Member States debate medical leaflets in pharmaceutical packaging
Discussions on the role of packaging in pharmaceutical legislation are underway, with Member States beginning to consider the inclusion of electronic Product Information (ePI) as an alternative to printed medical leafle ts. According to updates from the industry coalition MLPS, early Council discussions indicate openness to the voluntary use of ePI.
However, some Member States are strongly opposed to giving the European Commission the authority to introduce mandatory ePI via secondary legislation. Concerns have also been raised about the funding and implementation of printon-demand systems for medical leaflets. While some Member States support shifting these costs to manufacturers, others oppose burdening healthcare systems or pharmacies with additional expenses. Meanwhile, the Commission maintains that ePI’s value will become evident once paper leaflets are phased out, a position that raises significant concerns for patient safety and accessibility advocates.
With the Polish Presidency aiming to adopt a Council position by June 2025, this is a critical moment for stakeholders to engage with national ministries and advocate for the retention of printed medical leaflets. Printed versions remain essential for accessibility and patient safety, particularly for individuals without reliable digital access. Intergraf encourages stakeholders to take advantage of the advocacy materials and information available upon request to ensure these concerns are represented in ongoing discussions
Source Inergraf Feb 2025