Hospital Exemption in Europe: Different Paths, a Common Goal
European countries have been using the hospital exemption for different types of advanced therapy medicinal products for several years, and their experience shows that it is not limited to a single treatment approach or diagnosis. The first-ever Czech hospital exemption, obtained by the Centre of Excellence CREATIC at the Faculty of Medicine, Masaryk University, therefore builds on European practice and comes at a time when the Czech Republic is strengthening the wider framework of care for patients with rare diseases.
One European Principle, Different National Experiences
The hospital exemption is based on common European rules, but its specific implementation differs between countries. A European Commission study published in 2025 described experience with its implementation in 19 EU Member States.
The basic principle is shared: an advanced therapy medicinal product is prepared individually, according to defined quality requirements, and used in a hospital under the responsibility of a physician.
Individual countries nevertheless differ in their procedures and in the types of therapies for which they use the hospital exemption.
The hospital exemption is based on common European rules, but its specific implementation differs between countries. A European Commission study published in 2025 described experience with its implementation in 19 EU Member States.
The basic principle is shared: an advanced therapy medicinal product is prepared individually, according to defined quality requirements, and used in a hospital under the responsibility of a physician.
Individual countries nevertheless differ in their procedures and in the types of therapies for which they use the hospital exemption.
From Orthopaedics to Oncology
Practice across Europe shows that the hospital exemption is used successfully for a wide range of treatment approaches. In Germany, for example, it includes cell and tissue therapies used in orthopaedics, haematology and oncology. In Belgium, a medicinal product for patients with a rare congenital bone disorder was available under this framework from 2019 to 2023. In Austria, the hospital exemption is used for a cell therapy for damaged articular cartilage.
The 2025 European study also records experience with dendritic cell-based immunotherapies. In Lithuania, such a medicinal product was authorised from 2016 to 2024 for the treatment of various types of solid tumours. In Sweden, a dendritic cell-based medicinal product was used between 2016 and 2021 to treat melanoma. The Netherlands also has experience with other specialised cell-based immunotherapies, such as tumour-infiltrating lymphocyte therapy for patients with advanced melanoma.
The common denominator is not a single diagnosis or technology. It is the preparation of a medicinal product outside routine mass production and its use in a healthcare facility under the professional responsibility of the treating physician.
Practice across Europe shows that the hospital exemption is used successfully for a wide range of treatment approaches. In Germany, for example, it includes cell and tissue therapies used in orthopaedics, haematology and oncology. In Belgium, a medicinal product for patients with a rare congenital bone disorder was available under this framework from 2019 to 2023. In Austria, the hospital exemption is used for a cell therapy for damaged articular cartilage.
The 2025 European study also records experience with dendritic cell-based immunotherapies. In Lithuania, such a medicinal product was authorised from 2016 to 2024 for the treatment of various types of solid tumours. In Sweden, a dendritic cell-based medicinal product was used between 2016 and 2021 to treat melanoma. The Netherlands also has experience with other specialised cell-based immunotherapies, such as tumour-infiltrating lymphocyte therapy for patients with advanced melanoma.
The common denominator is not a single diagnosis or technology. It is the preparation of a medicinal product outside routine mass production and its use in a healthcare facility under the professional responsibility of the treating physician.
The Czech Republic Joined Countries with Practical Experience in 2026
The first Czech hospital exemption was obtained by the Centre of Excellence CREATIC for an anticancer immunotherapy based on the patient's own dendritic cells producing interleukin-12.
This placed the Czech Republic among the countries that use this regulatory tool in practice. Establishing the first functioning pathway required coordination between manufacturing, the clinical site, the regulatory authority and experts responsible for quality and medicine safety monitoring.
The first Czech hospital exemption was obtained by the Centre of Excellence CREATIC for an anticancer immunotherapy based on the patient's own dendritic cells producing interleukin-12.
This placed the Czech Republic among the countries that use this regulatory tool in practice. Establishing the first functioning pathway required coordination between manufacturing, the clinical site, the regulatory authority and experts responsible for quality and medicine safety monitoring.
Rare Diseases as a System-Level Priority
In 2026, the Czech Republic also approved the National Strategy for Rare Diseases 2026-2035. Rare diseases are conditions that affect fewer than 5 people in 10,000 - fewer than 1 person in 2,000. Although each individual disease is rare, an estimated 27 to 36 million people in the European Union live with one of approximately 6,000 to 8,000 rare diseases. Rare diseases therefore often require highly specialised care.
The strategy aims to support a better coordinated system of care, earlier diagnosis, access to treatment, specialised centres, the use of data and cooperation among experts.
The National Strategy for Rare Diseases 2026-2035 and the use of the hospital exemption share a common aim: to respond more effectively to the needs of patients with rare and serious diseases.
In 2026, the Czech Republic also approved the National Strategy for Rare Diseases 2026-2035. Rare diseases are conditions that affect fewer than 5 people in 10,000 - fewer than 1 person in 2,000. Although each individual disease is rare, an estimated 27 to 36 million people in the European Union live with one of approximately 6,000 to 8,000 rare diseases. Rare diseases therefore often require highly specialised care.
The strategy aims to support a better coordinated system of care, earlier diagnosis, access to treatment, specialised centres, the use of data and cooperation among experts.
The National Strategy for Rare Diseases 2026-2035 and the use of the hospital exemption share a common aim: to respond more effectively to the needs of patients with rare and serious diseases.
From the First Authorisation to a Sustainable Long-Term Environment
The first hospital exemption is an important milestone, but it is not enough on its own. The development of advanced therapies requires long-term connections between research, manufacturing, clinical research, regulatory expertise and healthcare institutions. Interdisciplinary cooperation between experts from different fields and the sharing of experience with international partners are equally important, because the development and implementation of these therapies extend beyond the boundaries of individual disciplines and institutions.
The pathway of an advanced therapy medicinal product does not begin with an application for a hospital exemption, nor does it end when the exemption is authorised. It begins with the needs of specific patients and continues through research, manufacturing, quality control, expert assessment, use in clinical practice and subsequent follow-up. Each of these steps requires cooperation across different areas of expertise and often international exchange of experience and know-how.
European experience and the first Czech hospital exemption both show that the pathway of an advanced therapy to a patient is the result of many interconnected steps, rather than a single regulatory decision.
The first hospital exemption is an important milestone, but it is not enough on its own. The development of advanced therapies requires long-term connections between research, manufacturing, clinical research, regulatory expertise and healthcare institutions. Interdisciplinary cooperation between experts from different fields and the sharing of experience with international partners are equally important, because the development and implementation of these therapies extend beyond the boundaries of individual disciplines and institutions.
The pathway of an advanced therapy medicinal product does not begin with an application for a hospital exemption, nor does it end when the exemption is authorised. It begins with the needs of specific patients and continues through research, manufacturing, quality control, expert assessment, use in clinical practice and subsequent follow-up. Each of these steps requires cooperation across different areas of expertise and often international exchange of experience and know-how.
European experience and the first Czech hospital exemption both show that the pathway of an advanced therapy to a patient is the result of many interconnected steps, rather than a single regulatory decision.