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European Commission reports on package leaflets, SmPCs

The European Commission has issued its report on the shortcomings of the Package Leaflet and Summary of Product Characteristics - at last! 

The long-awaited report, which has featured on these pages before, has changed a little since a draft was discussed by the Commission's Pharmaceutical Committee in 2015. The main ideas discussed are:

  • Loosening the restrictions of the QRD template, which are felt to be "too restrictive in some respects"
  • Introducing best practice guidance on the presentation and content of PLs (in preference to SmPCs)
  • Suggested measures to preserve the "lay-ness" of lay language in PLs, even after translation
  • "Further improved" input from consultations with patients by clearer methodology, and making testing "more iterative", and better aligned to the regualtory timetable
  • Headline summaries of key information, and electronic presentations of patient information – both of which need further exploratory research, it suggests.  

There are puzzling aspects to the paper, not least the suggestion that "the iterative testing should focus on the content of the PL, rather than the format and layout, to ensure that information is clear and written in a way which is easily understood by patients." That appears to be at odds with the legal requirement to ensure that PLs are "written and designed" to be clear and understandable to the patient. There can be no clear information without clear formats and layout - and other parts of the paper stress the importance of "principles of good information design".   

To see the Commission's paper, click here.