Jump to navigation

DIs and Licence Holders under the Human Tissue Act

Designated Individuals and Licence Holders both play key roles in the licensing arrangements under the Human Tissue Act (2004). This section explains the roles and responsibilities of these individuals.

Designated Individuals

Designated Individuals (DIs) have a key role to play in implementing the requirements of the Human Tissue Act.  They are the person under whose supervision the licensed activity is authorised to be carried on. They have the primary (legal) responsibility under Section 18 of the HT Act to secure:

  • that suitable practices are used in undertaking the licensed activity
  • that the other persons who work under the licence are suitable
  • and that the conditions of the licence are complied with.

Potentially the DI might be a head of department, clinician, scientist or manager. What is important is that it is a person who is in a position to ensure that activities are conducted properly, by people who are suitable to carry out those activities, and that all the necessary requirements are complied with.  For those establishments that are storing tissue under the terms of the EU Tissues and Cells Directive there are further requirements that a DI must satisfy in order to be qualified to take up such a post within such an establishment.

The HTA has produced more information about the role of the DI and what it sees as the essential characteristics of the person. This information can be accessed by viewing the Guide to licensing for Designated Individuals and Licence Holders.

To assist potential DIs the HTA is organising a series of training days for DIs across the UK, which will provide information about the role and allow interactive discussion with colleagues across the sectors. All DIs shall complete HTA accredited training (online or otherwise). This must be completed to the HTA's satisfaction within a time period of 12 months from the date of the licence or such other period as maybe specified by the HTA.

Find out about and register for DI training days.

Licence Holders

In all cases the Licence Holder must have the prior consent of the DI to make the application. Whilst the DI must be an individual, the HTA has a preference for the licence holder to be a corporate body where possible (e.g. an NHS Trust).
 
Whilst the role of Licence Holder does not impose the duties that are expected of the DI, it is important to note that they have the right to apply to the HTA to vary the licence. This enables them to substitute another person as the DI and allows the establishment to cover circumstances where the DI is unable or incapable of overseeing the licensable activitie(s). Consequently, the HTA prefers indivdual licence holders to be more senior than the DI (i.e. Medical Director/ Chief Executive).
 
Establishments applying as a corporate body should provide the contact name of an individual who will act as a representative for the corporate body. This individual should also be more senior than the DI in order to subsitute the DI where necessary.
 
The HTA is required to provide all Notices of licence decisions to both the licence holder and the DI.