EU sets standards for safe blood products

The European Union has adopted legislation setting high quality and safety standards for blood and blood products in a bid to restore long term public confidence in transfusions. The new rules set testing, labelling, and traceability requirements. In addition, laboratories, hospitals, and other establishments that collect, handle, and process blood and blood components will be obliged to set up quality management systems. Staff involved in the collection, processing, storage, and distribution of blood will now have to be trained according to EU standards. The essential elements of the systems will be determined by a committee of national government experts that will begin meeting early next year. These will be based on best practice so that comparable management and safety standards apply throughout the EU. The legislation, which comes amid concerns over contamination from the agent causing Creutzfeldt-Jakob disease (CJD), has been widely welcomed. David Byrne, the EU health commissioner, said: "Europe's citizens can be confident that a high common standard of quality and safety of blood will be applied throughout the EU and will be regularly updated with the assistance of the best available expertise." John Bowis, the Conservative's European health spokesman, stated: "Patients in the UK need to know that the blood that they are getting is both safe and secure. This will go some way to ensuring a safe supply of blood across the European Union." The rules are designed to prevent any repetition of blood contamination scandals as occurred in France in the 1990s. They set union-wide standards for the labelling and traceability of whole blood and blood components from donor to patient. The legislation was finally adopted by the European parliament shortly before Christmas in the same week that the UK government confirmed that it had bought an American blood plasma company to ensure that British patients had access to safe blood. This followed earlier concerns that the risk of CJD being transmitted through transfusions of blood collected in Britain might be higher than previously thought. The rules also establish a mandatory surveillance and information exchange system to enable early identification of emerging risks in the blood chain so that contaminated batches can be swiftly withdrawn. The legislation complements existing EU rules on medicinal products derived from blood. Since 1989, blood and plasma used for the manufacture of plasma-derived products, such as coagulation factors and immunoglobulins, have been covered by EU pharmaceutical standards. The latest rules on whole blood, cellular components, and plasma used for transfusion are the first to have been approved under new treaty powers, which give the European Union the right to legislate on public health policy.