As disturbing levels of counterfeit drugs percolate the market, Diethard Schaefer, global key account manager, Schreiner MediPharm, discusses some of the countermeasures available to manufacturers
Product security in the pharmaceutical industry is becoming increasingly important. Regulatory requirements, patient protection and the growing incidence of product piracy call for decisive action. The specific objectives and security requirements of pharmaceutical corporations are as varied as the technological means available to address them. That is why successful product protection solutions have to be based on in-depth analyses and custom-tailored concepts.
Questions such as how to combine overt and covert security features and to provide effective protection for a drug throughout its life cycle are of crucial importance. Systematically answering them before deciding on a specific course of action is a key prerequisite for viable brand and product protection solutions.
Legislators around the world are in agreement that drug safety - and thus drug security - is of paramount importance to protect the health of citizens. Although regulatory requirements may vary among countries, there is a general trend toward tighter controls in the area of drug security. As a result, manufacturing and distribution processes as well as other product security requirements are now being defined in greater detail. This has the advantage that manufacturers merely need to implement relevant provisions without having to invest in complex and costly in-house analysis and selection processes.
However, despite these advantages, it is important to ensure that regulatory requirements do not unnecessarily restrict a manufacturer's freedom of action, but leave enough room for a company to pursue its own business strategy and objectives.
According to expert estimates, every tenth pharmaceutical product currently being traded anywhere in the world has been illegally produced and distributed. As a result, manufacturers of original products around the globe suffer losses in sales in the range of b35bn a year, and the upward trend continues. In many threshold countries, this situation is particularly alarming, as up to 70% of the pharmaceuticals being sold there are outright fakes or products of inferior quality.
Even economically advanced nations are affected. Germany, for example, is the only country in the European Union where prescription drugs can be ordered from Internet pharmacies without a prescription. The consequences for consumers and manufacturers are disastrous: test purchases revealed that the ratio of counterfeit products was as high as 50%.
Patient protection is of paramount importance and can be assured only if pharmaceuticals can be clearly identified as original products by patients as well as physicians and pharmacists. In addition, technical product protection is a strategic cornerstone of any brand protection programme. It safeguards the manufacturer's claim and standard of quality, from production all the way to the end consumer, and makes it easier to identify illegal practices within the distribution chain.
litigation risk
In the area of product liability it is crucial to provide forensic proof of authenticity. A manufacturer that is unable to distinguish an original from a fake in litigation runs a high risk of becoming a victim of unjustified liability claims, particularly in cases tried in the US, which can result in huge financial losses.
There is a wide range of viable technical solutions available, from overt, easily discernible security features and covert special markings all the way to proof of authenticity that qualifies as evidence in a court of law. Tamper protection features can also be added to indicate that a product pack has been opened after it was originally sealed. This makes it possible immediately to detect any damage to or contamination of the product and prevents the undetected exchange or repackaging of drugs by criminals. For individual batches or product packs, a track & trace system can be installed. It enables seamless monitoring of the distribution chain and frustrates attempts illegally to exchange original products and to introduce fakes.
Every security concept starts with a comprehensive analysis to identify what requirements and functionalities are to be met. What target groups are supposed to be able to authenticate the product? What security level will effectively address the concrete threat? Three different security levels (see Figure 1) provide the basis for a systematic approach.
The smooth integration of the labelling solution in the manufacturer's production process is another key criterion to be considered. In the final step, the specific security requirements and the relevant technical frame-work as well as economic aspects are balanced against each other to create a concept tailored specifically to the manufacturer's needs. It combines various overt and - if necessary - covert features in a unique way and dramatically raises the technical hurdles for counterfeiters.
Technical solutions include special labels with several overt and covert security features. They can be combined in various ways to ensure extremely reliable authentication. Customer-specific designs of holographic strips with 2D/3D effects, dynamic structures, and micro- or nano-text are just a few examples of available options. In addition to being difficult to copy, they enhance the product visually and can even increase the stimulus for consumer purchase.
Another overt feature that can be used is special colour-shifting inks such as those known from banknote printing. These inks appear in different colours, depending on the angle of light. Each colour sequence is exactly defined, issued only once anywhere in the world, and centrally managed by trust centres.
The colour combinations are read by specifically developed readers and assure reliable identification. Within a matter of seconds, the authenticity of a product can be verified automatically. As colour-shifting inks are extremely durable, they enable the authentication of a product even several years after printing.
The use of thermo-reactive print enhances product security as well. Despite the fact that thermo-reactive features are semi-covert, they are effective eye-catchers. The print changes its colour upon contact with body heat, for instance when being touched by a finger. This special experience actively involves the consumer in the product authentication process.
The addition of covert features takes product security to an even higher level. For example, digital watermarks in conjunction with special UV luminescence effects may be integrated in the product identification label. This system has been successfully used as covert copying protection in banknote and bond printing. The concealed contents can be made visible by means of a special filter.
optical fingerprints
Reliable product authentication can also be achieved by using laser pigments. They are embedded in the label and remain invisible until being hit and reflected by a pre-defined laser beam. Taggants that are odourless as well as colourless and otherwise invisible represent an even more advanced evolutionary step in the fight against product piracy. These special pigments can be used to integrate an optical "fingerprint" in the security solution that can be detected only using a spectroscopic reader.
Combined, these security features deliver maximum counterfeiting protection. The security concept makes it possible for laypersons to authenticate products and also provides proof of authenticity for forensic purposes within an extremely short period of time.
For even greater security, a modular tracing solution with Key-Secure numbering, for instance, enables web-based global tracking and tracing as well as authentication of pharmaceuticals. The patient simply enters the printed 15-digit number code provided with the product and is immediately informed by the encrypted website whether the drug is an original or a fake. The unique data matrix code on the label can be queried at any stage of the distribution chain. This enhances security and establishes a dialogue with the consumer that can be used for complementary marketing communication purposes.
Security labels can also be equipped with RFID tags. These can be programmed to perform numerous functions and are suitable for establishing an intelligent track & trace system.
No matter how sophisticated and effective a particular security technology may be, counterfeiters can be expected ultimately to find a way to copy it. Hence it is crucial for the industry always to stay a step ahead. Of paramount importance in this endeavour are concepts that - in an intelligent way - match innovative security features with the knowhow of the individuals performing the authentication as well as with the manufacturer's requirements. This leads to customised, comprehensive solutions that confront even professional counterfeiters with insurmountable obstacles. When the investment required to create a high-quality copy exceeds the potential profit, there is no more incentive to fake the original product.
What is more, the required investment in viable security solutions is reasonable and pays multiple dividends. System solutions for brand protection not only safeguard a manufacturer's sales and earnings, but also provide protection from unjustified warranty claims and maintain consumer confidence and brand loyalty, help systematically to detect vulnerabilities in the distribution chain and can be used as an integrated marketing tool for customer retention purposes. Consequently, manufacturers who actively shape their product security benefit from the availability of a wider range of strategic tools and add value to their business over the long term.
