Portugal

New SiNATS: more integration, more data and greater pressure on the demonstrated value

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Based on a feed excerpt; full article content has not been acquired. Source evidence retrieved 14/10/2026, 12:16:24 UTC.

Briefings

Portugal's SiNATS system, replacing the 2015 decree, mandates public access to health technologies through a unified evaluation process. Key changes include a 300-day public access period for innovative drugs, mandatory contracts with risk-sharing clauses, and strict economic value thresholds (5% for innovators, 30% for generics). Data from real-world use must be submitted to INFARMED, and contracts must be renewed every two years, with mandatory renegotiation if population size or costs exceed 60%. The system entered into force on July 1, 2026, with a transition period for pending applications.

Key points

• The Decreto-Lei n.º 118/2026 replaced the 2015 regime, aligning Portugal's health technology assessment with EU Regulation (UE) 2021/2282.
• Innovative drugs face a 300-day public access period before evaluation, with automatic financing for generics and biosimilares.

Context

This legislation establishes a new framework for public access to health technologies in Portugal, replacing the previous regime. It introduces a unified evaluation process combining clinical and economic assessment, with stricter economic value thresholds and mandatory contract clauses. The system aims to balance public access with evidence-based evaluation, impacting the pharmaceutical industry through new commercial and regulatory obligations.

Limitations

The evidence covers the legislative framework and key operational rules as of the article's publication date. Specific implementation timelines for contract renegotiations and data submission requirements are detailed but may vary based on individual drug characteristics and market conditions. The transition period for pending applications is noted, but the full scope of transitional impacts remains partially unquantified.

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