How licensing works under the Human Tissue Quality and Safety Regulations

The activities of storing and importing human tissues and cells for human application can only be carried out by an establishment holding an appropriate HTA licence.

The following activities may be carried out either under an appropriate HTA licence or under the authority of a third party agreement:

• procurement
• testing
• processing
• export
• distribution

The above-listed activities can be carried out under the authority of a third party agreement in the following circumstances:

1. when the establishment carrying out the activity is acting on behalf of an appropriately licensed establishment; and
2. when the third party agreement meets the standards set out in the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatment (the Guide) as implemented by HTA Directions 001/2021.

A licensed establishment will need to have third party agreements with anyone who carries on a licensed activity (other than import or storage) on its behalf or supplies to the licensed establishment any goods or services which may affect the quality or safety of tissues and/or cells.

Satellite establishments are premises that are under the same governance processes as the main site (the hub) and are supervised by the same Designated Individual (DI). The DI at the hub must have systems in place to ensure that the governance framework is properly implemented and maintained at the satellite. You can find out more about satellite sites at the satellite information page.

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.

In all cases the licence holder 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 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 licence fees are paid

The licence holder 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 licence holder 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.

You are required to report serious adverse events (SAEs) or serious adverse reactions (SARs) to the HTA within 24 hours of discovery.

Find out more about SAEARs and how to report them.  

Any preparation processes carried out on tissues or cells intended for patient treatment (human application) must be validated and must not render the tissues or cells clinically ineffective or harmful. The HTA uses Preparation Process Dossiers (PPD) to assist with reviewing process validation.

Find out more about when to submit a PPD and the information you will need in our guidance.

Each January, you are required to submit annual activity data for the previous year. We will contact Designated Individuals and Licence Holders to notify them when and how to submit data. We will also publish information in our newsletter.