A sense of security

The growing proliferation of over the counter pharmaceuticals is making products accessible in more ways than one. While counterfeiting is a problem with serious consequences for prescriptive medicines, OTCs typically have fewer gatekeepers along the supply chain, leaving them particularly vulnerable to corruption.

Considering the billions ploughed into marketing these products, it is surprising that counterfeiting remains such an extensive problem to the industry.

According to the International Counterfeiting Intelligence Bureau, counterfeiting across food, pharmaceuticals and luxury goods is worth around 7% of the world's GNP. Research by Pira reveals that companies across Europe are losing an estimated £28-40bn to counterfeiting, while the World Health Organisation assesses 6% of pharmaceuticals worldwide to be fakes. In parts of Africa this could be as high as 50–60% and more than 25% in Latin America.

Incidences of counterfeiting are being further fuelled by the practice of diversion where the product is shipped from one country to another, re-packaged and then reshipped to the country of origin, usually at a higher price. While these may be genuine medicines, those involved in a diversion network may be in collusion with counterfeiters and so often genuine pharmaceuticals are mixed with counterfeit.

The Internet is also proving to be an invaluable tool for crooks. In June 2001, the US Food and Drug Administration (FDA) reported that it had come across 300-400 web sites selling prescriptive drugs. Many of these are likely to be counterfeit, out-of-date or contaminated.

"Considering the intensity of impact counterfeiting might have on consumer safety and lost revenue to pharmaceutical companies, you would expect the industry to spend a good deal of money on anti-counterfeiting measures. But that is not the case," says Keith Widdowson, head of Pharmaceuticals and Chemicals at De La Rue Brand Protection.

He puts this down to the conservative approach of the pharmaceutical manufacturers which have been reluctant to draw attention to problems with counterfeiting. "This has left them rather naïve and vulnerable to criminals who are drawn to the pharmaceutical industry because the price of products can be very high – some oncology medicines can be worth $1000 a month – and because packs are fairly easy to copy and distribute."

So far the approach has been more reactive than proactive, but a couple of drivers have come into play over the last two years which has seen a far more prolific adoption of anti-counterfeiting measures.

"Pharmaceutical companies have woken up to the realisation that they are not just selling products but brands that need to be protected," says Mr Widdowson.

At the same time, a number of recent high profile counterfeiting incidences in the US – which is home to 11 of the top 20 pharmaceutical companies – has made the FDA sit up and take notice of a problem that was perceived to be happening elsewhere.

Finally, the balance is beginning to shift from a reactive to proactive approach with the introduction of specialised teams in drugs companies employed to focus on security solutions.

Closer working relationships with the manufacturers and security solution providers mean that it is now becoming easier to strike the right balance between the value of the product and threat of attack.

When advising companies on anti-counterfeiting measures to suit their applications, Keith Widdowson says defining the problem is key. "Adding lots of technology is probably just a waste of money unless you are fully aware of the nature of the problem you are facing – is it tampering, diversion or counterfeiting or a mix of these?

"When we [De La Rue] talk to a company we ask what issues they know about and what are the incidences and risks? But we often find that issues that the company did not know about arise out of discussions on the kind of products that are being targeted, which regions they are being sold into and how they are being sold."

Budget, of course, is a major deciding factor when considering anti-counterfeiting solutions. The difficulty in monitoring how much revenue is lost through counterfeiting makes it notoriously hard to calculate how much money to spend on brand protection. De La Rue encourages some lateral thinking on how much is spent on legal fees, test-piloting and branding which tends to help justify spending that bit more in order to get a cost benefit in the long run. The advantage of most anti-counterfeiting solutions is that they can be incorporated into manufacturing lines.

In terms of choosing a solution, Mr Widdowson says it is advisable not to rely on only one security feature, believing that a holistic approach based on a layer of solutions provides the most effective protection.

The current main areas of anti-counterfeiting fall into the categories of overt and covert solutions, of which De La Rue supplies both.

Overt solutions are designed to assure the supply chain and end user that the product is genuine. They include optical variable devices (OVDs) such as holograms that may take the form of a secure label, over-wrap or tear-strip, while offering the added protection of tamper evidence. Thermochromic inks and threads which change colour when rubbed with a finger along with barcodes have also become popular devices.

On their own these are considered to provide a low level of protection as they rely on the awareness of the consumer to look for the security systems and their visibility can leave them vulnerable to copying. However, origination techniques in OVDs are being constantly advanced to make duplication harder with ordinary printers and scanners through the use of proprietary stereograms and dot matrix technology combined with the traditional 2D and 3D systems.

Having started life as a secondary packaging solution, there have also been some major developments to bring OVD technology closer to the product it is to protect. This year Applied OpSec, which offers a range of OVD solutions, launched a holographic blister pack that features a secure optical image that can be overprinted with logos and graphics. It follows the introduction of optical transfer films incorporating OVDs that can be transferred onto heat sealable aluminium using the same platen sealing blister machinery used in the production of conventional blister packs.

Light Impressions International also offers holographic pharmaceutical foils that can be applied to blister packs and branded with the company logo.

Covert solutions provide a deeper level of protection to primary packaging by being invisible to the naked eye. They also carry advantages to brand owners who want to hide the fact that anti-counterfeiting measures are being employed.

Types of covert technology include secure packaging substrates that feature fluorescent fibres scattered throughout the paper and which glow when viewed under ultraviolet light. Similarly, taggant technology has been developed using tagging materials such as inks, magnetics and chemicals that are invisible until machine reading equipment is applied. The idea is to limit the number of people with the technology to read a taggant.

It is when these systems are teamed with overt solutions that security levels can be really stepped up. For example, a unique number that might feature on an overt security label might be replicated in UV ink hidden until passed under a UV light. Getting as close to the product as possible is likely to drive future developments in taggant technology and there are already some advances in applications onto blister packs and bottles.

A purveyor of OVDs that can offer both systems is US based Kurz Transfer Products. Its patented Trustseal system is used as a hot-stamp foil, offering tamper-evidence and a seal cap. At the same time it can provide covert and overt protection levels – including serial numbering, tamper indicators, nanotext, hidden images, partial demetallisation and machine verification. Kurz additionally produces 2D, 3D and dot matrix holograms.

The use of digital watermarking in pharmaceutical applications is an area of covert solutions currently under development. It involves software technology that can digitally produce images containing hidden information such as codes that are then applied during the printing process and can only be read by certain scanners.

So far the problem with digital watermarking in relation to pharmaceutical products has been that a pack requires an image with suitable detail and resolution to hide the code. As most prescriptive packs tend be on the bland side they have not presented adequate opportunity. However, if the trend in branding continues, particularly for OTC packs this may change.

Dotrix, the Belgium-based digital printing solutions company formed out of Barco Graphics in 2001, is one company working with different digital watermark producers to develop suitable solutions for the pharmaceutical sector. Although there are no existing pharmaceutical applications, Dotrix believes it has found a development that overcomes the problems surrounding images. In theory, such a development could be combined with the Dotrix SecuSeal system which is an overt solution based on complex security designs.

Digimarc in the US and Signum Technologies in the UK are two digital watermark software producers working on developments in the pharmaceutical area.

Tracking and tracing technology, including RFID, barcoding and magnetic tagging, is another area that is likely to see an increase in activity, predicts Keith Widdowson. "As the cost and size of technology comes down it will be increasingly possible to track and trace products along the supply chain and verify their integrity at point of sale. This will be most appropriate in the prescriptive pharmaceutical area where security risks are highest and warrant the extra expense," he adds.

An agreement made 18 months ago between magnetic tagging developer Flying Null and Light Impressions International has brought OVD and tracking technology together in the form of OptoCode.

Flying Null developed the magnetic tagging device for incorporation into packaging to hold detailed information identifiable by a hand-held scanner. It is combined with a holographic image to be applied to an adhesive label that offers tamper evidence, while confirming the authenticity and origin of the product.