Amsterdam, 29 September 2025EMA has published a draft reflection paper on patient experience data for public consultation. These are data directly reflecting patients’ experience or preferences on treatments or outcomes, without any interpretation by a clinician or anyone else. Patient experience data provide medicines regulators and other decision-makers in healthcare systems with valuable insights into what matters most to patients, beyond other well-established scientific outcomes. Patient experience data can be provided through Patient Reported Outcomes (PROs), Patient Preference Studies (PPSs), as well as other forms of information obtained via patient engagement activities. This draft reflection paper is open for public consultation until 31 January 2026.