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White Paper: The Impact of Spain’s HTA Reform

The market access and pricing landscape in Spain has undergone its most sig-nificant legislative transformation in more than a decade. For life sciences compa-nies, this is an important but complex shift, and one that raises the bar on the evidence requirements. IGES Iberia has published a white paper analysing the reform in depth.

The landscape of market access and pricing in Spain has undergone its most pro-found legislative transformation in over a decade. With the entry into force of Royal Decree 415/2026 on June 18, 2026 and Draft Royal Decree regulating the proce-dure for the public financing and pricing of medicinal products within the Spanish National Health System (SNS), Spain has officially phased out the Informe de Posi-cionamiento Terapéutico (IPT - Therapeutic Positioning Report) system and estab-lished its first unified, regulatory framework for Health Technology Assessment (HTA).

Driven by the need to resolve domestic judicial vulnerabilities and align with EU Regulation 2021/2282 on Joint Clinical Assessments (JCA), the new framework insti-tutes a highly regulated, dual-report system separating clinical and non-clinical evaluations. For life sciences and medtech manufacturers, this shift removes historic administrative fragmentation but simultaneously escalates the burden of proof. Economic evaluation, budget impact modeling, and real-world evidence (RWE) are no longer secondary components; they are codified legal prerequisites for achieving public financing within the Spanish National Health System (Sistema Nacional de Salud - SNS).

Chus Castillo and Marta Aguado of IGES Iberia have published a white paper on the reform. It analyses the key pillars of the 2026 HTA reform, sets out the operational timetables and provides strategic recommendations for planning market launch.

The white paper can be ordered from us; please feel free to contact us by email:

Contact:

E-mail: pharma@iges.com