Spain

In May 2026, Spain approved its first state framework for health technology assessment (HTA) in the National Health System. Royal Decree 415/2026 establishes the rules for HTA activities used to support decisions on the incorporation, financing, pricing, reimbursement, modification of use conditions, or disinvestment of health technologies. The framework will enter into force 20 days after publication of the Decree, followed by phased implementation.

In April 2026, two HTA agencies working under the Spanish Network of HTA Agencies (RedETS) released several New and Emerging Health Technology Fact Sheets in cardiovascular, dermatology, diagnostic imaging, e-health, in-vitro diagnostics, men’s health, obstetrics and gynecology, peripheral vascular, robotic surgery and some other fields. The purpose of the Fact Sheets is to inform the prioritization of new and emerging technologies for evaluation by RedETS.

On April 20, 2026, the Common Package of Benefits of the Spanish National Health System was amended (by Order SND/356/2026, of April 13, 2026). The key changes relate to diagnostic imaging, in-vitro diagnostics, obstetrics and gynecology, and some other fields.

On April 9, 2026, the Spanish Network of HTA Agencies (RedETS) published the 2026 working plan for health technology assessments. The plan includes a wide range of topics in cardiovascular, dermatology, diagnostic imaging, e-health, endocrine, endoscopy, gastrointestinal, ICU/OR, in-vitro diagnostics, neurology and neurosurgery, neuromodulation, ophthalmology, radiology, robotic surgery, and some other fields.

In April 2026, the Canary Islands Healthcare Evaluation Service is working on several HTAs, including evaluations in e-health, IVD, neuromodulation, obstetrics and gynecology, and some other fields.

In March 2026, the Galician Agency for Health Technology Assessment (Avalia-t) is working on several HTAs, including in cardiovascular, dermatology, e-health, gastrointestinal, interventional radiology, robotic surgery, in-vitro diagnostics, peripheral vascular, neurology and neurosurgery, neuromodulation, and some other fields.

In February 2026, the Royal Decree was issued, regulating the selective financing procedure for certain health products – specifically, some types of medical aids – covered under the pharmaceutical benefit of the National Health System for non-hospitalized patients, and establishing the margins for their distribution and dispensing. The new regulation will update the old framework in place since 1996, establishing a clear, transparent, and structured system for selective financing and price-setting, with uniform criteria for the inclusion, modification, and exclusion of health products. The regulation will enter into force on July 1, 2026.

In November 2025, the Ministry of Health approved new Agreements concerning the designation of Benchmark centers, departments, and units of the National Health System (CSURs) for the treatment of rare or complex pathologies. These updates include the decision on new procedures requiring CSUR designation (surgery for complex central airway stenosis), as well as the designation, redesignation, and revocation of CSURs across multiple fields, including in the endocrine, endoscopy, gastrointestinal, nephrology and urology, neurology and neurosurgery, neuromodulation, and neurovascular fields.

On September 22, 2025, the Spanish Ministry of Health launched a prior public consultation on the preliminary bill for the Law on Digital Health, which will regulate the use of big data, digital technologies, and emerging tools in healthcare and research. Among other things, it is expected that the Law will establish conditions for incorporating and financing digital health products such as apps, connected devices, or monitoring systems. Citizens and organizations can submit input via an online form until October 20, 2025.

On September 5, 2025, the Ministry of Health opened a public consultation on a Draft Ministerial Order to update the Common Package of Benefits of the National Health System. The key planned changes are expected in diagnostic imaging, endocrine, gastrointestinal, in-vitro diagnostics, neurology and neurosurgery, and obstetrics and gynecology fields. Input can be submitted via email until September 26, 2025.

In August 2025, the Common Catalog of Genetic and Genomic Tests of the National Health System in Spain was updated. Two sections with a total of 140 new genetic tests were introduced: one for bone diseases, including craniofacial anomalies, and another for kidney diseases and urogenital disorders. Furthermore, six new tests were added in pediatric oncohematology. Other changes concerned adult oncohaematology, hereditary metabolic, and mitochondrial diseases.

In July 2025, the Common Catalog of Genetic and Genomic Tests of Spain’s National Health System was updated. Two sections with a total of 25 new genetic tests were introduced for ENT diseases and non-hepatic gastrointestinal diseases.