Preparing for the electronic patient insert in Europe
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Hanna Saari
There has been some steady progress towards adoption. Several technical steps have been taken toward the EMA’s roadmap to achieve an EU ePI common standard based on the Fast Healthcare Interoperability Resources (FHIR) standard. In support of these objectives, the agency has published a submission portal and implementation and style guide for the HL7 FHIR standard to generate ePI.3 During a public system demonstration by EMA held in September, it was announced that the agency plans to start adopting ePI for centralized products in 2026.4
EMA’s draft reflection paper, published in March 2025, calls for stakeholders to commit to a Europe-wide ePI.5 So far, several countries have adopted pilots to build acceptance and support for electronic leaflets, mainly in hospital environments.
Pilots for electronic leaflets
Surveys of hospital pharmacists were conducted at various points during the pilot. The final survey found lack of a paper leaflet presented no inconvenience to the pharmacists or to physicians. During consultations, 97% of pharmacists accessed the online PL directly and just 3% printed the leaflet from that online source.
Similar outcomes are seen in the surveys conducted in other countries. A project carried out in Portugal involving hospital pharmacists, doctors and nurses had largely positive feedback with most healthcare professionals (HCPs) noting that absence of a paper PL did not affect their daily practice, and 80% agreeing the PL could be removed from hospital medicine packaging.7 Germany is also carrying out a pilot -- Pilot Project digital – to identify and test situations where electronic product leaflets could be used.8
Electronic initiatives in the Nordics
The Swedish Medical Products Agency (Läkemedelsverket) carried out a survey of healthcare professionals on replacing paper PILs with digital information.9 The survey was also part of an assessment to determine adaptability to having package inserts in English. The survey found that while a majority of HCPs search for information digitally, having product information in English only would pose a challenge. The survey allowed multiple options to be selected. It found that 84% search for medicine information via the trusted digital source Fass (Farmacevtiska Specialiteter i Sverige), produced by the Pharmaceutical Industry Association's Service AB (Lif), but 47% also use paper package inserts.
In Norway, where there is a high degree of digital literacy, the national competent authority, NOMA, is co-operating with Felleskatalogen (known as the Common Catalogue, a compendium of pharmaceuticals marketed in Norway) and other relevant stakeholders to raise public awareness about the availability of digital medical information not only to healthcare professionals but to patients as well.10 The initiative seeks to guide the public in the use of trusted and authorized electronic leaflets as opposed to turning to non-controlled sources such as Google and ChatGPT. This approach serves to steer the change to ePI in a more controlled manner.
Acceptance of digital information was further underscored by a Finnish study into patients’ views on the package leaflet and the potential for an electronic leaflet finding a majority (88%) see a positive in using electronic leaflets.11 The study found that even with the paper leaflet many patients don’t read the information supplied (81% of repeat medicine users and 38% of new medicine users don’t read the leaflet.)
The European Commission's proposed pharmaceutical legislation recognizes the importance of ePI, but concerns have been raised about how to operationalize its gradual implementation, depending on member state readiness, if it is not implemented in a harmonized way.12
Familiarity leads to electronic comfort
Digital literacy is another consideration, with data from the EU showing about 32% of Europeans lack basic digital skills, which has led the EU to implement a variety of policies and initiatives aimed at addressing that gap.13
Nevertheless, these pilots give some insight into how HCPs adapt to, and even prefer, electronic product information once they become accustomed to it. Furthermore, people generally are growing more comfortable with using digital resources for information in every aspect of their lives. While the switch to ePI can be daunting at first, the indication from the pilots is that for many it has become the preferred way of working. This bodes well for a future transition to electronic patient leaflets.
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Disclaimer:
The information provided in this article does not constitute legal advice. Cencora, Inc., strongly encourages readers to review available information related to the topics discussed and to rely on their own experience and expertise in making decisions related thereto.
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Sources
1. Electronic product information for human medicines in the EU: key principles. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/electronic-product-information-human-medicines-european-union-key-principles_en.pdf
2. DIGITAL LEAP: Industry Proposes Phased Rollout of ePI for Patient Safety and Environmental Sustainability, Jan 2025. https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/digital-leap-industry-proposes-phased-rollout-of-epi-for-patient-safety-and-environmental-sustainability/
3. Product Lifecycle Management Portal, EMA. Knowledge Base - Category Details - PLM · PLM
4. https://www.youtube.com/watch?v=_tHxDbLKI18&t=3s
5Reflection paper on linking to electronic product information (ePI) from EU medicine packages, EMA, March 2025. https://www.ema.europa.eu/system/files/documents/other/draft-reflection-paper-linking-epi-eu-medicine-packages_en.pdf
6.Electronic patient information: Results of the e-PIL pilot from Belgium and Luxembourg hospitals, Regulatory Rapporteur, Sept 2025. Electronic patient information: Results of the e-PIL pilot from Belgium and Luxembourg hospitals | Licence | Regulatory Rapporteur
7.Electronic product information for medicines, European Commission, European Commission, Pharmaceutical Committee, April 2025. 470a1385-c63d-40d3-ac7b-9a0277618158_en
8.What is the Pilot Project diGItal? Project Overview - diGItal Pilotprojekt
9.https://www.lakemedelsverket.se/globalassets/dokument/publikationer/information-fran-lakemedelsverket/info-fr-lv-2-2024-webb.pdf (information in Swedish)
10.Use digital package leaflets, NOMA. Use digital package leaflets - Norwegian Medical Products Agency
11.Medicine users’ views on reading the package leaflet and the potential for an electronic package leaflet, University of Helsinki. https://helda.helsinki.fi/items/20c81db8-8723-488f-a8cd-043cb8eeb2e8
12.Position Papers on Electronic Product Information (ePI), Inter-Association Task Force (IATF), Jan 2025. https://www.efpia.eu/media/2sgl2zyh/iatf-position-papers-on-epi.pdf
13.Digital literacy in the EU: An overview, European Union, Dec 2023. Digital literacy in the EU: An overview | data.europa.eu
