Julia Chain, Chair of the Human Fertilisation and Embryology Authority (HFEA)
The HFEA has been the UK's regulator of fertility treatment and embryo research for over 30 years, created to make policy and regulate standards as the fertility sector developed following the birth of the world’s first IVF baby, Louise Brown, in 1978. We are one of the few UK wide regulators, overseeing treatment in both the NHS and private sector.
It is a huge privilege to be a Board member of this internationally renowned and respected organisation and to be able to contribute to policy and licensing decisions in such an innovative and ethically contested area of medicine.
We are a small body with around 80 staff, but we monitor global scientific developments which could become patient treatment in the years to come, make policy and advise Ministers, Parliament, and Government, alongside our core functions of setting standards, licensing research projects and treatment clinics and maintaining a register of all UK fertility treatments, the largest database of its kind in the world.
We are mid-way through our strategy for 2025-2028 and you will have an opportunity to help oversee its delivery over the coming year and contribute to the development of our strategic thinking from 2028.
Your role as a Board member would be to actively participate on the Authority and in committee work as we support pioneering science and fertility medicine but, above all, do our utmost to uphold and improve standards in fertility treatment so that as many people as possible can achieve their much longed-for family. The HFEA is at the heart of creating life, and I am constantly reminded what a privileged role our Board members have and how interesting and rewarding our work is.
Our lay and professional Members bring a huge variety of experience and expertise to their role from genetics, fertility medicine, counselling, life sciences and research, communications and the media, faith, ethics, and the law. If you are successful in your application, you would have the chance to contribute your personal expertise towards our new vision. We want to see everyone receive the best possible care and the right information at the right time. As science and society advance, the HFEA needs to shape and respond to future changes in the legislative landscape and the changing fields of modern family creation, genetics, and artificial intelligence and the use of data.
I have chaired the HFEA since April 2021, and in this time, I have been impressed at the organisation’s reputation as a body that enables innovation to flourish within a robust ethical framework. The breadth of work the HFEA covers means the role of a Member is fascinating and your contribution could make a real difference to many people for years to come.
Catharine Seddon, Member of HFEA.
“For me, the HFEA board serves at the heart of creating life. As NEDS, our job, first and foremost, is to protect people at one of the most vulnerable times of their life: when they need help to achieve a much longed-for family. In all our work - whether raising standards in fertility care, licensing innovative treatments or making policy in ethically charged areas, I feel a huge sense of responsibility to the public and therefore an equal sense of reward. This Board really matters.”
Members are required to build and retain public and professional confidence in the regulation of fertility treatment and embryo research and to play a key part in the effective and successful governance of the HFEA.
The Human Fertilisation
and Embryology Authority (HFEA) is the UK-wide independent regulator for
fertility treatment and embryo research. The HFEA was established by the
Human Fertilisation and Embryology Act 1990 (the ‘Act’). The Act sets out
prohibitions relating to the creation, use, and storage of human embryos and
human admixed embryos, and the use and storage of human gametes.
In 2007, as a result of
the implementation of three EU Directives setting quality and safety standards
for human tissue and cells intended for human application, the HFEA’s remit was
extended to cover licensing and regulation of donation, procurement, testing,
processing, preservation and distribution of gametes and embryos. The UK’s exit
from the EU means that this relationship is changing going forward, although
the UK’s high standards will remain.
The HFEA has the power to
license the following activities in the course of providing fertility treatment
(for example, in vitro fertilisation (IVF)):
- bringing about the creation of a human embryo
outside the body;
- procuring, keeping, testing, processing or
distributing human embryos;
- procuring, keeping, testing, processing or
distributing gametes;
- using human embryos for training others in
embryological techniques;
- ensuring human embryos are in a suitable condition
to be used in treatment;
- placing human embryos in a woman;
- carrying out testing of sperm;
- other activities specified in regulations.
The HFEA can also license
activities as part of a project of research involving human embryos (and human
admixed embryos), provided they are necessary or desirable for:
- increasing knowledge about serious disease or other
serious medical conditions;
- developing treatments for serious disease or other
serious medical conditions;
- increasing knowledge about the causes of congenital
disease or congenital medical conditions;
- promoting advances in the treatment of infertility;
- increasing knowledge about the causes of
miscarriage;
- developing more effective techniques of
contraception;
- developing methods for detecting the presence of
gene, chromosome, or mitochondrion abnormalities in embryos before
implantation;
- increasing knowledge about the development of
embryos so long as the use of an embryo is necessary.
The HFEA can also grant
licences for the procurement and distribution of sperm while providing
non-medical fertility services and for the storage of gametes and embryos.
Ethical Safeguards
The Act contains several
ethical safeguards; some of which are described here. The principle of informed
consent is key in that gametes, embryos and other human tissue, the use of
which is governed by the Act, can only be used for treatment or research purposes
with the informed and clearly expressed consent of the person(s) providing the
tissue. Where such consent cannot be given, in a very limited number of
circumstances, use of the tissue can only take place if strict conditions can
be met.
The restrictions of the
use of human embryos in treatment and research and of particular techniques in
assisted reproduction underpin the licensing provisions in the Act.
Clinics must assess the
welfare of any child that might be born as a result of treatment, or any
existing child that may be affected, as part of the process of determining a
patient’s suitability for treatment.
Licensing and Inspection
There are currently 135
HFEA-licensed establishments providing treatments, related services, or
carrying out embryo research. Every licence designates an individual who has
the responsibility under the Act for the proper operation of the establishment
and its compliance with the Act, all licence conditions, and the HFEA’s Code
of Practice. This individual is described as the Person
Responsible.
The Act requires the HFEA
to carry out an inspection of all licensed establishments at least once every
two years. The HFEA inspection team evaluate and monitor:
- premises, equipment, and facilities;
- laboratory processes;
- documentation, including standard patient
information;
- the ability of the establishment to provide the
services it offers;
- the suitability of the person responsible and staff
providing the services.
As part of its licensing
function, the HFEA also assesses applications from establishments to use novel
or adjusted treatment techniques and to test embryos for the presence of
inheritable genetic conditions. Pre-implantation
genetic testing for monogenic disorders (PGT-M) is a technique used to screen embryos before
implantation, as part of an IVF treatment cycle, to exclude those with a
serious genetic condition. The procedure is intended to help couples at risk of
passing on a serious inheritable genetic condition to their offspring. None of
these activities can take place without the HFEA’s prior approval.
Linked to its regulatory
functions, the Act enables the HFEA to issue directions and requires it to
maintain a Code
of Practice setting out standards of practice for the delivery
of treatments, fertility services, and embryo research that all licensed
clinics and research centres are required to observe.
Key
non-licensing functions
There are a number of
functions carried out by the HFEA that are not part of the licensing process
but are integral to fulfilling the aims set out in legislation:
Maintaining
Registers: The Act requires the HFEA to keep registers,
notably one that records every treatment cycle, patient, gamete/embryo
donor and all resulting offspring. The Act also sets out
the circumstances in which identifying information held on this register may be
disclosed to third parties.
Sharing
research information: The administration of a scheme for
researchers to apply to receive access to identifying information held on the
treatment register where it is not practicable to obtain consent to the
disclosure from the persons to whom the information relates.
Providing
information: The HFEA has a statutory duty to provide a range
of information to stakeholders, including patients and licensed establishments.
The HFEA does this by:
- publishing advice and information for patients and
the public about fertility treatments and services, such as ratings for
treatment add-ons.
- providing information and guidance for licensed
establishments and healthcare professionals on topical issues via bulletins and
also Chair’s letters;
- responding to individual queries, verbally and in
writing, from the fertility and wider healthcare sectors and the public
The HFEA is funded by
licence fees, IVF treatment fees and a grant from UK central government with an
expenditure of over £7 million.
Further information on the HFEA and what it does can
be found at: https://www.hfea.gov.uk/about-us/
This post is regulated by the Commissioner for Public Appointments. For more information, please refer to the
Commissioner’s website 