On this page:

• What is the regulatory process?
• What are the legal requirements on clinics?

What is the regulatory process?

The HFEA regulatory priorities are ensuring patient safety and promoting the highest standards of clinical care and effectiveness by making sure clinics comply with the HFE 1990 Act.

The Licence Committee will consider the application in relation to the requirements of the HFE Act, and the HFEA Code of Practice.

Clinics have the right to appeal a Licence Committee decision.

• What is the appeal process?

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What are the legal requirements on clinics?

Clinics must maintain appropriate standards of quality and safety, appoint a "Person Responsible" for compliance matters, record, submit and verify information, provide information and the opportunity of counselling to patients and take account of the welfare of the children born as a result of certain fertility treatments.

These obligations flow from with the Human Fertilisation and Embryology Act 1990 (HFE Act) (as amended by the Human Fertilisation and Embryology Act (Quality and Safety) Regulations 2007). Clinics must also comply with HFEA issued directions, and the Code of Practice.

• This covers all uses of sperm, eggs and embryos for human application and all research involving the use of live human embryos. 
• These terms and conditions are set out in licences, which are legal documents that every clinic must have before it can offer and carry out a licensable fertility treatment at specified premises.

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