HTA Legislation: Powers, Consent and Licensing

This page provides a summary of the key pieces of legislation, licensing frameworks, and a brief overview of responsibilities for Designated Individuals (DIs), Named Contacts (ODT sector only), Persons Designated (PDs) and Licence Holders.

Legislation

The HTA ’s powers come from three pieces of legislation:

  1. The Human Tissue Act 2004 (HT Act)
  2. The Human Tissue (Quality and Safety for Human Application) Regulations 2007
  3. The Quality and Safety of Organs Intended for Transplantation Regulations 2012

These set out the consent and licensing requirements for different sectors, as well as the responsibilities of Designated Individuals.

Consent is the fundamental principle of the Human Tissue Act. Different consent requirements apply when dealing with tissue from the deceased and the living. The Human Tissue Act 2004 lists the purposes for which consent is required. These are called scheduled purposes:

  1. Anatomical examination.
  2. Determining the cause of death.
  3. Establishing after a person’s death the efficacy of any drug or other treatment administered to him.
  4. Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person).
  5. Public Display.
  6. Research in connection with disorders, or the functioning, of the human body.
  7. Transplantation.

The HTA licenses and inspects organisations across the six different sectors:

  • Anatomy
  • Post-mortem
  • Public Display
  • Research
  • Human Application
  • Organ Donation and Transplantation

The HTA Codes of Practice and standards provide practical guidance to professionals carrying out activities within the scope of the HTA's remit.

 

The Human Tissue Act 2004 and associated Regulations:

Essential information and guidance for each sector covered by the Act can be found in the following sections:

The Human Tissue (Quality and Safety for Human Application) Regulations 2007:

Essential information and guidance for each sector covered by the Regulations can be found in the following section:

The Quality and Safety of Organs Intended for Transplantation Regulations 2012:

Essential information and guidance for each sector covered by the Regulations can be found in the following section:

HTA Portal

If you are a DI or a named contact, you will need access to the HTA Portal. You will use the HTA portal to securely send data and reports to the HTA.

For example:

  • submitting compliance updates
  • submitting annual activity data
  • reporting Serious Adverse Events or Reactions
  • reporting post mortem HTA Reportable Incidents

We recommend that you make sure your PDs also have access to the Portal.