Human Tissue Authority

The regulator for human tissue and organs

About the HTA

The HTA is an executive Non-Departmental Public Body sponsored by the Department of Health and Social Care, established under the Human Tissue Act 2004.

Our overall goal is to maintain public confidence by ensuring that the removal, storage and use of human tissue and organs are undertaken safely and ethically, and with proper consent, in accordance with the provisions of the Human Tissue Act 2004, Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) and the Quality and Safety of Organs Intended for Transplantation Regulations 2012 (as amended).

We also have a role in maintaining both public and professional confidence, by assuring that human material being used by professionals has been obtained with the proper consent and is managed with appropriate care.

Our role

  • We license organisations that remove, store and use human tissue for activities set out within the Human Tissue Act 2004.
  • We license organisations involved in preparing tissues and cells for use in patient treatment as required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007.
  • We license organisations involved in organ donation and transplantation as required by the Quality and Safety of Organs Intended for Transplantation Regulations 2012.
  • We monitor and inspect or audit organisations to ensure they comply with the requirements of the legislation and our Codes of Practice.
  • We use our powers to take regulatory action where we identify non-compliance.
  • We assess living organ donations to ensure donors are protected from duress or coercion, and that no reward is offered or given.
  • We provide information, advice and guidance to the public and professionals about the nature and purpose of activities within our remit.
  • We monitor developments relating to activities within our remit and advise Government on related issues.

In addition to our statutory role we are increasingly called upon to provide advice on areas related to, but not specified in, our legislation. This is particularly important in areas of emerging technology and cutting-edge research not originally envisaged when the Human Tissue Act was enacted.

Areas which we regulate

  • Removal, storage and use of human tissue and organs for a number of activities and scheduled purposes as set out in the Human Tissue Act 2004: post-mortem examination, anatomical examination, research, transplantation and public display.
  • Procurement, testing, preservation, processing, storage, distribution, import and export of tissues and cells for use in patient treatment (human application).
  • Donation, testing, characterisation, procurement, preservation, transport, transplantation and disposal of organs for transplantation.

Our remit under the Human Tissue Act 2004 extends to England, Wales and Northern Ireland; however, we also carry out some activities in relation to the approval of living organ donations on behalf of the Scottish Government. Our remit as the Competent Authority for the quality and safety of tissues, cells and organs used in transplantation extends to the whole of the UK.

We license over 800 premises across the six sectors that we regulate and publish standards and requirements that those working within these regulated fields must meet. 

Whilst the HTA has a statutory duty to superintend compliance and an influential role in promoting good practice, public confidence in the use of human tissue cannot be safeguarded by the HTA alone. Public confidence is also dependent on the individuals and organisations that undertake activities within the HTA’s regulatory remit acting within the standards and requirements of the legislation.

Guiding principles

Four guiding principles continue to drive our work and underpin our regulatory framework. They should be followed in dealing with human bodies, tissue and organs:

  • Consent - and the wishes of the donor (or in some cases, their nominated representatives or relatives) are the primary consideration when removing, storing and using human tissue
  • Dignity - is paramount in the treatment of human bodies and tissue
  • Quality - must underpin the management of human bodies and tissue
  • Honesty and openness - are the foundation of communications in matters pertaining to the use of human tissue and bodies

Our values

Our values as an organisation in carrying out our role, expressed in all interactions are:

  • Professionalism - the high standards we apply in the conduct of our individual and collective responsibilities
  • Respect - proper regards for the abilities and perspectives of others
  • Expertise - the skills, knowledge and experience we apply for the benefit of our stakeholders and each other
  • Agility- rapid and positive response to changes in the internal and external environment without losing momentum

Key activities

We group our key activities into three themes:

  • Delivery - how we achieve our strategic objectives today
  • Development - how we will improve in the future
  • Deployment - how we effectively use our people and resources

Through these themes, our strategy sets out the ways in which we will strive to be a more resilient, sustainable and agile organisation. in order to meet the challenges ahead.

Last updated on: 10 Nov 2020