Packaging
Serialisation: Headache or Opportunity?
The scourge of counterfeit drugs continues to threaten global health programmes. When it comes to dealing with the impact of counterfeit trade, there is an increasingly heavy burden placed upon healthcare systems, healthcare professionals, national medicine regulatory authorities, law enforcement agencies and criminal justice systems. To counter this growing threat, government bodies are enacting more robust and stricter regulations to control the genesis and proliferation of fake medicines. Track-and-trace is an important aspect of serialisation and has long been recognised for its ability to protect against counterfeiters, as well as facilitating more effective recalls. Despite the critical nature of governmentenforced initiatives to ensure the safety of consumers, as well as overall trust in the industry, many regulations are presenting real challenges to pharmaceutical manufacturers. In this article we will examine three key questions: • • •
Why is serialisation perceived as a headache by pharmaceutical companies? How can we understand and address the challenges that arise from serialisation? What are the opportunities for companies which effectively utilise this technology and what can be achieved by embracing serialisation?
What is Serialisation? Serialisation entails the encoding of each pharmaceutical product coming off a packaging line, with a unique identification code which can be traced and pinpointed at each stage in the supply chain. The unique identification code can be stored in an online database along with other valuable information about the product, such as manufacturer and batch details. This process enables complete monitoring and 68 INTERNATIONAL PHARMACEUTICAL INDUSTRY
tracing of each product – from the packaging line right through to the patient. Serialisation regulations vary between regions and countries, as well as being at different phases of implementation across the globe. To meet the demands of the country-specific deadlines, most global pharmaceutical companies should be trackand-trace and serialisation ready. Why is Serialisation Needed? The main challenge we face in combatting counterfeit medicine is that counterfeiters are getting smarter. In today’s world, access to technology has become incredibly easy, so criminals and counterfeiters are able to keep up with ongoing changes and technological developments in the industry. Increasing numbers of internet pharmacies are also helping the fake medicines industry reach directly to the customer. Also, a lack of consumer awareness about counterfeit medicines is helping counterfeiters to expand their business. Innovative and effective solutions have become essential to secure the supply chain and ensure safe products for consumers. Product authentication and implementing track-and-trace technology are two key aspects of ensuring supply chain integrity in the current climate. A recent report by the UN Office on Drugs and Crime says “counterfeit goods and fraudulent medicines pose a serious risk to public health and safety”.1 We can also note the economic cost of counterfeit medicines for industry, government and society as a whole. Each year in the European Union alone it causes: • • • •
Loss of 4.4% of legitimate sales Loss of €10.2 billion in revenue for the sector Destruction of 90,900 direct and indirect jobs Loss of €1.7 billion in government revenue (taxes and social contributions) 2
Establishing a robust, global system has far-reaching benefits for all stakeholders, from the pharmaceutical manufacturer to the end consumer. Track-and-trace will
help overall control of the supply chain, coupled with providing brand protection for pharmaceutical companies. The technology improves trust in the product, due to supply chain visibility and data security between different stakeholders. During the last 10 years, the track-andtrace industry has undergone vast change. Customers have moved from a reluctance to meet the regulation mandates, to utilising track-and-trace data for supply chain and production planning. Today, implementation is recognised as not just printing on cartons; businesses are now beginning to embrace the data management and security benefits from track-and-trace. The industry is moving from solely focusing on compliance, to creating real value for businesses and to consumer safety. Why is Serialisation Considered to be a Headache? Although serialisation offers fair transparency and is a necessary requirement by regulatory bodies, it still presents a major challenge for the pharmaceutical industry. Firstly, it is a long-term, substantial investment for individual companies. Secondly, it involves increased risk and complexity of current operations. Various bodies of evidence from early adopters of serialisation have demonstrated that productivity in terms of overall equipment effectiveness (OEE) has the potential to decrease. Serialisation demands tremendous changes to the entire IT structure, packaging and warehouse equipment and – most importantly – the data exchange system at each level of the value supply chain. For example, pharmaceutical companies in the EU have expressed concerns about the cost implications associated with the upgrading of pharmaceutical packaging lines to apply serialisation and tamper-verification features for the EUFMD. Additionally, the changing regulatory frameworks, lack of uniform standards, and complex distribution networks make it difficult for pharmaceutical companies to cope with the overall implementation deadlines. Because of these challenges, pharmaceutical companies can be reluctant Summer 2021 Volume 13 Issue 2
