The Human Tissue Authority (HTA), on behalf of Scottish Ministers, is responsible for assessing all living organ donation cases that take place in Scotland. The HTA also considers allogeneic donation of regenerative tissue where the donor is under 16 or an adult with incapacity in Scotland. Only once HTA approval is in place can these donations go ahead. The Human Tissue (Scotland) Act 2006 (HT Scotland Act) and The Human Organ and Tissue Live Transplants (Scotland) Regulations 2006 (the Regulations) govern living donation in Scotland.

Clinicians and transplant teams are responsible for the overall care of donors and recipients, and for assessing the medical suitability of potential donors. The Regulations require the clinician with responsibility for the donor to refer the matter to the HTA.  As part of this referral specific information, certain assurances are required to ensure the legislative requirements are addressed.

This section contains guidance for professionals involved in living organ donation assessments.

The HTA regulates establishments in England, Wales and Northern Ireland that conduct licensed activities under the Human Tissue Act 2004 (HT Act). This includes establishments that remove samples from the deceased for certain purposes in the HT Act – called scheduled purposes.

The Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) (the Q&S Regulations) and the Blood Safety and Quality Regulations 2005 define ‘blood component’ as ‘a therapeutic constituent of human blood (red cells, white cells, platelets and plasma) that can be prepared by various methods’.

The HTA and MHRA have agreed to extend their existing policy relating to dendritic cells to allow collection of blood as a starting material for an ATMP to be performed under either a Tissues and Cells or Blood Establishment Licence.

This will make it more straightforward to procure blood and increase the number of sites in the UK where this activity can occur without increasing the number of licences required. 

This page provides information about the Human Tissue Authority (HTA) regulatory assessment process.

Advance Therapy Medicinal Products (ATMPs) are medicinal products which are prepared industrially or manufactured by a method involving an industrial process. ATMPs fall into three categories; Gene Therapies, Somatic Cell Therapies and Tissue Engineered Products.

RASRM is a ‘one stop shop’ for research and development professionals across academia, industry, and the NHS. It offers a single point of access to free, clear, expert responses to queries about the regulation of regenerative medicines.