Annual activity data

This page provides information and guidance about the annual collection of information about the amount of licensable activities carried out by establishments in the human application sector.

Data collection for the period 1 January to 31 December 2011

All establishments licensed under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 have been contacted to request annual activity data submission. The data covers the period 1 January to 31 December 2011. As we did in 2010, we are asking establishments to submit the data online via our website.

Access to the data submission form is available from 3 January 2012 by following this link. An instructional email has been sent out to relevant Designated Individuals. We have extended the deadline to submit the completed annual activity data; it must now be submitted to us by 7 February.

A guidance document is available to download on the left to help you complete the form. Please ensure you read this before completing the online form. Please collect your information in advance so you can complete the form in one session as it is not possible to save and return to the form later.

Description of licensable activities

As part of your submission you will need to provide information about the level of your licensable activities as well as additional activities that may be carried out at your Tissue establishment (TE) (e.g. release for treatment and disposal). We require the latter information for our submission to EUROCET.

Procurement – Establishments involved in retrieving tissues or cells from donors within the UK, carried out by your own establishment or an unlicensed third party on your behalf. Procurement includes autologous donations as well as allogeneic donation. However, tissues and cells used as an autologous graft within the same surgical procedure (removed and transplanted back to the same individual without being subjected to any banking process or processing outside theatre), are excluded from the Tissue and Cells Regulations, and are not reportable.

Procurement as a licensable activity is not:

a. Buying tissues and cells released for end use (e.g. from other licensed establishments in the UK such as NHS Blood and Transplant).
b. Receipt of tissues and cells for processing where these have been procured by another licensed establishment.
c. Obtaining the material outside of the UK and shipping it into the UK; such an activity is classed either as distribution in (where material is obtained from another accredited establishment within the EEA) or as import.

Donor Testing refers to donor blood testing that has been performed to establish the serological status of the donor (including autologous donors) carried out by your own TE or an unlicensed third party on your behalf.

Processing carried out by your own TE or an unlicensed third party on your behalf, includes all operations involved in the preparation, manipulation, preservation and packaging of tissues or cells intended for human applications. All processed units should be included in this number, even if they are not released or distributed. The units for processing should be considered to be equivalent to those of the final product. Processing is not the processing of test results.

Storage – Storing tissues or cells intended for human application for more than 48 hours at the licensed TE. Any storage for periods less than this time is not licensable. Reportable are units that have been put into storage in 2011; a separate calculation is made regarding your stock at the beginning and the end of the year. You will not be able to report storage of more units than you have received or procured. Storage must be carried out by a licensed establishment and cannot be subject to a third party agreement with an unlicensed third party.

Distribution – carried out by your own establishment or an unlicensed third party on your behalf. This activity takes place whenever tissues or cells are moved between establishments in the UK or to another licensed establishment in the EEA. See paragraph 140-142 of the Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment for a full definition. You will be asked to submit information regarding the number of units of tissue you have distributed to another TE within the UK or EEA for either end use or for other activities (e.g. processing or storage).

Import – applies only to countries outside the European Economic Area (EEA). The EEA consists of the 27 Member States of the European Union in addition to Iceland, Norway and Liechtenstein. Tissue procured outside the EEA, also on behalf of the TE (as in the case of cord blood) should be reported as ‘imported’ not ‘procured’.

Export - Tissues and cells exported from the UK to countries outside the EEA.

If you have any questions about which licensable activities you are carrying out, please contact the HTA by email licensing.enquiries@hta.gov.uk or phone 020 7269 1900 and ask for a member of the Regulation Team.

Why is the HTA asking me to give this information?

Under Article 10(1) of the European Tissues and Cells Directive (2004/23/EC) the HTA as the Competent Authority is required to collect information about licensed establishments’ activity on an annual basis and make this information publicly available. The HTA adheres to the latter requirement by submitting a digested and anonymous set of data to Eurocet, who make this information available on their website in the form of bulk data for each country. The information is also submitted on request to the European Commission and additionally provides important background information for data analysis of serious adverse event and reaction reported in this sector.

It is a standard condition on the human application licences to provide this information to the HTA on request, and this is also set out in more detail in paragraph 20 to 22 of the Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment.