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Spain Halves Time to Fund Innovative Medicines, Health Ministry Reports

Officials now seek to cut the authorization‑to‑funding timeline to roughly 180 days through planned legal and organizational changes.

Overview

  • Median time from national registration to public funding fell from 615 to 303 days for medicines authorized between July 2023 and June 2024.
  • The national health system funded 149 of 230 EU‑authorized innovative medicines (64.8% overall), covering 78.8% of those that applied for funding in Spain.
  • About one in six EMA‑cleared medicines did not enter Spain’s pricing and reimbursement process because companies did not request national registration.
  • Early‑access pathways under Medicamentos en Situaciones Especiales were used for 57.8% of EU‑authorized drugs, with 85.9% of funded cases approved on first review.
  • Total EU authorization‑to‑funding medians declined to 503 days, 90% of decisions arrived within 18 months, and initial AEMPS registration remained quick at a 42‑day median.