The Human Tissue Act 2004: reflections on recent changes in regulatory affairs in the United Kingdom.

Author:Whitman, Birgit


US Federal regulators have increased their oversight in areas that use human tissue, in particular targeting companies that remove tissue for use in medical procedures. The UK has recently undertaken a comprehensive review of the existing law that surrounds human tissue as a result of inquiries that identified a need to improve current practice. The inquiries related to a misinterpretation of legislation that led to a distressing and unacceptable situation for relatives of children and adults whose bodies, or part of their bodies, were used without their consent, after their deaths. The Retained Organs Commission (ROC) made recommendations for changes to the existing law (Department of Health, 2001a). The Human Tissue Act 2004 (HT Act) was created and relates to England, Wales and Northern Ireland. A separate Act, the Human Tissue (Scottish) Act 2006, is in place in Scotland.

This review explores the events leading up to the creation of the HT Act with a brief overview of the key points, remit and impact of the HT Act. (Editor's Note: The term "remit" may be understood as scope or responsibilities.)

The events leading to the development of the Human Tissue Act in the UK

Two public inquiries at the Bristol Royal Infirmary and the Alder Hey Children's Hospital were the catalyst for the creation of the HT Act in the UK. Both inquiries highlighted issues of consent, retention, and use of human tissue obtained from people after their deaths. The Isaacs Report summarised the findings from both inquiries and highlighted the fact that after people had died it was commonplace to find storage and use of their organs and tissue without proper consent being obtained (Department of Health, 2001a, 2001b, 2003).

These events caused much distress to relatives who were often unaware that organs had been retained. There was an urgent need to address this with a legislative review of the existing law to ensure that guidance for good practice in the storage and use of human tissue was developed and implemented. This review also served to restore public confidence and ensure that tissue obtained with consent would still be available for research and teaching purposes.

A public consultation was undertaken by the government as part of an overall legislative review to address this lack of attention to policies and procedures outlined in the existing legislation. The report (Department of Health, 2001c) summarised the changes necessary to the legal and regulatory framework to reflect advances in good practice and provided a lessons-to-learn approach. This made it clear that living patients would be required to consent to the retention and use of their organs and tissue for particular purposes beyond their diagnosis and treatment. There would also be mandatory consent for removal, retention, and use of tissue from the deceased given either by these people while still alive; or, in the event that they died without expressing their wishes, given by someone nominated by or close to them (Department of Health, 2001c). The independent Retained Organs Commission (ROC) was set-up as a recommendation from the legislative review and provided advice to the Government about the changes needed in the law, based on two rounds of consultations carried out in 2002 and 2003.

Summary of the HT Act 2004

The HT Act repeals and replaces a number of previous pieces of legislation. It provides a framework for regulating the storage and use of human organs and tissue from the living; and the removal, storage, and...

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