HFEA Annual Report 2003/04 - Human Fertilisation and Embryology ...
HFEA Annual Report 2003/04 - Human Fertilisation and Embryology ...
HFEA Annual Report 2003/04 - Human Fertilisation and Embryology ...
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Facing up to the challenge<br />
<strong>HFEA</strong> <strong>Annual</strong> <strong>Report</strong> <strong>2003</strong>/<strong>04</strong>
Copyright <strong>Human</strong> <strong>Fertilisation</strong> <strong>and</strong> <strong>Embryology</strong> Authority 20<strong>04</strong>. First published 20<strong>04</strong>.<br />
This report covers the year to 31 August 20<strong>04</strong> with a forward look for the year to August 2005.
contents<br />
Chair’s Introduction 01<br />
Forward Look by the Chief Executive 03<br />
About the <strong>HFEA</strong> 05<br />
Licensing <strong>and</strong> inspection 07<br />
Information management 09<br />
Clinic audit 11<br />
Arm’s Length Bodies review 12<br />
Research 13<br />
Policy 15<br />
Communications 17<br />
Working together 19<br />
Appendices<br />
1. St<strong>and</strong>ing Committee Membership 21<br />
2. Centres licensed by the <strong>HFEA</strong> 22<br />
3. Clinical Inspectors 25<br />
4. Ongoing research projects licensed by the <strong>HFEA</strong> 27<br />
5. <strong>HFEA</strong> peer reviewers 29<br />
6. Members’ interests 31<br />
7. Performance indicators 35<br />
Accounts 40<br />
Supplementary statement by the Comptroller <strong>and</strong> Auditor General 47
<strong>HFEA</strong> <strong>Report</strong> | 01
Chair’s Introduction<br />
Leading the way<br />
In many democratic systems there is<br />
renewed debate about reproductive<br />
technologies. In Europe, there has been<br />
abrupt change in national policy in Italy<br />
where, following years of unregulated<br />
activity, highly restrictive legislation has<br />
been introduced. The debate in other<br />
countries, sometimes no less volatile, has<br />
mostly been about extending reproductive<br />
autonomy. The announcement of the first<br />
therapeutic cloning licence issued by the<br />
<strong>HFEA</strong> was global news. Embryonic stem<br />
cell research is even an issue in the US<br />
presidential election.<br />
While there is no universal agreement<br />
between, or indeed within, countries<br />
about many of the ethical dilemmas<br />
which assisted reproduction <strong>and</strong> embryo<br />
research generates, there is widespread<br />
admiration for the UK system of regulation<br />
<strong>and</strong> decision-making in this controversial<br />
field. Indeed, the last twelve months have<br />
seen several countries passing legislation<br />
introducing regulatory bodies akin to<br />
the <strong>HFEA</strong>.<br />
In all fields of medicine, independent<br />
regulatory oversight has replaced<br />
professional self-regulation. Reproductive<br />
medicine was the first area of medicine to<br />
be subject to the control of a regulatory<br />
body, the <strong>HFEA</strong>. Just as IVF was<br />
developed by UK scientists <strong>and</strong> clinicians,<br />
so too, we pioneered its regulation.<br />
That system of regulation is being<br />
continually updated <strong>and</strong> strengthened<br />
<strong>and</strong> we welcome the opportunity to work<br />
with the government on the forthcoming<br />
review of the <strong>Human</strong> <strong>Fertilisation</strong> &<br />
<strong>Embryology</strong> Act 1990.<br />
This annual report demonstrates how we<br />
are ensuring that in all our functions we<br />
remain fit for our complex purposes <strong>and</strong><br />
how we help improve services <strong>and</strong> patient<br />
<strong>and</strong> public confidence. I very much agree<br />
with the Lords Select Committee on the<br />
Constitution which stated in a report this<br />
year that ‘regulation is a means to an end,<br />
not an end in itself.’<br />
The <strong>HFEA</strong>’s regulatory purposes are<br />
clear. We inform <strong>and</strong> protect patients. We<br />
ensure that the uses of embryos (both in<br />
treatment <strong>and</strong> research) are suitable<br />
<strong>and</strong> within the purposes laid down by<br />
Parliament. We guide professionals in<br />
clinics day by day. We keep a register of<br />
all licensed treatment so that in time all<br />
people created by these treatments can<br />
find out information about their origins.<br />
We have put tremendous efforts this year<br />
into further improving our effectiveness,<br />
rigorousness <strong>and</strong> accountability, <strong>and</strong> to<br />
building confidence <strong>and</strong> underst<strong>and</strong>ing<br />
in our actions <strong>and</strong> decisions.<br />
The ability to create a human embryo<br />
outside the body, the technique started<br />
more than a quarter of a century ago <strong>and</strong><br />
responsible for the birth of more than one<br />
million babies worldwide, continues both<br />
to fascinate <strong>and</strong> challenge. Dem<strong>and</strong> for<br />
treatment increases by the year – as do<br />
success rates in UK clinics. Patients <strong>and</strong><br />
health commissioners are faced with<br />
wider <strong>and</strong> more complex treatment<br />
options. Increasingly they turn to the<br />
<strong>HFEA</strong> to inform <strong>and</strong> guide their choices.<br />
The Warnock report which recommended<br />
setting up the <strong>HFEA</strong> was published in<br />
1984. As the report observed:<br />
‘Society’s views on the new techniques<br />
were divided between pride in the<br />
technological achievement, pleasure at the<br />
new-found means to relieve, at least for<br />
some, the unhappiness of infertility, <strong>and</strong><br />
unease at the apparently uncontrolled<br />
advance of science, bringing with it new<br />
possibilities for manipulating the early<br />
stages of human development.’<br />
Twenty years on, the need for, <strong>and</strong><br />
dem<strong>and</strong>s on, the regulator have never<br />
been greater. The dedicated hard work of<br />
our headquarters’ staff <strong>and</strong> our inspectors<br />
<strong>and</strong> auditors in the field means that this<br />
year we have made very significant<br />
progress in our modernisation programme.<br />
Always a leader in our field, we are striving<br />
for continual improvement.<br />
Suzi Leather<br />
Chair<br />
<strong>HFEA</strong> <strong>Report</strong> | 02
<strong>HFEA</strong> <strong>Report</strong> | 03
Forward Look by the Chief Executive<br />
Where we go from here<br />
The pages that follow show the<br />
tremendous strides the <strong>HFEA</strong> has made<br />
in the past year. As ever these have<br />
been driven by our commitment to<br />
ensuring the wellbeing of those who<br />
turn to the clinics we oversee for help<br />
in conceiving a baby <strong>and</strong> to the many<br />
families created as a result.<br />
We are proud of the role we play in striving<br />
for patient <strong>and</strong> child safety <strong>and</strong> of the<br />
achievements we have made in improving<br />
our extremely high st<strong>and</strong>ards of practice<br />
even further. These include streamlining<br />
our inspection process, introducing<br />
unannounced inspections <strong>and</strong> issuing new<br />
guidance about adding alarm systems to<br />
the storage vessels in which eggs, sperm<br />
<strong>and</strong> embryos are frozen to reduce the<br />
likelihood of their loss if the vessels fail.<br />
Our new Alert system, which provides<br />
a process for clinics to report mistakes,<br />
is now firmly in place, enabling lessons<br />
learned to be shared quickly to minimise<br />
the risk of the same thing happening<br />
again. Our information management<br />
system has also greatly improved, with<br />
the introduction of the New Data Register<br />
<strong>and</strong> Centres Database, to help safeguard<br />
the information that people give us.<br />
The substantial modernisation of our<br />
organisation has resulted in more effective<br />
performance, greater transparency <strong>and</strong><br />
an improved dialogue with the public.<br />
Our introduction of open meetings that<br />
anyone can attend has been very well<br />
received. We also consulted extensively<br />
with the public in the process of updating<br />
our Code of Practice, compiling our<br />
report on sex selection <strong>and</strong> strengthening<br />
our guidelines on two-embryo transfer.<br />
With these successes firmly under our belt<br />
we look forward to achieving even more in<br />
the coming year. We will continue to focus<br />
on our objectives of strong, effective,<br />
efficient regulation of IVF treatment <strong>and</strong><br />
embryo research, improving the way we<br />
communicate <strong>and</strong> investing in the crucial<br />
development of our information systems.<br />
In the year ahead we will face many new<br />
challenges. These include the EU Tissue<br />
Directive, the review of the 1990 HFE Act<br />
<strong>and</strong> the lifting of donor anonymity. In<br />
addition, we will be working closely with<br />
the <strong>Human</strong> Tissue Authority (which is<br />
soon to be set up) as we look ahead to<br />
the creation of a new Regulatory Authority<br />
for Fertility <strong>and</strong> Tissue.<br />
Like many people in the <strong>HFEA</strong>, I am<br />
continually inspired by our role of<br />
protecting the health <strong>and</strong> safety of so<br />
many prospective mothers, fathers <strong>and</strong><br />
children, <strong>and</strong> by the need to ensure that<br />
the decisions we make about IVF <strong>and</strong><br />
embryo research are right for society as<br />
a whole.<br />
I feel confident that the <strong>HFEA</strong> has never<br />
been in a stronger position to meet the<br />
challenges that lie ahead <strong>and</strong> to realise<br />
its many necessary, ambitious <strong>and</strong><br />
achievable goals in 20<strong>04</strong>/05.<br />
Angela McNab<br />
Chief Executive<br />
Financial statements<br />
The financial statements on pages 48 to<br />
62 together with the foreword <strong>and</strong> other<br />
statements on pages 41 to 46 <strong>and</strong> the<br />
Certificate <strong>and</strong> <strong>Report</strong> of the Comptroller<br />
<strong>and</strong> Auditor General on page 47,<br />
reproduce in full those included in the<br />
Accounts for the <strong>HFEA</strong> for <strong>2003</strong>/<strong>04</strong> laid<br />
before the House of Commons on 21<br />
July 20<strong>04</strong> under reference HC962.<br />
Pages 1 to 38 of this <strong>Annual</strong> <strong>Report</strong><br />
provide additional information for which I<br />
am responsible, that is not included with<br />
those accounts. The Auditor is required<br />
by auditing st<strong>and</strong>ards to read other<br />
information in documents containing<br />
audited financial statements <strong>and</strong> to<br />
consider the implications for his audit<br />
opinion. A supplementary statement<br />
has accordingly been provided by the<br />
Comptroller <strong>and</strong> Auditor General at page<br />
47 in respect of his reading of the<br />
additional information.<br />
<strong>HFEA</strong> <strong>Report</strong> | <strong>04</strong>
About the <strong>HFEA</strong><br />
Regulating the creation of life<br />
The birth of the first ‘test tube’ baby,<br />
Louise Brown, in 1978 established<br />
the UK as a world leader in assisted<br />
reproductive technology (ART) <strong>and</strong><br />
provoked a storm of debate that<br />
continues to this day.<br />
The debate was to lead to the passing of<br />
the <strong>Human</strong> <strong>Fertilisation</strong> <strong>and</strong> <strong>Embryology</strong><br />
(HFE) Act in 1990. Out of this was<br />
established, a year later, the <strong>Human</strong><br />
<strong>Fertilisation</strong> <strong>and</strong> <strong>Embryology</strong> Authority<br />
(<strong>HFEA</strong>), the first assisted reproduction<br />
regulatory body in the world.<br />
The world of assisted reproduction has<br />
changed dramatically since 1991. New<br />
developments in science <strong>and</strong> medicine,<br />
the rising numbers seeking fertility<br />
treatment <strong>and</strong> changes in government<br />
policy have placed growing <strong>and</strong> complex<br />
dem<strong>and</strong>s on us. But now, as then, our<br />
aim is to balance scientific <strong>and</strong> medical<br />
advances against the need to safeguard<br />
people seeking help to have a family, the<br />
embryos they create <strong>and</strong> the children<br />
they hope to have.<br />
Who are we?<br />
The <strong>HFEA</strong> is made up of 18 members<br />
appointed by the UK government <strong>and</strong> a<br />
staff of around 100 who are responsible<br />
for running the organisation day to day.<br />
To ensure our independence <strong>and</strong><br />
objectivity, in accordance with the HFE<br />
Act, our chair, deputy chair <strong>and</strong> at least<br />
half our members are lay people drawn<br />
from disciplines such as the law,<br />
management, sociology, philosophy <strong>and</strong><br />
religion, as well as patient representatives,<br />
rather than clinicians <strong>and</strong> scientists<br />
involved in human embryo research<br />
or fertility treatment.<br />
What do we do?<br />
Our job is to license <strong>and</strong> monitor all<br />
clinics or centres carrying out IVF <strong>and</strong>/or<br />
donor insemination <strong>and</strong> embryo research<br />
to ensure that the principles of the HFE<br />
Act are upheld. We also regulate the<br />
storage of sperm, eggs <strong>and</strong> embryos.<br />
To achieve this we:<br />
• create, update <strong>and</strong> enforce a Code of<br />
Practice which gives clear operational<br />
<strong>HFEA</strong> <strong>Report</strong> | 05<br />
guidelines to fertility clinics<br />
• keep a register of patients <strong>and</strong> the<br />
result of treatments they received, the<br />
details of any donor involved <strong>and</strong> the<br />
children who are born<br />
• inform <strong>and</strong> advise patients, donors <strong>and</strong><br />
clinics about fertility treatments <strong>and</strong> the<br />
issues they raise<br />
• keep abreast of developments in<br />
the field of embryo <strong>and</strong> reproductive<br />
research to ensure any progress made<br />
is in everyone’s best interests before it<br />
is adopted<br />
Where are we going?<br />
To ensure that we remain efficient,<br />
focused <strong>and</strong> responsive in the complex<br />
<strong>and</strong> rapidly changing world of<br />
reproductive technology, we have<br />
developed a five-year Corporate Plan<br />
(20<strong>04</strong>/2009), which serves as a<br />
touchstone for everything we do.<br />
The plan was created with the<br />
involvement <strong>and</strong> insights of patients,<br />
scientists <strong>and</strong> healthcare professionals,<br />
<strong>and</strong> agreed by the Department of Health<br />
<strong>and</strong> will be used to measure our<br />
effectiveness.<br />
The seven strategic goals that we<br />
are committed to achieving include:<br />
• building <strong>and</strong> strengthening our role<br />
as the UK’s regulator of IVF <strong>and</strong><br />
human embryo research<br />
• encouraging partnerships with all<br />
those with a stake in IVF <strong>and</strong> the<br />
<strong>HFEA</strong>, <strong>and</strong> communicating with them<br />
in a clear, open way<br />
• working closely with other regulators<br />
<strong>and</strong> international agencies to share<br />
knowledge <strong>and</strong> expertise<br />
• making our process of policy<br />
development stronger <strong>and</strong> even more<br />
effective in meeting <strong>and</strong> anticipating<br />
change<br />
• developing a robust information<br />
system to protect the privacy <strong>and</strong><br />
interests of patients, donors, children<br />
born as a result of fertility treatments<br />
<strong>and</strong> other stakeholders at the same<br />
time as feeding into our regulatory<br />
<strong>and</strong> public health functions<br />
• supporting the development of<br />
research in assisted reproduction<br />
from laboratory to clinic<br />
• growing a strong, businesslike<br />
organisation that can achieve all<br />
these goals with maximum efficiency.<br />
The year ahead<br />
In the past year we have made excellent<br />
progress in modernising our organisation<br />
<strong>and</strong> are now ready to build on that<br />
success. Our starting point is our 20<strong>04</strong>/05<br />
Business Plan. This mirrors our key<br />
objectives of improving our regulatory<br />
performance, communicating clearly <strong>and</strong><br />
openly with stakeholders <strong>and</strong> transforming<br />
our information base.
Looking forward<br />
In the next year we will be:<br />
• Strengthening our position. We will<br />
ensure we are in a strong position to<br />
meet new challenges including working<br />
towards the creation of the new<br />
Regulatory Authority for Fertility <strong>and</strong><br />
Tissue, implementing the EU Tissue<br />
Directive, the review of the 1990 HFE<br />
Act; <strong>and</strong> lifting donor anonymity<br />
• Improving regulation. We will<br />
continue to improve the effectiveness<br />
<strong>and</strong> efficiency of the way we regulate<br />
clinics. This includes intensifying clinic<br />
inspections <strong>and</strong> employing<br />
unannounced inspections, particularly<br />
where there is evidence of risk<br />
• Enhancing information management.<br />
We aim to achieve even greater<br />
accuracy <strong>and</strong> efficiency in collecting<br />
<strong>and</strong> managing information in order<br />
to give patients <strong>and</strong> the public the<br />
information they need through our<br />
updated IT <strong>and</strong> information<br />
management systems<br />
• Tuning in to our stakeholders.<br />
We will be listening to the voices of<br />
patients <strong>and</strong> the public to ensure that<br />
they are heard <strong>and</strong> included in our<br />
decision making processes<br />
• Increasing patient safety. We will be<br />
creating new policies with patient safety<br />
in mind, based both on sound ethical<br />
judgements <strong>and</strong> on the hard evidence.<br />
Money matters<br />
During <strong>2003</strong>/<strong>04</strong> we received income<br />
of £7.5 million from the Department of<br />
Health <strong>and</strong> from centres for treatment<br />
<strong>and</strong> research. This funded our normal<br />
operations <strong>and</strong> our modernisation<br />
programme. Turn to pages 40 to 62<br />
for full details.<br />
<strong>HFEA</strong> <strong>Report</strong> | 06
Licensing <strong>and</strong> inspection<br />
Protecting patients <strong>and</strong> their children<br />
All those who turn to a fertility clinic<br />
for help in having a family need to feel<br />
confident that they will be well cared for,<br />
that the treatments <strong>and</strong> services they<br />
receive will be of the highest st<strong>and</strong>ard<br />
<strong>and</strong> that the risks of anything going<br />
wrong are minimal.<br />
In <strong>2003</strong>/<strong>04</strong> we continued to improve the<br />
rigour of our inspection <strong>and</strong> licensing<br />
processes to ensure that the clinics we<br />
regulate are safe, professional <strong>and</strong> well<br />
managed <strong>and</strong> meet the real needs of<br />
people seeking fertility treatment.<br />
Maintaining st<strong>and</strong>ards of excellence<br />
The UK is acknowledged as one of the<br />
safest places in the world to seek fertility<br />
treatment. The bedrock on which this<br />
high reputation rests is the requirement,<br />
laid down by law, that all clinics offering<br />
IVF or donor insemination <strong>and</strong> related<br />
activities such as sperm, egg <strong>and</strong> embryo<br />
storage or research be licensed <strong>and</strong><br />
regularly inspected by the <strong>HFEA</strong>.<br />
At the heart of the licensing <strong>and</strong><br />
inspection process is our team of 75 parttime<br />
inspectors. These include clinicians,<br />
scientists, embryologists, counsellors,<br />
psychologists, nurses <strong>and</strong> other experts<br />
whose job it is to make sure that new <strong>and</strong><br />
existing clinics meet the high professional<br />
st<strong>and</strong>ards that their clients have a right<br />
to expect.<br />
In the past year we have set up training<br />
programmes for all our inspectors to<br />
ensure that they have the up-to-date<br />
knowledge <strong>and</strong> skills needed to assess<br />
clinics <strong>and</strong> limit the risks to patients.<br />
We have established a team of full-time<br />
regulatory managers to manage<br />
inspections <strong>and</strong> ensure they are<br />
systematic, consistent <strong>and</strong> rigorous.<br />
Keeping a close watch<br />
When a clinic first applies to be licensed,<br />
an inspection team visits to assess its<br />
staff <strong>and</strong> facilities <strong>and</strong> check that they are<br />
adequate. We look at examination rooms,<br />
laboratories <strong>and</strong> equipment to ensure that<br />
they are clean, comfortable <strong>and</strong> safe <strong>and</strong><br />
that procedures for h<strong>and</strong>ling sperm, eggs<br />
<strong>and</strong> embryos are safe. Just as importantly,<br />
we look at the care <strong>and</strong> support patients<br />
<strong>HFEA</strong> <strong>Report</strong> | 07<br />
receive – everything from the qualifications<br />
<strong>and</strong> experience of staff to the availability of<br />
counselling <strong>and</strong> the kind of information<br />
provided. Scrutiny includes how fertility<br />
drugs are administered <strong>and</strong> how doctors<br />
moderate drug regimens to avoid<br />
problems such as over-stimulation of the<br />
ovaries. This can take one to two days<br />
depending on the size <strong>and</strong> type of the<br />
centre. The team’s report is then referred<br />
to one of our licence committees, who<br />
decide whether to grant a licence.<br />
Initially, licences are granted for a year<br />
<strong>and</strong> renewed annually after a satisfactory<br />
inspection, usually for three years. A<br />
three-year licence may then be granted<br />
if the cllinic has been operating to the<br />
required st<strong>and</strong>ard. Clinics with a threeyear<br />
licence continue to be inspected<br />
annually. Inspections have usually been<br />
booked six months in advance to give<br />
centres <strong>and</strong> inspection teams time<br />
to prepare.<br />
But in order to reduce risk still further, we<br />
have introduced a system of spot checks.<br />
In the past year we carried out three of<br />
these. Their purpose is to assess any<br />
potential problems <strong>and</strong> check that the<br />
information clinics have provided us with<br />
is accurate. Where follow-up is needed<br />
we are able to examine all the information<br />
we hold internally <strong>and</strong> crosscheck this<br />
against such factors as the number of<br />
adverse incidents <strong>and</strong> patient complaints.<br />
Involving patients<br />
In <strong>2003</strong> we piloted three schemes<br />
designed to identify how best to involve<br />
one of our most important stakeholders,<br />
people using fertility services, in helping<br />
us to assess the quality of the clinics.<br />
The results of our consultations showed<br />
that, while the vast majority of those<br />
undergoing treatment were positive<br />
about the care <strong>and</strong> treatment they<br />
received, some were concerned about<br />
how information was given <strong>and</strong> its timing.<br />
As a result we specifically addressed this<br />
issue in our subsequent inspections.<br />
In June 20<strong>04</strong> we started to ask<br />
patients at fertility clinics to complete<br />
a questionnaire about their experience<br />
of care at the centre. We also put an<br />
electronic version of the questionnaire<br />
on our web site for people to complete.<br />
This will help ensure that we stay in<br />
touch with the needs of individuals<br />
as they go through fertility treatment.<br />
Learning from experience<br />
Mistakes can happen in any area of life,<br />
but where fertility treatment is concerned<br />
the consequences of human or mechanical<br />
error can be devastating. What if an<br />
embryologist drops a precious embryo,<br />
for example? What if the liquid nitrogen<br />
in which frozen embryos are stored is not<br />
kept at the proper temperature? Or what<br />
if the unthinkable happens <strong>and</strong> a woman<br />
is inseminated with the wrong sperm or<br />
embryos get mixed up?<br />
In the past year we have strengthened<br />
our procedure for dealing with adverse<br />
incidents <strong>and</strong> put in place a new Incident<br />
Alert System to warn clinics, inspectors<br />
<strong>and</strong> professional bodies, such as The<br />
British Fertility Society <strong>and</strong> Association<br />
of Clinical Embryologists about potential<br />
or actual dangers to minimise the risk of<br />
a repetition.<br />
Where an incident has occurred we aim to<br />
work with the clinic <strong>and</strong>, when appropriate,<br />
professional organisations to work out<br />
what went wrong <strong>and</strong> why. We have<br />
appointed a Head of Clinical Governance<br />
<strong>and</strong> Patient Safety responsible for making<br />
sure that all incidents are thoroughly<br />
investigated <strong>and</strong> an Alert is issued to all<br />
the clinics we regulate where there are<br />
opportunities to learn from mistakes.<br />
The new system, which we believe is the<br />
first of its kind in use within the IVF world,<br />
has been widely welcomed <strong>and</strong> has led<br />
to an improved dialogue with centres<br />
regarding areas of possible risk. This will<br />
help us reduce the chances of harm to<br />
sperm, eggs, embryos or people seeking<br />
fertility treatment <strong>and</strong> their families to as<br />
low a level as possible.
Licensed centres <strong>and</strong> treatments<br />
Type of <strong>HFEA</strong> Licensed Centre Number of centres (as at 31 August 20<strong>04</strong>)<br />
Treatment only 2<br />
Storage only 9<br />
Treatment with Storage 73<br />
Treatment with Storage <strong>and</strong> Research 17<br />
Research Only 7<br />
<strong>HFEA</strong> Licensed Treatments<br />
Storage of Eggs (including ovarian tissue) 21<br />
Storage of Sperm (including testicular tissue) 99<br />
Storage of Embryos 75<br />
DI 90<br />
IVF 75<br />
ICSI 74<br />
PGD 8<br />
Preimplantation Genetic Screening 8<br />
The terms<br />
DI – Donor insemination<br />
Where sperm donated by a man other than the woman’s partner are inserted into<br />
the vagina, cervix or uterus.<br />
ICSI – Intracytoplasmic Sperm Injection<br />
A type of IVF that involves injecting a single sperm straight into an egg.<br />
IVF – In vitro fertilization<br />
The technique that involves fertilising human eggs with sperm outside the body<br />
before transferring the resulting embryos into the woman.<br />
PGD – Preimplantation Genetic Diagnosis<br />
A technique used to detect whether an embryo created by IVF is carrying an inherited<br />
genetic defect that will cause a serious genetic disorder.<br />
PGS – Preimplantation Genetic Screening for Aneuploidy<br />
A procedure offered to patients thought to be at a higher than average risk of having<br />
a baby with a chromosomal abnormality in order to reduce the risk of miscarriage <strong>and</strong><br />
help them have a healthy baby. It involves removing one or two cells from an embryo<br />
for testing to ensure the number of chromosomes is correct (euploidy) <strong>and</strong> not more<br />
or less than usual (aneuploidy). Only embryos with the correct number are replaced.<br />
> Looking forward<br />
In the next year we will be:<br />
• Introducing new protocols. We are<br />
consistently looking to improve our<br />
current inspection processes <strong>and</strong> are<br />
now introducing new protocols for all<br />
planned inspections.<br />
• Doing more spot checks.<br />
We intend to increase the number<br />
of unannounced inspections to<br />
eight – four at r<strong>and</strong>om <strong>and</strong> four of<br />
‘at risk’ clinics<br />
• Underst<strong>and</strong>ing the fertility<br />
journey better. We are increasing our<br />
involvement with patients during<br />
inspections <strong>and</strong> in developing our<br />
methods of working to help<br />
underst<strong>and</strong> their views on the quality<br />
of treatment provided.<br />
• Increasing collaboration. Where a<br />
unit has to be inspected both by the<br />
<strong>HFEA</strong> <strong>and</strong> another regulatory body<br />
such as the Healthcare Commission,<br />
we are investigating how we can<br />
collaborate to reduce duplication<br />
of time <strong>and</strong> effort.<br />
“The <strong>HFEA</strong>’s introduction of a system of<br />
incident reporting is, in my view, a major<br />
step forward in the management of risk in<br />
licensed centres. While no system will ever<br />
be totally error free, it is something that we<br />
all should strive for. If things do subsequently<br />
go wrong, we should have the knowledge<br />
that we have the appropriate support to<br />
manage the situation effectively <strong>and</strong><br />
knowledge that others will ultimately learn<br />
from our misfortune. The incident reports<br />
now circulated by the <strong>HFEA</strong> allow this to<br />
happen in a positive way by providing key<br />
details of events <strong>and</strong> making appropriate<br />
recommendations – while protecting the<br />
identity of the centre concerned. We should<br />
be reassured that, over time, it may be able<br />
to spot trends <strong>and</strong> common themes in<br />
incidents that will lead to developments in<br />
technology or improvements to training<br />
programmes. I hope that this will encourage<br />
staff to embrace the culture of reporting.”<br />
Allan Pacey,<br />
Senior Lecturer in Andrology University<br />
of Sheffield <strong>and</strong> Head of Andrology for<br />
Sheffield Teaching Hospitals.<br />
<strong>HFEA</strong> <strong>Report</strong> | 08
Information management<br />
Protecting rights <strong>and</strong> guarding st<strong>and</strong>ards<br />
The information we hold can help underpin<br />
important policy decisions <strong>and</strong> enable us<br />
to monitor clinic performance more<br />
effectively. But it is crucial that the details<br />
we are entrusted with concerning IVF<br />
treatments, their results <strong>and</strong> in particular<br />
the source of donated sperm, eggs <strong>and</strong><br />
embryos are kept safe <strong>and</strong> confidential.<br />
In <strong>2003</strong>/<strong>04</strong> we have made considerable<br />
progress in updating our information<br />
systems to ensure they are robust,<br />
comprehensive <strong>and</strong> adaptable to current<br />
<strong>and</strong> future needs.<br />
Who’s who?<br />
The knowledge that one day, any child<br />
born as a result of a donated egg or<br />
sperm may come to the <strong>HFEA</strong> <strong>and</strong><br />
ask if they are related to someone they<br />
are about to marry is central to our<br />
information policy. The need to be able<br />
to answer questions such as this with<br />
absolute accuracy has driven our<br />
commitment to developing a reliable,<br />
comprehensive Data Register, which<br />
was introduced last year.<br />
Now, for the first time ever, all our data<br />
is held in one place from the time it is<br />
generated. A rigorous verification system<br />
has been created to crosscheck all data<br />
transfers <strong>and</strong> entries from both old <strong>and</strong><br />
current records to ensure their accuracy<br />
before acceptance. As a result we can<br />
reliably trace people, the treatment<br />
service they used, <strong>and</strong> the outcome.<br />
Most importantly of all we can identify<br />
the children who resulted <strong>and</strong> the donors<br />
who helped to create them. All of this<br />
information is kept confidentially<br />
<strong>and</strong> securely.<br />
Performance <strong>and</strong> policy<br />
To help ensure the quality <strong>and</strong> safety<br />
of treatments, we can use the Register<br />
to check whether a clinic is offering only<br />
those services it is licensed to carry out,<br />
<strong>and</strong> to monitor clinic performance<br />
in general.<br />
The Register can also help inform policy<br />
decisions. For example, it can produce<br />
evidence about the number of embryos<br />
being replaced in relation to a woman’s<br />
age to help identify the optimum number<br />
<strong>HFEA</strong> <strong>Report</strong> | 09<br />
needed to provide the best chance of a<br />
pregnancy without increasing the risk of<br />
a multiple birth.<br />
Watching over clinics<br />
This year saw the development <strong>and</strong><br />
introduction of our new Centres Database,<br />
which holds detailed information about<br />
every licensed clinic in the UK. <strong>HFEA</strong> staff<br />
can now access details about inspections,<br />
treatments, staff, management issues,<br />
licenses <strong>and</strong> assessments at any clinic,<br />
instantly. This not only saves time, it also<br />
helps protect patients by enabling<br />
incidents to be reported quickly, so they<br />
can be fed into our Incident Alert system<br />
(refer to page 7).<br />
Utilising the Internet<br />
In order to be able to trace donors <strong>and</strong><br />
children who are born as a result, it is<br />
essential that we gather accurate<br />
information about patients, the treatment<br />
they received <strong>and</strong> details about sperm, egg<br />
or embryo donation from the clinics, which<br />
we can input into the Data Register. Until<br />
now this has largely been a paper-based<br />
process. To help speed the accuracy <strong>and</strong><br />
efficiency of the system, we have been<br />
developing Electronic Data Interchange<br />
(EDI) software since January 20<strong>04</strong>. This<br />
will be piloted in a h<strong>and</strong>ful of centres<br />
during the autumn <strong>and</strong> winter of 2005.<br />
Using Electronic Data Interchange,<br />
centres will be able to key vital patient<br />
<strong>and</strong> donor information directly <strong>and</strong> send<br />
it via a secure Internet connection to our<br />
centrally controlled Data Register.<br />
This will not only save time <strong>and</strong> money<br />
but most importantly it will reduce the<br />
possibility of error, <strong>and</strong> help keep patient,<br />
treatment <strong>and</strong> donor information safe<br />
<strong>and</strong> sound.<br />
Belts <strong>and</strong> braces<br />
To make absolutely certain that every<br />
piece of information we hold is as<br />
accurate as we can make it we have<br />
launched the Historic Audit Project. This<br />
massive review involves comparing key<br />
information about donors, patients,<br />
treatments <strong>and</strong> births we have received<br />
from clinics with the information that they<br />
hold to double check its authenticity <strong>and</strong><br />
fill in any gaps. In many cases this means<br />
going back to original medical records to<br />
confirm the details currently held on the<br />
Data Register.<br />
Although this is an enormous undertaking,<br />
we believe it is extremely important for the<br />
emotional wellbeing of children born from<br />
donated eggs <strong>and</strong> sperm to be able to<br />
trace their genetic origins. While donor<br />
details registered to date remain<br />
confidential by law (there are new<br />
regulations lifting anonymity for donors<br />
registering from 1 April 2005), we are able<br />
to tell people if they have been conceived<br />
as a result of a donation when they are 18<br />
years old (or 16 if wishing to marry).<br />
Pilots of the project are already running,<br />
with roll out scheduled for late 20<strong>04</strong> <strong>and</strong><br />
completion by March 2006.
Our Directory goes live<br />
Our comprehensive “<strong>HFEA</strong> Directory of<br />
Clinics: Your Guide to Infertility” (see<br />
page 17) includes a wide range of useful<br />
information about infertility treatments in<br />
the UK, including the contact details of<br />
every registered clinic.<br />
This year we have begun work on the next<br />
edition, to be launched in Spring 2005,<br />
that will be available in a paper <strong>and</strong> webbased<br />
form. It will include a search facility<br />
that will provide statistical information to<br />
help answer patients’ questions quickly,<br />
easily <strong>and</strong> in a more tailored way. For<br />
instance, a patient would be able to<br />
search for their nearest clinics by postcode<br />
<strong>and</strong> compare the different services on<br />
offer. They could also find out the number<br />
of patients each clinic has treated over a<br />
> Looking forward<br />
In the next year we will be:<br />
• Achieving openness. Having<br />
invested in the necessary systems<br />
<strong>and</strong> personnel, we will be introducing<br />
new procedures to ensure we are<br />
ready for the Freedom of Information<br />
Act which comes into force in January<br />
2005. This will require us to be able<br />
to provide information about our<br />
operations upon request within 20<br />
working days.<br />
• Opening the record. Our Information<br />
Management team will be looking at<br />
how we capture <strong>and</strong> track requests<br />
for information from people born as<br />
a result of fertility treatment about<br />
their origins quickly <strong>and</strong> efficiently<br />
<strong>and</strong> then respond to them sensitively<br />
<strong>and</strong> confidentially.<br />
• Monitoring research. We will<br />
be researching <strong>and</strong> assessing new<br />
referencing systems for tracking<br />
sperm, eggs <strong>and</strong> embryos used in<br />
research, such as bar coding <strong>and</strong><br />
Radio Frequency Identification<br />
(RFID), to improve our tight controls<br />
within Centres in order to meet<br />
the requirements of the EU<br />
Tissue Directive.<br />
year, how old those patients were, <strong>and</strong><br />
what the outcome of each kind of licensed<br />
treatment was for different age groups.<br />
We have been working with patient<br />
focus groups, patient organisations<br />
<strong>and</strong> clinicians to establish what kind of<br />
statistical information is of most value<br />
to patients to help them make informed<br />
decisions about where they would like<br />
to be treated <strong>and</strong> to have some<br />
underst<strong>and</strong>ing of their chances of<br />
a successful pregnancy.<br />
Statistics for each clinic will also be<br />
included in future editions so that<br />
prospective patients can see which clinic in<br />
their area may give them the best chance<br />
of having a baby, depending on their age<br />
<strong>and</strong> the type of treatment they are seeking.<br />
“In clinics, we have huge amounts of<br />
paperwork to h<strong>and</strong>le <strong>and</strong> obviously this is<br />
very time-consuming. At the same time, it is<br />
important that appropriate records are kept<br />
as accurately as possible. The electronic<br />
data interchange system for information<br />
required by the <strong>HFEA</strong> will significantly<br />
reduce the administrative burden on staff<br />
here by reducing the amount of form filling<br />
by h<strong>and</strong> <strong>and</strong> duplication onto our database.<br />
This should improve the accuracy of data<br />
entry. In the long term this can only be<br />
beneficial to patients.”<br />
Dr Jane Stewart,<br />
Consultant Gynaecologist,<br />
Newcastle Fertility Centre.<br />
<strong>HFEA</strong> <strong>Report</strong> | 10
Clinic audit<br />
Fostering trust <strong>and</strong> accountability<br />
Which fertility clinic should we choose?<br />
And which treatment is most likely to<br />
help us have a child? These are among<br />
the many questions couples ask <strong>and</strong> we<br />
seek to answer through our clinic audits.<br />
In <strong>2003</strong>/<strong>04</strong> we continued to develop<br />
our auditing processes, working in<br />
collaboration with other teams within the<br />
<strong>HFEA</strong>, to make certain that all the details<br />
we hold about treatments <strong>and</strong> patients<br />
are full <strong>and</strong> accurate.<br />
Meeting the need to know<br />
It is vital that the information we hold<br />
about the origins of people born as a<br />
result of fertility treatment <strong>and</strong> about the<br />
numbers of treatments performed <strong>and</strong><br />
their success rates is reliable if we are<br />
to provide answers to people seeking<br />
treatment <strong>and</strong> their offspring, <strong>and</strong><br />
meaningful figures about the efficacy<br />
<strong>and</strong>/or safety of various assisted<br />
conception techniques. Accurate<br />
information also aids us in the collection<br />
of the correct licence fees from clinics<br />
<strong>and</strong> can help inform legislation on<br />
assisted conception.<br />
In the past year we have been improving<br />
our Operational Audit, which looks<br />
at current data about patients <strong>and</strong><br />
treatments, cross checking forms sent in<br />
by clinics for the <strong>HFEA</strong> Register against<br />
patients’ records taken by clinics at the<br />
time of treatment to make sure they<br />
concur. We carried out visits to 40<br />
centres under our operational audit cycle<br />
to assess the completeness of reporting<br />
of treatment cycles <strong>and</strong> check the<br />
accuracy of <strong>HFEA</strong> form completion in<br />
order to help avoid significant inaccuracies,<br />
errors or omissions in the information<br />
contained in our Register.<br />
We have also been busy planning <strong>and</strong><br />
piloting audits for our ambitious Historic<br />
Audit Project, which will verify all data on<br />
IVF births from 1991 to 2002 (see page<br />
9). A new Head of Audit for the project<br />
has been appointed <strong>and</strong> a trial team of<br />
auditors has now started, with further<br />
teams to be recruited imminently.<br />
> Looking forward<br />
In the next year we will be:<br />
• Advancing our historic audit. Now<br />
staff are in place we intend to focus<br />
on our audit of all information since<br />
1991. This will enable us to answer<br />
questions that we may under the<br />
HFE Act be asked, such as ‘Was I<br />
conceived through IVF using donated<br />
gametes?’ <strong>and</strong> ‘Am I related to this<br />
person I am thinking of marrying?’<br />
• Sharing best practice. Improving<br />
clinics’ information systems will benefit<br />
the Registry, too. In the course of our<br />
audit visits, we will seek to identify<br />
best practice on administrative <strong>and</strong><br />
information systems <strong>and</strong> share this<br />
with all <strong>HFEA</strong>-licensed clinics.<br />
<strong>HFEA</strong> <strong>Report</strong> | 11
Arm’s Length Bodies review<br />
Shaping the future<br />
Since 1991 we can justly claim to have<br />
led the world in regulating the complex<br />
<strong>and</strong> ethically sensitive area of assisted<br />
reproduction. In 20<strong>04</strong> we welcomed the<br />
news that our work will continue under<br />
the auspices of a new regulatory body<br />
that will be established in the future to<br />
license <strong>and</strong> monitor treatment <strong>and</strong><br />
research involving human tissue.<br />
Tomorrow’s medicine<br />
Treatments such as bone marrow<br />
transplants for leukaemia <strong>and</strong> skin cell<br />
grafts for burns already make use of<br />
human cells <strong>and</strong> tissues. And the rapid<br />
pace of scientific discovery means that,<br />
in future, tissues <strong>and</strong> cells (including<br />
embryonic stem cells) will play an<br />
increasingly important role in diagnosing<br />
<strong>and</strong> treating disease. Tissue engineering<br />
<strong>and</strong> cell replacement therapy for<br />
conditions such as diabetes, heart failure<br />
<strong>and</strong> spinal cord injury will become a reality.<br />
These prospective developments raise<br />
a whole new area of ethics <strong>and</strong> law.<br />
Unlike organs such as the heart <strong>and</strong><br />
lungs, which have to be transplanted<br />
immediately, tissues <strong>and</strong> cells can be<br />
stored in banks until they are ready to<br />
be used, a prospect which raises<br />
obvious issues of safety.<br />
It is against this backdrop that we learnt,<br />
in July 20<strong>04</strong>, that we are to become part<br />
of a new body charged with regulating<br />
treatments <strong>and</strong> research involving human<br />
tissues <strong>and</strong> cells including sperm, eggs<br />
<strong>and</strong> embryos, blood, organs <strong>and</strong> other<br />
materials in order to assure their safety<br />
<strong>and</strong> quality.<br />
Joining our strengths<br />
The new body to be known as the<br />
Regulatory Authority for Fertility <strong>and</strong><br />
Tissue (RAFT) will be formed by a<br />
merger between ourselves <strong>and</strong> the<br />
<strong>Human</strong> Tissue Authority (HTA). The HTA<br />
will be established following the passing<br />
of the <strong>Human</strong> Tissue Bill, currently<br />
before parliament. The creation of<br />
RAFT will need primary legislation. The<br />
reconfiguration makes sense in light of<br />
the many common areas we share with<br />
the proposed HTA, such as our remit to<br />
regulate <strong>and</strong> monitor an ethically<br />
sensitive area of medicine <strong>and</strong> to ensure<br />
the safety <strong>and</strong> quality of both research<br />
<strong>and</strong> treatment throughout the UK.<br />
In addition, many of the functions we<br />
regulate take place in settings outside<br />
hospitals <strong>and</strong> clinics, such as sperm<br />
banks – <strong>and</strong>, in the case of the HTA,<br />
university anatomy schools.<br />
The announcement of the merger came<br />
in the wake of the Arm’s Length Review,<br />
set up in October <strong>2003</strong> to look at ways<br />
of streamlining the functions of 42 st<strong>and</strong>alone<br />
bodies accountable to the<br />
Department of Health, in order to improve<br />
efficiency <strong>and</strong> reduce NHS bureaucracy.<br />
Playing a vital role<br />
It will be several years before RAFT,<br />
which will be set up under a new Act<br />
of Parliament, is established. In the<br />
meantime the HTA will be set up <strong>and</strong> will<br />
carry out the intensive work involved in<br />
setting up st<strong>and</strong>ards <strong>and</strong> codes of practice<br />
<strong>and</strong> implement operational/inspection<br />
procedures prior to the establishment<br />
of the new regulatory body.<br />
> Looking forward<br />
In the next year we will be:<br />
• Working with the government.<br />
In partnership with the Department<br />
of Health, we will be supporting the<br />
establishment of the HTA. We will also<br />
be contributing to the review of the<br />
HFE Act <strong>and</strong> the Select Committee<br />
for Science <strong>and</strong> Technology’s report<br />
on reproductive technology, both of<br />
which will help shape our future role.<br />
• Calling on experience. Further<br />
ahead, we look forward to helping to<br />
create RAFT. We expect to apply the<br />
lessons we have learned about issues<br />
such as consent <strong>and</strong> the importance<br />
of creating a strong ethical framework<br />
in order to promote public confidence<br />
that the use of human tissue will be<br />
responsible <strong>and</strong> well regulated.<br />
• Enhancing public support. We will<br />
work to maintain a strong base of<br />
public support for scientific <strong>and</strong><br />
medical research, education, training<br />
<strong>and</strong> public health surveillance in<br />
tissues <strong>and</strong> organs.<br />
Feature<br />
<strong>HFEA</strong> <strong>Report</strong> | 12
Research<br />
Researching today for health tomorrow<br />
Our long experience of regulating<br />
assisted reproduction gives us a unique<br />
underst<strong>and</strong>ing of the scientific, medical,<br />
psychological, social <strong>and</strong> ethical<br />
dimensions of embryo research.<br />
In <strong>2003</strong>/<strong>04</strong> we made significant<br />
improvements to our research licensing<br />
process in order to ensure that the<br />
increasing number of applications we<br />
receive are dealt with speedily <strong>and</strong><br />
efficiently <strong>and</strong> that every project we<br />
license is necessary, responsible <strong>and</strong><br />
has the potential to benefit health.<br />
Strengthening our strategy<br />
Few subjects arouse such strong opinions<br />
<strong>and</strong> emotions as human embryo research.<br />
There is no doubt that such research has<br />
enormous potential benefits. But, in the<br />
wrong h<strong>and</strong>s, it could be open to abuse.<br />
As part of our reforms we have set up a<br />
dedicated research regulation team with its<br />
own head <strong>and</strong> research officer to oversee<br />
the licensing process <strong>and</strong> established a<br />
permanent licensing committee to enable<br />
us to build expertise.<br />
Our regulatory team is responsible for<br />
advising prospective researchers on how<br />
to frame proposals which helps avoid<br />
delays in the licensing process, inspecting<br />
premises, investigating adverse incidents,<br />
following up progress <strong>and</strong> processing<br />
research renewal applications. We publish<br />
lay summaries of research projects<br />
licensed by the <strong>HFEA</strong>, <strong>and</strong> of research<br />
applications, on our website.<br />
Involving experts<br />
In order to speed up the licensing<br />
process <strong>and</strong> ensure that proposals<br />
are based on robust science, we have<br />
widened our range of experts, recruited<br />
more peer reviewers <strong>and</strong> co-opted new<br />
experts onto our committees. We have<br />
also strengthened our partnerships with<br />
research funding bodies such as the<br />
Medical Research Council, the Wellcome<br />
Trust <strong>and</strong> the Biotechnology <strong>and</strong><br />
Biological Sciences Research Council.<br />
As ever we are mindful of the fact that<br />
research is only possible because those<br />
undergoing fertility treatment are generous<br />
<strong>HFEA</strong> <strong>Report</strong> | 13<br />
enough to donate their surplus eggs,<br />
sperm <strong>and</strong> embryos for use in research.<br />
Safeguarding embryos <strong>and</strong> our future<br />
To some an embryo is just a bundle of<br />
cells, but to most prospective parents<br />
<strong>and</strong> the wider public, it is a potential<br />
baby. In recognition of this special status<br />
strict legal controls apply to the use of<br />
embryos in research <strong>and</strong> a great deal of<br />
debate <strong>and</strong> discussion goes on before a<br />
licence is issued. Any research must be<br />
linked to one or more of the following:<br />
• Enhancing the success of IVF<br />
• Helping couples have healthy babies<br />
free from inherited disease<br />
• Increasing knowledge about the<br />
causes of miscarriage<br />
• Developing more effective<br />
contraceptive techniques<br />
• Developing screening methods for the<br />
detection of genetic or chromosomal<br />
abnormalities in embryos before they<br />
are implanted<br />
• Increasing knowledge about the<br />
development of embryos<br />
• Increasing knowledge about serious<br />
disease <strong>and</strong>/or translating such<br />
knowledge into new methods of<br />
treatment or diagnosis<br />
The law forbids the use of embryos in<br />
research after 14 days <strong>and</strong> bans the<br />
placing of a human embryo in an animal,<br />
the alteration of the genetic structure of<br />
cells forming part of an embryo <strong>and</strong> the<br />
use of embryos for purposes other than<br />
those for which a licence has been<br />
awarded.<br />
Awarding a licence<br />
Each new proposal must detail what the<br />
research is about, why the researcher<br />
wants to do it <strong>and</strong> why it is necessary to<br />
use human embryos. Once we have all<br />
the relevant information, the proposal is<br />
sent out to at least two peer reviewers<br />
to check that it is sound scientifically <strong>and</strong><br />
to consider whether the use of human<br />
embryos is justified.<br />
We now have a team of over 40 nationally<br />
<strong>and</strong> internationally known fertility experts<br />
<strong>and</strong> stem cell scientists as well as<br />
specialists in specific diseases that we<br />
can call upon in order to establish whether<br />
a particular project really will add to<br />
current medical knowledge.<br />
We inform the applicant of any comments<br />
made by the peer reviewers <strong>and</strong> they<br />
have the opportunity to raise queries if<br />
they wish. The proposal is then sent to<br />
our research licence committee. This<br />
committee, which meets at least six times<br />
a year, consists of five members of the<br />
<strong>HFEA</strong> including a lay chair <strong>and</strong> a clinical<br />
<strong>and</strong> scientific adviser.<br />
Underst<strong>and</strong>ing stem cells<br />
In 2001 our remit was extended to include<br />
the use of embryos to derive stem cell<br />
lines. Stem cells are the master cells found<br />
in the embryo that have the potential to<br />
develop into any kind of tissue or organ.<br />
Studying these cells, which derive from<br />
embryos created for IVF but not used<br />
for treatment, is helping advance<br />
underst<strong>and</strong>ing of how the body’s cells<br />
<strong>and</strong> tissues develop <strong>and</strong> what goes<br />
wrong in illness or disease.<br />
To ensure that embryos are only used<br />
when strictly necessary, a sample of the<br />
stem cell line must be deposited in the<br />
UK Stem Cell Bank set up in May 20<strong>04</strong><br />
by the Medical Research Council (MRC)<br />
& the Biotechnology <strong>and</strong> Biological<br />
Sciences Research Council (BBSRC).<br />
This means that in future before granting<br />
a licence for stem cell research we will<br />
have to be satisfied that it cannot be<br />
done using existing stem cell ‘lines’ from<br />
the bank. We are continuing to work<br />
closely with the UK Stem Cell Bank to<br />
ensure that our respective guidelines are<br />
in line with each other.<br />
Sharing knowledge <strong>and</strong> ideas<br />
What do patients want to know about<br />
embryo research? And how are new<br />
discoveries about the development of<br />
embryos changing our thinking? These are<br />
some of the questions raised in our first<br />
ever research conference held in November<br />
<strong>2003</strong>. 120 delegates – mainly scientists<br />
<strong>and</strong> clinicians from licensed UK fertility<br />
centres – gathered to discuss the state of<br />
embryo research across the UK <strong>and</strong> share<br />
knowledge <strong>and</strong> ideas. The conference<br />
included presentations from ethicists,<br />
lawyers <strong>and</strong> patient group representatives.
Looking forward<br />
In the next year we will be:<br />
• Talking to the public. We will be<br />
looking at how we can improve our<br />
dialogue with the public still further to<br />
bring the facts about embryo research<br />
to an even wider audience <strong>and</strong><br />
encourage informed debate.<br />
• Streamlining the process.<br />
We will continue to examine <strong>and</strong><br />
update our licensing processes <strong>and</strong><br />
aim to ensure that decisions are<br />
given within three months of an<br />
application being received.<br />
• Bringing experts together. We are<br />
holding another research conference<br />
in November 20<strong>04</strong>.<br />
• Increasing partnerships. We will be<br />
working with other agencies to ensure<br />
that we continue to approve only the<br />
best quality research <strong>and</strong> stimulating<br />
dialogue with scientists to encourage<br />
awareness of our aims <strong>and</strong> help them<br />
track emerging issues.<br />
> Research Statistics (as at 31 August 20<strong>04</strong>)<br />
• 156 research licence applications<br />
received by <strong>HFEA</strong> since 1991<br />
• 124 research projects have been<br />
licensed by the <strong>HFEA</strong> since 1991<br />
• 30 research projects are currently<br />
licensed by the <strong>HFEA</strong><br />
• 10 licensed research projects relate<br />
to embryonic stem cells<br />
• 3 licensed research projects relate<br />
to parthenogenesis<br />
• 1 licensed research project relates<br />
to cell nuclear replacement<br />
“For many infertile couples, one solution is<br />
in vitro fertilisation (IVF). This treatment has<br />
helped many thous<strong>and</strong>s of couples, but<br />
success rates remain disappointingly low,<br />
with a live birth rate per IVF cycle of around<br />
22%. Moreover, since two, exceptionally<br />
three embryos may be transferred in any<br />
one cycle, there is a high risk of multiple<br />
births. These babies are often underweight<br />
<strong>and</strong> perinatal mortality is above average.<br />
A solution would be to transfer single<br />
embryos with a high chance of forming a<br />
pregnancy but we know very little about<br />
what makes some embryos more healthy<br />
than others. The aim of our work is to<br />
carry out a detailed examination of the<br />
development of the early human embryo, to<br />
learn how to improve culture conditions <strong>and</strong><br />
devise diagnostic methods that allow the<br />
transfer of single, healthy embryos. This<br />
would increase the possibility of a pregnancy<br />
<strong>and</strong> reduce the risk of multiple births.”<br />
Dr Franchesca Houghton,<br />
Wellcome Trust Research<br />
Career Development Fellow,<br />
Department of Biology,<br />
University of York.<br />
<strong>HFEA</strong> <strong>Report</strong> | 14
Policy<br />
Deciding the big issues<br />
One of our most important roles is to<br />
ensure that the use <strong>and</strong> development<br />
of IVF <strong>and</strong> embryo research is ethical<br />
<strong>and</strong> protects the physical <strong>and</strong> emotional<br />
wellbeing of parents, children<br />
<strong>and</strong> siblings.<br />
<strong>2003</strong>/<strong>04</strong> has seen the development of<br />
a number of key policies developed in<br />
consultation with the public, to help<br />
create high quality services that have<br />
everyone’s best interests at heart.<br />
Sex Selection<br />
The ability to screen embryos for<br />
chromosomes that determine sex<br />
makes it possible – theoretically at least –<br />
for parents to choose to have a boy or a<br />
girl. But should this be allowed? And if<br />
so, should there be limits?<br />
In the past we recommended that sex<br />
selection might be carried out for medical<br />
reasons – to avoid having a baby with a<br />
sex-linked hereditary disease such as<br />
Duchenne muscular dystrophy, which only<br />
affects boys – but not for social reasons,<br />
such as balancing the number of boys<br />
<strong>and</strong> girls in a family.<br />
Our review of sex selection, carried out at<br />
the request of the Minister for Health <strong>and</strong><br />
published at the end of <strong>2003</strong>, re-affirmed<br />
this conclusion. The recommendations<br />
were published following widespread<br />
consultation with experts <strong>and</strong> the public,<br />
which revealed that over 80% of people<br />
did not approve of sex selection purely<br />
on social grounds.<br />
We concluded that sex selection should<br />
not be allowed for any non-medical<br />
reason. We also stipulated that where<br />
used for medical reasons it should be<br />
strictly regulated <strong>and</strong> that any long-term<br />
effects should be recorded. Care must<br />
also be taken to ensure the welfare of<br />
families <strong>and</strong> children.<br />
“Saviour siblings”<br />
Sometimes, the only chance a child has<br />
of surviving a serious illness is through<br />
the donation of compatible tissue from a<br />
sister or brother. But should an embryo<br />
created by IVF be specifically tested <strong>and</strong><br />
selected for this purpose?<br />
<strong>HFEA</strong> <strong>Report</strong> | 15<br />
When we first looked at this issue three<br />
years ago, we agreed that there was<br />
no reason to think that children born<br />
following tissue typing <strong>and</strong> embryo<br />
selection would not be valued for their<br />
own sake. But we also noted the limited<br />
evidence then available about the risks<br />
inherent in the procedure of removing one<br />
or two cells from an embryo for testing<br />
(known as embryo biopsy). For these<br />
reasons we adopted a cautious attitude<br />
<strong>and</strong> concluded that it should be permitted<br />
only when these risks were already<br />
discounted because embryo biopsy<br />
was to be undertaken anyway in order<br />
to select embryos free from a serious<br />
genetic disorder. Where there was no<br />
genetic disorder in the family, tissue<br />
typing <strong>and</strong> embryo selection were not<br />
allowed because of the risk that a child<br />
born following the procedure might be<br />
damaged by a test undertaken solely for<br />
the benefit of a sibling.<br />
We have now reviewed the medical,<br />
psychological <strong>and</strong> emotional implications<br />
for children <strong>and</strong> their families as well as<br />
the safety of the technique. There have<br />
been three further years during which the<br />
number of successful embryo biopsies<br />
has increased greatly, both in the UK <strong>and</strong><br />
abroad. In the light of this there is now<br />
much more evidence that the procedure<br />
does not bring an increased risk of harm<br />
to children born following embryo biopsy.<br />
The Court of Appeal also stated that it is<br />
in our powers to license this.<br />
Taking all these factors into consideration<br />
we have amended our 6th Code of<br />
Practice to allow tissue typing on<br />
embryos to help parents save a sick<br />
child. Each application is considered<br />
individually <strong>and</strong> this approach is very<br />
much a last resort. Before an embryo<br />
is selected in this way full consideration<br />
must first be given to every other<br />
appropriate treatment.<br />
Safety first<br />
On rare occasions the storage vessels<br />
in which sperm, eggs <strong>and</strong> embryos are<br />
frozen can fail. This can spell the end of<br />
any hope of a child for couples who may<br />
have had their last viable sperm, eggs or<br />
embryos frozen, especially in cases<br />
where their fertility has since been<br />
affected by medical treatment, such<br />
as chemotherapy for cancer.<br />
To help prevent such tragic <strong>and</strong> avoidable<br />
accidents we have issued new guidelines<br />
on the safety of these vessels, known as<br />
dewars, to be put in place by the end of<br />
June 2005. These include fitting alarms<br />
linked to an auto-dial system to enable<br />
staff to be contacted outside normal<br />
hours, together with the provision of<br />
spare storage capacity as a fallback in<br />
case a dewar unexpectedly fails. As an<br />
added precaution, the sperm, eggs or<br />
embryos of patients whose fertility may<br />
be affected by medical treatment must<br />
be divided between two or more vessels<br />
to reduce the chances of loss.<br />
By its nature there are always uncertainties<br />
with IVF treatment. We believe the survival<br />
of stored eggs, sperm <strong>and</strong> embryos<br />
shouldn’t be one of them <strong>and</strong> that these<br />
new measures will prevent losses in future.<br />
Deciding the rules on donation<br />
Should people who donate sperm,<br />
eggs or embryos be paid? Should there<br />
be any age limits on donors? How many<br />
offspring should a donor be allowed to<br />
create? These are just some of the<br />
complex questions we are addressing<br />
in our review of sperm, egg <strong>and</strong> embryo<br />
donation. Over recent months we have<br />
been gathering evidence from clinics <strong>and</strong><br />
patient bodies <strong>and</strong> are now drawing up<br />
a consultation document with detailed<br />
proposals. The impending change in law<br />
ending anonymity for new sperm, egg<br />
<strong>and</strong> embryo donors from 1 April 2005<br />
forms a background to this review, the<br />
outcome of which will be announced in<br />
Spring 2005.<br />
Assessing children’s welfare<br />
Under the HFE Act as it st<strong>and</strong>s, clinics<br />
are obliged to consider the welfare of<br />
children who may be born as a result<br />
of fertility treatment. Most fertility clinics<br />
approach the woman or couple’s GP<br />
(with their permission) to ask whether<br />
they have any reason to believe that a<br />
child resulting from the treatment might<br />
be at risk. Some clinics also ask clients<br />
to fill in ‘child welfare’ forms or have an
assessment interview. But how useful is<br />
this in predicting the welfare of a potential<br />
child <strong>and</strong> could there be a better way to<br />
go about it? In the past few months we<br />
have been canvassing the views of<br />
patients <strong>and</strong> clinics to see what they<br />
think. Over the next year will be setting<br />
up workshops with stakeholders, patient<br />
groups, counselling organisations <strong>and</strong><br />
clinicians to try <strong>and</strong> work out the most<br />
effective <strong>and</strong> sensitive way of taking into<br />
account the welfare of children born as a<br />
result of assisted conception.<br />
> Looking forward<br />
In the next year we will be:<br />
• Scanning the horizon. To ensure<br />
we are in a position to anticipate new<br />
techniques <strong>and</strong> treatments that clinics<br />
may wish to provide, we have set up<br />
a worldwide scientific panel to gather<br />
intelligence about new developments<br />
in assisted conception <strong>and</strong> give us<br />
time to explore these in terms of<br />
safety, ethics <strong>and</strong> the law. This should<br />
in turn speed up licence applications<br />
<strong>and</strong> accelerate access to new<br />
treatments for those seeking<br />
fertility treatment.<br />
• Preparing for change. The European<br />
Tissue Directive, due to come into<br />
force in the UK in April 2006, will<br />
extend our role into new areas such<br />
as intra-uterine insemination. The<br />
Directive aims to ensure the safety <strong>and</strong><br />
quality of human organs, tissues <strong>and</strong><br />
cells, including sperm <strong>and</strong> embryos,<br />
used for medical purposes in every<br />
member state. We are working closely<br />
with the Department of Health <strong>and</strong> our<br />
stakeholders to make sure we’re ready<br />
to embrace our new role.<br />
• Looking at the law. We will<br />
continue to work with the Department<br />
of Health on its review of the HFE<br />
Act, announced early in 20<strong>04</strong>, to<br />
ensure that it reflects the enormous<br />
changes in reproductive technology<br />
since1990. We are also contributing<br />
our knowledge <strong>and</strong> experience to the<br />
House of Common’s Science <strong>and</strong><br />
Technology Select Committee’s<br />
review of human reproductive<br />
technologies <strong>and</strong> the law.<br />
“Whatever the <strong>HFEA</strong>’s decision in making<br />
new policy, not everyone will agree. In my<br />
opinion the <strong>HFEA</strong>’s recommendation not<br />
to permit sex selection for non-medical<br />
reasons was correct. Sex is not a disease.<br />
Some feel that denying access to sex<br />
selection is against human rights, but in my<br />
view this would be stepping over a fine line.<br />
Initially the <strong>HFEA</strong> took a cautious approach<br />
on saviour siblings, prohibiting PGD for<br />
tissue typing alone. One argument was<br />
that embryo biopsy may be harmful, yet<br />
the <strong>HFEA</strong> granted licences to use PGD to<br />
improve IVF pregnancy rates (aneuploidy<br />
screening). I am glad that after a thorough<br />
review of the evidence, including research<br />
into public opinion, the Authority has<br />
reversed its decision.<br />
It is important for the <strong>HFEA</strong> to have public<br />
consultations <strong>and</strong> make informed decisions.<br />
The rest of the world looks to the UK, so<br />
it is important that we get things as right<br />
as possible.”<br />
Dr Joyce Harper,<br />
Senior Lecturer in <strong>Human</strong> Genetics<br />
<strong>and</strong> <strong>Embryology</strong>,<br />
University College London.<br />
<strong>HFEA</strong> <strong>Report</strong> | 16
Communications<br />
Engaging with the public<br />
How far should couples go in their quest<br />
for a child? And where should we draw<br />
the line in reproductive medicine? Such<br />
questions are rightly a source of intense<br />
interest <strong>and</strong> debate, not just to those<br />
going through fertility treatment but to<br />
doctors, scientists, MPs <strong>and</strong> the<br />
wider public.<br />
In <strong>2003</strong>/<strong>04</strong> we strengthened our<br />
relationship with key stakeholders <strong>and</strong><br />
improved the quality <strong>and</strong> range of<br />
information available through our website,<br />
publications, conferences <strong>and</strong> other<br />
events, <strong>and</strong> the media.<br />
Widening our reach<br />
We continued to develop our website<br />
to make it more accessible <strong>and</strong> reader<br />
friendly, more than doubling the amount<br />
of information available, including lay<br />
summaries of licensed research projects<br />
(see page 27). Between July <strong>2003</strong> <strong>and</strong><br />
July 20<strong>04</strong>, the site attracted 11.5m hits,<br />
a considerable increase on last year.<br />
Visit www.hfea.gov.uk to see<br />
what we have done.<br />
We also extended our range of patient<br />
publications (see below) <strong>and</strong> introduced<br />
a new Parliamentary Briefing designed to<br />
inform MPs about our role <strong>and</strong> keep them<br />
up-to-date with our activities. Our other<br />
newsletter, Update, is a channel for<br />
communicating with licensed centres,<br />
together with monthly mailings detailing<br />
policy changes <strong>and</strong> general information.<br />
Events such as National Infertility Day<br />
<strong>and</strong> the NHS Confederation <strong>Annual</strong><br />
Conference gave us the opportunity<br />
to meet stakeholders face-to-face.<br />
We attended many other conferences<br />
such as the European Society for<br />
<strong>Human</strong> Reproduction <strong>and</strong> <strong>Embryology</strong><br />
<strong>and</strong> we have set up regular meetings<br />
with patient groups <strong>and</strong> professional<br />
organisations to discuss how we can<br />
best meet their information needs.<br />
Opening our meetings to the public<br />
In order to increase transparency <strong>and</strong><br />
encourage people to gain a greater insight<br />
into how we work <strong>and</strong> reach decisions,<br />
in October <strong>2003</strong> we held the first of three<br />
open meetings in London. These were<br />
<strong>HFEA</strong> <strong>Report</strong> | 17<br />
advertised, <strong>and</strong> papers for discussion<br />
were posted in advance on our website.<br />
Students, MPs, patients <strong>and</strong> patient<br />
group representatives <strong>and</strong> clinicians were<br />
among those attending. Questions were<br />
invited from the floor <strong>and</strong>, afterwards,<br />
there was a chance to meet <strong>HFEA</strong><br />
members informally. This was particularly<br />
welcomed by the observers.<br />
Helping patients decide<br />
Men <strong>and</strong> women about to embark upon,<br />
or going through, fertility treatment <strong>and</strong><br />
their families need reliable, easy-tounderst<strong>and</strong><br />
information about different<br />
treatments <strong>and</strong> the services they can<br />
expect from fertility clinics. In order to<br />
meet this need, in <strong>2003</strong> we launched a<br />
major new information guide, the “<strong>HFEA</strong><br />
Directory of Clinics: Your Guide to<br />
Infertility”, in partnership with Dr Foster,<br />
which has proved hugely popular with<br />
patients. We worked with patient<br />
groups, including Infertility Network UK,<br />
to illustrate the Directory with stories<br />
from former patients about their<br />
experiences, <strong>and</strong> what they learnt.<br />
Its easy-to-read format helps people<br />
about to embark upon or going through<br />
fertility treatment ask the right questions<br />
of those caring for them. The personal<br />
experiences illustrate what it is like to<br />
undergo treatment to help readers feel<br />
less alone. Equally importantly the guide<br />
contains information about every <strong>HFEA</strong>licensed<br />
centre, <strong>and</strong> the services they<br />
provide. Like all our literature, it is free.<br />
Listening <strong>and</strong> responding<br />
Our annual conference provides another<br />
opportunity for us to interact with<br />
stakeholders <strong>and</strong> hear their views. Over<br />
100 delegates including MPs, clinicians<br />
<strong>and</strong> patient group representatives<br />
attended this year’s event held in January.<br />
Public Health Minister, Melanie Johnson,<br />
announced plans for lifting anonymity<br />
from future sperm, egg <strong>and</strong> embryo<br />
donors, enabling children conceived<br />
through donation to trace their origins<br />
when they reach 18 years of age. She<br />
also announced a review of the HFE<br />
Act to take into account the scientific<br />
developments <strong>and</strong> changes in public<br />
attitudes towards IVF treatment <strong>and</strong><br />
research that have occurred since 1990.<br />
Speakers addressed issues including the<br />
welfare of the child, the role of primary<br />
care trusts in IVF, the implications of the<br />
EU Tissue Directive <strong>and</strong> of the forthcoming<br />
Freedom of Information Act.<br />
Media matters<br />
The <strong>HFEA</strong> operates in a fast moving <strong>and</strong><br />
often controversial area of science. The<br />
key to communicating our activities to<br />
the wider public depends on keeping<br />
the media updated <strong>and</strong> informed to<br />
ensure that issues <strong>and</strong> debates are<br />
reported accurately.<br />
In <strong>2003</strong>/<strong>04</strong> we continued to develop our<br />
media profile <strong>and</strong> to foster productive<br />
working relationships with science,<br />
health <strong>and</strong> medical journalists both<br />
here <strong>and</strong> abroad.<br />
Our press office is on call 24 hours a day,<br />
seven days a week providing fast <strong>and</strong><br />
accurate briefings to journalists on all<br />
aspects of our work. On the busiest days<br />
we may receive as many as 150 calls<br />
from print <strong>and</strong> broadcast journalists<br />
seeking information or comment.<br />
The dedicated press section of our<br />
website is extremely popular, providing<br />
background briefings <strong>and</strong> fact sheets on<br />
the whole range of <strong>HFEA</strong> activities <strong>and</strong><br />
giving reporters <strong>and</strong> other commentators<br />
easy access to information whenever<br />
they need it.<br />
Journalists from print <strong>and</strong> broadcast<br />
media ran a well attended workshop<br />
at our annual conference, providing<br />
practical advice to fertility specialists <strong>and</strong><br />
scientists on how to h<strong>and</strong>le the media.<br />
The workshop’s success has guaranteed<br />
it a slot on next year’s agenda.<br />
Encouraging responsible reporting<br />
Two policy decisions made in <strong>2003</strong>/<strong>04</strong><br />
illustrate how we work with the media<br />
to help ensure sound reporting.<br />
The first in November <strong>2003</strong> concerned our<br />
year-long review of sex selection (see page<br />
15). The day before the announcement we
arranged a press conference at the Royal<br />
Institution’s Science Media Centre, which<br />
was attended by over 30 journalists from<br />
print <strong>and</strong> broadcast media. We also held<br />
a parliamentary launch at the House of<br />
Commons for MPs <strong>and</strong> other interested<br />
parties, an event which drew over<br />
80 people.<br />
As a result of our efforts, coverage of<br />
our recommendations was very positive,<br />
reporting was accurate <strong>and</strong> the moral<br />
issues surrounding parents choosing the<br />
sex of their children responsibly dealt with.<br />
The decision that embryos could be<br />
tested before being implanted in order<br />
for families to have a child who could be<br />
a tissue match for a seriously ill sibling<br />
(see page 15) was announced in July<br />
20<strong>04</strong>. Our announcement of a policy<br />
review two months before this re-ignited<br />
media interest in this controversial issue.<br />
Following our decision <strong>HFEA</strong> chair, Suzi<br />
Leather, met journalists <strong>and</strong> TV crews to<br />
make an early, clear statement, which<br />
resulted in wide <strong>and</strong> sensitive coverage.<br />
> Looking forward<br />
In the next year we will be:<br />
• Consulting on policy. We intend to<br />
strengthen the relationship with our<br />
main stakeholders, involving them<br />
<strong>and</strong> consulting with them on policy<br />
<strong>and</strong> regulatory developments.<br />
• Informing opinion formers.<br />
We intend to make a more proactive<br />
contribution to parliamentary debate.<br />
We also want to reach other<br />
important opinion formers <strong>and</strong> groups<br />
such as GPs <strong>and</strong> Primary Care Trusts<br />
(PCTs), who are likely to become<br />
more involved in decisions about<br />
access to IVF treatment.<br />
• Increasing transparency. We will<br />
continue to hold open our meetings<br />
to members of the public <strong>and</strong> will hold<br />
our first open meeting outside London<br />
in Edinburgh in October 20<strong>04</strong>.<br />
• Informing choice. We are looking at<br />
ways of developing the next edition of<br />
our Directory of Clinics to include<br />
statistics on success rates for<br />
treatments, <strong>and</strong> commissioning<br />
research with people at different<br />
stages of treatment to find out how<br />
we can best equip them to make<br />
informed choices.<br />
• Exp<strong>and</strong>ing our web briefings.<br />
We hope to develop the press<br />
section of the website to exp<strong>and</strong><br />
our briefings for journalists in the<br />
UK <strong>and</strong> overseas.<br />
• Connecting with patients. In order<br />
to implement a patients’ strategy we<br />
will be building formal relationships<br />
with patient groups <strong>and</strong> setting up<br />
a Patients’ Consultative Panel. We will<br />
also be extending our media relations<br />
to target patients via consumer,<br />
lifestyle <strong>and</strong> women’s magazines<br />
<strong>and</strong> the regional press.<br />
“Most people considering fertility treatment<br />
want as much information as possible not<br />
just about the kind of treatment that may<br />
be most suitable for them, but about issues<br />
such as the emotional <strong>and</strong> financial cost,<br />
<strong>and</strong> what kind of support is available.<br />
Having been a patient myself, I believe the<br />
<strong>HFEA</strong> exists to protect patients, <strong>and</strong> that<br />
we are the envy of the world for having<br />
such a well-regulated system. This also<br />
means that information the <strong>HFEA</strong> produces<br />
is trusted to be reliable <strong>and</strong> authoritative.<br />
Infertility Network UK worked with the<br />
<strong>HFEA</strong> on the <strong>HFEA</strong> Directory of Clinics<br />
so that it best meets the needs of patients<br />
<strong>and</strong> prospective patients. The case<br />
histories are especially useful in illustrating<br />
people’s different personal experiences.<br />
Our members have been very positive<br />
about the publication <strong>and</strong> think it’s<br />
fantastic – very user-friendly!”<br />
Sheena Young, Head of Business<br />
Development, Infertility Network UK.<br />
<strong>HFEA</strong> <strong>Report</strong> | 18
Working together<br />
Reducing multiple births<br />
How many embryos should be transferred<br />
during IVF? In <strong>2003</strong>/<strong>04</strong> after extensive<br />
research <strong>and</strong> public consultation, we<br />
decided to reduce the number of embryos<br />
permitted to be replaced in the womb<br />
during IVF from three to two in women<br />
under 40 in order to minimise the risk<br />
of a multiple birth.<br />
The new ruling, incorporated in our 6th<br />
Code of Practice, provides an example<br />
of how the <strong>HFEA</strong> strives to reach sound<br />
evidence-based decisions.<br />
Looking at the background<br />
To protect the welfare of mothers <strong>and</strong><br />
babies, our Code of Practice had always<br />
limited the number of embryos permitted<br />
to be transferred in a single IVF cycle to<br />
three. The question was: should this be<br />
reduced still further?<br />
Our first step was to examine the<br />
statistics. There has been a dramatic<br />
increase in the number of triplets born<br />
in this country since the 1980s. The<br />
number of twins born has also risen.<br />
Behind these figures lies the steady<br />
climb in IVF treatments.<br />
<strong>HFEA</strong> <strong>Report</strong> | 19<br />
At first glance it may not seem such a<br />
problem. Having twins or triplets can be<br />
a quick way to have an instant family<br />
without the need for further IVF treatment.<br />
The health consequences for the mother<br />
can, however, be serious, a fact that is<br />
often not recognised. During pregnancy<br />
she has a higher risk of miscarriage <strong>and</strong><br />
of the high blood pressure disease of<br />
pregnancy, pre-eclampsia. Meanwhile<br />
her babies have an increased chance of<br />
being born prematurely, dying before birth<br />
or during the first year, or suffering some<br />
form of disability.<br />
What’s more, research has shown that<br />
the levels of exhaustion <strong>and</strong> financial<br />
pressure triplets, <strong>and</strong> even twins, bring<br />
can put a crippling strain on families<br />
<strong>and</strong> ultimately on the rest of society.<br />
Exploring the data<br />
Our next step was to search the data<br />
contained in our own Register <strong>and</strong><br />
compare it with statistics from the US.<br />
This showed that, for women in their<br />
30s or under, limiting the number of<br />
embryos transferred to a maximum of<br />
two made no real difference to their<br />
chances of becoming pregnant. It did,<br />
however, reduce the number of triplets<br />
or twins born.<br />
The data showed that for women aged<br />
40 <strong>and</strong> over the situation is different.<br />
Transferring three embryos will not<br />
usually result in a triplet birth <strong>and</strong> will<br />
slightly improve their chance of<br />
becoming pregnant.<br />
We also talked to patient groups about<br />
the way people might feel about this<br />
rule changing, <strong>and</strong> what their concerns<br />
might be.<br />
These various elements helped shape the<br />
policy in our latest Code of Practice that<br />
the number of embryos replaced should<br />
be reduced to two in women under 40.<br />
In this way, the Code supports clinics in<br />
achieving the maximum number of single,<br />
healthy babies without jeopardising a<br />
woman’s chances of conceiving.<br />
Publicising our findings<br />
The change in policy was made public<br />
at the launch of the 6th Code of Practice<br />
at the joint British Fertility Society <strong>and</strong> the
Feature<strong>HFEA</strong> <strong>Report</strong><br />
Association of Clinical Embryologists’<br />
<strong>Annual</strong> Meeting in Liverpool in January<br />
20<strong>04</strong>. The launch was an opportunity to<br />
engage the media in informing the public<br />
of the risks associated with multiple<br />
births. It centred around a joint<br />
presentation by our chair Suzi Leather<br />
<strong>and</strong> Jane Denton, Director of the Multiple<br />
Births Foundation, who was able to reveal<br />
many personal stories of families coming<br />
to terms with multiple births <strong>and</strong> the<br />
difficulties they faced.<br />
Ms Leather <strong>and</strong> Ms Denton gave many<br />
television, radio <strong>and</strong> print interviews.<br />
This resulted in a great deal of coverage<br />
raising the profile of risks associated with<br />
multiple births.<br />
Explaining policy to patients<br />
Whenever we make a policy change, it is<br />
important that we make sure that anyone<br />
who could be affected knows about it,<br />
<strong>and</strong> the reasons for it. In the case of the<br />
change to two-embryo transfer this<br />
involved issuing guidance to clinics to<br />
make sure they were operating in line<br />
with the new Code of Practice.<br />
Just as importantly, patients undergoing<br />
fertility treatment needed to underst<strong>and</strong><br />
why we were restricting the number of<br />
embryos that could be transferred during<br />
their treatment, particularly since other<br />
countries have different approaches.<br />
To this end we produced a new patient<br />
information leaflet, “Avoiding Multiple<br />
Births”, which answered questions they<br />
might have. It explained the medical risks<br />
associated with multiple pregnancies, <strong>and</strong><br />
addressed the fear that some patients<br />
might have that, by reducing the number<br />
of embryos transferred during treatment,<br />
they might be less likely to have a baby.<br />
As always with our leaflets, we listed<br />
details of other relevant organisations<br />
that could provide further support <strong>and</strong><br />
information, such as the Multiple Births<br />
Foundation <strong>and</strong> the Twins <strong>and</strong> Multiple<br />
Births Association (TAMBA).<br />
The leaflet is now widely used in clinics<br />
around the UK <strong>and</strong> by patient groups,<br />
<strong>and</strong> is available free of charge from<br />
the <strong>HFEA</strong>.<br />
> It doesn’t stop there<br />
We are constantly <strong>and</strong> actively engaged<br />
in shaping our policies <strong>and</strong> practices to<br />
ensure that they meet the needs of those<br />
undergoing fertility treatment <strong>and</strong> the rest<br />
of society.<br />
In future, we would like to get to the<br />
position where women need only to<br />
have a single embryo replaced, to mimic<br />
more closely what happens naturally.<br />
In order to make this possible we have<br />
licensed a multi-centre project to<br />
examine the development of early<br />
human embryos in the hope of finding<br />
ways to identify those with the best<br />
possible chance of implanting in the<br />
womb <strong>and</strong> developing into a healthy<br />
baby. As well as helping people<br />
undergoing IVF, this could also help<br />
ensure the health of babies naturally<br />
conceived.<br />
We will continue to monitor the impact<br />
of this <strong>and</strong> other areas of policy through<br />
data submitted by clinics to our Register,<br />
our licensing process <strong>and</strong> information<br />
obtained from our stakeholders. In this<br />
way we aim to ensure that our policies<br />
<strong>and</strong> practices are at all times in line with<br />
the most up-to-date knowledge <strong>and</strong><br />
findings in the field of fertility treatment<br />
<strong>and</strong> research.<br />
| 20
Appendix One<br />
St<strong>and</strong>ing Committee Membership (as of 12 May 20<strong>04</strong>)<br />
Organisation & Finance Committee<br />
Chair: Suzi Leather<br />
Tom Baldwin<br />
Chris Barratt<br />
Clare Brown<br />
Ivor Brecker<br />
Sharmila Nebhrajani<br />
Regulation Committee<br />
Chair: Sharmila Nebhrajani<br />
David Barlow<br />
Ivor Brecker<br />
Clare Brown<br />
Iain Cameron<br />
Maybeth Jamieson<br />
Audit Committee<br />
Chair: Walter Merricks<br />
Jane Denton<br />
Emily Jackson<br />
Simon Jenkins<br />
Luke March (co-opted member)<br />
Alison Bexfield (co-opted member)<br />
Kim Hayes (Department of Health observer)<br />
Scientific & Clinical Advances Group<br />
Chair: Neva Haites<br />
Tom Baldwin<br />
David Barlow<br />
Chris Barratt<br />
Peter Braude<br />
Clare Brown<br />
Iain Cameron<br />
Jane Denton<br />
Maybeth Jamieson<br />
Sara Nathan (co-opted member)<br />
Roger Pedersen (co-opted member)<br />
Ted Webb (DH Observer)<br />
Ethics & Law Committee<br />
Chair: Tom Baldwin<br />
Ivor Brecker<br />
Richard D. Harries<br />
Jennifer Hunt<br />
Emily Jackson<br />
Simon Jenkins<br />
Suzi Leather<br />
Sara Nathan<br />
Walter Merricks<br />
Felicity Collier<br />
Celia Deane-Drummond (co-opted member)<br />
<strong>Human</strong> Genetics Commission representative<br />
(co-opted member)<br />
Information Management Programme<br />
Chair: Angela McNab<br />
Suzi Leather<br />
David Barlow<br />
Peter Braude<br />
Jane Denton<br />
Mark Kinsella<br />
Neva Haites<br />
Barry MacDonald<br />
David Moysen<br />
Sharmila Nebhrajani<br />
David Tellis<br />
Kim Hayes (DH Observer)<br />
Steve Carroll (co-opted member)<br />
<strong>HFEA</strong> <strong>Report</strong> | 21
Appendix Two<br />
Centres licensed by the <strong>HFEA</strong> (as of 31 August 20<strong>04</strong>)<br />
East Midl<strong>and</strong>s<br />
Centre Number Name Licenses Held<br />
0016 CARE Northampton Treatment <strong>and</strong> Storage<br />
0101 CARE Nottingham Treatment, Storage <strong>and</strong> Research<br />
0149 Derby City General Hospital Treatment <strong>and</strong> Storage<br />
0068 Leicester Royal Infirmary Treatment <strong>and</strong> Storage<br />
0069 Middle Engl<strong>and</strong> Fertility Centre (Leicester) Treatment <strong>and</strong> Storage<br />
0162 Queens Medical Centre Fertility Unit (Nottingham) Treatment <strong>and</strong> Storage<br />
East of Engl<strong>and</strong><br />
Centre Number Name Licenses Held<br />
0100 Bourn Hall Clinic (Cambridge) Treatment <strong>and</strong> Storage<br />
0165 Brentwood Fertility Centre Treatment <strong>and</strong> Storage<br />
0178 Fertility Unit, Peterborough District Hospital Treatment <strong>and</strong> Storage<br />
0188 Isis Fertility Centre (Colchester) Treatment <strong>and</strong> Storage<br />
0051 Rosie Hospital (Cambridge) Treatment <strong>and</strong> Storage<br />
0190 Subfertility Unit, James Paget Healthcare (Gorleston-on-Sea) Storage<br />
0002 Watford General Hospital Treatment <strong>and</strong> Storage<br />
London<br />
Centre Number Name Licenses Held<br />
0080 Andrology Unit, Hammersmith Hospital (W12) Storage<br />
0109 Assisted Conception Unit, King's College Hospital (SE5) Treatment <strong>and</strong> Storage<br />
0157 Assisted Reproduction <strong>and</strong> Gynaecology Centre (W1) Treatment <strong>and</strong> Storage<br />
0094 Barts <strong>and</strong> the London Fertility Centre (EC1) Treatment <strong>and</strong> Storage<br />
0086 BMI Chelsfield Park ACU (Orpington) Treatment <strong>and</strong> Storage<br />
0070 Bridge Centre (SE1) Treatment <strong>and</strong> Storage<br />
0171 Bridge Centre Cryoservices (SE1) Storage<br />
0158 Chelsea & Westminster Hospital (SW10) Treatment, Storage <strong>and</strong> Research<br />
0199 CRM London (NW8) Treatment <strong>and</strong> Storage<br />
0074 Cromwell IVF <strong>and</strong> Fertility Centre, London (SW5) Treatment <strong>and</strong> Storage<br />
0030 Essex Fertility Centre (Buckhurst Hill) Treatment <strong>and</strong> Storage<br />
0102 Guys Hospital (SE1) Treatment, Storage <strong>and</strong> Research<br />
0078 Hammersmith Hospital (W12) Treatment, Storage <strong>and</strong> Research<br />
0187 Harley Street Clinic (W1) Treatment<br />
0186 Harley Street Fertility Centre (W1) Treatment <strong>and</strong> Storage<br />
0153 Homerton University Hospital (E9) Treatment <strong>and</strong> Storage<br />
0006 Lister Fertility Clinic (SW1) Treatment <strong>and</strong> Storage<br />
0143 London Female And Male Fertility Centre (N6) Treatment <strong>and</strong> Storage<br />
0088 London Fertility Centre (W1) Treatment, Storage <strong>and</strong> Research<br />
0105 London Women's Clinic/Hallam Medical Centre (W1) Treatment <strong>and</strong> Storage<br />
0011 Louis Hughes (W1) Storage<br />
0138 North East London Fertility Services (Ilford) Treatment <strong>and</strong> Storage<br />
0117 Queen Mary's Hospital (Sidcup) Treatment<br />
0206 Reproductive Genetics Institute (W1) Treatment <strong>and</strong> Storage<br />
0167 Reproductive Medicine Unit (WC1) Treatment <strong>and</strong> Storage<br />
0163 Shirley Oaks Hospital (Croydon) Treatment <strong>and</strong> Storage<br />
0<strong>04</strong>4 U C H London (WC1) Treatment, Storage <strong>and</strong> Research<br />
0207 University College London (WC1) Research<br />
0<strong>04</strong>8 West Middlesex University Hospital (Isleworth) Treatment <strong>and</strong> Storage<br />
<strong>HFEA</strong> <strong>Report</strong> | 22
North East<br />
Centre Number Name Licenses Held<br />
0168 Bishop Auckl<strong>and</strong> General Hospital Treatment <strong>and</strong> Storage<br />
0170 Centre for Assisted Reproduction, Gateshead Treatment <strong>and</strong> Storage<br />
0056 Clevel<strong>and</strong> Gynaecology <strong>and</strong> Fertility Centre (Middlesbrough) Treatment <strong>and</strong> Storage<br />
0075 Cromwell IVF <strong>and</strong> Fertility Centre, Darlington Treatment <strong>and</strong> Storage<br />
0031 Hartlepool General Hospital Treatment <strong>and</strong> Storage<br />
0055 James Cook University Hospital (Middlesbrough) Treatment <strong>and</strong> Storage<br />
0017 Newcastle Fertility Centre at Life Treatment, Storage <strong>and</strong> Research<br />
0076 NURTURE (Nottingham) Treatment, Storage <strong>and</strong> Research<br />
0096 Sunderl<strong>and</strong> Fertility Centre Treatment <strong>and</strong> Storage<br />
North Irel<strong>and</strong><br />
Centre Number Name Licenses Held<br />
0200 Origin Fertility Care (Belfast) Treatment <strong>and</strong> Storage<br />
0077 Regional Fertility Centre, Belfast Treatment <strong>and</strong> Storage<br />
North West<br />
Centre Number Name Licenses Held<br />
0185 CARE Manchester Treatment <strong>and</strong> Storage<br />
0071 CARE Wirral Treatment <strong>and</strong> Storage<br />
0189 Christie Hospital NHS Trust (Manchester) Storage<br />
0007 Hewitt Centre for Reproductive Medicine (Liverpool) Treatment, Storage <strong>and</strong> Research<br />
0033 Manchester Fertility Services LTD Treatment, Storage <strong>and</strong> Research<br />
0067 St Mary's Hospital (Manchester) Treatment, Storage <strong>and</strong> Research<br />
0175 University of Manchester Research<br />
Scotl<strong>and</strong><br />
Centre Number Name Licenses Held<br />
0202 Division of Gene Expression <strong>and</strong> Development, Roslin Institute Research<br />
0201 Edinburgh Assisted Conception Unit Treatment <strong>and</strong> Storage<br />
0115 Glasgow Nuffield Hospital Treatment <strong>and</strong> Storage<br />
0037 Glasgow Royal Infirmary Treatment, Storage <strong>and</strong> Research<br />
0166 Institute for Stem Cell Research (Edinburgh) Research<br />
0098 Lanarkshire Acute Hospital NHS Trust (Aidrie) Treatment <strong>and</strong> Storage<br />
00<strong>04</strong> Ninewells Hospital (Dundee) Treatment <strong>and</strong> Storage<br />
0019 University of Aberdeen Treatment <strong>and</strong> Storage<br />
South East<br />
Centre Number Name Licenses Held<br />
0161 BMI The Chaucer Hospital (Canterbury) Treatment <strong>and</strong> Storage<br />
0064 Chiltern Hospital Fertility Services Unit (Great Missenden) Treatment <strong>and</strong> Storage<br />
0015 Esperance Private Hospital (Eastborne) Treatment <strong>and</strong> Storage<br />
0035 Oxford Fertility Unit Treatment, Storage <strong>and</strong> Research<br />
0121 Princess Anne Hospital Fertility Unit (Southampton) Treatment, Storage <strong>and</strong> Research<br />
0159 Royal Surrey County Hospital (Guildford) Storage<br />
0208 South East Fertility Group (Tunbridge Wells) Treatment <strong>and</strong> Storage<br />
0144 The Woking Nuffield Hospital Treatment <strong>and</strong> Storage<br />
0057 Wessex Fertility Limited (Southampton) Treatment <strong>and</strong> Storage<br />
0180 Willow Suite, Thames Valley Nuffield Hospital (nr Slough) Treatment <strong>and</strong> Storage<br />
<strong>HFEA</strong> <strong>Report</strong> | 23
South West<br />
Centre Number Name Licenses Held<br />
0139 Bath Assisted Conception Clinic Treatment <strong>and</strong> Storage<br />
0024 Centre for Reproductive Medicine, University of Bristol Treatment <strong>and</strong> Storage<br />
0151 Gloucestershire Hospitals NHS Trust (Cheltenham) Storage<br />
0010 New Life Centre (Bristol) Treatment <strong>and</strong> Storage<br />
0176 Obstetrics & Gynaecology (Clinical Science at South Bristol) Treatment <strong>and</strong> Storage<br />
0005 Peninsular Centre for Reproductive Medicine (Exeter) Treatment <strong>and</strong> Storage<br />
0197 Salisbury Fertility Centre Treatment <strong>and</strong> Storage<br />
0179 South West Centre for Reproductive Medicine (Plymouth) Treatment <strong>and</strong> Storage<br />
0032 Southmead Hospital (Bristol) Treatment <strong>and</strong> Storage<br />
0133 Winterbourne Hospital (Dorchester) Treatment <strong>and</strong> Storage<br />
Wales<br />
Centre Number Name Licenses Held<br />
0<strong>04</strong>9 Cardiff Assisted Reproduction Unit Treatment <strong>and</strong> Storage<br />
0059 Cromwell IVF <strong>and</strong> Fertility Centre, Swansea Treatment <strong>and</strong> Storage<br />
0130 North West Wales Fertility Centre (Bangor) Storage<br />
0152 Singleton Hospital (Swansea) Storage<br />
West Midl<strong>and</strong>s<br />
Centre Number Name Licenses Held<br />
0181 ACU, Lifestyle S<strong>and</strong>y Lane Clinic (Newcastle-under-Lyme) Treatment <strong>and</strong> Storage<br />
0119 Birmingham Women's Hospital Treatment, Storage <strong>and</strong> Research<br />
0026 BMI Priory Hospital (Birmingham) Treatment <strong>and</strong> Storage<br />
0184 Burton Hospitals NHS Trust (Burton-upon-Trent) Treatment <strong>and</strong> Storage<br />
0013 Centre for Reproductive Medicine, Coventry Treatment, Storage <strong>and</strong> Research<br />
0209 Institute of Biomedical Research (Birmingham) Research<br />
0008 Midl<strong>and</strong> Fertility Services (Aldridge) Treatment <strong>and</strong> Storage<br />
0148 Shropshire <strong>and</strong> Mid-Wales Fertility Centre (Shrewsbury) Treatment <strong>and</strong> Storage<br />
0198 St Jude's Clinic for Fertility & Gynaecology (Wolverhampton) Treatment <strong>and</strong> Storage<br />
Yorkshire <strong>and</strong> the Humber<br />
Centre Number Name Licenses Held<br />
0063 Assisted Conception Unit, St James' University Hospital – Leeds Treatment <strong>and</strong> Storage<br />
0061 CARE at The Sheffield Fertility Centre Treatment <strong>and</strong> Storage<br />
0196 Centre for Reproductive Medicine <strong>and</strong> Fertility, Sheffield Treatment <strong>and</strong> Storage<br />
0052 Clarendon Wing – Leeds (General Infirmary) Treatment, Storage <strong>and</strong> Research<br />
0021 Hull IVF Unit Treatment <strong>and</strong> Storage<br />
0191 Section of Reproductive <strong>and</strong> Developmental Medicine (Sheffield) Research<br />
0062 University of York Research<br />
<strong>HFEA</strong> <strong>Report</strong> | 24
Appendix Three<br />
Clinical Inspectors (as of 31 August 20<strong>04</strong>)<br />
Mr Masoud Afnan<br />
Consultant Obstetrician & Gynaecologist,<br />
Honorary Senior Lecturer, Director of ACU<br />
Birmingham Women's Hospital<br />
Mr Bernard Bentick<br />
Consultant Obstetrician & Gynaecologist<br />
Royal Shrewsbury Hospital NHS Trust<br />
Mr Peter Brinsden<br />
Medical Director/Department of<br />
Obstetrics & Gynaecology,<br />
University of Cambridge<br />
Bourn Hall Clinic/Cambridge University<br />
Dr Ruth Curson<br />
Associate Specialist<br />
King's College Hospital, London<br />
Dr Melanie Davies<br />
Consultant Obstetrician & Gynaecologist<br />
University College London Hospitals<br />
Mr Robert Forman<br />
Medical Director<br />
CRM London<br />
Professor Stephen Franks<br />
Professor of Reproductive Endocrinology<br />
St Mary's ICSM Campus, London<br />
Dr Mark Hamilton<br />
Consultant Obstetrician & Gynaecologist<br />
<strong>and</strong> Clinical Senior Lecturer<br />
University Of Aberdeen<br />
Dr Stewart Irvine<br />
Consultant/Clinical Scientist<br />
MRC <strong>Human</strong> Reproductive Sciences Unit,<br />
Edinburgh<br />
Mr Richard Kennedy<br />
Consultant Obstetrician & Gynaecologist<br />
Walsgrave Hospital, Coventry<br />
Mr Yacoub Khalaf<br />
Subspecialty Consultant<br />
in Reproductive Medicine<br />
Guy's <strong>and</strong> St Thomas' Hospitals Trust,<br />
London<br />
Mr Charles Kingsl<strong>and</strong><br />
Consultant Obstetrician & Gynaecologist<br />
<strong>and</strong> Honorary Lecturer<br />
Liverpool Women's Hospital<br />
Dr Gillian Lockwood<br />
Medical Director<br />
Midl<strong>and</strong> Fertility Services<br />
Mr Stephen Maguiness<br />
Consultant <strong>and</strong> Hon. Senior Lecturer,<br />
Obstetrics <strong>and</strong> Gynaecology<br />
Hull Royal Infirmary<br />
Mr Mohamed Menabawey<br />
Consultant Obstetrician & Gynaecologist<br />
University Hospital of Hartlepool<br />
Dr John Mills<br />
Consultant Obstetrician & Gynaecologist<br />
Ninewells Hospital, Dundee<br />
Dr Alison Murdoch<br />
Consultant Obstetrician & Gynaecologist,<br />
Honorary Senior Lecturer <strong>and</strong> Director of<br />
the Centre for Reproductive Medicine<br />
Newcastle Fertility Centre at Life<br />
Mr Roger Neuberg<br />
Co-Director BUPA, Leicester, Consultant<br />
Obstetrician & Gynaecologist <strong>and</strong> Director<br />
of Infertility Service<br />
Leicester Royal Infirmary<br />
Mr Julian Pampiglione<br />
Consultant Obstetrician & Gynaecologist<br />
The Royal Bournemouth Hospital<br />
Mr John Parsons<br />
Senior Lecturer <strong>and</strong> Honorary Consultant<br />
King's College Hospital, London<br />
Dr Elizabeth Pease<br />
Consultant<br />
St Mary's Hospital, Manchester<br />
Mr Nigel Perks<br />
Consultant Obstetrician & Gynaecologist<br />
Queen Elizabeth Hospital, Woolwich<br />
Dr David Polson<br />
Consultant Obstetrician & Gynaecologist<br />
Salford Royal IVF & Fertility Centre<br />
Mr Nagy Rafla<br />
Consultant Obstetrician & Gynaecologist<br />
Chaucer Hospital, Canterbury<br />
Mr Andrew Riddle<br />
Consultant Obstetrician & Gynaecologist<br />
Frimley Park Hospital NHS Trust,<br />
Camberley<br />
Mr Robert Sawers<br />
Consultant Obstetrician & Gynaecologist<br />
<strong>and</strong> Programme Director<br />
BMI Priory Hospital, Edgbaston<br />
Mr Eric Simons<br />
Medical Director<br />
Cromwell Hospital, London<br />
Dr Alison Taylor<br />
Consultant in Gynaecology <strong>and</strong><br />
Reproductive Medicine <strong>and</strong> Senior Lecturer<br />
Guy's <strong>and</strong> St Thomas' Hospitals Trust,<br />
London<br />
Dr K. Joo Thong<br />
Consultant,<br />
Assisted Conception Programme<br />
Edinburgh Assisted Conception Unit<br />
Mr Peter Wardle<br />
Consultant <strong>and</strong> Senior Lecturer in<br />
Obstetrics <strong>and</strong> Gynaecology<br />
Southmead Hospital, Bristol<br />
Dr Robin Yates<br />
Medical Research Director<br />
Assisted Conception Unit,<br />
Royal Infirmary, Glasgow<br />
Embryo Biopsy Inspectors<br />
Dr Anick De Vos<br />
Clinical Embryologist<br />
Academish Ziekenhuis Laarbeeklaan,<br />
Belgium<br />
Professor Alan H<strong>and</strong>yside<br />
Professor<br />
Leeds Teaching Hospitals<br />
Dr Joyce Harper<br />
Lecturer in <strong>Human</strong> Genetics<br />
<strong>and</strong> <strong>Embryology</strong><br />
University College London Hospitals<br />
Dr Sue Pickering<br />
Scientific Director<br />
Guy's <strong>and</strong> St Thomas' Hospitals Trust,<br />
London<br />
Professor Andre van Steirteghem<br />
Scientific Co-ordinator<br />
Academish Ziekenhuis Laarbeeklaan,<br />
Belgium<br />
<strong>HFEA</strong> <strong>Report</strong> | 25
Scientific Inspectors<br />
Dr Virginia Bolton<br />
Senior Lecturer <strong>and</strong> Senior Embryologist<br />
King's College Hospital, London<br />
Dr John Clarke<br />
Retired Lecturer in Zoology<br />
University of Oxford<br />
Mrs Jane Cuthbert<br />
Fertility Centre Manager<br />
<strong>and</strong> Senior Embryologist<br />
BMI Priory Hospital, Edgbaston<br />
Ms Karin Dawson<br />
Consultant Embryologist<br />
Hammersmith Hospital<br />
Dr Simon Fishel<br />
Managing Director<br />
Centres for Assisted Reproduction<br />
(CARE) Ltd, Park Hospital, Arnold,<br />
Nottingham<br />
Professor Tom Fleming<br />
Professor<br />
University of Southampton<br />
Professor Lynn Fraser<br />
Professor of Reproductive Biology<br />
King's College, London<br />
Dr Ceinwen Gearon<br />
IVF Laboratory Director<br />
Lister Hospital, London<br />
Mr David Gibbon<br />
Senior Embryologist<br />
South Clevel<strong>and</strong> Hospital<br />
Dr John Keith<br />
Senior Scientist<br />
Edinburgh Assisted Conception Unit<br />
Mr Terry Leonard<br />
Co-Director<br />
Isis Fertility Centre, Colchester<br />
Mr Stephen Lynch<br />
Senior Embryologist <strong>and</strong><br />
Person Responsible<br />
BMI Chaucer Hospital, Canterbury<br />
Dr Alan McDermott<br />
Director<br />
Regional Cytogenetics Centre,<br />
Southmead Hospital, Bristol<br />
Dr David Morroll<br />
Consultant Embryologist<br />
Leeds Teaching Hospitals<br />
Dr Lynne Nice<br />
Fertility Services Manager<br />
BMI Chiltern Hospital, Great Missenden<br />
Dr Allan Pacey<br />
Senior Lecturer in Andrology<br />
University of Sheffield<br />
Ms Barbara Ray<br />
Principle Embryologist<br />
Centre for Reproductive Medicine,<br />
Bristol<br />
Dr John Robinson<br />
Scientific Director<br />
Hull IVF Programme,<br />
Princess Royal Hospital, Hull<br />
Reverend Professor Mary Seller<br />
Professor of Development Genetics<br />
Medical <strong>and</strong> Molecular Genetics,<br />
Guy's Hospital London<br />
Dr Arasaratnam Srikantharajah<br />
Research Embryologist<br />
University Of Aberdeen<br />
Dr Stephen Troup<br />
Scientific Director<br />
Liverpool Women's Hospital<br />
Dr Karen Turner<br />
Clinical Laboratory Director<br />
Oxford Fertility Unit<br />
Dr Maureen Wood<br />
Scientist<br />
University Of Aberdeen<br />
Social <strong>and</strong> Ethical Inspectors<br />
Mrs Linda Breeze<br />
Psychosexual Therapist <strong>and</strong><br />
Fertility Counsellor<br />
Royal Devon <strong>and</strong> Exeter Hospital<br />
Mrs Jennifer Clifford<br />
Counsellor<br />
Self Employed<br />
Mrs Elizabeth Corrigan<br />
Business Manager <strong>and</strong> Nursing Director<br />
Centre for Reproductive Medicine, Bristol<br />
Ms Marilyn Crawshaw<br />
Teaching fellow in Social Work<br />
University of York<br />
Mrs Jennifer Dunlop<br />
Senior Counsellor<br />
Central Manchester Healthcare Trust (NHS)<br />
Mrs Heideh Hillier<br />
IVF Nurse Manager<br />
Edinburgh Assisted Conception Unit<br />
Ms Margret Inglis<br />
Counsellor<br />
Royal Free Hospital, London<br />
Mrs Helen Kendrew<br />
Clinical Nurse Manager<br />
Bath Assisted Conception Clinic<br />
Ms Janice Kerr<br />
Manager of Cancer Service,<br />
National Service Framework<br />
Worchester Acute NHS Trust<br />
Mrs Caroline Lewis<br />
Assisted Conception Unit Manager<br />
Woking Nuffield Hospital ACS Unit<br />
Ms Katherine Mangold<br />
Unit Manager of IVF &<br />
Out Patients Department<br />
BMI Portl<strong>and</strong> Hospital, London<br />
Dr Jim Monach<br />
Lecturer<br />
School of Health <strong>and</strong> Related Research,<br />
University of Sheffield<br />
Mrs Yvonne Payne<br />
Assisted Conception Services Manager<br />
Thames Valley Nuffield Hospital<br />
Mrs Roz Shaw-Smith<br />
Counselling Psychologist<br />
John Radcliffe Hospital, Oxford<br />
Ms Jennifer Speirs<br />
Infertility Counsellor <strong>and</strong> Social Work Consultant<br />
Freelance, Edinburgh<br />
Other Inspectors<br />
Ms Sarah Biggs<br />
Stroud Gloucester<br />
Ms Marney Prouse<br />
Vice President<br />
Guy Carpenter <strong>and</strong> Co (Ltd)<br />
<strong>HFEA</strong> <strong>Report</strong> | 26
Appendix Four<br />
Ongoing research projects licensed by the <strong>HFEA</strong> (as of 31 August 20<strong>04</strong>)<br />
In vitro development <strong>and</strong> implantation of<br />
normal human pre-implantation embryos<br />
<strong>and</strong> comparison with uni- or poly-pronucleate<br />
pre-embryos<br />
University of Manchester R0026*<br />
Research started: 1 March 1997<br />
Number of <strong>HFEA</strong> licences issued: 5<br />
To measure the activity of metabolic enzymes<br />
in spare human pre-implantation embryos<br />
Hammersmith Hospital R0030<br />
Research started: 30 July 1993<br />
Number of <strong>HFEA</strong> licences issued: 8<br />
To measure the activity of enzymes implicated<br />
in genetic disorders<br />
Hammersmith Hospital R0031<br />
Research started: 30 July 1997<br />
Number of <strong>HFEA</strong> licences issued: 8<br />
Pre-implantation genetic diagnosis –<br />
parallel investigations<br />
Hammersmith Hospital R0033<br />
Research started: 30 July 1997<br />
Number of <strong>HFEA</strong> licences issued: 8<br />
Biochemistry of early human embryos<br />
University of York R0067<br />
Research started: 25 January 1995<br />
Number of <strong>HFEA</strong> licences issued: 6<br />
Improving methods for pre-implantation<br />
genetic diagnosis of inherited genetic<br />
disease <strong>and</strong> predicting embryo quality<br />
Guys Hospital R0075<br />
Research started: 15 July 1994<br />
Number of <strong>HFEA</strong> licences issued: 8<br />
A study of the effects of the cell death on the<br />
further development of human embryos in vitro<br />
Centre for Reproductive Medicine,<br />
Coventry R0094<br />
Research started: 25 February 1996<br />
Number of <strong>HFEA</strong> licences issued: 5<br />
Maturation <strong>and</strong> fertilisation of human eggs<br />
in vitro<br />
Clarendon Wing – Leeds R01<strong>04</strong><br />
Research started: 14 March 1997<br />
Number of <strong>HFEA</strong> licences issued: 3<br />
Detection of autosome <strong>and</strong> sex chromosome<br />
abnormalities in human preimplantion embryos<br />
using fluorescent in situ hyridisation (FISH) <strong>and</strong><br />
the polymerase chain reaction (PCR)<br />
Glasgow Royal Infirmary R0108<br />
Research started: 2 March 1998<br />
Number of <strong>HFEA</strong> licences issued: 3<br />
in vitro maturation <strong>and</strong> fertilisation of<br />
immature oocytes from woman under going<br />
icsi treatment<br />
Centre for Reproductive Medicine, Coventry R0110<br />
Research started: 11 May 1998<br />
Number of <strong>HFEA</strong> licences issued: 4<br />
Development of a model to study<br />
implantation in the human<br />
Oxford Fertility Unit R0111<br />
Research started: 9 March 1998<br />
Number of <strong>HFEA</strong> licences issued: 3<br />
The development of novel PGD procedures<br />
<strong>and</strong> the study of early human development<br />
UCH London R0113<br />
Research started: 22 June 1998<br />
Number of <strong>HFEA</strong> licences issued: 3<br />
An investigation of embryonic-endometrial<br />
dialogue during the pre-implantation period<br />
in vitro<br />
Section of Reproductive <strong>and</strong> Developmental<br />
Medicine R0115<br />
Research started: 1 September 1998<br />
Number of <strong>HFEA</strong> licences issued: 4<br />
Biopsy of pronucleate embryos<br />
Hewitt Centre for Reproductive Medicine R0121<br />
Research started: 14 February 2000<br />
Number of <strong>HFEA</strong> licences issued: 3<br />
An investigation of the effect of blastomere<br />
removal for preimplantation genetic diagnosis<br />
on subsequent embryonic development<br />
Newcastle Fertility Centre at Life R0122<br />
Research started: 21 June 2000<br />
Number of <strong>HFEA</strong> licences issued: 2<br />
Derivation of pluripotent human embryo<br />
cell lines<br />
Institute for Stem Cell Research R0132<br />
Research started: 4 November 2002<br />
Number of <strong>HFEA</strong> licences issued: 1<br />
Correlation of embryo morphology with ability<br />
to generate embryonic stem cell lines <strong>and</strong><br />
subsequent growth <strong>and</strong> differentiative<br />
characteristics<br />
Guys Hosptial R0133<br />
Research started: 15 April 2002<br />
Number of <strong>HFEA</strong> licences issued: 1<br />
A novel protocol for extracting cells during<br />
embryo biopsy without the use of acid tyrodes<br />
CARE Nottingham R0135<br />
Research started: 17 September 2002<br />
Number of <strong>HFEA</strong> licences issued: 1<br />
<strong>HFEA</strong> <strong>Report</strong> | 27
Platform technologies underpinning human<br />
embryonic stem cell derivation<br />
Division of Gene Expression <strong>and</strong> Development,<br />
Roslin Institute R0136<br />
Research started: 1 July <strong>2003</strong><br />
Number of <strong>HFEA</strong> licences issued: 2<br />
Analysis of chromosomes in human<br />
preimplantation embryos using FISH <strong>and</strong> CGH<br />
London Fertility Centre R0140<br />
Research started: 1 October <strong>2003</strong><br />
Number of <strong>HFEA</strong> licences issued: 1<br />
Evaluation of cardio myocytes derived from<br />
embryonic stem cells as a means to characterise<br />
receptor/channel expression in human tissue<br />
NURTURE R0141<br />
Research started: 1 March 20<strong>04</strong><br />
Number of <strong>HFEA</strong> licences issued: 1<br />
Enviromental sensitivity of the human<br />
pre-implantation embryo<br />
Princess Anne Hospital Fertility Unit R0142<br />
Research started: 30 September <strong>2003</strong><br />
Number of <strong>HFEA</strong> licences issued: 1<br />
Isolation of human embryonic stem cells<br />
<strong>and</strong> in vitro derivation of specific cell types<br />
Chelsea & Westminster Hospital R0150<br />
Research started: 19 February 20<strong>04</strong><br />
Number of <strong>HFEA</strong> licences issued: 1<br />
Chromatin <strong>and</strong> epigenetic associated with<br />
the development <strong>and</strong> generation of ES cells<br />
Birmingham Women's Hospital R0151*<br />
Research started: 8 March 20<strong>04</strong><br />
Number of <strong>HFEA</strong> licences issued: 1<br />
Derivation of human embryonic stem cell lines<br />
using nuclear transfer <strong>and</strong> pathenogenetically<br />
activated oocytes<br />
Newcastle Fertility Centre at Life R0152<br />
Research started: 11 August 20<strong>04</strong><br />
Number of <strong>HFEA</strong> licences issued: 1<br />
* research based at more than one centre<br />
To derive human embryonic stem cells <strong>and</strong><br />
trophoblast cell lines<br />
Oxford Fertility Unit R0143<br />
Research started: 14 August <strong>2003</strong><br />
Number of <strong>HFEA</strong> licences issued: 1<br />
The derivation, characterisation <strong>and</strong><br />
differentiation of human embryonic stem cells –<br />
a comparative analysis with normal human<br />
embryonic <strong>and</strong> foetal development <strong>and</strong> human<br />
embryonic germ cells<br />
Princess Anne Hospital Fertility Unit R0144<br />
Research started: 20 November <strong>2003</strong><br />
Number of <strong>HFEA</strong> licences issued: 1<br />
Epigenetic studies of preimplantation embryos<br />
<strong>and</strong> derived stem cells<br />
Newcastle Fertility Centre at Life R0145<br />
Research started: 5 August <strong>2003</strong><br />
Number of <strong>HFEA</strong> licences issued: 1<br />
Investigation into the role of sperm plc zeta<br />
In human oocyte activation<br />
University College London R0147<br />
Research started: 30 September <strong>2003</strong><br />
Number of <strong>HFEA</strong> licences issued: 1<br />
To develop pre-implantation genetic diagnosis<br />
(PGD) for mitochondrial dna disease<br />
Oxford Fertility Unit R0149<br />
Research started: 3 June 20<strong>04</strong><br />
Number of <strong>HFEA</strong> licences issued: 1<br />
<strong>HFEA</strong> <strong>Report</strong> | 28
Appendix Five<br />
<strong>HFEA</strong> peer reviewers (as of 31 August 20<strong>04</strong>)<br />
Professor R J Aitken<br />
Professor of Reproductive Biology<br />
University of Newcastle, Australia<br />
Mr Adam Balen<br />
Person Responsible <strong>and</strong> Accredited Consultant<br />
Leeds General Infirmary<br />
Dr Siladitya Bhattacharya<br />
Senior Clinical Lecturer<br />
University of Aberdeen<br />
Dr Virginia Bolton<br />
Senior Lecturer <strong>and</strong> Senior Embryologist<br />
King's College Hospital, London<br />
Professor Nigel Brown<br />
Professor of Developmental Biology<br />
St George’s Hospital Medical School<br />
Professor Keith Campbell<br />
Professor of Animal Development<br />
University of Nottingham<br />
Dr John Carroll<br />
Lecturer in the field of Physiology <strong>and</strong><br />
Developmental Biology<br />
University College London<br />
Professor Jose Cibelli<br />
Professor of Biotechnology<br />
Michigan State University, USA<br />
Dr J R T Coutts<br />
Retired Reader in Reproductive Endocrine<br />
Glasgow<br />
Professor Mark Curry<br />
Senior Lecturer in Equine Science<br />
De Montford University<br />
Ms Karin Dawson<br />
Consultant Embryologist<br />
Hammersmith Hospital<br />
Professor Joy Delhanty<br />
Professor of <strong>Human</strong> Genetics<br />
University College London<br />
Dr Simon Fishel<br />
Managing Director<br />
Centres for Assisted Reproduction (CARE) Ltd.,<br />
Nottingham<br />
Dr Richard Fleming<br />
Consultant Biochemist<br />
Glasgow Royal Infirmary<br />
Professor Stephen Franks<br />
Professor of Reproductive Endocrinology<br />
St Mary’s Imperial College<br />
Professor Lynn Fraser<br />
Professor of Reproductive Biology<br />
King’s College London<br />
Dr Rafet Gazvani<br />
Consultant Gynaecologist <strong>and</strong> sub-specialist<br />
in New Production Medicine<br />
Liverpool Women’s Hospital<br />
Dr Mark Hamilton<br />
Consultant Obstetrician <strong>and</strong> Gynaecologist<br />
<strong>and</strong> Clinical Senior Lecturer<br />
University of Aberdeen<br />
Professor Alan H<strong>and</strong>yside<br />
Chair of Dev. Biology<br />
University of Leeds/London Bridge Fertility,<br />
Gynaecology & Genetic Centre<br />
Dr Joyce Harper<br />
Lecturer in <strong>Human</strong> Genetics <strong>and</strong> <strong>Embryology</strong><br />
University College London<br />
Dr Geraldine Hartshorne<br />
Principal Research Fellow<br />
University of Warwick<br />
Dr D S Irvine<br />
Clinical Consultant<br />
Medical Research Council<br />
Dr Mark Johnson<br />
Consultant Obstetrician<br />
Chelsea <strong>and</strong> Westminster NHS Trust<br />
Professor Martin Johnson<br />
Professor of Reproductive Sciences<br />
University of Cambridge<br />
Dr Sue Kimber<br />
Reader, Faculty of Life Science<br />
University of Manchester<br />
Mr Charles Kingsl<strong>and</strong><br />
Consultant Obstetrician <strong>and</strong><br />
Gynaecologist <strong>and</strong> Honorary Lecturer<br />
The Women’s Hospital,<br />
Liverpool<br />
Professor G E Lamming<br />
Retired/Emeritus Professor<br />
University of Nottingham<br />
<strong>HFEA</strong> <strong>Report</strong> | 29
Dr Alan McDermott<br />
Scientific Director<br />
University of Bristol<br />
Professor Alan McNeilly<br />
Professor <strong>and</strong> Deputy Director<br />
MRC, Edinburgh<br />
Dr Tony Michael<br />
Senior Lecturer in Biochemistry & Molecular<br />
Biology<br />
University College London<br />
Professor Marilyn Monk<br />
Head of Molecular <strong>Embryology</strong> Unit<br />
Institute of Child Health, London<br />
Professor Robert Webb<br />
Professor of Animal Science<br />
University of Nottingham<br />
Dr Michael Whitaker<br />
Dean of Research<br />
University of Newcastle<br />
Professor David Whittingham<br />
Retired but Emeritus Professor Experimental<br />
<strong>Embryology</strong><br />
London<br />
Dr Maureen Wood<br />
Research Embryologist<br />
University of Aberdeen<br />
Professor H D M Moore<br />
Professor of Reproductive Biology<br />
Hallamshire Hospital, Sheffield<br />
Professor R Moore<br />
Officially Retired, Molecular Embryologist<br />
AFRC, Cambridge<br />
Dr David Pegg<br />
Director of Medical Cryobiology Unit<br />
University of York<br />
Dr Helen Picton<br />
Reader in Reproduction & Early Development<br />
University of Leeds<br />
Dr Ian Sargent<br />
Professor<br />
University of Oxford<br />
Dr Bert Smeets<br />
Associate Professor <strong>and</strong> Head of Genome Centre<br />
University of Maastricht, Netherl<strong>and</strong>s<br />
Professor Austin Smith<br />
Head of Institute for Stem Cell Research<br />
University of Edinburgh<br />
Dr Karl Swann<br />
Reader in Cell Physiology<br />
University College London<br />
Professor Allan Templeton<br />
Head of Department<br />
University of Aberdeen<br />
Professor James Thomson<br />
Professor of Anatomy<br />
University of Wisconsin-Madison, USA<br />
<strong>HFEA</strong> <strong>Report</strong> | 30
Appendix Six<br />
Members’ Interests (as of 31 August 20<strong>04</strong>)<br />
Please note in the Financial Accounts<br />
for the Year Ended 31 March 20<strong>04</strong> at<br />
note 15 to the accounts (related party<br />
transactions), there are references to<br />
fees invoiced by <strong>HFEA</strong> to the clinics<br />
or NHS Trusts where some <strong>HFEA</strong><br />
members have senior management<br />
responsibilities. These fees are licence<br />
fees paid by the clinics to <strong>HFEA</strong> <strong>and</strong><br />
are not amounts paid to the members.<br />
Suzi Leather (Chair)<br />
Personal interests<br />
Consultancies <strong>and</strong>/or direct employment:<br />
• None<br />
Fee-paid work other than that associated<br />
with the <strong>HFEA</strong>:<br />
• None<br />
Shareholdings:<br />
• None<br />
Other Public Appointments:<br />
• None<br />
Other:<br />
• Member of the Labour Party<br />
• Member of the Christian<br />
Socialist Movement<br />
• Individual member of the National<br />
Heart Forum<br />
• Member of the Child Poverty<br />
Action Group<br />
• Member of the Organophosphate<br />
Information Network<br />
• Member of Council, University of Exeter<br />
• Member of the Chancellor’s Advisory<br />
Council, University of Exeter<br />
• Honorary Fellow, Royal College of<br />
Obstetricians <strong>and</strong> Gynaecologists<br />
• Glasgow Centre for Population Health –<br />
Member of the External Advisory Group<br />
• Member of the Better Hospital<br />
Food Forum<br />
• Chair of Steering Committee<br />
(Tommy’s, the Baby Charity)<br />
– Teenage Pregnancies: Dietary<br />
Measures to improve nutrition <strong>and</strong><br />
pregnancy outcome<br />
Professor Tom Baldwin<br />
Personal interests<br />
Consultancies <strong>and</strong>/or direct employment:<br />
• Professor of Philosophy at the University<br />
of York<br />
Fee-paid work other than that associated<br />
with the <strong>HFEA</strong>:<br />
• None<br />
Shareholdings:<br />
• GlaxoSmithKline<br />
• Pfizer<br />
<strong>HFEA</strong> <strong>Report</strong> | 31<br />
• Johnson & Johnson<br />
• AstraZeneca<br />
Other Public Appointments:<br />
• Member of Stem Cell Steering<br />
Committee<br />
Other:<br />
• Member of the Nuffield Council<br />
on Bioethics<br />
Professor David Barlow<br />
Personal interests<br />
Consultancies <strong>and</strong>/or direct employment:<br />
• Nuffield Professor of Obstetrics <strong>and</strong><br />
Gynaecology, University of Oxford<br />
• Head of Oxford Fertility Unit <strong>and</strong> <strong>HFEA</strong><br />
Person Responsible<br />
Fee-paid work other than that associated<br />
with the <strong>HFEA</strong>:<br />
• Astra Zeneca<br />
(Advisory Board Consultancy)<br />
Shareholdings:<br />
• Oxford Reproductive Biosystems –<br />
(potential University of Oxford spin-out,<br />
not trading) – shares as founder have<br />
no current value<br />
• Minor shareholdings resulting from<br />
building society <strong>and</strong> insurance<br />
company flotations<br />
Other Public Appointments:<br />
• None<br />
Other:<br />
• Directorships:<br />
• British Menopause Society<br />
Publications Limited<br />
• British Menopause Society<br />
• Oxford Reproductive Biosystems<br />
(not trading)<br />
• Memberships:<br />
• Academy of Medical Sciences<br />
(Fellow)<br />
• National Osteoporosis Society<br />
(Chairman)<br />
• British Menopause Society<br />
(Past Chairman)<br />
• Royal College of Obstetricians<br />
& Gynaecologists (Fellow)<br />
• Royal College of Physicians (Member)<br />
• American Society for Reproductive<br />
Medicine<br />
• British Fertility Society<br />
• European Society for <strong>Human</strong><br />
Reproduction <strong>and</strong> <strong>Embryology</strong><br />
• International Menopause Society<br />
• NICE Osteoporosis Guidelines<br />
Development Group (Chairman)<br />
• European Menopause <strong>and</strong><br />
Andropause Society (EMAS)<br />
(Vice President)<br />
• Trusteeships:<br />
• National Osteoporosis Society<br />
• British Menopause Society<br />
• Oxford Hospitals Charitable<br />
Trust Funds<br />
• Publishing:<br />
• Oxford University Press – Editor in<br />
Chief of <strong>Human</strong> Reproduction<br />
• Cochrane Collaboration – Editor of<br />
Menstrual Disorders & Subfertility<br />
Group Health Press<br />
• Member of Editorial Boards of<br />
“Menopause” <strong>and</strong> “Best Practice<br />
in Obstetrics <strong>and</strong> Gynaecology”<br />
• Advisory Committees:<br />
• Astra Zeneca<br />
• Eli Lilly<br />
• Medical Research Council<br />
• Merck<br />
• Pharmacia<br />
• Servier<br />
• Takeda<br />
• Novo Nordisk<br />
• Research Grants held at Department:<br />
• Action Research<br />
• Astra Zeneca<br />
• European Union<br />
• Medical Research Council<br />
• National Endometriosis Society<br />
• NHS R&D project grants scheme<br />
• Organon<br />
• OXAGEN<br />
• Schering<br />
• Serono<br />
• Servier<br />
• Shire<br />
• Takeda<br />
• Wellcome Trust<br />
• Wellbeing<br />
Professor Christopher Barratt<br />
Personal interests<br />
Consultancies <strong>and</strong>/or direct employment:<br />
• Scientific Director of the Assisted<br />
Conception Unit Birmingham Women's<br />
Health Care NHS Trust<br />
• Occasional consultancy in legal cases<br />
relating to assisted conception <strong>and</strong> male<br />
factor infertility<br />
Fee-paid work other than that associated<br />
with the <strong>HFEA</strong>:<br />
• None<br />
Shareholdings:<br />
• Genosis<br />
Other Public Appointments:<br />
• None<br />
Other: None
Professor Peter Braude<br />
Personal interests<br />
Consultancies <strong>and</strong>/or direct employment:<br />
• Head of Department of Women's<br />
Health, Guy’s, Kings <strong>and</strong> St Thomas'<br />
School of Medicine<br />
• Director of the Centre for<br />
Pre-implantation Genetic Diagnosis,<br />
Guy's <strong>and</strong> St Thomas' Trust<br />
• Honorary consultant in Gynaecology,<br />
Guy's <strong>and</strong> St Thomas' Trust<br />
• Occasional Consultancy <strong>and</strong> expert<br />
advisor to:<br />
• Serono Pharmaceuticals<br />
• Ares Serono<br />
• Tommy's the Baby Charity<br />
• Wellbeing<br />
• PPP<br />
• Progress<br />
• Bertarelli Foundation<br />
Fee-paid work other than that associated<br />
with the <strong>HFEA</strong>:<br />
• Publishing:<br />
• Mosby / Harcourt-Brace<br />
• Oxford University Press<br />
• British Medical Journal books<br />
Shareholdings:<br />
• Marks & Spencer<br />
• Centrica<br />
Other Public Appointments:<br />
• None<br />
Memberships:<br />
• Royal College of Obstetricians<br />
& Gynaecologists<br />
• British Fertility Society<br />
• American Society for<br />
Reproductive Medicine<br />
• European Society for <strong>Human</strong><br />
Reproduction <strong>and</strong> <strong>Embryology</strong><br />
• The Galton Society<br />
• Association of Professors of Obstetrics<br />
<strong>and</strong> Gynaecology<br />
Other:<br />
• Grants held at Department:<br />
• Tommy's the Baby Charity<br />
• Medical Research Council<br />
• Economic <strong>and</strong> Social<br />
Research Council<br />
• The Wellcome Foundation<br />
• British Heart Foundation<br />
• Organon<br />
• Ares Serono<br />
• Serono Pharmaceuticals UK<br />
• Wellbeing<br />
• Perkin Elmer<br />
• Guy's <strong>and</strong> St Thomas'<br />
Charitable Foundation<br />
• Sir Jules Thorn Trust<br />
• Zeneca<br />
Mr Ivor Brecker<br />
Personal interests<br />
Consultancies <strong>and</strong>/or direct employment:<br />
• General Dental Practitioner, Retired<br />
• Medico-legal consultancy for<br />
Community Health Councils (voluntary)<br />
• Consultancies for Dentists <strong>and</strong> Solicitors<br />
Fee-paid work other than that associated<br />
with the <strong>HFEA</strong>:<br />
• None<br />
Shareholdings:<br />
• GlaxoSmithKline<br />
• Abbey National<br />
• Bradford & Bingley<br />
Other Public Appointments:<br />
• None<br />
Other:<br />
• None<br />
Clare Brown<br />
Personal interests<br />
Consultancies <strong>and</strong>/or direct employment:<br />
• Chief Executive, Infertility Network UK<br />
Fee-paid work other than that associated<br />
with the <strong>HFEA</strong>:<br />
• None<br />
Shareholdings:<br />
• None<br />
Other Public Appointments:<br />
• None<br />
Other:<br />
• Patient representative on the British<br />
Fertility Society Management Committee<br />
• Member of the European Society of<br />
<strong>Human</strong> Reproduction <strong>and</strong> <strong>Embryology</strong><br />
• Member of the Labour Party<br />
• Chair of the National Infertility<br />
Awareness Campaign<br />
• Chair of the Organising Committee<br />
of National Infertility Day<br />
• Member of NICE Fertility Guideline Group<br />
• Chair of the European Infertility Alliance<br />
Professor Iain Cameron<br />
Personal interests<br />
Consultancies <strong>and</strong>/or direct employment:<br />
• Professor of Obstetrics <strong>and</strong><br />
Gynaecology <strong>and</strong> Head of the<br />
School of Medicine at the University<br />
of Southampton<br />
• Past consultancy with Leiras,<br />
Schering <strong>and</strong> Takeda (Pharmaceutical)<br />
Fee-paid work other than that associated<br />
with <strong>HFEA</strong>:<br />
• Publishing / Lecturing for various<br />
organisations<br />
Shareholdings:<br />
• None<br />
Other Public Appointments:<br />
• None<br />
Other:<br />
• Royal College of Obstetricians <strong>and</strong><br />
Gynaecologists (Chairman joint RCOG /<br />
WellBeing Research Advisory Committee)<br />
• MRC Advisory Board<br />
• Scientific Committee,<br />
National Endometriosis Society<br />
• Expert Advisory Network, Health<br />
Technology Assessment Programme<br />
• Scientific <strong>and</strong> Ethical Review Group,<br />
Special Programme of Research,<br />
Development <strong>and</strong> Research Training<br />
in <strong>Human</strong> Reproduction, World Health<br />
Organisation<br />
Memberships:<br />
• Society for Reproduction <strong>and</strong> Fertility<br />
• Blair Bell Research Society<br />
• British Fertility Society<br />
• American Society for<br />
Reproductive Medicine<br />
• Endocrine Society<br />
• Society for the Study<br />
of Reproduction<br />
• Society for Gynaecologic<br />
Investigation<br />
• Society for Endocrinology<br />
• Research:<br />
• Current work focuses on<br />
mechanisms underlying the<br />
developmental origins of adult<br />
disease, including collaborations<br />
investigating the embryo, stem cells,<br />
placenta <strong>and</strong> endometrium<br />
• Grants held in the Department of<br />
Obstetrics <strong>and</strong> Gynaecology:<br />
• The Solent Subfertility Trust<br />
• Pharmaceutical Industry<br />
Mrs Jane Denton<br />
Personal interests<br />
Consultancies <strong>and</strong>/or direct employment:<br />
• Director of the Multiple Births<br />
Foundation, Queen Charlotte's &<br />
Chelsea Hospital London<br />
Fee-paid work other than that associated<br />
with the <strong>HFEA</strong>:<br />
• None<br />
Shareholdings:<br />
• TSB<br />
Other Public Appointments:<br />
• None<br />
Memberships:<br />
• <strong>Human</strong> Fertility (Editorial Board)<br />
• Royal College of Nursing – Fertility<br />
<strong>HFEA</strong> <strong>Report</strong> | 32
Nurses Group<br />
• Ethics Advisory Panel, Royal College<br />
of Nursing<br />
• British Infertility Counselling Association<br />
• International Society for Twin Studies<br />
• Grants held at MBF:<br />
• Hammersmith Hospitals Trust<br />
Special Trustees<br />
• The Henry Smith Charity<br />
Professor Neva Haites<br />
Personal interests<br />
Consultancies <strong>and</strong>/or direct employment:<br />
• Vice Principal <strong>and</strong> Head of the College<br />
on Life Science <strong>and</strong> Medicine<br />
• Professor at University of Aberdeen<br />
• Honorary Consultant in Clinical Genetics<br />
at NHS Grampian<br />
• Board Member – NHS Grampian<br />
• Special Advisor (Medical Genetics) to<br />
Chief Medical Officer (Scotl<strong>and</strong>)<br />
Fee-paid work other than that associated<br />
with the <strong>HFEA</strong>:<br />
• Member of Government Advisory<br />
Committee – Committee on Medical<br />
Aspects of Radiation in the Environment<br />
(COMARE)<br />
• Examining Post-Graduate Degrees<br />
Shareholdings:<br />
• Weatherford International PLC<br />
• A portfolio of shares managed under<br />
terms of a discretionary management<br />
agreement<br />
Other Public Appointments:<br />
• Member of National Screening Committee<br />
• Member of Advisory Group on<br />
General Research (Department<br />
of Health, Engl<strong>and</strong>)<br />
Other:<br />
• Chair appointment committees for<br />
University of Aberdeen appointments<br />
including ones in Department of<br />
Obstetricians <strong>and</strong> Gynaecologists.<br />
These individuals may be involved in<br />
Infertility Clinic<br />
• Member of the Biomedical <strong>and</strong><br />
Therapeutics Research Committee<br />
(Chief Scientist Office, Scotl<strong>and</strong>)<br />
Memberships:<br />
• Academy of Medical<br />
Sciences (Fellow)<br />
• American Society of<br />
Cancer Research<br />
• American Society of<br />
<strong>Human</strong> Genetics<br />
• British Society of <strong>Human</strong> Genetics<br />
• European Society of<br />
<strong>Human</strong> Genetics<br />
• Royal College of Pathology (Fellow)<br />
• Royal College of Physicians (Fellow)<br />
• Royal College of Physicians<br />
(Edinburgh) (Fellow)<br />
• Sing Guidelines on Breast Cancer<br />
<strong>HFEA</strong> <strong>Report</strong> | 33<br />
The Right Reverend Richard D Harries<br />
Personal interests<br />
Direct employment:<br />
• Bishop of Oxford<br />
Fee-paid work other than that associated<br />
with the <strong>HFEA</strong>:<br />
• Writer <strong>and</strong> broadcasting<br />
Shareholdings:<br />
• None<br />
Other Public Appointments:<br />
• None<br />
Other:<br />
• Member of Nuffield Council on<br />
Bio Ethics<br />
Ms Jennifer Hunt<br />
Personal interests<br />
Consultancies <strong>and</strong>/or direct employment:<br />
• Senior Infertility Counsellor, Wolfson<br />
Family Clinic, Hammersmith Hospital<br />
Fee-paid work other than that associated<br />
with the <strong>HFEA</strong>:<br />
• None<br />
Shareholdings:<br />
• None<br />
Other Public Appointments:<br />
• None<br />
Other:<br />
• Member of the Project Group on<br />
Assisted Reproduction (PROGAR)<br />
• Member of the British Fertility Society<br />
• Member of the British Infertility<br />
Counselling Association<br />
• Member of the UK Donorlink<br />
Advisory Group<br />
• Member of the National Accreditation<br />
Board for Infertility Counselling<br />
Emily Jackson<br />
Personal interests<br />
Consultancies <strong>and</strong>/or direct employment:<br />
• Senior Lecturer in Law,<br />
London School of Economics<br />
• Professor, Queen Mary,<br />
University of London<br />
Fee-paid work other than that associated<br />
with the <strong>HFEA</strong>:<br />
• Fees for external examining<br />
Shareholdings:<br />
• None<br />
Other Public Appointments:<br />
• None<br />
Other:<br />
• Publishing:<br />
• Author royalties from<br />
academic publishers<br />
Dr Maybeth Jamieson<br />
Personal interests<br />
Consultancies <strong>and</strong>/or direct employment:<br />
• Consultant Embryologist;<br />
Assisted Conception Service,<br />
Glasgow Royal Infirmary<br />
Fee-paid work other than that associated<br />
with the <strong>HFEA</strong>:<br />
• None<br />
Shareholdings:<br />
• Scottish Power PLC<br />
Other Public Appointments:<br />
• None<br />
Other:<br />
• Member of the Association of Clinical<br />
Embryologists (Executive Committee <strong>and</strong><br />
Professional Development Committee)<br />
• Department Of Health Assessor For<br />
Clinical <strong>Embryology</strong><br />
• <strong>Embryology</strong> Assessor for the<br />
Association of Clinical Scientists<br />
• Member of the European Society for<br />
<strong>Human</strong> Reproduction <strong>and</strong> <strong>Embryology</strong><br />
• Member of the British Fertility Society<br />
• Member of the Society for Reproduction<br />
<strong>and</strong> Fertility<br />
Mr Simon Jenkins<br />
Personal interests<br />
Consultancies <strong>and</strong>/or direct employment:<br />
• Columnist – The Times, Evening St<strong>and</strong>ard<br />
Fee-paid work other than that associated<br />
with the <strong>HFEA</strong>:<br />
• Author, Broadcasting <strong>and</strong><br />
Freelance writing<br />
Shareholdings:<br />
• Newscorp<br />
• Emap<br />
• Abbey National<br />
Other Public Appointments:<br />
• Somerset House Trust<br />
• Architecture Foundation<br />
Other:<br />
• None<br />
Mr Walter Merricks<br />
Personal interests<br />
Consultancies <strong>and</strong>/or direct employment:<br />
• Chief Ombudsman, Financial<br />
Ombudsman Service – a scheme<br />
operated under the terms of the Financial<br />
Services <strong>and</strong> Markets Act 2000<br />
Fee-paid work other than that associated<br />
with the <strong>HFEA</strong>:<br />
• None<br />
Shareholdings:<br />
• A portfolio of shares managed under the<br />
terms of a discretionary management<br />
agreement by L A Invest of Lewes,<br />
East Sussex<br />
Other Public Appointments:<br />
• None<br />
Other:<br />
• Secretary <strong>and</strong> Treasurer of Donor<br />
Conception Network, a charitable network<br />
of parents with children conceived with<br />
donated gametes – donor insemination<br />
<strong>and</strong> IVF with donor sperm or eggs – adult<br />
offspring <strong>and</strong> those contemplating or
undergoing treatment<br />
• A parent of two children conceived<br />
through donor insemination<br />
Ms Sara Nathan<br />
Personal interests<br />
Consultancies <strong>and</strong>/or direct employment:<br />
• Freelance broadcast producer<br />
Fee-paid work other than that associated<br />
with the <strong>HFEA</strong>:<br />
• Lay Member, Professional Conduct<br />
Committee of the Bar Council<br />
Shareholdings:<br />
• Williams<br />
• Rio Tinto<br />
• Shell<br />
• Imperial Chemical<br />
• Cookson Group<br />
• Diageo<br />
• GlaxoSmithKlein<br />
Other Public Appointments:<br />
• Member of the Criminal Injuries<br />
Compensation Appeals Panel<br />
• Member, Regulatory Decisions<br />
Committee, Financial Services Authority<br />
• Marshall Commissioner<br />
• Member, Ofcom <strong>and</strong> Deputy Chairman<br />
of Ofcom's Content Board<br />
• Member, ICSTIS<br />
Other:<br />
• Council Member, Jewish Museum<br />
Ms Sharmila Nebhrajani<br />
Personal interests<br />
Consultancies <strong>and</strong>/or direct employment:<br />
• Chief Operating Officer <strong>and</strong> Finance<br />
Director, BBC New Media & Technology<br />
Fee-paid work other than that associated<br />
with the <strong>HFEA</strong>:<br />
• None<br />
Shareholdings:<br />
• Small personal shareholdings in<br />
selected plcs<br />
Other Public Appointments:<br />
• None<br />
<strong>HFEA</strong> <strong>Report</strong> | 34
Appendix Seven<br />
Performance indicators (for the period April <strong>2003</strong> – March 20<strong>04</strong>, unless otherwise indicated)<br />
Inspection <strong>and</strong> Regulation<br />
Inspections – Unannounced<br />
A formal programme of unannounced inspections was introduced in April <strong>2003</strong>. Centres targeted by<br />
the three unannounced inspections where selected at r<strong>and</strong>om. Following the inspections feedback<br />
<strong>and</strong> learning points were assessed <strong>and</strong> future unannounced inspections will not only be carried out<br />
on a r<strong>and</strong>om selection of centres but also on centres which have been assessed to be of specific risk.<br />
A target of eight unannounced inspections has been set for the year April 20<strong>04</strong> – March 2005.<br />
Performance Indicator Target April <strong>2003</strong> – April 2002 –<br />
March 20<strong>04</strong> March <strong>2003</strong><br />
Minimum of three unannounced 90% (3) 3 N/A<br />
inspections carried out in the year<br />
Inspections – Announced<br />
As a guide, an average of 8.75 inspections need to be carried out each month in order to ensure<br />
that each centre receives one inspection per year. Figure 1 shows inspection activity against a<br />
minimum target.<br />
Figure 1 – Planned <strong>and</strong> Completed Inspections April <strong>2003</strong> – March 20<strong>04</strong><br />
25<br />
20<br />
15<br />
10<br />
5<br />
0<br />
Apr-03 May-03 Jun-03 Jul-03 Aug-03 Sep-03 Oct-03 Nov-03 Dec-03 Jan-<strong>04</strong> Feb-<strong>04</strong> Mar-<strong>04</strong><br />
Inspections Planned<br />
Inspections Completed<br />
8.75 Inspections<br />
Planned <strong>and</strong> Completed Cumulative Inspection data April <strong>2003</strong> – March 20<strong>04</strong><br />
Inspections April <strong>2003</strong> – April 2002 –<br />
March 20<strong>04</strong> March <strong>2003</strong><br />
Planned 117 124*<br />
Completed (<strong>Annual</strong> <strong>and</strong> Unannounced) 129 121<br />
Minimum Target 105 105<br />
* three centres exempted from inspection by Licence Committee<br />
Performance Indicator Target April <strong>2003</strong> – April 2002 –<br />
March 20<strong>04</strong> March <strong>2003</strong><br />
<strong>Report</strong>s Resulting from inspection 90% 61% 60%<br />
available to centre within 4 weeks<br />
<strong>HFEA</strong> <strong>Report</strong> | 35
Figure 2 – Overall <strong>Report</strong> Production within 28 Days April <strong>2003</strong> – March 20<strong>04</strong><br />
100%<br />
90%<br />
80%<br />
70%<br />
60%<br />
50%<br />
40%<br />
30%<br />
20%<br />
10%<br />
0%<br />
Apr-03 May-03 Jun-03<br />
Jul-03 Aug-03 Sep-03 Oct-03 Nov-03 Dec-03 Jan-<strong>04</strong> Feb-<strong>04</strong> Mar-<strong>04</strong><br />
Rolling Average<br />
Target<br />
61 percent (73/119) of the reports issued in draft to the centres were sent within 28 days, compared<br />
to the performance target of 90%. Performance between April <strong>2003</strong> <strong>and</strong> March 20<strong>04</strong> matched the<br />
previous 12 month period. The lack of greater improvement in this key performance indicator was<br />
a disappointment for the <strong>HFEA</strong>; steps have been taken to ensure improvements over the next<br />
twelve months.<br />
Incidents<br />
Incidents are categorised according to severity:<br />
• Category A incidents include those involving major/serious harm to patients, gametes or embryos,<br />
or major/serious consequences for staff safety <strong>and</strong>/or service quality<br />
• Category B incidents relate to minor harm to patients, gametes or embryos, or major/serious<br />
consequences for staff safety <strong>and</strong>/or service quality<br />
• Near miss<br />
Figure 3 – Number of Incidents <strong>Report</strong>ed by Severity April <strong>2003</strong> – March 20<strong>04</strong><br />
10<br />
9<br />
8<br />
7<br />
6<br />
5<br />
4<br />
3<br />
2<br />
1<br />
0<br />
Apr-03 May-03 Jun-03 Jul-03 Aug-03 Sep-03 Oct-03 Nov-03 Dec-03 Jan-<strong>04</strong> Feb-<strong>04</strong> Mar-<strong>04</strong><br />
A B Near Miss<br />
<strong>HFEA</strong> Accounts | 36
Figure 4 – Split of Incident <strong>Report</strong>ed by Category April <strong>2003</strong> – March 20<strong>04</strong><br />
30 Laboratory Operator<br />
13 Laboratory Process<br />
10 General<br />
7 Laboratory Equipment<br />
7 Clinical<br />
5 Administration<br />
4 Consent<br />
3 Other<br />
Figure 4 shows the proportional split of incident categories for incidents reported in the year.<br />
Laboratory incidents continue to be the most commonly reported.<br />
Incidents reported April <strong>2003</strong> – March 20<strong>04</strong><br />
April <strong>2003</strong> – April 2002 –<br />
March 20<strong>04</strong> March <strong>2003</strong><br />
Incidents <strong>Report</strong>ed* 79 65<br />
* incidents can take several months to investigate <strong>and</strong> resolve<br />
No analysis of the incidents or breaches was released by the <strong>HFEA</strong> between April <strong>2003</strong> <strong>and</strong> March<br />
20<strong>04</strong>. An analysis of all incidents was distributed to centres in July 20<strong>04</strong>.<br />
Alerts<br />
The <strong>HFEA</strong> Alert system was introduced in April <strong>2003</strong>. The purpose of the <strong>HFEA</strong> Alerts is to help<br />
reduce risk <strong>and</strong> improve patient safety. A <strong>HFEA</strong> Alert is distributed whenever there are incidents which<br />
could occur at other centres. Between April <strong>2003</strong> <strong>and</strong> March 20<strong>04</strong> there were nine alerts issued, one<br />
of which was circulation of another organisation’s Alert (the Medicines <strong>and</strong> Healthcare products<br />
Regulatory Agency, MHRA).<br />
Performance Indicator Target April <strong>2003</strong> – April 2002 –<br />
March 20<strong>04</strong> March <strong>2003</strong><br />
Notification of events/incidents 90% 1 (11%) N/A<br />
circulated within 48 working hours<br />
on new Alert System<br />
This target was set before the <strong>HFEA</strong> Alert process was formalised. <strong>HFEA</strong> Alerts are sent out after full<br />
investigation of incidents <strong>and</strong> lengthy consultations with experts in the field on what lessons can be<br />
learned from the incident. In addition, great care is taken to ensure that patients affected have also<br />
been informed. This process has meant that only one Alert has been sent out within the target period.<br />
A more realistic goal will be set for April 20<strong>04</strong> – March 2005.<br />
Licensing Activity<br />
Licensing is a core duty of the Authority. Licence Committees met on 41 occasions <strong>and</strong> considered 287<br />
items of business. The total number of licences issued, which includes those that have been reissued<br />
following a change/variation is: 141 for treatment <strong>and</strong> storage centres <strong>and</strong> 15 for research projects.<br />
<strong>HFEA</strong> <strong>Report</strong> | 37
Figure 5 – Licence Committee April <strong>2003</strong> – March 20<strong>04</strong><br />
50 Interim Inspections<br />
63 Variations<br />
8 Short Licences<br />
2 Audits<br />
31 Practitioners<br />
14 Initial Inspections<br />
62 Renewal Inspections<br />
8 Closures<br />
32 Incidents<br />
17 Other<br />
Performance Indicator Target April <strong>2003</strong> – April 2002 –<br />
March 20<strong>04</strong> March <strong>2003</strong><br />
New licence applications processed 90% 1/1 (100%) 100%<br />
within four months from receipt<br />
Completed research licence applications 90% 4/5 (80%) 4/4 (100%)<br />
processed within four months of receipt<br />
Financial<br />
Payments<br />
Target: 90% of undisputed invoices to be paid in 30 days<br />
Out-turn <strong>2003</strong>/<strong>04</strong>: 89% (90% in 2002/03)<br />
Debts<br />
Target: 90% collected in 60 days<br />
Out-turn <strong>2003</strong>/<strong>04</strong>: 81% (2002/03: 74%). Achievement of this target was affected by a number of<br />
clinics requiring many reminders for payment<br />
Unqualified Audit <strong>Report</strong><br />
Out-turn <strong>2003</strong>/<strong>04</strong>: Achieved (2002/03: achieved)<br />
Monthly billing of clinics achieved in 3 weeks<br />
Target: 90%. Out-turn <strong>2003</strong>/<strong>04</strong>: 92% (2002/03: 75%)<br />
Corporate<br />
Number of hits on the <strong>HFEA</strong> website: 12,072,176 from August <strong>2003</strong> to August 20<strong>04</strong>. (3,070,815 from<br />
August 2002 – August <strong>2003</strong>)<br />
Number of events organised by the <strong>HFEA</strong>: 8 – the <strong>Annual</strong> Conference, the <strong>Annual</strong> Research<br />
Conference, the Code of Practice launch, Directory of Clinics launch, Sex Selection launch, BA Science<br />
Festival seminar, PGD Focus Group <strong>and</strong> Patient Information Focus Group (seven events in 2002/03)<br />
Number of patient/public enquiries h<strong>and</strong>led between August <strong>2003</strong> <strong>and</strong> August 20<strong>04</strong>: 10,500<br />
(8,022 for September 2002 – July <strong>2003</strong>)<br />
Authority Meetings held in public from September <strong>2003</strong> – September 20<strong>04</strong>: 3 (October <strong>2003</strong>,<br />
February <strong>and</strong> May 20<strong>04</strong>)<br />
<strong>HFEA</strong> Accounts | 38
<strong>HFEA</strong> <strong>Report</strong> | 39
Financial Accounts<br />
For the year ended 31 March 20<strong>04</strong><br />
<strong>HFEA</strong> Accounts | 40
Financial Accounts <strong>2003</strong>/20<strong>04</strong><br />
Foreword<br />
Background<br />
The <strong>Human</strong> <strong>Fertilisation</strong> <strong>and</strong> <strong>Embryology</strong><br />
Authority (<strong>HFEA</strong>) formally came into being<br />
on 7th November 1990 <strong>and</strong> began<br />
operating on 1st August 1991. The <strong>HFEA</strong><br />
was created by the <strong>Human</strong> <strong>Fertilisation</strong><br />
<strong>and</strong> <strong>Embryology</strong> Act 1990 to license <strong>and</strong><br />
regulate human embryo research <strong>and</strong><br />
specified forms of infertility treatment. The<br />
<strong>HFEA</strong> is an executive Non-Departmental<br />
Public Body sponsored by the Department<br />
of Health.<br />
Statutory Remit<br />
One of the main statutory functions of<br />
the <strong>HFEA</strong> is to regulate, by means of a<br />
licensing system, centres undertaking<br />
infertility treatments involving the<br />
creation or use of human embryos<br />
outside the body, the storage or<br />
donation of embryos or gametes or<br />
research involving human embryos.<br />
The <strong>HFEA</strong> is also required to maintain a<br />
register of information about all licensed<br />
treatments performed in the United<br />
Kingdom. This contains information about<br />
those receiving treatment, donors of<br />
gametes <strong>and</strong> embryos <strong>and</strong> any children<br />
born as a result of such treatments. At<br />
the age of 18 (or 16 if wishing to marry),<br />
people may enquire as to whether<br />
information held on the register shows<br />
that they were born as a result of this<br />
treatment, <strong>and</strong>, if so, whether they are<br />
related to a prospective spouse.<br />
In addition, the <strong>HFEA</strong> has other<br />
statutory responsibilities including:<br />
• publicising the services provided by<br />
it <strong>and</strong> by the centres it licenses;<br />
• publishing a Code of Practice giving<br />
guidance to centres on how they<br />
should carry out licensed activities;<br />
• giving information <strong>and</strong> advice to<br />
donors, to people seeking treatment or<br />
storage, or to people considering such<br />
action; <strong>and</strong><br />
• keeping the field under review <strong>and</strong><br />
providing advice to the Secretary of<br />
State for Health, if so requested.<br />
<strong>HFEA</strong> Accounts | 41<br />
Principal Activities<br />
The year <strong>2003</strong>/<strong>04</strong> saw a continuation<br />
of major developments to strengthen<br />
the work of the <strong>HFEA</strong>, with significant<br />
improvements in regulation <strong>and</strong><br />
communication with patients <strong>and</strong><br />
stakeholders.<br />
Regulation<br />
The <strong>HFEA</strong>’s primary objective remains the<br />
licensing <strong>and</strong> inspection of clinics <strong>and</strong><br />
centres carrying out in vitro fertilisation,<br />
donor insemination <strong>and</strong> human embryo<br />
research. This includes regulation of the<br />
storage of gametes <strong>and</strong> embryos.<br />
Improvements put in place during the<br />
year include:<br />
• r<strong>and</strong>om unannounced inspections<br />
established ;<br />
• new inspectors recruited <strong>and</strong> trained,<br />
<strong>and</strong> yearly validation of all inspectors<br />
initiated ;<br />
• pilot projects for patient involvement in<br />
inspections completed, following<br />
consultations with patients <strong>and</strong><br />
professional groups ;<br />
• implementation of st<strong>and</strong>ard inspection<br />
protocols <strong>and</strong> processes;<br />
• Alert System established to<br />
disseminate to all licensed centres the<br />
lessons from untoward incidents<br />
During <strong>2003</strong>/<strong>04</strong>, there were 242 <strong>HFEA</strong><br />
visits to licensed centres comprising:<br />
• 126 annual inspection visits<br />
• 45 audit visits<br />
• 23 visits for incident management<br />
• 6 variation inspections<br />
• 20 advisory visits<br />
• 18 practitioner inspections (embryo<br />
biopsy/Intra-Cytoplasmic Sperm<br />
Injection-ICSI)<br />
• 1 visits to new centres<br />
• 3 unannounced inspections<br />
During <strong>2003</strong>/<strong>04</strong>, 287 items of business<br />
were considered at 41 Licence<br />
Committee meetings; of these were:<br />
• 50 interim licenses<br />
• 63 variations to licenses<br />
• 8 short licenses<br />
• 31 applications for recognition of<br />
specific practitioners<br />
• 14 initial licenses<br />
• 8 revocations of license<br />
• 62 renewals<br />
• 32 Incidents<br />
• 19 miscellaneous<br />
Established centres are subject to a three<br />
year licensing cycle composed of one full<br />
<strong>and</strong> two interim inspections.<br />
Information Management<br />
The <strong>HFEA</strong> collects data from all licensed<br />
centres about IVF <strong>and</strong> donor insemination<br />
treatments, their outcomes <strong>and</strong> about<br />
every donor. A new database for the Data<br />
Register was developed with transfer <strong>and</strong><br />
validation of data from old systems well<br />
underway, to ensure the organisation can<br />
fulfil its statutory obligation to provide<br />
information to offspring. The <strong>HFEA</strong><br />
published a Directory of Clinics with<br />
user friendly information for patients on<br />
licensed centres, in collaboration with<br />
the Dr Foster organisation.<br />
Communications<br />
The <strong>HFEA</strong> launched a new website with<br />
sections for public, press <strong>and</strong> licensed<br />
centres. All information leaflets were<br />
updated <strong>and</strong> redesigned in consultation<br />
with user groups. A new leaflet on<br />
avoiding multiple births was published.<br />
<strong>HFEA</strong> held its first Research Conference<br />
in November <strong>2003</strong>.<br />
Policy<br />
A report on Sex Selection was published,<br />
following public consultation. A 6th<br />
edition of the Code of Practice for<br />
licensed centres was published after<br />
wide-ranging consultations, including a<br />
clear policy on limiting the number of<br />
embryos transferred.<br />
<strong>HFEA</strong> Clinic Audits<br />
Detailed <strong>and</strong> intensive audit of clinics<br />
continued during <strong>2003</strong>/<strong>04</strong> by a<br />
specialist <strong>HFEA</strong> audit team. In total,<br />
there were 45 clinic audit visits during<br />
the year. The findings of these audits<br />
demonstrated clearly that:<br />
• there was no significant underreporting<br />
of treatment activity by<br />
licensed clinics;<br />
• there was no material variance<br />
between the value of fees billed by the<br />
<strong>HFEA</strong> <strong>and</strong> the clinics’ declared activity.<br />
Financial Results for <strong>2003</strong>/<strong>04</strong><br />
<strong>HFEA</strong> made a surplus of £1,368,019<br />
during the year. This includes the funding<br />
received to meet the provisions made in<br />
financial years 2001/02 to <strong>2003</strong>/<strong>04</strong> in<br />
relation to future pension liabilities relating
to the transfer of the <strong>HFEA</strong>’s by-analogy<br />
pension scheme into membership of the<br />
Principal Civil Service Pension Scheme<br />
(PCSPS). Excluding this funding, <strong>and</strong> the<br />
movement in pension provision in<br />
<strong>2003</strong>/<strong>04</strong>, the surplus would have<br />
been £148,0<strong>04</strong>.<br />
The total future pension liability at<br />
31 March <strong>2003</strong> had been calculated by<br />
the Government Actuary’s Department in<br />
the sum of £1,220,015. The net increase<br />
in provision needed to reflect this liability<br />
in the Income & Expenditure Account for<br />
the year ended 31st March 20<strong>04</strong><br />
amounted to £56,201.<br />
The Department of Health undertook to<br />
fund the full liability of £1.276m <strong>and</strong> this<br />
was incorporated in their approved<br />
expenditure estimates. This money was<br />
received by <strong>HFEA</strong> on 27 June <strong>2003</strong>, <strong>and</strong><br />
payment in full settlement of the liability<br />
was made on 30th June <strong>2003</strong> to the Civil<br />
Superannuation Vote.<br />
The National Audit Office (NAO) required<br />
us to follow the accounting treatment for<br />
this item contained in Treasury guidance.<br />
The full future pension liability as at<br />
31 March <strong>2003</strong> was included in the<br />
Accounts for the year ended 31 March<br />
<strong>2003</strong>, however, no provision was made<br />
for the funding subsequently received<br />
from the Department of Health.<br />
Accordingly the previously published<br />
balance sheet of the <strong>HFEA</strong> at 31st March<br />
<strong>2003</strong> showed net liabilities of £541,261.<br />
The explanation provided by the Treasury<br />
<strong>and</strong> NAO for this treatment, <strong>and</strong> for not<br />
recognising a post balance sheet<br />
adjusting event under UK GAAP, is that<br />
under the normal conventions applying<br />
to parliamentary control over income<br />
<strong>and</strong> expenditure, such grants must be<br />
accounted for on a cash basis.<br />
Therefore this funding could not be<br />
recognised until received, <strong>and</strong><br />
accordingly the Accounts for the year<br />
ended 31 March 20<strong>04</strong> now present the<br />
receipt of the funding for the provision<br />
that existed at 31 March <strong>2003</strong>, <strong>and</strong> the<br />
movement in the pensions’ liability in the<br />
period April – June <strong>2003</strong>. The balance<br />
sheet shows at 31 March 20<strong>04</strong> net<br />
assets <strong>and</strong> reserves of £1.68m.<br />
It should however be noted that a prior<br />
year adjustment, the circumstances of<br />
which are detailed in note 2 to these<br />
Accounts, shows a restated balance<br />
sheet total as at 31 March <strong>2003</strong><br />
of £154,769.<br />
Disabled Employees<br />
The policy of <strong>HFEA</strong> is to make all<br />
reasonable adjustments to the working<br />
environment when required to meet the<br />
needs of disabled employees.<br />
Equal Opportunities<br />
The <strong>HFEA</strong> is an equal opportunities<br />
employer with a policy of providing<br />
equality of opportunity for all staff<br />
members <strong>and</strong> job applicants. The <strong>HFEA</strong><br />
does not discriminate against anyone on<br />
the grounds of age, race, colour, ethnic<br />
or national origin, gender, marital status,<br />
responsibility for children or dependents,<br />
disability, sexual orientation or religious or<br />
political beliefs.<br />
Consultation with Employees<br />
The <strong>HFEA</strong>’s policy is to involve staff <strong>and</strong> to<br />
consult them on relevant matters such as<br />
health, safety <strong>and</strong> welfare. Issues that may<br />
be of interest or concern are discussed at<br />
regular staff meetings. An appraisal<br />
system has been enforced throughout the<br />
year to improve performance review <strong>and</strong><br />
the development of staff.<br />
Payment of Suppliers<br />
The <strong>HFEA</strong> has adopted the principles of<br />
the ‘Better Payment Practice Code’ <strong>and</strong><br />
works to ensure that all undisputed<br />
invoices are paid within 30 days. In<br />
<strong>2003</strong>/<strong>04</strong> the <strong>HFEA</strong> paid 89% of invoices<br />
within 30 days (2002/03 90%) <strong>and</strong> 98%<br />
were paid within 60 days (2002/03 99%).<br />
Future Developments<br />
During 20<strong>04</strong>/05 the <strong>HFEA</strong> will work<br />
towards the following objectives:-<br />
• To deliver high quality, effective <strong>and</strong><br />
professional regulation of infertility<br />
services <strong>and</strong> storage of gametes<br />
<strong>and</strong> embryos, focusing on risk,<br />
safety <strong>and</strong> quality.<br />
• To achieve a stronger, more efficient<br />
<strong>and</strong> publicly accountable process of<br />
regulating research.<br />
• To develop an efficient <strong>and</strong> effective<br />
process for licensing centres as<br />
required by the EU tissue directive<br />
<strong>and</strong> to put in place a process for<br />
accreditation of all licensed<br />
clinics/ART laboratories.<br />
• To deliver robust, comprehensive <strong>and</strong><br />
timely information management, which<br />
informs safety <strong>and</strong> quality.<br />
• To put in place a strategy for<br />
supporting <strong>and</strong> involving patients.<br />
• To communicate effectively with all<br />
stakeholders <strong>and</strong> the public, to<br />
increase underst<strong>and</strong>ing of the <strong>HFEA</strong>’s<br />
role <strong>and</strong> the regulation of IVF <strong>and</strong><br />
research, enabling informed patient<br />
choice <strong>and</strong> public debate.<br />
• To develop <strong>and</strong> implement clear<br />
policies based on evidence, ethical<br />
considerations <strong>and</strong> public views –<br />
supporting continuous improvements<br />
in quality <strong>and</strong> safety <strong>and</strong> appropriate<br />
access to new technologies.<br />
• To ensure through clear systems that<br />
the Authority meets its statutory<br />
financial <strong>and</strong> corporate responsibilities<br />
demonstrating efficiency, effectiveness<br />
<strong>and</strong> value for money.<br />
• To agree <strong>and</strong> implement a <strong>Human</strong><br />
Resources Strategy valuing staff,<br />
ensuring capacity <strong>and</strong> skills meet<br />
the organisation’s needs <strong>and</strong><br />
the development of integrated<br />
work patterns.<br />
• To build partnerships with other<br />
statutory <strong>and</strong> voluntary organisations.<br />
Ms Angela McNab<br />
Chief Executive<br />
19 July 20<strong>04</strong><br />
<strong>HFEA</strong> Accounts | 42
Annex A<br />
Authority Members<br />
Membership of the <strong>Human</strong> <strong>Fertilisation</strong> <strong>and</strong> <strong>Embryology</strong> Authority during the year<br />
<strong>2003</strong>/<strong>04</strong> was as follows:-<br />
Suzi Leather (Chair)<br />
Professor Thomas Baldwin (re-appointed 30/9/03)<br />
Mrs Jane Denton (Director of Sub-committees)<br />
Professor David Barlow (re-appointed 24/11/03)<br />
Professor Christopher Barratt<br />
Professor Peter Braude<br />
Mr Ivor Brecker (re-appointed 30/9/03)<br />
Ms Clare Brown<br />
Professor Iain Cameron (re-appointed 30/9/03)<br />
Professor Andrew Grubb (retired 6/11/03)<br />
Professor Neva Haites<br />
Rt. Revd. Richard Harries (appointed 24/11/03)<br />
Ms Jennifer Hunt (appointed 24/11/03)<br />
Ms Emily Jackson (appointed 12/6/03)<br />
Dr Maybeth Jamieson<br />
Mr Simon Jenkins (re-appointed 30/9/03)<br />
Mr Walter Merricks<br />
Ms Sara Nathan<br />
Rt. Revd. Dr Michael Nazir-Ali (retired 6/11/03)<br />
Ms Sharmila Nebhrajani<br />
<strong>HFEA</strong> Accounts | 43
Statement of the Authority's <strong>and</strong> Chief Executive’s Responsibilities<br />
Authority Members’ Responsibilities<br />
Under section 6(1) of the <strong>Human</strong> <strong>Fertilisation</strong> <strong>and</strong> <strong>Embryology</strong> Act 1990, the <strong>Human</strong><br />
<strong>Fertilisation</strong> <strong>and</strong> <strong>Embryology</strong> Authority is required to prepare a statement of accounts<br />
for each financial year in the form <strong>and</strong> on the basis determined by the Secretary of<br />
State, with the consent of the Treasury. The accounts are prepared on the accruals<br />
basis, <strong>and</strong> must show a true <strong>and</strong> fair view of the Authority’s state of affairs at the yearend<br />
<strong>and</strong> of its income <strong>and</strong> expenditure, total recognised gains <strong>and</strong> losses, <strong>and</strong> cash<br />
flow for the financial year.<br />
In preparing the accounts the Authority is required to:-<br />
• observe the Accounts Directions issued by the Secretary of State, including the<br />
relevant accounting <strong>and</strong> disclosure requirements, <strong>and</strong> apply suitable accounting<br />
policies on a consistent basis;<br />
• make judgements <strong>and</strong> estimates on a reasonable basis;<br />
• state whether applicable accounting st<strong>and</strong>ards have been followed, <strong>and</strong> disclose<br />
<strong>and</strong> explain any material departures in the financial statements;<br />
• prepare the financial statements on the going concern basis unless it is<br />
inappropriate to presume that the Authority will continue in operation.<br />
Accounting Officer’s Responsibilities<br />
The Accounting Officer of the Department of Health has designated the Chief Executive<br />
of the <strong>Human</strong> <strong>Fertilisation</strong> <strong>and</strong> <strong>Embryology</strong> Authority as the Accounting Officer for the<br />
Authority. Her relevant responsibilities as Accounting Officer, including her responsibility<br />
for the propriety <strong>and</strong> regularity of the public finances for which she is answerable <strong>and</strong><br />
for the keeping of proper records, are set out in the Non Departmental Public Bodies’<br />
Accounting Officer Memor<strong>and</strong>um.<br />
<strong>HFEA</strong> Accounts | 44
Statement on Internal Control<br />
1. Scope of Responsibility<br />
As Accounting Officer, I have<br />
responsibility for maintaining a sound<br />
system of internal control that supports<br />
the achievement of the <strong>HFEA</strong>’s policies,<br />
aims <strong>and</strong> objectives as set out in the<br />
<strong>Human</strong> <strong>Fertilisation</strong> <strong>and</strong> <strong>Embryology</strong> Act<br />
1990, the Authority’s Business Plan, <strong>and</strong><br />
by Ministers within the Department of<br />
Health (DH), whilst safeguarding the<br />
public funds <strong>and</strong> departmental assets<br />
for which I am personally responsible,<br />
in accordance with the responsibilities<br />
assigned to me in DH correspondence.<br />
The Management Statement, agreed<br />
between the Department of Health <strong>and</strong><br />
the <strong>HFEA</strong>, sets out the accountability<br />
framework within which the Authority‘s<br />
work will be monitored. This requires:-<br />
• Prior approval by the Department of<br />
the <strong>HFEA</strong>’s annual Business Plan,<br />
including an assessment of risks to<br />
the organisation.<br />
• Submission to the Department of<br />
regular monitoring information on<br />
progress in implementing the Plan.<br />
• An annual accountability meeting<br />
between DH Ministers <strong>and</strong> the Chair<br />
<strong>and</strong> Chief Executive of the <strong>HFEA</strong>.<br />
DH representatives customarily<br />
attend Authority meetings, <strong>and</strong><br />
meetings of key st<strong>and</strong>ing committees<br />
(Organisation & Finance, Audit,<br />
Information Management<br />
Programming Board). The rapid<br />
pace of change within the <strong>HFEA</strong><br />
has continued throughout <strong>2003</strong>/<strong>04</strong>,<br />
<strong>and</strong> therefore close liaison has been<br />
maintained with DH. In addition to<br />
the formal accountability framework,<br />
there have been monthly meetings<br />
between the Department’s<br />
Sponsoring Division <strong>and</strong> the<br />
Authority’s Senior Management Team<br />
(SMT).<br />
2. The Purpose of the System<br />
of Internal Control<br />
The system of internal control is<br />
designed to manage risk to a reasonable<br />
level rather than to eliminate all risk of<br />
failure to achieve policies, aims <strong>and</strong><br />
objectives; it can therefore only provide<br />
reasonable <strong>and</strong> not absolute assurance<br />
of effectiveness.<br />
In the Statement of Internal Control of<br />
10th July <strong>2003</strong>, I gave a commitment<br />
that the risk management framework<br />
established in <strong>2003</strong>/<strong>04</strong> would be<br />
<strong>HFEA</strong> Accounts | 45<br />
embedded within the organisation, <strong>and</strong><br />
integrated into the business planning<br />
process. This has been implemented.<br />
The system of internal control is based<br />
on an ongoing process designed to<br />
identify <strong>and</strong> prioritise the risks to the<br />
achievement of the <strong>HFEA</strong>’s policies, aims<br />
<strong>and</strong> objectives, to evaluate the likelihood<br />
of those risks being realised <strong>and</strong> the<br />
impact should they be realised, <strong>and</strong> to<br />
manage them efficiently, effectively <strong>and</strong><br />
economically. The system of internal<br />
control was in place in the <strong>HFEA</strong> by<br />
31 March 20<strong>04</strong> <strong>and</strong> up to the date of<br />
approval of the annual accounts, <strong>and</strong><br />
accords with Treasury guidance.<br />
3. Capacity to H<strong>and</strong>le Risk<br />
The Authority is very aware that the<br />
<strong>HFEA</strong> is operating in a high risk area<br />
with a high public profile, <strong>and</strong> hence<br />
of the importance that risks are<br />
identified <strong>and</strong> managed appropriately.<br />
The policy underpinning the <strong>HFEA</strong>’s<br />
risk management process aims to help<br />
members <strong>and</strong> staff to consider risk, the<br />
probability <strong>and</strong> impact in a consistent<br />
manner; <strong>and</strong> to make clear risk<br />
exposure may vary with new activities,<br />
or changes to existing activities.<br />
It is recognised that effective risk<br />
management must be resourced, <strong>and</strong><br />
this is reflected in the development of<br />
the organisation <strong>and</strong> staffing levels. An<br />
experienced Senior Management Team<br />
(SMT) is in place, <strong>and</strong> there has been<br />
continued expansion of skilled staff in<br />
key areas, such as Regulation, IT<br />
<strong>and</strong> Communications.<br />
The <strong>HFEA</strong> policy makes clear that risk<br />
management is the responsibility of all<br />
staff; however, it is recognised that the<br />
process needs strong leadership. Risk<br />
management is led at SMT level by the<br />
Director of Resources <strong>and</strong> Corporate<br />
Development; the Head of Corporate<br />
Development has specific responsibility<br />
for supporting the development of risk<br />
management across the organisation.<br />
All operational managers are actively<br />
involved in risk management, including<br />
membership of the Authority-wide Risk<br />
Management Group (RMG).<br />
4. The Risk <strong>and</strong> Control Framework<br />
The <strong>HFEA</strong> aims to operate with a wellbalanced<br />
regard for risk. The risk<br />
strategy defines risk as the failure to<br />
perform the Authority’s statutory<br />
functions, <strong>and</strong> inability to achieve the<br />
Business Plan objectives, whether<br />
through negative action, or inaction.<br />
This could also include the failure to<br />
identify <strong>and</strong> exploit new opportunities.<br />
The main focus for consideration of risk<br />
is the High Level Risk Register. This was<br />
initially developed through workshops<br />
with staff in all departments, <strong>and</strong><br />
identifies the probability <strong>and</strong> impact<br />
of each risk <strong>and</strong> the related controls.<br />
The process of rapid change within<br />
the <strong>HFEA</strong> continued during <strong>2003</strong>/<strong>04</strong>.<br />
The modernisation of all the functions<br />
of the <strong>HFEA</strong> is being undertaken against<br />
a background of close scrutiny by our<br />
stakeholders; continued media interest;<br />
<strong>and</strong> significant external change (EU<br />
Tissue Directive, new Government policy<br />
on donor anonymity, <strong>and</strong> a review of the<br />
1990 <strong>Human</strong> <strong>Fertilisation</strong> & <strong>Embryology</strong><br />
Act). An overarching risk, therefore, is the<br />
pressure of the growing agenda, <strong>and</strong> the<br />
threat to the reputation of the <strong>HFEA</strong> if we<br />
fail to achieve key business objectives,<br />
<strong>and</strong> are unable to meet the expectations<br />
of our stakeholders. These are central<br />
themes in the management of risk in<br />
the <strong>HFEA</strong>.<br />
There was continued streamlining of<br />
regulation, communications, <strong>and</strong> policy<br />
development during <strong>2003</strong>/<strong>04</strong>. This<br />
included a new Alert system to improve<br />
our response to adverse incidents in<br />
licensed centres <strong>and</strong> disseminate learning<br />
from such events; the increasing use of<br />
risk assessment to inform the inspection<br />
process, including the introduction of<br />
unannounced inspections.<br />
Other key developments during the<br />
year included:<br />
Information Management Continued<br />
progress was made during the year<br />
on the development of the <strong>HFEA</strong>’s<br />
information systems, to enable the<br />
Authority to fulfil its statutory obligations.<br />
The transfer of data from the legacy<br />
systems has been completed, <strong>and</strong> is<br />
now being validated. The development<br />
has begun of an Electronic Data<br />
Interchange (EDI) system between the<br />
<strong>HFEA</strong> <strong>and</strong> licensed centres, <strong>and</strong> the<br />
preparation for the historic audit of<br />
records (HAP). The whole register<br />
development is being managed within<br />
a PRINCE framework, <strong>and</strong> overseen by<br />
a high-level Information Management
Programming Board, chaired by myself,<br />
<strong>and</strong> involving members <strong>and</strong> an<br />
independent IT expert.<br />
Audit The detailed audit of reporting<br />
of treatment activity by clinics was<br />
maintained during <strong>2003</strong>/<strong>04</strong>. The findings<br />
of this audit again showed that there<br />
was no significant under-reporting of<br />
treatment activity by licensed clinics.<br />
As promised last year, the work of the<br />
specialist <strong>HFEA</strong> audit team has been<br />
integrated more closely within the wider<br />
inspection process.<br />
EU Tissues & Cells Directive<br />
This introduces new legal requirements<br />
for all units involved in the donation,<br />
procurement, processing, storage <strong>and</strong><br />
distribution of gametes <strong>and</strong> embryos;<br />
<strong>and</strong> brings within the scope of<br />
regulation many units which have not<br />
been covered hitherto. The <strong>HFEA</strong> is<br />
likely to be the competent authority in<br />
relation to gametes <strong>and</strong> embryos under<br />
the legislation, which will bring this<br />
Directive into effect. This will exp<strong>and</strong><br />
the remit of the <strong>HFEA</strong> <strong>and</strong> have major<br />
implications for the whole organisation,<br />
alongside our existing programme of<br />
major change. We have begun preparing<br />
for the implementation of the Directive.<br />
Freedom of Information Act<br />
The implementation of public access<br />
rights under FOI presents a major<br />
challenge to the <strong>HFEA</strong>, given the often<br />
controversial nature of our work <strong>and</strong> the<br />
likely high level of interest it generates.<br />
We have begun the work to ensure the<br />
<strong>HFEA</strong> can respond appropriately to<br />
requests made under FOI.<br />
Work on these <strong>and</strong> other projects will<br />
continue in the current year.<br />
5. Review of Effectiveness<br />
As Accounting Officer, I have<br />
responsibility for reviewing the<br />
effectiveness of the system of internal<br />
control. My review of the effectiveness<br />
of the system of internal control is<br />
informed by the work of the internal<br />
auditors <strong>and</strong> the executive managers<br />
within the <strong>HFEA</strong>, who have responsibility<br />
for the development <strong>and</strong> maintenance<br />
of the internal control framework,<br />
<strong>and</strong> comments made by the external<br />
auditors in their management letter <strong>and</strong><br />
other reports. I have been advised on<br />
the implications of the results of my<br />
review of the effectiveness of the system<br />
of internal control by the Authority, the<br />
Audit Committee, the SMT <strong>and</strong> the<br />
RMG, <strong>and</strong> a plan to address<br />
weaknesses <strong>and</strong> ensure continuous<br />
improvement of the system is in place.<br />
The Risk Strategy introduced in <strong>2003</strong><br />
includes an organisation-wide process<br />
for reviewing risk <strong>and</strong> monitoring<br />
implementation of controls. This takes<br />
place at departmental level, the SMT,<br />
St<strong>and</strong>ing Committees <strong>and</strong> at the<br />
Authority itself.<br />
• The Authority:<br />
Reviews the effectiveness of risk<br />
management twice during the year,<br />
including a full report from the Audit<br />
Committee at the year end.<br />
• The Audit Committee:<br />
The Committee is the main source of<br />
reassurance to the Authority on the<br />
effectiveness of risk management,<br />
<strong>and</strong> receives a report on risk at each<br />
meeting. There will be a formal review<br />
in September, <strong>and</strong> a report submitted<br />
to the Authority at the year end.<br />
• Other St<strong>and</strong>ing Committees:<br />
The work of the <strong>HFEA</strong> is led by a<br />
series of Member Committees which<br />
reflect the varied <strong>and</strong> complex<br />
functions of the Authority. All the<br />
committees have reviewed strategic<br />
risks in their area <strong>and</strong> the related<br />
controls during the year.<br />
• SMT:<br />
Directors review the strategic risks<br />
every 2 months, <strong>and</strong> are closely<br />
involved in ensuring risks are<br />
identified <strong>and</strong> managed.<br />
• Risk Management Group (RMG):<br />
This group, which includes all<br />
operational managers, is charged with<br />
the regular monitoring of emerging<br />
risks, the implementation of controls<br />
over known risks; <strong>and</strong> making<br />
recommendations to the SMT. The<br />
Group is facilitated <strong>and</strong> supported by<br />
the Head of Corporate Development.<br />
• Other Staff:<br />
It is recognised that all staff must<br />
be involved in, <strong>and</strong> have some<br />
underst<strong>and</strong>ing of, risk management.<br />
The individual members of the RMG<br />
are a key focus in developing this<br />
awareness. Work has begun to<br />
review detailed, departmental risk<br />
registers, <strong>and</strong> the work being done<br />
to address them.<br />
• Internal Audit:<br />
The Internal Audit Team has reviewed<br />
the management of key areas of<br />
work during the year, <strong>and</strong> will report<br />
on these to the Audit Committee.<br />
The value of the corporate risk process<br />
now in place is in highlighting the interrelationship<br />
of key risks, <strong>and</strong> the<br />
importance of a coordinated approach<br />
to managing them. It is also recognised<br />
that the management of risk is an<br />
integral part of the wider business<br />
planning process, <strong>and</strong> we will continue<br />
to strengthen risk management as part<br />
of our 20<strong>04</strong>/05 Business Plan.<br />
Ms Angela McNab<br />
Chief Executive<br />
19 July 20<strong>04</strong><br />
<strong>HFEA</strong> Accounts | 46
<strong>Human</strong> <strong>Fertilisation</strong> <strong>and</strong> <strong>Embryology</strong> Authority <strong>2003</strong>/20<strong>04</strong><br />
Certificate <strong>and</strong> <strong>Report</strong> of the Comptroller <strong>and</strong> Auditor General to the Houses of Parliament<br />
I certify that I have audited the financial<br />
statements on pages 48 to 62 under<br />
Section 6(4) of the <strong>Human</strong> <strong>Fertilisation</strong><br />
<strong>and</strong> <strong>Embryology</strong> Act 1990. These<br />
financial statements have been prepared<br />
under the historical cost convention as<br />
modified by the revaluation of certain<br />
fixed assets <strong>and</strong> the accounting policies<br />
set out on page 50.<br />
Respective responsibilities of<br />
the Authority, the Chief Executive<br />
<strong>and</strong> Auditor<br />
As described on page 44 the Authority<br />
<strong>and</strong> Chief Executive are responsible for<br />
the preparation of the financial statements<br />
in accordance with the <strong>Human</strong> <strong>Fertilisation</strong><br />
<strong>and</strong> <strong>Embryology</strong> Act 1990 <strong>and</strong> directions<br />
made thereunder by the Secretary of<br />
State with the approval of the Treasury,<br />
<strong>and</strong> for ensuring the regularity of financial<br />
transactions. The Authority <strong>and</strong> Chief<br />
Executive are also responsible for the<br />
preparation of the Foreword. My<br />
responsibilities, as independent auditor,<br />
are established by statute <strong>and</strong> I have<br />
regard to the st<strong>and</strong>ards <strong>and</strong> guidance<br />
issued by the Auditing Practices Board<br />
<strong>and</strong> the ethical guidance applicable to<br />
the auditing profession.<br />
I report my opinion as to whether the<br />
financial statements give a true <strong>and</strong><br />
fair view <strong>and</strong> are properly prepared in<br />
accordance with the <strong>Human</strong> <strong>Fertilisation</strong><br />
<strong>and</strong> <strong>Embryology</strong> Act 1990 <strong>and</strong> directions<br />
made thereunder by the Secretary of<br />
State, <strong>and</strong> whether in all material respects<br />
the expenditure <strong>and</strong> income have been<br />
applied to the purposes intended by<br />
Parliament <strong>and</strong> the financial transactions<br />
conform to the authorities which govern<br />
them. I also report if, in my opinion,<br />
the Foreword is not consistent with the<br />
financial statements, if the Authority has<br />
not kept proper accounting records, or if<br />
I have not received all the information <strong>and</strong><br />
explanations I require for my audit.<br />
I review whether the statement on<br />
pages 45 to 46 reflects the Authority's<br />
compliance with Treasury’s guidance on<br />
the Statement on Internal Control. I report<br />
if it does not meet the requirements<br />
specified by Treasury, or if the statement<br />
is misleading or inconsistent with other<br />
information I am aware of from my audit<br />
of the financial statements. I am not<br />
required to consider, nor have I<br />
<strong>HFEA</strong> Accounts | 47<br />
considered whether the Accounting<br />
Officer’s Statement on Internal Control<br />
covers all risks <strong>and</strong> controls. I am also<br />
not required to form an opinion on the<br />
effectiveness of the Authority's corporate<br />
governance procedures or its risk <strong>and</strong><br />
control procedures.<br />
Basis of audit opinion<br />
I conducted my audit in accordance<br />
with United Kingdom Auditing St<strong>and</strong>ards<br />
issued by the Auditing Practices Board.<br />
An audit includes examination, on a<br />
test basis, of evidence relevant to the<br />
amounts, disclosures <strong>and</strong> regularity of<br />
financial transactions included in the<br />
financial statements. It also includes an<br />
assessment of the significant estimates<br />
<strong>and</strong> judgements made by the Authority<br />
<strong>and</strong> Chief Executive in the preparation<br />
of the financial statements, <strong>and</strong> of<br />
whether the accounting policies are<br />
appropriate to the Authority's<br />
circumstances, consistently applied<br />
<strong>and</strong> adequately disclosed.<br />
I planned <strong>and</strong> performed my audit so<br />
as to obtain all the information <strong>and</strong><br />
explanations which I considered<br />
necessary in order to provide me with<br />
sufficient evidence to give reasonable<br />
assurance that the financial statements<br />
are free from material misstatement,<br />
whether caused by error, or by fraud or<br />
other irregularity <strong>and</strong> that, in all material<br />
respects, the expenditure <strong>and</strong> income<br />
have been applied to the purposes<br />
intended by Parliament <strong>and</strong> the financial<br />
transactions conform to the authorities<br />
which govern them. In forming my opinion<br />
I have also evaluated the overall adequacy<br />
of the presentation of information in the<br />
financial statements.<br />
Opinion<br />
In my opinion:<br />
• the financial statements give a true<br />
<strong>and</strong> fair view of the state of affairs<br />
of the <strong>Human</strong> <strong>Fertilisation</strong> <strong>and</strong><br />
<strong>Embryology</strong> Authority at 31 March<br />
20<strong>04</strong> <strong>and</strong> of the surplus, total<br />
recognised gains <strong>and</strong> losses <strong>and</strong><br />
cash flows for the year then ended<br />
<strong>and</strong> have been properly prepared<br />
in accordance with the <strong>Human</strong><br />
<strong>Fertilisation</strong> <strong>and</strong> <strong>Embryology</strong> Act 1990<br />
<strong>and</strong> directions made thereunder by<br />
the Secretary of State with the<br />
approval of Treasury; <strong>and</strong><br />
• in all material respects the expenditure<br />
<strong>and</strong> income have been applied to the<br />
purposes intended by Parliament <strong>and</strong><br />
the financial transactions conform to<br />
the authorities which govern them.<br />
I have no observations to make on these<br />
financial statements.<br />
John Bourn<br />
Comptroller <strong>and</strong> Auditor General<br />
19 July 20<strong>04</strong><br />
National Audit Office<br />
157-197 Buckingham Palace Road<br />
Victoria<br />
London SW1W 9SP<br />
Supplementary statement by the<br />
Comptroller <strong>and</strong> Auditor General in<br />
respect of material included at pages 1<br />
to 38 of this <strong>Annual</strong> <strong>Report</strong>, not included<br />
with the financial statements to which<br />
the audit opinion above relates.<br />
In respect alone of my responsibility<br />
under United Kingdom auditing<br />
st<strong>and</strong>ards to read the other information<br />
included with financial statements on<br />
which I express an audit opinion, I have<br />
read the additional information on pages<br />
1 to 38 which was not included with the<br />
financial statements on which I reached<br />
the audit opinion set out in my<br />
Certificate above <strong>and</strong> considered<br />
whether it is consistent with the audited<br />
financial statements. I have considered<br />
the implications for my audit opinion if<br />
I have thereby become aware of any<br />
apparent mis-statement or material<br />
inconsistencies with the financial<br />
statements. I have not considered the<br />
effects of any events since the date of<br />
my Certificate.<br />
In this regard, my audit opinion on the<br />
financial statements is unchanged.<br />
John Bourn<br />
Comptroller <strong>and</strong> Auditor General<br />
3 November 20<strong>04</strong><br />
National Audit Office<br />
157-197 Buckingham Palace Road<br />
Victoria<br />
London SW1W 9SP
Income <strong>and</strong> Expenditure Account for the Year Ended 31 March 20<strong>04</strong><br />
Notes <strong>2003</strong>/20<strong>04</strong> 2002/<strong>2003</strong><br />
Restated<br />
£ £<br />
Income<br />
Gross Income 2 7,471,860 6,228,562<br />
Transfer from Government Grant Reserve (Capital Spend) 11 120,724 79,390<br />
7,592,584 6,307,952<br />
Expenditure<br />
Staff Costs 3 3,665,2<strong>04</strong> 2,523,912<br />
Other Operating Charges 4 3,658,652 3,028,529<br />
Depreciation 5 112,535 77,472<br />
Loss/(Surplus) on Disposal of Fixed Assets 8,189 (353)<br />
Total Expenditure 7,444,580 5,629,560<br />
Operating Surplus 148,0<strong>04</strong> 678,392<br />
Exceptional Items : Increase In Pension Provision for Year 9 (56,201) (288,330)<br />
: Funding Received for Pension Provision 9 1,276,216 0<br />
Notional Interest (Capital Charges) 1(g) (32,055) 3,106<br />
Surplus on Ordinary Activities 1,335,964 393,168<br />
Write back of Notional Interest 1(g) 32,055 (3,106)<br />
Surplus for the Financial Year 1,368,019 390,062<br />
Retained (Deficit) brought forward – as restated 11 (44,389) (434,451)<br />
Retained Surplus/(Deficit) carried forward 11 1,323,630 (44,389)<br />
All operations are continuing.<br />
Statement of Total Recognised Gains <strong>and</strong> Losses<br />
for the Year Ended 31 March 20<strong>04</strong><br />
Notes <strong>2003</strong>/20<strong>04</strong> 2002/<strong>2003</strong><br />
Restated<br />
£ £<br />
Surplus for the Financial Year 1,368,019 390,062<br />
Unrealised Surplus on Revaluation of Fixed Assets 0 0<br />
Total Recognised Gains for the Year 1,368,019 390,062<br />
Prior Period Adjustment (note 2) 696,030 0<br />
Total (Losses) Recognised Since Last <strong>Annual</strong> <strong>Report</strong> 2,064,<strong>04</strong>9 390,062<br />
The notes on pages 50 to 62 form part of these Accounts.<br />
<strong>HFEA</strong> Accounts | 48
Balance Sheet as at 31 March 20<strong>04</strong><br />
Notes 31 March 20<strong>04</strong> 31 March <strong>2003</strong><br />
Restated<br />
£ £<br />
Fixed Assets 5 353,360 199,158<br />
Current Assets:<br />
Debtors: Amounts Falling Due Within One Year 6 1,386,541 1,346,255<br />
Cash at Bank <strong>and</strong> in H<strong>and</strong> 17 307,947 29,191<br />
Creditors: Amounts Falling Due Within One Year 7 (370,858) (199,820)<br />
Net Current Assets 1,323,630 1,175,626<br />
Long Term Liabilities<br />
Provisions for Liabilities <strong>and</strong> Charges 9 0 (1,220,015)<br />
Total Assets less Current Liabilities 1,676,990 154,769<br />
Financed By<br />
Capital <strong>and</strong> Reserves<br />
– Government Grant Reserve (Capital Spend) 11 353,360 186,641<br />
– Income <strong>and</strong> Expenditure Reserve 11 1,323,630 (44,389)<br />
– Revaluation Reserve 11 0 12,517<br />
1,676,990 154,769<br />
The notes on pages 50 to 62 form part of these Accounts.<br />
Ms Angela McNab<br />
Chief Executive<br />
19 July 20<strong>04</strong><br />
Cash Flow Statement for the Year Ended 31 March 20<strong>04</strong><br />
Notes <strong>2003</strong>/20<strong>04</strong> 2002/<strong>2003</strong><br />
£ £<br />
Operating Activities<br />
Net Cash Inflow/(Outflow) 18(a) 278,756 (6,195)<br />
Capital (Expenditure)/Income<br />
– Purchase of Fixed Assets 5 (274,926) (102,388)<br />
– Cash Received on Disposal of Assets 0 353<br />
Net Cash Inflow/(Outflow) Before Financing 3,830 (108,230)<br />
Financing<br />
– Receipts of Government Grants for Purchase 11 274,926 102,388<br />
of Fixed Assets<br />
– Net Cash Inflow from Financing 274,926 102,388<br />
Increase/(Decrease) in Cash 18(b) 278,756 (5,842)<br />
The notes on pages 50 to 62 form part of these Accounts.<br />
<strong>HFEA</strong> Accounts | 49
Notes to the Accounts<br />
1. Accounting Policies<br />
(a) Accounting Convention<br />
The <strong>HFEA</strong>’s accounts are prepared in<br />
accordance with the provisions of the<br />
<strong>Human</strong> <strong>Fertilisation</strong> <strong>and</strong> <strong>Embryology</strong> Act<br />
1990 <strong>and</strong> an Accounts Determination issued<br />
by the Secretary of State for Health in May<br />
1997 (reproduced as an appendix to<br />
these accounts).<br />
These accounts are prepared, in accordance<br />
with applicable accounting st<strong>and</strong>ards, under<br />
the historical cost convention modified to allow<br />
for the revaluation of fixed assets. Without<br />
limiting the information given, the accounts<br />
meet the accounting <strong>and</strong> disclosure<br />
requirements of the Companies Acts <strong>and</strong><br />
Accounting St<strong>and</strong>ards issued or adopted by<br />
the Accounting St<strong>and</strong>ards Board so far as<br />
those requirements are appropriate.<br />
(b)Fixed Assets<br />
Fixed Assets include tangible <strong>and</strong> intangible<br />
fixed assets <strong>and</strong> the costs of acquiring or<br />
creating computer systems or software. Only<br />
items, or groups of related items, costing<br />
£1,000 or more <strong>and</strong> with individual values<br />
over £250, are capitalised. Those costing<br />
less are treated as revenue expenditure.<br />
Assets purchased prior to the current financial<br />
year are indexed annually using the Office for<br />
National Statistics’ indices if there is a material<br />
difference between historic cost <strong>and</strong> current<br />
replacement cost. In <strong>2003</strong>/<strong>04</strong>, <strong>HFEA</strong> decided<br />
that no material adjustment was necessary <strong>and</strong><br />
therefore modified historic cost accounting has<br />
not been applied in financial year <strong>2003</strong>/<strong>04</strong>.<br />
(c) Depreciation <strong>and</strong> Amortisation<br />
Depreciation is provided on all tangible fixed<br />
assets on a monthly basis from the date of<br />
acquisition at rates calculated to write off the<br />
cost of each asset evenly over its expected<br />
useful life. Expected useful lives are as follows:<br />
Computer equipment <strong>and</strong> software<br />
Office equipment<br />
Furniture, fixtures <strong>and</strong> fittings<br />
3 years<br />
4 years<br />
4 years<br />
Amortisation is provided on intangible fixed<br />
assets (which comprise software licenses) on<br />
a monthly basis at a rate calculated to write<br />
off the cost of each intangible asset over its<br />
expected useful life. The expected useful life<br />
of these software licenses is 3 years.<br />
(d)Operating Leases<br />
Operating leases are charged to the accounts<br />
on a straight line basis over the lease term.<br />
(e) Register of Information<br />
Expenditure on development of the computer<br />
programme for the Register of Information is<br />
charged to the Income <strong>and</strong> Expenditure<br />
Account as it is incurred.<br />
(f) Government Grants<br />
Government grants received for revenue<br />
expenditure are credited to income in the<br />
year to which they relate. Government grants<br />
received for capital expenditure are credited to<br />
the government grant reserve <strong>and</strong> released to<br />
the Income <strong>and</strong> Expenditure Account to match<br />
depreciation <strong>and</strong> downward indexation,<br />
where appropriate.<br />
(g)Notional Charges<br />
In accordance with Treasury guidance,<br />
notional interest at 3.5% (2002/03 6%) of the<br />
average capital employed has been debited in<br />
the Income <strong>and</strong> Expenditure Account<br />
amounting to £32,055 (2002/<strong>2003</strong> – restated<br />
<strong>and</strong> credited, £3,106).<br />
(h) Pensions<br />
Past <strong>and</strong> present employees are covered by<br />
the provisions of the Principal Civil Service<br />
Pension Scheme (PCSPS.) The defined<br />
benefit elements of the schemes are<br />
unfunded <strong>and</strong> are non-contributory except in<br />
respect of dependents’ benefits. The <strong>HFEA</strong><br />
recognises the expected cost of these<br />
elements on a systematic <strong>and</strong> rational basis<br />
over the period during which it benefits from<br />
employees’ services by payment to the<br />
PCSPS of amounts calculated on an accruing<br />
basis. Liability for payment of future benefits is<br />
a charge on the PCSPS. In respect of the<br />
defined contribution elements of the schemes,<br />
the <strong>HFEA</strong> recognises the contributions<br />
payable for the year.<br />
(i) Fees <strong>and</strong> Charges Guide<br />
From <strong>2003</strong>/<strong>04</strong> it was agreed with the<br />
Department of Health that the <strong>HFEA</strong> is a<br />
single purpose organisation. These accounts<br />
therefore no longer show a note of segmental<br />
information for different services or forms of<br />
services, as required by HM Treasury’s “The<br />
Fees <strong>and</strong> Charges Guide”.<br />
<strong>HFEA</strong> Accounts | 50
2. Gross Income<br />
Gross income is made up of Government grants<br />
received in the year <strong>and</strong> of license fee <strong>and</strong> other<br />
incomes which are recorded on an accruals basis.<br />
Analysis of Income <strong>2003</strong>/20<strong>04</strong> 2002/<strong>2003</strong><br />
£ £<br />
Restated<br />
License Fee Income<br />
– <strong>Annual</strong> billing 0 874,094<br />
– Monthly billing 3,528,427 2,346,464<br />
Other Income 7,359 2,392<br />
Cash Received from the Department of Health 4,211,000 3,108,000<br />
Less Capital Grant element (274,926) (102,388)<br />
3,936,074 3,005,612<br />
7,471,860 6,228,562<br />
Income received from the Department of Health<br />
included contributions from the devolved<br />
administrations for Scotl<strong>and</strong>, Wales <strong>and</strong><br />
Northern Irel<strong>and</strong>.<br />
As from 1st April 2002, the process for billing<br />
centres for License fees was changed. Previously,<br />
centres were invoiced once per year close to the<br />
anniversary of license renewal date, to cover all<br />
billable treatment cycles reported in the preceding<br />
12 months. From April 2002, treatment cycles<br />
have been reported each month <strong>and</strong> invoiced in<br />
the following month. The point at which a cycle<br />
becomes billable is assumed to be when it is<br />
reported under these monthly invoicing procedures.<br />
An accrual was made as at 31 March <strong>2003</strong> to<br />
include income from cycles reported in March<br />
<strong>2003</strong>, which were invoiced after the year end.<br />
Cycles reported up to March 2002 <strong>and</strong> not<br />
previously invoiced continued during 2002/03 to<br />
be invoiced at the license renewal anniversary date.<br />
The effect of the change in process was to bring<br />
forward the timing of payments by centres with a<br />
consequential one-off rise in income to <strong>HFEA</strong> in<br />
2002/03. However, over a multi-year period neither<br />
income to <strong>HFEA</strong>, nor payments by centres was<br />
raised by this change in invoicing process.<br />
The opening fee income accrual has been<br />
adjusted to reflect the actual value of treatments<br />
undertaken prior to 31 March <strong>2003</strong> but not<br />
invoiced until after that date. The impact of this<br />
change in accounting policy on the results for the<br />
year ended 31 March <strong>2003</strong> is to increase license<br />
fee income <strong>and</strong> debtors by £696,030 <strong>and</strong> this is<br />
shown in the prior year adjustment which is<br />
disclosed in note 11.<br />
The closing income accrual has likewise been<br />
based on the value of treatments undertaken<br />
during the year ended 31 March 20<strong>04</strong> but not<br />
invoiced until after 1 April 20<strong>04</strong>. The impact of<br />
this change in accounting treatment for financial<br />
year <strong>2003</strong>/<strong>04</strong> has been to decrease license fee<br />
income by £161,392 <strong>and</strong> to increase debtors as<br />
at 31 March 20<strong>04</strong> by £534,638. Under the former<br />
accounting policy, license fee income would have<br />
been reported at £3,689,819 <strong>and</strong> license fee<br />
debtors would have been stated at £659,172.<br />
During <strong>2003</strong>/<strong>04</strong> <strong>HFEA</strong> developed its systems to<br />
enable fuller analysis of treatment forms received<br />
<strong>and</strong> hence enable income to be analysed by the<br />
time of treatment. The Accounts for 2002/03 stated<br />
that it was planned that the Accounts for financial<br />
year <strong>2003</strong>/<strong>04</strong> would reflect a new accounting<br />
treatment, recognising income at the time of<br />
treatment rather than when reported to <strong>HFEA</strong>.<br />
These Accounts have accordingly been prepared<br />
on the basis of recognising income at the time of<br />
treatment date, to more accurately reflect the<br />
accounting value of activity undertaken in the year.<br />
<strong>HFEA</strong> Accounts | 51
3. Staff Costs<br />
<strong>2003</strong>/20<strong>04</strong> 2002/<strong>2003</strong><br />
£ £<br />
All Staff<br />
Salaries – <strong>HFEA</strong> Staff 2,462,266 1,381,525<br />
Salaries – Seconded Staff 112,621 138,174<br />
Social Security Costs 238,264 128,721<br />
Superannuation Costs – Seconded Staff 21,232 24,770<br />
Superannuation Costs – <strong>HFEA</strong> Staff 293,949 131,413<br />
Agency/Temporary Staff 270,275 561,119<br />
Compensation Payment 130,000 31,600<br />
3,528,607 2,397,322<br />
Members’ Costs 136,597 126,590<br />
Total 3,665,2<strong>04</strong> 2,523,912<br />
The average monthly number of full time <strong>and</strong> part-time staff employed, including secondees <strong>and</strong><br />
temporary staff, during the year was as follows:<br />
<strong>2003</strong>/20<strong>04</strong> 2002/<strong>2003</strong><br />
Management 5 3<br />
Administrative 86 54<br />
91 57<br />
Remuneration of Key Management<br />
<strong>2003</strong>/20<strong>04</strong> 2002/<strong>2003</strong><br />
£ £<br />
Former Chief Executive (to 17 November 2002): Dr Maureen Dalziel<br />
Total Paid to Seconding Body,<br />
the London School of Hygiene <strong>and</strong> Tropical Medicine 19,086 47,715<br />
(for the period November 2002 – February <strong>2003</strong>)<br />
Compensation payment made to Dr Dalziel on early termination<br />
of office (note 20) 130,000 0<br />
Current Chief Executive: Ms Angela McNab<br />
Ms Angela McNab was on secondment from the Department of Health during the financial year until<br />
1 September <strong>2003</strong>, when Ms McNab joined the <strong>HFEA</strong> as a member of staff. During the period to<br />
1 September <strong>2003</strong> <strong>HFEA</strong> made payments to the Department of Health in respect of this secondment<br />
totalling £52,<strong>04</strong>2 (during 2002/03, for the period 11 November 2002 – 31 March <strong>2003</strong>, £45,808.)<br />
<strong>HFEA</strong> was not responsible for the pension arrangements of Ms McNab during this period.<br />
In the period 1 September <strong>2003</strong> to 31 March 20<strong>04</strong>, the salary <strong>and</strong> pension entitlements of Ms McNab<br />
from <strong>HFEA</strong> were as follows :<br />
Salary £55,000 - £60,000<br />
Real Increase in Pension at age 60 £0 - £2,500<br />
Real Increase in lump sum £0 - £2,500<br />
Total Accrued Pension at age 60 at 31/3/<strong>04</strong> £0 - £5,000<br />
Related Lump Sum at 31/3/<strong>04</strong> £0 - £5,000<br />
CETV at 31/3/03 (nearest £’000) 0<br />
CETV at 31/3/<strong>04</strong> (nearest £’000) 11<br />
Real increase in CETV as funded by <strong>HFEA</strong> (nearest £’000) 13<br />
<strong>HFEA</strong> Accounts | 52
Other Senior Managers<br />
The Resource Accounting Manual requires the <strong>HFEA</strong> to provide information on the salary <strong>and</strong> pension<br />
rights of the named individuals who are the “most senior managers” of the <strong>HFEA</strong>, subject to the<br />
individuals concerned consenting to disclosure.<br />
The salary <strong>and</strong> pension entitlements of the Senior Managers in <strong>HFEA</strong> during the year were as follows:<br />
Name of Senior Manager Salary Real Real Total Related CETV at CETV at Real<br />
(£) increase increase accrued lump 31/3/03 31/3/<strong>04</strong> Increase<br />
in pension in lump pension sum at (nearest (nearest in CETV<br />
at age 60 sum at age 60 31/3/<strong>04</strong> £’000) £’000) as funded<br />
(£) (£) at 31/3/<strong>04</strong> (£) by <strong>HFEA</strong><br />
(£) (nearest<br />
£’000)<br />
Trish Davies* £5,000- £0- £0- £0- £0- 0 1 0<br />
Commenced 1/3/<strong>04</strong> £10,000 £2,500 £2,500 £5,000 £5,000<br />
Ann Furedi £10,000- £0- £0- £0- £0- 9 11 2<br />
Left 30/5/03 £15,000 £2,500 £2,500 £5,000 £5,000<br />
Paul Gemmill £35,000- £0- £2,501- £0- £5,001 22 33 13<br />
Commenced 27/5/03, £40,000 £2,500 £5,000 £5,000 £10,000<br />
Left 12/12/03<br />
Barry MacDonald* £75,000- £0- £2,501- £0- £5,001 16 33 19<br />
£80,000 £2,500 £5,000 £5,000 £10,000<br />
David Tellis* £65,000- £0- £0- £0- £0- 4 14 7<br />
Appointed 27/5/03 £70,000 £2,500 £2,500 £5,000 £5,000<br />
Tim Whitaker* £55,000- £0- £0- £0- £0- 0 10 12<br />
Commenced 17/6/03 £60,000 £2,500 £2,500 £5,000 £5,000<br />
* denotes current staff<br />
Salary<br />
‘Salary’ includes gross salary, performance pay or bonuses, overtime, <strong>and</strong> any other allowance to the<br />
extent that it is subject to UK taxation.<br />
Pension<br />
Full details in respect of the pension arrangements in place for <strong>HFEA</strong> staff are provided in note 8 to<br />
these Accounts.<br />
Columns 6 & 7 of the foregoing tables show the member’s Cash Equivalent Transfer Value (CETV)<br />
accrued at the beginning <strong>and</strong> the end of the reporting period. Column 8 reflects the increase in<br />
CETV effectively funded by the employer. It takes account of the increase in accrued pension due<br />
to inflation, contributions paid by the employee (including the value of any benefits transferred from<br />
another pension scheme or arrangement) <strong>and</strong> uses common market valuation factors for the start<br />
<strong>and</strong> end of the period.<br />
A CETV is the actuarially assessed capitalised value of the pension scheme benefits accrued by a<br />
member at a particular point in time. The benefits valued are the member’s accrued benefits <strong>and</strong> any<br />
contingent spouse’s pension payable from the scheme. A CETV is a payment made by a pension<br />
scheme or arrangement to secure pension benefits in another pension scheme or arrangement when<br />
the member leaves a scheme <strong>and</strong> chooses to transfer the benefits accrued in their former scheme.<br />
The pension figures shown relate to the benefits that the individual has accrued as a consequence of<br />
their total membership of the pension scheme, not just their service in a senior capacity to which<br />
disclosure applies. The CETV figures, <strong>and</strong> from <strong>2003</strong>/<strong>04</strong> the other pension details, include the value<br />
of any pension benefit in another scheme or arrangement which the individual has transferred to the<br />
PCSPS arrangements <strong>and</strong> for which the Civil Superannuation Vote has received a transfer payment<br />
commensurate to the additional pension liabilities being assumed. They also include any additional<br />
pension benefit accrued to the member as a result of their purchasing additional years of pension<br />
service in the scheme at their own cost. CETVs are calculated within the guidelines <strong>and</strong> framework<br />
prescribed by the Institute <strong>and</strong> Faculty of Actuaries.<br />
<strong>HFEA</strong> Accounts | 53
Remuneration of Authority Members<br />
Chairman – Suzi Leather <strong>2003</strong>/20<strong>04</strong> 2002/<strong>2003</strong><br />
Remuneration – in the b<strong>and</strong>s of: £30,000-£35,000 £20,000-£25,000<br />
Pension contributions in the b<strong>and</strong> of £4,000-£4,500 were made on behalf of Suzi Leather in <strong>2003</strong>/<strong>04</strong><br />
(2002/03 – in the b<strong>and</strong> of £0-£2500). The real increase in pension at age 60 during the year was in the<br />
b<strong>and</strong> £0 - £2,500 (2002/03 – £0-£2500). The total accrued pension at 60 as at 31 March 20<strong>04</strong> was in<br />
the b<strong>and</strong> £0 - £5,000 (2002/03 – £0 - £5,000) At the balance sheet date, Suzi Leather was aged 47.<br />
Members Costs (including Chairman) <strong>2003</strong>/20<strong>04</strong> 2002/<strong>2003</strong><br />
£ £<br />
Total fees payable to members 121,928 115,893<br />
Social Security Costs 10,338 8,334<br />
Superannuation Costs 4,331 2,363<br />
136,597 126,590<br />
The Deputy Chairman received a fee of £185 per day. Members received a fee of £169 per day.<br />
No pension contributions were paid on behalf of any Board Member other than the Chairman.<br />
Remuneration payable to individual members for attendance at meetings <strong>and</strong> inspections during the<br />
financial year was in the following b<strong>and</strong>s:-<br />
£0 - £5,000<br />
Professor David Barlow<br />
Professor Peter Braude<br />
Professor Iain Cameron<br />
Professor Andrew Grubb<br />
Rt. Revd. Richard Harries<br />
Ms J Hunt<br />
Ms E Jackson<br />
Mr Simon Jenkins<br />
Rt. Revd. Dr Michael Nazir-Ali<br />
Ms Sharmila Nebhrajani<br />
£5,001 - £10,000<br />
Professor Thomas Baldwin (Deputy Chair)<br />
Professor Christopher Barratt<br />
Mr Ivor Brecker<br />
Ms Clare Brown<br />
Mrs Jane Denton (Director of Sub-Committees)<br />
Professor Neva Haites<br />
Dr Maybeth Jamieson<br />
Mr Walter Merricks<br />
Ms Sara Nathan<br />
<strong>HFEA</strong> Accounts | 54
4. Other Operating Charges<br />
<strong>2003</strong>/20<strong>04</strong> 2002/<strong>2003</strong><br />
£ £<br />
Operating Lease Payments<br />
– L<strong>and</strong> <strong>and</strong> Buildings 273,149 246,880<br />
– Other Leases 13,<strong>04</strong>2 10,533<br />
Accommodation (note 1) 1,350,915 172,628<br />
Travel & Subsistence 241,375 211,095<br />
Attendance Fees – Inspectors 52,283 26,192<br />
Professional & Administrative Fees 288,825 1,005,435<br />
Audit Fees<br />
– External (note 2) 56,500 32,500<br />
– Internal 21,752 21,620<br />
Register of Information (note 3) 465,359 305,596<br />
Stationery, Photocopying & Printing 264,4<strong>04</strong> 178,023<br />
Telephones & Postage 78,598 68,352<br />
Training & Development 100,175 122,842<br />
Recruitment & Advertising 167,910 345,220<br />
Conferences & Meeting Expenses 90,607 39,305<br />
Library & Reading Materials 44,468 29,774<br />
Sundry Office Equipment 52,849 83,120<br />
IT Costs (Including Website) 52,972 95,806<br />
Miscellaneous 43,469 33,608<br />
Total 3,658,652 3,028,529<br />
Notes<br />
1. Accommodation costs in <strong>2003</strong>/<strong>04</strong> include one off costs of £558k associated with the move of <strong>HFEA</strong><br />
from its previous premises into a single office. These costs, approved by the Department of Health,<br />
settled outst<strong>and</strong>ing lease obligations in respect of the main building <strong>HFEA</strong> previously occupied.<br />
Other such one-off costs included removals, fit out <strong>and</strong> IT installations at the new premises.<br />
2. The external audit fee from the NAO represents the cost for the audit of the financial statements<br />
carried out by the Comptroller <strong>and</strong> Auditor General. This account does not include fees in respect<br />
of non-audit work. No such work was undertaken by the NAO on behalf of the <strong>HFEA</strong> during the year.<br />
Approximately £20,000 of the fee charged for the year relates to additional fees charged for audit<br />
work undertaken during 2002/03.<br />
3. Costs charged to the register of information include some expenditure relating to this project which<br />
would normally fall within other expenditure lines, such as some accommodation <strong>and</strong> related costs,<br />
recruitment <strong>and</strong> legal <strong>and</strong> professional fees, IT costs, <strong>and</strong> travel <strong>and</strong> subsistence.<br />
<strong>HFEA</strong> Accounts | 55
5 (a) Tangible Fixed Assets as at 31 March 20<strong>04</strong><br />
Computer Office Furniture<br />
Equipment Equipment & Fittings Totals<br />
£ £ £ £<br />
Cost/valuation as at 31 March <strong>2003</strong> 221,933 206,209 88,380 516,522<br />
Additions 192,233 36,256 22,586 251,075<br />
Disposals (19,111) (95,991) (70,480) (185,582)<br />
As at 31 March 20<strong>04</strong> 395,055 146,474 40,486 582,015<br />
Depreciation as at 31 March <strong>2003</strong> 84,585 150,206 85,102 319,893<br />
Charge for the year 84,233 21,659 1,878 107,770<br />
Disposals (14,200) (95,991) (67,202) (177,393)<br />
As at 31 March 20<strong>04</strong> 154,618 75,874 19,778 250,270<br />
Net Book Value (NBV)<br />
At 31 March 20<strong>04</strong> 240,437 70,600 20,708 331,745<br />
At 31 March <strong>2003</strong> 137,348 56,003 3,278 196,629<br />
Increase/(Decrease) in NBV 103,089 14,597 17,430 135,116<br />
5 (b) Intangible Fixed Assets as at 31 March 20<strong>04</strong> <strong>and</strong> Summary of Fixed Assets<br />
Software Total Intangible Total Tangible Gr<strong>and</strong> Total of<br />
Licenses Assets Fixed Assets Fixed Assets<br />
£ £ £ £<br />
Cost/valuation as at 31 March <strong>2003</strong> 3,035 3,035 516,522 519,557<br />
Additions 23,851 23,851 251,075 274,926<br />
Disposals 0 0 (185,582) (185,582)<br />
As at 31 March 20<strong>04</strong> 26,886 26,886 582,015 608,901<br />
Amortisation/Depreciation<br />
as at 31 March <strong>2003</strong> 506 506 319,893 320,399<br />
Charge for the year 4,765 4,765 107,770 112,535<br />
Disposals 0 0 (177,393) (177,393)<br />
As at 31 March 20<strong>04</strong> 5,271 5,271 250,270 255,541<br />
Net Book Value (NBV)<br />
At 31 March 20<strong>04</strong> 21,615 21,615 331,745 353,360<br />
At 31 March <strong>2003</strong> 2,529 2,529 196,629 199,158<br />
Increase/(Decrease) in NBV 19,086 19,086 135,116 154,202<br />
As recorded in note 1(b) to these Accounts, modified historic cost accounting has not been applied to fixed assets in these<br />
Accounts this year, as there is no material difference between historic cost <strong>and</strong> current replacement cost.<br />
6. Debtors: Amounts Falling Due Within One Year<br />
31 March 20<strong>04</strong> 31 March <strong>2003</strong><br />
Restated<br />
£ £<br />
License Fee & Accrued Income 1,193,810 1,158,992<br />
Other Debtors 114,189 16,425<br />
Pre-payments 78,542 170,838<br />
1,386,541 1,346,255<br />
<strong>HFEA</strong> Accounts | 56
7. Creditors: Amounts Falling Due Within One Year<br />
31 March 20<strong>04</strong> 31 March <strong>2003</strong><br />
£ £<br />
Trade Creditors 57,396 2,240<br />
Other Taxes <strong>and</strong> Social Security 1,390 4,486<br />
Accruals <strong>and</strong> Deferred Income 312,072 193,094<br />
370,858 199,820<br />
8. Pension Arrangements (<strong>HFEA</strong> Staff)<br />
As per 2001 Statutory Instrument No. 1587, <strong>HFEA</strong> staff were conditionally admitted to the Principal Civil<br />
Service Pension Scheme (PCSPS) as from 1st April 2000, transferring from the <strong>HFEA</strong> by-analogy Scheme.<br />
The PCSPS is an unfunded multi-employer defined benefit scheme but <strong>HFEA</strong> is unable to identify its<br />
share of the underlying assets <strong>and</strong> liabilities. A full actuarial valuation was carried out as at 31 March<br />
<strong>2003</strong>. Details can be found in the resource accounts of the Cabinet Office : Civil Superannuation<br />
(www.civilservice-pensions.gov.uk).<br />
Pension benefits are provided through the PCSPS arrangements. From 1 October 2002, staff may be in<br />
one of three statutory based ‘final salary’ defined benefit schemes (classic, premium, <strong>and</strong> classic plus).<br />
The Schemes are unfunded with the cost of benefits met by monies voted by Parliament each year.<br />
Pensions payable under classic, premium, <strong>and</strong> classic plus are increased annually in line with changes<br />
in the Retail Prices Index. New entrants after 1 October 2002 may choose between membership of<br />
premium or joining a good quality ‘money purchase’ stakeholder arrangement with a significant employer<br />
contribution (partnership pension account).<br />
For <strong>2003</strong>/<strong>04</strong>, employers’ contributions of £272,656 were payable to the PCSPS (2002/03 £133,776)<br />
at one of four rates in the range 12 to 18.5 per cent of pensionable pay, based on salary b<strong>and</strong>s.<br />
The scheme’s Actuary reviews employer contributions every four years following a full scheme valuation.<br />
Rates will remain the same next year, subject to revalorisation of the salary b<strong>and</strong>s, but will increase from<br />
2005/06. The contribution rates reflect benefits as they are accrued, not when the costs are actually<br />
incurred, <strong>and</strong> reflect past experience of the scheme.<br />
In addition, employer contributions of 0.8 per cent of pensionable pay were payable to the PCSPS to<br />
cover the cost of the future provision of lump sum benefits on death in service <strong>and</strong> ill health retirement<br />
of these employees.<br />
Employee contributions are set at the rate of 1.5% of pensionable earnings for classic <strong>and</strong> 3.5% for<br />
premium <strong>and</strong> classic plus. Benefits in classic accrue at the rate of 1/80th of pensionable salary for each<br />
year of service. In addition, a lump sum equivalent to three years’ pension is payable on retirement.<br />
For premium, benefits accrue at the rate of 1/60th of final pensionable earnings for each year of service.<br />
Unlike classic, there is no automatic lump sum (but members may give up (commute) some of their<br />
pension to provide a lump sum). Classic plus is essentially a variation of premium, but with benefits in<br />
respect of service before 1 October 2002 calculated broadly as per classic.<br />
Further details about the PCSPS arrangements can be found at the website<br />
www.civilservice-pensions.gov.uk.<br />
Employees joining after 1 October 2002 could opt to open a partnership pension account, a stakeholder<br />
pension with an employer contribution. Employers’ contributions of £25,624 were paid during financial<br />
year <strong>2003</strong>/<strong>04</strong> (2002/03 £nil) to one or more companies chosen by these employees from a panel of four<br />
appointed stakeholder pension providers. Employer contributions are age-related <strong>and</strong> range from 3 to<br />
12.5 per cent of pensionable pay. Employees do not have to contribute but where they do make<br />
contributions, <strong>HFEA</strong> will match these up to a limit of 3% of pensionable salary (in addition to the<br />
employer’s basic contribution).<br />
£223 in contributions were due to the partnership pension providers at the balance sheet date.<br />
No contributions were prepaid at that date.<br />
<strong>HFEA</strong> Accounts | 57
9. Provisions For Liabilities <strong>and</strong> Charges<br />
<strong>2003</strong>/20<strong>04</strong> 2002/<strong>2003</strong><br />
£ £<br />
Accrued Pension Liability Brought Forward 1,220,015 667,513<br />
Movement in Liability for Pensions Transfer During the Year:<br />
Opening Creditor 0 216,638<br />
Payments to/from JSS 0 (15,354)<br />
Current Year Notional Pension Costs 0 62,888<br />
Increase in Provision for Year 56,201 288,330<br />
Write back of Total Provision for Year (1,276,216) 0<br />
Total Provision for Liabilities <strong>and</strong> Charges 0 1,220,015<br />
Further information about the <strong>HFEA</strong>’s transfer from its by-analogy pension scheme into membership<br />
of the PCSPS, together with details of the write back of the provision for the year, is provided in the<br />
Foreword to these Accounts, under “Financial Results for <strong>2003</strong>/<strong>04</strong>.”<br />
10. Post Balance Sheet Events<br />
As a NDPB, the <strong>HFEA</strong> is classified as an arms’ length body.<br />
In October <strong>2003</strong>, the Secretary of State for Health announced his intention to review the Department<br />
of Health’s “Arms’ Length Bodies.” On 20 May 20<strong>04</strong> he outlined the first stage of this review.<br />
There are 42 separate arms’ length bodies which employ 22,000 staff with a combined budget of<br />
£2.5bn. The Secretary of State announced that by 2007/08 there will be a 50% reduction in the<br />
number of arms’ length bodies reducing total expenditure by £0.5bn <strong>and</strong> staff posts by 25%.<br />
The final outcome of the review should be announced before the Parliamentary summer recess. As at<br />
the date of signing these financial statements, the implications of the review for the <strong>HFEA</strong> have not yet<br />
been announced.<br />
<strong>HFEA</strong> Accounts | 58
17. Cash at Bank <strong>and</strong> in H<strong>and</strong><br />
<strong>2003</strong>/20<strong>04</strong> 2002/<strong>2003</strong><br />
£ £<br />
Cash at Bank <strong>and</strong> in H<strong>and</strong> 307,947 25,329<br />
OPG Account 0 3,862<br />
307,947 29,191<br />
18. Notes to the Cash Flow Statement<br />
a. Reconciliation of Operating Surplus<br />
to Net Cash (Outflow)/Inflow From Operating Activities:<br />
<strong>2003</strong>/20<strong>04</strong> 2002/<strong>2003</strong><br />
Restated<br />
£ £<br />
Operating Surplus 1,368,019 390,062<br />
Loss/(Profit) on Disposals of Fixed Assets 8,189 (353)<br />
Depreciation Charges 112,535 77,472<br />
Downward Indexation Charge 0 0<br />
(Increase) in Debtors (40,286) (802,654)<br />
Increase/(Decrease) in Creditors 171,038 (143,834)<br />
Transfer from Government Grant (Capital Spend) (120,724) (79,390)<br />
(Decrease)/Increase in Provision for Pension Transfer Costs: (1,220,015) 552,502<br />
Net Cash Inflow/(Outflow) from Operating Activities 278,756 (6195)<br />
b. Analysis of Changes in Cash<br />
At 31 March Cash Flows At 31 March<br />
<strong>2003</strong> 20<strong>04</strong><br />
£ £ £<br />
Cash at Bank <strong>and</strong> in H<strong>and</strong> 29,191 278,756 307,947<br />
<strong>HFEA</strong> Accounts | 61
19. Financial Instruments<br />
FRS 13, Derivatives <strong>and</strong> Other Financial Instruments, requires disclosure of the role financial instruments<br />
have had during the period in creating or changing the risks an entity faces in undertaking its activities.<br />
As permitted by FRS 13, debtors <strong>and</strong> creditors which mature or become payable within 12 months from<br />
the balance sheet date have been omitted from this note.<br />
Liquidity Risk<br />
The principal source of revenues (47% of total gross income) is derived directly from the number of IVF<br />
<strong>and</strong> DI treatment cycles performed by the licensed clinics <strong>and</strong> reported to the <strong>HFEA</strong>. The remaining<br />
source of revenue is derived from Government grants made on a cash basis.<br />
There are procedures in place to identify late <strong>and</strong> non-reporting of treatment cycles by clinics <strong>and</strong> also<br />
procedures for chasing up debts. <strong>HFEA</strong> is therefore not exposed to significant liquidity risks.<br />
Investments <strong>and</strong> Interest Rate Risk<br />
The <strong>HFEA</strong> follows an investment policy of placing any surplus funds on deposit in an interest bearing<br />
bank account. Interest income was less than £5,000 of the revenues of the <strong>HFEA</strong>, <strong>and</strong> the <strong>HFEA</strong> is not<br />
therefore exposed to significant interest rate risk.<br />
Financial Assets Total Non-Interest Floating-rate<br />
bearing cash cash deposits<br />
deposits<br />
£ £ £<br />
At 31 March 20<strong>04</strong> 307,720 0 307,720<br />
At 31 March <strong>2003</strong> 28,791 0 28,791<br />
Petty cash held on site amounted to £227 (2002/03: £400).<br />
The fair value of the financial assets was equal to the book value.<br />
Financial Liabilities<br />
The <strong>HFEA</strong> had no financial liabilities at 31 March 20<strong>04</strong> requiring disclosure under FRS 13.<br />
Foreign Currency Risk<br />
There were minimal foreign currency transactions conducted by the <strong>HFEA</strong> during the year ended<br />
31 March 20<strong>04</strong>. There was therefore no significant foreign currency risk during the year.<br />
20. Special Payments<br />
As disclosed in note 3 to these accounts, a compensation payment of £130,000 was made to<br />
Dr Maureen Dalziel, a former Chief Executive of <strong>HFEA</strong>, on the early termination of her office.<br />
<strong>HFEA</strong> Accounts | 62
Appendix<br />
The <strong>Human</strong> <strong>Fertilisation</strong> <strong>and</strong> <strong>Embryology</strong> Authority<br />
Accounts Determination<br />
The Secretary of State, with the approval of the Treasury, in pursuance of Section 6 of the <strong>Human</strong> <strong>Fertilisation</strong> <strong>and</strong> <strong>Embryology</strong> Act<br />
1990, hereby gives the following determination.<br />
Directions given by the Secretary<br />
of State Form of Accounts<br />
1. In this determination "the Authority" means the <strong>Human</strong> <strong>Fertilisation</strong> <strong>and</strong><br />
<strong>Embryology</strong> Authority.<br />
2. The Authority shall prepare accounts for the financial year ended 31st March 1997<br />
<strong>and</strong> subsequent financial years comprising:<br />
a) a Foreword;<br />
b) an Income <strong>and</strong> Expenditure account;<br />
c) a Balance Sheet;<br />
d) a Cash Flow Statement; <strong>and</strong><br />
e) a Statement of Total Recognised Gains <strong>and</strong> Losses;<br />
including such notes as may be necessary for the purposes referred to in the<br />
following paragraphs.<br />
3. The Accounts shall give a true <strong>and</strong> fair view of the income <strong>and</strong> expenditure<br />
<strong>and</strong> cash flows for the financial year, <strong>and</strong> the state of affairs as at the end of the<br />
financial year.<br />
4. Subject to this requirement, the Accounts shall be prepared in accordance with:<br />
a) Generally accepted accounting practice in the United Kingdom (UK GAAP);<br />
b) The disclosure <strong>and</strong> accounting requirements contained in “The Fees <strong>and</strong><br />
Charges Guide” (in particular those relating to the need for appropriate<br />
segmental information for services or forms of service provided) <strong>and</strong> in other<br />
guidance which the Treasury or the Secretary of State may issue from time to<br />
time in respect of Accounts which are required to give a true <strong>and</strong> fair view;<br />
c) The accounting <strong>and</strong> disclosure requirements given in “Government Accounting”<br />
<strong>and</strong> in "Executive NDPBs: <strong>Annual</strong> <strong>Report</strong>s <strong>and</strong> Accounts Guidance”; as amended<br />
or augmented from time to time: insofar as these are appropriate to the Authority<br />
<strong>and</strong> are in force for the financial year for which the Statement of Accounts is to<br />
be prepared.<br />
5. Clarification of the application of the accounting <strong>and</strong> disclosure requirements of<br />
the Companies Act <strong>and</strong> accounting st<strong>and</strong>ards is given in Schedule 1 attached.<br />
Additional disclosure requirements are set out in Schedule 2 attached.<br />
6. The Income <strong>and</strong> Expenditure Account <strong>and</strong> Balance Sheet shall be prepared under<br />
the historical cost convention modified by the inclusion of:<br />
a) fixed assets at their value to the business by reference to current costs; <strong>and</strong><br />
b) stocks valued at the lower of net current replacement cost (or historical cost if<br />
this is not materially different) <strong>and</strong> net realisable value.<br />
7. This Accounts Determination supersedes that dated 26th April 1996 <strong>and</strong> shall be<br />
reproduced as an appendix to the accounts.<br />
Date: 6th May 1997<br />
Signed by the authority of the Secretary of State for Health<br />
P. Kendall<br />
Branch Head (RMF- EAC Division)<br />
Department of Health<br />
<strong>HFEA</strong> Accounts | 63
Schedule 1<br />
Application of the Accounting <strong>and</strong> Disclosure Requirements of the Companies Act <strong>and</strong><br />
Accounting St<strong>and</strong>ards.<br />
Companies Act<br />
1. The disclosure exemptions permitted by the Companies Act shall not apply to the Authority unless<br />
specifically authorised by the Secretary of State with the approval of the Treasury.<br />
2. The Companies Act requires certain information to be disclosed in the Directors' <strong>Report</strong>.<br />
To the extent that it is appropriate, the information relating to the Authority shall be contained in<br />
the Foreword.<br />
3. When preparing its Income <strong>and</strong> Expenditure Account, the Authority shall have regard to the profit<br />
<strong>and</strong> loss format 2 prescribed in Schedule 4 to the Companies Act 1985 (as amended).<br />
4. When preparing its Balance Sheet, the Authority shall have regard to the Balance Sheet format 1<br />
prescribed in Schedule 4 to the Companies Act 1985 (as amended). The Balance Sheet totals<br />
shall be struck at ‘Total Assets less Current Liabilities'.<br />
5. The Authority is not required to provide the additional information required by paragraph 33(3)<br />
of Schedule 4 to the Companies Act 1985.<br />
6. The Foreword <strong>and</strong> Balance Sheet shall be signed by the Chief Executive to the Authority<br />
<strong>and</strong> dated.<br />
Accounting St<strong>and</strong>ards<br />
7. The Authority is not required to include a note showing historical cost profits <strong>and</strong> losses as<br />
described in FRS3.<br />
8. The Authority shall not adopt the Financial <strong>Report</strong>ing St<strong>and</strong>ard for Smaller Entities unless<br />
specifically approved by the Treasury.<br />
Schedule 2<br />
Additional Disclosure Requirements<br />
1. The Foreword shall, inter alia:<br />
a) State that the Accounts have been prepared in a form determined by the Secretary of State<br />
with the approval of the Treasury in accordance with Section 6 of the <strong>Human</strong> <strong>Fertilisation</strong> <strong>and</strong><br />
<strong>Embryology</strong> Act 1990;<br />
b) Include a brief history of the Authority <strong>and</strong> its statutory background.<br />
2. The notes to the accounts shall, inter alia:<br />
a) Include details for the accounting policies adopted;<br />
b) Provide further explanations of figures in the accounts where it is considered appropriate for a<br />
proper underst<strong>and</strong>ing of the accounts;<br />
c) Include details of the key corporate financial targets set by Ministers together with the<br />
performance achieved.<br />
<strong>HFEA</strong> Accounts | 64 45
Writing <strong>and</strong> editing Patsy Westcott <strong>and</strong> Annie Corbett<br />
Design glow<br />
Photography Poppy Berry <strong>and</strong> Kim Brett<br />
Print HenDi Systems