The European Union is planning to do away with paper leaflets for medicines, in favor of access via QR code. This reform, designed to simplify and update medical information, raises major concerns about accessibility and industrial sovereignty. This change raises major issues for the pharmaceutical printing industry.
Pharmaceutical printing and the abolition of leaflets
Printing leaflets is a specialized activity, governed by strict standards (GMP, ISO 15378, ISO 9001) and highly automated. It's not just a printed and folded leaflet, but a highly standardized product that calls for technical know-how involving mastery of the medium's low grammage, legibility and complex folding.
Reducing or eliminating this service would have a direct impact on printers specialized in printing these leaflets on fine paper, and would lead to a complete reconfiguration of the value chain.
QR codes, the new standard for accessing medical information?
In this project, the printed leaflet would be replaced by a QR code on the packaging. The QR code offers real-time updating, multilingual translation and accessibility (such as audio versions). However, integrating the QR code into the boxes would require a new packaging design, a new organization of data flows and management of the secure digital link.
For packaging manufacturers and printers, this means upgrading to variable-data digital printing tools, dynamic link management and compatibility with pharmaceutical companies' IT infrastructures. QR codes can only be integrated as part of a healthcare data security program, with encryption and compliant hosting.
From October 1, as part of an experiment supervised by France's Agence nationale de sécurité du médicament et des produits de santé (ANSM), the packaging of 93 prescription drugs and over 400 hospital drugs will display a QR code directly on the boxes. In the hospital sector, the paper leaflet should be completely eliminated.
A digital divide incompatible with universal access to information
The European Union assures us that this change will ensure that information flows more smoothly. User associations, however, denounce the risk of exclusion. For many patients - particularly the elderly or those living in poorly-covered areas - access to medical information via a QR code, which requires an Internet connection, remains a technological barrier.
In an open letter published on April 11, addressed to the Minister of Health and the Minister of Europe and Foreign Affairs, the UFC-Que Choisir association warns of this risk. It states that "the paper leaflet, inserted in every pack of medicine, is currently the most accessible information medium" and calls for it to be maintained "without exception or progressive substitution logic" . This initiative is part of a wider mobilization of consumer and healthcare user associations, also relayed at European level by the European Consumers' Organisation (BEUC) and the European Patients' Forum.
Similarly, France Assos Santé published an information note on March 13, in which it acknowledges the benefits of digital package inserts (such as rapid updates, multilingual accessibility or formats adapted for the visually impaired), while firmly opposing their exclusive generalization. The organization, which represents patients and users of the healthcare system, calls on European parliamentarians and French authorities to "defend the complementary nature of the dematerialized leaflet compared with the paper version, ruling out any replacement in the short or medium term".
In addition to accessibility issues, the association also points to a risk in terms of privacy protection: online access to these notices could "provide sensitive information on patients' state of health" to unauthorized third parties. These fears raise the question of data sovereignty and the responsibilities of players in a digitized system.
A challenge to the economic equilibrium of subcontractors
For some specialist printers, the volume of leaflets represents a significant proportion of their sales. A drop in this volume, without immediate industrial compensation (transfer to interactive packaging or other production segments), could affect sites already weakened by price pressure from the pharmaceutical sector.
The necessary adaptations - variable data printing, digital authentication solutions, development of intelligent packaging - require high technical investment for low margins. Without support for the industry or co-development with laboratories, the transition could lead to the disappearance of long-established players.
