Spain has introduced a common national protocol for high-complexity pharmaceutical treatments provided outside a patient’s autonomous community of residence. Approved by the Interterritorial Council of the National Health System (Consejo Interterritorial del Sistema Nacional de Salud, CISNS) on 10 July 2026, it initially covers 12 advanced therapy medicinal products and 54 other treatments costing at least €80,000 per patient per year.
Specialist expertise and infrastructure for these treatments may be concentrated in particular centres. Patients in autonomous communities without the required capacity may therefore need referral elsewhere. The protocol provides a common framework for these cases, with the aim of improving equity of access across regions.
When a reference centre identifies a potential candidate, it must notify the patient’s hospital and autonomous community of origin. The home hospital and region will assess whether the referral is appropriate and whether the proposed indication meets the applicable National Health System funding conditions. Following a positive assessment, the reference centre may indicate and provide the treatment.
As a general rule, the home autonomous community will acquire and fund the medicine, including where another region administers it. The protocol therefore clarifies financial responsibility for cross-regional care and reduces the scope for uncertainty over funding to delay treatment.
Where clinically and organisationally possible, prescribing, dispensing and administration should take place in the patient’s home region, particularly for chronic or long-term treatment. Follow-up may be shared between the home hospital and the reference centre, with at least annual review by the reference centre recommended for chronic treatment.
A standardised form and clinical report will support communication initially, with a national digital platform envisaged later. The treatment list will be updated as further medicines qualify. By linking national funding decisions with common referral, funding and follow-up arrangements, the protocol should provide patients in regions without the required specialist capacity with a clearer and more consistent route to treatment.
Source: Ministry of Health, Spain
Link: Sanidad aprueba un protocolo común para tratamientos de alta complejidad de 80.000 euros o más por paciente y año (Health approves a common protocol for high-complexity treatments costing €80,000 or more per patient per year)
Date: 10 July 2026
