Royal Decree 415/2026: key aspects of the new health technology assessment system

Royal Decree 415/2026 establishes a unified framework for the assessment of health technologies in Spain, distinguishing between the technical assessment and the administrative decision regarding funding, pricing or inclusion in the service catalogue, and incorporating the requirements of Regulation (EU) 2021/2282. The aspect that raises the most legal questions in this new piece of legislation is the connection between the assessment regulated by the Royal Decree and the procedures for funding, pricing, and inclusion in the service catalogue.

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