16 / 2019
The new version of the German Haemophilia Register (Deutsches Hämophilieregister, dhr) started on 1 August 2019 with modified legal framework conditions and extended user facilities. The website is easy to use and allows the user to capture both established and new therapy options, thus contributing to long-term research of haemophilia treatment – for the wellbeing of the patients. As laid down by the laws, an office for the dhr has been created at the Paul-Ehrlich-Institut (PEI).
The dhr is a national clinical register, which has been used to capture therapy relevant data of patients with haemostasis disorders (blood coagulation disorders) for ten years. Medical data of patients with haemophilia A, haemophilia B, von Willebrand disease or other coagulation deficiency disorders are registered in the dhr and documented on a long-term basis. To meet the legal registration obligation on the use of blood products pursuant to Section 21 Transfusion Act (Transfusionsgesetz [TFG]), the dhr is conceived in such a way that the data on the number of haemophilia patients in Germany and their use of coagulation products can be evaluated on an annual basis.
Previously, the dhr was a voluntary co-operation project between the two patient advocacy organisations – the Deutsche Hämophiliegesellschaft zur Bekämpfung von Blutungskrankheiten e. V. (DHG) (German Haemophilia Association for Combating Bleeding Disorders) and the Interessengemeinschaft Hämophiler e. V. (IGH) (Interest Group of Haemophiliacs), as well as the Gesellschaft für Thrombose- und Hämostaseforschung e. V. (GTH) (Organisation for Thrombosis and Haemostasis Research) in its quality as scientific specialist organisation of treating doctors and the PEI. As per 1 August 2019 and in line with the adaptations in the German Transfusion Act (Transfusionsgesetz [TFG]), Section 21 a), the PEI has now been assigned the responsibility to manage the register. The duties, the structure and the work processes of the dhr have been laid down in more detail in the Statutory Regulation on the German Haemophilia Register (Deutsches Hämophilieregister [DHRV]) of 21 May 2019.
As from now, both doctors and persons affected are equally obliged to document all relevant data on the therapy of coagulation disorders and to capture them in the online database of the dhr.
Patients will support the new dhr by updating their patient information and informed consent in accordance with the requirements of the current data protection laws and by reliably documenting their treatment by means of an app or diary. Treating doctors inform their patients on the dhr and transmit data in order to access the patients’ reported data, perform their own evaluations, and analyse them in future by means of a benchmarking tool.
The new option of the dhr will provide valuable register data on the efficacy and safety of therapies for the area of marketing authorisation. For rare diseases such a haemophilia, this is of major importance to obtain a sufficient amount of data for valid analyses. A number of innovative therapy options (gene therapy, monoclonal antibodies, modified cells, etc.) are currently being developed, such as treatment with gene therapy or monoclonal antibodies. The dhr will be able to make an important contribution to support the use of these therapies in future: It captures the data of therapies, including the new ones, so that the development of their use will be followed up on a long-term basis and new findings can be obtained on the efficient and safe use.
Link to the patient information and informed consent form (German only): www.pei.de/dhr
Contact:
Paul-Ehrlich-Institut
Press Office
Telefon: +49 6103 77 1030
Email: presse@pei.de
Updated: 01.08.2019
