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 Systems to explore how the industry can approach this new healthcare landscape.

The 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 brief overview, they include: tamper-evident labels, track & trace solutions, holograms, synthetic DNA and laser codes, 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, the internet can still pose a problem: for example, Viagra is prescribed but you can still find many pharmacies on the internet that sell the product and you have no clue whether it is genuine or not. You may even see a serial number on the product but there’s no way for consumers to check that number; only pharmacies have access to the database and when that link is taken out of the equation, that’s when serialization can be less effective.” This risk is increased by the fact that products can be ordered from around the world and the FMD Directive is only applicable in Europe.

When it comes to anti-counterfeiting, it’s clear that a multi-pronged approach is the most effective one: physical anti-tampering solutions as well as digital verification. In the future, we may also see serialization extended further. In fact, Bart Vansteenkiste suggests we might look to Russia as an example here.

“Russia is ahead of the curve because, while areas like Europe and the US have only been focusing on prescribed medicines for serialization, this market has extended it to every consumable – right down to bottled water. Therefore, in the future counterfeiting should become more difficult because everything you buy and consume will have a serial number.”

Data, data and more data

Which brings us to the question of data: it should go without saying that anti-counterfeiting solutions in the age of e-commerce rely on the processing and storage of huge amounts of this.

“The next step of serialization will be to have a serial number not just on each packet of pills, but on each pill itself,” says Bart Vansteenkiste. “Having a barcode on each pill will not necessarily make a huge difference when it comes to counterfeiting but it will help address another problem, which is human error in care settings. However, this would require huge investments in data storage as the batch code and expiry date would need to be stored for each pill, not just each packet. Understandably, perhaps, manufacturers are pushing back against this for now but it’s something we can expect to see in future if we are serious about increased security.”

But leaving the storage question aside for a moment, when it comes to the question of data security we have been hearing a lot about the benefits of blockchain. In brief, this is a digital ledger or a computerized database of transactions, allowing manufacturers to safely exchange information with suppliers, without the need of a third party.

“Data security is always very difficult: if companies have an anticounterfeit feature such as ahologram then they clearly want as few people as possible to know how this looks on the other hand, you want patients to know how your security sign / hologram is looking so they can authorize and distinguish the genuine product from the fake one,” says Ewa Weglinska. “And there are of course digital ways to authenticate which are very difficult for the counterfeiters to mimic: blockchain and also RFID are key here. So on the one hand you have the product itself and then there is its digital twin which we often talk about, which can be authenticated only once. At Avery we see the future of authentication lying in these digital technologies.”

“While blockchain technology and for example sensors cannot prevent fake medication, they can certainly guarantee the authenticity of products,” adds Arman Sarhadder. “Using tamper-proof blockchain technology in combination with copy- and cloning-protected anti-tamper devices on labels and packages is something we do at Vault Security Systems.”

What have we learned from Covid?

Over the past year, the COVID-19 crisis has served to further expose the existing vulnerabilities in the pharmaceutical supply chain. The problem of counterfeit vaccines, for example, has thrown into stark relief what can happen when there is a sudden spike in demand for a particular product; with the supply chain under huge pressure to act quickly, it has left openings for producers of counterfeit medicines and ingredients to gain a foothold.

“There are always problems when you are in a hurry but also if you are desperate,” says Ewa Weglinska. “So many governments have been trying to get their citizens vaccinated as fast as possible. The EU has been trying to make this safe by taking over the whole distribution process, but still we have seen examples such as in Mexico where people were actually given fake Pfizer vaccines through the ‘legal’ stream. Counterfeit Pfizer vaccines have also been found in Poland and, while these were not in the official stream, there is good reason to believe they were distributed to individuals. Clearly, people who were desperate to get vaccinated were trying to purchase them.”

And if we are talking about vulnerabilities in the supply chain we might also look to the API stream. Often the final production stage may be very well controlled and supervised but the APIs and components can come from Asian countries which cannot be monitored so easily by pharma companies. In situations like Covid-19, this becomes particularly dangerous as these suppliers are under increased pressure to provide more and more of these APIs and may well come to look at different, less secure routes. This shows how, even in the official supply chains, there can be weak links in times of crisis.

The question of consumer responsibility

Stepping briefly away from the supply side: many in the industry also feel that consumers need to take their share of responsibility by doing their due diligence when purchasing medicines online. After all, most of us are by now aware of the risks of purchasing medications online, are we not?

 “I think in 5-10 years from now virtually anything you buy anywhere will have a serial number but it’s up to YOU – the patient – to decide whether you want to buy it through a legal supplier or somewhere that could potentially sell fake products,” says Bart Vansteenkiste.

And yes, it’s true that we should all be mindful of what we are purchasing – not just with pharmaceuticals but in any walk of life. The only sticking point here would seem to be that not everybody has the same awareness of the dangers; some are less internet-savvy, others are simply more vulnerable for other reasons. Asking all consumers to use their common sense in such issues may be like, for example, asking the public to exercise their own judgment when it comes to choosing whether or not to wear masks to protect others against Covid-19.

One of the keys to addressing all of the above would be to increase public knowledge of this issue and educate consumers in the authentication markers to look out for when purchasing goods online – whether that’s holograms, luminescence or scannable product codes.

“Pharmacies may be able to check the authenticity of products, but customers do not yet have that ability,” points out Arman Sarhaddar. “With e-commerce gaining traction and the risks coming with it, pharmaceutical brand owners can protect their products and their brand by giving customers the ability to check for the authenticity of their products.”

Moves are already being made in this direction. Bart Vansteenkiste points out that Interpol are in fact currently talking to EMVO about working on a system where consumers can easily access a database from Interpol and scan product codes on their smartphones to check what they have bought is genuine.

While this certainly doesn’t and shouldn’t take the responsibility away from the pharmaceutical companies themselves, it would provide a certain amount of empowerment. Allowing the public to validate products more easily using both physical and online tools should form a major part of the fight against counterfeiting.

Cooperating for future security

If the pharmaceutical sector is going to keep pace with the online counterfeit medicine suppliers in future, it is clear that there is no one single solution but rather a range of complementary measures: it’s about the digital and the physical; the individual and the collective. Our interviewees agree that cooperation, as with everything, will be key. It is no longer enough to simply look after our own geographical patch or our own part of the supply chain.

“I think the problem is the magnitude of these occurrences,” agrees Ewa Weglinska. “There are so many involved in the counterfeit business because it is, frankly, so lucrative and controlling the internet is a difficult task: if you close one fake medicines website then another three will open. What is needed increasingly in the future is cooperation between governments across different global regions. In Europe we are quite good at controlling our own space but what about other areas that are out of our scope? China, or India, for example?”

If we’re talking about the package itself then there surely needs to be more cooperation between the pharmaceutical company, and their packaging and labelling suppliers, so that for example the labels they produce can be produced only for this specific purpose and destroyed if they are unused. In short, we need to keep single supply chains tight on the one hand, but open up global dialogue and global standardization for supply chain security on the other hand.”

This is a complex balance to achieve, but Ewa Weglinska believes the world is slowly but surely edging in that direction. “Serialization is already in place in the USA and is kicking off in Europe and South America. Of course, in an ideal future there would be one legislation that overlaps through the whole world but I think realistically that is several years off at least.”

Several years off maybe, but it’s encouraging to see the roadmaps slowly being put in place as we move towards a more global approach to securing our vital pharmaceutical supply chains.