Press release: Legal opinion warns against replacing medicine leaflets with QR codes alone
A new legal opinion has found that electronic Product Information (ePI) cannot automatically replace the printed medical leaflet with a QR code or online link, highlighting potential risks to patient safety and accessibility if essential medicine information is provided digitally only.
Prepared by Prof. Martin Wesch of a law firm in Stuttgart, Germany, for the European Carton Manufacturers Association (ECMA), the legal opinion examines whether ePI can replace traditional printed medical leaflets completely and considers what the proposed new EU pharmaceutical legislation means for the future of medicine information.
It concludes that patients must have a reasonable opportunity to access and familiarise themselves with the information needed to use their medicines safely. While digital information should be easily accessible, patients who cannot readily access electronic information must not be left without the information they need.
New EU rules do not require digital-only medicine information
The proposed EU Pharmaceutical Directive would give ePI possibly a greater role but would not establish a mandatory digital-only system across Europe. Under the proposed legislation, the default approach would be to provide the package leaflet both in paper form inside the medicine pack and electronically.
Member States could, following consultation with major stakeholders of the healthcare system, allow electronic-only provision for certain categories of medicines, or potentially more broadly. However, even where electronic-only provision is permitted, patients would retain the right to obtain a printed copy free of charge on request.
The political agreement between the European Parliament and Council was reached in December 2025, with the legislation expected to enter into force before the end of 2026.
Concerns over pharmacy print-on-demand systems
The legal opinion by Prof. Wesch highlights an important patient safety question around the practical implementation of print-on-demand systems. Where electronic-only provision is permitted, patients could request a printed leaflet, which may then be produced at a pharmacy rather than supplied as a professionally produced leaflet inside the medicine pack.
According to the legal analysis, these systems could introduce new risks for patient safety. Unlike pharmaceutical manufacturers, pharmacies are generally not subject to the same Good Manufacturing Practice (GMP) requirements that govern leaflet production, and their printing processes may not be validated to the same standards. The opinion also points to the absence of certain controls associated with industrial leaflet production, including retained control samples that can verify exactly which version was supplied to a patient.
There are also practical risks. Pharmacy staff could select the wrong leaflet, particularly where medicines with the same name are available in different strengths or dosages. Printing errors, missing text, smudging or poor print quality could also affect important safety information.
For these reasons, the opinion concludes that industrially produced paper leaflets provide important safety safeguards that may be lost through pharmacy print-on-demand systems.
Supporting a hybrid approach Rather than treating paper and digital information as competing alternatives, the legal opinion recommends a hybrid “paper plus ePI” approach. Under this model, the paper leaflet could focus on essential safety information, while more detailed or supplementary content is provided electronically. A shorter paper leaflet could also improve readability through clearer layouts and larger type.
ePI offers important advantages, including rapid updates and access to additional information. At the same time, the opinion highlights the importance of ensuring that patients receive information corresponding to the relevant version of their medicinal product information.
“Digital tools have an important role to play in the future of healthcare, but they should make access to medicine information easier, not more complicated,” said Mike Turner, Member of the Executive Board of ECMA’s subgroup “Medical Leaflets Patient Safety”. “Not every patient has the same level of digital access or confidence. That’s why it’s so important that essential medicine information remains available to everyone.”
The legal opinion therefore supports digitalisation without automatically replacing the physical leaflet. Its preferred approach is for paper and ePI to complement each other, keeping essential safety information in a professionally produced leaflet while using digital information to provide additional, accessible and up-to-date content.
About Medical Leaflets Patient Safety
Medical Leaflets Patient Safety (MLPS) is a European coalition advocating for safe, accessible and inclusive access to medicine information. MLPS supports a patient-centred approach in which printed and digital medicine information work together to ensure that all patients can access the information they need to use medicines safely. Established in 2020, MLPS is supported and financed by specialist healthcare packaging manufacturers within the European Carton Manufacturers Association (ECMA).
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