From Product Information to Promotional Material - Electronic Product Information: Creating a Meaningful Future for Patient Information in Europe

Description: The patient information leaflet (PIL) is the primary tool to provide patients with the proper information for safe and effective use of their medicinal products. The debate on how to improve this document has not resulted in significant changes. A call for change is reflected in current legislation, where the EU Commission was called to prepare a report on current shortcomings in both the SmPC / PIL and how they could be improved to better meet the needs of patients and healthcare professionals. This led to the publication of the EMA action plan.

The main recommendation outlines that patients’ comprehension of especially the PIL and its readability can be improved. The language used is often too complex and the design and lay-out are not always user-friendly. Those with low literacy skills are particularly disadvantaged, but generally these problems hold for all patient groups. (Digital) health literacy is now a priority in EU, this is the time to continue the debate in a broader context and develop actionable recommendations in light of the action plan. Together with the recently published electronic product information (ePI) principles there is a need to have a broad discussion on both the development and dissemination of electronic formats and how these can improve patients knowledge, motivation and competencies to access, understand, appraise, in applying health information in order to make subsequent judgments and decisions regarding their health and treatment.

Concluding: this session should consider current technological advances and developments in digital health. Especially since the foundations of ePI are currently being developed, it is of essence to ensure that this goes hand in hand with the discussion on improving patients understanding of the content, and enhancing integration with healthcare systems, and distribution of the most current medication information.