EU Blood Product Regs Sought By Irish Presidency

Irish Health Minister Michael Noonan has called for regulations in all European Union member states to restore public confidence in blood and blood products. He told a conference of EU blood experts in Ireland, held as part of the Irish EU presidency, that the lack of consistent regulatory standard is tending to undermine the aim of achieving self-sufficiency in blood products.

There is consensus on the need for an EU strategy covering source material for medicinal and drug products and blood used for transfusion, he said. This is also the view of a recent European Commission report on Directive 89/381/EEC, which proposes: agreed procedures in donor selection; implementation of reliable screening tests; development of quality assessment criteria and good manufacturing practices in collection, testing, processing and transfusion and patient follow-up procedures; development of a hemovigilence system for collection of epidemiological data related to the blood transfusion chain; and education programs for health care professionals.

On tests and screening, the experts said ALT screening is redundant and should be abandoned, and noted concerns that the In Vitro Diagnostic Directive does not adequately address the criteria needed to ensure safety and test performance. National authorities should inform their counterparts of tests, including batch releases, that are licensed or relicensed, rejected or withdrawn, they said, and felt that techniques such as Genomic Amplification Technology will eventually become part of routine blood screening as "directly relevant to the investigation of reactive donor specimens and plasma pools."