Integrating the Portuguese HTA Regulation into National Health Systems

The Portuguese HTA Regulation has delivered the most significant overhaul of the National System for Health Technology Assessment (SiNATS) since its creation in 2015. Published through Decreto-Lei n.º 118/2026, the regulation fully embeds the European HTA Regulation (HTAR) into national processes, requiring Joint Clinical Assessments (JCA) to inform — but not replace — Portuguese decisions on added therapeutic value.

Clinical-Economic-Therapeutic Decision Chain

Under the Portuguese HTA Regulation, Portugal participates in shaping the European PICO (population, intervention, comparator, outcome) parameters through consultations with patient groups and scientific societies. INFARMED must then incorporate the final JCA report into its national clinical assessment, explicitly document its use, and report annually to the European Commission. This is followed by Portugal-specific economic modelling using cost-effectiveness, budget-impact, and real-world evidence from national registries, before the National Commission for Pharmacy and Therapeutics (CNFT) issues therapeutic positioning guidance for the NHS.

How Portugal Differs from Other EU Systems

The model created by the Portuguese HTA Regulation sits between Germany’s strict clinical-benefit separation and France’s combined clinical-economic review. By prohibiting duplicate requests for evidence already submitted at EU level, the framework shortens national appraisal timelines from 180 to 150 days for JCA-supported submissions. The regulation also formalises horizon scanning in partnership with the International Horizon Scanning Initiative and extends systematic evaluation to medical devices, IVDs, digital health tools, AI applications, and advanced therapies.

Practical Implications for HEOR and Market Access

HEOR teams must now focus on early national PICO dialogue, rapid adaptation of European clinical findings into Portuguese economic models, and generation of local real-world evidence to address uncertainties. While the Portuguese HTA Regulation promises faster patient access and greater predictability for industry, it also highlights the risk of divergent national conclusions when local value perspectives differ from European ones. Successful implementation will depend on robust stakeholder platforms and interoperable data systems to translate European consensus into sustainable funding decisions.