The Human Tissue Authority - A Matter of Life and Death

I generally cite this Powell and Pressburger / Archer Films classic (starring the wonderful David Niven) as my favourite film. But this isn’t a film review, so why mention it here? Let’s see. 

The Human Tissue Authority (HTA) was established nearly 15 years ago in response to a national scandal concerning the retention of tissue taken without the knowledge or consent of families. The Human Tissue Act 2004 (the Act) built on, and largely replaced, existing legislation governing the use of human tissue (such as for anatomy training) and established a legal framework to ensure consent is in place for the removal, storage and use of human tissue for a variety of defined purposes. The HTA sat at the heart of this system as the regulator, with a statutory duty to provide advice and guidance to ensure that the provisions of the the Act were understood and followed by those to whom it applied.

So what sort of activities does the HTA cover and how does it do its work? As noted above, the Act covers the removal, storage and use of human tissue for defined (or ‘scheduled purposes’), such as post-mortem examinations, certain types of scientific research, education and training and for public display in England, Wales and Northern Ireland. The HTA also has an important role to play throughout the UK in approving all living organ donations and as the Competent Authority under EU Directives concerning the safety and quality of organs and tissue used for organ donation and transplantation and ‘human application’ (for example, when human tissue and cells are used in medical treatments).

How do we fulfil our role? A licensing regime, under which we mostly license premises, is one of our main regulatory tools. We also set clear licensing standards, derived from the underlying legislation and supported by guidance for practitioners, to give a practical framework for those operating in areas within our remit. We use a combination of regulatory approaches to help those we regulate understand and meet our standards and give us assurance that they are being met. These range from formal mechanisms, such as inspections and investigations, to the less formal, such as raising awareness through newsletters and publications. We also often work in partnership with other regulators and professional bodies.

We take our duty under the HT Act seriously to provide guidance on matters within our remit. We fulfil this duty formally through our published standards, associated guidance, and Codes of Practice. We also fulfil it less formally through our regular newsletters, advice given to those we regulate and our responses to enquiries on matters over which there is uncertainty, for example new scientific or medical developments. All of this makes our role interestingly broad and ever evolving.

We also pride ourselves on our transparency. Anyone interested in finding out more about the HTA can find plenty of helpful information on our website, including copies of all inspection reports.

So, where does ‘a matter of life and death’ come in? Well, the HTA has a central role in regulating the removal, storage and use of human tissue, whether from the living or the dead, for use in any of the various purposes listed in the HT Act. Just two examples of uses of human tissue we regulate are umbilical cord blood taken at the start of life as a source of stem cells and donated bodies after death for use in anatomical training - and of course we cover much, much more than that.

So our remit ranges from life to death and after – close enough for me...

Future blogs (by a variety of authors and published at regular intervals) are likely to focus on more specific topics. I hope this initial blog has given you a flavour of what we do and has whetted your appetite to come back for more - and maybe also to find and watch that amazing film?

Last updated on: 29 May 2019