Study supporting the evaluation of the EU legislation on blood and tissues and cells : final report

The European Union legislation on blood and tissues and cells aims to safeguard public health by setting clear standards for quality and safety. The legislation on blood comprises Directive 2002/98/EC and implementing (technical) Directives 2004/33/EC as amended, 2005/61/EC, 2005/62/EC and 2009/135/EC while that on tissues and cells is Directive 2004/23/EC and implementing (technical) Directives 2006/17/EC as amended, 2006/86/EC as amended, 2015/565/EC and 2015/566/EC. No evaluation of the legislation has taken place since it was adopted at the turn of the century. Over that period there has been continuous innovation in the field of substances of human origin, significant changes in society and health care services, and changes in other relevant legislation. In this context the European Commission recognised the need to evaluate the existing legal requirements to understand if the Directives are still up to date and serving their original purpose, and determine whether they require amendment. This report describes the results of an independent study conducted to support the Commission Services in their evaluation. A comprehensive assessment of the main pillars of both sets of legislation was made against five mandatory evaluation criteria (relevance, effectiveness, efficiency, coherence and EU added value). A wide range of methods were used to inform this assessment, including a systematic review of key documents and scientific and grey literature; interviews and focus groups with relevant stakeholders; analysis of an Open Public Consultation; and additional targeted data collection. The results are summarised under fourteen evaluation questions. Whilst potential areas for improvement have been identified, this report does not provide recommendations.