Blood Under The Microscope Of The European Commission: An Article by TIF’s Executive Director

by Dr Androulla Eleftheriou

The European Commission published in October 2019 the Evaluation Report of the European legal framework for quality standards and blood, tissues and cells. This framework is contained in Directive 2002/98 / EC, which covers all stages of the transfusion process from donation and collection to control, processing, storage and distribution. This is the first document demonstrating the need to review and upgrade the framework governing the use of blood in all EU Member States.

The evaluation of this Directive, also known as the „Blood Directive“, and the related additional implementing acts[1], which began in 2017 and will be completed by the end of 2021, aims to determine whether this framework has achieved the initial objectives and whether it continues to cover existing practices and procedures. The Thalassaemia International Federation (TIF) participated in both the open public consultation and the evaluation process of the relevant Commission roadmap, contributing to the common finding that the current legal framework needs to be revised, supplemented and upgraded.

More specifically, TIF, as a representative of the global community of transfusion patients, was in favor of strengthening the supervisory role of the European Commission for promoting the quality of procedures and services. It also stressed the importance of the promotion and mandatory adoption of voluntary blood donation by Member States, as a proven method of ensuring blood safety, in accordance with the protocols of the World Health Organization (WHO) and the many years of experience of technical laboratories, clinicians, and transfusion-dependent patients across the world.

In this light, and given the heterogeneity of the Member States in terms of quality, safety standards and blood vigilance, TIF proposes that the Commission cooperates with the European scientific bodies responsible for blood, i.e. the European Directorate for the Quality of Medicines and Healthcare (EDQM) and the European Center for Disease Prevention and Control (ECDC) to upgrade quality control standards and establish a European Blood Surveillance Mechanism.  Such an initiative will further strengthen the foundations of the European Union for Health announced by the European Commissioner for Health and Food Safety, Stella Kyriakidou, in an effort to better coordinate the national health systems of the Member States.

The adoption of quality standards in all EU countries and the supervision of their implementation will strengthen the structures of Blood Banks and Centres, and will promote the employment of laboratory experts and clinical doctors, so that the national management systems for blood and blood products works properly.

As a patient organization, we expect that the revised legal framework for blood will include provisions for the establishment of a European supervisory mechanism, the provision of common guidelines and training to the competent bodies in the Member States, the mandatory recording of blood needs and the adoption of specific measures in cases of shortages (e.g. immediate information of blood centers at national level and transnational cooperation), and the inclusion of new substances of human origin, the use of which is not governed by the existing regulatory framework.

As a representative of the end users of blood products and in particular of red blood cells, TIF declares its readiness to contribute to the enhancement of the viability of the national blood management bodies, through promoting the quality and safety of the blood and its products, but also through communication, exchange of best practices and the formation of a common understanding between the EU Member States on the upgrading and implementation of the European Directives.

 Dr Androulla Eleftheriou

TIF Executive Director

[1] These are the Commission Directive 2004/33 / EC on the technical requirements for donating blood and blood components, Commission Directive 2005/61 / EC on traceability requirements and notification responsibilities in the event of serious adverse reactions and events, Commission Directive 2005/62 / EC establishing Community standards and specifications for a quality system in blood banks. Directives 2009/135 / EC, 2011/38 / EU, 2014/110 / EU and 2016/1214 / EU address certain additional specific technical requirements.