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Role of Hospital Exemption in Europe: position paper from the Spanish Advanced Therapy Network (TERAV)
Open accessAbstract
The Hospital Exemption rule is considered a valuable European legislative initiative that guarantees patient access to novel therapies based on the use of advanced therapy medicinal products (ATMPs) in the Member States. On the occasion of the update of the European General Pharmaceutical Legislation, the Spanish Network of Advanced Therapies (TERAV, formerly TerCel), which has played a recognized leadership in Europe in the development of both academic and pharmaceutically commercialized ATMPs [ 1 ], would like to make the following position statement:
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In some jurisdictions, the hospital exemption pathway allows non-commercial use of ATMPs within the same institution under defined conditions, facilitating certain POC manufacturing models.
“In some jurisdictions, the “hospital exemption” pathway allows for non-commercial use of ATMPs within the same institution under defined conditions, facilitating certain POC manufacturing models (Sánchez-Guijo et al., 2023).”
From Isolator-based point-of-care manufacturing: a practical solution for GMP-compliant cell and extracellular vesicles therapy production (2025) · cites this paper as Sánchez-Guijo et al., 2023
The Hospital Exemption section (page unavailable) describes non-routine ATMP manufacture outside the standard marketing-authorization pathway, subject to quality standards, national authorization, and use in a hospital within the same Member State. It also describes academic manufacturing, but does not require manufacture and use within the same institution or explicitly link the exemption to point-of-care manufacturing models. (LLM, conf=0.88)
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Research works printed but not linked: 4
- Sánchez-Guijo F, García-Olmo D, Prósper F, Martínez S, Zapata A, Fernández-Avilés F, et al. Spanish Cell Therapy Network (TerCel): 15 years of successful collaborative translational research. Cytotherapy. 2020;22:1–5. · DOI
- Cuende N, Ciccocioppo R, Forte M, Galipeau J, Ikonomou L, Levine BL, et al. Patient access to and ethical considerations of the application of the European Union hospital exemption rule for advanced therapy medicinal products. Cytotherapy. 2022;24:686–90. · DOI
- Fox T, Bueren J, Candotti F, Fischer A, Aiuti A, Lankester A, et al. Access to gene therapy for rare diseases when commercialization is not fit for purpose. Nat Med. 2023. https://doi.org/10.1038/s41591-023-02208-8. · DOI
- Juan M, Delgado J, Calvo G, Trias E, Urbano-Ispizua A. Is Hospital Exemption an alternative or a bridge to european medicines agency for developing academic chimeric antigen receptor T-cell in Europe? Our experience with ARI-0001. Hum Gene Ther. 2021;32:1004–7. · DOI
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Chiu, Y.-S., Wang, K.-L., & Wu, K.-L. (2025) · Frontiers in Bioengineering and Biotechnology · doi:10.3389/fbioe.2025.1644318 · Cited by 17
Metadata
- Authors
- Sánchez-Guijo, F., Avendaño-Solá, C., Badimón, L., Bueren, J. A., Canals, J. M., Delgadillo, J., Delgado, J., Eguizábal, C., Fernández-Santos, M.-E., García-Olmo, D., González-Aseguinolaza, G., Juan, M., Martín, F., Mata, R., Montserrat, N., Pérez-Martínez, A., Pérez-Simón, J. A., Prósper, F., Urbano-Ispizua, Á., Zapata, A. G., Sureda, A., & Moraleda, J. M.
- Affiliations
- Hospital de Sant Pau (ES)
- Centro de Investigaciones Energéticas, Medioambientales y Tecnológicas (ES)
- Consorci Institut D'Investigacions Biomediques August Pi I Sunyer (ES)
- Banc de Sang i Teixits (ES)
- Hospital Clínic de Barcelona (ES)
- BioCruces Health research Institute (ES)
- Clinica Universidad de Navarra (ES)
- Universidad Complutense de Madrid (ES)
- Institut d'Investigació Biomédica de Bellvitge (ES)
- ORCID
- Venue
- Bone Marrow Transplantation
- Published
- 2023-03-25
- Volume
- 58
- Issue
- 6
- Pages
- 727-728
- ISSN
- 0268-3369 (ISSN-L)
- 1476-5365
- PMC
- PMC10247360
- OpenAlex
- W4360939369
- Cited by
- 25
- References
- 0
- Citations by year
- 2026: 10 · 2025: 8 · 2024: 3 · 2023: 4
- FWCI
- 4.44
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Bone Marrow Transplantation (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Dipòsit Digital de Documents de la UAB (Universitat Autònoma de Barcelona) (submittedVersion, cc-by)
- Institutional Repository of the University of Granada (University of Granada) (submittedVersion, cc-by)
- Hispana (submittedVersion, cc-by)
- Biblos-e Archivo (Universidad Autónoma de Madrid) (submittedVersion, public-domain)
- Funders
- Ministry of Economy and Competitiveness | Instituto de Salud Carlos III (RD21/0017/0001)
- Topics
- Health Sciences › Nursing › Issues, ethics and legal aspects › Biomedical Ethics and Regulation
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Healthcare Regulation
- Keywords
- hospital exemption, advanced therapy medicinal products, regulatory policy, European Union law
- MeSH terms
- Europe, Hospitals, Humans
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