Medicines are assessed on quality, safety and efficacy. Patients and carers experience the full picture: what improves day to day, what trade-offs come with treatment and what is realistic to manage outside the hospital.
Right now, this part of the story is not always captured as structured evidence in medicine development and review. That is the gap patient experience data (PED) is meant to fill. PED brings together patients and carers experiences of living with a condition and using treatments, including symptoms, side effects, quality of life and treatment burden, in a way that can be used as evidence during medicine development and review.
In January 2026, EFA responded to the EMA stakeholder consultation on a draft European Medicines Agency (EMA) Reflection Paper on patient experience data (PED). EFA’s input reflects the needs of people living with allergy and airways diseases and their carers when it comes to medicines.
EFA Community provides input from 6 European countries
The Reflection Paper has the potential to change how medicines are reviewed in the EU. It could also improve the adequacy and appropriateness of medicines for people living with allergy and airways diseases as well as carers.
Building on steps taken by other regulators, such as the UK and the U.S. Food and Drug Administration (FDA), the EU is moving towards an approach to include patient experience data (PED) in the medicine development cycle. In this context, the European Medicines Agency (EMA) drafted a Reflection Paper on what this guidance could include and opened it for stakeholder comments.
EFA responded to the consultation with three practical messages on clearer access to information, better collection methods, and the barriers patients face. Our input was shaped through an EFA community workshop in December 2025 with patient representatives from Italy, Germany, Slovenia, Spain, Luxembourg and Austria.
Three main points raised by EFA
Make it easier to understand how patients can take part: Patients often want to contribute, but opportunities can be hard to find and processes can be unclear. EFA encouraged EMA to work closer with national authorities to make information on how to engage with PED opportunities easier to understand. Clinical trial information should be shared further to improve patient decision-making. EFA members suggested online activities on specific medicines, such as online webinars or social media campaigns.
Improve how PED is collected so it supports decisions across the medicines lifecycle: EFA encouraged EMA to work more with patient organisations, as they deal with patient experience every day and have many sources of useful data for regulators. EMA should strengthen digital collection methods of data and develop approaches designed for specific population groups, rather than relying on one-size-fits-all tools.
Reduce the practical barriers that make engagement difficult: patients and carers face barriers such as complex language, unclear requests and websites that are difficult to navigate. EFA also noted a broader risk: when official information is hard to find or understand, people may turn to informal online spaces for guidance. EMA and national authorities should make reliable resources easier to access and use for patients and carers to make decisions without relying on fragmented sources.
EFA’s response was developed based on the EFA community workshop. We thank the following EFA members for their valuable input: Food Allergy Italia, Österreichische Lungenunion, Luxembourg Allergy Network (LAN), Federación Española de Asociaciones de Pacientes Alérgicos y con Enfermedades Respiratorias (FENEAR), Asociación Española de Personas con Alergia a Alimentos y Látex (AEPNAA), Deutscher Allergie- und Asthmabund (DAAB), Društvo Atopijski dermatitis.
Read more about our response to the consultation here.