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 (see documents below).
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:
- 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.
Establishments carrying out the above activities are required to meet the standards which are detailed in the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatments as implemented by HTA Directions 003/2010.
HTA Directions 003/2010
HTA Directions 003/2010 consolidate and clarify the standards required under the Human Tissue (Quality and Safety of Tissues and Cells for Human Application) Regulations 2007.
These Directions revoke Directions 001/2006, 002/2007 and 004/2007.
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:
- import/export and
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.