How licensing works under the Human Tissue Act
The Human Tissue Act covers primarily England, Wales and Northern Ireland; only section 45 and schedule 4 of the Human Tissue Act include Scotland. There is separate legislation in Scotland – the Human Tissue (Scotland) Act 2006 – and the HTA performs certain tasks on behalf of the Scottish Government.
Who needs a licence?
The activities licensed by the HTA under the Human Tissue Act are:
- Carrying out of an anatomical examination;
- Making of a post-mortem examination;
- Removal of relevant material from a deceased person;
- Storage of relevant material for a number of “scheduled purposes”;
- Storage of anatomical specimens; and
- Public display of a body or relevant material from a deceased person.
There are some specific licensing exemptions under the Human Tissue Act.
Activities relating to tissues and cells from the living or deceased for tissue and cells for patient treatment (human application) are licensed by the HTA under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (the Q&S Regulations). More information is available on licensing under the Q&S Regulations.
Satellite establishments are small premises that are under the same governance process as a larger establishment (the hub) and are supervised by the same Designated Individual (DI) as the hub. The DI at the hub must have systems in place to ensure that the governance framework is properly implemented and maintained. You can find out more about satellite sites at the satellite information page.
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:
- that suitable practices are used in undertaking the licensed activity;
- that other persons working under the licence are suitable; and
- 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 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, such as an NHS Trust.
The role of licence holder does not impose the duties that are expected of the DI, 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 DI and allows the establishment to cover circumstances where the DI is unable to oversee the licensable activities. Consequently, the HTA prefers individual licence holders to be more senior than the DI, 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 DI 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 DI.