The Danish Medicines Council (Medicinrådet) is changing the structure of its medicine assessment reports to show more explicitly how patient experience contributes to assessment and recommendation decisions.
Patient representatives already participate in almost all of the Council's expert committees and contribute evidence on living with the disease, treatment effects and adverse effects, and their consequences for quality of life. The change does not create a new participation route but introduces a dedicated section in assessment reports documenting how that evidence has informed the committee's work and the basis for the Council's decision.
The Council currently has 85 patient representatives across 63 expert committees. Representatives may be patients, relatives or nominees from patient organisations and participate in committee meetings alongside other members.
The revised reporting format follows a 2024 evaluation undertaken with the Danish Patients organisation and the Centre for User Involvement in Healthcare. Patient representatives generally reported positive involvement in committee work but sought greater visibility of their contribution and clearer insight into how patient perspectives were reflected in subsequent decisions.
The new section will apply to medicines with application dates from August 2026 and is expected to appear in assessment reports for cases considered from December onwards.
The change strengthens the traceability of qualitative patient evidence within Danish medicine assessment. It will make clearer which aspects of disease burden, treatment experience and patient priorities have influenced the expert committee's assessment and how those considerations sit alongside clinical and economic evidence in the published decision record.
Source: Danish Medicines Council
Link: Medicinrådet styrker synligheden af patienternes bidrag i vurderingen af ny medicin (Danish Medicines Council strengthens the visibility of patient contributions in the assessment of new medicines)
Date: 10 September 2026
Source: Danish Medicines Council
Link: Ny rapport: Hvad er vigtigt for patientrepræsentanterne i Medicinrådets fagudvalg? (New report: What is important to patient representatives on the Danish Medicines Council's expert committees?)
Date: 5 December 2024
