In advance of new European measures to help reduce counterfeit medicines, Wayne Miller, healthcare director EMEA at Zebra Technologies, asks if the pharmaceutical supply chain is ready for true medicine traceability.
Traceability
More than 400,000 pharmacies in Europe will be impacted by European Directive 2011/62/EU, ratified by the European Parliament in 2016 and effective in February 2019. The intent of this measure is to prevent the introduction of illegal medicine into the legal supply chain. This means pharmaceutical industry players must consolidate their medicine traceability practices to fight a rise in medicine counterfeiting. What lessons can be learnt from this supply chain revolution?
According to the World Health Organization, about 700,000 deaths worldwide every year are caused by the sale of counterfeit medicines. No country is immune from this scourge, with traffickers primarily targeting anti-cancer drugs which can carry an annual treatment cost of more than $50,000. To counter this trend and alleviate patient concerns, the pharmaceutical industry has already established several defensive procedures which will be reinforced with the Parliament’s Directive. But how ready is the entire pharma supply chain to apply this new regulation?
"No country is immune from this scourge, with traffickers primarily targeting anti-cancer drugs which can carry an annual treatment cost of more than $50,000."
The pharmaceutical industry is committed to patient protection
One result of Directive 2011/62/EU is the introduction of a unique serial number to be applied to the packaging of all medication. Known as serialisation, this labelling process has set a race against time for all branches of the global pharmaceutical industry including laboratories, manufacturers and pharmacies who must integrate it to help ensure the meticulous monitoring of all medicines, from their manufacture to their sale in pharmacies.
Updating production lines and installing appropriate coding equipment is a complex task. It requires first-rate technical abilities and machines which can deliver high-quality printing. Similarly, serialisation introduces substantial production investments for most companies in the pharmaceutical industry, as revealed in a KPMG survey published in May 2017. Europe’s pharmacies will also have to adapt by procuring 2D barcode scanners, which are critical in checking the compliance of any medicine sold. The result is a major upheaval throughout the supply chain, where monitoring of this new unique number is vital both upstream and downstream.
Traceability is vital in fighting counterfeiting
This substantial investment is a critical support in fighting counterfeit medicines and vaccines. In fact, anti-counterfeiting and safety procedures will continue to play a significant role in the folding carton packaging sector. According to a report by the Smithers Pira design office titled “The Future of Folding Cartons to 2022”, traceability solutions represent one of the four major advances in technology set to transform the market by 2022.
Indeed, once it is possible to identify where a medicine package has come from, the risk of getting a counterfeit product is drastically reduced. An increase in traceability procedures should help scale down a massive global counterfeiting industry, estimated by the World Economic Forum to exceed $200 billion worldwide in 2017.
Serialisation provides a means to secure every level in the supply chain
That which holds true for the pharmaceutical industry also applies to other sectors like the food, textiles and leather goods industries, which are also facing increasingly sophisticated counterfeiting schemes. In certain food industry scandals, serialisation would have helped in identifying fraudulent products or batches bearing inaccurate labels.
Thanks to a unique identification code, specific to each unit being sold, the origin and composition of a product could easily be ascertained. Using a basic 2D barcode flash, distributors would be able to follow their listed products in real time anywhere in the world. In the example of a bacterial contamination, distributors could react quickly to prevent it reaching consumers.
This trend involves the entire supply chain. Beyond printing and monitoring hardware, it also requires software to be integrated into the production line to generate unique codes that can be adapted to the MES (Manufacturing Execution System) and ERP (Enterprise Resource Planning) widely used by enterprises. With this in place, all that remains is applying the unique code to the primary package using printers that can produce a code which will remain legible throughout the product’s lifecycle.
Boosting product traceability: A key objective for other sectors
The serialisation set to come into effect within the pharmaceutical industry should help monitor the supply chain and fight the spread of fraudulent medicines and vaccines. The process may also provide some additional benefits including a more accurate view of stocked products with better historical data of the origin and quality of the purchased goods. These benefits could also apply to other sectors confronted with the hazards of counterfeiting.
Serialisation represents an opportunity to modernise current traceability systems. Through this win-win model, any action taken against parallel markets would be significantly enhanced by controlling the supply chain and the application of data-driven best practices.