The impact on histopathology practice of new human tissue legislation in the UK

The undisclosed or unauthorized retention of tissue from autopsies in the UK and elsewhere has caused considerable public concern and much distress to some families. Histopathologists involved in these cases have also been discomfited. These events have exposed deficiencies in prevailing legislation, principally in the Human Tissue Act 1961 and the Coroners Rules 1984. New human tissue legislation comes into force in the UK in September 2006. The Human Tissue Act 2004 and the Human Tissue (Scotland) Act 2006 make it unlawful to remove, store and use tissue from the dead without appropriate authority. The Human Tissue Act 2004, which does not apply in Scotland, also prohibits the removal, storage and use of tissue from living individuals for purposes specified in the Act unless appropriate consent has been obtained. The Coroners (Amendment) Rules 2005, which came into force in June 2005, introduced new arrangements for dealing with the retention of tissue from bodies undergoing coroner's autopsies. This new legislative regime is intended to create a climate in which pathologists, patients and the public can have confidence that tissue is used appropriately and, when necessary, with proper authority or valid consent. However, other than in Scotland, there may be unintended consequences arising from restrictions on archiving, for audit and diagnostic review, tissue samples from coronial autopsies.