A policy paper entitled ‘Report evaluating the impact of the reform of derogatory access on the methods of access, financing and regulation of new innovative medicines’ (Rapport évaluant l’impact de la refonte des accès dérogatoires sur les modalités d’accès, de financement et de régulation des nouveaux médicaments innovants), was issued on 24 November 2025. It was produced by the Inspection générale des affaires sociales (Social Affairs Inspectorate General) and the Inspection générale des finances (Finance Inspectorate General). The document assesses the results of the 2021 reform, which replaced the previous system of temporary use authorisations (Autorisations Temporaires d’Utilisation, ATU), and temporary use recommendations (Recommandations Temporaires d’Utilisation, RTU) with two updated categories: early access (accès précoce) and compassionate use (accès compassionnel).
Accès précoce is reserved for innovative medicines that are intended for serious, rare, or disabling diseases where no appropriate treatment exists and the treatment cannot be delayed. Accès compassionnel is intended for medicines that are not necessarily innovative but meet a therapeutic need, often for drugs already authorised abroad or for a different indication. This category is further divided into autorisation d'accès compassionnel (AAC) granted on a single, named patient basis and cadre de prescription compassionnelle (CPC) on a group basis,
Prior to these changes, the regulatory landscape was considered fragmented and difficult for manufacturers to navigate. The current framework was designed to ensure that patients with life-threatening or rare diseases could receive breakthrough treatments before full marketing authorisation. The report, led by the Inspectors General of both departments, indicates that the system has met its primary goal of speed, with the average time to grant early access now standing at approximately 80 days.
However, the inspectors highlight that gross spending on these schemes has surged, reaching over €1.2 billion annually. The data show that the number of patients benefiting from early access has increased significantly, placing pressure on the national health budget. To address this, the report proposes new measures for implementation within the 2026 Social Security Financing Act. These include more frequent price reviews and stricter rebate mechanisms.
Market entry for innovative therapies will likely involve more rigorous clinical evidence requirements and intensified price negotiations. Greater emphasis will be placed on real-world data to justify continued premium pricing, ensuring that only the most effective treatments maintain their early funding status.
Source: Inspection générale des affaires sociales (IGAS) and Inspection générale des finances (IGF)
Link: Report assessing the impact of the reform of derogatory access routes on the access, financing and regulation of new innovative medicines
Date: 24 November 2025