European Commission releases report recommending changes to the SmPC and PIL

The European Commission has published a report summarising the findings of two studies carried out to establish if and how the SmPC and the PIL can be improved for patients and healthcare providers.

The studies were carried out by NIVEL (Netherlands Institute for Health Services Research) and the University of Leeds, UK and are referred to as PIL-S and PIL-BOX. The PIL-S study intended to look at the overall readability of the SmPC and PIL to assess whether they provide easily understandable information. Ultimately, the report intended to identify the shortcomings of the current SmPC and PIL layout and content and make any recommendations for necessary improvements. The PIL-BOX study looked at the feasibility and desirability of introducing a “key information section” in both the SmPC and the PIL to further enhance the delivery of key information to patients and healthcare providers.

The conclusions of the PIL-S study were that, although in general the SmPC is satisfactory, the PIL requires changes to ensure that the information provided and the layout in how it is provided are optimal for the patient. The report advises that the guidelines relating to the content and structure of the PIL are updated to provide guidance on “the principles of good information design”. The report identified that there are certain sections of the PIL that are considered to be less relevant than others to the patient, and suggested that these sections could be deleted in order to make room for more relevant information to be included. The report found that the current user testing is valuable to the design of the PIL, but also states that there is room for improvement by making the process more iterative. Flexibility in allowing the content of the PIL to be adapted more specifically to each product was also recommended, and lastly the report identified the importance of good translations, ensuring that lay language is maintained when the document is translated. The report also touched upon the possibility of electronic media in delivering information to patients, but concluded that this should be explored in more detail before introduction and should enhance rather than replace the current hard copy approach.

The conclusions of the PIL-BOX study were that although it was of potential interest to add a “key information section” to the SmPC and PIL, further investigative work needs to be carried out to establish how this would be achieved. It is possible that this may follow on the back of the planned test introduction of a similar section in the summary EPAR, which could assist with identifying the relevant information that may benefit from being delivered in such a way.

The conclusions of these two reports will be taken into account by the European Commission and the European Medicines Agency, who will both begin work to implement these recommendations in collaboration with the member states and in consultation with the industry. The movement towards greater involvement of patients in their treatment will benefit from these recommendations, and the improvement in a patient’s ability to understand the information provided to them ultimately will help to improve compliance, reduce medication errors and interactions, and build greater trust and collaboration between patients and their healthcare providers.

The report from the European Commission can be found here.