Spain approves national HTA framework aligned with EU HTAR under new Royal Decree

Spain has approved a new Royal Decree establishing a national framework for health technology assessment, introducing defined governance structures, timelines, and transparency requirements while aligning the country’s evaluation processes with the EU Health Technology Assessment Regulation (HTAR).

The Baseline

• Spain has approved its first comprehensive national HTA framework covering medicines, medical devices, diagnostics, digital therapeutics, and clinical procedures.
• The framework aligns with the EU HTAR and formally separates scientific evaluation from pricing and reimbursement decision-making.
• The regulation places greater emphasis on real-world evidence (RWE), patient participation, transparency, and defined assessment timelines.

Spain has approved a new Royal Decree establishing, for the first time, a “complete, transparent and coordinated” national framework for HTA within the country’s National Health System (SNS). The regulation introduces a structured system for evaluating medicines, medical devices, diagnostic tests, digital therapeutics, clinical procedures, and healthcare delivery models, while aligning Spain’s processes with the EU HTAR.

The decree was approved by the Council of Ministers on May 26, 2026, following an earlier draft published by the Ministry of Health in August 2024. The reform follows broader efforts to modernize Spain’s HTA processes after a 2023 court ruling invalidated aspects of the country’s previous therapeutic positioning report system and also reflects wider international efforts to strengthen HTA governance, transparency, and methodological consistency.

Recent research examining Spanish HTA processes concluded that the criteria used to justify reimbursement decisions have not always aligned with the information included in HTA assessments, highlighting the need for a more transparent and methodologically consistent appraisal framework. The new Royal Decree seeks to address these concerns through a more structured governance model, clearer assessment procedures, and greater separation between scientific evaluation and policy decision-making.

Under the new framework, HTA evaluations will be mandatory, although not legally binding, when supporting decisions related to pricing, reimbursement, market access, service inclusion, or withdrawal of technologies from the SNS.

A core feature of the regulation is the formal separation between scientific evaluation and policy decision-making. The framework distinguishes between clinical assessments, which examine efficacy and safety, and non-clinical assessments evaluating economic, organizational, ethical, social, and environmental impact.

The regulation also adapts Spain’s HTA processes to the EU HTAR, with Spain’s framework “expressly prohibiting” duplication of EU-level joint clinical assessments (JCAs). Instead, national evaluations will focus on contextual factors relevant to the Spanish healthcare system, including cost-effectiveness and implementation considerations. In cases where a JCA has already been completed at EU level, Spain will issue its national clinical report within 15 calendar days of publication.

The new HTA system is structured around three core pillars designed to separate scientific assessment from political decision-making while improving coordination across the evaluation pathway:

1. The Governance Council, which will sit within the State Secretariat for Health and act as the system’s highest governing body. The council will oversee evaluation strategy, approve methodological guidance, and ensure consistency with broader health and pharmaceutical policy. Its membership includes health economists, patient representatives, and regional health authorities.
2. Establishment of two independent HTA Offices responsible for conducting evaluations. The Office for the Evaluation of Medicines will operate within the Spanish Agency of Medicines and Medical Devices (AEMPS), while the Office for the Evaluation of Non-Pharmacological Health Technologies will be coordinated through the Spanish Network of HTA Agencies (RedETS). These offices will conduct both clinical and non-clinical assessments.
3. The Health Technology Adoption Group, which will act as a bridge between the scientific assessment process and national decision-making bodies, including pricing and reimbursement committees. The group will synthesize evidence and assess the relative positioning of technologies within clinical practice.

The decree establishes defined assessment timelines, including up to 90 calendar days each for clinical and non-clinical evaluations of medicines and up to 180 days for non-pharmaceutical technologies.

The framework also strengthens the role of RWE in post-market evaluation and reassessment activities. The regulation highlights the use of data generated during routine clinical practice to evaluate long-term outcomes and reassess technologies already incorporated into the healthcare system. This may support future decisions regarding continued use, replacement, or withdrawal of technologies as additional evidence emerges.

Patient and civil society participation are also formally embedded throughout the evaluation process. According to the Ministry of Health, assessments will consider factors including usability, accessibility, and quality-of-life impact alongside clinical and economic outcomes.

The regulation additionally introduces stricter transparency and conflict-of-interest requirements. Participants involved in assessments will be required to submit public declarations of interest and meeting documentation and final reports will be publicly accessible.