiters, manufacturers do not reveal which methods they are using.

Traceability at Any Point in the Supply Chain

Track & trace techniques have been used for years to mark and/or serialize products to ensure authenticity and provide traceability of batches and packages as they pass through the distribution channel.

Despite, or perhaps because of, the fact that these methods have been in use for so long, there is as yet no standardized worldwide approach to documentation. One simple solution is autonomous recording of product movements at each point in the supply chain. Electronic pedigree systems are another option. Serial numbers are passed along the supply chain, creating a distributed database containing electronic proof of origin. When complete end-to-end verification is implemented, each segment of the supply chain has an obligation to forward the product codes to a central server. The location of every product can then be determined no matter where it is, and the movement of goods can be traced after the fact using information which is available at a central location.

Whatever the method, every product must have a unique identifier, e.g. product name, batch number and possibly the expiration date. Additional product details, for example the distribution channel, can be included when the encoding is more complex. Making the coding or serialization more specific (e.g. pallets, cartons or individual packages) enhances the security of product authentication.

A number of identification techniques are available which provide varying degrees of anti-counterfeiting protection:

  • Barcodes
  • 2D codes
  • RFID tags

Linear barcodes have a proven track record, and they have been in use worldwide for many years. However, they can store only a limited amount of information, and they are hardly suitable for product individualization.

The information density of 2D codes is even higher. Information is encoded in stacked barcodes, a rectangular matrix made up of individual pixels (e.g. QR codes), or circular barcodes (e.g. ShotCodes). Matrix codes in particular are used worldwide, and they can be scanned with CCD cameras. Nevertheless, matrix codes are not standardized either. Quick-response (QR) codes are very popular in Japan, whereas data matrix codes as defined in ISO/IEC 16022 are more widely used in Europe and the US. However, there are fewer matrix code versions compared to barcodes. Matrix codes are more suitable for international product identification which is standardized, unique and traceable. RFID (radio-frequency identification) works with transponders. Special readers extract the information and may write data back depending on the version.

Printing techniques which are now available for producing the transponders make them much less expensive than they were just a few years ago. Nevertheless, they are still relatively expensive compared to barcodes and 2D codes. The equipment needed to read out the information is also generally more expensive than barcode scanners, etc. The tags can be located inside sealed packaging for added product protection. However, RFID tags are not standardized worldwide and operating frequencies may vary.

In addition to the traceability aspect, track & trace also helps to identify weaknesses in the logistics chain. Cost can be eliminated by increasing the efficiency of the distribution channel.

No Agreed Method for Identifying Pharmaceuticals

The FDA already recommends the use of RFID tags, at least for identification of pharmaceuticals. The experts at IMPACT also see considerable potential in RFID technology. However, until the technology has reached a sufficient stage of maturity, they currently favor 2D codes which have a proven track record.

The European Union is currently working on standardized identification for pharmaceuticals. Directive 2011/62/EU of the European Parliament and the Council defines the information which must appear on the outer packaging of pharmaceuticals which in the future will have to have certain security features which allow verification of the product‘s authenticity and which prevent manipulation of the packaging. 2D codes are regarded as the most likely method of identification. Information such as a unique, randomized serial number, batch identifier, expiration date and Pharmacy Product Number (PPN) could be stored in the code.

Following the test phase for technical implementation of product serialization which has been underway since December 2010, mandatory security features will be introduced in 2015. Matrix codes and a central database will provide the foundation for end-to-end verification. The extent to which consumers will be involved in the verification process is not yet clear. In any case, state-of-the-art communication devices such as smart phones give consumers new ways of detecting counterfeit products.

Apart from specific identification techniques, there are other ways of making secure packaging. Besides the methods discussed above, the list of options includes sealing labels and adhesive strips which prevent tampering or provide evidence that the packaging has been opened. These items can also be used as warranty seals, security labels or asset labels.

Summary: Intelligent brand protection systems can deter counterfeiters if imitation of the identification/marking is made impossible or very costly. These technologies can also help clarify what is happening in the distribution and logistics chain and contribute to supply chain optimization. Suppliers and developers of these technologies will put their security systems on display in Hall 3.0 at Achema 2012.

Facts for Decision-makers – For Operators

  • The marking can range from very simple to high-tech in different places such as the various components of the packaging or the product itself with physical or chemical markers.
  • Counterfeiters have to adapt to new coding solutions, which are sometimes hidden attached to the product, which generates huge long term costs.
  • Labelling strengthens customer confidence and protects against unjustified warranty claims.
  • Tagging mechanism allows to understand and optimize the distribution and supply chain.

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