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Digital Medicines Information gains momentum

 

Europe is moving towards a digital future for medical information. A new report from AESGP, EFPIA and Medicines for Europe provides a comprehensive overview of electronic Product Information (ePI) pilot projects across 31 countries. The findings reveal a landscape of innovation, collaboration, and cautious optimism as countries prepare to move from paper-based patient leaflets to digital solutions, aligned with the revision of the European pharmaceutical legislation.

 

Scope

  1. The identified pilot projects are run in collaboration with the national competent authorities, approved by the European Commission (where necessary), and are conducted together with national stakeholders.
  2. Pilots aim to test and prepare Member States, the pharmaceutical Industry, healthcare professionals (HCPs), and patients for the transition from traditional paper-based patient information leaflets (PILs) to digital.
  3. Most pilots focus on hospital-only and healthcare professional-administered medicines, but some, like France, are breaking new ground by including prescription and non-prescription medicines.

Key highlights (at the time of the survey)

  • 14 countriesare actively running ePI pilots.
  • 7 countriesare in the planning stages of ePI projects.
  • 10 countries have not initiated ePI pilots, often citing legal, technical, or resource barriers.

Notable approaches & results

  1. The Nordic pilot (Finland, Denmark, Norway, Sweden, Iceland) features English-only outer packaging with ePI in local languages, aiming to simplify logistics and improve access.
  2. Belgium/Luxembourg: After seven years, 97% of hospital pharmacists reported no inconveniencefrom the absence of paper leaflets; 100% saw no issues for physicians. Over 4 million packs were distributed with minimal queries.
  3. Portugal: One year in, most healthcare professionals praised ePI, with easy access and minimal need for paper copies.
  4. Baltics: Estonia, Latvia, and Lithuania report positive feedback from pharmacistsand growing support for ePI.
  5. Slovakia is among the ten countries that do not plan to run a pilot (Bulgaria, Czech Republic, Greece, Hungary, Ireland, Italy, Romania, Slovakia, Slovenia, Malta). Industry is in favour of a pilot, and there have been discussions. However, there is currently no legal framework for running a pilot.

A call for knowledge sharing and collaboration

This report showcases the progress made in implementing ePI across Europe and highlights the importance of sharing knowledge and best practices from successful pilots to support countries that have yet to launch ePI initiatives. Legal and regulatory barriers, technical infrastructure, and stakeholder engagement remain significant hurdles in several countries.

Insights from ongoing pilots demonstrate that ePI can be successfully integrated into healthcare systems and call for continued collaboration among stakeholders to ensure a smooth, inclusive transition to ePI, supporting patient safety, addressing logistical challenges and environmental sustainability.

Next steps

This report is a detailed resource on ePI pilots in Europe, providing valuable insights for policymakers, healthcare professionals, and industry stakeholders. It highlights both the progress made and the challenges ahead, offering a factual basis for future discussions and decisions on the digital transformation of medicinal product information.

AESGP, EFPIA and Medicines for Europe reaffirm their commitment to working with all stakeholders to drive the successful rollout of ePI across Europe. The findings from this report will serve as a valuable resource in shaping the future of medicinal product information.

Source: EFPIA


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