The Human Tissue Act 2004 came into effect on 1 September 2006. Under its provisions, introduced in the wake of the organ retention scandals at the Alder Hey Hospital and the Bristol Royal Infirmary, it is an offence to have bodily material with the intention of analysing the DNA, without the consent of the individual from which it was obtained (or those close to them if they have died). It also establishes the Human Tissue Authority to regulate the removal, storage and use of human tissue. 

Not much, for pathologists

We’ve already changed, says Peter Furness

We hope that the legislation will provide necessary reassurance to the public that our work is being properly regulated.

The legislation undoubtedly provides a framework for those of us who use human tissue for the benefit of society to carry on our work, knowing that what we are doing is lawful. To that extent the implementation of the Act is an improvement, though we still struggle to understand the legal complexities of what is and is not lawful. There is a danger that excessive caution and fear of the law may inhibit legitimate work done for the benefit of patients. Hopefully this problem will decline as we become more familiar with the rules.

For pathologists, the big changes happened at the time of the 'organ retention scandal' in 2000. We had acted in good faith, but our assumptions about the acceptability of retaining organs at post mortem were invalid. Practice changed almost overnight.  So in relation to the big issue, implementing the Act in 2006 makes comparatively little difference.

The main practical difference from 1 September 2006 is the requirement for Human Tissue Authority licences. Obtaining such licences is proving time-consuming and expensive, using resources which would otherwise be available for healthcare. But if the public, through our elected representatives, decides that the cost is worth paying, then it must be paid.

Effects of the scandal

Since 2000, we do far fewer ‘consent’ post mortems– not because consent is not forthcoming, but because relatives are rarely asked. Causes of death are less rigorously investigated by microscopic examination of tissue.  It is now possible to prosecute someone who behaves as Professor van Veltzen did at Alder Hey – a change which most pathologists applaud.

But contrary to public perception, post mortems are not actually our 'core business'.  Most pathologists diagnose disease in living patients, by examining samples of their blood or tissue.  In England (but not Scotland) the new legislation covers tissue from the living – and ‘tissue’ even includes urine and faeces.

Research using surgically resected tissue underlies our classification and understanding of many diseases, especially cancer. We feared that new requirements for explicit consent would inhibit this work. We don't meet the patients, and for us to discover what they want after they have gone home is rarely practicable.  Such research has indeed been reduced dramatically; but again, this happened six years ago due to the introduction of a requirement for ‘research ethics’ approval. 

So for NHS pathology departments, change has already happened.

Professor Peter Furness is Vice-President of the Royal College of Pathologists