Comments on the Draft Royal Decree Regulating the Pricing and Reimbursement of Medicines in the Spanish National Health System

The Ministry of Health should adopt an explicit methodology for assessing clinical benefit, specifying appropriate comparators, evidence quality standards, and validated tools such as the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS), and should reconcile the several overlapping benefit definitions used across the decree. Reassessment of reimbursed medicines should be mandatory every three to five years rather than discretionary, and assessment bodies should have access to actual net prices, with limits on confidential discounts that weaken public negotiating power and undermine international reference pricing.