What We do

About the Human Fertilisation and Embryology Authority (HFEA)

The Human Fertilisation and Embryology Authority (HFEA) is the UK´s independent regulator overseeing the use of gametes and embryos in infertility treatment and research.

The HFEA licenses clinics and research establishments carrying out In Vitro Fertilisation (IVF), donor insemination, other assisted conception procedures and human embryo research, and provides a range of detailed information for patients, professionals, the public and Government.

The HFEA´s aim is to be a leading healthcare regulator exercising its functions fairly and proportionately, supplying good quality, relevant and accessible information to all its stakeholders. The Authority has recently developed the following statement of its purpose and principles:

Purpose

We are the UK´s independent regulator of treatment using eggs and sperm, and of treatment and research involving human embryos. We set standards for, and issue licences to centres.

We provide authoritative information for the public, in particular for people seeking treatment, donorconceived people and donors. We determine the policy framework for fertility issues, which are sometimes ethically and clinically complex.

Principles

  • We treat people and their information with sensitivity, respect and confidentiality
  • We observe the highest standards of integrity and professionalism
  • We consult widely - listening to and learning from those with an interest in what we do
  • We keep abreast of scientific and clinical advances
  • We exercise our functions consistently, proportionately, openly and fairly.

Statutory remit

Within this context, the HFEA has a number of statutory functions. They are based on two specific roles: firstly the licensing and regulation of clinics and research establishments providing treatment, storage and research; and secondly, the maintenance and publication of information about donor treatment and assisted conception.

The current statutory functions are:

  • To license and monitor clinics carrying out IVF and donor insemination
  • To license and monitor establishments undertaking human embryo research
  • To maintain a register of licences held by clinics, research establishments and storage centres
  • To regulate the storage of gametes (eggs and sperm) and embryos
  • To implement the requirements of the European Union Tissue and Cells Directive (EUTCD) to relicense IVF clinics and to license Intrauterine Insemination (IUI), Gamete Intrafallopian Transfer (GIFT) and other services new to regulation (in 2007)
  • To investigate serious adverse incidents and reactions, and to keep a register of serious adverse incidents and serious adverse reactions
  • To produce and maintain a Code of Practice, providing guidelines to clinics and research establishments about the proper conduct of licensed activities
  • To maintain a formal register of information about donors, licensed treatments and children born as a result of those treatments
  • To publicise the HFEA´s role and provide relevant advice and information to donor conceived people, donors, clinics, research establishments and patients, including servicing the statutory right of access to register information
  • To review information about:

  • Human embryos and developments in research involving human embryos
  • The provision of treatment services and activities governed by the Human Fertilisation and Embryology (HFE) Act 1990 (or a revised Act, if and when this comes into force)
  • To advise the Secretary of State for Health on developments in the above fields where appropriate.

Current operating context

Over the past few years, the HFEA has been modernising the way it fulfils its regulatory duties, with improvements such as Electronic Data Interchange (EDI) to improve the accuracy of data submitted by clinics and new risk-based inspection methodology.

In 2007/08, a number of pieces of new and recent legislation will profoundly affect the way the HFEA operates in the future. Parliament is currently considering the Human Fertilisation and Embryology (HFE) Bill. Therefore, the HFEA´s functions may be subject to change in light of this forthcoming legislation.

The new HFE Bill will not only affect what and how the HFEA regulates, but also the range of information the HFEA collects and releases to other people.

There is also now a Regulators´ Compliance Code, with which the HFEA must comply, and a continuing drive to reduce the burden of regulation for clinics. In addition, the Regulatory Enforcement and Sanctions (RES) Bill covers the operation of a large number of Government regulators, including the HFEA. This Bill may result in the HFEA becoming eligible to apply for additional powers during the coming year.

To prepare for all of these changes the HFEA is conducting a comprehensive review of its organisational functions in a programme of work called Programme 2010. The HFEA will be involving clinics and other stakeholders in this work as it progresses, to ensure that the organisation´s future ways of working will be as efficient and effective as possible.

In light of new Cabinet Office requirements relating to data security, the HFEA will also be ensuring it is fully compliant with the recently introduced information control framework.

The HFEA already operates to stringent data encryption standards, restricts the use of removable media, and has conducted penetration testing to ensure that data is secure from external attack.

Further information about the HFEA's data security controls can be found in the Statement on Internal Control on page 59 of the HFEA's 2007/2008 Annual Report.

Longer term goals

The current 5 year corporate strategy (published as the HFEA´s Corporate Plan for 2004/09), has been regularly reviewed and updated to take into account new legislation and other events with a key impact on the HFEA´s role.

The current corporate goals, as set out below, were revised in 2006 to reflect the intention to create a Regulatory Authority for Tissue and Embryos (RATE), in or before 2009. However, in response to the Report from the Joint Committee on the Human Tissue and Embryos (draft) Bill, the Government subsequently withdrew the proposal to create RATE.

The HFEA intends to develop a new medium to long term strategy during the 2008/09 business year. This will set out fresh corporate strategic goals for the future, and will be informed by the legislative changes going through Parliament, and the HFEA´s Programme 2010 organisational development work programme.

Last updated: 24 July 2008