EPTRI supports the joint statement on Hospital Exemption. The signatories of this statement are key stakeholders in the healthcare ecosystem at both the European Union and Member State level comprising of health care professionals’ associations, patient organisations and national competent authorities for organs, tissues and cells.
Advanced therapy medicinal products (ATMPs) prepared under Hospital Exemption (HE) are the closest we have to personalised affordable therapies and are used “within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient” [Article 2 of proposed Directive 2023/0132 (COD); article 28 of current regulation].
HE has provided access to safe and affordable innovative therapies, the leveraging of nonprofit activities, and the mitigation of the risks to accessing innovative and affordable therapies.
We welcome the general will to regulate and strengthen the HE use in the European Union, however, we would like to express collectively our deep concerns regarding certain changes in the original text of the European Commission on HE as proposed in the ENVI and ITRE reports.
The proposed changes ignore the nonprofit nature of HE and the principles of research integrity regarding reproducibility and replicability of research findings.
Our collective recommendations will strengthen the nonprofit activities under HE and allow our healthcare professionals and researchers to contribute to the ambitious political vision for a healthier European Union.
You can access our joint concerns and recommendations here.