Inspection and licensing process

The HFEA has a range of powers to help ensure that centres are acting in a safe, appropriate and legal manner and to help centres to continually improve the way they work.

If matters are relatively minor then HFEA staff may just advise clinic personnel on how to improve their practice. If formal measures are appropriate then the issue will go before an HFEA licence committee.


The licensing process and HFEA Licence Committees  

Before any centre can carry out IVF treatment (or other fertility treatment or services that fall under the EU Tissues and Cells Directive) it must have a licence from the HFEA.  Research centres carrying out research on human embryos have to be similarly licensed.

Each licence will list exactly what the centre is entitled to do and may specify conditions on how the centre will work. Licences are normally offered for a period of between 1 and 5 years, but the length of a licence can be varied to another period if this is appropriate.

Decisions on whether licences are granted, whether they are renewed or amended are made by HFEA Licence Committees. These are committees made up of a number (typically five) of Authority members.

These committees are separate to the main Authority and are are responsible for exercising the HFEA's licensing powers under the Human Fertilisation and Embryology Act 1990.

Meetings take place about 30 times each year.

 

The inspection process
Three inspectors ? a scientist, a clinician and a generalist, such as an auditor, usually carry out clinic inspections. However, two inspectors may carry out the visit if the clinic is fairly small. Research facilities' inspection teams may include two scientists. Usually the team members are all HFEA-employed inspectors but occasionally external advisers are included when necessary.

Prior to inspection, the clinic's ´person responsible' (PR) completes a pre-inspection questionnaire to provide the HFEA with details of any changes since the last inspection, plus factual information, such as details of all treatments carried out.

Questionnaires are sent to each centre for distribution to patients, and a self-assessment document is given to the PR as an annual return to complete so that he or she, and their staff, can identify areas needing improvement. All this information is analysed by the lead inspector prior to a visit taking place.

During the inspection the inspection team assesses the effectiveness of the centre through five criteria:

  • How well the centre is organised
  • Quality of the service for patients and donors
  • Premises and equipment
  • Information provided to patients and to the HFEA
  • The clinical and laboratory processes and competence of staff.

Each area is evaluated and categorised and an overall judgment is given:

  • No improvements required ? given to centres where there are no code of practice, legal requirements, recommendations or conditions that need to be imposed.
  • Some improvements required ? given to centres that are generally satisfactory but have areas that need attention. Recommendations will usually be made to help PRs to improve the service. 
  • Significant improvements required ? given to centres that have considerable scope for improvement and have unacceptable outcomes in at least one area. An immediate action plan will be imposed and/ or conditions could be put on the licence.

 

Clinic inspection reports
Why does the HFEA produce clinic inspection reports?

  • To enable the licence committee to make decisions
  • They contribute to the HFEA's aim to improve services
  • Help providers to assess their services
  • Reduces the risk of under-performing establishments damaging the reputation of others in the industry
  • The reports enable the HFEA to keep the public informed of the availability, safety and quality of licensed centres
  • By publishing clinic inspection reports, we enable the public to choose providers on the basis of sound, unbiased evidence of the quality of services
  • The reports help licence committees to make evidence-based decisions.


 

What's the legal background?
The purpose of inspections is to ensure that centres are providing a quality service for patients in compliance with the Human Fertilisation and Embryology Act 1990, HFEA sixth edition Code of practice and to ensure that they are working towards compliance with the EU Tissue and Cells Directive 2004/23/EC. Inspections are always carried out when a licence is due for renewal, although other visits ? interim inspections ? may occur at other times.

Reports are used to summarise the findings of the licence renewal inspection, highlighting areas good practice, as well as areas where further improvement is required to improve patient services and meet regulatory requirements.

 

How do I view an individual clinic's inspection report?
Inspection reports are made public once the Licence Committee has considered the report, unless legal action is being taken.

We publish clinic inspection reports in the For Clinic Staff section of this website.

For any further details or information, please contact the Regulation Department on
020 7291 8251 or email admin@hfea.gov.uk

 

Formal sanctions of the HFEA  
This is a lay summary of the requirements and processes under the Human Fertilisation and Embryology Act 1990, as amended. For the precise legal meaning and application of these rules, please refer to the Act itself.

There are a range of formal sanctions that HFEA can exercise. These are all decided upon by HFEA licence committees.

The sanctions are:

  • Adding conditions to a licence
  • Revocation of a licence
  • Immediate suspension of a licence

 

Adding conditions to a licence
A licence committee has the power to add additional conditions to a licence if it thinks this is appropriate.

A condition may be used to restrict the operation of a centre (for example restricting the amount of treatment that takes place or prohibiting certain procedures) if there are concerns over the operation of the centre in certain areas.

If a licence committee decides to add a condition to a centres's licence then the Person Responsible (the individual with legal responsibility for the operation of the clinic) may appeal (see below).

 

Revocation of licence  
The HFEA may revoke a centre's licence for one of five reasons:

  • If any information given in the application for the licence was false or misleading
  • If the premises are no longer suitable for providing the service detailed in the licence
  • If the Person Responsible has failed to discharge their legal duties (detailed in Section 17 of the HFE Act) or cannot discharge them through incapacity
  • If the Person Responsible has failed to comply with Directions (HFEA rulings with specific legal status under the HFE Act) given in connection with a licence
  • If there has been any other material change of circumstances since the licence was granted

If an HFEA licence committee decides it is appropriate to revoke a centre's licence, then it will send a formal notice stating this to the Person Responsible for running the centre (This is the person legally responsible for running the centre under the HFE Act).

The centre has a right to appeal against this ruling following the appeals process (below).

 

Appeals against conditions or revocation  
The Person Responsible may appeal within 28 days if they wish the HFEA to reconsider conditions put on a licence or a proposal to revoke a licence. If an appeal is lodged at this stage (known as the 'Representations' stage) then the same licence committee will meet again to discuss this representations case.

Having looked again at the case, considering any new evidence brought forward, the licence committee will then rule again on the licence for the centre.

If committee still rules that the licence should be changed or revoked, it will send a notice out saying this to the Person Responsible. 

The Person Responsible then has a further 28 day period to appeal to a separate Appeal Committee made up of HFEA Authority members who have not previously considered the case.

If such an Appeal Committee meets, this is the final stage of the HFEA ruling and, once the Appeal Committee has set out a notice of its ruling, the clinic must comply with their judgement. However, the clinic may appeal to the High Court (or the Court of Session in Scotland) on a point of law.

 

What happens to patients if a licence is revoked  
If a licence is finally revoked (ie there is no further appeal pending, see above) then the clinic must stop treatment. It is a criminal offence to provide treatment without a licence, or outside the terms specified in a licence.

However, if some patients are midway through their treatment, the HFEA may give permission through Special Directions (HFEA rulings with specific legal status under the HFE Act) to allow those patients to continue and complete their treatment if the HFEA is satisfied that they will not be at immediate risk from doing this.

 

Immediate suspension of licence  
An HFEA licence committee also has the additional power to immediately suspend a licence.

Once a licence has been suspended no further treatment can take place until the suspension has been lifted.

A licence committee can only suspend a licence if there are grounds for revoking the licence (see above) and it believes that there is good reason for the licence to be immediately suspended (for example if there is immediate risk to the health and safety of patients).

There is no appeal against a suspension and treatment (or research) must stop immediately a notice of suspension has been given. A suspension can last for no longer than 3 months.

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Last updated: 18 July 2007