Spain has adopted a national health technology assessment framework that connects scientific assessment with later decisions on public financing, price, reimbursement, inclusion in the common service portfolio, changes in use and disinvestment.
The Council of Ministers (Consejo de Ministros) approved Real Decreto 415/2026, de 27 de mayo, por el que se regula la evaluación de tecnologías sanitarias (Royal Decree 415/2026 of 27 May regulating health technology assessment) on 26 May 2026. The decree was published in the State Official Gazette (Boletín Oficial del Estado, BOE) on 29 May and will enter into force on 18 June 2026.
The decree covers centrally authorised medicines intended for commercialisation in Spain, selected medicines authorised through other routes, new indications, high-risk medical devices, in vitro diagnostics, digital technologies, clinical procedures, organisational models and reassessments of technologies already evaluated.
For medicines, the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) will host the medicine assessment office. The Spanish Network of Health Technology Assessment Agencies (Red Española de Agencias de Evaluación de Tecnologías Sanitarias y Prestaciones del Sistema Nacional de Salud, RedETS) will act as the office for non-pharmacological technologies.
The decree separates the clinical and non-clinical stages. Clinical assessment will include a category for added clinical value. Non-clinical assessment will include economic evaluation, budget impact and ethical, organisational, social, legal, gender and environmental dimensions. The evaluation offices will not make pricing, financing or service-portfolio decisions. A separate adoption group will integrate the assessment into a final view on the technology’s relative position before the relevant decision-making body acts.
Spain will use EU joint clinical assessment as the basis for national clinical work where it exists. In those cases, the national clinical report must be completed within 15 days of publication of the EU joint clinical assessment report. The decree also states that developers must not be asked again for evidence already submitted at EU level, except where additional analysis is needed for the Spanish context.
The decree gives Spain a defined route for taking on board EU HTA outputs while preserving national judgement on added value, economic impact and positioning in the National Health System. The detailed methods and procedural instructions are still to follow, with the first version due within one year of entry into force and progressive implementation after that point.
Source: Ministry of Health and State Official Gazette
Link: El Consejo de Ministros aprueba el primer marco estatal para evaluar tecnologías sanitarias en el Sistema Nacional de Salud (The Council of Ministers approves the first state framework for assessing health technologies in the National Health System)
Link: Real Decreto 415/2026, de 27 de mayo, por el que se regula la evaluación de tecnologías sanitarias (Royal Decree 415/2026 of 27 May regulating health technology assessment)
Date: 26 May 2026 and 29 May 2026
