Portugal has adopted a renewed framework for the National Health Technology Assessment System (Sistema Nacional de Avaliação de Tecnologias de Saúde, SiNATS), updating the route through which health technologies are assessed for price, reimbursement, hospital use and public financing. The measure is a system-level reform of the access framework, ensuring alignment with the EU joint HTA process while widening its impact on medicines, medical devices and other health technologies used in the National Health Service (Serviço Nacional de Saúde, SNS).
The National Authority of Medicines and Health Products (Autoridade Nacional do Medicamento e Produtos de Saúde, INFARMED) announced publication of Decreto-Lei n.º 118/2026 (Decree-Law no. 118/2026) on 17 June. The decree establishes the SiNATS regime within INFARMED and integrates national application of Regulation (EU) 2021/2282 on health technology assessment.
The decree places clinical and non-clinical assessment within a single framework for determining or monitoring the relative effectiveness of new and existing technologies. It states that HTA will inform decisions on price-setting, state reimbursement, exclusion from reimbursement, availability for use in the SNS and clinical practice.
The revised model also broadens the data base used for access decisions. INFARMED will be able to draw on prescribing, utilisation, expenditure and outcomes data from health-system information sources. Companies may also be required to provide utilisation and real-world outcomes data where these affect approved conditions of use.
Medical devices receive a more explicit place in the system. The decree provides for maximum-price regimes, reimbursement arrangements and reference-price groups for selected devices and other health technologies. It also reflects the EU framework for joint clinical assessment, joint scientific consultation, identification of emerging technologies and methodological guidance.
The decree enters into force on 1 July 2026. Pending public-availability applications remain under the previous route, although the new confidentiality rules apply to those files and to contracts already in force. Reassessments and contract reviews under the previous 2015 regime move into the new framework.
The reform gives INFARMED a wider legal basis for linking evidence, financing, monitoring and reassessment. It should make Portuguese access decisions more data-dependent, with greater use of real-world evidence and closer alignment between national financing decisions and EU-level clinical assessment.
Source: National Authority of Medicines and Health Products and Diário da República
Link: Novo diploma do SiNATS reforça a avaliação de tecnologias de saúde em Portugal (New SiNATS diploma strengthens health technology assessment in Portugal); Decreto-Lei n.º 118/2026, de 17 de junho (Decree-Law no. 118/2026 of 17 June)
Date: 17 June 2026
