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European Regulations and Their Impact on Tissue Banking

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Abstract

Extensive CoE-EU cooperation ensures coherence and complementarities between the principles of the CoE guides which can be regarded as recommendations on best practice, and the technical requirements of the EU directives which set out legally binding requirements. This means that the same standards now exist throughout European continent. Having a common set of standards facilitates cooperation between different healthcare systems, especially in cases of emergencies, and the export–import issues. Adoption of the same quality management and traceability systems helps to minimise the risks and prevent disease transmissions. It reassures patients who undergo treatments outside of their countries. The tissue establishments need to introduce technical and structural changes to adhere to the new regulations which ultimately results in saving and improving of lives of many patients.

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References

CoE recommendations and publications in the field of transplantation:

  • Health, Ethics and Human Rights – The Council of Europe Meeting the Challenge

  • Recommendation (2005)11 on the role and training of professionals responsible for organ donation (transplant “donor co-ordinators”)

  • Guide to safety and quality assurance for organs, tissues and cells – 2nd edition (2004)

  • Transplant Newsletter – September 2004 Vol. 9 No. 1

  • Recommendation (2004)19 on criteria for the authorisation of organ transplantation facilities

  • Recommendation (2004)8 on autologous cord blood banks and explanatory memorandum

  • Replies to the questionnaire for member states on organ trafficking (2004)

  • Recommendation (2004)7 on organ trafficking

  • Recommendation (2003)12 on organ donor registers

  • Recommendation 1611 (2003) of the Parliamentary Assembly on trafficking in organs in Europe

  • Additional Protocol to the Convention on Human Rights and Biomedicine, on Transplantation of Organs and Tissues of Human Origin (2002)

  • Recommendation (2001)5 on the management of organ transplant waiting lists and waiting times

  • Meeting the organ shortage: Current status and strategies for improvement of organ donation – a European consensus document (1999)

  • Recommendation (94)1 on human tissue banks

  • Recommendation 1240 of the Parliamentary Assembly on the protection of material of human origin (1994)

  • List of tissue typing laboratories in the member states of the Council of Europe (1992)

  • Conference of European Ministers of Health, Paris, 1987. Reports

  • Essential aspects of tissue typing (1983)

  • Resolution (78) 29 on harmonisation of legislations of member States relating to removal, grafting and transplantation of human substances

  • Treaty of Amsterdam amending the Treaty on European Union, the Treaties establishing the European Communities and certain related acts.Official Journal C 340 , 10/11/1997 P. 0141

  • 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. Official Journal L 102 , 07/04/2004 P. 0048–0058.

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Correspondence to Alina Tatarenko.

Additional information

This and other EU documents on tissues and cells are also available at http://www.europa.eu.int/comm/health/ph_ threats/human_substance/tissues_en.htm

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Tatarenko, A. European Regulations and Their Impact on Tissue Banking. Cell Tissue Banking 7, 231–235 (2006). https://doi.org/10.1007/s10561-006-9008-x

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  • DOI: https://doi.org/10.1007/s10561-006-9008-x

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