Jump to navigation

Licensing of procurement organisations

This page provided information on the licensing of procurement organisations by the HTA, including the deadline for applying for a licence and the licence fee.

Procurement is defined as the processes by which tissues and cells are made available, including the physical act of removing tissue and the donor selection and evaluation. 

If you or someone within your organisation is carrying out procurement of tissues and / or cells for human application, an HTA licence will normally be required, unless the procurement is being carried out on behalf of a licensed organisation under a third party agreement. In these circumstances:

  • the procuring organisations must be acting on behalf of a licensed establishment; and
  • the third party agreement must meet the standards set out in HTA Directions 001/2006 and 002/2007.

If you are procuring tissues and / or cells and transferring them to an HTA licensed tissue establishment for storage and / or processing, please contact the Designated Individual (DI) to discuss whether your existing arrangement is valid. The HTA has found that many organisations that procure tissues and / or cells are not acting on behalf of licensed establishments, and so will need to apply for a licence.

If your organisation requires a procurement licence, you must apply on the HTA website by 5 July 2008. If your organisation requires a licence and you do not apply by 5 July, you will have to suspend all procurement activity until you have: submitted an application, the HTA has evaluated it and issued you with a licence for the activity of procurement. This process can take between two and four months, depending on factors such as the quality of information provided in the initial application and the degree of compliance with the standards.

The HTA does not expect procurement organisations to be fully compliant at the point of application for a licence in July 2008. The HTA’s approach is to work with licence applicants to identify deficiencies and offer advice and guidance about how best to meet them. We will therefore work with licence applicants to agree a timeframe for meeting the requirements of the Q&S Regulations.

What do you need to do?

A. If your organisation already holds an HTA licence under the Q&S Regulations which includes procurement activity

1. If procurement is under the DI’s supervision on the same premises:

  • No action is required since you are already licensed for procurement.

2. If procurement is taking place in a different department on the same premises and the DI is willing and able to supervise the activity:

  • The DI will need to set up systems to supervise that activity and will need to inform the HTA in writing that this is the case by 5 July 2008.

3. If procurement is taking place on different premises and the DI is willing and able to supervise the procurement:

  • The DI will need to set up systems to supervise that activity and will need to apply for a satellite licence by 5 July 2008. The DI can do this via this website - apply for satellite licence

B. If your organisation does not hold an HTA licence for procurement but carries out this activity

You will need to:

  • Check if you are procuring tissues and / or cells and transferring them to an HTA licensed tissue establishment for storage and / or processing under the authority of a third party agreement. If so, please contact the DI at that establishment to clarify whether this agreement is still valid. If not you will need to apply for a procurement licence.
  • Identify a suitable person to apply for the role of DI. Ideally they should complete the DI e-learning course on the HTA website so that they understand more about the role before they apply for it. You can access the e-learning course on this website.
  • Submit a compliance report licence application form via the HTA website by 5 July 2008. When completing the application form please provide as much detail as possible and ensure that all relevant questions are answered to the best of your ability. 
     
    Access the human application compliance report licence application form

    You can also download a PDF version of the compliance report, to help you prepare your answers before completing the online form.

What happens after an organisation has applied for a licence?

Following receipt of a licence application, the HTA completes a thorough desk-based inspection of the information provided. This involves conducting a detailed review and evaluation of the compliance report. During this process we normally need to contact prospective DIs and licence applicants, by email or telephone, to request further information or to clarify aspects of the information submitted. We will ask for this additional information to be provided as soon as possible and no later than 10 working days following our request. With this in mind you should ensure that that the prospective DI and licence applicant are available to answer any queries relating to the application.

Following the review we will inform the organisation of our proposed licensing decision. In most cases this will be a licence offer subject to additional conditions which are normally linked to areas of partial or non compliance. These additional conditions are time limited and are supported by a clear rationale. 

Licence fee

In setting the fee level for procurement organisations for 2008/09, the HTA has used its experience of licensing the human application and other sectors since 2006.  We understand from speaking to the sector that procurement organisations are typically small and that procurement may often be incidental to the main activity taking place on those premises, and it may take place intermittently and infrequently.

In calculating the fee we have also continued to apply the principles of proportionality, risk-based approach and value for money. The fundamental principle for setting fee levels is that they must be determined by the work required to license each sector. The fees set must meet all costs not supported by Grant-in-Aid from the Department of Health; and there should be no cross-subsidy.

Based on these factors we have developed a one-year interim licence fee for procurement organisations, pending a broader licence fee review across all sectors. This fee is £2900 and will be chargeable in the 2008/09 financial year.

More information

More information about the licensing of procurement organisations is available as a series of frequently asked questions. You can also email enquiries@hta.gov.uk