Management of centres causing concern

The HFEA continually monitor licensed centres to ensure their compliance with the HF&E Act (as amended), standard licence conditions, additional licence conditions, directions and the Code of Practice.

Where the inspector becomes aware that a licensed centre has failed to comply with any of these requirements we will seek to achieve compliance via an escalating scale of informal measures to formal enforcement action.

What actions we can take

Low risk issues

If the area of non-compliance does not pose an immediate risk to patients, donors or embryos then we will contact the Person Responsible to discuss the area(s) of non-compliance and the action which must be taken and the timescales for doing.

We may also ask to meet with the Person Responsible to discuss requirements and improvement options required and to set an improvement plan.

We will check improvements have been made. If the necessary improvements are not made then we can escalate the action taken. This may include an unannounced inspection visit to monitor compliance or sending a warning letter to the Person Responsible, informing him that formal enforcement will be undertaken if the identified remedial actions are not completed within a given time scale.

High risk issues

If the area of non compliance poses a risk to patients, donors or to gametes and / or embryos or there is evidence that a criminal offence may have been, or is being, committed then more formal enforcement will be taken.

This may include referring the centre to our Executive Licensing Panel / Licence Committees with a recommendation that:

the licence should be varied to include additional condition(s)
the length of the licence be shortened
the licence should be revoked (or suspended); or
where a criminal offence may have been committed, referring the matter to the police for criminal investigation.

Our Compliance and Enforcement Policy outlines in detail the possible actions we can take.

Compliance and enforcement policy (192 Kb)

Case studies

Examples of how the HFEA may deal with centres where area(s) of non-compliance has been identified may be found in the following case studies. These are only examples, the exact regulatory action taken against a centre would be up to the Executive Licensing Panel / Licence Committee.

Complaints against clinics

The Authority can only consider a complaint made by a patient, where that complaint indicates a potential breach of the Act, licence conditions, directions issued by the Authority or the guidance set out in our Code of Practice.

If the complaint indicates that a potential serious adverse event or serious adverse reaction may have occurred, we shall consider the matter in accordance with our policy for investigating serious adverse events and adverse reactions.

How we deal with complaints about a licensed clinic – HFEA Policy (54 Kb)