EU pharma industry calls for accelerated adoption of digital package inserts

EU – Trade organizations representing the European prescription and over-the-counter pharmaceutical sectors have urged regulators to fast-track the implementation of electronic product information (ePI).

This call to action comes from three prominent bodies: the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Association of the European Self-Care Industry (AESGP), and Medicines for Europe, which represents the generic pharmaceutical industry.

In a series of position papers, these organizations have outlined a detailed plan for a phased introduction of ePI and digital patient leaflets to replace traditional paper-based inserts over a four-year period.

According to a joint statement, meeting this timeline would mark a major step forward in modernizing patient care, enhancing regulatory efficiency, and promoting environmental sustainability.

Currently, the pharmaceutical industry produces an estimated 100 billion paper product information leaflets annually, resulting in approximately 500,000 tonnes of carbon dioxide emissions—equivalent to the annual electricity use of nearly 100,000 homes.

Transitioning to ePI could significantly reduce this environmental burden while ensuring patients have uninterrupted access to vital medical information through secure and standardized digital platforms.

Digital product information leaflets are also expected to improve layout and readability, thereby fostering the safe use of medicines and improving health literacy across the population.

To support this transition, the European Medicines Agency (EMA) and national regulatory authorities in Denmark, the Netherlands, Spain, and Sweden conducted a one-year pilot project from July 2023 to August 2024.

This initiative led to recommendations for additional guidance to facilitate the EU-wide adoption of ePI.

Central to the proposal is the establishment of a centralized EMA portal that would serve as a single, trustworthy source of information.

This portal aims to enhance transparency and streamline regulatory processes across the EU. However, the pilot study revealed areas requiring further development, which the EMA plans to address in 2025 to improve functionality.

Ongoing reforms to core EU pharmaceutical legislation, adopted by the European Parliament last year, could influence the timeline, implementation, and evolution of ePI.

While approximately 90% of EU citizens regularly access the internet and would likely face minimal barriers to using digital platforms, the pilot project emphasized the need for robust systems that ensure patients can easily obtain package leaflets in their preferred format, whether electronic or paper.

For the pharmaceutical industry, the adoption of ePI offers several advantages. It could reduce costs associated with multi-country packs by simplifying language requirements and harmonizing labeling standards.

These improvements could, in turn, increase the availability of medicines in smaller EU markets, benefiting patients and healthcare systems alike.

In their joint position paper, the trade organizations stressed the importance of regulatory harmonization across Europe to ensure the smooth implementation of ePI.

They noted that this transition is essential not only for advancing patient care but also for improving regulatory operations and addressing pressing environmental challenges.