Designated Individuals and Licence Holders under the Q&S Regulations

Designated Individuals 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 (also known as the Q&S Regulations).

This section explains the roles and responsibilities of these individuals under the Q&S Regulations. Separate guidance is available on the role of 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 Q&S Regulations.  They authorise and supervise the licensed activity or activities. They have the primary (legal) responsibility under Regulation 12 of the Q&S Regulations to ensure:

  • that suitable practices are used in undertaking the licensed activity or activities
  • that other persons working 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, up-to-date and correct and held securely.

The above list of responsibilities is not exhaustive and DIs should refer to paragraphs 1-4 of the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatment as bought into force by Directions 001/2021 for further specific information.

It is expected that DIs have an awareness of all the relevant legislation covering the use of tissues and cells for human application.

The Q&S 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 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.

Licence Holders

In all cases the LH must have the prior consent of the DI to make the licence application. Although the DI must be an individual, the HTA has a preference for the LH to be a corporate body where possible (e.g. an NHS Trust).
The role of LH 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 licence 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 the DI is unable or incapable of overseeing the licensable activity or activities. Consequently, the HTA prefers individual LHs 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.