Spain adds social‑value criteria to innovative drug assessments

Spain has introduced a new legal framework for evaluating innovative medicines, adding social value as a key criterion alongside clinical benefit and economic assessment. The Royal Decree on Evaluation of Health Technologies and the draft Royal Decree on Financing and Pricing of Medicines consider factors such as patient autonomy, quality of life, reduced need for dependency‑related resources, shorter sick‑leave periods and productivity gains. The changes were discussed at a summer course organized by the Universidad Complutense de Madrid and Roche Farma, attended by health authorities, health‑economics experts, clinicians and patient‑association representatives. Roche Farma Spain’s Federico Plaza said the measures aim to sustain the health system while positioning Spain as a European hub for biomedical innovation.

The new framework also proposes accounting for informal‑care costs, out‑of‑pocket expenses (transport, home adaptations, copayments, private physiotherapy or psychology) and productivity losses from absenteeism and presenteeism of patients and caregivers, thereby integrating the patient perspective more fully into reimbursement decisions.