The primary objective of any anti-counterfeiting technology is to empower someone — either the consumer, a salesman, a security agent, or a government official — to authenticate a product and thereby ensure that it is the genuine article. There is a long history of attempts at combating counterfeiting and along the way, various types of authentication technologies have been developed and applied with mixed success. In this part of the document, the author discusses the currently available passive technologies in the global marketplace for dealing with counterfeit and spurious drugs. The technologies are divided into different categories for ease of comparison. This segment of the document is a continuation of Part I published earlier in Pharmabiz which described the general features to look when considering the adoption of an anti-counterfeiting technology.
The current landscape of anti-counterfeiting solutions presents a mind-boggling array of technologies in terms of both sheer number and variety. It would be a major exercise for any company to have to sort through all of the technology offerings. This section of the manuscript provides a succinct overview of the anti-counterfeiting solutions that are currently available to drug makers. It turns out that all anti-counterfeiting solutions can be placed into one of three major categories. The discussions that follow revolve around these three categories, with further sub-classifications within them based on additional distinguishing features.
Passive technologies
The first category of anti-counterfeiting technologies concerns those that allow a genuine product to be distinguished only by visual inspection. In other words, no special devices or readers are needed. This category is referred to as the passive technologies and includes three sub-categories, as discussed below. In all cases, the technology is applied directly onto the drug package, which then allows a consumer to use its presence as a means of verification and therefore presume the product to be authentic. The advantages and disadvantages of these technologies are taken up briefly in each subsection below.
a) Holograms and security seals
The science of holography dates back to the post-War era of the late 1940s when it was originally developed. The creation of a holographic image, or hologram, requires some technical knowledge and expertise, though a recent explosion of companies and low-cost machinery has made this technology extremely accessible within many sectors of the consumer marketplace. A hologram typically incorporates an image that appears as an illusory 3-dimensional object with vivid depth characteristics (Figure 1).
A security hologram is a special reflective type of hologram that is custom-made for a brand owner. A number of pharmaceutical brand owners have relied on hologram application as a means to reduce counterfeiting, especially in the pharmaceutical industry.There are currently a large number of hologram suppliers in the global marketplace.
A common way to apply a hologram onto a product is by way of a security seal or label. There are many different types of security labels in the marketplace, all of which allow brand owners to place a distinguishing feature on their products. One particular type of security seal that can be used in conjunction with a hologram is the so-called tamper-evident label . These types of labels require one part of the seal to be removed to display a message or security code. Once removed, the two parts of the label cannot be reaffixed and therefore provides clear evidence that the product has been tampered with. The argument behind using tamper-evident and other types of security seals as an anti-counterfeiting tool is that they generally contain a special engraving, message, code, or holographic image that sets the brand owner’s products apart from those belonging to an imposter.
The advantages that holograms and security seals offer is that they are generally of low price, easy to apply, and represent a rapid way of providing a distinguishing feature to a branded product.The major disadvantage is that this solution is easily replicable by a counterfeiter, and indeed, there have been numerous instances where genuine security holograms have been easily and expertly copied or simulated , leading to the contention that holograms when used alone are less about security and more about sparkle. An additional difficulty relates to consumer awareness. With a plethora of branded products in the marketplace, the average consumer has an extremely difficult time keeping up with which products should contain a particular type of hologram or seal. Related to this is the fact that fake holograms used by counterfeiters, which may be of inferior quality, are not easily distinguishable as such by the lay consumer.
Overt and hidden imaging
A second type of passive technology is associated with special types of imaging that can be applied either in an overt (visible) or semi-covert (hidden) manner on a product or label. Again, the justification here for use as an anti-counterfeiting tool rests on the claim that such specialized features are specific to a branded product and therefore serve to distinguish it from a fake one. As with holograms, the use of these technologies is reliant entirely upon a consumer being able to know and visibly detect the presence of this feature on the product, hence their classification as a passive technology.
There are several different options in this category. One is to apply an optically variable device (OVD), which is similar to a hologram but without a 3D component. These overt images are made on transparent film, which serves as a carrier, and then placed on a reflective backing layer to produce different visual impressions, such as image flips, transitions, color shifts, or a floating sensation.
The other technology offerings in this category concern semi-covert or hidden image features that require a small additional effort on the part of the consumer to detect their presence . There are a variety of possibilities in this regard, including embedded images that are only visible from one particular angle of view, digital watermarks, and optically variable inks (OVI). The latter two are often applied on sensitive documents and have been used in various worldwide currencies. Watermarks, for example, have now become quite common in currency, such as the image of Mahatma Gandhi in Indian rupee banknotes. OVI, which is also known as colour-shifting ink, is a particularly intriguing technology because it changes color as an object is rotated. An example is United States currency, where the dollar amount is printed with OVI.
The advantages of this group of passive technologies are that they are easily applied onto various types of packaging material. The result is an esthetically appealing end-result that can incorporate highly specific iconic images that are unique to the brand owner, such as its logo or other trademark. In anti-counterfeiting terms, these solutions provide a clear distinguishing feature that sets apart branded products from their fake counterparts. The disadvantages, however, are similar to those with holograms. Given that these are passive technologies, there is a heavy reliance upon consumer ability to identify the special images (overt or semi-covert) and thereafter associate them with that particular brand. This kind of visual confirmation is an onerous task for most individuals, and becomes more so when counterfeited copies are introduced in the marketplace because of the greater confusion created in sorting through genuine from fake products. Although certain technologies in this sub-category can be more robust as a security feature in comparison to holograms, it is nevertheless true that duplication is extremely feasible by highly motivated counterfeiters. Indeed, there have also been several instances of counterfeiting with OVI on various products, including the creation of fake currency .
Package modification
The final set of passive solutions concerns changes to product packaging or incorporating specialized packaging materials and formats. Package modification represents a low-tech solution, although the incorporation of new-age materials in the package can represent a fairly sophisticated approach. Many pharmaceutical companies in the past have tried to modify their packaging format with the reasoning that it forces the counterfeiter to spend large sums to follow suit. The assumption is that some may not bother to do so, or that there will be a delay during which the branded product is immune to the counterfeiting problem. A number of branded medicine packs, for example, have undergone packaging change to stay ahead of the counterfeiters, either by introduction of a new sleeve, a change in the colour and graphical design of the package, or simply altering the compositional layout.
The major advantage to adopting package modification as an anti-counterfeiting strategy is that it represents a minimalist approach in that no new technologies need to be evaluated or deployed. Many brand owners routinely alter their packaging formats in any case as a means of upgrading the appearance of their products in the retail setting. The disadvantage of this approach, however, is that it also represents a minimalist approach for the counterfeiter to keep pace and introduce fake products in an identically copied format. Counterfeiters have become increasingly sophisticated and can make use of advanced technologies to duplicate a package in as little as 12–18 months. The major investments often needed to modify retail packaging are therefore short-lived in terms of brand protection. Another disadvantage to package modification as an anti-counterfeiting strategy is that consumers must continually be made aware of the new format. The brand owner must therefore rely on customer memory and ability at identifying the correct package construction of a genuine branded product in the marketplace in the midst of the many products, including medicines, which they routinely purchase.
Note
This document is continued in another part, which contains the different active technologies. The author lives in Montréal and advises various stakeholders, such as governmental agencies, industry, and trade bodies, on optimal solutions to combating pharmaceutical counterfeiting and protecting consumers.