New Portuguese Health Technology Assessment System

Decree-Law No. 118/2026, of June 17, establishes the new regime of the National Health Technology Assessment System (SiNATS), replacing the previous SiNATS regime, approved by Decree-Law No. 97/2015, of June 1.

Background and Objectives

The revision of SiNATS has as its central objectives, as signaled by the Government, to ensure that decisions regarding health technologies are based on the best available evidence, promoting access to innovation, efficiency in the use of public resources, and the sustainability of the National Health Service (SNS).

The new regime also brings the long-awaited alignment with the joint clinical assessment conducted at the European level under Regulation (EU) 2021/2282 of the European Parliament and of the Council of December 15, 2021 on health technology assessment ("HTA Regulation"), a new organization of assessment procedures, and new terminologies.

Key Changes

• Alignment with the European health technology assessment system: The new regime integrates Joint Clinical Assessments, Joint Scientific Consultations, and coordination with the Member States Coordination Group, harmonizing the national process with the European framework, as provided in the HTA Regulation.
• Participation of patient associations and other stakeholders: In line with the HTA Regulation, the new regime strengthens and structures the participation of patient associations, consumer associations, healthcare professional organizations, scientific societies, and industry representatives in the assessment process, with future regulation from INFARMED expected.
• Use of real-world data: Innovatively, the legislator recognizes the importance of real-world data and outcomes (real-world evidence), imposing on the industry a specific obligation to provide this data whenever it has an impact on the assessment or whenever requested by INFARMED.
• Simplification and streamlining of assessment processes: The new regime provides for prioritization mechanisms (for example, for unmet therapeutic needs or innovative technologies) and simplification (exemption from clinical assessment or simplified process in already identified situations), as well as the possibility of prior scientific advice from INFARMED.
• Medicinal products: For medicinal products specifically, some criteria for setting maximum prices and economic assessment are adjusted for certain types of medicines.
• Medical devices: Specific rules on maximum prices, economic assessment, and a dedicated general reimbursement regime for medical devices are now established, with the adapted medicines regime no longer being applicable to them.
  
  It remains to be seen how these new rules will be applied in practice and, in particular, whether medical devices will have to operate within a framework of maximum prices (similar to what already happens with medicinal products).
  
  
• Exceptional availability: The possibility of exceptional use of medicinal products during the financing process is maintained, now designated “exceptional availability.”
  
  In this regard, it is noteworthy that there is no longer a reference to a maximum exemption period from charges and that the express requirement to open an Early Access Program (PAP) disappears, and it remains unknown whether there will be a true practical change in these situations.
  
  
• Confidentiality of contracts: The possibility of safeguarding the confidentiality of reimbursement conditions agreed with between the industry and the Portuguese State is now expressly provided for – which appears to be a positive development for the industry.
  
  
• Market supply obligations: The new regime also establishes specific market supply obligations, providing that any reimbursement decision may lapse due to non-commercialization or interruption of commercialization during a certain period, with the impossibility of new submission for two years after the lapse.

Entry into force and transitional regime

The new legislation entered into force on July 1, 2026, and is not applicable to pending assessment procedures.

Additional regulation is also expected, with the previous regulation remaining in force until its publication. In other words, until the new implementing ordinances are approved, the procedures and rules already known to the industry should, generally, remain in place.

For more information, please contact our specialists through the Knowledge and Innovation Area.