The National Institute for Health and Disability Insurance (Institut national d'assurance maladie-invalidité, INAMI / Rijksinstituut voor Ziekte- en Invaliditeitsverzekering, RIZIV) issued a practical guide on 4 March 2026 requiring the digitisation of the Belgian early access framework. From 1 March 2026, developers must submit applications for Early Access (Accès précoce) and Fast Access (Accès rapide) exclusively via the Healthstat.be portal. This shift applies the procedural standards established in the Royal Decree (Arrêté royal) AR of 14 February 2026 regarding health insurance intervention for innovative treatments.
The new system centralises decision making within the Advisory Commission for Temporary Intervention in the Use of a Medicine (Commission d'avis en cas d'intervention temporaire pour l'utilisation d'un médicament) CAIT. While the CAIT retains direct authority over Early Access decisions, the Minister for Social Affairs acts as the final decision maker for Fast Access dossiers – with the CAIT serving in an advisory capacity. This digital transition aims to consolidate the Early and Equitable Fast Access procedure, which replaced legacy manual workflows on 1 January 2026.
Applicants must now navigate the Interactive Pharmaceutical Specialities Application (Application interactive SSP) to upload dossiers and track progress. Initial registration still requires the submission of a descriptive identification sheet to the Federal Agency for Medicines and Health Products (Agence fédérale des médicaments et des produits de santé, AFMPS). However, subsequent administrative interactions – including the signing of formal commitment documents – now occur within the secured digital environment.
This policy signals a move towards structured data collection and more rigorous timeline management. The portal ensures that submission data are tracked in real-time, reducing the administrative discretion previously inherent in email-based exchanges. Centralising these flows via Healthstat.be will likely accelerate the transition from temporary early access to permanent reimbursement status.
Source: National Institute for Health and Disability Insurance, INAMI/RIZIV
Link: Entreprises responsables d’un médicament ou d’une spécialité pharmaceutique éligible à un accès précoce ou à un accès rapide (Companies responsible for a medicine or a pharmaceutical speciality eligible for early access or rapid access)
Date: 4 March 2026
