DIs and Licence Holders under the Regulations
Here you will find information on Designated Individuals (DIs) and Licence Holders under the Regulations.
DIs and Licence Holders both play key roles in the licensing arrangements under the Human Tissue Act (2004) and the Human Tissue (Quality and Safety for Human Application) Regulations 2007. This section explains the roles and responsibilities of these individuals under the Regulations, separate guidance is available on the role of the Designated Individuals and Licence Holders under the Act.
Designated Individuals
Designated Individuals (DIs) have a key role to play in implementing the requirements of the Regulations. They are the person under whose supervision the licensed activity is authorised to be carried on. They have the primary (legal) responsibility under Regulation 12 of the Regulations to secure:
- that suitable practices are used in undertaking the licensed activity
- that the other persons who work under the licence are suitable
- that the conditions of the licence are complied with
- that the conditions of third party agreements are complied with, and
- that all information relating to licensable activities
- is available for tracing donations
- is up to date and correct
- is held securely.
The Regulations also require that the DI must have either:
- a diploma, certificate or other evidence of formal qualification in the fields of medical or biological sciences, or
- be otherwise considered by the Authority to be suitably qualified on the basis of academic qualifications and practical experience, and
- have at least two years’ practical experience which is directly relevant to the activity to be authorised by the licence.
Potentially the DI might be a head of department, clinician, scientist or manager. It is important is that the DI 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.
To assist DIs the HTA is organising a series of training days for DIs across the UK, which will provide information about the role of the DI and provide a forum for discussion with colleagues across the sector. It is a condition of a licence that DIs 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 issued 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).
The role of Licence Holder does not impose the duties that are expected of the DI however they do have the duty to ensure
- that the conditions of third party agreements are complied with
- that the Directions are complied with
- that fees are paid
The LH does have the right to vary a 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 individual 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 substitute the DI where necessary.
The HTA is required to provide all Notices of licence decisions to both the licence holder and the DI.