Regulation - ODT Clinical - NHS Blood And Transplant

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2. ODT structure & standards
3. Regulation

Regulation

Organ transplantation services in the UK are primarily regulated by the Human Tissue Authority (HTA), a body set up under the Human Tissue Acts to oversee the uses of human tissues. NHS Blood and Transplant (NHSBT) assists the HTA by holding data on organ donation and transplantation, but we are not a regulator, and are indeed subject to oversight by the HTA.

The key legislation surrounding organ donation and transplantation in the UK are the Human Tissue Act 2004, covering England, Wales and Northern Ireland, and the Human Tissue (Scotland) Act 2006, covering Scotland, together with various Statutory Instruments arising from those Acts. This legislation specifies the arrangements for donor consent or authorisation, how organs and tissues may be acceptably used, and the data that must be recorded to ensure compliance.

There is also legislation arising from the EU Organ Donation Directive and the EU Tissues & Cells Directive. These regulations are principally concerned with organ organ donation, testing, characterisation, procurement, preservation, transport and transplantation, together with the quality, safety and traceability of cells and tissues.

Quick links

NHSBT is a Special Health Authority in the NHS and operates under the Directions 2005 which were issued by the Secretary of State for Health. There are minor modifications over time but these Directions identify the key roles and responsibilities of NHSBT.

• Guidance on updated Directions NHSBT (England) 2020 (PDF 131KB) 
• Updated Directions NHSBT (England) 2020 (PDF 103KB)
• Updated Directions NHSBT - Human Transplantation (Wales) Act 2015
• NHS Blood and Transplant Directions 2005 (PDF 49KB)

 

Quality and Safety of Organs Intended for Transplantation Regulations

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Human Tissue (Quality and Safety for Human Application) Regulations

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The Human Tissue Act 2004

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The Human Tissue Scotland Act 2006

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Mental Capacity Act 2005

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