ATMPs advanced therapies: UniSR with EUHA in The Lancet Regional Health–Europe

Vita-Salute San Raffaele University has contributed, as a member of the European University Hospital Alliance (EUHA), to a position paper published in May 2026 in The Lancet Regional Health – Europe on advanced therapy medicinal products (ATMPs): CAR-T cells, gene therapies, and tissue-engineered products. The paper, co-authored by Professors Alessandro Aiuti, Chiara Bonini, Fabio Ciceri and Gianvito Martino, proposes a European roadmap to address the barriers currently limiting the widespread use of these therapies — from the complexity of manufacturing processes to the fragmentation of regulatory pathways across member states, to reimbursement models that remain inadequate. The position paper originated at the EUHA symposium “European academia at the forefront of Advanced Therapy Medicinal Products development”, held under the EUHA presidency of Ospedale San Raffaele at the Milan campus on 13 November 2024, with the presentation of the Declaration of Milan on Cell and Gene Therapy. 

ATMPs are reshaping the treatment of certain oncological and rare diseases, achieving results that conventional drugs cannot. The European regulatory framework, however, was not designed for the biological and manufacturing complexity of these therapies. Against this backdrop, global competition is intensifying: the United States and China have already established significant advantages in ATMP development, and Europe risks falling behind if it does not update its regulatory and production tools. The position paper identifies where and how to intervene. 

The roadmap operates on two levels. 

Research and clinical development: 

• Regulate the use of organoids, artificial intelligence models and other systems as alternatives to animal models in the preclinical evaluation of ATMPs 
• Adapt clinical trial design by incorporating real world evidence — data collected in routine clinical practice — to accelerate ATMP market entry 
• Develop decentralised manufacturing through a European network of specialised centres, to broaden access to these therapies 

Regulatory, financial and access frameworks: 

• Harmonise hospital exemption pathways across member states, currently highly inconsistent, particularly for bioengineered products and cell therapies targeting rare conditions 
• Strengthening the role of universities and hospitals in translating ATMP research into accessible treatments — for example through a dedicated non-profit marketing authorisation pathway, with streamlined procedures and public funding schemes 
• Simplify and harmonise regulatory pathways while maintaining safety standards 
• Develop reimbursement models for the sustainable integration of ATMPs into national health systems 

Anna Flavia d’Amelio Einaudi, UniSR board delegate and EUHA president at the time of the symposium, stated:

Advanced therapies represent one of the most promising revolutions in contemporary medicine, but their impact will depend on our capacity to make them safe, accessible and ethically sustainable. European university hospitals have a responsibility to lead innovation with the patient at the centre. Only through close collaboration between research, clinical practice and institutions can we translate this potential into concrete benefits for society. 

The collaboration between UniSR-OSR and other EUHA members has also given rise to strategic European projects such as JOIN4ATMP, which aims to accelerate and de-risk ATMP development in Europe while promoting broader and more sustainable access. The project maps existing barriers, analyses evidence-based solutions, and defines new operational pathways for the future of the sector. 

Link to the paper