JPAC Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee

19.1: Regulatory environment in the UK

The whole process of tissue banking is now covered by legislation. The EU Directive on Tissues and Cells (2004/23/EC)1 and its associated Commission Directives (2006/17/EC and 2006/86/EC)2,3 have been transposed into UK law as the Human Tissue (Quality and Safety for Human Application) Regulations 2007.4 These regulations lay down standards of quality and safety for all aspects of banking of human tissues and cells intended for human applications. In addition, the Human Tissue Act 20045 applies throughout the UK with the exception of Scotland, where the Human Tissue (Scotland) Act 20066 applies.

All Tissue Establishments need to be licensed by the ‘Competent Authority’, which in the case of the UK is the Human Tissue Authority (HTA). Under the Human Tissue Act the HTA issues its expected standards in the form of ‘Directions’7 and ‘Codes of Practice’8 to Tissue Establishments. HTA expected standards are contained in the Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment,7 which is implemented via Directions and is periodically updated.

Every Tissue Establishment must designate a responsible person (termed the Designated Individual4) who shall be responsible for ensuring that all activities relating to human tissues and cells intended for human application are in accordance with the laws in force in the UK. It is therefore the responsibility of the Designated Individual to ensure that all the requirements of the HTA are met in a timely and comprehensive manner.