Human Tissue Authority

The regulator for human tissue and organs

Licensing of procurement organisations

Please see below for a number of frequently asked questions from a specific category. Simply select one of the questions of interest, the answer will then appear below. For the complete list of categories please visit the main FAQs page.

Procurement is defined by the EU Tissue and Cells Directives as a process by which tissues or cells are made available. This includes the donor selection procedure as well as the physical act of removing tissue and / or cells intended for patient treatment (human application).

If you or someone within your organisation is carrying out procurement of tissues and / or cells for patient treatment, an HTA licence will normally be required. Procurement may be carried out by an unlicensed establishment under the terms of a third party agreement, provided:

 

There are specific circumstances when you can carry out procurement under a third party agreement rather than a licence. In order to carry out procurement under a third party agreement you must:

If you are procuring tissues or cells on behalf of a patient at your own establishment you cannot do this under a third party agreement with another licensed establishment; this is because you are procuring on your own behalf not on behalf of the licensed establishment. In this case a licence for procurement would be needed.

Procurement of tissue for human application, such as bone, skin, heart valves and corneas requires a licence for procurement from the HTA under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended). There are circumstances where a procurement licence is not required and these are set out below:

 

A licence for the removal of relevant material from a deceased person authorises an establishment to remove material for purposes such as research. It does not authorise the procurement of tissues and / or cells for human application.

A third party agreement is an agreement in writing between a Licence Holder (LH) or Designated Individual (DI) and another person that carries out a licensable activity on behalf of the LH / DI. The agreement needs to be made in accordance standards set out in the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatment as implemented by HTA's Directions 002/2018. If the licensable activity is carried out under a third party agreement as described above, the organisation carrying out that activity will not require a licence.

The following licensable activities can take place under a third party agreement: procurement, testing, processing, distribution and export. The activities of import and storage cannot take place under a third party agreement.

Our current licence fee for procurement organisations can be found here.

The HTA will send an invoice with your licence offer. This invoice will cover the period from the date that a licence is issued, extending up until the following 4 July. Thereafter you will normally be charged annually.

Please contact our licensing team if you have further queries.

It is possible for procurement sites to be satellite sites of a licensed establishment. Satellite establishments are normally smaller premises on a separate site to the licensed establishment. The satellite establishment must be under the same governance framework as the larger licensed establishment (the hub) and 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. The DI should plan to make regular visits to satellites to verify that the licensing framework and systems and processes are working in practice.

Any activity carried out under an HTA licence needs to be under the supervision of a DI. If you wish to carry out the activity of procurement at an organisation that is already licensed by the HTA you will need to contact the DI and ensure that they are willing and able to supervise the activity.

Please note, it is a standard condition of licences issued in the HA sector that:

“Where a new type of tissues and/or cells is to be procured, tested, processed, stored, distributed, imported or exported by the establishment, or under a third party agreement, the Designated Individual must first notify the HTA and the new type of tissues and/or cells may not be procured, tested, processed, stored, distributed, imported or exported by the establishment (or the third party) until the HTA is satisfied that the establishment has suitable premises and employs suitable practices to carry out the proposed activity in respect of these tissues and/or cells.

With this in mind, if you wish to procure a new type of tissue or cells under the authority of an existing HTA licence, the DI should notify the HTA prior to this activity commencing.

It is a requirement that the DI must have:

  • 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.

    The LH has the right to vary a licence. This enables them to substitute another person as the Designated Individual (DI) and allows the establishment to cover circumstances where the DI is unable or incapable of overseeing the licensable activities. Consequently, the HTA requires individual LH to be more senior than the DI (e.g. Medical Director / Chief Executive).

    Where the LH is a corporate body, establishments should provide contact details 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 has a preference for LHs to be a corporate body.

    It is possible for a licence to cover all procurement activities carried out within a Trust. However if tissues or cells are procured on multiple sites within the same Trust, the HTA should be contacted to see if a hub-satellite licensing arrangement is needed.

    No. An application for a licence must specify the premises where the licensed activity is to take place. If the licensed activity will take place in premises at more than one place, a separate licence will be needed. Premises in different streets or with different post codes will be considered as being in different places. In contrast, different buildings on a hospital site could be regarded as in the same place. The HTA will consider this on a case-by-case basis, depending on the facts in each application.

    Yes. However, standard condition 14 in Annex B to all HTA licences, requires the Licence Holder or the Designated Individual (DI) to notify the HTA when any new type of tissues and /or cells is to be procured, tested, processed, stored, distributed, imported or exported by the establishment. Where the processes required for this new type of tissues or cells differ substantially from those previously employed by the establishment, the DI must first notify the HTA. The new type of tissues and /or cells may not be procured, tested, processed, stored, distributed, imported or exported by the establishment until the HTA is satisfied that the establishment has suitable premises and employs suitable practices to carry out the proposed activity in respect of these tissues and /or cells.

    All activities carried out under the licence must be supervised by the DI, and the DI must have suitable qualifications and experience to supervise the complete range of tissue types covered by the licence.

    Yes. Organisations procuring tissues and cells for human application require a licence from the HTA unless procurement is being carried out under a third party agreement. In these circumstances:

    In the UK, procurement of tissues and cells for human application is licensed under The Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) which were transcribed into UK law from the European Union Tissues and Cells Directives (EUTCD).

    The latter is legislation that is applicable to all countries in the European Union with each country having its own Competent Authority responsible for the licensing of procurement organisations. Hence, any organisations that procure tissue for human application in Europe will be subject to the EUTCD and will require a licence from the national Competent Authority, rather than the HTA.