Enhancing Health Technology Assessment Through Real-World Evidence in Portugal

Real-world evidence Portugal has moved from supplementary tool to statutory requirement under Decree-Law 118/2026, which compels national health systems to share interoperable data so that promised outcomes can be verified after medicines and devices reach patients. The legislation converts one-time reimbursement decisions into continuous “learn-and-adapt” cycles that trigger price adjustments, risk-sharing contracts, or delisting when real-world performance falls short of expectations.

Data Infrastructure That Never Stops Watching

All Ministry of Health entities must now feed prescription, expenditure, registry, and outcome data into the central SIATS platform. Technology sponsors face binding obligations to supply real-world evidence when requested for both exceptional access schemes and routine funding reviews. These interoperability rules, aligned with the European Health Data Space, give INFARMED and the National Commission for Pharmacy and Therapeutics live signals to recalibrate therapeutic positioning and clinical guidance without waiting for the next formal assessment.

Registries Become Pricing Triggers

Oncology, hepatitis C, and spinal muscular atrophy registries—once isolated—now flow directly into SIATS. When observed outcomes diverge from trial projections, automatic renegotiation clauses activate: expenditure 60 % above target demands at least a 10 % price cut, while conditional approvals cannot exceed 24 months without interim price reductions of up to 15 %. The same adaptive rules apply to medicines, medical devices, in-vitro diagnostics, and AI-enabled digital health technologies.

Real-world evidence in Portugal therefore shifts industry accountability from dossier submission to continuous performance reporting against contractually defined endpoints. Manufacturers must accept financial downside risk when real-world results underperform, while patient associations gain structured input across scoping, appraisal, and reassessment. The result is a value-based ecosystem in which sustained funding depends on demonstrated health gain inside the Portuguese health system, not merely on pre-market evidence.