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.

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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.

 

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Legislation

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

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The Human Tissue Act 2004 and associated Regulations:

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

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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:

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

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.

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HTA Portal
What are licences?

Licences are granted for particular activities, for example the removal of tissue from the body of a deceased person, or storage of human tissue, for a particular purpose, to take place on specified premises. These activities are stated on your licence certificate as well as on the licensed establishment page on our website.

If you are licensed in any of the following sectors:

  • Anatomy;
  • Human Application;
  • Post Mortem;
  • Public Display; or
  • Research,

your licence will specify the premises where the licensed activities are authorised to take place.

For the Organ Donation and Transplantation sector, a licence will authorise corporate bodies or individuals to carry out licensed activities.

Making changes to licenses

You can vary your licence at any time. To do this, you will need to apply for a licence variation. Your application needs to be approved before you implement any changes.

To change any details about your licence, please refer to guidance on licence variations.

Any changes to your licence(s) may affect your licensing fees.

Please contact our licensing team for further information: licensing.enquiries@hta.gov.uk.

Satellites

You can apply for other premises to be licensed as part of your licensing arrangements with the HTA. A satellite site is a separate location where licensed activities can be carried out, provided they are subject to the same governance arrangements as the main (hub) site with oversight by the same DI.

Find out more about satellite sites.

HTA Licensing Framework
Designated Individuals (DIs)

DIs have a legal duty to ensure that statutory and regulatory requirements are met. They are responsible for supervising licensed activities and ensuring suitable practices are taking place.  An establishment licensed under the HT Act or Q&S Regulations must have a DI.

Named Contacts (ODT sector only)

For licences under The Quality and Safety of Organs Intended for Transplantation Regulations 2012, there must be a Named Contact for each clinical area of specialty.

Persons Designated (PDs)

PDs assist DIs in ensuring compliance with HTA standards. PDs can assist with developing procedures, as well as reporting incidents. If you have satellite sites, there should be at least one PD for each site.

Licence Holders

A licence holder can be an individual or a corporate body. We recommend that a licence holder is a senior manager from a corporate body, acting as the representative on its behalf.

Roles and Responsibilities
Body

There are four primary roles under HTA licences. The list below gives a short definition of each role. You can find more details on the responsibilities that come with each role under the sector-specific information.

Inspections

We carry out inspections of premises licensed in the Anatomy, Human Application, Post mortem, Public Display and Research sectors.

Information about the standards you will be inspected against is contained in the sector-specific pages of this section.

You can also read our general guidance on HTA inspections.

When you have a planned inspection coming up, we will send you a draft timetable for the day. We will usually also send you a document review checklist, relevant to your sector:

  • Anatomy
  • Human Application
  • Post mortem
  • Public Display
  • Research

In most cases, you will be notified in advance of your inspection. However, we may also carry out an unannounced inspection if we think it is necessary.

Audits

We carry out audits of establishments licensed in the organ donation and transplantation sector.

We audit establishments against specific assessment criteria and gather evidence through a combination of an audit of the premises, review, and interviews with staff involved in each aspect of the ‘organ pathway’.

In most cases, you will be notified in advance of your audit. However, we may also carry out an unannounced audit if we think it is necessary.

Compliance updates

We collect compliance information every two years from establishments licensed in the Anatomy, Organ Donation and Transplantation, Post mortem, Public Display and Research sectors.

We will contact DIs and named contacts directly to notify you when you need to submit compliance information.

Assessing Compliance
Body

As part of the regulatory framework, the HTA licenses establishments and reviews their compliance against sector-specific standards. We will also assess compliance against these standards as part of a new application process.

For licensed premises, there are three main forms of checks:

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