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Role of Hospital Exemption in Europe: position paper from the Spanish Advanced Therapy Network (TERAV).医院豁免在欧洲的作用：来自西班牙先进治疗网络（TERAV）的立场文件。
Bone Marrow Transplant. 2023 Jun;58(6):727-728. doi: 10.1038/s41409-023-01962-0. Epub 2023 Mar 25.
2
The puzzling situation of hospital exemption for advanced therapy medicinal products in Europe and stakeholders' concerns.欧洲先进治疗药品的医院豁免的令人困惑的情况及利益相关者的担忧。
Cytotherapy. 2014 Dec;16(12):1597-600. doi: 10.1016/j.jcyt.2014.08.007. Epub 2014 Oct 5.
3
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.医院豁免是在欧洲开发学术嵌合抗原受体 T 细胞的欧洲药品管理局的替代方案或桥梁吗？我们在 ARI-0001 方面的经验。
Hum Gene Ther. 2021 Oct;32(19-20):1004-1007. doi: 10.1089/hum.2021.168.
4
Focus Hospital Exemption on developing innovative and safe treatments for patients.聚焦医院豁免权，为患者开发创新和安全的治疗方法。
Regen Med. 2013 Mar;8(2):121-3. doi: 10.2217/rme.12.116.
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Hospital Exemption for Advanced Therapy Medicinal Products: Issue in Application in the European Union Member States.高级治疗用医药产品的医院豁免：欧盟成员国的应用问题
Curr Stem Cell Res Ther. 2017;12(1):45-51. doi: 10.2174/1574888x11666160714114854.
6
The conundrum of charitability: reassessing tax exemption for hospitals.
Am J Law Med. 1990;16(3):327-80.
7
Advanced therapy medicinal product manufacturing under the hospital exemption and other exemption pathways in seven European Union countries.七个欧盟国家中，豁免医院和其他途径下的先进治疗药物产品制造。
Cytotherapy. 2020 Oct;22(10):592-600. doi: 10.1016/j.jcyt.2020.04.092. Epub 2020 Jun 17.
8
Adopting a portfolio of ultrasonic and advanced bipolar electrosurgery devices from a single manufacturer compared to currently used ultrasonic and advanced bipolar devices: a probabilistic budget impact analysis from a Spanish hospital perspective.与目前使用的超声和先进双极设备相比，采用单一制造商的超声和先进双极电外科设备组合：从西班牙一家医院的角度进行概率预算影响分析。
J Med Econ. 2023 Jan-Dec;26(1):179-188. doi: 10.1080/13696998.2023.2169496.
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The European hospital exemption clause-new option for gene therapy?欧洲医院豁免条款——基因治疗的新选择？
Hum Gene Ther. 2012 Jan;23(1):7-12. doi: 10.1089/hum.2011.2529.
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Comparing the value of community benefit and Tax-Exemption in non-profit hospitals.比较非营利性医院的社会效益与免税政策的价值。
Health Serv Res. 2022 Apr;57(2):270-284. doi: 10.1111/1475-6773.13668. Epub 2021 May 9.

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Allogeneic CAR T cells: A new player in the field and the peculiar opportunities of the hospital exemption path.同种异体嵌合抗原受体T细胞：该领域的新参与者以及医院豁免途径的特殊机遇。
Mol Ther. 2025 Jun 4;33(6):2326-2327. doi: 10.1016/j.ymthe.2025.05.018. Epub 2025 May 24.
2
Ethical Issues in Pediatric Precision Oncology in Singapore.新加坡儿科精准肿瘤学中的伦理问题。
Asian Bioeth Rev. 2025 Mar 3;17(2):293-306. doi: 10.1007/s41649-024-00351-z. eCollection 2025 Apr.
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Improving access to chimeric antigen receptor T-cells for refractory or relapsing diffuse large B cell lymphoma therapy in Asia.改善亚洲难治性或复发性弥漫性大B细胞淋巴瘤患者获得嵌合抗原受体T细胞治疗的机会。
Discov Oncol. 2025 Feb 14;16(1):181. doi: 10.1007/s12672-025-01860-5.
4
A roadmap for affordable genetic medicines.负担得起的基因药物路线图。
Nature. 2024 Oct;634(8033):307-314. doi: 10.1038/s41586-024-07800-7. Epub 2024 Jul 17.
5
Polish regulatory system regarding ATMP hospital exemptions.波兰关于 ATMP 医院豁免的监管体系。
Front Immunol. 2024 May 13;15:1379134. doi: 10.3389/fimmu.2024.1379134. eCollection 2024.
6
The Relevance of Advanced Therapy Medicinal Products in the Field of Transplantation and the Need for Academic Research Access: Overcoming Bottlenecks and Claiming a New Time.先进治疗药品在移植领域的相关性及学术研究获取的必要性：克服瓶颈，开创崭新时代
Transpl Int. 2023 Sep 27;36:11633. doi: 10.3389/ti.2023.11633. eCollection 2023.

本文引用的文献

1
Access to gene therapy for rare diseases when commercialization is not fit for purpose.当商业化不适用时，罕见病患者获得基因治疗的途径。
Nat Med. 2023 Mar;29(3):518-519. doi: 10.1038/s41591-023-02208-8.
2
Patient access to and ethical considerations of the application of the European Union hospital exemption rule for advanced therapy medicinal products.患者获取和应用欧盟医院豁免规则的伦理考虑——高级治疗药品。
Cytotherapy. 2022 Jul;24(7):686-690. doi: 10.1016/j.jcyt.2022.03.007. Epub 2022 May 8.
3
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.医院豁免是在欧洲开发学术嵌合抗原受体 T 细胞的欧洲药品管理局的替代方案或桥梁吗？我们在 ARI-0001 方面的经验。
Hum Gene Ther. 2021 Oct;32(19-20):1004-1007. doi: 10.1089/hum.2021.168.
4
Spanish Cell Therapy Network (TerCel): 15 years of successful collaborative translational research.西班牙细胞治疗网络（TerCel）：15 年成功的合作转化研究。
Cytotherapy. 2020 Jan;22(1):1-5. doi: 10.1016/j.jcyt.2019.11.001. Epub 2019 Dec 19.

Role of Hospital Exemption in Europe: position paper from the Spanish Advanced Therapy Network (TERAV).

作者信息

Sánchez-Guijo Fermín, Avendaño-Solá Cristina, Badimón Lina, Bueren Juan A, Canals Josep M, Delgadillo Joaquim, Delgado Julio, Eguizábal Cristina, Fernández-Santos María-Eugenia, García-Olmo Damián, González-Aseguinolaza Gloria, Juan Manel, Martín Francisco, Mata Rosario, Montserrat Nuria, Pérez-Martínez Antonio, Pérez-Simón José A, Prósper Felipe, Urbano-Ispizua Álvaro, Zapata Agustín G, Sureda Anna, Moraleda José M

机构信息

University of Salamanca, IBSAL-University Hospital of Salamanca, Salamanca, Spain.

Clinical Pharmacology Department, Hospital Universitario Puerta de Hierro-Majadahonda, IDIPHISA, Madrid, Spain.

出版信息

Bone Marrow Transplant. 2023 Jun;58(6):727-728. doi: 10.1038/s41409-023-01962-0. Epub 2023 Mar 25.

DOI:10.1038/s41409-023-01962-0
PMID:36966215
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10247360/
Abstract
摘要