Serialization and product protection

Various government and industry responses to this problem have been proposed worldwide. Many of these planned counter-measures to counterfeiting employ serialization systems. These give a numerical identifier of some type to each unit pack. The “name tag” for that pack can then be read either directly or indirectly (via a database). The data carriers can include various forms of barcodes, RFID tags, or even physical features of the product itself in the case of some fingerprinting systems.

These systems solve one aspect of the problem – how to identify and track an individual unit among billions of similar items. However, the logistics and tracking issue is only one part of the requirement for a fully secure system.

Information-based track-and-trace technology, whether RFID or printed codes, can be vulnerable. Unprotected RFID tags and printed codes can be copied, altered, or removed. Whole systems can be bypassed. Criminals have been known to create a “parallel universe” where there fake products carry freephone numbers or website addresses for the consumer to “authenticate” their product using its serial number. These are backed up by real people answering calls or by plausible-looking websites. Labour is so cheap in some countries that these costs are small versus the extremely high profit margin for fake goods.

SICPA uses a combination of both material-based and information-based technologies to ensure that pharmaceutical products are secured against the risks that the industry faces today. By doing this we can combine the advantages of logistics systems with the safety of security technology. Many of our systems employ covert coding technologies, or overt coding with extra security features.

Some in the healthcare industry still view product security as a “nice-to-have”, a useful but costly and non-essential addition to their packaging and an extra manufacturing expense. In today’s cost-control environment it is tempting to avoid it on some product lines or economize on the quality of the features and systems.

The rationale for this is obvious. Most counterfeits remain undetected. The sick may die more quickly or not get well so fast, but in most cases this won’t be put down to ineffective medication. This makes the issue and its impact very hard to quantify. When making a pitch for investment in new technology, if you can’t quantify the risks and benefits then you are going to get a hard time from the CFO.

The financial return-on-investment for product security is undoubtedly hard to measure, but maybe that’s not the point. Our role in the pharmaceutical industry should be to ensure that counterfeit medicine is not the direct or indirect cause of sickness or death, whether or not this is the reason written on the hospital file or the death certificate.

In the current unclear legislative climate, those companies who firmly take the initiative are likely to have a big influence on government and regulatory standards. As legal approaches gather pace globally, the emphasis in fighting counterfeit drugs will shift from the drug companies towards the consumer. Those companies who prepare for this will likely reap financial rewards. The tools to control this problem are already with us – 2D codes, RFID, overt, covert and forensic technologies. By starting with a basic universal standard and building from there we can at least begin to control drug counterfeiting.

Vendors can help too. At SICPA we work with customers on a proactive basis and at corporate level. This means we can help them to plan their security features ahead of time, across their whole product portfolio. We can pass on economies of scale in terms of lower unit pricing, and we can make sure that security systems are efficient, globally consistent and upgradeable. This is far cheaper, both in invoiced costs and in hidden costs such as management time, than addressing individual problems reactively as they occur.

We are working closely with governments and with drug and healthcare companies to implement a range of security measures which are tailored to the specific circumstances (geography, product, threat etc). We always advocate a layered approach, where multiple security features are combined to give a strong measure of protection. The approaches we use include various overt technologies as well as covert features and forensic taggants. We also use our experience gained in other industries, such as banknotes and value documents, to bring insight into the pharmaceutical security field. Pharmaceutical packaging should be seen almost as a value document such as a passport, validating the drug contents of the pack, and not just as commodity board and foil to be sourced as cheaply as possible.

SICPA provides a range of technologies and services, including multi-layered material-based and information-based security. Our rigorous control of all aspects of the supply chain ensures that security features really are secure. It is important that authentication and/or secure track and trace should take place all along the supply chain. The chain is only as strong as its weakest link.

There are no magic bullets against counterfeiters in any industry, but by applying a risk management approach, together with appropriate technology, the impact of this crime on patients and revenues can be minimized.