How do counterfeit pharmaceuticals find their way into the supply chain?
“Counterfeit pharmaceuticals is the world’s largest fraud market, worth over $200 billion per year. The link between fake drugs and organised crime is well established, as sophisticated criminal networks try to get their slice of the ever-growing and profitable pharmaceutical industry.
While small isolated traffickers engaged in highly localised illicit sales do exist, large scale fake drugs trafficking as it is observed today requires considerable financial and human means. So much so, only structured networks can have access to them. But it’s not just the matter of lost earnings for legitimate manufacturers that’s the issue.
Patients consuming fake products have no guarantee what they’re taking is what it claims to be, which in some cases can contribute to the spread (rather than cure) of illnesses and antimicrobial resistance.
In a bid to tackle counterfeiting, a new EU law came into effect in 2019, making digital mass serialisation a compulsory part of pharma manufacturing. This involves random, pseudo codes being generated for each product and verified on the databases of supplier companies before going to market.”
The FMD ensures complete product traceability from manufacturing to decommissioning, instead of placing the burden of authentication on any single stage of the process. It’s aim is to greatly reduce the number of fraudulent products from circulation opening-up a wider market and profit for legitimate manufacturers, and above all else, protect patient safety.
Pharmacists, industry bodies and the healthcare industry also benefit from the regulation of medicine, with less risk to the public and money spent on treating those affected by false medicine.”
What kind of methods does anti-counterfeit packaging use to combat this?
“The Falsified Medicines Directive (FMD) requires pharma products sold in the EU market to comply with certain regulations, incorporating visible tamper-proof packaging and a 2D barcode.
Each barcode consists of a unique number used to identify the batch at the production stage which is checked against once received and ‘decommissioned’ at the point of dispensing.
The database is regulated by the European Medicines Verification Organisation (EMVO) and supported by the UK Medicines Verification Organisation (UKVMO) in the UK, placing responsibility on these bodies to verify each product.
Pharma packaging companies have been key players in incorporating these barcodes in line with the new legislation, alongside developing tamper-evident features which are now compulsory.
Code data is stored in the database after the product is shipped out, and dispensaries are required to scan all new products as they’re received and dispensed to confirm the end of the product’s journey.
Digital watermarks are also becoming more widely used, offering an extra layer of protection by providing invisible, encoded data on packaging that can only be verified by specialised software. It can be captured using webcam, mobile phones and other scanning equipment, but is invisible to the human eye.”
Does Brexit pose a substantial risk to this supply chain, and can anti-counterfeit packaging help?
“At the time of writing, no decision has been finalised on the UK’s leaving terms, meaning it’s difficult to qualify the extent to which pharma regulation will be disrupted and risk of criminals acting on this vulnerability.
If the UK secures a long-term deal with the EU, there’ll be little to no difference for the foreseeable future, with UK businesses expected to facilitate the new legislation like a member state.
However, in the case of a no-deal exit which looks increasingly likely, the UK supply chain will be under no obligation to exercise the terms of the FMD. This would also leave UK organisations without access to the EU central database, unable to upload and store product data, and left facing the same risks currently faced with fraudulent products.
At present, the Department of Health and the Medicines and Healthcare products Regulatory Agency (MHRA), the “national competent authorities” (NCAs) for the UK, have stated that they are continuing with work to implement FMD in the UK and this is “business as usual” for them.
So, it’s likely the UK will see similar product regulation in some capacity, whether through the EU FMD or not in the case of a no-deal Brexit. If anything, leaving the EU could mean the UK Government places even greater responsibility on the pharmaceutical industry to protect patients from falsified medicine and become a world-leader in tamper-proof design. Watch this space.”
What could emerging Covid-19 treatments mean for counterfeiters, and what could packaging do to prevent fake medicines emerging onto the market?
“With huge worldwide demand for COVID-19 treatments, this has created a very lucrative market for criminals. The speed and scale at which COVID-19 treatments are being discovered and supplied also increases the risk of failure to enforce safety protocols, particularly in emerging countries.
Smart and tamper-proof packaging will pay a key role in end-to-end visibility of the global and complex supply chain needed to deliver the COVID-19 vaccine and relevant treatments.
Big data, provided by smart packaging in part, will be key to giving pharma companies a more granular, real-time picture of events taking place along the supply chain, from manufacture to healthcare settings. Advanced tracking systems, built into primary and secondary packaging, is an exciting area of innovation. By managing and recording all the typical activities that occur in the supply chain or designed to cover special requirements, tracking chips can log events or raise queries that occur across a product’s lifespan remotely.
This is invaluable information for anti-tampering strategies, allowing companies to locate and interrogate a product anywhere in the supply chain. For example, the geographical location of a product and the route it took to arrive there can all be captured and stored, thus revealing any unauthorised journey routes or interventions. Collected data can also highlight inefficiencies and bottlenecks which can be addressed to streamline processes and drive cost-savings.”
Some digital anti-counterfeiting technologies providers have launched COVID-19 initiatives, giving WHO and pharmaceutical manufacturers access to all the tools they need to minimise the risk of falsification and counterfeiting in the supply chain for relevant vaccines and treatments.”