Who are the HFEA and what do they do

There are lots of good reasons for choosing a UK clinic for your treatment. Having the reassurance of licensed and regulated centres is one of them. Lucy Jenner is the Person Responsible at CARE Nottingham and a senior embryologist. 

Lucy explains the role and responsibilities of the HFEA in regulating patient care and safety whilst undergoing fertility treatment.


Who are the HFEA and what do they do?

The Human Fertilisation and Embryology Authority (HFEA) is a statutory body that regulates fertility clinics in the UK. They ensure that the law as set down in the Human Fertilisation and Embryology Act (1990) is interpreted correctly and adhered to and that any updates and changes to regulation are disseminated. 


How do they regulate clinics?

To achieve this, UK clinics undergo a full HFEA inspection, following which the clinic will, all being well, be issued a licence to offer treatment and storage of gametes and embryos for 4 years. At the 2 year interval clinics also undergo an interim inspection to ensure that any areas of non-compliance identified at inspection have been addressed. Each clinic has a single person who has to gather evidence, ensure compliance, report incidents and prepare for inspection, this role is referred to as the PR (Person Responsible).  In Nottingham – that’s me!


What do they regulate?

The HFEA regulate, advise, audit and inspect:

  • The use of eggs and sperm in fertility treatment
  • The storage of eggs and sperm
  • The creation and storage of human embryos
  • The use of donated eggs, sperm and embryos
  • The movement of gametes and embryos between clinics


How do they help patients?

The HFEA also gather data about every fertility treatment carried out in the UK since 1990, allowing analysis of results and trends. They keep a database of all cycles and the use of donated gametes, and they also gather information about adverse events and incidents that may occur in clinics. As a result of these activities, reports are issued to the media and via the HFEA website showing analysis of results, information about incidents, and summaries of treatments carried out across the UK. 


What does it mean to me?

The HFEA issue consent forms which you will complete before your treatment. The forms needed are determined by your situation and your reason for being here. The forms cover various aspects of treatment including consent to disclosure of your information to others, assessment of the welfare of the child, gamete and embryo storage, the creation of embryos and their use in treatment, intra-uterine insemination, parenthood provision, gamete donation, surrogacy and withdrawal of consent. 


Do the regulations change?

Some of the changes that have been introduced across clinics by the HFEA have been:

2002 – Witnessing was required to be carried out as part of treatment to ensure traceability of gametes from collection to transfer.

2004 – Donor anonymity was removed so that donor-conceived offspring have the right to apply to the HFEA for information about their origins at the age of 16 and 18.

2006 – The EU tissue directive was applied to Assisted Conception Laboratories.

2007 – A focus on the lowering of the multiple birth rate resulting from fertility treatments by increasing single embryo transfer rates.

2008 – The HFE Act was amended, which resulted in some changes to the law and revision of some of the consent forms

2009 – A new suite of consent forms allowing the provision of legal parenthood for couples using donor sperm in treatment. 


How can I find out more?

The HFEA website has lots of useful information for patients to assist with finding a clinic, finding out about treatments and storage. There is also information about donating gametes or having treatment using donated gametes.

If you are interested you can read the HFE Act (1990, as amended 2008).



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