HFEA Annual Report 2003/04 - Human Fertilisation and Embryology ...

Facing up to the challenge 

HFEA Annual Report 2003/04

Copyright Human Fertilisation and Embryology Authority 2004. First published 2004. 

This report covers the year to 31 August 2004 with a forward look for the year to August 2005.

contents 

Chair’s Introduction 01 

Forward Look by the Chief Executive 03 

About the HFEA 05 

Licensing and inspection 07 

Information management 09 

Clinic audit 11 

Arm’s Length Bodies review 12 

Research 13 

Policy 15 

Communications 17 

Working together 19 

Appendices 

1. Standing Committee Membership 21 

2. Centres licensed by the HFEA 22 

3. Clinical Inspectors 25 

4. Ongoing research projects licensed by the HFEA 27 

5. HFEA peer reviewers 29 

6. Members’ interests 31 

7. Performance indicators 35 

Accounts 40 

Supplementary statement by the Comptroller and Auditor General 47

HFEA Report | 01

Chair’s Introduction 

Leading the way 

In many democratic systems there is 

renewed debate about reproductive 

technologies. In Europe, there has been 

abrupt change in national policy in Italy 

where, following years of unregulated 

activity, highly restrictive legislation has 

been introduced. The debate in other 

countries, sometimes no less volatile, has 

mostly been about extending reproductive 

autonomy. The announcement of the first 

therapeutic cloning licence issued by the 

HFEA was global news. Embryonic stem 

cell research is even an issue in the US 

presidential election. 

While there is no universal agreement 

between, or indeed within, countries 

about many of the ethical dilemmas 

which assisted reproduction and embryo 

research generates, there is widespread 

admiration for the UK system of regulation 

and decision-making in this controversial 

field. Indeed, the last twelve months have 

seen several countries passing legislation 

introducing regulatory bodies akin to 

the HFEA. 

In all fields of medicine, independent 

regulatory oversight has replaced 

professional self-regulation. Reproductive 

medicine was the first area of medicine to 

be subject to the control of a regulatory 

body, the HFEA. Just as IVF was 

developed by UK scientists and clinicians, 

so too, we pioneered its regulation. 

That system of regulation is being 

continually updated and strengthened 

and we welcome the opportunity to work 

with the government on the forthcoming 

review of the Human Fertilisation & 

Embryology Act 1990. 

This annual report demonstrates how we 

are ensuring that in all our functions we 

remain fit for our complex purposes and 

how we help improve services and patient 

and public confidence. I very much agree 

with the Lords Select Committee on the 

Constitution which stated in a report this 

year that ‘regulation is a means to an end, 

not an end in itself.’ 

The HFEA’s regulatory purposes are 

clear. We inform and protect patients. We 

ensure that the uses of embryos (both in 

treatment and research) are suitable 

and within the purposes laid down by 

Parliament. We guide professionals in 

clinics day by day. We keep a register of 

all licensed treatment so that in time all 

people created by these treatments can 

find out information about their origins. 

We have put tremendous efforts this year 

into further improving our effectiveness, 

rigorousness and accountability, and to 

building confidence and understanding 

in our actions and decisions. 

The ability to create a human embryo 

outside the body, the technique started 

more than a quarter of a century ago and 

responsible for the birth of more than one 

million babies worldwide, continues both 

to fascinate and challenge. Demand for 

treatment increases by the year – as do 

success rates in UK clinics. Patients and 

health commissioners are faced with 

wider and more complex treatment 

options. Increasingly they turn to the 

HFEA to inform and guide their choices. 

The Warnock report which recommended 

setting up the HFEA was published in 

1984. As the report observed: 

‘Society’s views on the new techniques 

were divided between pride in the 

technological achievement, pleasure at the 

new-found means to relieve, at least for 

some, the unhappiness of infertility, and 

unease at the apparently uncontrolled 

advance of science, bringing with it new 

possibilities for manipulating the early 

stages of human development.’ 

Twenty years on, the need for, and 

demands on, the regulator have never 

been greater. The dedicated hard work of 

our headquarters’ staff and our inspectors 

and auditors in the field means that this 

year we have made very significant 

progress in our modernisation programme. 

Always a leader in our field, we are striving 

for continual improvement. 

Suzi Leather 

Chair 



Forward Look by the Chief Executive 

Where we go from here 

The pages that follow show the 

tremendous strides the HFEA has made 

in the past year. As ever these have 

been driven by our commitment to 

ensuring the wellbeing of those who 

turn to the clinics we oversee for help 

in conceiving a baby and to the many 

families created as a result. 

We are proud of the role we play in striving 

for patient and child safety and of the 

achievements we have made in improving 

our extremely high standards of practice 

even further. These include streamlining 

our inspection process, introducing 

unannounced inspections and issuing new 

guidance about adding alarm systems to 

the storage vessels in which eggs, sperm 

and embryos are frozen to reduce the 

likelihood of their loss if the vessels fail. 

Our new Alert system, which provides 

a process for clinics to report mistakes, 

is now firmly in place, enabling lessons 

learned to be shared quickly to minimise 

the risk of the same thing happening 

again. Our information management 

system has also greatly improved, with 

the introduction of the New Data Register 

and Centres Database, to help safeguard 

the information that people give us. 

The substantial modernisation of our 

organisation has resulted in more effective 

performance, greater transparency and 

an improved dialogue with the public. 

Our introduction of open meetings that 

anyone can attend has been very well 

received. We also consulted extensively 

with the public in the process of updating 

our Code of Practice, compiling our 

report on sex selection and strengthening 

our guidelines on two-embryo transfer. 

With these successes firmly under our belt 

we look forward to achieving even more in 

the coming year. We will continue to focus 

on our objectives of strong, effective, 

efficient regulation of IVF treatment and 

embryo research, improving the way we 

communicate and investing in the crucial 

development of our information systems. 

In the year ahead we will face many new 

challenges. These include the EU Tissue 

Directive, the review of the 1990 HFE Act 

and the lifting of donor anonymity. In 

addition, we will be working closely with 

the Human Tissue Authority (which is 

soon to be set up) as we look ahead to 

the creation of a new Regulatory Authority 

for Fertility and Tissue. 

Like many people in the HFEA, I am 

continually inspired by our role of 

protecting the health and safety of so 

many prospective mothers, fathers and 

children, and by the need to ensure that 

the decisions we make about IVF and 

embryo research are right for society as 

a whole. 

I feel confident that the HFEA has never 

been in a stronger position to meet the 

challenges that lie ahead and to realise 

its many necessary, ambitious and 

achievable goals in 2004/05. 

Angela McNab 

Chief Executive 

Financial statements 

The financial statements on pages 48 to 

62 together with the foreword and other 

statements on pages 41 to 46 and the 

Certificate and Report of the Comptroller 

and Auditor General on page 47, 

reproduce in full those included in the 

Accounts for the HFEA for 2003/04 laid 

before the House of Commons on 21 

July 2004 under reference HC962. 

Pages 1 to 38 of this Annual Report 

provide additional information for which I 

am responsible, that is not included with 

those accounts. The Auditor is required 

by auditing standards to read other 

information in documents containing 

audited financial statements and to 

consider the implications for his audit 

opinion. A supplementary statement 

has accordingly been provided by the 

Comptroller and Auditor General at page 

47 in respect of his reading of the 

additional information. 

HFEA Report | 04

About the HFEA 

Regulating the creation of life 

The birth of the first ‘test tube’ baby, 

Louise Brown, in 1978 established 

the UK as a world leader in assisted 

reproductive technology (ART) and 

provoked a storm of debate that 

continues to this day. 

The debate was to lead to the passing of 

the Human Fertilisation and Embryology 

(HFE) Act in 1990. Out of this was 

established, a year later, the Human 

Fertilisation and Embryology Authority 

(HFEA), the first assisted reproduction 

regulatory body in the world. 

The world of assisted reproduction has 

changed dramatically since 1991. New 

developments in science and medicine, 

the rising numbers seeking fertility 

treatment and changes in government 

policy have placed growing and complex 

demands on us. But now, as then, our 

aim is to balance scientific and medical 

advances against the need to safeguard 

people seeking help to have a family, the 

embryos they create and the children 

they hope to have. 

Who are we? 

The HFEA is made up of 18 members 

appointed by the UK government and a 

staff of around 100 who are responsible 

for running the organisation day to day. 

To ensure our independence and 

objectivity, in accordance with the HFE 

Act, our chair, deputy chair and at least 

half our members are lay people drawn 

from disciplines such as the law, 

management, sociology, philosophy and 

religion, as well as patient representatives, 

rather than clinicians and scientists 

involved in human embryo research 

or fertility treatment. 

What do we do? 

Our job is to license and monitor all 

clinics or centres carrying out IVF and/or 

donor insemination and embryo research 

to ensure that the principles of the HFE 

Act are upheld. We also regulate the 

storage of sperm, eggs and embryos. 

To achieve this we: 

• create, update and enforce a Code of 

Practice which gives clear operational 

HFEA Report | 05 

guidelines to fertility clinics 

• keep a register of patients and the 

result of treatments they received, the 

details of any donor involved and the 

children who are born 

• inform and advise patients, donors and 

clinics about fertility treatments and the 

issues they raise 

• keep abreast of developments in 

the field of embryo and reproductive 

research to ensure any progress made 

is in everyone’s best interests before it 

is adopted 

Where are we going? 

To ensure that we remain efficient, 

focused and responsive in the complex 

and rapidly changing world of 

reproductive technology, we have 

developed a five-year Corporate Plan 

(2004/2009), which serves as a 

touchstone for everything we do. 

The plan was created with the 

involvement and insights of patients, 

scientists and healthcare professionals, 

and agreed by the Department of Health 

and will be used to measure our 

effectiveness. 

The seven strategic goals that we 

are committed to achieving include: 

• building and strengthening our role 

as the UK’s regulator of IVF and 

human embryo research 

• encouraging partnerships with all 

those with a stake in IVF and the 

HFEA, and communicating with them 

in a clear, open way 

• working closely with other regulators 

and international agencies to share 

knowledge and expertise 

• making our process of policy 

development stronger and even more 

effective in meeting and anticipating 

change 

• developing a robust information 

system to protect the privacy and 

interests of patients, donors, children 

born as a result of fertility treatments 

and other stakeholders at the same 

time as feeding into our regulatory 

and public health functions 

• supporting the development of 

research in assisted reproduction 

from laboratory to clinic 

• growing a strong, businesslike 

organisation that can achieve all 

these goals with maximum efficiency. 

The year ahead 

In the past year we have made excellent 

progress in modernising our organisation 

and are now ready to build on that 

success. Our starting point is our 2004/05 

Business Plan. This mirrors our key 

objectives of improving our regulatory 

performance, communicating clearly and 

openly with stakeholders and transforming 

our information base.

Looking forward 

In the next year we will be: 

• Strengthening our position. We will 

ensure we are in a strong position to 

meet new challenges including working 

towards the creation of the new 

Regulatory Authority for Fertility and 

Tissue, implementing the EU Tissue 

Directive, the review of the 1990 HFE 

Act; and lifting donor anonymity 

• Improving regulation. We will 

continue to improve the effectiveness 

and efficiency of the way we regulate 

clinics. This includes intensifying clinic 

inspections and employing 

unannounced inspections, particularly 

where there is evidence of risk 

• Enhancing information management. 

We aim to achieve even greater 

accuracy and efficiency in collecting 

and managing information in order 

to give patients and the public the 

information they need through our 

updated IT and information 

management systems 

• Tuning in to our stakeholders. 

We will be listening to the voices of 

patients and the public to ensure that 

they are heard and included in our 

decision making processes 

• Increasing patient safety. We will be 

creating new policies with patient safety 

in mind, based both on sound ethical 

judgements and on the hard evidence. 

Money matters 

During 2003/04 we received income 

of £7.5 million from the Department of 

Health and from centres for treatment 

and research. This funded our normal 

operations and our modernisation 

programme. Turn to pages 40 to 62 

for full details. 


Licensing and inspection 

Protecting patients and their children 

All those who turn to a fertility clinic 

for help in having a family need to feel 

confident that they will be well cared for, 

that the treatments and services they 

receive will be of the highest standard 

and that the risks of anything going 

wrong are minimal. 

In 2003/04 we continued to improve the 

rigour of our inspection and licensing 

processes to ensure that the clinics we 

regulate are safe, professional and well 

managed and meet the real needs of 

people seeking fertility treatment. 

Maintaining standards of excellence 

The UK is acknowledged as one of the 

safest places in the world to seek fertility 

treatment. The bedrock on which this 

high reputation rests is the requirement, 

laid down by law, that all clinics offering 

IVF or donor insemination and related 

activities such as sperm, egg and embryo 

storage or research be licensed and 

regularly inspected by the HFEA. 

At the heart of the licensing and 

inspection process is our team of 75 parttime 

inspectors. These include clinicians, 

scientists, embryologists, counsellors, 

psychologists, nurses and other experts 

whose job it is to make sure that new and 

existing clinics meet the high professional 

standards that their clients have a right 

to expect. 

In the past year we have set up training 

programmes for all our inspectors to 

ensure that they have the up-to-date 

knowledge and skills needed to assess 

clinics and limit the risks to patients. 

We have established a team of full-time 

regulatory managers to manage 

inspections and ensure they are 

systematic, consistent and rigorous. 

Keeping a close watch 

When a clinic first applies to be licensed, 

an inspection team visits to assess its 

staff and facilities and check that they are 

adequate. We look at examination rooms, 

laboratories and equipment to ensure that 

they are clean, comfortable and safe and 

that procedures for handling sperm, eggs 

and embryos are safe. Just as importantly, 

we look at the care and support patients 


receive – everything from the qualifications 

and experience of staff to the availability of 

counselling and the kind of information 

provided. Scrutiny includes how fertility 

drugs are administered and how doctors 

moderate drug regimens to avoid 

problems such as over-stimulation of the 

ovaries. This can take one to two days 

depending on the size and type of the 

centre. The team’s report is then referred 

to one of our licence committees, who 

decide whether to grant a licence. 

Initially, licences are granted for a year 

and renewed annually after a satisfactory 

inspection, usually for three years. A 

three-year licence may then be granted 

if the cllinic has been operating to the 

required standard. Clinics with a threeyear 

licence continue to be inspected 

annually. Inspections have usually been 

booked six months in advance to give 

centres and inspection teams time 

to prepare. 

But in order to reduce risk still further, we 

have introduced a system of spot checks. 

In the past year we carried out three of 

these. Their purpose is to assess any 

potential problems and check that the 

information clinics have provided us with 

is accurate. Where follow-up is needed 

we are able to examine all the information 

we hold internally and crosscheck this 

against such factors as the number of 

adverse incidents and patient complaints. 

Involving patients 

In 2003 we piloted three schemes 

designed to identify how best to involve 

one of our most important stakeholders, 

people using fertility services, in helping 

us to assess the quality of the clinics. 

The results of our consultations showed 

that, while the vast majority of those 

undergoing treatment were positive 

about the care and treatment they 

received, some were concerned about 

how information was given and its timing. 

As a result we specifically addressed this 

issue in our subsequent inspections. 

In June 2004 we started to ask 

patients at fertility clinics to complete 

a questionnaire about their experience 

of care at the centre. We also put an 

electronic version of the questionnaire 

on our web site for people to complete. 

This will help ensure that we stay in 

touch with the needs of individuals 

as they go through fertility treatment. 

Learning from experience 

Mistakes can happen in any area of life, 

but where fertility treatment is concerned 

the consequences of human or mechanical 

error can be devastating. What if an 

embryologist drops a precious embryo, 

for example? What if the liquid nitrogen 

in which frozen embryos are stored is not 

kept at the proper temperature? Or what 

if the unthinkable happens and a woman 

is inseminated with the wrong sperm or 

embryos get mixed up? 

In the past year we have strengthened 

our procedure for dealing with adverse 

incidents and put in place a new Incident 

Alert System to warn clinics, inspectors 

and professional bodies, such as The 

British Fertility Society and Association 

of Clinical Embryologists about potential 

or actual dangers to minimise the risk of 

a repetition. 

Where an incident has occurred we aim to 

work with the clinic and, when appropriate, 

professional organisations to work out 

what went wrong and why. We have 

appointed a Head of Clinical Governance 

and Patient Safety responsible for making 

sure that all incidents are thoroughly 

investigated and an Alert is issued to all 

the clinics we regulate where there are 

opportunities to learn from mistakes. 

The new system, which we believe is the 

first of its kind in use within the IVF world, 

has been widely welcomed and has led 

to an improved dialogue with centres 

regarding areas of possible risk. This will 

help us reduce the chances of harm to 

sperm, eggs, embryos or people seeking 

fertility treatment and their families to as 

low a level as possible.

Licensed centres and treatments 

Type of HFEA Licensed Centre Number of centres (as at 31 August 2004) 

Treatment only 2 

Storage only 9 

Treatment with Storage 73 

Treatment with Storage and Research 17 

Research Only 7 

HFEA Licensed Treatments 

Storage of Eggs (including ovarian tissue) 21 

Storage of Sperm (including testicular tissue) 99 

Storage of Embryos 75 

DI 90 

IVF 75 

ICSI 74 

PGD 8 

Preimplantation Genetic Screening 8 

The terms 

DI – Donor insemination 

Where sperm donated by a man other than the woman’s partner are inserted into 

the vagina, cervix or uterus. 

ICSI – Intracytoplasmic Sperm Injection 

A type of IVF that involves injecting a single sperm straight into an egg. 

IVF – In vitro fertilization 

The technique that involves fertilising human eggs with sperm outside the body 

before transferring the resulting embryos into the woman. 

PGD – Preimplantation Genetic Diagnosis 

A technique used to detect whether an embryo created by IVF is carrying an inherited 

genetic defect that will cause a serious genetic disorder. 

PGS – Preimplantation Genetic Screening for Aneuploidy 

A procedure offered to patients thought to be at a higher than average risk of having 

a baby with a chromosomal abnormality in order to reduce the risk of miscarriage and 

help them have a healthy baby. It involves removing one or two cells from an embryo 

for testing to ensure the number of chromosomes is correct (euploidy) and not more 

or less than usual (aneuploidy). Only embryos with the correct number are replaced. 

> Looking forward 


• Introducing new protocols. We are 

consistently looking to improve our 

current inspection processes and are 

now introducing new protocols for all 

planned inspections. 

• Doing more spot checks. 

We intend to increase the number 

of unannounced inspections to 

eight – four at random and four of 

‘at risk’ clinics 

• Understanding the fertility 

journey better. We are increasing our 

involvement with patients during 

inspections and in developing our 

methods of working to help 

understand their views on the quality 

of treatment provided. 

• Increasing collaboration. Where a 

unit has to be inspected both by the 

HFEA and another regulatory body 

such as the Healthcare Commission, 

we are investigating how we can 

collaborate to reduce duplication 

of time and effort. 

“The HFEA’s introduction of a system of 

incident reporting is, in my view, a major 

step forward in the management of risk in 

licensed centres. While no system will ever 

be totally error free, it is something that we 

all should strive for. If things do subsequently 

go wrong, we should have the knowledge 

that we have the appropriate support to 

manage the situation effectively and 

knowledge that others will ultimately learn 

from our misfortune. The incident reports 

now circulated by the HFEA allow this to 

happen in a positive way by providing key 

details of events and making appropriate 

recommendations – while protecting the 

identity of the centre concerned. We should 

be reassured that, over time, it may be able 

to spot trends and common themes in 

incidents that will lead to developments in 

technology or improvements to training 

programmes. I hope that this will encourage 

staff to embrace the culture of reporting.” 

Allan Pacey, 

Senior Lecturer in Andrology University 

of Sheffield and Head of Andrology for 

Sheffield Teaching Hospitals. 


Information management 

Protecting rights and guarding standards 

The information we hold can help underpin 

important policy decisions and enable us 

to monitor clinic performance more 

effectively. But it is crucial that the details 

we are entrusted with concerning IVF 

treatments, their results and in particular 

the source of donated sperm, eggs and 

embryos are kept safe and confidential. 

In 2003/04 we have made considerable 

progress in updating our information 

systems to ensure they are robust, 

comprehensive and adaptable to current 

and future needs. 

Who’s who? 

The knowledge that one day, any child 

born as a result of a donated egg or 

sperm may come to the HFEA and 

ask if they are related to someone they 

are about to marry is central to our 

information policy. The need to be able 

to answer questions such as this with 

absolute accuracy has driven our 

commitment to developing a reliable, 

comprehensive Data Register, which 

was introduced last year. 

Now, for the first time ever, all our data 

is held in one place from the time it is 

generated. A rigorous verification system 

has been created to crosscheck all data 

transfers and entries from both old and 

current records to ensure their accuracy 

before acceptance. As a result we can 

reliably trace people, the treatment 

service they used, and the outcome. 

Most importantly of all we can identify 

the children who resulted and the donors 

who helped to create them. All of this 

information is kept confidentially 

and securely. 

Performance and policy 

To help ensure the quality and safety 

of treatments, we can use the Register 

to check whether a clinic is offering only 

those services it is licensed to carry out, 

and to monitor clinic performance 

in general. 

The Register can also help inform policy 

decisions. For example, it can produce 

evidence about the number of embryos 

being replaced in relation to a woman’s 

age to help identify the optimum number 


needed to provide the best chance of a 

pregnancy without increasing the risk of 

a multiple birth. 

Watching over clinics 

This year saw the development and 

introduction of our new Centres Database, 

which holds detailed information about 

every licensed clinic in the UK. HFEA staff 

can now access details about inspections, 

treatments, staff, management issues, 

licenses and assessments at any clinic, 

instantly. This not only saves time, it also 

helps protect patients by enabling 

incidents to be reported quickly, so they 

can be fed into our Incident Alert system 

(refer to page 7). 

Utilising the Internet 

In order to be able to trace donors and 

children who are born as a result, it is 

essential that we gather accurate 

information about patients, the treatment 

they received and details about sperm, egg 

or embryo donation from the clinics, which 

we can input into the Data Register. Until 

now this has largely been a paper-based 

process. To help speed the accuracy and 

efficiency of the system, we have been 

developing Electronic Data Interchange 

(EDI) software since January 2004. This 

will be piloted in a handful of centres 

during the autumn and winter of 2005. 

Using Electronic Data Interchange, 

centres will be able to key vital patient 

and donor information directly and send 

it via a secure Internet connection to our 

centrally controlled Data Register. 

This will not only save time and money 

but most importantly it will reduce the 

possibility of error, and help keep patient, 

treatment and donor information safe 

and sound. 

Belts and braces 

To make absolutely certain that every 

piece of information we hold is as 

accurate as we can make it we have 

launched the Historic Audit Project. This 

massive review involves comparing key 

information about donors, patients, 

treatments and births we have received 

from clinics with the information that they 

hold to double check its authenticity and 

fill in any gaps. In many cases this means 

going back to original medical records to 

confirm the details currently held on the 

Data Register. 

Although this is an enormous undertaking, 

we believe it is extremely important for the 

emotional wellbeing of children born from 

donated eggs and sperm to be able to 

trace their genetic origins. While donor 

details registered to date remain 

confidential by law (there are new 

regulations lifting anonymity for donors 

registering from 1 April 2005), we are able 

to tell people if they have been conceived 

as a result of a donation when they are 18 

years old (or 16 if wishing to marry). 

Pilots of the project are already running, 

with roll out scheduled for late 2004 and 

completion by March 2006.

Our Directory goes live 

Our comprehensive “HFEA Directory of 

Clinics: Your Guide to Infertility” (see 

page 17) includes a wide range of useful 

information about infertility treatments in 

the UK, including the contact details of 

every registered clinic. 

This year we have begun work on the next 

edition, to be launched in Spring 2005, 

that will be available in a paper and webbased 

form. It will include a search facility 

that will provide statistical information to 

help answer patients’ questions quickly, 

easily and in a more tailored way. For 

instance, a patient would be able to 

search for their nearest clinics by postcode 

and compare the different services on 

offer. They could also find out the number 

of patients each clinic has treated over a 



• Achieving openness. Having 

invested in the necessary systems 

and personnel, we will be introducing 

new procedures to ensure we are 

ready for the Freedom of Information 

Act which comes into force in January 

2005. This will require us to be able 

to provide information about our 

operations upon request within 20 

working days. 

• Opening the record. Our Information 

Management team will be looking at 

how we capture and track requests 

for information from people born as 

a result of fertility treatment about 

their origins quickly and efficiently 

and then respond to them sensitively 

and confidentially. 

• Monitoring research. We will 

be researching and assessing new 

referencing systems for tracking 

sperm, eggs and embryos used in 

research, such as bar coding and 

Radio Frequency Identification 

(RFID), to improve our tight controls 

within Centres in order to meet 

the requirements of the EU 

Tissue Directive. 

year, how old those patients were, and 

what the outcome of each kind of licensed 

treatment was for different age groups. 

We have been working with patient 

focus groups, patient organisations 

and clinicians to establish what kind of 

statistical information is of most value 

to patients to help them make informed 

decisions about where they would like 

to be treated and to have some 

understanding of their chances of 

a successful pregnancy. 

Statistics for each clinic will also be 

included in future editions so that 

prospective patients can see which clinic in 

their area may give them the best chance 

of having a baby, depending on their age 

and the type of treatment they are seeking. 

“In clinics, we have huge amounts of 

paperwork to handle and obviously this is 

very time-consuming. At the same time, it is 

important that appropriate records are kept 

as accurately as possible. The electronic 

data interchange system for information 

required by the HFEA will significantly 

reduce the administrative burden on staff 

here by reducing the amount of form filling 

by hand and duplication onto our database. 

This should improve the accuracy of data 

entry. In the long term this can only be 

beneficial to patients.” 

Dr Jane Stewart, 

Consultant Gynaecologist, 

Newcastle Fertility Centre. 


Clinic audit 

Fostering trust and accountability 

Which fertility clinic should we choose? 

And which treatment is most likely to 

help us have a child? These are among 

the many questions couples ask and we 

seek to answer through our clinic audits. 

In 2003/04 we continued to develop 

our auditing processes, working in 

collaboration with other teams within the 

HFEA, to make certain that all the details 

we hold about treatments and patients 

are full and accurate. 

Meeting the need to know 

It is vital that the information we hold 

about the origins of people born as a 

result of fertility treatment and about the 

numbers of treatments performed and 

their success rates is reliable if we are 

to provide answers to people seeking 

treatment and their offspring, and 

meaningful figures about the efficacy 

and/or safety of various assisted 

conception techniques. Accurate 

information also aids us in the collection 

of the correct licence fees from clinics 

and can help inform legislation on 

assisted conception. 

In the past year we have been improving 

our Operational Audit, which looks 

at current data about patients and 

treatments, cross checking forms sent in 

by clinics for the HFEA Register against 

patients’ records taken by clinics at the 

time of treatment to make sure they 

concur. We carried out visits to 40 

centres under our operational audit cycle 

to assess the completeness of reporting 

of treatment cycles and check the 

accuracy of HFEA form completion in 

order to help avoid significant inaccuracies, 

errors or omissions in the information 

contained in our Register. 

We have also been busy planning and 

piloting audits for our ambitious Historic 

Audit Project, which will verify all data on 

IVF births from 1991 to 2002 (see page 

9). A new Head of Audit for the project 

has been appointed and a trial team of 

auditors has now started, with further 

teams to be recruited imminently. 



• Advancing our historic audit. Now 

staff are in place we intend to focus 

on our audit of all information since 

1991. This will enable us to answer 

questions that we may under the 

HFE Act be asked, such as ‘Was I 

conceived through IVF using donated 

gametes?’ and ‘Am I related to this 

person I am thinking of marrying?’ 

• Sharing best practice. Improving 

clinics’ information systems will benefit 

the Registry, too. In the course of our 

audit visits, we will seek to identify 

best practice on administrative and 

information systems and share this 

with all HFEA-licensed clinics. 


Arm’s Length Bodies review 

Shaping the future 

Since 1991 we can justly claim to have 

led the world in regulating the complex 

and ethically sensitive area of assisted 

reproduction. In 2004 we welcomed the 

news that our work will continue under 

the auspices of a new regulatory body 

that will be established in the future to 

license and monitor treatment and 

research involving human tissue. 

Tomorrow’s medicine 

Treatments such as bone marrow 

transplants for leukaemia and skin cell 

grafts for burns already make use of 

human cells and tissues. And the rapid 

pace of scientific discovery means that, 

in future, tissues and cells (including 

embryonic stem cells) will play an 

increasingly important role in diagnosing 

and treating disease. Tissue engineering 

and cell replacement therapy for 

conditions such as diabetes, heart failure 

and spinal cord injury will become a reality. 

These prospective developments raise 

a whole new area of ethics and law. 

Unlike organs such as the heart and 

lungs, which have to be transplanted 

immediately, tissues and cells can be 

stored in banks until they are ready to 

be used, a prospect which raises 

obvious issues of safety. 

It is against this backdrop that we learnt, 

in July 2004, that we are to become part 

of a new body charged with regulating 

treatments and research involving human 

tissues and cells including sperm, eggs 

and embryos, blood, organs and other 

materials in order to assure their safety 

and quality. 

Joining our strengths 

The new body to be known as the 

Regulatory Authority for Fertility and 

Tissue (RAFT) will be formed by a 

merger between ourselves and the 

Human Tissue Authority (HTA). The HTA 

will be established following the passing 

of the Human Tissue Bill, currently 

before parliament. The creation of 

RAFT will need primary legislation. The 

reconfiguration makes sense in light of 

the many common areas we share with 

the proposed HTA, such as our remit to 

regulate and monitor an ethically 

sensitive area of medicine and to ensure 

the safety and quality of both research 

and treatment throughout the UK. 

In addition, many of the functions we 

regulate take place in settings outside 

hospitals and clinics, such as sperm 

banks – and, in the case of the HTA, 

university anatomy schools. 

The announcement of the merger came 

in the wake of the Arm’s Length Review, 

set up in October 2003 to look at ways 

of streamlining the functions of 42 standalone 

bodies accountable to the 

Department of Health, in order to improve 

efficiency and reduce NHS bureaucracy. 

Playing a vital role 

It will be several years before RAFT, 

which will be set up under a new Act 

of Parliament, is established. In the 

meantime the HTA will be set up and will 

carry out the intensive work involved in 

setting up standards and codes of practice 

and implement operational/inspection 

procedures prior to the establishment 

of the new regulatory body. 



• Working with the government. 

In partnership with the Department 

of Health, we will be supporting the 

establishment of the HTA. We will also 

be contributing to the review of the 

HFE Act and the Select Committee 

for Science and Technology’s report 

on reproductive technology, both of 

which will help shape our future role. 

• Calling on experience. Further 

ahead, we look forward to helping to 

create RAFT. We expect to apply the 

lessons we have learned about issues 

such as consent and the importance 

of creating a strong ethical framework 

in order to promote public confidence 

that the use of human tissue will be 

responsible and well regulated. 

• Enhancing public support. We will 

work to maintain a strong base of 

public support for scientific and 

medical research, education, training 

and public health surveillance in 

tissues and organs. 

Feature 


Research 

Researching today for health tomorrow 

Our long experience of regulating 

assisted reproduction gives us a unique 

understanding of the scientific, medical, 

psychological, social and ethical 

dimensions of embryo research. 

In 2003/04 we made significant 

improvements to our research licensing 

process in order to ensure that the 

increasing number of applications we 

receive are dealt with speedily and 

efficiently and that every project we 

license is necessary, responsible and 

has the potential to benefit health. 

Strengthening our strategy 

Few subjects arouse such strong opinions 

and emotions as human embryo research. 

There is no doubt that such research has 

enormous potential benefits. But, in the 

wrong hands, it could be open to abuse. 

As part of our reforms we have set up a 

dedicated research regulation team with its 

own head and research officer to oversee 

the licensing process and established a 

permanent licensing committee to enable 

us to build expertise. 

Our regulatory team is responsible for 

advising prospective researchers on how 

to frame proposals which helps avoid 

delays in the licensing process, inspecting 

premises, investigating adverse incidents, 

following up progress and processing 

research renewal applications. We publish 

lay summaries of research projects 

licensed by the HFEA, and of research 

applications, on our website. 

Involving experts 

In order to speed up the licensing 

process and ensure that proposals 

are based on robust science, we have 

widened our range of experts, recruited 

more peer reviewers and co-opted new 

experts onto our committees. We have 

also strengthened our partnerships with 

research funding bodies such as the 

Medical Research Council, the Wellcome 

Trust and the Biotechnology and 

Biological Sciences Research Council. 

As ever we are mindful of the fact that 

research is only possible because those 

undergoing fertility treatment are generous 


enough to donate their surplus eggs, 

sperm and embryos for use in research. 

Safeguarding embryos and our future 

To some an embryo is just a bundle of 

cells, but to most prospective parents 

and the wider public, it is a potential 

baby. In recognition of this special status 

strict legal controls apply to the use of 

embryos in research and a great deal of 

debate and discussion goes on before a 

licence is issued. Any research must be 

linked to one or more of the following: 

• Enhancing the success of IVF 

• Helping couples have healthy babies 

free from inherited disease 

• Increasing knowledge about the 

causes of miscarriage 

• Developing more effective 

contraceptive techniques 

• Developing screening methods for the 

detection of genetic or chromosomal 

abnormalities in embryos before they 

are implanted 

• Increasing knowledge about the 

development of embryos 

• Increasing knowledge about serious 

disease and/or translating such 

knowledge into new methods of 

treatment or diagnosis 

The law forbids the use of embryos in 

research after 14 days and bans the 

placing of a human embryo in an animal, 

the alteration of the genetic structure of 

cells forming part of an embryo and the 

use of embryos for purposes other than 

those for which a licence has been 

awarded. 

Awarding a licence 

Each new proposal must detail what the 

research is about, why the researcher 

wants to do it and why it is necessary to 

use human embryos. Once we have all 

the relevant information, the proposal is 

sent out to at least two peer reviewers 

to check that it is sound scientifically and 

to consider whether the use of human 

embryos is justified. 

We now have a team of over 40 nationally 

and internationally known fertility experts 

and stem cell scientists as well as 

specialists in specific diseases that we 

can call upon in order to establish whether 

a particular project really will add to 

current medical knowledge. 

We inform the applicant of any comments 

made by the peer reviewers and they 

have the opportunity to raise queries if 

they wish. The proposal is then sent to 

our research licence committee. This 

committee, which meets at least six times 

a year, consists of five members of the 

HFEA including a lay chair and a clinical 

and scientific adviser. 

Understanding stem cells 

In 2001 our remit was extended to include 

the use of embryos to derive stem cell 

lines. Stem cells are the master cells found 

in the embryo that have the potential to 

develop into any kind of tissue or organ. 

Studying these cells, which derive from 

embryos created for IVF but not used 

for treatment, is helping advance 

understanding of how the body’s cells 

and tissues develop and what goes 

wrong in illness or disease. 

To ensure that embryos are only used 

when strictly necessary, a sample of the 

stem cell line must be deposited in the 

UK Stem Cell Bank set up in May 2004 

by the Medical Research Council (MRC) 

& the Biotechnology and Biological 

Sciences Research Council (BBSRC). 

This means that in future before granting 

a licence for stem cell research we will 

have to be satisfied that it cannot be 

done using existing stem cell ‘lines’ from 

the bank. We are continuing to work 

closely with the UK Stem Cell Bank to 

ensure that our respective guidelines are 

in line with each other. 

Sharing knowledge and ideas 

What do patients want to know about 

embryo research? And how are new 

discoveries about the development of 

embryos changing our thinking? These are 

some of the questions raised in our first 

ever research conference held in November 

2003. 120 delegates – mainly scientists 

and clinicians from licensed UK fertility 

centres – gathered to discuss the state of 

embryo research across the UK and share 

knowledge and ideas. The conference 

included presentations from ethicists, 

lawyers and patient group representatives.

Looking forward 


• Talking to the public. We will be 

looking at how we can improve our 

dialogue with the public still further to 

bring the facts about embryo research 

to an even wider audience and 

encourage informed debate. 

• Streamlining the process. 

We will continue to examine and 

update our licensing processes and 

aim to ensure that decisions are 

given within three months of an 

application being received. 

• Bringing experts together. We are 

holding another research conference 

in November 2004. 

• Increasing partnerships. We will be 

working with other agencies to ensure 

that we continue to approve only the 

best quality research and stimulating 

dialogue with scientists to encourage 

awareness of our aims and help them 

track emerging issues. 

> Research Statistics (as at 31 August 2004) 

• 156 research licence applications 

received by HFEA since 1991 

• 124 research projects have been 

licensed by the HFEA since 1991 

• 30 research projects are currently 

licensed by the HFEA 

• 10 licensed research projects relate 

to embryonic stem cells 

• 3 licensed research projects relate 

to parthenogenesis 

• 1 licensed research project relates 

to cell nuclear replacement 

“For many infertile couples, one solution is 

in vitro fertilisation (IVF). This treatment has 

helped many thousands of couples, but 

success rates remain disappointingly low, 

with a live birth rate per IVF cycle of around 

22%. Moreover, since two, exceptionally 

three embryos may be transferred in any 

one cycle, there is a high risk of multiple 

births. These babies are often underweight 

and perinatal mortality is above average. 

A solution would be to transfer single 

embryos with a high chance of forming a 

pregnancy but we know very little about 

what makes some embryos more healthy 

than others. The aim of our work is to 

carry out a detailed examination of the 

development of the early human embryo, to 

learn how to improve culture conditions and 

devise diagnostic methods that allow the 

transfer of single, healthy embryos. This 

would increase the possibility of a pregnancy 

and reduce the risk of multiple births.” 

Dr Franchesca Houghton, 

Wellcome Trust Research 

Career Development Fellow, 

Department of Biology, 

University of York. 


Policy 

Deciding the big issues 

One of our most important roles is to 

ensure that the use and development 

of IVF and embryo research is ethical 

and protects the physical and emotional 

wellbeing of parents, children 

and siblings. 

2003/04 has seen the development of 

a number of key policies developed in 

consultation with the public, to help 

create high quality services that have 

everyone’s best interests at heart. 

Sex Selection 

The ability to screen embryos for 

chromosomes that determine sex 

makes it possible – theoretically at least – 

for parents to choose to have a boy or a 

girl. But should this be allowed? And if 

so, should there be limits? 

In the past we recommended that sex 

selection might be carried out for medical 

reasons – to avoid having a baby with a 

sex-linked hereditary disease such as 

Duchenne muscular dystrophy, which only 

affects boys – but not for social reasons, 

such as balancing the number of boys 

and girls in a family. 

Our review of sex selection, carried out at 

the request of the Minister for Health and 

published at the end of 2003, re-affirmed 

this conclusion. The recommendations 

were published following widespread 

consultation with experts and the public, 

which revealed that over 80% of people 

did not approve of sex selection purely 

on social grounds. 

We concluded that sex selection should 

not be allowed for any non-medical 

reason. We also stipulated that where 

used for medical reasons it should be 

strictly regulated and that any long-term 

effects should be recorded. Care must 

also be taken to ensure the welfare of 

families and children. 

“Saviour siblings” 

Sometimes, the only chance a child has 

of surviving a serious illness is through 

the donation of compatible tissue from a 

sister or brother. But should an embryo 

created by IVF be specifically tested and 

selected for this purpose? 


When we first looked at this issue three 

years ago, we agreed that there was 

no reason to think that children born 

following tissue typing and embryo 

selection would not be valued for their 

own sake. But we also noted the limited 

evidence then available about the risks 

inherent in the procedure of removing one 

or two cells from an embryo for testing 

(known as embryo biopsy). For these 

reasons we adopted a cautious attitude 

and concluded that it should be permitted 

only when these risks were already 

discounted because embryo biopsy 

was to be undertaken anyway in order 

to select embryos free from a serious 

genetic disorder. Where there was no 

genetic disorder in the family, tissue 

typing and embryo selection were not 

allowed because of the risk that a child 

born following the procedure might be 

damaged by a test undertaken solely for 

the benefit of a sibling. 

We have now reviewed the medical, 

psychological and emotional implications 

for children and their families as well as 

the safety of the technique. There have 

been three further years during which the 

number of successful embryo biopsies 

has increased greatly, both in the UK and 

abroad. In the light of this there is now 

much more evidence that the procedure 

does not bring an increased risk of harm 

to children born following embryo biopsy. 

The Court of Appeal also stated that it is 

in our powers to license this. 

Taking all these factors into consideration 

we have amended our 6th Code of 

Practice to allow tissue typing on 

embryos to help parents save a sick 

child. Each application is considered 

individually and this approach is very 

much a last resort. Before an embryo 

is selected in this way full consideration 

must first be given to every other 

appropriate treatment. 

Safety first 

On rare occasions the storage vessels 

in which sperm, eggs and embryos are 

frozen can fail. This can spell the end of 

any hope of a child for couples who may 

have had their last viable sperm, eggs or 

embryos frozen, especially in cases 

where their fertility has since been 

affected by medical treatment, such 

as chemotherapy for cancer. 

To help prevent such tragic and avoidable 

accidents we have issued new guidelines 

on the safety of these vessels, known as 

dewars, to be put in place by the end of 

June 2005. These include fitting alarms 

linked to an auto-dial system to enable 

staff to be contacted outside normal 

hours, together with the provision of 

spare storage capacity as a fallback in 

case a dewar unexpectedly fails. As an 

added precaution, the sperm, eggs or 

embryos of patients whose fertility may 

be affected by medical treatment must 

be divided between two or more vessels 

to reduce the chances of loss. 

By its nature there are always uncertainties 

with IVF treatment. We believe the survival 

of stored eggs, sperm and embryos 

shouldn’t be one of them and that these 

new measures will prevent losses in future. 

Deciding the rules on donation 

Should people who donate sperm, 

eggs or embryos be paid? Should there 

be any age limits on donors? How many 

offspring should a donor be allowed to 

create? These are just some of the 

complex questions we are addressing 

in our review of sperm, egg and embryo 

donation. Over recent months we have 

been gathering evidence from clinics and 

patient bodies and are now drawing up 

a consultation document with detailed 

proposals. The impending change in law 

ending anonymity for new sperm, egg 

and embryo donors from 1 April 2005 

forms a background to this review, the 

outcome of which will be announced in 

Spring 2005. 

Assessing children’s welfare 

Under the HFE Act as it stands, clinics 

are obliged to consider the welfare of 

children who may be born as a result 

of fertility treatment. Most fertility clinics 

approach the woman or couple’s GP 

(with their permission) to ask whether 

they have any reason to believe that a 

child resulting from the treatment might 

be at risk. Some clinics also ask clients 

to fill in ‘child welfare’ forms or have an

assessment interview. But how useful is 

this in predicting the welfare of a potential 

child and could there be a better way to 

go about it? In the past few months we 

have been canvassing the views of 

patients and clinics to see what they 

think. Over the next year will be setting 

up workshops with stakeholders, patient 

groups, counselling organisations and 

clinicians to try and work out the most 

effective and sensitive way of taking into 

account the welfare of children born as a 

result of assisted conception. 



• Scanning the horizon. To ensure 

we are in a position to anticipate new 

techniques and treatments that clinics 

may wish to provide, we have set up 

a worldwide scientific panel to gather 

intelligence about new developments 

in assisted conception and give us 

time to explore these in terms of 

safety, ethics and the law. This should 

in turn speed up licence applications 

and accelerate access to new 

treatments for those seeking 

fertility treatment. 

• Preparing for change. The European 

Tissue Directive, due to come into 

force in the UK in April 2006, will 

extend our role into new areas such 

as intra-uterine insemination. The 

Directive aims to ensure the safety and 

quality of human organs, tissues and 

cells, including sperm and embryos, 

used for medical purposes in every 

member state. We are working closely 

with the Department of Health and our 

stakeholders to make sure we’re ready 

to embrace our new role. 

• Looking at the law. We will 

continue to work with the Department 

of Health on its review of the HFE 

Act, announced early in 2004, to 

ensure that it reflects the enormous 

changes in reproductive technology 

since1990. We are also contributing 

our knowledge and experience to the 

House of Common’s Science and 

Technology Select Committee’s 

review of human reproductive 

technologies and the law. 

“Whatever the HFEA’s decision in making 

new policy, not everyone will agree. In my 

opinion the HFEA’s recommendation not 

to permit sex selection for non-medical 

reasons was correct. Sex is not a disease. 

Some feel that denying access to sex 

selection is against human rights, but in my 

view this would be stepping over a fine line. 

Initially the HFEA took a cautious approach 

on saviour siblings, prohibiting PGD for 

tissue typing alone. One argument was 

that embryo biopsy may be harmful, yet 

the HFEA granted licences to use PGD to 

improve IVF pregnancy rates (aneuploidy 

screening). I am glad that after a thorough 

review of the evidence, including research 

into public opinion, the Authority has 

reversed its decision. 

It is important for the HFEA to have public 

consultations and make informed decisions. 

The rest of the world looks to the UK, so 

it is important that we get things as right 

as possible.” 

Dr Joyce Harper, 

Senior Lecturer in Human Genetics 

and Embryology, 

University College London. 


Communications 

Engaging with the public 

How far should couples go in their quest 

for a child? And where should we draw 

the line in reproductive medicine? Such 

questions are rightly a source of intense 

interest and debate, not just to those 

going through fertility treatment but to 

doctors, scientists, MPs and the 

wider public. 

In 2003/04 we strengthened our 

relationship with key stakeholders and 

improved the quality and range of 

information available through our website, 

publications, conferences and other 

events, and the media. 

Widening our reach 

We continued to develop our website 

to make it more accessible and reader 

friendly, more than doubling the amount 

of information available, including lay 

summaries of licensed research projects 

(see page 27). Between July 2003 and 

July 2004, the site attracted 11.5m hits, 

a considerable increase on last year. 

Visit www.hfea.gov.uk to see 

what we have done. 

We also extended our range of patient 

publications (see below) and introduced 

a new Parliamentary Briefing designed to 

inform MPs about our role and keep them 

up-to-date with our activities. Our other 

newsletter, Update, is a channel for 

communicating with licensed centres, 

together with monthly mailings detailing 

policy changes and general information. 

Events such as National Infertility Day 

and the NHS Confederation Annual 

Conference gave us the opportunity 

to meet stakeholders face-to-face. 

We attended many other conferences 

such as the European Society for 

Human Reproduction and Embryology 

and we have set up regular meetings 

with patient groups and professional 

organisations to discuss how we can 

best meet their information needs. 

Opening our meetings to the public 

In order to increase transparency and 

encourage people to gain a greater insight 

into how we work and reach decisions, 

in October 2003 we held the first of three 

open meetings in London. These were 


advertised, and papers for discussion 

were posted in advance on our website. 

Students, MPs, patients and patient 

group representatives and clinicians were 

among those attending. Questions were 

invited from the floor and, afterwards, 

there was a chance to meet HFEA 

members informally. This was particularly 

welcomed by the observers. 

Helping patients decide 

Men and women about to embark upon, 

or going through, fertility treatment and 

their families need reliable, easy-tounderstand 

information about different 

treatments and the services they can 

expect from fertility clinics. In order to 

meet this need, in 2003 we launched a 

major new information guide, the “HFEA 

Directory of Clinics: Your Guide to 

Infertility”, in partnership with Dr Foster, 

which has proved hugely popular with 

patients. We worked with patient 

groups, including Infertility Network UK, 

to illustrate the Directory with stories 

from former patients about their 

experiences, and what they learnt. 

Its easy-to-read format helps people 

about to embark upon or going through 

fertility treatment ask the right questions 

of those caring for them. The personal 

experiences illustrate what it is like to 

undergo treatment to help readers feel 

less alone. Equally importantly the guide 

contains information about every HFEAlicensed 

centre, and the services they 

provide. Like all our literature, it is free. 

Listening and responding 

Our annual conference provides another 

opportunity for us to interact with 

stakeholders and hear their views. Over 

100 delegates including MPs, clinicians 

and patient group representatives 

attended this year’s event held in January. 

Public Health Minister, Melanie Johnson, 

announced plans for lifting anonymity 

from future sperm, egg and embryo 

donors, enabling children conceived 

through donation to trace their origins 

when they reach 18 years of age. She 

also announced a review of the HFE 

Act to take into account the scientific 

developments and changes in public 

attitudes towards IVF treatment and 

research that have occurred since 1990. 

Speakers addressed issues including the 

welfare of the child, the role of primary 

care trusts in IVF, the implications of the 

EU Tissue Directive and of the forthcoming 

Freedom of Information Act. 

Media matters 

The HFEA operates in a fast moving and 

often controversial area of science. The 

key to communicating our activities to 

the wider public depends on keeping 

the media updated and informed to 

ensure that issues and debates are 

reported accurately. 

In 2003/04 we continued to develop our 

media profile and to foster productive 

working relationships with science, 

health and medical journalists both 

here and abroad. 

Our press office is on call 24 hours a day, 

seven days a week providing fast and 

accurate briefings to journalists on all 

aspects of our work. On the busiest days 

we may receive as many as 150 calls 

from print and broadcast journalists 

seeking information or comment. 

The dedicated press section of our 

website is extremely popular, providing 

background briefings and fact sheets on 

the whole range of HFEA activities and 

giving reporters and other commentators 

easy access to information whenever 

they need it. 

Journalists from print and broadcast 

media ran a well attended workshop 

at our annual conference, providing 

practical advice to fertility specialists and 

scientists on how to handle the media. 

The workshop’s success has guaranteed 

it a slot on next year’s agenda. 

Encouraging responsible reporting 

Two policy decisions made in 2003/04 

illustrate how we work with the media 

to help ensure sound reporting. 

The first in November 2003 concerned our 

year-long review of sex selection (see page 

15). The day before the announcement we

arranged a press conference at the Royal 

Institution’s Science Media Centre, which 

was attended by over 30 journalists from 

print and broadcast media. We also held 

a parliamentary launch at the House of 

Commons for MPs and other interested 

parties, an event which drew over 

80 people. 

As a result of our efforts, coverage of 

our recommendations was very positive, 

reporting was accurate and the moral 

issues surrounding parents choosing the 

sex of their children responsibly dealt with. 

The decision that embryos could be 

tested before being implanted in order 

for families to have a child who could be 

a tissue match for a seriously ill sibling 

(see page 15) was announced in July 

2004. Our announcement of a policy 

review two months before this re-ignited 

media interest in this controversial issue. 

Following our decision HFEA chair, Suzi 

Leather, met journalists and TV crews to 

make an early, clear statement, which 

resulted in wide and sensitive coverage. 



• Consulting on policy. We intend to 

strengthen the relationship with our 

main stakeholders, involving them 

and consulting with them on policy 

and regulatory developments. 

• Informing opinion formers. 

We intend to make a more proactive 

contribution to parliamentary debate. 

We also want to reach other 

important opinion formers and groups 

such as GPs and Primary Care Trusts 

(PCTs), who are likely to become 

more involved in decisions about 

access to IVF treatment. 

• Increasing transparency. We will 

continue to hold open our meetings 

to members of the public and will hold 

our first open meeting outside London 

in Edinburgh in October 2004. 

• Informing choice. We are looking at 

ways of developing the next edition of 

our Directory of Clinics to include 

statistics on success rates for 

treatments, and commissioning 

research with people at different 

stages of treatment to find out how 

we can best equip them to make 

informed choices. 

• Expanding our web briefings. 

We hope to develop the press 

section of the website to expand 

our briefings for journalists in the 

UK and overseas. 

• Connecting with patients. In order 

to implement a patients’ strategy we 

will be building formal relationships 

with patient groups and setting up 

a Patients’ Consultative Panel. We will 

also be extending our media relations 

to target patients via consumer, 

lifestyle and women’s magazines 

and the regional press. 

“Most people considering fertility treatment 

want as much information as possible not 

just about the kind of treatment that may 

be most suitable for them, but about issues 

such as the emotional and financial cost, 

and what kind of support is available. 

Having been a patient myself, I believe the 

HFEA exists to protect patients, and that 

we are the envy of the world for having 

such a well-regulated system. This also 

means that information the HFEA produces 

is trusted to be reliable and authoritative. 

Infertility Network UK worked with the 

HFEA on the HFEA Directory of Clinics 

so that it best meets the needs of patients 

and prospective patients. The case 

histories are especially useful in illustrating 

people’s different personal experiences. 

Our members have been very positive 

about the publication and think it’s 

fantastic – very user-friendly!” 

Sheena Young, Head of Business 

Development, Infertility Network UK. 


Working together 

Reducing multiple births 

How many embryos should be transferred 

during IVF? In 2003/04 after extensive 

research and public consultation, we 

decided to reduce the number of embryos 

permitted to be replaced in the womb 

during IVF from three to two in women 

under 40 in order to minimise the risk 

of a multiple birth. 

The new ruling, incorporated in our 6th 

Code of Practice, provides an example 

of how the HFEA strives to reach sound 

evidence-based decisions. 

Looking at the background 

To protect the welfare of mothers and 

babies, our Code of Practice had always 

limited the number of embryos permitted 

to be transferred in a single IVF cycle to 

three. The question was: should this be 

reduced still further? 

Our first step was to examine the 

statistics. There has been a dramatic 

increase in the number of triplets born 

in this country since the 1980s. The 

number of twins born has also risen. 

Behind these figures lies the steady 

climb in IVF treatments. 


At first glance it may not seem such a 

problem. Having twins or triplets can be 

a quick way to have an instant family 

without the need for further IVF treatment. 

The health consequences for the mother 

can, however, be serious, a fact that is 

often not recognised. During pregnancy 

she has a higher risk of miscarriage and 

of the high blood pressure disease of 

pregnancy, pre-eclampsia. Meanwhile 

her babies have an increased chance of 

being born prematurely, dying before birth 

or during the first year, or suffering some 

form of disability. 

What’s more, research has shown that 

the levels of exhaustion and financial 

pressure triplets, and even twins, bring 

can put a crippling strain on families 

and ultimately on the rest of society. 

Exploring the data 

Our next step was to search the data 

contained in our own Register and 

compare it with statistics from the US. 

This showed that, for women in their 

30s or under, limiting the number of 

embryos transferred to a maximum of 

two made no real difference to their 

chances of becoming pregnant. It did, 

however, reduce the number of triplets 

or twins born. 

The data showed that for women aged 

40 and over the situation is different. 

Transferring three embryos will not 

usually result in a triplet birth and will 

slightly improve their chance of 

becoming pregnant. 

We also talked to patient groups about 

the way people might feel about this 

rule changing, and what their concerns 

might be. 

These various elements helped shape the 

policy in our latest Code of Practice that 

the number of embryos replaced should 

be reduced to two in women under 40. 

In this way, the Code supports clinics in 

achieving the maximum number of single, 

healthy babies without jeopardising a 

woman’s chances of conceiving. 

Publicising our findings 

The change in policy was made public 

at the launch of the 6th Code of Practice 

at the joint British Fertility Society and the

FeatureHFEA Report 

Association of Clinical Embryologists’ 

Annual Meeting in Liverpool in January 

2004. The launch was an opportunity to 

engage the media in informing the public 

of the risks associated with multiple 

births. It centred around a joint 

presentation by our chair Suzi Leather 

and Jane Denton, Director of the Multiple 

Births Foundation, who was able to reveal 

many personal stories of families coming 

to terms with multiple births and the 

difficulties they faced. 

Ms Leather and Ms Denton gave many 

television, radio and print interviews. 

This resulted in a great deal of coverage 

raising the profile of risks associated with 

multiple births. 

Explaining policy to patients 

Whenever we make a policy change, it is 

important that we make sure that anyone 

who could be affected knows about it, 

and the reasons for it. In the case of the 

change to two-embryo transfer this 

involved issuing guidance to clinics to 

make sure they were operating in line 

with the new Code of Practice. 

Just as importantly, patients undergoing 

fertility treatment needed to understand 

why we were restricting the number of 

embryos that could be transferred during 

their treatment, particularly since other 

countries have different approaches. 

To this end we produced a new patient 

information leaflet, “Avoiding Multiple 

Births”, which answered questions they 

might have. It explained the medical risks 

associated with multiple pregnancies, and 

addressed the fear that some patients 

might have that, by reducing the number 

of embryos transferred during treatment, 

they might be less likely to have a baby. 

As always with our leaflets, we listed 

details of other relevant organisations 

that could provide further support and 

information, such as the Multiple Births 

Foundation and the Twins and Multiple 

Births Association (TAMBA). 

The leaflet is now widely used in clinics 

around the UK and by patient groups, 

and is available free of charge from 


> It doesn’t stop there 

We are constantly and actively engaged 

in shaping our policies and practices to 

ensure that they meet the needs of those 

undergoing fertility treatment and the rest 

of society. 

In future, we would like to get to the 

position where women need only to 

have a single embryo replaced, to mimic 

more closely what happens naturally. 

In order to make this possible we have 

licensed a multi-centre project to 

examine the development of early 

human embryos in the hope of finding 

ways to identify those with the best 

possible chance of implanting in the 

womb and developing into a healthy 

baby. As well as helping people 

undergoing IVF, this could also help 

ensure the health of babies naturally 

conceived. 

We will continue to monitor the impact 

of this and other areas of policy through 

data submitted by clinics to our Register, 

our licensing process and information 

obtained from our stakeholders. In this 

way we aim to ensure that our policies 

and practices are at all times in line with 

the most up-to-date knowledge and 

findings in the field of fertility treatment 

and research. 

| 20

Appendix One 

Standing Committee Membership (as of 12 May 2004) 

Organisation & Finance Committee 

Chair: Suzi Leather 

Tom Baldwin 

Chris Barratt 

Clare Brown 

Ivor Brecker 

Sharmila Nebhrajani 

Regulation Committee 

Chair: Sharmila Nebhrajani 

David Barlow 

Ivor Brecker 

Clare Brown 

Iain Cameron 

Maybeth Jamieson 

Audit Committee 

Chair: Walter Merricks 

Jane Denton 

Emily Jackson 

Simon Jenkins 

Luke March (co-opted member) 

Alison Bexfield (co-opted member) 

Kim Hayes (Department of Health observer) 

Scientific & Clinical Advances Group 

Chair: Neva Haites 

Tom Baldwin 

David Barlow 

Chris Barratt 

Peter Braude 

Clare Brown 

Iain Cameron 

Jane Denton 

Maybeth Jamieson 

Sara Nathan (co-opted member) 

Roger Pedersen (co-opted member) 

Ted Webb (DH Observer) 

Ethics & Law Committee 

Chair: Tom Baldwin 

Ivor Brecker 

Richard D. Harries 

Jennifer Hunt 

Emily Jackson 

Simon Jenkins 

Suzi Leather 

Sara Nathan 

Walter Merricks 

Felicity Collier 

Celia Deane-Drummond (co-opted member) 

Human Genetics Commission representative 

(co-opted member) 

Information Management Programme 

Chair: Angela McNab 

Suzi Leather 

David Barlow 

Peter Braude 

Jane Denton 

Mark Kinsella 

Neva Haites 

Barry MacDonald 

David Moysen 

Sharmila Nebhrajani 

David Tellis 

Kim Hayes (DH Observer) 

Steve Carroll (co-opted member) 


Appendix Two 

Centres licensed by the HFEA (as of 31 August 2004) 

East Midlands 

Centre Number Name Licenses Held 

0016 CARE Northampton Treatment and Storage 

0101 CARE Nottingham Treatment, Storage and Research 

0149 Derby City General Hospital Treatment and Storage 

0068 Leicester Royal Infirmary Treatment and Storage 

0069 Middle England Fertility Centre (Leicester) Treatment and Storage 

0162 Queens Medical Centre Fertility Unit (Nottingham) Treatment and Storage 

East of England 


0100 Bourn Hall Clinic (Cambridge) Treatment and Storage 

0165 Brentwood Fertility Centre Treatment and Storage 

0178 Fertility Unit, Peterborough District Hospital Treatment and Storage 

0188 Isis Fertility Centre (Colchester) Treatment and Storage 

0051 Rosie Hospital (Cambridge) Treatment and Storage 

0190 Subfertility Unit, James Paget Healthcare (Gorleston-on-Sea) Storage 

0002 Watford General Hospital Treatment and Storage 

London 


0080 Andrology Unit, Hammersmith Hospital (W12) Storage 

0109 Assisted Conception Unit, King's College Hospital (SE5) Treatment and Storage 

0157 Assisted Reproduction and Gynaecology Centre (W1) Treatment and Storage 

0094 Barts and the London Fertility Centre (EC1) Treatment and Storage 

0086 BMI Chelsfield Park ACU (Orpington) Treatment and Storage 

0070 Bridge Centre (SE1) Treatment and Storage 

0171 Bridge Centre Cryoservices (SE1) Storage 

0158 Chelsea & Westminster Hospital (SW10) Treatment, Storage and Research 

0199 CRM London (NW8) Treatment and Storage 

0074 Cromwell IVF and Fertility Centre, London (SW5) Treatment and Storage 

0030 Essex Fertility Centre (Buckhurst Hill) Treatment and Storage 

0102 Guys Hospital (SE1) Treatment, Storage and Research 

0078 Hammersmith Hospital (W12) Treatment, Storage and Research 

0187 Harley Street Clinic (W1) Treatment 

0186 Harley Street Fertility Centre (W1) Treatment and Storage 

0153 Homerton University Hospital (E9) Treatment and Storage 

0006 Lister Fertility Clinic (SW1) Treatment and Storage 

0143 London Female And Male Fertility Centre (N6) Treatment and Storage 

0088 London Fertility Centre (W1) Treatment, Storage and Research 

0105 London Women's Clinic/Hallam Medical Centre (W1) Treatment and Storage 

0011 Louis Hughes (W1) Storage 

0138 North East London Fertility Services (Ilford) Treatment and Storage 

0117 Queen Mary's Hospital (Sidcup) Treatment 

0206 Reproductive Genetics Institute (W1) Treatment and Storage 

0167 Reproductive Medicine Unit (WC1) Treatment and Storage 

0163 Shirley Oaks Hospital (Croydon) Treatment and Storage 

0044 U C H London (WC1) Treatment, Storage and Research 

0207 University College London (WC1) Research 

0048 West Middlesex University Hospital (Isleworth) Treatment and Storage 


North East 


0168 Bishop Auckland General Hospital Treatment and Storage 

0170 Centre for Assisted Reproduction, Gateshead Treatment and Storage 

0056 Cleveland Gynaecology and Fertility Centre (Middlesbrough) Treatment and Storage 

0075 Cromwell IVF and Fertility Centre, Darlington Treatment and Storage 

0031 Hartlepool General Hospital Treatment and Storage 

0055 James Cook University Hospital (Middlesbrough) Treatment and Storage 

0017 Newcastle Fertility Centre at Life Treatment, Storage and Research 

0076 NURTURE (Nottingham) Treatment, Storage and Research 

0096 Sunderland Fertility Centre Treatment and Storage 

North Ireland 


0200 Origin Fertility Care (Belfast) Treatment and Storage 

0077 Regional Fertility Centre, Belfast Treatment and Storage 

North West 


0185 CARE Manchester Treatment and Storage 

0071 CARE Wirral Treatment and Storage 

0189 Christie Hospital NHS Trust (Manchester) Storage 

0007 Hewitt Centre for Reproductive Medicine (Liverpool) Treatment, Storage and Research 

0033 Manchester Fertility Services LTD Treatment, Storage and Research 

0067 St Mary's Hospital (Manchester) Treatment, Storage and Research 

0175 University of Manchester Research 

Scotland 


0202 Division of Gene Expression and Development, Roslin Institute Research 

0201 Edinburgh Assisted Conception Unit Treatment and Storage 

0115 Glasgow Nuffield Hospital Treatment and Storage 

0037 Glasgow Royal Infirmary Treatment, Storage and Research 

0166 Institute for Stem Cell Research (Edinburgh) Research 

0098 Lanarkshire Acute Hospital NHS Trust (Aidrie) Treatment and Storage 

0004 Ninewells Hospital (Dundee) Treatment and Storage 

0019 University of Aberdeen Treatment and Storage 

South East 


0161 BMI The Chaucer Hospital (Canterbury) Treatment and Storage 

0064 Chiltern Hospital Fertility Services Unit (Great Missenden) Treatment and Storage 

0015 Esperance Private Hospital (Eastborne) Treatment and Storage 

0035 Oxford Fertility Unit Treatment, Storage and Research 

0121 Princess Anne Hospital Fertility Unit (Southampton) Treatment, Storage and Research 

0159 Royal Surrey County Hospital (Guildford) Storage 

0208 South East Fertility Group (Tunbridge Wells) Treatment and Storage 

0144 The Woking Nuffield Hospital Treatment and Storage 

0057 Wessex Fertility Limited (Southampton) Treatment and Storage 

0180 Willow Suite, Thames Valley Nuffield Hospital (nr Slough) Treatment and Storage 


South West 


0139 Bath Assisted Conception Clinic Treatment and Storage 

0024 Centre for Reproductive Medicine, University of Bristol Treatment and Storage 

0151 Gloucestershire Hospitals NHS Trust (Cheltenham) Storage 

0010 New Life Centre (Bristol) Treatment and Storage 

0176 Obstetrics & Gynaecology (Clinical Science at South Bristol) Treatment and Storage 

0005 Peninsular Centre for Reproductive Medicine (Exeter) Treatment and Storage 

0197 Salisbury Fertility Centre Treatment and Storage 

0179 South West Centre for Reproductive Medicine (Plymouth) Treatment and Storage 

0032 Southmead Hospital (Bristol) Treatment and Storage 

0133 Winterbourne Hospital (Dorchester) Treatment and Storage 

Wales 


0049 Cardiff Assisted Reproduction Unit Treatment and Storage 

0059 Cromwell IVF and Fertility Centre, Swansea Treatment and Storage 

0130 North West Wales Fertility Centre (Bangor) Storage 

0152 Singleton Hospital (Swansea) Storage 

West Midlands 


0181 ACU, Lifestyle Sandy Lane Clinic (Newcastle-under-Lyme) Treatment and Storage 

0119 Birmingham Women's Hospital Treatment, Storage and Research 

0026 BMI Priory Hospital (Birmingham) Treatment and Storage 

0184 Burton Hospitals NHS Trust (Burton-upon-Trent) Treatment and Storage 

0013 Centre for Reproductive Medicine, Coventry Treatment, Storage and Research 

0209 Institute of Biomedical Research (Birmingham) Research 

0008 Midland Fertility Services (Aldridge) Treatment and Storage 

0148 Shropshire and Mid-Wales Fertility Centre (Shrewsbury) Treatment and Storage 

0198 St Jude's Clinic for Fertility & Gynaecology (Wolverhampton) Treatment and Storage 

Yorkshire and the Humber 


0063 Assisted Conception Unit, St James' University Hospital – Leeds Treatment and Storage 

0061 CARE at The Sheffield Fertility Centre Treatment and Storage 

0196 Centre for Reproductive Medicine and Fertility, Sheffield Treatment and Storage 

0052 Clarendon Wing – Leeds (General Infirmary) Treatment, Storage and Research 

0021 Hull IVF Unit Treatment and Storage 

0191 Section of Reproductive and Developmental Medicine (Sheffield) Research 

0062 University of York Research 


Appendix Three 

Clinical Inspectors (as of 31 August 2004) 

Mr Masoud Afnan 

Consultant Obstetrician & Gynaecologist, 

Honorary Senior Lecturer, Director of ACU 

Birmingham Women's Hospital 

Mr Bernard Bentick 

Consultant Obstetrician & Gynaecologist 

Royal Shrewsbury Hospital NHS Trust 

Mr Peter Brinsden 

Medical Director/Department of 

Obstetrics & Gynaecology, 

University of Cambridge 

Bourn Hall Clinic/Cambridge University 

Dr Ruth Curson 

Associate Specialist 

King's College Hospital, London 

Dr Melanie Davies 


University College London Hospitals 

Mr Robert Forman 

Medical Director 

CRM London 

Professor Stephen Franks 

Professor of Reproductive Endocrinology 

St Mary's ICSM Campus, London 

Dr Mark Hamilton 


and Clinical Senior Lecturer 

University Of Aberdeen 

Dr Stewart Irvine 

Consultant/Clinical Scientist 

MRC Human Reproductive Sciences Unit, 

Edinburgh 

Mr Richard Kennedy 


Walsgrave Hospital, Coventry 

Mr Yacoub Khalaf 

Subspecialty Consultant 

in Reproductive Medicine 

Guy's and St Thomas' Hospitals Trust, 

London 

Mr Charles Kingsland 


and Honorary Lecturer 

Liverpool Women's Hospital 

Dr Gillian Lockwood 


Midland Fertility Services 

Mr Stephen Maguiness 

Consultant and Hon. Senior Lecturer, 

Obstetrics and Gynaecology 

Hull Royal Infirmary 

Mr Mohamed Menabawey 


University Hospital of Hartlepool 

Dr John Mills 


Ninewells Hospital, Dundee 

Dr Alison Murdoch 

Consultant Obstetrician & Gynaecologist, 

Honorary Senior Lecturer and Director of 

the Centre for Reproductive Medicine 

Newcastle Fertility Centre at Life 

Mr Roger Neuberg 

Co-Director BUPA, Leicester, Consultant 

Obstetrician & Gynaecologist and Director 

of Infertility Service 

Leicester Royal Infirmary 

Mr Julian Pampiglione 


The Royal Bournemouth Hospital 

Mr John Parsons 

Senior Lecturer and Honorary Consultant 


Dr Elizabeth Pease 

Consultant 

St Mary's Hospital, Manchester 

Mr Nigel Perks 


Queen Elizabeth Hospital, Woolwich 

Dr David Polson 


Salford Royal IVF & Fertility Centre 

Mr Nagy Rafla 


Chaucer Hospital, Canterbury 

Mr Andrew Riddle 


Frimley Park Hospital NHS Trust, 

Camberley 

Mr Robert Sawers 


and Programme Director 

BMI Priory Hospital, Edgbaston 

Mr Eric Simons 


Cromwell Hospital, London 

Dr Alison Taylor 

Consultant in Gynaecology and 

Reproductive Medicine and Senior Lecturer 


London 

Dr K. Joo Thong 

Consultant, 

Assisted Conception Programme 

Edinburgh Assisted Conception Unit 

Mr Peter Wardle 

Consultant and Senior Lecturer in 

Obstetrics and Gynaecology 

Southmead Hospital, Bristol 

Dr Robin Yates 

Medical Research Director 

Assisted Conception Unit, 

Royal Infirmary, Glasgow 

Embryo Biopsy Inspectors 

Dr Anick De Vos 

Clinical Embryologist 

Academish Ziekenhuis Laarbeeklaan, 

Belgium 

Professor Alan Handyside 

Professor 

Leeds Teaching Hospitals 

Dr Joyce Harper 

Lecturer in Human Genetics 

and Embryology 

University College London Hospitals 

Dr Sue Pickering 

Scientific Director 


London 

Professor Andre van Steirteghem 

Scientific Co-ordinator 

Academish Ziekenhuis Laarbeeklaan, 

Belgium 


Scientific Inspectors 

Dr Virginia Bolton 

Senior Lecturer and Senior Embryologist 


Dr John Clarke 

Retired Lecturer in Zoology 

University of Oxford 

Mrs Jane Cuthbert 

Fertility Centre Manager 

and Senior Embryologist 

BMI Priory Hospital, Edgbaston 

Ms Karin Dawson 

Consultant Embryologist 

Hammersmith Hospital 

Dr Simon Fishel 

Managing Director 

Centres for Assisted Reproduction 

(CARE) Ltd, Park Hospital, Arnold, 

Nottingham 

Professor Tom Fleming 

Professor 

University of Southampton 

Professor Lynn Fraser 

Professor of Reproductive Biology 

King's College, London 

Dr Ceinwen Gearon 

IVF Laboratory Director 

Lister Hospital, London 

Mr David Gibbon 

Senior Embryologist 

South Cleveland Hospital 

Dr John Keith 

Senior Scientist 


Mr Terry Leonard 

Co-Director 

Isis Fertility Centre, Colchester 

Mr Stephen Lynch 

Senior Embryologist and 

Person Responsible 

BMI Chaucer Hospital, Canterbury 

Dr Alan McDermott 

Director 

Regional Cytogenetics Centre, 

Southmead Hospital, Bristol 

Dr David Morroll 


Leeds Teaching Hospitals 

Dr Lynne Nice 

Fertility Services Manager 

BMI Chiltern Hospital, Great Missenden 

Dr Allan Pacey 

Senior Lecturer in Andrology 

University of Sheffield 

Ms Barbara Ray 

Principle Embryologist 

Centre for Reproductive Medicine, 

Bristol 

Dr John Robinson 


Hull IVF Programme, 

Princess Royal Hospital, Hull 

Reverend Professor Mary Seller 

Professor of Development Genetics 

Medical and Molecular Genetics, 

Guy's Hospital London 

Dr Arasaratnam Srikantharajah 

Research Embryologist 


Dr Stephen Troup 


Liverpool Women's Hospital 

Dr Karen Turner 

Clinical Laboratory Director 

Oxford Fertility Unit 

Dr Maureen Wood 

Scientist 


Social and Ethical Inspectors 

Mrs Linda Breeze 

Psychosexual Therapist and 

Fertility Counsellor 

Royal Devon and Exeter Hospital 

Mrs Jennifer Clifford 

Counsellor 

Self Employed 

Mrs Elizabeth Corrigan 

Business Manager and Nursing Director 

Centre for Reproductive Medicine, Bristol 

Ms Marilyn Crawshaw 

Teaching fellow in Social Work 

University of York 

Mrs Jennifer Dunlop 

Senior Counsellor 

Central Manchester Healthcare Trust (NHS) 

Mrs Heideh Hillier 

IVF Nurse Manager 


Ms Margret Inglis 

Counsellor 

Royal Free Hospital, London 

Mrs Helen Kendrew 

Clinical Nurse Manager 

Bath Assisted Conception Clinic 

Ms Janice Kerr 

Manager of Cancer Service, 

National Service Framework 

Worchester Acute NHS Trust 

Mrs Caroline Lewis 

Assisted Conception Unit Manager 

Woking Nuffield Hospital ACS Unit 

Ms Katherine Mangold 

Unit Manager of IVF & 

Out Patients Department 

BMI Portland Hospital, London 

Dr Jim Monach 

Lecturer 

School of Health and Related Research, 

University of Sheffield 

Mrs Yvonne Payne 

Assisted Conception Services Manager 

Thames Valley Nuffield Hospital 

Mrs Roz Shaw-Smith 

Counselling Psychologist 

John Radcliffe Hospital, Oxford 

Ms Jennifer Speirs 

Infertility Counsellor and Social Work Consultant 

Freelance, Edinburgh 

Other Inspectors 

Ms Sarah Biggs 

Stroud Gloucester 

Ms Marney Prouse 

Vice President 

Guy Carpenter and Co (Ltd) 


Appendix Four 

Ongoing research projects licensed by the HFEA (as of 31 August 2004) 

In vitro development and implantation of 

normal human pre-implantation embryos 

and comparison with uni- or poly-pronucleate 

pre-embryos 

University of Manchester R0026* 

Research started: 1 March 1997 

Number of HFEA licences issued: 5 

To measure the activity of metabolic enzymes 

in spare human pre-implantation embryos 

Hammersmith Hospital R0030 

Research started: 30 July 1993 


To measure the activity of enzymes implicated 

in genetic disorders 




Pre-implantation genetic diagnosis – 

parallel investigations 




Biochemistry of early human embryos 

University of York R0067 

Research started: 25 January 1995 


Improving methods for pre-implantation 

genetic diagnosis of inherited genetic 

disease and predicting embryo quality 

Guys Hospital R0075 



A study of the effects of the cell death on the 

further development of human embryos in vitro 

Centre for Reproductive Medicine, 

Coventry R0094 

Research started: 25 February 1996 


Maturation and fertilisation of human eggs 

in vitro 

Clarendon Wing – Leeds R0104 



Detection of autosome and sex chromosome 

abnormalities in human preimplantion embryos 

using fluorescent in situ hyridisation (FISH) and 

the polymerase chain reaction (PCR) 

Glasgow Royal Infirmary R0108 



in vitro maturation and fertilisation of 

immature oocytes from woman under going 

icsi treatment 

Centre for Reproductive Medicine, Coventry R0110 

Research started: 11 May 1998 


Development of a model to study 

implantation in the human 

Oxford Fertility Unit R0111 



The development of novel PGD procedures 

and the study of early human development 

UCH London R0113 

Research started: 22 June 1998 


An investigation of embryonic-endometrial 

dialogue during the pre-implantation period 

in vitro 

Section of Reproductive and Developmental 

Medicine R0115 

Research started: 1 September 1998 


Biopsy of pronucleate embryos 

Hewitt Centre for Reproductive Medicine R0121 

Research started: 14 February 2000 


An investigation of the effect of blastomere 

removal for preimplantation genetic diagnosis 

on subsequent embryonic development 

Newcastle Fertility Centre at Life R0122 

Research started: 21 June 2000 


Derivation of pluripotent human embryo 

cell lines 

Institute for Stem Cell Research R0132 

Research started: 4 November 2002 


Correlation of embryo morphology with ability 

to generate embryonic stem cell lines and 

subsequent growth and differentiative 

characteristics 

Guys Hosptial R0133 

Research started: 15 April 2002 


A novel protocol for extracting cells during 

embryo biopsy without the use of acid tyrodes 

CARE Nottingham R0135 

Research started: 17 September 2002 



Platform technologies underpinning human 

embryonic stem cell derivation 

Division of Gene Expression and Development, 

Roslin Institute R0136 

Research started: 1 July 2003 


Analysis of chromosomes in human 

preimplantation embryos using FISH and CGH 

London Fertility Centre R0140 

Research started: 1 October 2003 


Evaluation of cardio myocytes derived from 

embryonic stem cells as a means to characterise 

receptor/channel expression in human tissue 

NURTURE R0141 

Research started: 1 March 2004 


Enviromental sensitivity of the human 

pre-implantation embryo 

Princess Anne Hospital Fertility Unit R0142 

Research started: 30 September 2003 


Isolation of human embryonic stem cells 

and in vitro derivation of specific cell types 

Chelsea & Westminster Hospital R0150 

Research started: 19 February 2004 


Chromatin and epigenetic associated with 

the development and generation of ES cells 

Birmingham Women's Hospital R0151* 

Research started: 8 March 2004 


Derivation of human embryonic stem cell lines 

using nuclear transfer and pathenogenetically 

activated oocytes 


Research started: 11 August 2004 


* research based at more than one centre 

To derive human embryonic stem cells and 

trophoblast cell lines 


Research started: 14 August 2003 


The derivation, characterisation and 

differentiation of human embryonic stem cells – 

a comparative analysis with normal human 

embryonic and foetal development and human 

embryonic germ cells 

Princess Anne Hospital Fertility Unit R0144 

Research started: 20 November 2003 


Epigenetic studies of preimplantation embryos 

and derived stem cells 


Research started: 5 August 2003 


Investigation into the role of sperm plc zeta 

In human oocyte activation 

University College London R0147 

Research started: 30 September 2003 


To develop pre-implantation genetic diagnosis 

(PGD) for mitochondrial dna disease 


Research started: 3 June 2004 



Appendix Five 

HFEA peer reviewers (as of 31 August 2004) 

Professor R J Aitken 


University of Newcastle, Australia 

Mr Adam Balen 

Person Responsible and Accredited Consultant 

Leeds General Infirmary 

Dr Siladitya Bhattacharya 

Senior Clinical Lecturer 

University of Aberdeen 

Dr Virginia Bolton 

Senior Lecturer and Senior Embryologist 


Professor Nigel Brown 

Professor of Developmental Biology 

St George’s Hospital Medical School 

Professor Keith Campbell 

Professor of Animal Development 

University of Nottingham 

Dr John Carroll 

Lecturer in the field of Physiology and 

Developmental Biology 

University College London 

Professor Jose Cibelli 

Professor of Biotechnology 

Michigan State University, USA 

Dr J R T Coutts 

Retired Reader in Reproductive Endocrine 

Glasgow 

Professor Mark Curry 

Senior Lecturer in Equine Science 

De Montford University 

Ms Karin Dawson 


Hammersmith Hospital 

Professor Joy Delhanty 

Professor of Human Genetics 


Dr Simon Fishel 

Managing Director 

Centres for Assisted Reproduction (CARE) Ltd., 

Nottingham 

Dr Richard Fleming 

Consultant Biochemist 

Glasgow Royal Infirmary 

Professor Stephen Franks 

Professor of Reproductive Endocrinology 

St Mary’s Imperial College 

Professor Lynn Fraser 


King’s College London 

Dr Rafet Gazvani 

Consultant Gynaecologist and sub-specialist 

in New Production Medicine 

Liverpool Women’s Hospital 

Dr Mark Hamilton 

Consultant Obstetrician and Gynaecologist 

and Clinical Senior Lecturer 


Professor Alan Handyside 

Chair of Dev. Biology 

University of Leeds/London Bridge Fertility, 

Gynaecology & Genetic Centre 

Dr Joyce Harper 

Lecturer in Human Genetics and Embryology 


Dr Geraldine Hartshorne 

Principal Research Fellow 

University of Warwick 

Dr D S Irvine 

Clinical Consultant 

Medical Research Council 

Dr Mark Johnson 

Consultant Obstetrician 

Chelsea and Westminster NHS Trust 

Professor Martin Johnson 

Professor of Reproductive Sciences 

University of Cambridge 

Dr Sue Kimber 

Reader, Faculty of Life Science 

University of Manchester 

Mr Charles Kingsland 

Consultant Obstetrician and 

Gynaecologist and Honorary Lecturer 

The Women’s Hospital, 

Liverpool 

Professor G E Lamming 

Retired/Emeritus Professor 



Dr Alan McDermott 


University of Bristol 

Professor Alan McNeilly 

Professor and Deputy Director 

MRC, Edinburgh 

Dr Tony Michael 

Senior Lecturer in Biochemistry & Molecular 

Biology 


Professor Marilyn Monk 

Head of Molecular Embryology Unit 

Institute of Child Health, London 

Professor Robert Webb 

Professor of Animal Science 


Dr Michael Whitaker 

Dean of Research 

University of Newcastle 

Professor David Whittingham 

Retired but Emeritus Professor Experimental 

Embryology 

London 

Dr Maureen Wood 

Research Embryologist 


Professor H D M Moore 


Hallamshire Hospital, Sheffield 

Professor R Moore 

Officially Retired, Molecular Embryologist 

AFRC, Cambridge 

Dr David Pegg 

Director of Medical Cryobiology Unit 

University of York 

Dr Helen Picton 

Reader in Reproduction & Early Development 

University of Leeds 

Dr Ian Sargent 

Professor 

University of Oxford 

Dr Bert Smeets 

Associate Professor and Head of Genome Centre 

University of Maastricht, Netherlands 

Professor Austin Smith 

Head of Institute for Stem Cell Research 

University of Edinburgh 

Dr Karl Swann 

Reader in Cell Physiology 


Professor Allan Templeton 

Head of Department 


Professor James Thomson 

Professor of Anatomy 

University of Wisconsin-Madison, USA 


Appendix Six 

Members’ Interests (as of 31 August 2004) 

Please note in the Financial Accounts 

for the Year Ended 31 March 2004 at 

note 15 to the accounts (related party 

transactions), there are references to 

fees invoiced by HFEA to the clinics 

or NHS Trusts where some HFEA 

members have senior management 

responsibilities. These fees are licence 

fees paid by the clinics to HFEA and 

are not amounts paid to the members. 

Suzi Leather (Chair) 

Personal interests 

Consultancies and/or direct employment: 

• None 

Fee-paid work other than that associated 

with the HFEA: 

• None 

Shareholdings: 

• None 

Other Public Appointments: 

• None 

Other: 

• Member of the Labour Party 

• Member of the Christian 

Socialist Movement 

• Individual member of the National 

Heart Forum 

• Member of the Child Poverty 

Action Group 

• Member of the Organophosphate 

Information Network 

• Member of Council, University of Exeter 

• Member of the Chancellor’s Advisory 

Council, University of Exeter 

• Honorary Fellow, Royal College of 

Obstetricians and Gynaecologists 

• Glasgow Centre for Population Health – 

Member of the External Advisory Group 

• Member of the Better Hospital 

Food Forum 

• Chair of Steering Committee 

(Tommy’s, the Baby Charity) 

– Teenage Pregnancies: Dietary 

Measures to improve nutrition and 

pregnancy outcome 

Professor Tom Baldwin 



• Professor of Philosophy at the University 

of York 



• None 


• GlaxoSmithKline 

• Pfizer 


• Johnson & Johnson 

• AstraZeneca 


• Member of Stem Cell Steering 

Committee 

Other: 

• Member of the Nuffield Council 

on Bioethics 

Professor David Barlow 



• Nuffield Professor of Obstetrics and 

Gynaecology, University of Oxford 

• Head of Oxford Fertility Unit and HFEA 

Person Responsible 



• Astra Zeneca 

(Advisory Board Consultancy) 


• Oxford Reproductive Biosystems – 

(potential University of Oxford spin-out, 

not trading) – shares as founder have 

no current value 

• Minor shareholdings resulting from 

building society and insurance 

company flotations 


• None 

Other: 

• Directorships: 

• British Menopause Society 

Publications Limited 


• Oxford Reproductive Biosystems 

(not trading) 

• Memberships: 

• Academy of Medical Sciences 

(Fellow) 

• National Osteoporosis Society 

(Chairman) 


(Past Chairman) 

• Royal College of Obstetricians 

& Gynaecologists (Fellow) 

• Royal College of Physicians (Member) 

• American Society for Reproductive 

Medicine 

• British Fertility Society 

• European Society for Human 

Reproduction and Embryology 

• International Menopause Society 

• NICE Osteoporosis Guidelines 

Development Group (Chairman) 

• European Menopause and 

Andropause Society (EMAS) 

(Vice President) 

• Trusteeships: 

• National Osteoporosis Society 


• Oxford Hospitals Charitable 

Trust Funds 

• Publishing: 

• Oxford University Press – Editor in 

Chief of Human Reproduction 

• Cochrane Collaboration – Editor of 

Menstrual Disorders & Subfertility 

Group Health Press 

• Member of Editorial Boards of 

“Menopause” and “Best Practice 

in Obstetrics and Gynaecology” 

• Advisory Committees: 


• Eli Lilly 

• Medical Research Council 

• Merck 

• Pharmacia 

• Servier 

• Takeda 

• Novo Nordisk 

• Research Grants held at Department: 

• Action Research 


• European Union 


• National Endometriosis Society 

• NHS R&D project grants scheme 

• Organon 

• OXAGEN 

• Schering 

• Serono 

• Servier 

• Shire 

• Takeda 

• Wellcome Trust 

• Wellbeing 

Professor Christopher Barratt 



• Scientific Director of the Assisted 

Conception Unit Birmingham Women's 

Health Care NHS Trust 

• Occasional consultancy in legal cases 

relating to assisted conception and male 

factor infertility 



• None 


• Genosis 


• None 

Other: None

Professor Peter Braude 



• Head of Department of Women's 

Health, Guy’s, Kings and St Thomas' 

School of Medicine 

• Director of the Centre for 

Pre-implantation Genetic Diagnosis, 

Guy's and St Thomas' Trust 

• Honorary consultant in Gynaecology, 

Guy's and St Thomas' Trust 

• Occasional Consultancy and expert 

advisor to: 

• Serono Pharmaceuticals 

• Ares Serono 

• Tommy's the Baby Charity 

• Wellbeing 

• PPP 

• Progress 

• Bertarelli Foundation 




• Mosby / Harcourt-Brace 

• Oxford University Press 

• British Medical Journal books 


• Marks & Spencer 

• Centrica 


• None 

Memberships: 

• Royal College of Obstetricians 

& Gynaecologists 


• American Society for 

Reproductive Medicine 

• European Society for Human 

Reproduction and Embryology 

• The Galton Society 

• Association of Professors of Obstetrics 

and Gynaecology 

Other: 

• Grants held at Department: 

• Tommy's the Baby Charity 


• Economic and Social 

Research Council 

• The Wellcome Foundation 

• British Heart Foundation 

• Organon 

• Ares Serono 

• Serono Pharmaceuticals UK 

• Wellbeing 

• Perkin Elmer 

• Guy's and St Thomas' 

Charitable Foundation 

• Sir Jules Thorn Trust 

• Zeneca 

Mr Ivor Brecker 



• General Dental Practitioner, Retired 

• Medico-legal consultancy for 

Community Health Councils (voluntary) 

• Consultancies for Dentists and Solicitors 



• None 


• GlaxoSmithKline 

• Abbey National 

• Bradford & Bingley 


• None 

Other: 

• None 

Clare Brown 



• Chief Executive, Infertility Network UK 



• None 


• None 


• None 

Other: 

• Patient representative on the British 

Fertility Society Management Committee 

• Member of the European Society of 


• Member of the Labour Party 

• Chair of the National Infertility 

Awareness Campaign 

• Chair of the Organising Committee 

of National Infertility Day 

• Member of NICE Fertility Guideline Group 

• Chair of the European Infertility Alliance 

Professor Iain Cameron 



• Professor of Obstetrics and 

Gynaecology and Head of the 

School of Medicine at the University 

of Southampton 

• Past consultancy with Leiras, 

Schering and Takeda (Pharmaceutical) 


with HFEA: 

• Publishing / Lecturing for various 

organisations 


• None 


• None 

Other: 

• Royal College of Obstetricians and 

Gynaecologists (Chairman joint RCOG / 

WellBeing Research Advisory Committee) 

• MRC Advisory Board 

• Scientific Committee, 

National Endometriosis Society 

• Expert Advisory Network, Health 

Technology Assessment Programme 

• Scientific and Ethical Review Group, 

Special Programme of Research, 

Development and Research Training 

in Human Reproduction, World Health 

Organisation 

Memberships: 

• Society for Reproduction and Fertility 

• Blair Bell Research Society 


• American Society for 

Reproductive Medicine 

• Endocrine Society 

• Society for the Study 

of Reproduction 

• Society for Gynaecologic 

Investigation 

• Society for Endocrinology 

• Research: 

• Current work focuses on 

mechanisms underlying the 

developmental origins of adult 

disease, including collaborations 

investigating the embryo, stem cells, 

placenta and endometrium 

• Grants held in the Department of 

Obstetrics and Gynaecology: 

• The Solent Subfertility Trust 

• Pharmaceutical Industry 

Mrs Jane Denton 



• Director of the Multiple Births 

Foundation, Queen Charlotte's & 

Chelsea Hospital London 



• None 


• TSB 


• None 

Memberships: 

• Human Fertility (Editorial Board) 

• Royal College of Nursing – Fertility 


Nurses Group 

• Ethics Advisory Panel, Royal College 

of Nursing 

• British Infertility Counselling Association 

• International Society for Twin Studies 

• Grants held at MBF: 

• Hammersmith Hospitals Trust 

Special Trustees 

• The Henry Smith Charity 

Professor Neva Haites 



• Vice Principal and Head of the College 

on Life Science and Medicine 

• Professor at University of Aberdeen 

• Honorary Consultant in Clinical Genetics 

at NHS Grampian 

• Board Member – NHS Grampian 

• Special Advisor (Medical Genetics) to 

Chief Medical Officer (Scotland) 



• Member of Government Advisory 

Committee – Committee on Medical 

Aspects of Radiation in the Environment 

(COMARE) 

• Examining Post-Graduate Degrees 


• Weatherford International PLC 

• A portfolio of shares managed under 

terms of a discretionary management 

agreement 


• Member of National Screening Committee 

• Member of Advisory Group on 

General Research (Department 

of Health, England) 

Other: 

• Chair appointment committees for 

University of Aberdeen appointments 

including ones in Department of 

Obstetricians and Gynaecologists. 

These individuals may be involved in 

Infertility Clinic 

• Member of the Biomedical and 

Therapeutics Research Committee 

(Chief Scientist Office, Scotland) 

Memberships: 

• Academy of Medical 

Sciences (Fellow) 

• American Society of 

Cancer Research 

• American Society of 

Human Genetics 

• British Society of Human Genetics 

• European Society of 

Human Genetics 

• Royal College of Pathology (Fellow) 

• Royal College of Physicians (Fellow) 

• Royal College of Physicians 

(Edinburgh) (Fellow) 

• Sing Guidelines on Breast Cancer 


The Right Reverend Richard D Harries 


Direct employment: 

• Bishop of Oxford 



• Writer and broadcasting 


• None 


• None 

Other: 

• Member of Nuffield Council on 

Bio Ethics 

Ms Jennifer Hunt 



• Senior Infertility Counsellor, Wolfson 

Family Clinic, Hammersmith Hospital 



• None 


• None 


• None 

Other: 

• Member of the Project Group on 

Assisted Reproduction (PROGAR) 

• Member of the British Fertility Society 

• Member of the British Infertility 

Counselling Association 

• Member of the UK Donorlink 

Advisory Group 

• Member of the National Accreditation 

Board for Infertility Counselling 

Emily Jackson 



• Senior Lecturer in Law, 

London School of Economics 

• Professor, Queen Mary, 

University of London 



• Fees for external examining 


• None 


• None 

Other: 


• Author royalties from 

academic publishers 

Dr Maybeth Jamieson 



• Consultant Embryologist; 

Assisted Conception Service, 

Glasgow Royal Infirmary 



• None 


• Scottish Power PLC 


• None 

Other: 

• Member of the Association of Clinical 

Embryologists (Executive Committee and 

Professional Development Committee) 

• Department Of Health Assessor For 

Clinical Embryology 

• Embryology Assessor for the 

Association of Clinical Scientists 

• Member of the European Society for 


• Member of the British Fertility Society 

• Member of the Society for Reproduction 

and Fertility 

Mr Simon Jenkins 



• Columnist – The Times, Evening Standard 



• Author, Broadcasting and 

Freelance writing 


• Newscorp 

• Emap 

• Abbey National 


• Somerset House Trust 

• Architecture Foundation 

Other: 

• None 

Mr Walter Merricks 



• Chief Ombudsman, Financial 

Ombudsman Service – a scheme 

operated under the terms of the Financial 

Services and Markets Act 2000 



• None 


• A portfolio of shares managed under the 

terms of a discretionary management 

agreement by L A Invest of Lewes, 

East Sussex 


• None 

Other: 

• Secretary and Treasurer of Donor 

Conception Network, a charitable network 

of parents with children conceived with 

donated gametes – donor insemination 

and IVF with donor sperm or eggs – adult 

offspring and those contemplating or

undergoing treatment 

• A parent of two children conceived 

through donor insemination 

Ms Sara Nathan 



• Freelance broadcast producer 



• Lay Member, Professional Conduct 

Committee of the Bar Council 


• Williams 

• Rio Tinto 

• Shell 

• Imperial Chemical 

• Cookson Group 

• Diageo 

• GlaxoSmithKlein 


• Member of the Criminal Injuries 

Compensation Appeals Panel 

• Member, Regulatory Decisions 

Committee, Financial Services Authority 

• Marshall Commissioner 

• Member, Ofcom and Deputy Chairman 

of Ofcom's Content Board 

• Member, ICSTIS 

Other: 

• Council Member, Jewish Museum 

Ms Sharmila Nebhrajani 



• Chief Operating Officer and Finance 

Director, BBC New Media & Technology 



• None 


• Small personal shareholdings in 

selected plcs 


• None 


Appendix Seven 

Performance indicators (for the period April 2003 – March 2004, unless otherwise indicated) 

Inspection and Regulation 

Inspections – Unannounced 

A formal programme of unannounced inspections was introduced in April 2003. Centres targeted by 

the three unannounced inspections where selected at random. Following the inspections feedback 

and learning points were assessed and future unannounced inspections will not only be carried out 

on a random selection of centres but also on centres which have been assessed to be of specific risk. 

A target of eight unannounced inspections has been set for the year April 2004 – March 2005. 

Performance Indicator Target April 2003 – April 2002 – 

March 2004 March 2003 

Minimum of three unannounced 90% (3) 3 N/A 

inspections carried out in the year 

Inspections – Announced 

As a guide, an average of 8.75 inspections need to be carried out each month in order to ensure 

that each centre receives one inspection per year. Figure 1 shows inspection activity against a 

minimum target. 

Figure 1 – Planned and Completed Inspections April 2003 – March 2004 

25 

20 

15 

10 

5 

0 

Apr-03 May-03 Jun-03 Jul-03 Aug-03 Sep-03 Oct-03 Nov-03 Dec-03 Jan-04 Feb-04 Mar-04 

Inspections Planned 

Inspections Completed 

8.75 Inspections 

Planned and Completed Cumulative Inspection data April 2003 – March 2004 

Inspections April 2003 – April 2002 – 


Planned 117 124* 

Completed (Annual and Unannounced) 129 121 

Minimum Target 105 105 

* three centres exempted from inspection by Licence Committee 



Reports Resulting from inspection 90% 61% 60% 

available to centre within 4 weeks 


Figure 2 – Overall Report Production within 28 Days April 2003 – March 2004 

100% 

90% 

80% 

70% 

60% 

50% 

40% 

30% 

20% 

10% 

0% 

Apr-03 May-03 Jun-03 

Jul-03 Aug-03 Sep-03 Oct-03 Nov-03 Dec-03 Jan-04 Feb-04 Mar-04 

Rolling Average 

Target 

61 percent (73/119) of the reports issued in draft to the centres were sent within 28 days, compared 

to the performance target of 90%. Performance between April 2003 and March 2004 matched the 

previous 12 month period. The lack of greater improvement in this key performance indicator was 

a disappointment for the HFEA; steps have been taken to ensure improvements over the next 

twelve months. 

Incidents 

Incidents are categorised according to severity: 

• Category A incidents include those involving major/serious harm to patients, gametes or embryos, 

or major/serious consequences for staff safety and/or service quality 

• Category B incidents relate to minor harm to patients, gametes or embryos, or major/serious 

consequences for staff safety and/or service quality 

• Near miss 

Figure 3 – Number of Incidents Reported by Severity April 2003 – March 2004 

10 

9 

8 

7 

6 

5 

4 

3 

2 

1 

0 

Apr-03 May-03 Jun-03 Jul-03 Aug-03 Sep-03 Oct-03 Nov-03 Dec-03 Jan-04 Feb-04 Mar-04 

A B Near Miss 

HFEA Accounts | 36

Figure 4 – Split of Incident Reported by Category April 2003 – March 2004 

30 Laboratory Operator 

13 Laboratory Process 

10 General 

7 Laboratory Equipment 

7 Clinical 

5 Administration 

4 Consent 

3 Other 

Figure 4 shows the proportional split of incident categories for incidents reported in the year. 

Laboratory incidents continue to be the most commonly reported. 

Incidents reported April 2003 – March 2004 

April 2003 – April 2002 – 


Incidents Reported* 79 65 

* incidents can take several months to investigate and resolve 

No analysis of the incidents or breaches was released by the HFEA between April 2003 and March 

2004. An analysis of all incidents was distributed to centres in July 2004. 

Alerts 

The HFEA Alert system was introduced in April 2003. The purpose of the HFEA Alerts is to help 

reduce risk and improve patient safety. A HFEA Alert is distributed whenever there are incidents which 

could occur at other centres. Between April 2003 and March 2004 there were nine alerts issued, one 

of which was circulation of another organisation’s Alert (the Medicines and Healthcare products 

Regulatory Agency, MHRA). 



Notification of events/incidents 90% 1 (11%) N/A 

circulated within 48 working hours 

on new Alert System 

This target was set before the HFEA Alert process was formalised. HFEA Alerts are sent out after full 

investigation of incidents and lengthy consultations with experts in the field on what lessons can be 

learned from the incident. In addition, great care is taken to ensure that patients affected have also 

been informed. This process has meant that only one Alert has been sent out within the target period. 

A more realistic goal will be set for April 2004 – March 2005. 

Licensing Activity 

Licensing is a core duty of the Authority. Licence Committees met on 41 occasions and considered 287 

items of business. The total number of licences issued, which includes those that have been reissued 

following a change/variation is: 141 for treatment and storage centres and 15 for research projects. 


Figure 5 – Licence Committee April 2003 – March 2004 

50 Interim Inspections 

63 Variations 

8 Short Licences 

2 Audits 

31 Practitioners 

14 Initial Inspections 

62 Renewal Inspections 

8 Closures 

32 Incidents 

17 Other 



New licence applications processed 90% 1/1 (100%) 100% 

within four months from receipt 

Completed research licence applications 90% 4/5 (80%) 4/4 (100%) 

processed within four months of receipt 

Financial 

Payments 

Target: 90% of undisputed invoices to be paid in 30 days 

Out-turn 2003/04: 89% (90% in 2002/03) 

Debts 

Target: 90% collected in 60 days 

Out-turn 2003/04: 81% (2002/03: 74%). Achievement of this target was affected by a number of 

clinics requiring many reminders for payment 

Unqualified Audit Report 

Out-turn 2003/04: Achieved (2002/03: achieved) 

Monthly billing of clinics achieved in 3 weeks 

Target: 90%. Out-turn 2003/04: 92% (2002/03: 75%) 

Corporate 

Number of hits on the HFEA website: 12,072,176 from August 2003 to August 2004. (3,070,815 from 

August 2002 – August 2003) 

Number of events organised by the HFEA: 8 – the Annual Conference, the Annual Research 

Conference, the Code of Practice launch, Directory of Clinics launch, Sex Selection launch, BA Science 

Festival seminar, PGD Focus Group and Patient Information Focus Group (seven events in 2002/03) 

Number of patient/public enquiries handled between August 2003 and August 2004: 10,500 

(8,022 for September 2002 – July 2003) 

Authority Meetings held in public from September 2003 – September 2004: 3 (October 2003, 

February and May 2004) 



Financial Accounts 

For the year ended 31 March 2004 


Financial Accounts 2003/2004 

Foreword 

Background 

The Human Fertilisation and Embryology 

Authority (HFEA) formally came into being 

on 7th November 1990 and began 

operating on 1st August 1991. The HFEA 

was created by the Human Fertilisation 

and Embryology Act 1990 to license and 

regulate human embryo research and 

specified forms of infertility treatment. The 

HFEA is an executive Non-Departmental 

Public Body sponsored by the Department 

of Health. 

Statutory Remit 

One of the main statutory functions of 

the HFEA is to regulate, by means of a 

licensing system, centres undertaking 

infertility treatments involving the 

creation or use of human embryos 

outside the body, the storage or 

donation of embryos or gametes or 

research involving human embryos. 

The HFEA is also required to maintain a 

register of information about all licensed 

treatments performed in the United 

Kingdom. This contains information about 

those receiving treatment, donors of 

gametes and embryos and any children 

born as a result of such treatments. At 

the age of 18 (or 16 if wishing to marry), 

people may enquire as to whether 

information held on the register shows 

that they were born as a result of this 

treatment, and, if so, whether they are 

related to a prospective spouse. 

In addition, the HFEA has other 

statutory responsibilities including: 

• publicising the services provided by 

it and by the centres it licenses; 

• publishing a Code of Practice giving 

guidance to centres on how they 

should carry out licensed activities; 

• giving information and advice to 

donors, to people seeking treatment or 

storage, or to people considering such 

action; and 

• keeping the field under review and 

providing advice to the Secretary of 

State for Health, if so requested. 

HFEA Accounts | 41 

Principal Activities 

The year 2003/04 saw a continuation 

of major developments to strengthen 

the work of the HFEA, with significant 

improvements in regulation and 

communication with patients and 

stakeholders. 

Regulation 

The HFEA’s primary objective remains the 

licensing and inspection of clinics and 

centres carrying out in vitro fertilisation, 

donor insemination and human embryo 

research. This includes regulation of the 

storage of gametes and embryos. 

Improvements put in place during the 

year include: 

• random unannounced inspections 

established ; 

• new inspectors recruited and trained, 

and yearly validation of all inspectors 

initiated ; 

• pilot projects for patient involvement in 

inspections completed, following 

consultations with patients and 

professional groups ; 

• implementation of standard inspection 

protocols and processes; 

• Alert System established to 

disseminate to all licensed centres the 

lessons from untoward incidents 

During 2003/04, there were 242 HFEA 

visits to licensed centres comprising: 

• 126 annual inspection visits 

• 45 audit visits 

• 23 visits for incident management 

• 6 variation inspections 

• 20 advisory visits 

• 18 practitioner inspections (embryo 

biopsy/Intra-Cytoplasmic Sperm 

Injection-ICSI) 

• 1 visits to new centres 

• 3 unannounced inspections 

During 2003/04, 287 items of business 

were considered at 41 Licence 

Committee meetings; of these were: 

• 50 interim licenses 

• 63 variations to licenses 

• 8 short licenses 

• 31 applications for recognition of 

specific practitioners 

• 14 initial licenses 

• 8 revocations of license 

• 62 renewals 

• 32 Incidents 

• 19 miscellaneous 

Established centres are subject to a three 

year licensing cycle composed of one full 

and two interim inspections. 

Information Management 

The HFEA collects data from all licensed 

centres about IVF and donor insemination 

treatments, their outcomes and about 

every donor. A new database for the Data 

Register was developed with transfer and 

validation of data from old systems well 

underway, to ensure the organisation can 

fulfil its statutory obligation to provide 

information to offspring. The HFEA 

published a Directory of Clinics with 

user friendly information for patients on 

licensed centres, in collaboration with 

the Dr Foster organisation. 

Communications 

The HFEA launched a new website with 

sections for public, press and licensed 

centres. All information leaflets were 

updated and redesigned in consultation 

with user groups. A new leaflet on 

avoiding multiple births was published. 

HFEA held its first Research Conference 

in November 2003. 

Policy 

A report on Sex Selection was published, 

following public consultation. A 6th 

edition of the Code of Practice for 

licensed centres was published after 

wide-ranging consultations, including a 

clear policy on limiting the number of 

embryos transferred. 

HFEA Clinic Audits 

Detailed and intensive audit of clinics 

continued during 2003/04 by a 

specialist HFEA audit team. In total, 

there were 45 clinic audit visits during 

the year. The findings of these audits 

demonstrated clearly that: 

• there was no significant underreporting 

of treatment activity by 

licensed clinics; 

• there was no material variance 

between the value of fees billed by the 

HFEA and the clinics’ declared activity. 

Financial Results for 2003/04 

HFEA made a surplus of £1,368,019 

during the year. This includes the funding 

received to meet the provisions made in 

financial years 2001/02 to 2003/04 in 

relation to future pension liabilities relating

to the transfer of the HFEA’s by-analogy 

pension scheme into membership of the 

Principal Civil Service Pension Scheme 

(PCSPS). Excluding this funding, and the 

movement in pension provision in 

2003/04, the surplus would have 

been £148,004. 

The total future pension liability at 

31 March 2003 had been calculated by 

the Government Actuary’s Department in 

the sum of £1,220,015. The net increase 

in provision needed to reflect this liability 

in the Income & Expenditure Account for 

the year ended 31st March 2004 

amounted to £56,201. 

The Department of Health undertook to 

fund the full liability of £1.276m and this 

was incorporated in their approved 

expenditure estimates. This money was 

received by HFEA on 27 June 2003, and 

payment in full settlement of the liability 

was made on 30th June 2003 to the Civil 

Superannuation Vote. 

The National Audit Office (NAO) required 

us to follow the accounting treatment for 

this item contained in Treasury guidance. 

The full future pension liability as at 

31 March 2003 was included in the 

Accounts for the year ended 31 March 

2003, however, no provision was made 

for the funding subsequently received 

from the Department of Health. 

Accordingly the previously published 

balance sheet of the HFEA at 31st March 

2003 showed net liabilities of £541,261. 

The explanation provided by the Treasury 

and NAO for this treatment, and for not 

recognising a post balance sheet 

adjusting event under UK GAAP, is that 

under the normal conventions applying 

to parliamentary control over income 

and expenditure, such grants must be 

accounted for on a cash basis. 

Therefore this funding could not be 

recognised until received, and 

accordingly the Accounts for the year 

ended 31 March 2004 now present the 

receipt of the funding for the provision 

that existed at 31 March 2003, and the 

movement in the pensions’ liability in the 

period April – June 2003. The balance 

sheet shows at 31 March 2004 net 

assets and reserves of £1.68m. 

It should however be noted that a prior 

year adjustment, the circumstances of 

which are detailed in note 2 to these 

Accounts, shows a restated balance 

sheet total as at 31 March 2003 

of £154,769. 

Disabled Employees 

The policy of HFEA is to make all 

reasonable adjustments to the working 

environment when required to meet the 

needs of disabled employees. 

Equal Opportunities 

The HFEA is an equal opportunities 

employer with a policy of providing 

equality of opportunity for all staff 

members and job applicants. The HFEA 

does not discriminate against anyone on 

the grounds of age, race, colour, ethnic 

or national origin, gender, marital status, 

responsibility for children or dependents, 

disability, sexual orientation or religious or 

political beliefs. 

Consultation with Employees 

The HFEA’s policy is to involve staff and to 

consult them on relevant matters such as 

health, safety and welfare. Issues that may 

be of interest or concern are discussed at 

regular staff meetings. An appraisal 

system has been enforced throughout the 

year to improve performance review and 

the development of staff. 

Payment of Suppliers 

The HFEA has adopted the principles of 

the ‘Better Payment Practice Code’ and 

works to ensure that all undisputed 

invoices are paid within 30 days. In 

2003/04 the HFEA paid 89% of invoices 

within 30 days (2002/03 90%) and 98% 

were paid within 60 days (2002/03 99%). 

Future Developments 

During 2004/05 the HFEA will work 

towards the following objectives:- 

• To deliver high quality, effective and 

professional regulation of infertility 

services and storage of gametes 

and embryos, focusing on risk, 

safety and quality. 

• To achieve a stronger, more efficient 

and publicly accountable process of 

regulating research. 

• To develop an efficient and effective 

process for licensing centres as 

required by the EU tissue directive 

and to put in place a process for 

accreditation of all licensed 

clinics/ART laboratories. 

• To deliver robust, comprehensive and 

timely information management, which 

informs safety and quality. 

• To put in place a strategy for 

supporting and involving patients. 

• To communicate effectively with all 

stakeholders and the public, to 

increase understanding of the HFEA’s 

role and the regulation of IVF and 

research, enabling informed patient 

choice and public debate. 

• To develop and implement clear 

policies based on evidence, ethical 

considerations and public views – 

supporting continuous improvements 

in quality and safety and appropriate 

access to new technologies. 

• To ensure through clear systems that 

the Authority meets its statutory 

financial and corporate responsibilities 

demonstrating efficiency, effectiveness 

and value for money. 

• To agree and implement a Human 

Resources Strategy valuing staff, 

ensuring capacity and skills meet 

the organisation’s needs and 

the development of integrated 

work patterns. 

• To build partnerships with other 

statutory and voluntary organisations. 

Ms Angela McNab 


19 July 2004 


Annex A 

Authority Members 

Membership of the Human Fertilisation and Embryology Authority during the year 

2003/04 was as follows:- 

Suzi Leather (Chair) 

Professor Thomas Baldwin (re-appointed 30/9/03) 

Mrs Jane Denton (Director of Sub-committees) 

Professor David Barlow (re-appointed 24/11/03) 



Mr Ivor Brecker (re-appointed 30/9/03) 

Ms Clare Brown 

Professor Iain Cameron (re-appointed 30/9/03) 

Professor Andrew Grubb (retired 6/11/03) 


Rt. Revd. Richard Harries (appointed 24/11/03) 

Ms Jennifer Hunt (appointed 24/11/03) 

Ms Emily Jackson (appointed 12/6/03) 


Mr Simon Jenkins (re-appointed 30/9/03) 



Rt. Revd. Dr Michael Nazir-Ali (retired 6/11/03) 



Statement of the Authority's and Chief Executive’s Responsibilities 

Authority Members’ Responsibilities 

Under section 6(1) of the Human Fertilisation and Embryology Act 1990, the Human 

Fertilisation and Embryology Authority is required to prepare a statement of accounts 

for each financial year in the form and on the basis determined by the Secretary of 

State, with the consent of the Treasury. The accounts are prepared on the accruals 

basis, and must show a true and fair view of the Authority’s state of affairs at the yearend 

and of its income and expenditure, total recognised gains and losses, and cash 

flow for the financial year. 

In preparing the accounts the Authority is required to:- 

• observe the Accounts Directions issued by the Secretary of State, including the 

relevant accounting and disclosure requirements, and apply suitable accounting 

policies on a consistent basis; 

• make judgements and estimates on a reasonable basis; 

• state whether applicable accounting standards have been followed, and disclose 

and explain any material departures in the financial statements; 

• prepare the financial statements on the going concern basis unless it is 

inappropriate to presume that the Authority will continue in operation. 

Accounting Officer’s Responsibilities 

The Accounting Officer of the Department of Health has designated the Chief Executive 

of the Human Fertilisation and Embryology Authority as the Accounting Officer for the 

Authority. Her relevant responsibilities as Accounting Officer, including her responsibility 

for the propriety and regularity of the public finances for which she is answerable and 

for the keeping of proper records, are set out in the Non Departmental Public Bodies’ 

Accounting Officer Memorandum. 


Statement on Internal Control 

1. Scope of Responsibility 

As Accounting Officer, I have 

responsibility for maintaining a sound 

system of internal control that supports 

the achievement of the HFEA’s policies, 

aims and objectives as set out in the 

Human Fertilisation and Embryology Act 

1990, the Authority’s Business Plan, and 

by Ministers within the Department of 

Health (DH), whilst safeguarding the 

public funds and departmental assets 

for which I am personally responsible, 

in accordance with the responsibilities 

assigned to me in DH correspondence. 

The Management Statement, agreed 

between the Department of Health and 

the HFEA, sets out the accountability 

framework within which the Authority‘s 

work will be monitored. This requires:- 

• Prior approval by the Department of 

the HFEA’s annual Business Plan, 

including an assessment of risks to 

the organisation. 

• Submission to the Department of 

regular monitoring information on 

progress in implementing the Plan. 

• An annual accountability meeting 

between DH Ministers and the Chair 

and Chief Executive of the HFEA. 

DH representatives customarily 

attend Authority meetings, and 

meetings of key standing committees 

(Organisation & Finance, Audit, 

Information Management 

Programming Board). The rapid 

pace of change within the HFEA 

has continued throughout 2003/04, 

and therefore close liaison has been 

maintained with DH. In addition to 

the formal accountability framework, 

there have been monthly meetings 

between the Department’s 

Sponsoring Division and the 

Authority’s Senior Management Team 

(SMT). 

2. The Purpose of the System 

of Internal Control 

The system of internal control is 

designed to manage risk to a reasonable 

level rather than to eliminate all risk of 

failure to achieve policies, aims and 

objectives; it can therefore only provide 

reasonable and not absolute assurance 

of effectiveness. 

In the Statement of Internal Control of 

10th July 2003, I gave a commitment 

that the risk management framework 

established in 2003/04 would be 


embedded within the organisation, and 

integrated into the business planning 

process. This has been implemented. 

The system of internal control is based 

on an ongoing process designed to 

identify and prioritise the risks to the 

achievement of the HFEA’s policies, aims 

and objectives, to evaluate the likelihood 

of those risks being realised and the 

impact should they be realised, and to 

manage them efficiently, effectively and 

economically. The system of internal 

control was in place in the HFEA by 

31 March 2004 and up to the date of 

approval of the annual accounts, and 

accords with Treasury guidance. 

3. Capacity to Handle Risk 

The Authority is very aware that the 

HFEA is operating in a high risk area 

with a high public profile, and hence 

of the importance that risks are 

identified and managed appropriately. 

The policy underpinning the HFEA’s 

risk management process aims to help 

members and staff to consider risk, the 

probability and impact in a consistent 

manner; and to make clear risk 

exposure may vary with new activities, 

or changes to existing activities. 

It is recognised that effective risk 

management must be resourced, and 

this is reflected in the development of 

the organisation and staffing levels. An 

experienced Senior Management Team 

(SMT) is in place, and there has been 

continued expansion of skilled staff in 

key areas, such as Regulation, IT 

and Communications. 

The HFEA policy makes clear that risk 

management is the responsibility of all 

staff; however, it is recognised that the 

process needs strong leadership. Risk 

management is led at SMT level by the 

Director of Resources and Corporate 

Development; the Head of Corporate 

Development has specific responsibility 

for supporting the development of risk 

management across the organisation. 

All operational managers are actively 

involved in risk management, including 

membership of the Authority-wide Risk 

Management Group (RMG). 

4. The Risk and Control Framework 

The HFEA aims to operate with a wellbalanced 

regard for risk. The risk 

strategy defines risk as the failure to 

perform the Authority’s statutory 

functions, and inability to achieve the 

Business Plan objectives, whether 

through negative action, or inaction. 

This could also include the failure to 

identify and exploit new opportunities. 

The main focus for consideration of risk 

is the High Level Risk Register. This was 

initially developed through workshops 

with staff in all departments, and 

identifies the probability and impact 

of each risk and the related controls. 

The process of rapid change within 

the HFEA continued during 2003/04. 

The modernisation of all the functions 

of the HFEA is being undertaken against 

a background of close scrutiny by our 

stakeholders; continued media interest; 

and significant external change (EU 

Tissue Directive, new Government policy 

on donor anonymity, and a review of the 

1990 Human Fertilisation & Embryology 

Act). An overarching risk, therefore, is the 

pressure of the growing agenda, and the 

threat to the reputation of the HFEA if we 

fail to achieve key business objectives, 

and are unable to meet the expectations 

of our stakeholders. These are central 

themes in the management of risk in 


There was continued streamlining of 

regulation, communications, and policy 

development during 2003/04. This 

included a new Alert system to improve 

our response to adverse incidents in 

licensed centres and disseminate learning 

from such events; the increasing use of 

risk assessment to inform the inspection 

process, including the introduction of 

unannounced inspections. 

Other key developments during the 

year included: 

Information Management Continued 

progress was made during the year 

on the development of the HFEA’s 

information systems, to enable the 

Authority to fulfil its statutory obligations. 

The transfer of data from the legacy 

systems has been completed, and is 

now being validated. The development 

has begun of an Electronic Data 

Interchange (EDI) system between the 

HFEA and licensed centres, and the 

preparation for the historic audit of 

records (HAP). The whole register 

development is being managed within 

a PRINCE framework, and overseen by 

a high-level Information Management

Programming Board, chaired by myself, 

and involving members and an 

independent IT expert. 

Audit The detailed audit of reporting 

of treatment activity by clinics was 

maintained during 2003/04. The findings 

of this audit again showed that there 

was no significant under-reporting of 

treatment activity by licensed clinics. 

As promised last year, the work of the 

specialist HFEA audit team has been 

integrated more closely within the wider 

inspection process. 

EU Tissues & Cells Directive 

This introduces new legal requirements 

for all units involved in the donation, 

procurement, processing, storage and 

distribution of gametes and embryos; 

and brings within the scope of 

regulation many units which have not 

been covered hitherto. The HFEA is 

likely to be the competent authority in 

relation to gametes and embryos under 

the legislation, which will bring this 

Directive into effect. This will expand 

the remit of the HFEA and have major 

implications for the whole organisation, 

alongside our existing programme of 

major change. We have begun preparing 

for the implementation of the Directive. 

Freedom of Information Act 

The implementation of public access 

rights under FOI presents a major 

challenge to the HFEA, given the often 

controversial nature of our work and the 

likely high level of interest it generates. 

We have begun the work to ensure the 

HFEA can respond appropriately to 

requests made under FOI. 

Work on these and other projects will 

continue in the current year. 

5. Review of Effectiveness 

As Accounting Officer, I have 

responsibility for reviewing the 

effectiveness of the system of internal 

control. My review of the effectiveness 

of the system of internal control is 

informed by the work of the internal 

auditors and the executive managers 

within the HFEA, who have responsibility 

for the development and maintenance 

of the internal control framework, 

and comments made by the external 

auditors in their management letter and 

other reports. I have been advised on 

the implications of the results of my 

review of the effectiveness of the system 

of internal control by the Authority, the 

Audit Committee, the SMT and the 

RMG, and a plan to address 

weaknesses and ensure continuous 

improvement of the system is in place. 

The Risk Strategy introduced in 2003 

includes an organisation-wide process 

for reviewing risk and monitoring 

implementation of controls. This takes 

place at departmental level, the SMT, 

Standing Committees and at the 

Authority itself. 

• The Authority: 

Reviews the effectiveness of risk 

management twice during the year, 

including a full report from the Audit 

Committee at the year end. 

• The Audit Committee: 

The Committee is the main source of 

reassurance to the Authority on the 

effectiveness of risk management, 

and receives a report on risk at each 

meeting. There will be a formal review 

in September, and a report submitted 

to the Authority at the year end. 

• Other Standing Committees: 

The work of the HFEA is led by a 

series of Member Committees which 

reflect the varied and complex 

functions of the Authority. All the 

committees have reviewed strategic 

risks in their area and the related 

controls during the year. 

• SMT: 

Directors review the strategic risks 

every 2 months, and are closely 

involved in ensuring risks are 

identified and managed. 

• Risk Management Group (RMG): 

This group, which includes all 

operational managers, is charged with 

the regular monitoring of emerging 

risks, the implementation of controls 

over known risks; and making 

recommendations to the SMT. The 

Group is facilitated and supported by 

the Head of Corporate Development. 

• Other Staff: 

It is recognised that all staff must 

be involved in, and have some 

understanding of, risk management. 

The individual members of the RMG 

are a key focus in developing this 

awareness. Work has begun to 

review detailed, departmental risk 

registers, and the work being done 

to address them. 

• Internal Audit: 

The Internal Audit Team has reviewed 

the management of key areas of 

work during the year, and will report 

on these to the Audit Committee. 

The value of the corporate risk process 

now in place is in highlighting the interrelationship 

of key risks, and the 

importance of a coordinated approach 

to managing them. It is also recognised 

that the management of risk is an 

integral part of the wider business 

planning process, and we will continue 

to strengthen risk management as part 

of our 2004/05 Business Plan. 





Human Fertilisation and Embryology Authority 2003/2004 

Certificate and Report of the Comptroller and Auditor General to the Houses of Parliament 

I certify that I have audited the financial 

statements on pages 48 to 62 under 

Section 6(4) of the Human Fertilisation 

and Embryology Act 1990. These 

financial statements have been prepared 

under the historical cost convention as 

modified by the revaluation of certain 

fixed assets and the accounting policies 

set out on page 50. 

Respective responsibilities of 

the Authority, the Chief Executive 

and Auditor 

As described on page 44 the Authority 

and Chief Executive are responsible for 

the preparation of the financial statements 

in accordance with the Human Fertilisation 

and Embryology Act 1990 and directions 

made thereunder by the Secretary of 

State with the approval of the Treasury, 

and for ensuring the regularity of financial 

transactions. The Authority and Chief 

Executive are also responsible for the 

preparation of the Foreword. My 

responsibilities, as independent auditor, 

are established by statute and I have 

regard to the standards and guidance 

issued by the Auditing Practices Board 

and the ethical guidance applicable to 

the auditing profession. 

I report my opinion as to whether the 

financial statements give a true and 

fair view and are properly prepared in 

accordance with the Human Fertilisation 

and Embryology Act 1990 and directions 

made thereunder by the Secretary of 

State, and whether in all material respects 

the expenditure and income have been 

applied to the purposes intended by 

Parliament and the financial transactions 

conform to the authorities which govern 

them. I also report if, in my opinion, 

the Foreword is not consistent with the 

financial statements, if the Authority has 

not kept proper accounting records, or if 

I have not received all the information and 

explanations I require for my audit. 

I review whether the statement on 

pages 45 to 46 reflects the Authority's 

compliance with Treasury’s guidance on 

the Statement on Internal Control. I report 

if it does not meet the requirements 

specified by Treasury, or if the statement 

is misleading or inconsistent with other 

information I am aware of from my audit 

of the financial statements. I am not 

required to consider, nor have I 


considered whether the Accounting 

Officer’s Statement on Internal Control 

covers all risks and controls. I am also 

not required to form an opinion on the 

effectiveness of the Authority's corporate 

governance procedures or its risk and 

control procedures. 

Basis of audit opinion 

I conducted my audit in accordance 

with United Kingdom Auditing Standards 

issued by the Auditing Practices Board. 

An audit includes examination, on a 

test basis, of evidence relevant to the 

amounts, disclosures and regularity of 

financial transactions included in the 

financial statements. It also includes an 

assessment of the significant estimates 

and judgements made by the Authority 

and Chief Executive in the preparation 

of the financial statements, and of 

whether the accounting policies are 

appropriate to the Authority's 

circumstances, consistently applied 

and adequately disclosed. 

I planned and performed my audit so 

as to obtain all the information and 

explanations which I considered 

necessary in order to provide me with 

sufficient evidence to give reasonable 

assurance that the financial statements 

are free from material misstatement, 

whether caused by error, or by fraud or 

other irregularity and that, in all material 

respects, the expenditure and income 

have been applied to the purposes 

intended by Parliament and the financial 

transactions conform to the authorities 

which govern them. In forming my opinion 

I have also evaluated the overall adequacy 

of the presentation of information in the 

financial statements. 

Opinion 

In my opinion: 

• the financial statements give a true 

and fair view of the state of affairs 

of the Human Fertilisation and 

Embryology Authority at 31 March 

2004 and of the surplus, total 

recognised gains and losses and 

cash flows for the year then ended 

and have been properly prepared 

in accordance with the Human 

Fertilisation and Embryology Act 1990 

and directions made thereunder by 

the Secretary of State with the 

approval of Treasury; and 

• in all material respects the expenditure 

and income have been applied to the 

purposes intended by Parliament and 

the financial transactions conform to 

the authorities which govern them. 

I have no observations to make on these 

financial statements. 

John Bourn 

Comptroller and Auditor General 


National Audit Office 

157-197 Buckingham Palace Road 

Victoria 

London SW1W 9SP 

Supplementary statement by the 

Comptroller and Auditor General in 

respect of material included at pages 1 

to 38 of this Annual Report, not included 

with the financial statements to which 

the audit opinion above relates. 

In respect alone of my responsibility 

under United Kingdom auditing 

standards to read the other information 

included with financial statements on 

which I express an audit opinion, I have 

read the additional information on pages 

1 to 38 which was not included with the 

financial statements on which I reached 

the audit opinion set out in my 

Certificate above and considered 

whether it is consistent with the audited 

financial statements. I have considered 

the implications for my audit opinion if 

I have thereby become aware of any 

apparent mis-statement or material 

inconsistencies with the financial 

statements. I have not considered the 

effects of any events since the date of 

my Certificate. 

In this regard, my audit opinion on the 

financial statements is unchanged. 

John Bourn 

Comptroller and Auditor General 

3 November 2004 

National Audit Office 

157-197 Buckingham Palace Road 

Victoria 

London SW1W 9SP

Income and Expenditure Account for the Year Ended 31 March 2004 

Notes 2003/2004 2002/2003 

Restated 

£ £ 

Income 

Gross Income 2 7,471,860 6,228,562 

Transfer from Government Grant Reserve (Capital Spend) 11 120,724 79,390 

7,592,584 6,307,952 

Expenditure 

Staff Costs 3 3,665,204 2,523,912 

Other Operating Charges 4 3,658,652 3,028,529 

Depreciation 5 112,535 77,472 

Loss/(Surplus) on Disposal of Fixed Assets 8,189 (353) 

Total Expenditure 7,444,580 5,629,560 

Operating Surplus 148,004 678,392 

Exceptional Items : Increase In Pension Provision for Year 9 (56,201) (288,330) 

: Funding Received for Pension Provision 9 1,276,216 0 

Notional Interest (Capital Charges) 1(g) (32,055) 3,106 

Surplus on Ordinary Activities 1,335,964 393,168 

Write back of Notional Interest 1(g) 32,055 (3,106) 

Surplus for the Financial Year 1,368,019 390,062 

Retained (Deficit) brought forward – as restated 11 (44,389) (434,451) 

Retained Surplus/(Deficit) carried forward 11 1,323,630 (44,389) 

All operations are continuing. 

Statement of Total Recognised Gains and Losses 

for the Year Ended 31 March 2004 


Restated 

£ £ 

Surplus for the Financial Year 1,368,019 390,062 

Unrealised Surplus on Revaluation of Fixed Assets 0 0 

Total Recognised Gains for the Year 1,368,019 390,062 

Prior Period Adjustment (note 2) 696,030 0 

Total (Losses) Recognised Since Last Annual Report 2,064,049 390,062 

The notes on pages 50 to 62 form part of these Accounts. 


Balance Sheet as at 31 March 2004 

Notes 31 March 2004 31 March 2003 

Restated 

£ £ 

Fixed Assets 5 353,360 199,158 

Current Assets: 

Debtors: Amounts Falling Due Within One Year 6 1,386,541 1,346,255 

Cash at Bank and in Hand 17 307,947 29,191 

Creditors: Amounts Falling Due Within One Year 7 (370,858) (199,820) 

Net Current Assets 1,323,630 1,175,626 

Long Term Liabilities 

Provisions for Liabilities and Charges 9 0 (1,220,015) 

Total Assets less Current Liabilities 1,676,990 154,769 

Financed By 

Capital and Reserves 

– Government Grant Reserve (Capital Spend) 11 353,360 186,641 

– Income and Expenditure Reserve 11 1,323,630 (44,389) 

– Revaluation Reserve 11 0 12,517 

1,676,990 154,769 





Cash Flow Statement for the Year Ended 31 March 2004 


£ £ 

Operating Activities 

Net Cash Inflow/(Outflow) 18(a) 278,756 (6,195) 

Capital (Expenditure)/Income 

– Purchase of Fixed Assets 5 (274,926) (102,388) 

– Cash Received on Disposal of Assets 0 353 

Net Cash Inflow/(Outflow) Before Financing 3,830 (108,230) 

Financing 

– Receipts of Government Grants for Purchase 11 274,926 102,388 

of Fixed Assets 

– Net Cash Inflow from Financing 274,926 102,388 

Increase/(Decrease) in Cash 18(b) 278,756 (5,842) 



Notes to the Accounts 

1. Accounting Policies 

(a) Accounting Convention 

The HFEA’s accounts are prepared in 

accordance with the provisions of the 

Human Fertilisation and Embryology Act 

1990 and an Accounts Determination issued 

by the Secretary of State for Health in May 

1997 (reproduced as an appendix to 

these accounts). 

These accounts are prepared, in accordance 

with applicable accounting standards, under 

the historical cost convention modified to allow 

for the revaluation of fixed assets. Without 

limiting the information given, the accounts 

meet the accounting and disclosure 

requirements of the Companies Acts and 

Accounting Standards issued or adopted by 

the Accounting Standards Board so far as 

those requirements are appropriate. 

(b)Fixed Assets 

Fixed Assets include tangible and intangible 

fixed assets and the costs of acquiring or 

creating computer systems or software. Only 

items, or groups of related items, costing 

£1,000 or more and with individual values 

over £250, are capitalised. Those costing 

less are treated as revenue expenditure. 

Assets purchased prior to the current financial 

year are indexed annually using the Office for 

National Statistics’ indices if there is a material 

difference between historic cost and current 

replacement cost. In 2003/04, HFEA decided 

that no material adjustment was necessary and 

therefore modified historic cost accounting has 

not been applied in financial year 2003/04. 

(c) Depreciation and Amortisation 

Depreciation is provided on all tangible fixed 

assets on a monthly basis from the date of 

acquisition at rates calculated to write off the 

cost of each asset evenly over its expected 

useful life. Expected useful lives are as follows: 

Computer equipment and software 

Office equipment 

Furniture, fixtures and fittings 

3 years 

4 years 

4 years 

Amortisation is provided on intangible fixed 

assets (which comprise software licenses) on 

a monthly basis at a rate calculated to write 

off the cost of each intangible asset over its 

expected useful life. The expected useful life 

of these software licenses is 3 years. 

(d)Operating Leases 

Operating leases are charged to the accounts 

on a straight line basis over the lease term. 

(e) Register of Information 

Expenditure on development of the computer 

programme for the Register of Information is 

charged to the Income and Expenditure 

Account as it is incurred. 

(f) Government Grants 

Government grants received for revenue 

expenditure are credited to income in the 

year to which they relate. Government grants 

received for capital expenditure are credited to 

the government grant reserve and released to 

the Income and Expenditure Account to match 

depreciation and downward indexation, 

where appropriate. 

(g)Notional Charges 

In accordance with Treasury guidance, 

notional interest at 3.5% (2002/03 6%) of the 

average capital employed has been debited in 

the Income and Expenditure Account 

amounting to £32,055 (2002/2003 – restated 

and credited, £3,106). 

(h) Pensions 

Past and present employees are covered by 

the provisions of the Principal Civil Service 

Pension Scheme (PCSPS.) The defined 

benefit elements of the schemes are 

unfunded and are non-contributory except in 

respect of dependents’ benefits. The HFEA 

recognises the expected cost of these 

elements on a systematic and rational basis 

over the period during which it benefits from 

employees’ services by payment to the 

PCSPS of amounts calculated on an accruing 

basis. Liability for payment of future benefits is 

a charge on the PCSPS. In respect of the 

defined contribution elements of the schemes, 

the HFEA recognises the contributions 

payable for the year. 

(i) Fees and Charges Guide 

From 2003/04 it was agreed with the 

Department of Health that the HFEA is a 

single purpose organisation. These accounts 

therefore no longer show a note of segmental 

information for different services or forms of 

services, as required by HM Treasury’s “The 

Fees and Charges Guide”. 


2. Gross Income 

Gross income is made up of Government grants 

received in the year and of license fee and other 

incomes which are recorded on an accruals basis. 

Analysis of Income 2003/2004 2002/2003 

£ £ 

Restated 

License Fee Income 

– Annual billing 0 874,094 

– Monthly billing 3,528,427 2,346,464 

Other Income 7,359 2,392 

Cash Received from the Department of Health 4,211,000 3,108,000 

Less Capital Grant element (274,926) (102,388) 

3,936,074 3,005,612 

7,471,860 6,228,562 

Income received from the Department of Health 

included contributions from the devolved 

administrations for Scotland, Wales and 

Northern Ireland. 

As from 1st April 2002, the process for billing 

centres for License fees was changed. Previously, 

centres were invoiced once per year close to the 

anniversary of license renewal date, to cover all 

billable treatment cycles reported in the preceding 

12 months. From April 2002, treatment cycles 

have been reported each month and invoiced in 

the following month. The point at which a cycle 

becomes billable is assumed to be when it is 

reported under these monthly invoicing procedures. 

An accrual was made as at 31 March 2003 to 

include income from cycles reported in March 

2003, which were invoiced after the year end. 

Cycles reported up to March 2002 and not 

previously invoiced continued during 2002/03 to 

be invoiced at the license renewal anniversary date. 

The effect of the change in process was to bring 

forward the timing of payments by centres with a 

consequential one-off rise in income to HFEA in 

2002/03. However, over a multi-year period neither 

income to HFEA, nor payments by centres was 

raised by this change in invoicing process. 

The opening fee income accrual has been 

adjusted to reflect the actual value of treatments 

undertaken prior to 31 March 2003 but not 

invoiced until after that date. The impact of this 

change in accounting policy on the results for the 

year ended 31 March 2003 is to increase license 

fee income and debtors by £696,030 and this is 

shown in the prior year adjustment which is 

disclosed in note 11. 

The closing income accrual has likewise been 

based on the value of treatments undertaken 

during the year ended 31 March 2004 but not 

invoiced until after 1 April 2004. The impact of 

this change in accounting treatment for financial 

year 2003/04 has been to decrease license fee 

income by £161,392 and to increase debtors as 

at 31 March 2004 by £534,638. Under the former 

accounting policy, license fee income would have 

been reported at £3,689,819 and license fee 

debtors would have been stated at £659,172. 

During 2003/04 HFEA developed its systems to 

enable fuller analysis of treatment forms received 

and hence enable income to be analysed by the 

time of treatment. The Accounts for 2002/03 stated 

that it was planned that the Accounts for financial 

year 2003/04 would reflect a new accounting 

treatment, recognising income at the time of 

treatment rather than when reported to HFEA. 

These Accounts have accordingly been prepared 

on the basis of recognising income at the time of 

treatment date, to more accurately reflect the 

accounting value of activity undertaken in the year. 


3. Staff Costs 

2003/2004 2002/2003 

£ £ 

All Staff 

Salaries – HFEA Staff 2,462,266 1,381,525 

Salaries – Seconded Staff 112,621 138,174 

Social Security Costs 238,264 128,721 

Superannuation Costs – Seconded Staff 21,232 24,770 

Superannuation Costs – HFEA Staff 293,949 131,413 

Agency/Temporary Staff 270,275 561,119 

Compensation Payment 130,000 31,600 

3,528,607 2,397,322 

Members’ Costs 136,597 126,590 

Total 3,665,204 2,523,912 

The average monthly number of full time and part-time staff employed, including secondees and 

temporary staff, during the year was as follows: 


Management 5 3 

Administrative 86 54 

91 57 

Remuneration of Key Management 


£ £ 

Former Chief Executive (to 17 November 2002): Dr Maureen Dalziel 

Total Paid to Seconding Body, 

the London School of Hygiene and Tropical Medicine 19,086 47,715 

(for the period November 2002 – February 2003) 

Compensation payment made to Dr Dalziel on early termination 

of office (note 20) 130,000 0 

Current Chief Executive: Ms Angela McNab 

Ms Angela McNab was on secondment from the Department of Health during the financial year until 

1 September 2003, when Ms McNab joined the HFEA as a member of staff. During the period to 

1 September 2003 HFEA made payments to the Department of Health in respect of this secondment 

totalling £52,042 (during 2002/03, for the period 11 November 2002 – 31 March 2003, £45,808.) 

HFEA was not responsible for the pension arrangements of Ms McNab during this period. 

In the period 1 September 2003 to 31 March 2004, the salary and pension entitlements of Ms McNab 

from HFEA were as follows : 

Salary £55,000 - £60,000 

Real Increase in Pension at age 60 £0 - £2,500 

Real Increase in lump sum £0 - £2,500 

Total Accrued Pension at age 60 at 31/3/04 £0 - £5,000 

Related Lump Sum at 31/3/04 £0 - £5,000 

CETV at 31/3/03 (nearest £’000) 0 

CETV at 31/3/04 (nearest £’000) 11 

Real increase in CETV as funded by HFEA (nearest £’000) 13 


Other Senior Managers 

The Resource Accounting Manual requires the HFEA to provide information on the salary and pension 

rights of the named individuals who are the “most senior managers” of the HFEA, subject to the 

individuals concerned consenting to disclosure. 

The salary and pension entitlements of the Senior Managers in HFEA during the year were as follows: 

Name of Senior Manager Salary Real Real Total Related CETV at CETV at Real 

(£) increase increase accrued lump 31/3/03 31/3/04 Increase 

in pension in lump pension sum at (nearest (nearest in CETV 

at age 60 sum at age 60 31/3/04 £’000) £’000) as funded 

(£) (£) at 31/3/04 (£) by HFEA 

(£) (nearest 

£’000) 

Trish Davies* £5,000- £0- £0- £0- £0- 0 1 0 

Commenced 1/3/04 £10,000 £2,500 £2,500 £5,000 £5,000 

Ann Furedi £10,000- £0- £0- £0- £0- 9 11 2 

Left 30/5/03 £15,000 £2,500 £2,500 £5,000 £5,000 

Paul Gemmill £35,000- £0- £2,501- £0- £5,001 22 33 13 

Commenced 27/5/03, £40,000 £2,500 £5,000 £5,000 £10,000 

Left 12/12/03 

Barry MacDonald* £75,000- £0- £2,501- £0- £5,001 16 33 19 

£80,000 £2,500 £5,000 £5,000 £10,000 

David Tellis* £65,000- £0- £0- £0- £0- 4 14 7 

Appointed 27/5/03 £70,000 £2,500 £2,500 £5,000 £5,000 

Tim Whitaker* £55,000- £0- £0- £0- £0- 0 10 12 

Commenced 17/6/03 £60,000 £2,500 £2,500 £5,000 £5,000 

* denotes current staff 

Salary 

‘Salary’ includes gross salary, performance pay or bonuses, overtime, and any other allowance to the 

extent that it is subject to UK taxation. 

Pension 

Full details in respect of the pension arrangements in place for HFEA staff are provided in note 8 to 

these Accounts. 

Columns 6 & 7 of the foregoing tables show the member’s Cash Equivalent Transfer Value (CETV) 

accrued at the beginning and the end of the reporting period. Column 8 reflects the increase in 

CETV effectively funded by the employer. It takes account of the increase in accrued pension due 

to inflation, contributions paid by the employee (including the value of any benefits transferred from 

another pension scheme or arrangement) and uses common market valuation factors for the start 

and end of the period. 

A CETV is the actuarially assessed capitalised value of the pension scheme benefits accrued by a 

member at a particular point in time. The benefits valued are the member’s accrued benefits and any 

contingent spouse’s pension payable from the scheme. A CETV is a payment made by a pension 

scheme or arrangement to secure pension benefits in another pension scheme or arrangement when 

the member leaves a scheme and chooses to transfer the benefits accrued in their former scheme. 

The pension figures shown relate to the benefits that the individual has accrued as a consequence of 

their total membership of the pension scheme, not just their service in a senior capacity to which 

disclosure applies. The CETV figures, and from 2003/04 the other pension details, include the value 

of any pension benefit in another scheme or arrangement which the individual has transferred to the 

PCSPS arrangements and for which the Civil Superannuation Vote has received a transfer payment 

commensurate to the additional pension liabilities being assumed. They also include any additional 

pension benefit accrued to the member as a result of their purchasing additional years of pension 

service in the scheme at their own cost. CETVs are calculated within the guidelines and framework 

prescribed by the Institute and Faculty of Actuaries. 


Remuneration of Authority Members 

Chairman – Suzi Leather 2003/2004 2002/2003 

Remuneration – in the bands of: £30,000-£35,000 £20,000-£25,000 

Pension contributions in the band of £4,000-£4,500 were made on behalf of Suzi Leather in 2003/04 

(2002/03 – in the band of £0-£2500). The real increase in pension at age 60 during the year was in the 

band £0 - £2,500 (2002/03 – £0-£2500). The total accrued pension at 60 as at 31 March 2004 was in 

the band £0 - £5,000 (2002/03 – £0 - £5,000) At the balance sheet date, Suzi Leather was aged 47. 

Members Costs (including Chairman) 2003/2004 2002/2003 

£ £ 

Total fees payable to members 121,928 115,893 

Social Security Costs 10,338 8,334 

Superannuation Costs 4,331 2,363 

136,597 126,590 

The Deputy Chairman received a fee of £185 per day. Members received a fee of £169 per day. 

No pension contributions were paid on behalf of any Board Member other than the Chairman. 

Remuneration payable to individual members for attendance at meetings and inspections during the 

financial year was in the following bands:- 

£0 - £5,000 

Professor David Barlow 


Professor Iain Cameron 

Professor Andrew Grubb 

Rt. Revd. Richard Harries 

Ms J Hunt 

Ms E Jackson 

Mr Simon Jenkins 

Rt. Revd. Dr Michael Nazir-Ali 


£5,001 - £10,000 

Professor Thomas Baldwin (Deputy Chair) 


Mr Ivor Brecker 

Ms Clare Brown 

Mrs Jane Denton (Director of Sub-Committees) 






4. Other Operating Charges 


£ £ 

Operating Lease Payments 

– Land and Buildings 273,149 246,880 

– Other Leases 13,042 10,533 

Accommodation (note 1) 1,350,915 172,628 

Travel & Subsistence 241,375 211,095 

Attendance Fees – Inspectors 52,283 26,192 

Professional & Administrative Fees 288,825 1,005,435 

Audit Fees 

– External (note 2) 56,500 32,500 

– Internal 21,752 21,620 

Register of Information (note 3) 465,359 305,596 

Stationery, Photocopying & Printing 264,404 178,023 

Telephones & Postage 78,598 68,352 

Training & Development 100,175 122,842 

Recruitment & Advertising 167,910 345,220 

Conferences & Meeting Expenses 90,607 39,305 

Library & Reading Materials 44,468 29,774 

Sundry Office Equipment 52,849 83,120 

IT Costs (Including Website) 52,972 95,806 

Miscellaneous 43,469 33,608 

Total 3,658,652 3,028,529 

Notes 

1. Accommodation costs in 2003/04 include one off costs of £558k associated with the move of HFEA 

from its previous premises into a single office. These costs, approved by the Department of Health, 

settled outstanding lease obligations in respect of the main building HFEA previously occupied. 

Other such one-off costs included removals, fit out and IT installations at the new premises. 

2. The external audit fee from the NAO represents the cost for the audit of the financial statements 

carried out by the Comptroller and Auditor General. This account does not include fees in respect 

of non-audit work. No such work was undertaken by the NAO on behalf of the HFEA during the year. 

Approximately £20,000 of the fee charged for the year relates to additional fees charged for audit 

work undertaken during 2002/03. 

3. Costs charged to the register of information include some expenditure relating to this project which 

would normally fall within other expenditure lines, such as some accommodation and related costs, 

recruitment and legal and professional fees, IT costs, and travel and subsistence. 


5 (a) Tangible Fixed Assets as at 31 March 2004 

Computer Office Furniture 

Equipment Equipment & Fittings Totals 

£ £ £ £ 

Cost/valuation as at 31 March 2003 221,933 206,209 88,380 516,522 

Additions 192,233 36,256 22,586 251,075 

Disposals (19,111) (95,991) (70,480) (185,582) 

As at 31 March 2004 395,055 146,474 40,486 582,015 

Depreciation as at 31 March 2003 84,585 150,206 85,102 319,893 

Charge for the year 84,233 21,659 1,878 107,770 

Disposals (14,200) (95,991) (67,202) (177,393) 


Net Book Value (NBV) 

At 31 March 2004 240,437 70,600 20,708 331,745 

At 31 March 2003 137,348 56,003 3,278 196,629 

Increase/(Decrease) in NBV 103,089 14,597 17,430 135,116 

5 (b) Intangible Fixed Assets as at 31 March 2004 and Summary of Fixed Assets 

Software Total Intangible Total Tangible Grand Total of 

Licenses Assets Fixed Assets Fixed Assets 

£ £ £ £ 

Cost/valuation as at 31 March 2003 3,035 3,035 516,522 519,557 

Additions 23,851 23,851 251,075 274,926 

Disposals 0 0 (185,582) (185,582) 


Amortisation/Depreciation 

as at 31 March 2003 506 506 319,893 320,399 

Charge for the year 4,765 4,765 107,770 112,535 

Disposals 0 0 (177,393) (177,393) 


Net Book Value (NBV) 

At 31 March 2004 21,615 21,615 331,745 353,360 

At 31 March 2003 2,529 2,529 196,629 199,158 

Increase/(Decrease) in NBV 19,086 19,086 135,116 154,202 

As recorded in note 1(b) to these Accounts, modified historic cost accounting has not been applied to fixed assets in these 

Accounts this year, as there is no material difference between historic cost and current replacement cost. 

6. Debtors: Amounts Falling Due Within One Year 

31 March 2004 31 March 2003 

Restated 

£ £ 

License Fee & Accrued Income 1,193,810 1,158,992 

Other Debtors 114,189 16,425 

Pre-payments 78,542 170,838 

1,386,541 1,346,255 


7. Creditors: Amounts Falling Due Within One Year 

31 March 2004 31 March 2003 

£ £ 

Trade Creditors 57,396 2,240 

Other Taxes and Social Security 1,390 4,486 

Accruals and Deferred Income 312,072 193,094 

370,858 199,820 

8. Pension Arrangements (HFEA Staff) 

As per 2001 Statutory Instrument No. 1587, HFEA staff were conditionally admitted to the Principal Civil 

Service Pension Scheme (PCSPS) as from 1st April 2000, transferring from the HFEA by-analogy Scheme. 

The PCSPS is an unfunded multi-employer defined benefit scheme but HFEA is unable to identify its 

share of the underlying assets and liabilities. A full actuarial valuation was carried out as at 31 March 

2003. Details can be found in the resource accounts of the Cabinet Office : Civil Superannuation 

(www.civilservice-pensions.gov.uk). 

Pension benefits are provided through the PCSPS arrangements. From 1 October 2002, staff may be in 

one of three statutory based ‘final salary’ defined benefit schemes (classic, premium, and classic plus). 

The Schemes are unfunded with the cost of benefits met by monies voted by Parliament each year. 

Pensions payable under classic, premium, and classic plus are increased annually in line with changes 

in the Retail Prices Index. New entrants after 1 October 2002 may choose between membership of 

premium or joining a good quality ‘money purchase’ stakeholder arrangement with a significant employer 

contribution (partnership pension account). 

For 2003/04, employers’ contributions of £272,656 were payable to the PCSPS (2002/03 £133,776) 

at one of four rates in the range 12 to 18.5 per cent of pensionable pay, based on salary bands. 

The scheme’s Actuary reviews employer contributions every four years following a full scheme valuation. 

Rates will remain the same next year, subject to revalorisation of the salary bands, but will increase from 

2005/06. The contribution rates reflect benefits as they are accrued, not when the costs are actually 

incurred, and reflect past experience of the scheme. 

In addition, employer contributions of 0.8 per cent of pensionable pay were payable to the PCSPS to 

cover the cost of the future provision of lump sum benefits on death in service and ill health retirement 

of these employees. 

Employee contributions are set at the rate of 1.5% of pensionable earnings for classic and 3.5% for 

premium and classic plus. Benefits in classic accrue at the rate of 1/80th of pensionable salary for each 

year of service. In addition, a lump sum equivalent to three years’ pension is payable on retirement. 

For premium, benefits accrue at the rate of 1/60th of final pensionable earnings for each year of service. 

Unlike classic, there is no automatic lump sum (but members may give up (commute) some of their 

pension to provide a lump sum). Classic plus is essentially a variation of premium, but with benefits in 

respect of service before 1 October 2002 calculated broadly as per classic. 

Further details about the PCSPS arrangements can be found at the website 

www.civilservice-pensions.gov.uk. 

Employees joining after 1 October 2002 could opt to open a partnership pension account, a stakeholder 

pension with an employer contribution. Employers’ contributions of £25,624 were paid during financial 

year 2003/04 (2002/03 £nil) to one or more companies chosen by these employees from a panel of four 

appointed stakeholder pension providers. Employer contributions are age-related and range from 3 to 

12.5 per cent of pensionable pay. Employees do not have to contribute but where they do make 

contributions, HFEA will match these up to a limit of 3% of pensionable salary (in addition to the 

employer’s basic contribution). 

£223 in contributions were due to the partnership pension providers at the balance sheet date. 

No contributions were prepaid at that date. 


9. Provisions For Liabilities and Charges 


£ £ 

Accrued Pension Liability Brought Forward 1,220,015 667,513 

Movement in Liability for Pensions Transfer During the Year: 

Opening Creditor 0 216,638 

Payments to/from JSS 0 (15,354) 

Current Year Notional Pension Costs 0 62,888 

Increase in Provision for Year 56,201 288,330 

Write back of Total Provision for Year (1,276,216) 0 

Total Provision for Liabilities and Charges 0 1,220,015 

Further information about the HFEA’s transfer from its by-analogy pension scheme into membership 

of the PCSPS, together with details of the write back of the provision for the year, is provided in the 

Foreword to these Accounts, under “Financial Results for 2003/04.” 

10. Post Balance Sheet Events 

As a NDPB, the HFEA is classified as an arms’ length body. 

In October 2003, the Secretary of State for Health announced his intention to review the Department 

of Health’s “Arms’ Length Bodies.” On 20 May 2004 he outlined the first stage of this review. 

There are 42 separate arms’ length bodies which employ 22,000 staff with a combined budget of 

£2.5bn. The Secretary of State announced that by 2007/08 there will be a 50% reduction in the 

number of arms’ length bodies reducing total expenditure by £0.5bn and staff posts by 25%. 

The final outcome of the review should be announced before the Parliamentary summer recess. As at 

the date of signing these financial statements, the implications of the review for the HFEA have not yet 

been announced. 


17. Cash at Bank and in Hand 


£ £ 

Cash at Bank and in Hand 307,947 25,329 

OPG Account 0 3,862 

307,947 29,191 

18. Notes to the Cash Flow Statement 

a. Reconciliation of Operating Surplus 

to Net Cash (Outflow)/Inflow From Operating Activities: 


Restated 

£ £ 

Operating Surplus 1,368,019 390,062 

Loss/(Profit) on Disposals of Fixed Assets 8,189 (353) 

Depreciation Charges 112,535 77,472 

Downward Indexation Charge 0 0 

(Increase) in Debtors (40,286) (802,654) 

Increase/(Decrease) in Creditors 171,038 (143,834) 

Transfer from Government Grant (Capital Spend) (120,724) (79,390) 

(Decrease)/Increase in Provision for Pension Transfer Costs: (1,220,015) 552,502 

Net Cash Inflow/(Outflow) from Operating Activities 278,756 (6195) 

b. Analysis of Changes in Cash 

At 31 March Cash Flows At 31 March 

2003 2004 

£ £ £ 

Cash at Bank and in Hand 29,191 278,756 307,947 


19. Financial Instruments 

FRS 13, Derivatives and Other Financial Instruments, requires disclosure of the role financial instruments 

have had during the period in creating or changing the risks an entity faces in undertaking its activities. 

As permitted by FRS 13, debtors and creditors which mature or become payable within 12 months from 

the balance sheet date have been omitted from this note. 

Liquidity Risk 

The principal source of revenues (47% of total gross income) is derived directly from the number of IVF 

and DI treatment cycles performed by the licensed clinics and reported to the HFEA. The remaining 

source of revenue is derived from Government grants made on a cash basis. 

There are procedures in place to identify late and non-reporting of treatment cycles by clinics and also 

procedures for chasing up debts. HFEA is therefore not exposed to significant liquidity risks. 

Investments and Interest Rate Risk 

The HFEA follows an investment policy of placing any surplus funds on deposit in an interest bearing 

bank account. Interest income was less than £5,000 of the revenues of the HFEA, and the HFEA is not 

therefore exposed to significant interest rate risk. 

Financial Assets Total Non-Interest Floating-rate 

bearing cash cash deposits 

deposits 

£ £ £ 

At 31 March 2004 307,720 0 307,720 

At 31 March 2003 28,791 0 28,791 

Petty cash held on site amounted to £227 (2002/03: £400). 

The fair value of the financial assets was equal to the book value. 

Financial Liabilities 

The HFEA had no financial liabilities at 31 March 2004 requiring disclosure under FRS 13. 

Foreign Currency Risk 

There were minimal foreign currency transactions conducted by the HFEA during the year ended 

31 March 2004. There was therefore no significant foreign currency risk during the year. 

20. Special Payments 

As disclosed in note 3 to these accounts, a compensation payment of £130,000 was made to 

Dr Maureen Dalziel, a former Chief Executive of HFEA, on the early termination of her office. 


Appendix 

The Human Fertilisation and Embryology Authority 

Accounts Determination 

The Secretary of State, with the approval of the Treasury, in pursuance of Section 6 of the Human Fertilisation and Embryology Act 

1990, hereby gives the following determination. 

Directions given by the Secretary 

of State Form of Accounts 

1. In this determination "the Authority" means the Human Fertilisation and 

Embryology Authority. 

2. The Authority shall prepare accounts for the financial year ended 31st March 1997 

and subsequent financial years comprising: 

a) a Foreword; 

b) an Income and Expenditure account; 

c) a Balance Sheet; 

d) a Cash Flow Statement; and 

e) a Statement of Total Recognised Gains and Losses; 

including such notes as may be necessary for the purposes referred to in the 

following paragraphs. 

3. The Accounts shall give a true and fair view of the income and expenditure 

and cash flows for the financial year, and the state of affairs as at the end of the 

financial year. 

4. Subject to this requirement, the Accounts shall be prepared in accordance with: 

a) Generally accepted accounting practice in the United Kingdom (UK GAAP); 

b) The disclosure and accounting requirements contained in “The Fees and 

Charges Guide” (in particular those relating to the need for appropriate 

segmental information for services or forms of service provided) and in other 

guidance which the Treasury or the Secretary of State may issue from time to 

time in respect of Accounts which are required to give a true and fair view; 

c) The accounting and disclosure requirements given in “Government Accounting” 

and in "Executive NDPBs: Annual Reports and Accounts Guidance”; as amended 

or augmented from time to time: insofar as these are appropriate to the Authority 

and are in force for the financial year for which the Statement of Accounts is to 

be prepared. 

5. Clarification of the application of the accounting and disclosure requirements of 

the Companies Act and accounting standards is given in Schedule 1 attached. 

Additional disclosure requirements are set out in Schedule 2 attached. 

6. The Income and Expenditure Account and Balance Sheet shall be prepared under 

the historical cost convention modified by the inclusion of: 

a) fixed assets at their value to the business by reference to current costs; and 

b) stocks valued at the lower of net current replacement cost (or historical cost if 

this is not materially different) and net realisable value. 

7. This Accounts Determination supersedes that dated 26th April 1996 and shall be 

reproduced as an appendix to the accounts. 

Date: 6th May 1997 

Signed by the authority of the Secretary of State for Health 

P. Kendall 

Branch Head (RMF- EAC Division) 

Department of Health 


Schedule 1 

Application of the Accounting and Disclosure Requirements of the Companies Act and 

Accounting Standards. 

Companies Act 

1. The disclosure exemptions permitted by the Companies Act shall not apply to the Authority unless 

specifically authorised by the Secretary of State with the approval of the Treasury. 

2. The Companies Act requires certain information to be disclosed in the Directors' Report. 

To the extent that it is appropriate, the information relating to the Authority shall be contained in 

the Foreword. 

3. When preparing its Income and Expenditure Account, the Authority shall have regard to the profit 

and loss format 2 prescribed in Schedule 4 to the Companies Act 1985 (as amended). 

4. When preparing its Balance Sheet, the Authority shall have regard to the Balance Sheet format 1 

prescribed in Schedule 4 to the Companies Act 1985 (as amended). The Balance Sheet totals 

shall be struck at ‘Total Assets less Current Liabilities'. 

5. The Authority is not required to provide the additional information required by paragraph 33(3) 

of Schedule 4 to the Companies Act 1985. 

6. The Foreword and Balance Sheet shall be signed by the Chief Executive to the Authority 

and dated. 

Accounting Standards 

7. The Authority is not required to include a note showing historical cost profits and losses as 

described in FRS3. 

8. The Authority shall not adopt the Financial Reporting Standard for Smaller Entities unless 

specifically approved by the Treasury. 

Schedule 2 

Additional Disclosure Requirements 

1. The Foreword shall, inter alia: 

a) State that the Accounts have been prepared in a form determined by the Secretary of State 

with the approval of the Treasury in accordance with Section 6 of the Human Fertilisation and 

Embryology Act 1990; 

b) Include a brief history of the Authority and its statutory background. 

2. The notes to the accounts shall, inter alia: 

a) Include details for the accounting policies adopted; 

b) Provide further explanations of figures in the accounts where it is considered appropriate for a 

proper understanding of the accounts; 

c) Include details of the key corporate financial targets set by Ministers together with the 

performance achieved. 

HFEA Accounts | 64 45

Writing and editing Patsy Westcott and Annie Corbett 

Design glow 

Photography Poppy Berry and Kim Brett 

Print HenDi Systems

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