Last week Myeloma Patients Europe (MPE) submitted a response to the European Medicines Agency (EMA) open consultation on their “Reflection paper on patient experience data (PED)”. PED refers to data from patients that includes their perspectives, preferences and experiences with different aspects of their disease and treatments, such as quality of life and risk tolerability,

You can read the MPE full response to the consultation here.

MPE, as a member of the EMA Patient and Consumers Working Party (PCWP) and as an organisation regularly involved in EMA activities and assessments, welcomed the opportunity to comment on this paper. The declared purpose of the document is to “encourage systematic consideration of PED in medicine development programmes and regulatory submissions” by setting up general principles on the use of PED, as well as main types and main sources of such data.

While MPE appreciated the paper for bringing PED into focus as part of a wider effort to have patient involvement in medicine regulation as an active, meaningful, and holistic process, it also identified a series of recommendations to strengthen these efforts:

• More clarity is needed on how PED can and should be used in EMA decision making.
• A stronger emphasis is needed on the importance of PED to EMA decision-making and stronger language incentivising industry to generate and utilise this data.
• The reflection paper should better address the challenges brought by the new EMA and EUHTA approaches to conflicts of interest (CoI).
• We would like to see clearer avenues set out on how patient groups seek advice from EMA on PED, how we submit it, what the EMA want to see from patient organisations and how it could be taken into account.
• Specific guidance is needed on how carers are and should be included in PED.
• Clearer examples and best practice case studies are missing from the text and should be highlighted.

The comments received during this public consultation will be reviewed by the EMA and the final version will be adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Medicinal Products for Human Use (CHMP).

Another consultation currently open at the EMA concerns Patient Preference Studies (PPS) and the value that patients place on characteristics of drugs. The consultation will be open until 12 April 2026. MPE intends to respond to this as well.

Please see the full text of the comments submitted by the MPE on the PED guidelines.

If you have any comments please message info@mpeurope.org.