What is a HTA licence

Anatomical examinations, public display of material from the deceased, post mortem examinations, removal of post mortem material, storage of post mortem material, storage of anatomical specimens, and storage of material from a living person for a scheduled purpose (e.g. other than for diagnosis).

The HTA has produced a paper offering guidance on the definition of relevant material

The Human Tissue Act 2004 covers England, Northern Ireland and Wales. Scotland has its own legislation covering human tissue - the Human Tissue (Scotland) Act 2006. The Human Tissue Regulations 2007 cover England, Northern Ireland, Wales and Scotland. Establishments in Scotland carrying out activities relating to tissues or cells for human application; may require a licence from the HTA. 

In this situation, it may not be necessary for an establishment to hold two separate HTA licences (for example, one for storage of tissues and cells for human application and another for storage of relevant material for use in a scheduled purpose) as the HTA can grant a licence that authorises both activities.

However, if only one licence is granted, a single Designated Individual is responsible for ensuring that suitable practices and systems are in place for both activities. If the DI only has limited oversight of either activity, this arrangement may not be appropriate.

If you unsure whether to apply for a single licence or multiple licences, please contact the HTA for advice.

The licence fee structure for all sectors is available on the fees and payment page.

Unless otherwise agreed, licences are continuous and remain in place until revoked.

If you discover an unlicensed activity please advise the relevant organisation to look at our website to find out more about our licensing processes and whether they need a licence, and if they are still unclear please tell them to contact us directly for advice. If the establishment doesn't contact us and doesn't apply for a licence, you may wish to advise the unlicensed centre that you would like to give their details to the HTA so we can contact them directly to offer more focused advice and guidance.

Those establishments who intend to conduct the activities specified above. The applicant for the Licence Holder could be the Designated Individual (DI) who has responsibilities under the Human Tissue to ensure good practice is followed and licence conditions are complied with. Alternatively, as opposed to an individual, the Licence Holder could be a corporate body (e.g. an NHS Trust) providing the named DI has consented to the application. Read our information for DIs and named contacts. 

This depends on the governance responsibilities for the establishment. More information is provided in the information for DIs and named contacts page.

The DI will have responsibility to ensure compliance with conditions on their licence, one of which relates to fees. The Licence Holder should pay any relevant licensing fee, as determined by the Authority.

Not necessarily, however the HT Act requires the licensed activity to be carried out under the supervision of the DI. The DI can designate others as being covered by the licence by providing written notice to the HTA, provided they are satisfied that that person is suitable to undertake the activity.

However the Human Tissue (Quality and Safety for Human Application) Regulations 2007 do require that the DI has certain qualifications.

Find out more on the information for DIs and named contact page.

The Person Designated (PD) by the DI is able to direct in relation to licensable activities. We see the role of the PD as supplementary to that of the DI in the governance framework, although the DI remains responsible for supervising the activities to be authorised by the licence. The PD could act at a local level to support the DI. This could be, for example, to advise other persons to whom the licence applies about the procedures and systems agreed by the DI that ensure compliance with the HT Act. It may be appropriate to have the processing manager and the quality manager as the PDs. 

No - not normally. The PD is a part of the statutory governance framework required by the HT Act to ensure compliance with the conditions of the licence. It would rarely, if ever, be the case that a forensic or other visiting pathologist would be in that position.

For further information about the roles of the DI and PD, please see the Guide to licensing for Designated Individuals and Licence Holders.

Licence conditions are actions which must be achieved (sometimes within a prescribed timescale) to reach the required standards.

Conditions are statutory, standard or additional. Statutory conditions are set out in the HT Act and the Human Tissue (Quality and Safety for Human Application) Regulations 2007. Standard conditions are applied to all licences (or a sub-set of them) by the HTA. Additional conditions are specific to a licence.

Depending on the licensable activity there could be 10 statutory conditions. There may be 6-18 standard conditions. There could be as many as 10 additional conditions.

Yes, the HTA has the power to impose conditions on specific licences where it feels this is appropriate. If it does so, the HTA has to provide a written notice to the DI (and the Licence Holder, if different) and allow an opportunity for them to make representations within 28 days of being notified. The conditions are intended to help the sectors meet the required standards and we will share best practice with the sectors.

Yes, this is known as a licence variation. We can envisage circumstances where licences may be varied, for example if the DI leaves or otherwise cannot fulfill their duties. Provided an application is made to the HTA we will consider varying the existing licence. Application forms to vary a licence can be found at changes to your licence.

Yes, for example, if we believe that any information provided within the application was in a material way either false or misleading, if we find that the DI cannot discharge their duties, or if we are no longer satisfied that the licensed premises are suitable for the purpose. There is also scope for either the applicant or the DI under a licence to ask the HTA to revoke their licence.

In certain circumstances, the Human Tissue Act 2004 makes provision for a Licence Holder or Designated Individual or Licence Applicant to make Representations against a proposed licensing decision and / or make an Appeal to the HTA about a licensing decision. 

The entitlement to make Representations about proposed licensing decisions ensures that licensing decisions are subject to general principles of due process, proportionality and transparency. 

If the person making Representations remains dissatisfied with the outcome of the Representations Meeting then reconsideration of the licensing decision can be undertaken by an Appeals Panel. Similarly, if following a decision by an Appeals Panel the appellant may seek leave for a judicial review of the decision. The right to make Representations is laid out under schedule 3 of the Human Tissue Act. The right to make Reconsiderations is laid out in section 19 of the Human Tissue Act.

There are two stages: representation and formal appeal. The HTA will produce standard operating procedures for both these processes.

If the HTA decides either to grant, revoke or vary a licence when an application has been made to do so, or otherwise decides to impose special conditions, we must advise the applicant giving our reasons. At that point the applicant has the right to ask the HTA to reconsider the decision, provided they give written notice within 28 days of being notified of the original decision. This would be in the form of representations.

If the applicant is not satisfied with that decision s/he can make an appeal against it. The HTA Appeals Panel will be comprised of five Authority members who have not taken any part in the original licensing process.

The HTA will be conducting site visits according to risk. Some site visits will be based on the risk apparent in the completed application and others will be selected on a random basis to assess if they are compliant with our requirements under the HT Act. Establishments regulated under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 will be inspected at least once every two years.

The HTA will appoint individuals to perform site visits. Our aim is to work collaboratively with other regulators and we may seek to delegate the inspection function or work together with another inspectorate.

The HTA will work with you to advise how you can meet the required standards. In extreme cases we may not be able to grant you a licence or where a licence has already been issued we may revoke it. More usually we will place conditions on a licence to limit your practice or to require an improvement in standards.