CTGCT (Centre for the Technologies of Gene and Cell Therapy, at National institute of Chemistry, Ljubljana) has joined the statement to preserve the Hospital Exemption in the revised EU pharmaceutical legislation. The Joint Statement, sent on October 9 to the European Parliament, the European Council, and the European Medicines Agency (EMA), emphasizes that the development of advanced therapies must be driven by patient needs and enable accessible, ethical, and non-profit solutions — not other interests.
The signing institutions emphasise that European legislation must remain focused on patient needs and on rapidly addressing rare and currently incurable diseases — with the aim to help patients primarily. For more than a decade, the Hospital Exemption has enabled the development of personalized, accessible, and ethically viable therapies in non-profit academic and clinical settings, where breakthroughs in advanced medicine are born.
Preserving this mechanism is crucial for ensuring equal patient access to innovative treatments and for strengthening Europe’s position as a leading region in the development of advanced biomedical technologies.
The statement was signed by:
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European Hematology Association (EHA)
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European Society for Paediatric Oncology (SIOP Europe)
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European Society for Organ Transplantation (ESOT)
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Dutch Infrastructure for Cancer-Specific ATMP Research (DIAS)
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CORE SOHO – Common Representation of Substances of Human Origin
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Centre for the Technologies of Gene and Cell Therapy (CTGCT)
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European Society for Blood and Marrow Transplantation (EBMT)
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Spanish Advanced Therapy Network (TERAV)
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European Alliance for Vision Research and Ophthalmology (EU EYE)
Co-signed by, as collected by CTGCT:
- prof. dr. Damjan Osredkar, MD, Pediatric clinic, University Medical Centre Ljubljana
- dr. Špela Mirošević, CTNNB1 Foundation
- prof. dr. Robert Zorec, univ. dipl. biol., Medical Faculty Ljubljana and Celica Biomedicals
- prim. dr. Gordana Živčec Kalan, MD, GaiaCell
- Patient organisations association of Slovenia, ZOPS
- Health insurance fund of Slovenia, ZZZS
- General Hospital Novo mesto, SB Novo mesto
- Prof. Natalia Marek- Trzonkowska, VMD, PhD, DSc, Medical University of Gdańsk, Poljska
- Assoc. Prof. Matjaž Sever, M.D., Ph.D., Clinical Department of Hematology, University Medical Centre Ljubljana
- Prof. Helena Chowdhury, Ph.D., Institute of Pathophysiology, Faculty of Medicine, University of Ljubljana
You can read the full statement by clicking on the image or on this link.
If you would also like to support the statement, please contact us at ctgct@ki.si.