Human Tissue Authority

The regulator for human tissue and organs

HTA Strategy 2016-19: Year Two

The HTA is an Executive Non-Departmental Public Body sponsored by the Department of Health. We were established under the Human Tissue Act 2004 (HT Act) – which covers England, Wales and Northern Ireland – to regulate activities relating to the removal, storage, use and disposal of human tissue. The HTA also regulates living donation, in compliance with Scottish legislation, on behalf of the Scottish Government.

Our overall purpose 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.

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

We also have a statutory function to inform the public, professionals and the Secretary of State for Health about issues within our remit.

We meet our requirement to inform professionals by providing guidance, including through our Codes of Practice, updated versions of which will be launched in April 2017. We also meet our requirement to inform the public by providing information, to help them to make informed decisions.

We license organisations that store and use tissue for purposes such as research, human application, organ transplantation, post-mortem examination, teaching, and public exhibitions.

We license approximately 860 premises and publish standards that they must meet on:

  • consent;
  • governance and quality systems (including traceability);
  • premises;
  • facilities and equipment; and
  • disposal of human tissue.

To ensure that these standards are maintained and that appropriate procedures are followed, we inspect these licensed premises periodically, and receive data updates via compliance reports between inspections.

The HTA regulates through an independent assessment process, the donation of solid organs from living people. We ensure that valid consent is given for organ donation and that no coercion takes place or reward is sought or offered. We fulfil a similar role for living 

donation of bone marrow and peripheral blood stem cells from children and adults who lack the capacity to give consent.

As well as licensing under the HT Act, the HTA is the Competent Authority for European Union (EU) Directives. We are responsible for the EU:

  • Tissue and Cells Directives (EUTCDs) – To ensure the quality and safety of human tissue and cells used for patient treatment.
  • Organ Donation Directive (EUODD) – To ensure the quality and safety of organs intended for transplantation.

In 2017, we will be bringing into force two new EU Directives, which amend and implement areas of the EUTCDs, with respect to the coding, important and export of human tissues and cells in the human application sector.

All of our activity is directed towards ensuring compliance with these standards. In this second year of our three-year Strategy, our key activities will be grouped into three themes:

  • Delivery – How we achieve our strategic objectives today;
  • Development – How we will improve in the future; and
  • Deployment – How we effectively use our people and resources.

Last updated on: 6 Apr 2017