Legal framework and regulation

UK countries must operate their blood and tissue services, as well as important aspects of hospital transfusion services, under the legal requirements of the Blood Safety and Quality Regulations 2005 (BSQR) and the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (TSQR).

For blood services, the Medicines and Healthcare products Regulatory Agency (MHRA) is the UK competent authority under BSQR and regulates services according to its interpretation of all relevant legislation.

For human tissues and cells, the Human Tissue Authority (HTA) is the UK competent authority under TSQR and is responsible for ensuring appropriate regulation of tissue services. The Human Tissue Act 2006 applies in England and Wales, the Human Tissue (Scotland) Act 2006 applies in Scotland and the Human Tissue Act 2004 applies in Northern Ireland.

The Department of Health and Social Care Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) provides policy advice to Ministers in the four countries of the UK on the most appropriate ways to ensure the safety of blood, cells, tissues and organs for transfusion and transplantation. Its remit includes providing independent advice on the microbiological safety of gametes and stem cells and risk management options for consideration by Ministers and UK Health Departments.

SaBTO receives information from many sources. SaBTO does not address the efficacy, effectiveness or clinical use of blood products and tissues. Much of the detailed evidence on which SaBTO deliberates is the result of work by Blood Services staff and the JPAC Standing Advisory Committee on Transfusion Transmitted Infection (SACTTI).