Mary Murphy is a consultant at MM Associates, Quebec, Canadia Road, Battle TN33 0LR, UK. Tel. +44 1424 777 783 Fax +44 1424 777 761 meamurphy@lineone.net

Mary Murphy

In a bid to fight counterfeit drugs, pharmaceutical manufacturers are turning to more advanced methods of security, focussing on areas such as packaging, which is invariably the first line of defence. This article highlights some of the issues regarding fake drugs and examines some of the techniques manufacturers can use to beat the counterfeiters. 

There can be little argument that packaging is at the forefront of the fight against counterfeit drugs, which currently costs the industry between 6-10% of the value of pharmaceutical sales. According to IMS Health, the figure is approximately $22 billion from global pharmaceutical sales of $364 billion. To set this in context, counterfeiting of all goods costs $200-400 billion annually, claims the Global Anti-Counterfeiting Group. According to the the US Pharmaceutical Manufacturers Association, it can take an average of $250 million and 10 years to legally develop and market a drug, but it is possible for a counterfeiter to 'reproduce' a product within a couple of months for as little as $250000.		

According to David Williams of pharmaceutical consultancy Calico Associates: "Counterfeits are products sold that do not contain the stated active or are relabelled out-of-date genuine products. Even a generic version of the same drug sold under a false label is considered a counterfeit as it is not the same product manufactured by the company specified on the label. Some consider parallel imports a form of counterfeit." The most important question is what effects are these counterfeit drugs having on patients?				

Although counterfeiting is spread throughout the world, a considerable proportion of the activity is in Asia and Africa, where up to 50% of pharmaceuticals may be fake. It is, therefore, important that manufacturers admit that there is an issue and take active steps to counter this threat. Because packaging is the first thing that physicians and patients see, it must form the first line of defence. 	

Security products are available to use in formulated pharmaceuticals; however, this is usually a covert approach and may be of little use to users who cannot see it. Before any device is used, manufacturers must develop a security strategy that they are prepared to work with and invest in. Methods of protecting the packaging include		

Covert inks (fugitive, thermochromic, photochromic). These are easily printed onto most packaging components and provide initial identification.

Overt holograms as labels or as part of blister foils. Holograms of this type can contain very detailed forensic information, but it is not easy for consumers to distinguish whether they are genuine or not. Additionally, they can be expensive. 

Radio frequency identification (RFID) tags with encoded information. These are becoming increasingly popular and can be company-specific if the volume justifies it. They are also relatively easy to identify in the market place.

Materials, such as unique boards or label stock, can be a lower cost option depending on the amount of material used. These are used mainly as a forensic tool.

Coding, such as dot matrix or barcoding. Includes one-off marking that contains fixed information and may be of benefit in intelligence gathering.

Although these methods are appropriate within a well-developed security strategy applied to a given pack and product combination, it must be emphasized that simply using the latest device does not guarantee security.	

One major aspect that must also be considered is how will the product user know what is a secure pack? And, who will use the security device -the user or the forensic laboratory? Despite much of the intelligent packaging used in the pharmaceutical and health care industries being shrouded in secrecy, it has enormous breadth ranging from electronic article surveillance (EAS) tagging for retailers through RFID supply chain management to the use of smart inks and laminates, as discussed in Pira International's report The Future of Intelligent Packaging. 		

For laminated films, packaging companies such as Alcan Packaging, Hueck Folien, Teich and VAW are developing a variety of security features. These include clearly visible features (such as holograms, watermarks, guilloche patterns and metameric colour combinations); hidden information technology (reagent inks, luminescence, microtaggants, photochromic/thermochromic inks, IR inks, melier fibres, planchettes and molecular structures); and microprinting and optically variable inks (OVI), and colour-shifting inks. Fluorescent inks, which are only visible under UV light, iridescent reflective features, holograms, and microtext and high-precision printing can also be used. When incorporated in a security system, they establish security barriers that offer high levels of protection. 				

Packaging combines a variety of materials ranging from paper and adhesives to more complex laminates and coatings. Blister packs, for example, may include several layers or types of synthetic or metallic materials, adhesives and coatings. It is possible to use layering technologies to incorporate several features in one pack. These can be a combination of both high and low security features which, when combined, create a profile that is more difficult to replicate. Even combinations of low security features may also deter counterfeiters.	

Hueck Folien has experience of combining several security elements (for example, in both the product itself and in the primary packaging) in such a way that the relationship is not apparent to anyone who is not directly involved in the product's security. For example, the company's Protecco range can combine security elements and, if necessary, interchange them, providing an advanced form of security that deters counterfeiters. Protecco has been used in Aventis' Novalgina; the banknote-type security features include a hologram printed in perfect register with the product name that is repeatedly reproduced across the surface of the blister pack. The combination is claimed to offer the highest level of brand and product protection, while at the same time the graphic gives consumers a higher level of perceived value, confidence and brand identification. 	

Holograms are the most popular overt tagging system and have the advantage of consumer confidence in the technology. Pacific Holographics' SpectraLock is a covert screen-reveal technology and decoding is undertaken via a film screen instead of an optical reader. It works by incorporating a word or character that can be invisibly incorporated into a holographic image and which is revealed when overlaid with a dot screen decoder. Suitable uses include second level product and document verification. The company has also revealed a new full coverage passport laminate that incorporates its SecureText technology.		

SecureText is embedded in a hologram to provide an additional layer of covert security. It is made up of nanotext, which can be up to 1000 characters per square inch. Users can choose what text they want embedded in the hologram, which is invisible to the naked eye. The new passport laminate will contain the nanotext incorporated into a hologram that is laminated onto a passport. 	

API Foils has revealed that its newly launched DieLESS Foil technology is suitable for use in brand protection applications in the form of secure holograms that contain variable data. The foil has been developed as digital package printing technology offering a cost-effective alternative to conventional printing methods. The combination of a customized foil and variable data included in the application would make it difficult to counterfeit and it is also highly visible, which can deter counterfeiters. API Foils is looking at potential markets for the new technology, including packaging, particularly heat-sensitive films. The technology could also be used for applying thermochromic and luminescent inks to packaging.	

The reflective surface of aluminium plays an important role when it comes to anticounterfeiting measures. For example Lawson Mardon Singen has developed a"pattern-shifting" process that is based on moire surface effects. It is particularly suitable for collapsible sachets and tubes. Other anticounterfeit measures rely on special coloured layers that cause colour-shifting when incident light is reflected by the surface of the aluminium foil. The laminate appears green or red depending on the angle of view.	

Regardless of how stringent the chosen security standard for a pharma-ceutical product might be, there is usually a complete system solution available that is economically attractive for the manufacturer. They rely on hidden information that is applied to a pack, such as an aluminium blister foil, via a high-precision printing process. They are developed specifically for the customer and are only visible using a decoder. The security concepts are subject to the highest levels of confidentiality, making it almost impossible for counterfeiters to crack them. 	

Covert security ink provider, InkSure Technologies, which already works with a number of pharmaceutical brand owners, has formed a partnership with the Sun Chemical Group to provide a new range of security inks to beat counterfeiters. SunSure inks will be embedded with unique codes that provide the ink with an individual fingerprint. The inks will be offered with a range of readers, including low cost hand-held devices and readers that can be installed at various points in the supply chain. 				

RFID is the use of small devices that store information and can be electronically identified at a distance using radio waves. It is expensive and suitable only for products of high-value or high-security. There is also concern that low cost RFID devices will not withstand gamma ray sterilization processes commonly used in the pharmaceutical industry.				

Among the new systems being developed is a line of DNA-embedded biotechnology products, from Applied DNA Sciences. The devices use a combination of DNA biotechnology and micromechanisms that create a DNA anticounterfeit chip. DNA is embedded into the chip, which can hold information such as product origin and date of manufacture. If the chip is sabotaged or removed from the host product it immediately stops functioning. The chip also sends out signals to a specially designed DNA reader - these are unique and will not work if the chip is removed from its casing.	

The company says it has developed the new chip because traditional circuit chips have become liable to sabotage. DNA structure is much more complex and, therefore, much harder to replicate. Given that prospective growth for intelligent devices within the pharmaceutical industry is forecast to grow to E99 million by 2007 from the current level of E22.6 million, pharmaceutical companies will need specific personnel if they are to get the most from their security investments. 	

As this article highlights, product security is not a simple issue with simple answers. 	

Anti-Counterfeiting, Brand Protection and Security Packaging for Pharmaceuticals - Strategic Quantitative Forecasts and Expert Insight is available from Pira International. Contact Rav Lally on T. +44 1372 802 271, F. +44 1372 802 079, E. 		

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Articles

There can be little argument that packaging is at the forefront of the fight against counterfeit drugs, which currently costs the industry between 6-10% of the value of pharmaceutical sales. According to IMS Health, the figure is approximately $22 billion from global pharmaceutical sales of $364 billion. To set this in context, counterfeiting of all goods costs $200-400 billion annually, claims the Global Anti-Counterfeiting Group. According to the the US Pharmaceutical Manufacturers Association, it can take an average of $250 million and 10 years to legally develop and market a drug, but it is possible for a counterfeiter to 'reproduce' a product within a couple of months for as little as $250000.