The medicines we buy in the EU contain a package leaflet which should provide us - the user, with clear information on the medicines we are taking – name of the product and the manufacturer, therapeutic indications, dosage, shelf life, adverse reactions, and more. EU rules in place since 2001 ensure this.
Today, the Commission publishes a report to the European Parliament and the Council on current shortcomings in the summary of product characteristics and the package leaflets, and puts forward recommendations on how they could be improved to better meet the needs of patients and healthcare professionals.
Some examples of recommendations identified in the report are:
- There is more room for improvement of the package leaflet rather than the summary of product characteristics.
- The package leaflet should be improved to make it more readable and understandable by all patient groups including the elderly and those with low literacy skills.
- With regard to readability, the content and layout, for example font size, line spacing and the length of the package leaflet, should be jointly taken into account.
- When translating the leaflet text into other languages, care should be taken that 'lay' language is not lost in translation.
- User-testing is important and input from patients during the leaflet development process should be further improved, focusing especially on the content.
- Good examples of package leaflets should be made available to pharmaceutical companies, on a suitable platform, to promote best practices.
- Making product information available in electronic in addition to paper form should be explored and key principles agreed upon.
- The potential introduction of the key information section in the package leaflets that would allow easy identification of the most important information needs to be further tested.
These recommendations should be implemented by improvements of the existing regulatory guidelines rather than by any changes of the legislation. The Commission and the European Medicines Agency (EMA) will work on this in collaboration with competent authorities in EU countries.
The assessment was based on two studies requested by the Commission. These were the "PIL-S Study" – a study on package leaflets and the summaries of product characteristics of medicinal products for human use, and the "PILS-BOX Study" on the feasibility and value of a possible "key information" section in such leaflets and summaries. Both studies involved input from key stakeholders and from Member States. The EMA collaborated closely with the Commission for the preparation of this report.
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