The Final Countdown for Drug Traceability in Europe: Are You Ready?

21 May

The Final Countdown for Drug Traceability in Europe: Are You Ready?

Nino Giguashvili
Senior Research Analyst
Read full bio  @ngiguashvili 

This next couple of years will be an incredibly busy time for drug manufacturers and wholesalers supplying pharmaceutical products to European markets. With the deadlines for meeting the EU’s new requirements for drug traceability and data exchange standards around the corner, European pharma companies need to address compliance issues more vigorously than ever before — and soon.  

The most immediate concerns for European pharma manufacturers and distributors relate to the EU’s February 2019 deadline for drug serialization, set by the EU’s Falsified Medicines Directive (FMD) to prevent falsified medicines from entering legal supply chains in the European markets.

While the industry is overwhelmed with the looming deadlines, the truth is that EU FMD compliance represents both a challenge and an opportunity. Beyond immediate compliance purposes, end-to-end implementation of serialization and track-and-trace solutions, and smart use of the rich data they generate, provide unparalleled opportunities to improve control over supply chains, increasing their transparency, safety, and reliability, as well as creating unique prospects for boosting consumer confidence and brand image. Smart application of track-and-trace and data management solutions can actually enhance overall supply chain performance by supporting a broad range of business aspects, including collaboration and integration across the entire supply chain ecosystem, data-driven decision-making, financial transparency and revenue management, as well as marketing and sales efforts.

In fact (given the potential benefits of technology investments), rather than approaching drug serialization as yet another step toward compliance, the best strategy is to take a step further and address the deeper layers of serialization and data management tasks, leveraging investments to digitally transform supply chain operations. Never before have pharma industry had an opportunity to gain such a holistic, 360-degree view of and control over their supply chains; by leveraging innovative technologies such as the Internet of things (IoT), cloud, and big data/analytics, European pharma companies can tackle supply chain fragmentation, optimize operations, and create an evidence-based culture that will turn their supply chains into a source of differentiation and competitive advantage.

The key drug traceability requirements under the EU FMD refer to the new safety features (a unique identifier both in human readable format and encoded in 2D data matrix, as well as an anti-tampering device) to be placed on individual packs of virtually all prescription medicines, and related compliance reporting. The practical implications of end-to-end implementation of serialization projects, however, go well beyond installing the serialization equipment and printing unique identifiers on product packages; implementations require mastering the massive amounts of serialization data, integrating the data throughout the supply chain links, and reporting the data as per the European Medicines Verification System requirements.

The EU is certainly not unique in the regulatory push for end-to-end traceability of pharmaceutical products: More than 50 countries across the world have initiated similar legislation in response to dramatic growth in falsified medicines and illegal distribution. But while other legislations envisage gradual implementation, in the European markets, the deadline requires serialization systems to become fully operational all at the same time, starting on February 9, 2019.

Many companies in Europe have been postponing serialization projects until closer to the deadline, with the hope of delaying financial outlays. But now that the FMD deadline is a less than a year away, most companies have begun preparations, and drug traceability projects in Europe are widely underway. Supply-chain serialization and track and trace solutions are currently in high demand among the pharma manufacturers and wholesalers operating in the EU. Nevertheless, considering the comprehensive nature of end-to-end drug traceability, very few companies are fully ready, and only a handful are approaching it as a strategic, transformational project.

So how should life science companies approach digital transformation to survive and thrive in European markets? How can they derive maximum business value from regulatory compliance efforts and ICT investments? And what are the best practices and the latest technology trends in the broader life science industry, and how will these trends evolve over time in Europe?

To help European life science companies (and their ICT vendors) answer these and other key questions around digital transformation trends in the region, IDC Health Insights EMEA decided to launch a new research program, specifically adapted to the needs and realities of the life science industry in European markets. To find out more about our new service, please access IDC Health Insights: European Life Science and Pharma, or email me at ngiguashvili@idc.com. I also invite you to visit our IDC Health Insights website, as well as follow our individual IDC Health Insight EMEA analysts on Twitter or via the handle @IDCInsightsEMEA.

// ]]>