Governance in the European union: the European Blood Directive as an evolving practice

This article reconstructs governance practices related to blood policy that have developed within in the European Union (EU) over the last 15 years. It describes core aspects of the policy and argues that, despite an integrated cooperative approach between policy-makers and practitioners, this policy remains an open and evolving process. The European Blood Directive (2002/98/EC) and its subsequent directives managed, for the first time, to create an overarching framework for transfusion procedures. This framework consists of a number of standard definitions as well as detailed standard operating procedures, yet leaves room for interpretation and different practices between EU member states. A recently published report on the progress of transposition of the Directives into national legislation reveals different standards, suggesting a lack of uniformity of safety and quality requirements. Further, gaps in the directives amount to practical medical problems, while increased mobility among EU citizens may add further problems to achieving the objective of a self-sufficient supply of blood and blood products. This might undermine public confidence in the quality of blood products and the health protection of donors, which, in turn, must be countered by a cooperative effort of policy-makers and blood establishments.