The European Haemophilia Safety Surveillance (EUHASS) project aims to establish a pharmacovigilance program to monitor the safety of treatments for people with haemophilia. In addition it will develop and maintain a database of all the Haemophilia centres in Europe and establish a Rapid Alert System for immediate Europe-wide notification in case of unexpected or serious adverse events.

The safety of haemophilia treatments is a public health priority following the contamination of plasma- derived treatments with viruses including HIV and Hepatitis C in the past – which resulted in infections in many patients. Concern of treatment safety also regards development of antibodies (inhibitors) to treatment, which is another current issue. In order to assess risks, data need to be collected from sufficient patient numbers. Because haemophilia is a rare disease, sufficient patient numbers can only be derived by taking a European approach

The surveillance system will be web-based and 45 of the largest haemophilia centres from 26 European countries will be prospectively contributing data. Information will be collected in a uniform manner using standardised criteria. EUHASS will provide regular surveillance reports of adverse events. EUHASS will also set up a publicly available database of all European haemophilia centres, including those in countries not represented in this project.

EUHASS will result in new sustainable monitoring and communication of health information and treatment safety data in haemophilia. The project will create a European network that will enable sharing of knowledge related to occurrence, treatment, risk factors and evaluation of best practice with the ultimate aim of providing evidence that will result in improved patient safety. On completion of this project, EUHASS will be rolled out to include a greater number of haemophilia centres across Europe.