De la norma a la práctica: cuestiones clave para las compañías en la evaluación de sus medicamentos tras la aprobación del real decreto

The approval of Royal Decree 415/2026 marks a new stage in health technology assessment in Spain, shifting the focus from the design of the new model to its practical implementation and its implications for pharmaceutical companies. This article examines the pathway that medicinal products will follow under the new system, with particular attention to the interplay between European joint clinical assessments and national assessment, the legal position and procedural safeguards afforded to companies, the principle of non-duplication of assessments, the applicable timelines, and the management of conflicts of interest. It also examines the regulatory and methodological instruments that are still pending approval and the arrangements for the gradual implementation of the new model.