WHAT IS THE AIM OF THE DIRECTIVE?
- Directive 2004/23/EC aims to minimise the risk of infection and prevent transmission of disease when transplanting human tissues and cells. The directive lays down quality and safety standards.
- It covers the entire chain of activities: from donation to procurement, testing, processing, preservation, storage and distribution to the site of medical use or to sites where manufactured products are made from these human substances.
KEY POINTS
European Union (EU) Member States must ensure:
- competent authorities are designated to implement and oversee implementation of the legislation;
- tissue and cell procurement and testing are carried out by appropriately trained and experienced personnel;
- all tissue establishments are properly accredited, designated, authorised and licensed. The licence may be suspended or withdrawn if inspections reveal non-compliance with the legislation;
- all tissues and cells used in the EU can be traced from donor to recipient and vice versa. The data involved should be kept for a minimum of 30 years after clinical use;
- all imports of tissues and cells from outside the EU comply with similar safety and quality standards;
- systems are in place to report, investigate, register and transmit information about any serious adverse effects or reactions;
- tissues and cells are encouraged to be provided on a voluntary, unpaid basis – although certain expenses may be covered – after mandatory consent has been given;
- all data are rendered anonymous so neither donor nor recipient can be identified.
Lastly, blood and blood components, organs or parts of organs are not covered by the directive. Nor are tissues and cells removed from, and applied in, the same person.
Repeal
Directive 2004/23/EC will be repealed and replaced by Regulation (EU) 2024/1938 (see summary) as from 6 August 2027.
FROM WHEN DO THE RULES APPLY?
Directive 2004/23/EC had to be transposed into national law by 7 April 2006. These rules came into effect on the same day.
BACKGROUND
- Human tissues and cells may come from live or dead donors. They include cardiovascular tissue (arteries, veins, and heart valves), ocular tissue (cornea), bone and musculo-skeletal elements (cartilage, tendons), nerve and brain cells, skin, foetal tissue, reproductive cells (semen, sperm, and ova) and stem cells.
- For further information, see:
MAIN DOCUMENT
Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48–58).
Successive amendments to Directive 2004/23/EC have been incorporated into the basic text. This consolidated version is of documentary value only.
RELATED DOCUMENTS
Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells (OJ L 38, 9.2.2006, pp. 40–52).
See consolidated version.
Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (OJ L294, 25.10.2006, pp. 32–50).
See consolidated version.
Commission Decision 2010/453/EU of 3 August 2010 establishing guidelines concerning the conditions of inspections and control measures, and on the training and qualification of officials, in the field of human tissues and cells provided for in Directive 2004/23/EC of the European Parliament and of the Council (notified under document C(2010) 5278) (OJ L 213, 13.8.2010, pp. 48–50).
Commission Directive (EU) 2015/565 of 8 April 2015 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells (OJ L 93, 9.4.2015, pp. 43–55).
Commission Directive (EU) 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells (OJ L 93, 9.4.2015, pp. 56–68).
