AGE endorses a joint statement calling on the EU to guarantee the right to maintain paper medicine package leaflets and to use electronic options as a complementary tool.
The removal of paper package leaflets for accessing medicine information and the shift to Electronic Product Information (ePI) will create a digital divide. This will impose a level of digitalisation without considering those who do not want to use a smartphone/tablet, or cannot, due to age, geographical location, disability, health, income, religion or social situation.
Paper package leaflets are essential for patients to safely and effectively use medicines. They offer immediate access to approved, complete and unbiased information that helps the patient to make an informed decision.
Ahead of the future co-legislators’ interinstitutional negotiations on the European Commission’s Proposal for a revised pharmaceutical legislation in the European Union, AGE Platform Europe, Standing Committee of European Doctors (CPME), Pharmaceutical Group of the European Union (PGEU), The European Consumer Organisation (BEUC), European Hospital and Healthcare Federation (HOPE), International association of mutual benefit societies (AIM), European Federation of Nurses Associations (EFN) and European Association of Hospital Pharmacists (EAHP), appeal for inclusive provisions that leave no one behind and are respectful of privacy and personal data protection to:
- Contribute to an inclusive society, without enacting discriminatory rules that increase the digital divide and limit individuals’ choice
- Recognise the importance of the package leaflet as a key tool for information accessibility
- Balance the advantages and disadvantages of Electronic Product Information (ePI)
- Protect patients’ privacy and guarantee that the information is not used for commercial purposes
- Listen to patients and other end users as an evidence-base for action
Paper leaflets must remain a key source of patient information, while electronic options should serve as a complementary tool, not a replacement.
Useful links
- AGE Paper: “Digitalisation and older people: our call to EU policy makers”
- BEUC: Position on the European Commission’s proposal for a revised pharmaceutical legislation.
- PGEU: Position paper on the reform of the EU Pharmaceutical Legislation and PGEU position on electronic product information.
- CPME: Proposed amendments to the Commission’s Proposals for the Directive on the Union code relating to medicinal products (...)
- EFN: EFN PS improving frontline nurses’ time for direct patient care with digitalisation & responsible AI
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