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HomeStudy supporting the impact assessment of the revision of Directive 2002/98/EC on safety and quality of human blood and blood components and of Directive 2004/23/EC on safety and quality of human tissues and cells and of their implementing acts
Final report
Study supporting the impact assessment of the revision of Directive 2002/98/EC on safety and quality of human blood and blood components and of Directive 2004/23/EC on safety and quality of human tissues and cells and of their implementing acts
Final report
Publication metadata
This study, commissioned by the European Commission’s European Health and Digital Executive Agency (HaDEA) and its Directorate-General for Health and Food Safety (DG SANTE), provides evidence to support the assessment of impacts of proposed reforms to the EU’s legislation on blood, tissues and cells (BTC). An evaluation of the BTC legislation, published by the European Commission in 2019, concluded that it was substantially effective but that there were five main areas with gaps and shortcomings to address. The Commission has been working on the development of options to address these issues. In this study evidence was collected from existing sources and new research undertaken to inform the identification and exploration of impacts. Activities undertaken included desk research, eleven participatory workshops which reached over 700 sector stakeholders, interview and other research for 15 case studies exploring the issues and challenges seen at the borderlines between BTC and other regulatory frameworks, targeted online consultations (surveys focusing on impacts and costs of the proposed options were distributed to BTC National Competent Authorities and BTC establishments and other stakeholder), and followup interviews with stakeholders. The evidence was brought together and used to assess the impacts of the options proposed by the European Commission, as compared to the baseline. The analysis suggests that the proposed "joint regulation" model (whereby establishments are obligated to follow guidelines specified by EU expert bodies) provides a useful combination of regulatory agility and consistency across the EU. Additionally, the package of measures being considered by the European Commission is expected to make a positive contribution to resolving borderline issues at the interface with other legal frameworks, increasing regulatory harmonisation, tackling barriers to innovation, improving resilience to supply shortages and providing a consistent level of protection for patients, donors and children born as a result of medically assisted reproduction. Securing these benefits will entail some additional costs for the sector and for regulators.
- Published:
- Corporate author(s): European Health and Digital Executive Agency (European Commission) , ICF S.A
- Themes: Public health
- Subject: blood transfusion , cytology , directive (EU) , health control , medicine , report , safety standard , substance of human origin , surgery , therapeutics
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| ISSN | ISBN 978-92-95224-07-0 | DOI 10.2925/057450 | Catalogue number HW-07-22-052-EN-N |
- Released on EU Publications:
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