Quality and Safety Regulations FAQs
Frequently asked questions about the Human Tissue (Quality and Safety for Human Application) Regulations 2007.
How was the EU Tissues and Cells Directive (EUTCD) brought into UK law?
From 7 April 2006, the European Commission required that Members States bring into force the laws, regulations and administrative provisions necessary to comply with the Parent Directive (Directive 2004/23/EC). In order to comply with the European Directive the HTA commenced licensing the storage of human tissues and cells for transplantation on 7 April 2006.
Alongside the commencement of licensing the HTA issued Directions (Directions 001/2006), summarising the requirements of the Parent Directive and the first technical Directive (Directive 2006/17/EC) to licensed establishments. All establishments were required to comply with Directions 001/2006 by April 2007.
The Parent Directive, the first technical Directive and the second technical Directive (Directive 2006/86/EC) were formally adopted into UK law on 5 July 2007 via a statutory instrument called 'The Human Tissue (Quality and Safety for Human application) Regulations 2007, in short 'the Regulations'.
The HTA issued a second set of Directions (Directions 002/2007), which set out the requirements of the Regulations and the second technical Directive of the EUTCD and supplement and amend the first set of Directions.
The HTA issued a further set of Directions (Directions 004/2007) which came into force on 7 October 2007. These Directions stipulate that imports of tissues and/ or cells from non-European Economic Area (EEA) states meet standards of quality, safety and traceability equivalent to those provided in the Regulations.
What activities will need a licence under the Regulations?
The activity of storing human tissues and cells for human application can only lawfully take place if the establishment is licensed to carry out that activity. However, the following activities may lawfully be carried out either under a licence or under a third party agreement with an establishment licensed to carry out activity/ies relating to tissue and cells for human application.
• Procurement
• Testing of donor samples
• Processing
• Import / export
• Distribution
N.B. Anyone carrying out the above activities and storing material for more than 48 hours must be in possession of a storage licence.
What happened to establishments that held a licence under the Human Tissue Act?
If an establishment held a licence to store relevant material for transplantation under the Human Tissue Act 2004, they were automatically considered to be licensed under the Regulations to carry out the activities listed below with regards to tissues and cells for human application.
• Procurement
• Testing of donor samples
• Processing
• Storage
• Import / export
• Distribution
This meant that establishments were no longer licensed to store tissues and cells for human application under the HT Act but are licensed to do so under the Regulations. However, establishments continue to be licensed under the HT Act for storage for scheduled purposes other than transplantation/human application e.g. establishments are still licensed under the HT Act to store human tissue for the scheduled purpose of research.
Will I need a licence if I am only procuring and not storing tissues and cells for human application?
If you are procuring on behalf of an establishment that has a licence to carry out activity/ies relating to tissues and cells for human application and you have a third party agreement in place with them to carry out the activity of procurement you will not require a licence. Otherwise a licence will be required to carry out this activity.
If I am storing cell lines for the purpose of human application will I require a licence?
Yes, under the regulations storing cell lines intended for human application will require a licence unless this storage is regulated by the MHRA.
If I am regulated by the MHRA will I need to be regulated by the HTA?
Where the storage, processing, import, export or distribution of cells or tissues (including cell lines) for human application is for use in manufactured products and these activities are regulated by
• the Medicines (Homeopathic Medicinal Products for Human Use) Regulations 1994
• the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994
• the Medical Devices Regulations 2002, or
• the Medicines for Human Use (Clinical Trials) Regulations 2004
then these activities will not be regulated by the HTA as well and a licence will not be required.
Does the Code of Practice on the import and export of human bodies, body parts and tissues apply to establishments in this sector?
The HTA has produced a Code of Practice on import and export . This Code is intended to offer guidance to anyone importing or exporting relevant material for a scheduled purpose. The Code provides guidance to persons importing or exporting tissues and cells for human application.
The HTA has issued Directions (Directions 004/2007) which came into force on 7 October 2007. These Directions stipulate that imports of tissues and/ or cells from non-European Economic Area (EEA) states meet standards of quality, safety and traceability equivalent to those provided in the Regulations.
What is a third party agreement?
A third party agreement is an agreement in writing between a licence holder (or the Designated Individual on behalf of the Licence Holder) and another person which is made in accordance with Directions 002/2007 issued by the HTA.
The Regulations allow for certain activities to be undertaken without a licence as long as the establishment has a third party agreement in place with an establishment licensed to carry out activity/ies relating to human tissues and cells for human application. The following activities may be undertaken without a licence but under a third party agreement
• Procurement
• Testing of donor samples
• Processing
• Import / export
• Distribution
The HTA has issued Directions (Directions 002/2007) which contain detailed requirements for third party agreements.
Who will I need to have third party agreements in place with?
You will need the third party agreements with anyone who
• carries on a licensed activity (other than storage), on behalf of the licensed establishment or
• supplies to the licensed establishment any goods or services which may affect the quality or safety of tissue or cells.
Will third party agreements be regulated?
The HTA has issued Directions (Directions 002/2007) setting the standards for third party agreements.
What is an EEA state?
An EEA state is a state within the European Economic Area. These include all EU states and Iceland, Liechtenstein and Norway.
Will the role of the DI change under the Regulations?
Yes. The role of the Designated Individual will change under the Regulations. Under the Regulations the DI will need to possess a formal qualification in a medical or biological field or be considered appropriate by the Authority on the basis of other qualifications and experience. The DI will also need at least 2 years practical experience in a relevant field.
There are also additional duties under the Regulations. The duties of the DI are set out in regulation 12 of the Regulations and are as follows
• that persons to whom the licence applies are suitable persons to participate in the carrying-on of the licensed activity,
• that suitable practices are used in the course of carrying on that activity, and
• that the conditions of the licence are complied with
• that the conditions of third party agreements, in relation to the licensed activities authorised to be carried on under his supervision are complied with
• that the requirements regarding information and confidentiality (including traceability) of tissues and cells set out in regulation 13(1) are complied with
Will the role of the Licence Holder change under the Regulations?
The role of Licence Holder will change under the Regulations. The Regulations require that third party agreements are made by the Licence Holder or on his behalf by the DI meaning that the Licence Holder will need to have involvement in making these agreements. The Licence holder will also be responsible for ensuring compliance with Directions issued under the Regulations.
Is there a European coding system in place for tissues and cells?
A working group is currently producing a coding system for the EU. The working group is due to report in March 2008. In the meantime establishments should ensure each donation and product is assigned a unique code and that all products can be traced from donor to recipient.
If I store tissues or cells for human application for less than 48 hours will I require a licence under the Regulations?
If you are only storing tissues or cells for human application and they are stored for less than 48 hours a licence will not be required.
Please note if you carry out any of the activities listed below then they will need to be carried out under a licence or a third party agreement with an establishment licensed to carry out activity/ies relating to tissues and cells for human application by the HTA.
• Procurement
• Testing of donor samples
• Processing
• Import / export
• Distribution
Does the HTA regulate donor lymphocyte infusions (DLIs)?
Yes, the HTA regulates the procurement, processing, storing, donor testing, distribution and import / export of DLIs.
What does the application form look like?
The HTA began accepting applications from the 1 July 2007. A PDF version of the application form is also available so that applicants can familiarise themselves with the application prior to applying online.