Will the European Union see the end of paper leaflets in medicine boxes? At any rate, that's the direction one of the European Commission's drug reform proposals is taking. Article 63.3 would make the paper version of package inserts optional, at the discretion of EU member states.
"Member States may decide to make the leaflet available electronically, or in both paper and electronic form." In the event of a Member State deciding that the package leaflet should be digital only, patients will be able to request a printed copy of the leaflet from the marketing authorization holder.
A high risk of exclusion from access to information
For Intergraf, this proposal undermines the accessibility of information for patients. The European Printing Association urges the European Union to reconsider this new regulation, underlining the essential role of medical leaflets in pharmaceutical packaging.
The organization cites data from Eurostat 2023, which shows that 70.7% of Europeans have only basic, weak or non-existent digital skills, and that 7.5% of European households have no access to the Internet.
"Thus, the use of digital access to drug information risks excluding many patients, particularly those who are vulnerable due to age, lack of digital skills or limited resources she points out. Progress in the digital healthcare system must not lead to the exclusion of a significant part of theâeuros population; it is crucial to give priority to the safety and health of all patients."
Print-on-demand for pharmacists? Not a practical solution
Furthermore, the patient's right to a printed copy is not, in Intergraf's view, a realistic solution. The proposal does not provide a practical solution for implementing this provision. "We understand that the proposal suggests that the provision of a printed copy could be provided at the point of sale, i.e. by pharmacists." Gold "pharmacies can't meet the rigorous printing standards and safety requirements of medical leaflets, unlike the industrial processes of the pharmaceutical industry." What's more, there's no analysis of the economic feasibility of this provision.
In view of these concerns, Intergraf is calling for the mandatory retention of paper leaflets in drug packaging.
