Licensing of procurement organisations FAQs
This pages includes a series of frequently asked questions about the licensing of procurement organisations by the HTA.
What is procurement?
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 human application (patient treatment).
When do I need a licence to procure tissue and / or cells?
If you or someone within your organisation is carrying out procurement of tissues and / or cells for human application, a HTA licence will normally be required, unless the procurement is being carried out under a third party agreement. In these circumstances:
- the procuring establishment must be acting on behalf of a licensed establishment, and
- the third party agreement must meet the standards set out in the HTA's Directions 001/2006 and 002/2007.
Does my organisation need to comply with all of the requirements of the Quality and Safety Regulations by 5 July 2008?
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.
When can I have a third party agreement in place instead of a procurement licence?
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
- be procuring on behalf of the establishment you have the third party agreement with and
- have a third party agreement that meets the requirements of the Directions 001/2006 and 002/2007.
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, even if the processing is carried out by a third party establishment. This is because you are procuring on your own behalf not on behalf of the processing site. In this case a licence for procurement would be needed.
Do I need a licence to procure tissue in a mortuary?
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. There are circumstances where a procurement licence is not required and these are set out below
- the organisation responsible for the mortuary e.g. the Local Authority or NHS Trust must be procuring on behalf of a licensed establishment under a third party agreement and,
- the third party agreement must meet the standards set out in the HTA's Directions 001/2006 and 002/2007.
I already have a licence under the Human Tissue Act 2004 for removal of relevant material from a deceased person; do I need a licence for procurement?
A licence for 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.
What is a third party agreement?
A third party agreement is an agreement in writing between a Licence Holder (LH) or Designated Individual (DI) and another organisation carrying out a licensable activity on behalf of the LH/DI. The agreement needs to be made in accordance with Directions 001/2006 and 002/2007. If the licensable activity is carried out under a third party agreement as described above a licence the organisation carrying out that activity will not require a licence.
When can licensable activities take place under a third party agreement?
Licensable activities that can take place under a third party agreement include procurement, testing, processing, distribution, import and export. The activity of storage cannot take place under a third party agreement.
Do I need a licence to procure cord blood?
Procurement of tissue such as cord blood requires a licence unless the procurement is being carried out under a third party agreement. In these circumstances:
- the procuring establishment must be procuring cord blood on behalf of a licensed establishment, and
- the third party agreement must meet the standards set out in the HTA's Directions 001/2006 and 002/2007.
Examples of the type of third party agreement that may be suitable for cord blood procurement
- a third party agreement between the licensed cord blood bank and the hospital carrying out the procurement on their behalf, or
- a third party agreement between the licensed cord blood bank and a procurer e.g. an independent phlebotomist, carrying out the procurement on their behalf within a hospital.
I have been asked to procure cord blood for a directed donation (for example directed donation of cord blood for a sick sibling) but don’t have a licence. How can I carry out the procurement?
In this situation a consultant in the NHS would normally refer a patient to a tissue establishment. The DI at the tissue establishment must have clear and explicit acceptance criteria for this sort of referral in relation to the critical clinical need of a specific named patient. The DI would then take responsibility for initiating and controlling the procedures from procurement, consent, testing, processing, storage etc through to distribution to the clinician who would use the material for the sick patient. In this instance the hospital would not need to apply for a separate procurement organisation licence but must ensure the Tissue Establishment sets up an appropriate third party agreement in place of a licence. This agreement must meet the requirements of the HTA Directions.
Do I need a licence to procure bone marrow or PBSCs?
Procurement of tissue such as bone marrow and PBSCs requires a licence unless the procurement is being carried out under a third party agreement e.g.
- the procuring establishment must be acting on behalf of a licensed establishment, and
- the third party agreement must meet the standards set out in the HTA's Directions 001/2006 and 002/2007.
If you are procuring bone marrow and PBSCs for patients at your organisation and sending them off-site to a licensed establishment for processing you will need a licence for the procurement. A third party agreement will not suffice because the procurement cannot be considered to be carried out on behalf of the processing establishment.
When do I need to apply for a licence?
You will need to apply for a licence by 5 July 2008. You can apply for a licence via this website.
What is the licence fee?
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.
I have applied for a procurement licence, when will the HTA invoice me for the cost of the licence?
The HTA will send an invoice with your licence offer. This invoice will cover a one year period from the date that a licence was required e.g. 5 July 2008 until 4 July 2009. You will then be invoiced on an annual basis. If you apply after the application date the full year fee will still be applicable, extending up until 4 July 2009. Thereafter you will normally be charged annually. Please note the HTA is currently reviewing all fees and will be consulting on the proposals before March 2009.
Can procurement sites be satellites of a main site?
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 (normally twice a year) to satellites to verify that the licensing framework and systems and processes are working in practice.
Another department within our organisation already has a procurement licence under the Regulations; does this allow us to procure in our department?
A list of licensed establishments is available on this website. Any activity carried out under a 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 this activity.
What are the roles of the DI and LH?
The DI has the primary (legal) responsibility under the Regulations to secure:
- that suitable practices are used in undertaking the licensed activity
- that the other persons who work 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
is up to date and correct
is held securely.
The role of Licence Holder does not impose the duties that are expected of the DI; however they do have a duty to ensure amongst other things:
- that the conditions of third party agreements are complied with
- that the Directions are complied with
- that fees are paid
What qualifications does the DI need?
It is a requirement 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.
Who should be the Licence Holder?
The LH has the right to vary a licence. This enables them to substitute another person as the DI and allows the establishment to cover circumstances where the DI is unable or incapable of overseeing the licensable activities(s). Consequently, the HTA requires individual Licence Holders 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 has a preference for licence holders to be the corporate body.
Can a licence cover a whole Trust?
Yes, a licence might cover all procurement carried out within a Trust provided that
- they are carried out on the same premises
- they are carried out under the supervision of the DI.
Can a licence cover more than one set of premises?
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.
Can a licence cover activities relating to more than one tissue or cell type?
Yes. A licence does not specify the type of tissue it relates to therefore if you have a licence to procure tissue and cells you can procure various types of tissues and cells under the authority of the licence. However activities carried out under the licence will need to be supervised by the DI.
Do I need a licence if I am producing a product that is regulated by the MHRA?
Where the storage, processing, import, export or distribution of cells or tissues (including cell lines) for human application is for use in manufactured products and these activities are regulated by
- the Medicines (Homeopathic Medicinal Products for Human Use) Regulations 1994
- the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994
- the Medical Devices Regulations 2002, or
- the Medicines for Human Use (Clinical Trials) Regulations 2004
then these activities will not be regulated by the HTA as well and a licence will not be required. Procurement and testing of tissues and cells will still require a licence.
If we have a standard operating procedure in place do we need a licence?
Yes. Organisations procuring tissues and cells for human application require a licence from the HTA unless the procurement is being carried out under a third party agreement. In these circumstances:
- the procuring establishment must be acting on behalf of a licensed establishment, and
- the third party agreement must meet the standards set out in the HTA's Directions 001/2006 and 002/2007.
If an organisation is carrying out procurement on their own behalf a licence will be required for this activity.
What should I do if I know someone is carrying out procurement without a licence after 5 July 2008?
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. 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. If establishments are carrying procurement of tissues and / or cells for human application after 5 July 2008 outside the authority of a licence or a third party agreement the HTA will take appropriate regulatory action.