Implementation of the New European Health Technology Assessment Regulation

This white paper discusses the implementation of the New European Health Technology Assessment Regulation (HTAR), which mandates that companies with products indicated for cancer treatment or Advanced Therapy Medicinal Products (ATMP) prepare and submit a Joint Clinical Assessment (JCA) dossier by 2025. The HTAR represents a significant shift in the European market access landscape, introducing a joint perspective among EU member states on clinical aspects of medicinal products, in vitro diagnostics, and high-risk medical devices. The document outlines the timeline for implementation, emphasizing the staggered process that begins with cancer treatments in 2025, followed by orphan drugs in 2028, and all remaining drugs by 2030. It details the components of the HTAR, including Joint Clinical Assessments and Joint Scientific Consultations, and the necessary steps companies must take to comply with the new regulations. Challenges and uncertainties surrounding the HTAR process are also highlighted, particularly regarding the preparation of the JCA dossier and the potential impact on patient access to new health technologies.