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Spain manages high-cost priority medicines through conditional national financing decisions within the ordinary public reimbursement framework. Additional funding is then delivered through hospital and regional budget mechanisms, with tightly controlled exceptional patient routes for defined clinical circumstances.

Spain’s early-access routes are administered nationally by the Spanish Agency of Medicines and Medical Devices and cover pre-authorisation compassionate use, access to foreign medicines and controlled off-label use, with route-specific funding and monitoring arrangements.

Spain controls medicines utilisation and expenditure through a system of national prescribing and dispensing rules, electronic prescribing controls, and regional management instruments.