Tissues and cells
The use of tissue and cell-based medical treatments is rising in both number and frequency thanks to significant advances in biotechnology.
Blood-forming stem cells are transplanted from bone marrow donors (or cord blood) to patients with blood cancer, and/whereas gametes are used for in-vitro fertilisation (IVF). Both are well known medical therapies that use human cells. Other invaluable uses of human tissues include skin grafting for burn victims, or corneal grafting to restore sight.
Bone marrow (haematopoietic stem cells) and gametes (sperm, egg cells) for IVF can be donated by living donors, while replacement tissues (like skin, bone, cornea or heart valves) can be donated after death.
The legal framework defining the safety and quality standards for tissues and cells is set out in Directive 2004/23/EC, also referred to as the European Tissues and Cells Directive, adopted in 2004 by the European Parliament and Council. It covers all steps in the transplant process from donation, over procurement, testing, processing, preservation, storage to distribution.
To help implement this basic act, the Commission proposed and adopted, in close collaboration with EU countries, the following implementing Directives:
- Commission Directive 2006/17/EC regarding certain technical requirements for the donation, procurement and testing of human tissues and cells
- Commission Directive 2006/86/EC concerning traceability requirements, notification of serious adverse reactions and events, additional technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells
- Commission Directive 2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells
- Commission Directive 2015/566 implementing Directive 2004/23/EC concerns the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells.
It is important to note that EU countries can always choose to apply more stringent rules to the quality and safety of tissues and cells then the ones outlined above.
Following an evaluation of the EU legislation on blood and tissues and cells, published in 2019, the Commission plans to propose a revision of this legislation at the end of 2021.
The European Commission collaborates closely with expert bodies such as the Council of Europe (CoE) and the European Centre for Disease Prevention and Control (ECDC) in the development of practical guidelines that support tissue establishments with the implementation of this binding legislative framework.
- The Council of Europe regularly reviews and updates technical requirements in its Guide to the quality and safety of tissues and cells for human application.
- ECDC prepares risk assessments and preparedness plans whenever epidemiological outbreaks are of relevance for blood, tissues, cells and organs. Most recently ECDC has provided input on:
Coordination and implementation
National Competent Authorities (CAs) are responsible for the implementation of the requirements established in EU legislation. The European Commission holds regular meetings with them to facilitate communication, to exchange best practices, and to reach a common understanding on the implementation of the Directives. Periodic surveys, completed by the CAs, allow the European Commission to draft reports on the implementation of the legislation.
Vigilance: Traceability (Single European Code)
The tissues and cells intended for human application in the EU must be traceable from donor to recipient, and vice versa. A unique identifier called the Single European Code (SEC), together with its accompanying documentation, allows for this traceability and provides information on the main characteristics of tissues and cells for human use. Users can retrieve relevant information on tissue and cell products through a publicly accessible IT platform. This platform gives access to the names of all authorised establishments in the EU, including their contact details, and those of the authorities overseeing them, as well as the different tissues and cells types distributed in the EU.
The Commission encourages national participation in the WHO's NOTIFY Library - a website where experts from across the globe share information on selected and documented adverse outcomes associated with the donation, processing or clinical use of human organs, blood, tissues and cells. The website's purpose is instructive, providing expert review and additional information on the records shown.
The European Commission provides funding for Actions in the area of SoHO through the EU Health Programme mainly in the form of projects or joint actions with national authorities.
Actions aim at supporting the EU mandate on safety and quality; but also serve to promote other policy priorities, such as improving the availability of SOHO or the efficiency of the health systems that support donation and supply. Some recent examples include:
- Economic Study focusing on Human tissues and cells for clinical application in the EU
- ECCTR - The European Cornea and Cell Transplantation Registry
- The Joint Action VISTART, harmonising oversight, in particular focusing on inspection, authorisation and vigilance systems for blood, tissues and cells
- The Joint Action ARTHIQS - a three year Action dealing with Assisted Reproductive Technologies and Haematopoietic Stem cells for transplantations
- EuroGTP2 - a project co-funded by the Commission on Good Tissue Practices
- Eurobarometer reports outlining the European public's attitude to blood and tissue and cells donation and transfusion and/or application
- Jacie - Joint Accreditation Committee ISCT Europe & EBMT
- Vigilance and Surveillance of Substances of Human Origin (SoHO V&S)
- EUSTITE - European Union standards and training for the inspection of tissues establishments
- Comparative analysis of Medically Assisted Reproduction in the EU: Regulation and Technologies.