EUTCD information
Background information on the implementation of the EU Tissue and Cells Directive via the Human Tissue (Quality and Safety for Human Application) Regulations 2007.
The European Union Tissue and Cells Directives
The European Union Tissue and Cells Directives (EUTCD) set out to establish a harmonised approach to the regulation of tissues and cells across Europe. The Directives set a benchmark for the standards that must be met when carrying out any activity involving tissues and cells for human application (patient treatment). The Directives also require that systems are put in place to ensure that all tissues and cells used in human application are traceable from donor to recipient.
The EUTCD is made up of three Directives, the parent Directive (2004/23/EC) which provides the framework legislation and two technical directives (2006/17/EC and 2006/86/EC), which provide the detailed requirements of the EUTCD.
The HTA as one of the Competent Authorities in the UK under the EUTCD, has responsibility for regulating tissues and cells (other than gametes and embryos) for human application. The Human Fertilisation and Embryology Authority (HFEA) is the other Competent Authority in the UK and is responsible for the regulation of gametes and embryos for human application.
Human Tissue (Quality and Safety for Human Application) Regulations 2007
The Directives were fully implemented into UK law on 5 July 2007, via the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations). The HTA's remit was extended by the Q&S Regulations to include the regulation of:
- procurement,
- testing,
- processing,
- storage,
- distribution and
- import / export
of tissues and cells for human application. Establishments where these activities are carried out will normally need a licence. Further information about licensing under the Q&S Regulations.
Directions
The standards establishments carrying out the above activities are required to meet the standards which are detailed in HTA Directions. There are three sets of Directions:
HTA Directions 001/2006
HTA Directions 001/2006 implement the requirements of the EUTC parent directive and first technical directive. The Directions include information on the standards that must be met when carrying out the activities of procurement, distribution, donor selection and evaluation, and the transport of tissues and/or cells.
HTA Directions 002/2007
HTA Directions 002/2007 implement the requirements of the second technical directive. The Directions include information on the standards that must be met regarding facilities and equipment, quality management and review, confidentiality, processing and storage. They also provide information on the requirement to report serious adverse events and reactions.
Directions 004/2007
Directions 004/2007 apply to the import of tissues and cells from outside of the European Economic Area (EEA). The Directions set out the standards that such imports need to meet.
Establishments previously licensed under the Human Tissue Act 2006 for storage for transplantation
Establishments licensed in April 2006 to store relevant material for transplantation under the Human Tissue Act 2004, were automatically deemed to be licensed under the Q&S Regulations to carry out the activities listed below with regard to tissues and cells for human application:
- procurement,
- testing,
- processing,
- storage,
- import/export and
- distribution
This means that establishments are no longer licensed to store tissues and cells for transplantation under the Human Tissue Act 2004. All establishments carrying out activities in relation to tissues and cells for human application are now licensed under the Q&S Regulations. A communication regarding this was sent to all DIs and Licence Holders on 1 June 2007.