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 patient treatment, 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 organisation must be acting on behalf of a licensed establishment; and
- the third party agreement must meet the standards set out in HTA Directions 002/2018.
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 ensure that your existing arrangement is valid. In the past, we found that many organisations procuring tissues and / or cells were not acting on behalf of licensed establishments, and needed to apply for a licence.
If your organisation requires a procurement licence, you will have to suspend all procurement activity until you have submitted a licence application, the HTA has evaluated it and issued you with a licence for the activity of procurement. This process can take up to three 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. Our 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 Human Tissue (Quality and Safety for Human Application) Regulations 2007 Q&S Regulations.
What do you need to do?
A. If your organisation already holds an HTA licence under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 - Q&S Regulations which includes procurement activity
- If procurement is under the DI’s supervision on the same premises: No action is required since you are already licensed for procurement.
- 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 needs to set up systems to supervise that activity and to inform the HTA in writing that this is the case.
- If procurement is taking place on different premises and the DI is willing and able to supervise the procurement: The DI needs to set up systems to supervise that activity and to apply for a satellite licence. 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 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 valid. If not, you need to apply for a procurement licence and to suspend all procurement activity until the HTA has issued you with a licence for the activity of procurement.
- Identify a suitable person to apply for the role of DI.
- Submit a compliance report licence application form via our website. 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.
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.
In setting the fee level for procurement organisations, the HTA used its experience of licensing the tissue and cells for patient treatment (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.
To see the latest fees for procurement organisations visit the fees and payments webpage.