How we regulate
We regulate fertility clinics and projects involving research with human embryos. This involves licensing, inspections and setting standards – find out more about each on this page.
What is regulation?
Regulation in our context means making sure fertility clinics and research centres comply with the law and the rules and standards we set to ensure high quality care and research.
What laws do fertility clinics and research centres have to comply with?
All fertility clinics and human embryo research centres in the UK must comply with:
- the Human Fertilisation and Embryology (HFE) Act 1990 (as amended)
- the HFE Act 2008, and
- a number of related pieces of legislation.
We provide guidance to clinics and research centres on how to meet their legal requirements in our Code of Practice.
Regulation is important because it ensures that the work carried out is to a certain standard; that only qualified people can do it; and that research on embryos is only done where there is a real need and in a way that’s ethical.
Fertility clinics and human embryo research centres must apply to us for a licence to carry out their work. We can grant a licence for up to four years, with new clinics automatically receiving a two-year licence.
Before granting a new licence, or renewing an existing one, we conduct an inspection to make sure their services are up to standard in line with our Code of Practice. The findings are presented to our Licence Committee, which makes a decision on whether to grant a licence (and if so for how long), refuse the licence, or, if they feel the quality of service needs to be better, put conditions on the licence which ensure it only remains in place if improvements are made.
Before we grant a new licence, or renew an existing one, we carry out an inspection.
By law, clinics and research centres must also be inspected every two years to make sure they are continuing to operate safe, legal and quality services and research in line with our Code of Practice. Sometimes we inspect clinics and centres more frequently if we need to, for example if something has happened to cause us concern, such as an incident or complaint.
Depending on the situation we can tell the clinic we’re coming in advance, at short notice or not tell them at all (an unannounced inspection).
At the inspection we check they’re making any improvements we’ve previously asked for and monitor how they’re doing against key areas agreed by our board. We also get feedback from patients, both online and face to face.
Our inspectors put all the findings into a report, identifying any areas which they are concerned about (non-compliances) and recommending how they can improve. This is presented to our Licence Committee, which decides on whether the clinic or centre’s licence can continue.
If the committee is very concerned about how the clinic or centre is performing, it can vary its licence (for example, adding a condition to ensure improvements are made), suspend it, or in extreme circumstances, revoke it.
All inspection reports are publicly available on our website. Search for a clinic or centre to read its latest inspection report.
The law on fertility treatment and human embryo research is complex. We help clinics and research centres to understand how to meet their legal requirements by producing a document called the Code of Practice.
The code also includes rules which we have made (known as directions) to ensure procedures and practices are carried out properly, in line with the latest evidence. We also include guidance on what high quality care looks like so that everyone can work towards achieving this.
It doesn’t stop there. We want clinics and research centres to keep improving so we touch base with them regularly via e-newsletters and in person with the latest advice and information on how to provide the best quality care.
No-one likes paperwork but fertility treatment is a big deal and should not be entered into lightly. It’s incredibly important that people know what lies ahead and have thought about all the things they need to before they start.
That’s why, by law, clinics have to get written consent to fertility treatment, storing sperm, eggs and embryos, donation, surrogacy, disclosure of information and, where applicable, parenthood and withdrawing consent. We produce these consent forms, and guidance for clinics on when and how to use them, to ensure consistency nationally.
Review date: 31 May 2024