Human Tissue Authority

The regulator for human tissue and organs

About us

Who we are and what we do

The HTA is an executive Non-Departmental Public Body sponsored by the Department of Health and Social Care (DHSC), established by 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 provision of:

  • the Human Tissue Act 2004 (and associated Regulations);
  • the 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 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 certain activities under 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 (as amended);
  • we license organisations involved in organ donation and transplantation as required by the Quality and Safety of Organs Intended for Transplantation Regulations 2012 (as amended);
  • we monitor and inspect or audit organisations to ensure they comply with the requirements of the legislation and our standards;
  • 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; and,
  • 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.

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 for the quality and safety of tissues, cells and organs used in human application and transplantation extends to the whole of the UK.

We license approximately 855 premises across the six sectors that we regulate and publish standards and requirements that those working within the regulated fields must meet.

Four guiding principles continue to drive our work and underpin our regulatory framework. They should be followed when 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.

The Authority – the HTA’s non-executive board – is made up of a Chair and nine Members who are appointed by the Secretary of State for Health and Social Care; one Member appointed by the Welsh Cabinet Secretary for Health and Social Services, and one by the Minister for Health in Northern Ireland. The professional Members of our board come from medical and scientific backgrounds linked to our work, and the lay Members bring a wide range of business, commercial and public sector experience.

The Authority’s primary role is to ensure that the HTA discharges its statutory responsibilities effectively. It achieves this by setting the HTA’s strategic direction and providing both support and challenge to our Executive Team, which is responsible for the delivery of these responsibilities on a day-to-day basis. Further details on our staff can be found in the Resources section of this business plan.

In line with government requirements, we produce this document annually. It should be read in conjunction with the HTA’s Strategy for 2019 – 2022, which outlines the HTA’s strategic approach and high-level objectives for the next three years.

Our essential activities remain grouped within three themes:

  1. Delivery – to deliver the right mix of operational activity to maintain public and professional confidence in the safe and proper use of human tissue
     
  2. Development – to make the right investment to continuously improve delivery and deployment
     
  3. Deployment – to make the most effective use of people and resources in pursuit of our goals
    Last updated on: 2 Jul 2019