4.5 Letter

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

Related references

Note: Only part of the references are listed.
Letter Biochemistry & Molecular Biology

Access to gene therapy for rare diseases when commercialization is not fit for purpose

Thomas Fox et al.

NATURE MEDICINE (2023)

Article Cell & Tissue Engineering

Patient access to and ethical considerations of the application of the European Union hospital exemption rule for advanced therapy medicinal products

Natividad Cuende et al.

Summary: This article reflects on the ethical concerns of hospital exemption (HE) application from the patient's perspective and emphasizes that HE must not be considered as a conduit for unproven and unethical ATMP-based interventions. However, the harmonization of HE across EU Member States and the limitations of ATMP use under the HE rule in the presence of centrally authorized products are controversial issues.

CYTOTHERAPY (2022)

Article Biotechnology & Applied Microbiology

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

Manel Juan et al.

Summary: The hospital exemption allows for the use of advanced therapy medicinal products under special conditions in the EU member states; mainly granted to academic centers by national competent authorities. It follows strict standards of traceability, pharmacovigilance, and quality, serving as an intermediate step before obtaining a centralized marketing authorization.

HUMAN GENE THERAPY (2021)

Review Cell & Tissue Engineering

Spanish Cell Therapy Network (TerCel): 15 years of successful collaborative translational research

Fermin Sanchez-Guijo et al.

CYTOTHERAPY (2020)