General BRBDR project information

Project name

Belgian Rare Bleeding Disorders Registry

Project abbreviation

BRBDR

Project code

HDBP0053

Primary organization that oversees implementation of project

• Sciensano

Partner organization participating in project

• Not available

Organization that commissioned this project

• National Institute for Health and Disability Insurance (RIZIV-INAMI)

Organization providing monetary or material support

• National Institute for Health and Disability Insurance (RIZIV-INAMI)

Brief project description

Hemophilia is a congenital anomaly in the body's ability to form blood clots, which can result in bleedings in joints, muscles and organs. In addition to hemophilia there are other bleeding disorders, of which the Von Willebrand disease is the most common form. It concerns rare disorders with an effective but expensive treatment. In Belgium, care for patients with Hemophilia is organized through a national convention and provided by specialized reference centres.

Public surveillance through a systematic collection of disease related date, is of crucial importance to monitor health outcome, variation in symptoms and changing trends. Thereby,  knowledge about the use of coagulation factors, the cost effectiveness and the results of different new treatments like gene therapy is still limited. The set-up of a systematic national data collection, will enable to compare them different treatment products and their effectiveness per patient group. Therefore, a national patient registry is a vital means to identify and list the treatments, keep track of the side effects, evaluate results and improve the treatment. A national hemophilia registry is one of the recommendations of the European Principles of Haemophilia Care (2008). The project goal is to set up a longitudinal, prospective patient registry, which provides patient level clinical and outcome data. The registry data can be used for different purposes:

• Giving insight into the total number of people with bleeding disorders, their diagnosis, the use of coagulation factors, bleedings, treatment results and side effects of the treatment.
• Comparing the quality of care (benchmarking) of hemophilia treatment centres in Belgium.
• Enabling large-scale international studies and comparison with hemophilia treatment abroad, using data sharing with the World Bleeding Disorders Registry, PedNet Registry, HemoNed and the European Commission’s Joint Research Centre Rare Diseases Registry.
• Reporting side effects of medication to the European Haemophilia Safety Surveillance database (EUHASS).
• Providing information for reports, scientific research and safety studies for (new) medications.

Regulatory framework of this project

• Agreement between the Health Care Insurance Committee of the National Institute for Health and Invalidity Insurance and the Scientific Institute of Public Health regarding the maintenance and the funding of a national haemophilia register (789800_ISP-INAMI_2016-2, signed on the 22nd of March 2017)
• Agreement between the committee of insurance of medical care from the National Institute for Health and Disability Insurance and the Reference Centers for Haemophilia (hemo_convention_v22-1.1CR_NL)
• Agreement between the Health Insurance Committee of the National Institute for Health and Disability Insurance and the National Coordination Center for Haemophilia (hemo_convention_v22-1.0_CCN_NL)
• Deliberation no. 13/105 of October 22, 2012, amended on June 16, 2015, regarding the processing of encrypted personal dataconcerning health by the healthdata.be platform in the context of the central register of rare diseases (SCSZG/15/107)