Start now on the Human Fertilisation and Embryology Authority (HFEA) website
If you undertake the procurement, testing, processing, preservation, storage and distribution of gametes, embryos and/or provide in-vitro fertilisation, or artificial insemination treatments, you need to register for a licence from the Human Fertilisation and Embryology Authority (HFEA).
You also need licences for:
- treatment, non-medical fertility services (eg procuring and distributing sperm) and storage of gametes and embryos (known collectively as treatment and storage licences).
- authorising activities for the purposes of a research project.
- authorise both treatment/storage and research.
You also need a separate licence for each premises at which licensed activities are to be carried out.
How to apply
Before applying for a licence, you should complete an initial enquiry form and email this to the HFEA.
The HFEA will then help get you started and assign an inspector who will be able to advise you on the licensing process and the requirements you need to meet in order to be granted a licence.
These relate to issues such as record-keeping, traceability of gametes and embryos, obtaining consents in writing, counselling for patients and the provision of information and documents to the HFEA.
You will also be expected to comply with the standards and supporting guidance set out in the HFEA Code of Practice which covers such things as professional conduct, clinical governance, quality management and confidentiality.
You need to nominate a named person to act as the ‘person responsible’ for your licensed centre. This person must meet certain qualifying criteria as they will be charged with ensuring that:
- all licensing conditions are complied with
- the HFEA is notified about serious incidents or serious adverse reactions
- staff at your centre are of good character and are suitably trained and qualified
- the centre’s premises are suitable
- proper equipment and suitable practices are used when carrying out licensed activities
- proper arrangements are made for the keeping and disposal of gametes and embryos
You must pay an application fee when you submit your completed application form. This depends on the type of licence you are applying for.
Treatment and storage licences may be granted for a period of up to five years and research licences for up to three years. On expiry, you will need to apply for renewal and pay a renewal fee.
Your compliance with the terms of your licence and with the Code of Practice will be monitored by the licensing authority which carries out regular inspections of licensed premises.
Fines and penalties
If you do not comply with the terms of your licence you may have your licence revoked. If you perform certain restricted activities, such as implanting a cloned embryo in a woman, or carrying out licensable treatment without a licence, you will be committing an offence.
If you breach conditions of the licence or fail to obtain a licence you may be fined, imprisoned for up to ten years or both.