European pharmaceutical trade bodies have launched a coordinated effort to accelerate the adoption of electronic product information (ePI) across the European Union, marking a significant shift in how medication information is delivered to patients and healthcare professionals.
The European Federation of Pharmaceutical Industries and Associations (EFPIA), representing brand-name manufacturers, along with the Association of the European Self-Medication Industry (AESGP) and Medicines for Europe, have proposed a comprehensive framework for transitioning from paper-based inserts to digital formats over four years.
Environmental Impact and Digital Innovation
The environmental implications of this transition are substantial. Currently, pharmaceutical companies produce approximately 100 billion paper product information leaflets annually, generating 500,000 tonnes of carbon dioxide emissions – equivalent to the annual electricity consumption of 100,000 households. The shift to digital formats represents a significant step toward reducing the industry's environmental footprint.
Digital Platform Development and Implementation
The European Medicines Agency (EMA) has already conducted a pivotal one-year pilot project from July 2023 to August 2024, collaborating with national authorities in Denmark, the Netherlands, Spain, and Sweden. The pilot's success has led to specific recommendations for implementing ePI across the European Union.
Central to the implementation strategy is the development of an EMA portal, designed to serve as a consolidated platform for accessing reliable medication information. The agency plans to enhance portal functionality throughout 2025, ensuring robust and user-friendly access to digital product information.
Patient Access and Market Benefits
With approximately 90% of EU citizens having regular internet access, the digital transition appears feasible from a technological standpoint. However, the industry emphasizes the importance of maintaining flexibility in information delivery, ensuring patients can access package leaflets in their preferred format – whether digital or traditional paper.
The shift to ePI offers several market advantages, particularly for multi-country pharmaceutical packaging. The digital format is expected to:
- Simplify language requirements
- Harmonize labeling standards
- Improve medicine availability in smaller EU markets
- Reduce production costs
Regulatory Considerations and Future Outlook
The implementation timeline may be influenced by ongoing reforms to core EU pharmaceutical legislation, recently adopted by the European Parliament. Industry stakeholders are advocating for a harmonized approach to ePI implementation across Europe, emphasizing its importance for:
- Advancing patient care quality
- Enhancing regulatory efficiency
- Meeting environmental sustainability goals
- Improving health literacy through better information presentation
The pharmaceutical industry's unified push for digital transformation reflects a broader commitment to modernizing healthcare delivery while addressing environmental concerns. As the initiative progresses, regulatory bodies across Europe face increasing pressure to facilitate this digital transition efficiently and uniformly.
