Industry association Intergraf has called for the retention of paper leaflets in medicinal products, as the EU considers legislation to ensure the accessibility and safety of patient information in a digital format.

Intergraf is a European printing industry association, representing employers in the graphical sector. The association’s primary goal is to represent and advocate for Europe’s printing industry, working with the European Union to support the sector’s competitiveness through advocacy, information[1]sharing, networking, social dialogue and European projects.

With this in mind, Intergraf has urged the European Union to reconsider Article 63.3 of the proposed Directive on Medicinal Products, and emphasised the ‘essential’ role of medical leaflets in pharmaceutical packaging.

The legislative proposal under consideration aims to ensure the accessibility and safety of patient information in a digital format. While Intergraf noted this goal as ‘commendable’, it cited Eurostat 2023 data that revealed 70.7% of Europeans possess only basic, low, or no digital skills, whilst 7.5% of European households have no internet access. ‘Thus, the reliance on digital access to medication information risks excluding many patients, particularly those who are vulnerable due to age, lack of digital skills or limited resources,’ Intergraf stated. ‘The advancement of the digital healthcare system should not result in the exclusion of a significant part of the population; it is crucial to prioritise the safety and health of all patients.’

Whilst Article 63.3 proposes that patients can request free printed copies of digital-only package leaflets, Intergraf claimed this ‘lacks practical implementation solutions’. Specifically, Intergraf warned that, ‘Pharmacies cannot meet the rigorous printing standards and security requirements for medical leaflets, unlike industrial-level processes in the pharmaceutical industry.’

Intergraf underscored the importance of complementarity between electronic product information (ePI) and paper leaflets. ePI enhances access to medication information for some demographics but cannot replace paper leaflets accompanying medicines. ‘The exclusive use of ePI should only be considered in exceptional circumstances, such as when medicines are administered by medical  professionals, like in-hospital patients,’ the association stated.

In light of these concerns, Intergraf is calling for the mandatory retention of paper leaflets in the packaging of medicinal products.

Intergraf is a supporter of MLPS – Medical Leaflet = Product Safety, a group formed in 2020 by a collective of specialist, regulated healthcare packaging makers within the European Carton Manufacturers Association. MLPS firmly believes that printed pharmaceutical literature should remain the primary source of information for patients and healthcare professionals, ‘to guarantee a safe and accurate delivery of medication information.’

Intergraf’s detailed position paper on the retention of printed packaging leaflets can be downloaded here