Portugal has taken a decisive step towards modernising its health technology access framework through the approval of Decree-Law No. 118/2026 of 17 June, which comprehensively revises the National Health Technology Assessment System (“SiNATS”) and, in general terms, repeals the previous regime established by Decree-Law No. 97/2015 of 1 June.
The reform, which will enter into force on 1 July 2026, responds to the need to adapt the Portuguese regulatory framework to the new European requirements arising from Regulation (EU) 2021/2282, applicable since 12 January 2025.
The objective is clear: to integrate joint clinical assessments carried out at European level while preserving national autonomy regarding pricing, public funding, reimbursement decisions and the determination of the added value of health technologies within the context of the Portuguese National Health Service.
A broader scope tailored to innovation
Although SiNATS already covered the assessment of health technologies beyond medicines, the new regime expressly broadens and clarifies its scope, encompassing: medicines; medical devices; in vitro diagnostic medical devices; digital health technologies; software-based and artificial intelligence solutions; medical and surgical procedures; preventive, diagnostic and treatment measures.
This expansion reflects the growing technological complexity of the healthcare sector and the need to establish consistent assessment mechanisms for increasingly innovative products and services.
More data, greater monitoring and increased accountability
One of the key pillars of the reform is the strengthening of continuous assessment throughout the lifecycle of health technologies.
The new regime reinforces the role of the Information System for the Assessment and Access to Health Technologies (SIATS), which will enable more comprehensive monitoring of utilisation, effectiveness and outcomes in real-world settings.
In this context, health technology companies will be subject to new obligations to provide data to INFARMED, particularly regarding evidence generated through clinical practice.
Data generation and management will therefore cease to be a secondary element and become a determining factor in maintaining access to publicly funded markets.
Faster assessments, but with higher standards
The new regime establishes specific deadlines for the assessment and decision-making processes relating to public funding.
New, non-funded health technologies must be assessed within:
- 150 days, where a joint European clinical assessment exists;
- 180 days, where no such assessment exists.
Specific timelines are also established for new pharmaceutical presentations, technological developments and medical devices.
However, the legislator allows for the suspension of these deadlines where additional information is requested, highlighting the strategic importance of submitting complete, robust and technically sound applications from the outset.
Public availability agreements: risk-sharing and sustainability
Another significant development is the reformulation of the so-called public availability agreements, which may include risk-sharing mechanisms, budget caps, usage restrictions and obligations to generate additional evidence.
Clinical, economic and budgetary uncertainty therefore ceases to be a purely technical issue and becomes a central element of the contractual negotiations between the State and health technology holders.
In practice, companies will need to prepare for access models that are increasingly outcome-based and subject to periodic review.
Enhanced transparency and stakeholder participation
The new SiNATS also strengthens the involvement of patient associations, consumer organisations, scientific societies and industry representatives.
In addition, it introduces new obligations concerning transparency and the management of conflicts of interest applicable to experts, assessors and national and European bodies involved in assessment processes.
Conclusion:
The revision of SiNATS represents a structural transformation of the Portuguese model for the assessment and public funding of health technologies.
For the pharmaceutical industry, medical device companies, digital health developers, healthcare operators and investors, access to the Portuguese market will depend more than ever on the ability to demonstrate clinical value, economic efficiency and measurable outcomes in clinical practice.
Innovation will remain a key differentiating factor, but it will need to be evidenced and sustained through continuous data generation over time.
Belzuz Abogados, S.L.P. is an International law firm headquartered in Madrid, with offices in Lisbon and Porto, providing legal advice to national and international companies operating in the pharmaceutical, healthcare and technology sectors on regulatory matters, market access, public procurement, health data protection, compliance and health technology assessment in Portugal.