Spain approves new health technology assessment decree and revamps drug copayment system

The Spanish Council of Ministers approved Real Decreto 415/2026 on health technology assessment, which was published in the Boletín Oficial del Estado three days later. The decree seeks to replace the fragmented national evaluation system with a unified framework aligned with the EU HTA regulation. It establishes a one‑year transition period to create the necessary bodies, notably the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), and to adopt methodological guidelines. Funding for the system will depend on available budgetary resources, and the rollout may be delayed if AEMPS does not receive sufficient staff, technology or material support. The decree also guarantees representation for Spain’s autonomous communities in the governance structure, aiming to avoid duplicated regional reviews that could slow patient access to medicines.

In parallel, the government is implementing a progressive drug‑copayment reform introduced by the new real‑decreto‑ley. The scheme sets income‑based contribution tiers, lowering the average patient share of pharmaceutical spending from 11.36 % to 9.55 % and raising public financing to 90.45 %. Officials, including Secretary of State for Health Javier Padilla and Health Minister Mónica García, are also studying a list of high‑value drugs that could be exempt from any copayment, further protecting low‑income patients.