Meeting The Challenges: How Ema Communicates The Benefits and Risks Of Medicines to The Public

Abstract

In an era of information overload and digital communication, patients increasingly welcome clear and unbiased information on the benefits and risks of medicines to participate in treatment decisions. Providing accurate information on benefit-risk evaluations (e.g. approval of a medicine or restrictions in its use), is key to EMA's role of promoting and protecting public health. From EMA's perspective as medicines regulator, challenges to overcome include: difficulty of summarising complex information while conveying a complete and balanced picture, addressing varying health literacy levels and measuring how useful the information is. EMA faces these challenges as it works to improve the information on the benefits and risks of medicines for the public, with the aim of ensuring that patients and healthcare professionals can access highquality information on medicines assessed by EMA.