New SiNATS: Impact on Market Access, Real-World Data, and European Alignment

With the publication of Decree-Law no. 118/2026 of June 17, the new framework for the National Health Technology Assessment System (SiNATS) will have a direct impact on market access strategies, pricing, reimbursement, contracting, evidence generation, and availability within the National Health Service (SNS).

Our Life Sciences and IP Litigation team analysed the new statute, which completely redesigns the framework applicable to the assessment of medicines, medical devices, digital health solutions, and other health technologies in Portugal.

Part of the "Medicines Package" (Pacote do Medicamento), this reform addresses two core challenges: the accelerated evolution of health technologies, including advanced therapies, complex medical devices, digital solutions, and the use of real-world data, and the growing European harmonisation in health technology assessment (HTA).

Key highlights include:

• European Integration: The articulation of European joint clinical assessments within the national decision-making process;
• Transparency and Governance: The strengthening of transparency and structured stakeholder participation in the system;
• Real-World Evidence: The centralisation of SIATS as a digital platform for management and monitoring, with increased reliance on real-world data;
• Market and Competition: More detailed rules for pricing, reimbursement, and the market entry of generics and biosimilars;
• Efficient Access: The definition of clear decision-making timelines and new access pathways, including early access and special schemes.

This new framework introduces significant changes for the healthcare and life sciences sector in Portugal. Its ultimate impact will largely depend on how it is implemented and regulated,  particularly regarding the balance between access to therapeutic innovation, predictability for operators, protection of rights, and the financial sustainability of the SNS ( National Health Service).

The new regulation is scheduled to enter into force on July 1, 2026.