On 17 June 2026, Decree-Law No. 118/2026 was published in Portugal, establishing a new framework for the National Health Technology Assessment System (SiNATS).

This guideline, which entered into force on 1 July 2026, updates the Portuguese legal framework for Health Technology Assessment, aligning it with Regulation (EU) 2021/2282, which establishes a European framework for joint assessment of health technologies and strengthens cooperation between Member States in the evaluation of medicines and other health technologies.

Although this is Portuguese guideline, it is still relevant for international companies that market or intend to market medicines and other health technologies in Portugal or in other European Union markets, as it may impact market access strategies and the evaluation processes.

Why was this revision necessary?

Since the establishment of SiNATS in 2015, the European context has evolved significantly, culminating in the adoption of Regulation (EU) 2021/2282.

Decree-Law No. 118/2026 updates the national legislation to ensure alignment with the European Health Technology Assessment model.

The revision also aims to make the system more responsive to current challenges in healthcare innovation, promoting evidence-based decision-making, greater predictability in processes, and more efficient use of healthcare system resources, while ensuring greater consistency between European and national assessment processes.

What changes in practice?

Integration of the European Health Technology Assessment model

One of the key changes is the integration of the framework established under Regulation (EU) 2021/2282 into the Portuguese system.

Whenever Joint Clinical Assessments (JCAs) are conducted at European Union level, these will now be considered in the national process, promoting greater harmonization among Member States and reducing duplication of clinical assessments when these have already been performed at EU level.

It is important to note, however, that decisions regarding pricing, reimbursement and funding remain under the responsibility of national authorities, based on the needs and reality of the Portuguese healthcare system.

Strengthening the evaluation of technologies throughout their lifecycle

The new legislation reinforces the principle that the evaluation of health technologies is not limited to the time of placing the product on the market.

Clinical, economic and real-world evidence may continue to be assessed throughout a technology’s lifecycle, enabling decisions to be supported by more robust and up-to-date data on effectiveness, safety and real-world impact in clinical practice.

Increasingly value-based decision-making

The new framework consolidates an integrated approach to health technology assessment, considering not only quality, safety and efficacy, but also:

• clinical benefit; 
• real-world effectiveness; 
• budget impact; 
• cost-effectiveness; 
• real-world evidence; 
• value added to the healthcare system. 

The aim is to support funding decisions that are increasingly based on demonstrated value, while promoting both access to innovation and the sustainability of the healthcare system.

Greater alignment with European processes

By aligning SiNATS with Regulation (EU) 2021/2282, Portugal is moving closer to the European Health Technology Assessment model, promoting greater methodological convergence and reducing duplication of efforts between European and national processes.

What is the impact for companies?

For companies developing or marketing medicines and other health technologies in the Portuguese market, the new framework reinforces the need of preparing dossiers with robust clinical and economic evidence, aligned with both European and national requirements.

Although many organizations are already adapting their processes to Regulation (EU) 2021/2282, this new legislation formalizes this alignment within Portuguese law, emphasizing the importance of monitoring the technical and procedural guidelines issued by the relevant authorities.

For International companies operating in Portugal — or those planning to enter the Portuguese market — must monitor these changes in order to design regulatory and market access strategies and to ensure that submitted documentation and evidence meet the current applicable requirements.

For more information, please refer to Decree-Law No. 118/2026 and the INFARMED information note on the revision of the National Health Technology Assessment System.

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