Designated Individuals and Licence Holders under the HT Act

A Designated Individual (DI) has 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 out. They have the primary legal responsibility under Section 18 of the Human Tissue Act to secure:

1. that suitable practices are used in undertaking the licensed activity;
2. that other persons working under the licence are suitable; and
3. that the conditions of the licence are complied with.

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 storing tissue under the terms of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) there are further requirements a DI must satisfy to be qualified to take up such a post within such an establishment.

In all cases the Licence Holder  must have the prior consent of the Designated Individual to make the application. Whilst the Designated Individual must be an individual, the HTA has a preference for the Licence Holder to be a corporate body where possible, such as an NHS Trust.
 
The role of Licence Holder does not impose the duties that are expected of the Designated Individual, however 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 Designated Individual and allows the establishment to cover circumstances where the Designated Individual is unable to oversee the licensable activities. Consequently, the HTA prefers individual Licence Holders to be more senior than the Designated Individuals, such as a Medical Director or 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 Designated Individual in order to substitute them where necessary.
 
The HTA is required to provide all notices of licence decisions to both the Licence Holder and the Designated Individual.