First EMA Workshop on Health Literacy! Impact on Risk Communication


On 17 March, the EMA hosted its first ever event on health literacy – a lunchtime talk titled “Getting the message across: How health literacy impacts risk communication”. Health literacy involves people’s capacity to find, understand and evaluate health-related information and take action about their health.

The challenges for regulators lie in creating comprehensive and balanced messages about the benefits and risks of medicines that are widely accessible to audiences with varying degrees of health literacy, medical knowledge and numeracy.

The lunch talk brought together three different but complementary perspectives on health literacy and benefit-risk. Kaisa Immonen-Charalambous on behalf of EPF started off the debates by introducing the concept of health literacy to the audience. Professor Wolfgang Gaissmaier from the University of Constanz in Germany then followed on by shedding some light on the current state of the research on benefit-risk communication. Finally, June Raine from the UK Medicines and Healthcare products Regulatory Agency (MHRA) and chair of the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) tied it all altogether and explained what this means for the regulators.

At the end of a somewhat lively discussion, some steps forward were identified: the first one is to review the current guidance on the patient information leaflet (PIL) with a view towards making those leaflets more patient friendly; and the second step agreed being to explore further the possibility of complementing this by a “drugs fact box” or similar.

Videos from the event will be available on the EMA website in due course.

If you have any questions or would like more information about this event please contact