MANUFACTURING |
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Authenticity, tamper
protection
and tracing of
genuine products
for the
pharmaceutical industry
Thomas Völcker, Schreiner ProSecure
In many respects product piracy is like a modern-day plague that has begun to infest virtually all sectors of the economy. Its preferred targets are products of relatively high value where the lower costs of producing and selling a fake do not immediately betray its illegal origin nor its inferior quality, and the sales price achieved by the product pirate make the criminal proposition particularly lucrative.
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Add other encouraging factors like complex, often world-spanning supply chains that facilitate the introduction of fakes, or product packaging that is easy to copy or tamper with, and the industry – or individual manufacturer and brand owner – exhibiting such vulnerabilities becomes a prime candidate for attack by product pirates. At least some, if not all of these factors apply to pharmaceuticals and hence they have long been an attractive target of counterfeiters and grey or black marketers. The scope of the problem has recently been exacerbated by the spawning of offshore internet-based pharmacies around the globe, enticing consumers to buy drugs of often dubious origin at cut-rate prices.
Only an authentic drug is a safe drug
While governments have traditionally considered the protection of their citizens from unsafe food and drugs an area of literally vital importance, the respective legal requirements and enforcement policies and practices in the past were focused primarily on assuring the safety of original products manufactured and commercialised by legitimate producers. In recent years, however, lawmakers and regulatory bodies at national and international levels, including the World Health Organization (WHO) with its International Medical Products Anti-Counterfeiting Taskforce (IMPACT), have shown increasing concern about the growing number of counterfeit pharmaceuticals hitting the market and their potentially disastrous consequences for public health, as well as the dramatic economic damage they inflict.
In May 2007, for example, the US Senate passed legislation with product authentication provisions in the pharmaceuticals sector and the EU heard from the European Federation of Pharmaceutical Industries and Associations (EFPIA) on proposed means to halt counterfeiting. No doubt the traditional definition of drug safety has acquired the additional dimension of drug security – or more precisely, security of the supply chain and chain of custody. But consumers, accustomed to their governments protecting them from “unsafe” drugs – for example, by requiring pharmaceutical manufacturers to perform exhaustive lab research as well as large-scale and costly clinical trials prior to approving a new drug – now also need to be made aware of the fact that “only an authentic drug can be considered a safe drug.”
Reluctance on the part of brand owners - five common misconceptions
The pharmaceutical industry itself has long been sensitive to the problem of large-scale drug counterfeiting and the resulting threat to consumer health, as well as business risks like major losses in revenues, product recalls, product liability claims and damaged brand image. However, encouraging exceptions notwithstanding, it seems that the industry has so far not embraced currently available authenticity, tamper protection or track & trace technology to the extent that is desirable and appropriate in view of the severity and scope of the problem.
Indications exist that this reluctance may at least in part be attributed to five common misconceptions about the viability of anticounterfeiting (ACF) technologies:
1. ACF technologies do not prevent counterfeiting
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Just a few examples are cited here to illustrate the point that ACF technologies have proved their effectiveness, particularly when used in combination with consumer education campaigns, law enforcement actions and penalties.
Global leaders like Nivea and Microsoft, for example, reduced the number of pirated products in certain segments by as much as 80% (Nivea, with shampoos in Russia) and 43% (Microsoft in Western Europe) within a few years. Pharmaceutical manufacturer CSL Behring was able to identify pirated products (blood plasma) due to security features in their protection labels. Jemella Ltd detected illegal distribution of their professional hairstyling products that enabled the company to identify the culprits and to “purge” its supply chain.
2. There are no industry standards and
no best
practices
The argument that there are no industry standards and no best practices can be countered as well, as there is general agreement among experts that anti-counterfeiting security must be based on the “best practice” of a “layered approach”. At the lowest level of security are relatively simple, overt features involving the use of holographic technology, void effects and colour-shifting inks that are primarily intended to provide immediately detectable tamper evidence as well as enabling product authentication by non-experts such as healthcare professionals, pharmacists and consumers.
At the next level (ie in the area of covert security features), there is a wealth of highly sophisticated technology available, including nanotechnology, micro-fonts, chemical markers and even DNA-based solutions. These can be combined with each other as well as with simpler, overt features. The intelligent combination of such technologies can achieve highly secure solutions. Key to their effectiveness is a careful analysis of the pharmaceutical manufacturer’s security requirements by an experienced security technology expert who then develops an integrated, tailor-made solution that best meets the needs of the client.
3. ACF technologies may be copied or compromised
Admittedly, the third notion that ACF technologies may be copied or compromised cannot be entirely disputed. As far as holograms are concerned, it is true that simpler versions in particular can be faked and that all holograms should be combined with other security elements. Covert or forensic features can hardly be copied, however, due to the high level of sophistication and technology involved. Similar to the techniques used in banknote and other value printing the technical hurdle to counterfeiters is in effect created by the skilful combination of various features.
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Banknotes in fact are a good example supporting the use of anticounterfeiting technology to stem product piracy in the pharmaceutical as well as other sectors. Just because counterfeit money continues to be put into circulation from time to time, nobody would seriously suggest stopping the use of security techniques to protect banknotes. By the same token, nobody in their right mind would advocate abolishing the police or fire brigade. It is in the nature of safety and security that neither is ever absolute but always relative.
4. ACF technologies are not affordable
Relative is also the keyword regarding the fourth misconception, ie that ACF technologies are not “affordable”. Apart from the fact that the costs depend on the level of sophistication of the technologies selected, and thus the level of protection provided, most brand owners would be surprised to see how much the security of their products (and supply chain) can be improved by a relatively small investment, even when using forensic features. In any event, a slight increase in product or packaging costs is a small price to pay in comparison to the constant loss of profit and the costs of product recalls, crisis management, liability claims and, last but not least, the repair of damaged brand image and recovery of lost consumer confidence.
What is more, the return on investment in anti-counterfeiting and tampering protection is even greater when such solutions are purposefully combined with additional functionalities that facilitate healthcare routines, like tamper-evident product identification labels with integrated hangers. A leading international pharmaceutical manufacturer, for instance, has been successfully using such a combined solution from Schreiner for infusion bottles containing a sensitive product exposed to a high risk of counterfeiting and tampering.
5. Nobody uses ACF technologies to protect products from tampering and counterfeiting
Actually, the fifth misconception “Nobody uses ACF…” has already been addressed above in conjunction with the alleged ineffectiveness of ACF technologies. As a matter of fact, Schreiner, for example, is currently working on over 35 security projects with the pharmaceutical industry worldwide. Schreiner ProSecure’s patented tamper-evident MultiSeal, for instance, is successfully being used by a leading producer of critical blood plasma products with global activities. The seal was customised to incorporate the pharmaceutical manufacturer’s corporate design as proof of product authenticity and provides tamper protection through an irreversible void effect that is triggered when the product pack is opened for the first time.
Tracking & tracing
In addition to the physical anti-tampering security of product packaging, the traceability of drugs is a vital element of securing the pharmaceutical supply chain. The US Food and Drug Administration (FDA) currently requires a bar code identifier of the manufacturer and product on “the lowest level of packaging” for prescription drugs while the European Federation of Pharmaceutical Industries and Associations (EFPIA) decided to recommend the use of Data Matrix on all medications in order to establish a single European symbology for identification purposes and as an anti-counterfeiting measure. GRIP, the Association of Pharmaceutical Full-Line Wholesalers, has also recommended the use of Data Matrix.
With a view towards electronic pedigrees (e-Pedigree) for pharmaceutical products, which may well become statutory requirements across the US and the European Union in future, there are a number of pilot projects currently underway (particularly in the United States) involving the use of RFID (radio frequency identification) technology. A different approach to serialisation, however, is currently being pursued by a UK based pharmaceutical manufacturer who, in addition to using tamper-evident seals, will provide each carton of its erosive esophagitis medication with a unique serial number encoded in data matrix.
Web-based authentication
Particularly for use by untrained consumers, Schreiner ProSecure has developed an easy-to-use yet highly reliable authentication technology, called KeySecure. The system allows pharmaceutical products to be authenticated anywhere in the world via the Internet or call centres by means of an encrypted tracing code.
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KeySecure provides each product with a unique, highly complex security code. The consumer enters the printed code at an internet website or calls a hotline. If a true code is entered (either directly by the consumer or the hotline operator), the system confirms authenticity, while entry of a false code – suggesting the presence of a fake product – will prompt a warning message on the PC screen. The system logs each product query and rejects multiple entries of the same code at pre-defined levels. Should unauthorised multiple queries be made, this would clearly indicate trafficking of fake pharmaceuticals. The web-based authentication system is based on a plug & play software platform. The enquiry template is run on the brand owner’s website, with the security hosting & decoding system supplied by ProSecure. The code can be printed or laser-engraved on primary and secondary packaging, embedded in numerical, barcode or data matrix. RFID applications are possible as well.
Summary
Securing the pharmaceutical supply chain and products is a challenging task. As varied as the threat itself are the means available to provide protection – for the consumer as well as the manufacturer. The key to a successful security strategy is a careful risk analysis, followed by the development and implementation of an integrated solution by an expert that leverages the best techniques and technologies currently available to deter, detect and avoid the criminal practices that jeopardise human lives and erode legitimate earnings.
Thomas Völcker, Dipl.-KFM
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Thomas Völcker obtained his masters degree in business administration from the University of Muenster in 1993. After starting his professional career in the product management with Kraft General Foods AG in Bremen, he worked in diverse marketing management positions for the Fasson Roll Division of Avery Dennison for seven years.
Since July 2001, Thomas Völcker has been driving innovations in product, processes and innovations as a director sales & marketing in the ProSecure business unit of the Schreiner Group in Germany. He is responsible for directing global marketing and sales activities for label-based solutions of brand and document protection.
Schreiner Group GmbH & Co. KG
Bruckmannring 22
85764 Oberschleissheim
Germany
Tel. +49 89 31584-5385
Fax +49 89 31584-5317
voelcker@schreiner-prosecure.com
www.schreiner-prosecure.com
