How we regulate (treatment and research)

Fertility clinics

The HFEA regularly inspects UK fertility clinics and research centres. This ensures that every licensed clinic or centre is adhering to standard safety and ethical rules set out by the UK government.

Following an inspection, the HFEA decides whether to grant or renew permission (in the form of a licence) for the clinic or centre to undertake fertility treatment or research.

What is the process?

The process for licensing a clinic or centre consists of four steps: 

1. Receiving the licence application 

The process begins when the Person Responsible for a centre submits an application form to the HFEA. The form can be:

  • an application for a new treatment, storage or research licence
  • an application to renew a treatment, storage or research licence.

Once the HFEA ensures the Person Responsible has provided all the correct information, an inspection visit is arranged.

 

2. Inspecting the clinic 

An HFEA inspection team is sent to visit the clinic. The team usually consists of two or three inspectors, including a clinician and a scientist.

During the inspection, the team evaluates:

  • the clinic’s premises and facilities
  • laboratory processes
  • the ability of the clinic to provide the services it offers
  • the suitability of the person responsible and the staff providing the services.

3. Publishing and presenting a report 

The findings from the clinic inspection are published in a report, which is presented to a Licence Committee of HFEA members. The report is sent to the PR within 28 days of inspection, and to the Licence Committee within three months of the inspection.

Inspection reports

For ease of use, the reports and Licence Committee minutes can be found in our Choose a Fertility Clinic search - alongside their corresponding clinic listing.

4. Deciding whether to grant a licence 

A Licence Committee uses the report to make a decision on whether a licence should be granted and if so, for how long.

Once a Licence Committee has come to a decision regarding an application, it will either:

  • grant a licence
  • grant a licence subject to specific conditions
  • refuse a licence (with reasons for refusal set out in writing).

The clinic must accept the licence conditions in writing before the HFEA can issue a licence.

Clinics have the right to make representations against the decision of the Licence Committee. If these are rejected, the Person Responsible has a right of appeal.

Inspection reports

For ease of use, the reports and Licence Committee minutes can be found in our Choose a Fertility Clinic search - alongside their corresponding clinic listing.

Interim inspections

As well as inspecting a clinic after receiving their initial application, the HFEA also carries out interim inspections on licensed clinics.

These interim inspections take place when:

  • a previous inspection concluded that the quality of a clinic’s service could be improved
  • there have been changes in a clinic’s operation since the last inspection (high turnover of staff, upgrading of the premises, for example)
  • the HFEA receives an incident report, or complaint about a particular clinic
  • there is a need to follow up on requirements from the last inspection
  • an HFEA Licence Committee has determined that another inspection is necessary.

Clinics can be inspected with notice, at short notice or without notice.

Further information:

 

Page last updated: 26 November 2013

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Filling out a licence formWant to apply for a HFEA licence? Find out about the process.

 

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