The European pharmaceutical landscape is approaching a pivotal digital milestone. A landmark report, co-authored by the EFPIA, the Association of the European Self-Care Industry (AESGP) and Medicines for Europe, offers a comprehensive analysis of electronic Product Information (ePI) pilot projects across 31 countries. By modernising these legal requirements, the EU is moving away from static, “one-size-fits-all” paper leaflets toward a dynamic system that can adapt to real-time safety data and diverse patient needs.
Tiered landscape of adoption
The report identifies a structured transition toward ePI with 14 countries actively running pilots and seven in the planning phases. These initiatives, conducted in coordination with national competent authorities, primarily focus on healthcare professionals administered medicines within hospitals. However, frontrunner countries like France are expanding the scope to include prescription and non-prescription medicines, signalling a broader digital vision for a personalised patient experience.
Compelling evidence for feasibility
The report also identifies success stories from the field, offering compelling evidence that a transition to ePI is feasible. In the Belgium-Luxembourg pilot, which has run for seven years, the results were overwhelming: 97% of hospital pharmacists reported no inconvenience from the absence of paper leaflets, while 100% of physicians reported no issues after the distribution of over 4m packs. Similarly, the Nordic pilot – spanning Finland, Denmark, Norway, Sweden and Iceland – has utilised ePI to simplify language logistics, trialling English-only outer packaging supported by local-language digital leaflets.
Strategic benefits for pharma
For pharma, the benefit of digitisation ensures that the most current safety information is instantly accessible in a reader-friendly format. It also provides strategic solutions to some of the most stubborn supply chain “bottlenecks”, such as stock reallocation during shortages, while supporting environmental sustainability goals by reducing paper waste. Yet the report does not shy away from the hurdles. Ten countries have yet to initiate pilots, citing legal, technical and resource-related barriers.
Fostering a unified future
To bridge this gap, the report emphasises a collaborative approach to ensure no European country is left behind. The findings highlight the “importance of sharing knowledge and best practices from successful pilots to support countries that have yet to launch ePI initiatives”. By fostering cross-border harmony, the industry can ensure that life-saving medicines reach patients faster while maintaining a single, real-time source of truth for safety data regardless of where they live.
To read the full report, click here.
