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Focus on Regulation

European Commission publishes recommendations concerning the summary of product characteristics and patient information leaflet for medicinal products

 

The European Commission (EC) has published a report (Report) recommending improvements in the summary of product characteristics (SmPC) and the Patient Information Leaflet (PIL) of medicinal products for human use. The report identifies shortcomings concerning the SmPC and the PIL, and provides recommendations on the way in which SmPC and PIL could be improved.

Background

The Report is the results of two studies, PIL-S and PILS-BOX, combined with another related survey involving European-wide stakeholders. The studies addressed the issues of readability and comprehensibility of the SmPC and PIL. The studies also examined the potential impact of the addition of a ”key information section” to the PIL and SmPC related to safety and efficacy of medicinal products.

Considering the results of the studies the European Commission concluded that the PIL required more improvements than did the SmPC. However, it was stated that more research needs to be done as far as the inclusion of the ”key information section” is concerned.

Shortcomings and Recommendations

Shortcomings were identified, in particular, with regard to the readability and comprehensibility of PIL, in relation to both content and layout.

It was argued in responses to the studies that the language used in the PIL was usually complicated. Moreover, the layout and design of the document are not always user-friendly. Among the main issues identified related to the length of the PIL, the small font size, as well as the narrow line spacing.

Although the current guidelines, namely the Readability Guideline, the Packaging Information Guideline, the SmPC Guideline, where appropriate, and the quality review of documents (QRD) template, assist stakeholders in developing the SmPC and PIL, it appears that there is still need for improvement.

The European Commission also concluded that ‘the current guidelines and the QRD templates are too restrictive’.

On the basis of these conclusions, the European Commission provided the following recommendations:

  • The revision of the current guidelines and the quality review of documents (QRD) template. The EC argued that the current guidelines should include the principles of good information design as well as an introductory guidance on translations;
  • The importance of patients’ involvement in the process of PIL development, and suggested to conduct iterative user testing in order to improve the PIL;
  • Promote and exchange best practice examples of the design of PIL and SmCP by developing an online platform. The platform could be accessible by pharmaceutical companies;
  • Create electronic formats of PILs and SmCPs, supplementing the paper ones. Electronic tools could be used, for example, in order to inform patients about changes in the SmPC and PIL.

The European Commission in cooperation with European Medicines Agency will ensure the implementation of these recommendations to improve both the PIL and SmPC.