Position Paper on the Application of the ATMP Hospital Exemption in the EU
Read our position on Article 28 of Regulation 1394/2007/EC on advanced therapy medicinal products (ATMPs),
Article 28 of Regulation 1394/2007/EC (hereafter, the ATMP Regulation) on advanced therapy medicinal products (ATMPs), referred to as the 'Hospital Exemption' (HE), foresees the exclusion of certain ATMPs from the scope of Directive 2001/83/EC on medicinal products for human use. Instead, national procedures regulate the preparation and manufacturing of such medicinal products. These products are defined in the ATMP Regulation as: "ATMPs prepared on a non-routine basis according to specific quality standards, and 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".
EuropaBio believe that the Hospital Exemption has a legitimate role to play in meeting unmet patient needs. Equally, action should be taken to ensure that the use of the exemption does not undermine the rights of patients to safe and effective treatment.
The Hospital Exemption should be interpreted and implemented in a strict and fully harmonised manner by all EU Member States, recognising that the exemption should only be applied in the absence of centrally authorised medicinal products. Commission guidance should support National Competent Authorities in achieving harmonisation.
Measures should be adopted to improve transparency of the use of the Hospital Exemption, including though the establishment of a register of exempted products and the adoption of a harmonised Informed Consent Form.
Finally, to safeguard incentives for innovation, steps should be taken to ensure the Hospital Exemption cannot be used an alternative route to market for developers of ATMPs.