Masterarbeit
The Hospital Exemption, a regulatory option for unauthorised advanced therapy medical products ***
Dr. Anna Schnitger (2014)
Summary
Since entry into force of Regulation (EC) No 1394/2007 (the ATMP regulation), the central marketing authorisation (MA) has become mandatory for advanced therapy medicinal products (ATMPs). However, the development of ATMPs has mainly be driven by small- and medium-sized-enterprises (SMEs), hospitals and academia with only limited resources and regulatory expertise available to meet the high requirements of a central MA. Thus, so far there have only been a few central MAs granted to ATMPs. Article 28 (2) of the ATMP regulation defines an exemption from the obligation to obtain a central MA for ATMPs, which are “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”.
The european provisions of the so-called Hospital Exemption (HE) had to be implemented into the national legislation of each EU Member State (MS). Therefore, the HE constitutes a national regulatory procedure. In Germany, the HE has been implemented into Section 4b of the German Medicinal Products Act (AMG) and the national authorisation pursuant to Section 4b AMG has become a regulatory option for ATMPs that had previously been on the German market and also for newly developed products.
In addition to clinical trials, compassionate use programmes and named patient use, the HE can be considered as an important early access option for patients to innovative treatments provided by unauthorised ATMPs.
However, there are differences in the implementation and the interpretation of the HE among the EU MSs and the HE is increasingly criticised as a possibility to circumvent the central MA.
Pages Total: 86,
Annexes: pages: 13 including CD