WHAT DOES THE E-COMMERCE BOOM MEAN FOR PHARMA SUPPLY CHAIN SECURITY?
Counterfeiting has been a problem for the pharmaceutical sector for as long as it has been in existence; that being said, it’s clear that the age of e-healthcare and online purchasing brings an entirely new set of challenges. Victoria Hattersley speaks to representatives from Avery Dennison, Domino Printing Sciences and Vault Security to explore how the industry can approach this new healthcare landscape.
Bart Vansteenkiste
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he problem of pharmaceutical counterfeiting is arguably greater than it’s ever been before. And the reason for this? In short, e-commerce. While there is no doubt that digitization has brought many positives for the healthcare sector – increasingly personalized service, greater accessibility for older or disabled people, greater speed and efficiency of ordering, to name just a few – the internet also provides many spaces for counterfeiters to exploit and online security measures are still lagging behind. With the internet, the consumer base for counterfeiters is direct and practically limitless; the dark web allows for anonymous transactions between manufacturers, distributors and consumers, while it is easy for online pharmacies selling faked medications to pose as legitimate. Indeed, even the ‘legitimate’ online pharmacies are not entirely safe, as it is still possible for counterfeiters to infiltrate them; there have been many cases of counterfeit batches being detected in well-established and legal supply chains. “In fact, I think the risk is much higher there,” says Arman Sarhaddar, CEO of Vault Security Systems. “People buying ‘lifestyle’ drugs online know they are purchasing unregulated products. If however a regulated product is available online for a bargain price, and can be ordered without a prescription, somebody may not consider that this product could be fake because the packaging looks identical. Appearing authentic while not being authentic is in my opinion a bigger risk to consumers than the ability to knowingly ordering unregulated products.”
What difference has the FMD Directive made? The strategies available to combat counterfeiting are numerous and we have discussed them all at Packaging Europe many times in the past. To give a | 12 | Packaging Europe
Arman Sarhaddar
brief overview, they include: tamper-evident labels, track & trace solutions, holograms, synthetic DNA and laser codes and special printing inks invisible to the naked eye, among others. In Europe, the 2019 FMD Directive has gone some way to regularizing the market, making digital mass serialization and tamper-evident design compulsory parts of pharmaceutical packaging design. Random 2D barcodes must be generated for each product and verified in suppliers’ databases before being distributed. Furthermore, the pharmaceutical companies themselves are now responsible for their own active pharmaceutical ingredient (API) suppliers, meaning they have to select suppliers very carefully to ensure they are safe and compliant. Finally, verified online pharmacies now need to include a quality sign that is clearly visible on their website with a hyperlink directly to the European Commission website. This is a step in the right direction but it obviously requires that consumers be aware of what to look for so they can ensure the goods they are buying online are genuine. “Although the FMD requires all those online pharmacies to have a quality sign the consumer can click, not everyone is aware of this and fake pharmacies often appear on top of Google searches because they are smart in positioning themselves,” says Ewa Weglinska, Product Manager Pharma at Avery Dennison. “So for those who are not so internet-aware there is a huge risk.” Bart Vansteenkiste, Global Life Sciences Sector Manager at Domino Printing Sciences, also stresses that serialization will only get us so far: “No doubt, serialization and the FMD Directive have really helped improve things. However,
