Distinguished stakeholders within the European healthcare ecosystem, including healthcare professionals’ associations, patient organisations, and national competent authorities for organs, tissues, and cells, have collaborated to voice their concerns regarding proposed changes to the regulation of Advanced Therapy Medicinal Products (ATMPs).
In a joint statement, the signatories highlight their crucial role as important contributors to the healthcare landscape at both the European Union and Member State levels. Their objective is to focus on ATMPs that are prepared under Hospital Exemption, which are a vital aspect of personalised and accessible therapies. As per the statement, these therapies are administered within the same Member State in a hospital, under the exclusive professional responsibility of a medical practitioner, to comply with an individual medical prescription for a custom-made product for an individual patient. This aligns with Article 2 of proposed Directive 2023/0132(COD) and Article 28 of the current regulation.
The signatories express their trust in the commitment of the European Commission, the European Council, and the European Parliament to the public good. They urge these institutions to safeguard the interests of European patients while ensuring the sustainability of healthcare systems and promoting cutting-edge innovation.
The signatories also reiterate their dedication to supporting EU institutions by offering their collective expertise and diverse perspectives.
