In this article, Origin Pharma Packaging, manufacturer and provider of innovative packaging solutions for the healthcare industry, discuss counterfeiting in the pharmaceutical industry and how to combat it.
How do counterfeit pharmaceuticals find their way into the supply chain?
鈥淐ounterfeit pharmaceuticals聽is the world鈥檚 largest fraud market, worth over聽. 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鈥檚 not just the matter of聽lost earnings for聽legitimate聽manufacturers that鈥檚 the issue.
Patients聽consuming聽fake products聽have聽no guarantee聽what they鈥檙e taking聽is what it claims to be, which in some cases can聽contribute聽to the spread聽(rather than cure)聽of illnesses and antimicrobial resistance.
In a bid to tackle counterfeiting, a new EU law came into effect in 2019, making digital mass serialisation聽a compulsory part of聽pharma聽manufacturing.聽This involves random, pseudo-codes being generated for each product and verified on the databases of supplier companies before going to market.鈥�
The FMD ensures complete product traceability from manufacturing to decommissioning, instead of placing the burden of authentication on any single stage of the process.聽聽 Its 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,聽with聽less risk to the public and money spent on聽treating those affected by false聽medicine.鈥�
What kind of methods does anti-counterfeit packaging use to combat this?
鈥淭he Falsified Medicines Directive (FMD) requires pharma products sold in the EU market to comply with certain regulations,聽incorporating聽visible聽tamper-proof packaging and a 2D barcode.
Each barcode consists of聽a unique number聽used to identify the batch at聽the聽production stage聽which is checked against聽once received聽and 鈥榙ecommissioned鈥櫬燼t the point of dispensing.
The database聽is聽regulated by the European Medicines Verification聽Organisation聽(EMVO)聽and聽supported by the UK Medicines Verification聽Organisation聽(UKVMO)聽in the UK,聽placing responsibility on these bodies to verify each product.
Pharma packaging companies聽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聽required to scan all new products as they鈥檙e received聽and dispensed聽to confirm the end of the product鈥檚 journey.
Digital watermarks are also becoming more widely used, offering an聽extra聽layer of protection by providing invisible, encoded聽data on packaging聽that can only be聽verified by specialised聽software.聽It聽can be captured using webcam, mobile phones聽and聽other scanning equipment, but is invisible to the human eye.鈥�
Does Brexit pose a substantial risk to this supply chain, and can anti-counterfeit packaging help?
鈥淎t the time of writing,聽no decision has been聽finalised聽on the UK鈥檚 leaving terms, meaning it鈥檚 difficult to qualify the extent to which聽pharma聽regulation聽will be disrupted and risk of criminals acting on this vulnerability.
If the UK secures a long-term deal with the EU, there鈥檒l be little to no difference for the foreseeable future, with UK businesses expected to facilitate聽the new legislation like a member state.
However, in the case of a no-deal exit which looks increasingly likely, the UK supply chain聽will be under no obligation to exercise the terms of the FMD. This would also leave UK聽organisations聽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 鈥渘ational competent authorities鈥� (NCAs) for the UK, have stated that they are continuing with work to implement FMD in the UK and this is 鈥渂usiness as usual鈥� for them.
So, it鈥檚 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.聽Watch this space.鈥�
What could emerging Covid-19 treatments mean for counterfeiters, and what could packaging do to prevent fake medicines emerging onto the market?
鈥淲ith 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 play 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鈥檚 lifespan remotely.
This is invaluable information for anti-tampering strategies, allowing companies to locate and interrogate a product anywhere in the supply chain.聽For example, the geographical location of聽a product聽and the route it took to arrive there can all be captured and stored, thus revealing any聽unauthorised聽journey routes or interventions. Collected data can also highlight inefficiencies and bottlenecks which can be addressed to streamline processes and drive cost-savings.鈥�
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.鈥�
For more information, please fill out the enquiry form attached to this page.