Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the implementation of the Directives 2002/98/EC, 2004/33/EC, 2005/61/EC and 2005/62/EC setting standards of quality and safety for human blood and blood components

Article 26 of Directive 2002/98/EC requires Member States to submit to the European Commission, before 31 December 2003 and every three years thereafter, a report on the activities carried out in relation to the provisions of the Directive, including an account of the measures taken in relation to inspection and control. The Commission is required to transmit these national reports to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. The Commission is also required to provide them with an overview report on the implementation of the requirements of the Directive, in particular as regards inspections and control.

In addition, Member States have to submit to the Commission reports on the application of the principle of voluntary and unpaid donation (VUD) every three years. On the basis of these national reports, the Commission is required to inform the European Parliament and the Council of any necessary further measures in relation to VUD it intends to take at Union level.

This overarching Report is a summary, drawing from the replies to questionnaires that the Commission sent to Member States in 2012 (verification of the completeness of transposition), 2013 (implementation survey) and 2014 (implementation of the VUD principle) and follows up on the Report in 2006 and the Commission Communication in 2010, as well as on the two Reports on the application of the principle of VUD for blood and blood components issued in 2006 and 2011. All Member States replied to the transposition questionnaire. The 2013 implementation survey was answered by all Member States and also by two EEA countries, Liechtenstein and Norway. All Member States, Liechtenstein and Norway also provided answers to the survey on the implementation of the principle of VUD.

The full analysis of the Member States' replies to the 2013 implementation survey and the 2014 survey on the implementation of the VUD principle is included in the two Staff Working Documents accompanying this Report.

Besides complying with the legal obligations, the current report sets out how Directive 2002/98/EC and its implementing Directives 2004/33/EC, 2005/61/EC and 2005/62/EC (henceforth commonly referred to as the EU blood legislation) function in practice, against a backdrop of significant scientific and organisational developments (internationalisation, commercialisation) that have taken place in the European blood and blood components sector over the past decade.

Where appropriate, data gathered through other channels and supporting the findings of the two surveys (e.g. exchanges with the national blood competent authorities during the bi-annual meetings with the Commission, mandatory annual reporting to the Commission of serious adverse reactions and events (SARE), alerts launched in the Rapid Alerts for Blood (RAB) platform, a study mapping the economic landscape of the sector and more recently a Eurobarometer survey as well as outputs of EU-funded projects were also taken into account.

See also:
- Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the implementation of Directives 2004/23/EC, 2006/17/EC and 2006/86/EC setting standards of quality and safety for human tissues and cells

EUR-Lex: SWD(2016)129: Commission Staff Working Document on the application of Directive 2002/98/EC on setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=SWD:2016:129:FIN

EUR-Lex: SWD(2016)130: Commission Staff Working Document on the implementation of the principle of voluntary and unpaid donation for human blood and blood components as foreseen in Directive 2002/98/EC on setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=SWD:2016:130:FIN

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