Human Tissue Authority

The regulator for human tissue and organs

HTA legislation

The HTA is an Executive Non-Departmental Public Body (ENDPB) sponsored by the Department of Health (DH). As a statutory body the core of what the HTA does is laid down in three pieces of legislation. These are: 

  1. The Human Tissue Act 2004 (HT Act) and associated Regulations. 
  2. The EU Tissue and Cells Directives (EUTCD), via the Human Tissue (Quality and Safety for Human Application) Regulations 2007
  3. The EU Organ Donation Directives (EUODD), via the Quality and Safety of Organs Intended for Transplantation Regulations 2012

These laws ensure human tissue is used safely and ethically, with proper consent.

Our aim is to make sure that these laws are followed by setting standards that are clear and reasonable, and in which the public and professionals can have confidence. We help people to understand these requirements by providing codes of practice and other advice, guidance and support.

Further information about each piece of legislation is provided below.

Human Tissue Act 2004

The EU Tissue and Cells Directives (EUTCD)

The EU Organ Donation Directives (EUODD)