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Human Tissue Act 2004 information

  • Last modified date:
    6 March 2007

Following consultation, the Government introduced legislation in the 2003/2004 Parliamentary session to regulate the removal, storage and use of Human Organs and Tissue. The Human Tissue Act 2004 received Royal Assent on 15th November 2004.

The Human Tissue Act 2004:

  • streamlines and updates current law on organs and tissue so that current gaps and anomalies are put right and the system is made fit for the 21st century;
  • provides safeguards and penalties to prevent a recurrence of the distress caused by retention of tissue and organs without proper consent.  Tissue or organs cannot be taken or kept without consent  other than for a Coroner to establish the cause of death
  • sets up an overarching authority which will rationalise existing regulation and will introduce regulation of post mortems and the retention of tissue for purposes like education and research;
  • provides for the Human Tissue Authority to issue Codes of practice giving practical guidance on the conduct of activities within its remit:
  • will help improve public confidence so that people will be more willing to agree to valuable uses of tissue and organs like research and transplantation;
  • will improve professional confidence so that properly authorised supplies of tissue for research, education and transplantation can be maintained or improved.

The substantive provisions of the Act will come into force on days appointed by the Secretary of State by order.  This is expected to be by September 2006.  However, to comply with the requirements of the EU Tissue and Cells Directive, those establishments that store material for human application will need to be licensed by the Human Tissue Authority from April 2006.  Further information can be found on the Human Tissue Authority website.

The Act and accompanying explanatory notes can be found on the Office of Public Sector Information website

Until the Human Tissue Act 2004 commences, and the Human Tissue Authority issues guidance, the Department of Health interim guidance should continue to apply.

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