Informace o publikaci
ATMP Innovation in Europe: An Ecosystem in Active Transition
| Autoři | |
|---|---|
| Rok publikování | 2026 |
| Druh | Recenzovaný odborný článek |
| Časopis / Zdroj | European Health and Pharmaceutical Law Review |
| Fakulta / Pracoviště MU | |
| Citace | |
| www | https://doi.org/10.21552/ehpl/2026/1/8 |
| Doi | https://doi.org/10.21552/ehpl/2026/1/8 |
| Klíčová slova | regulation; hospital exemption; clinical trials; manufacturing; international collaboration; advanced therapy medicinal products |
| Popis | Advanced Therapy Medicinal Products (ATMPs) belong to one of the most dynamic and promising areas of modern medicine. Their potential to address unmet medical needs, particularly in rare, ultra-rare and life-threatening conditions, remains substantial. Yet nearly two decades after the European Union (EU) introduced the ATMP Regulation, patient access across Europe is still uneven and limited: Although 30 ATMPs have been authorised centrally in the EU, none of them has reached patients in all Member States. Regional disparities are apparent, with Eastern and Southern Europe lagging behind. This highlights a persistent gap between regulatory approval and patient access. Moreover, at least six products have been withdrawn from the market for commercial reasons, underscoring that central authorisation and business focus are not one-size-fits-all solutions. Academic institutions, hospitals, and other non-profit developers are increasingly stepping in to bridge critical gaps in the ATMP development and access landscape by advancing clinical solutions for indications that lack commercial attractiveness, such as ultra-rare or paediatric conditions. The authors of this report are all affiliated with CREATIC, a Horizon Europe Teaming for Excellence project that aims to facilitate the translation of ATMPs through a multidisciplinary approach. As part of CREATIC’s ongoing efforts to monitor and share developments in this field, we publish quarterly newsletters covering regulatory news and perspectives on social, legal, and ethical issues. Through this initiative, we aim to support the stakeholder community with insights into developments and challenges to facilitate discussions on improving access to innovative treatments. All editions are available on the CREATIC’s website. In this report, we summarise the key topics from the recent newsletters, offering a comprehensive overview of the state of affairs and trends for the EU ATMP Ecosystem in 2025 from a legal, ethical and social perspective |
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