Human Fertilisation and Embryology Authority Annual Report & Accounts 2005

82 Pages·2006·0.34 MB·English

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Presented pursuant Section 6(1) of the Human Fertilisation and Embryology Act 1990
HUMAN FERTILISATION AND EMBRYOLOGY AUTHORITY
Annual Report & Accounts 2005 - 2006
ORDERED BY THE HOUSE OF COMMONS TO BE PRINTED 20 JULY 2006
HC 1444 LONDON: The Stationery Office Cost: £14.65

Contents
Page
1. Chair’s & Chief Executive’s Foreword 3
2. Management Commentary and Directors’ Report 5
3. Appendices 19-45
1 Standing Committee Membership Appointment 19
Summary of Authority Members as at 31 March 2006 20
Licence Committee Members as at 31 March 2006 21
Horizon-scanning Expert Panel Membership as at 31 March 2006 22
2 Centres licensed by the HFEA 23-25
3 External advisors 26-31
4 Research centres/projects licensed by the HFEA 32-34
5 HFEA peer reviewers 35-38
6 Members’ interests 39-45
4. Remuneration Report 46
5. Statement of the Authority’s and Chief Executive’s Responsibilities 54
6. Statement on Internal Control 55
7. The Certificate and Report of the Comptroller and Auditor General 59
to the Houses of Parliament
8. Financial Accounts 61
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Human Fertilisation and Embryology Authority Account 2005-2006
Chair’s & Chief Executive’s Foreword
One of the benefits of regulation is that it can secure and maintain consensus in a controversial
area. In the UK we have developed a mature system of regulation of IVF, donor conception and
embryo research which attracts praise from other countries and is, in many cases, being
replicated into new regulatory frameworks elsewhere in the world.
In fulfilling one of our roles - to maintain public confidence in fertility treatment and embryo
research - we work in close partnership with the fertility sector, patients, donor groups,
researchers, the Department of Health and the general wider public. The rapid advances in the
field require us to anticipate and adapt to many challenges. We, in turn, have to ensure that
regulation can be flexible and able to evolve according to new circumstances. By working with
other partners we can ensure safe, quality care for patients and offspring in a culture of
continuous improvement.
The past year has demonstrated how the HFEA has adapted, anticipated and improved. There
have been many demands placed on regulation. The following pages in this report outline some
of the achievements during the year and demonstrate how we have continually updated and
strengthened how we regulate.
We have continued to streamline regulation of treatment and research to ensure it is
proportionate, targeted and efficient. A major highlight has been the 20 per cent efficiency
saving in the type and number of information requests to centres as part of the inspection
process. On research we have similarly improved processes including new inspection methods
and extending the pool of peer reviewers. Our approach has been to work closely with clinics
and a new initiative was the setting-up of the Licensed Centres’ Panel which enables a range of
staff in clinics to give us their views and raise issues for us to address.
A major strand of work has been implementing the European Tissue and Cells Directive. We
have developed guidance for existing centres as well as those not previously regulated, again
working closely with the professional bodies. We have taken the lead in working with other
regulators and practitioners through the new European Assisted Conception Consortium.
We have further progressed our major modernisation programme on HFEA data. We completed
the Historic Audit Project of all key data on offspring and donors which will prove to be a real
benefit for clinics and offspring. Our Electronic Data Interchange plan has been implemented to
give clinics the capacity to transmit timely and accurate data electronically to HFEA. This will
further reduce the burden of regulation.
Throughout the year we have worked hard to make sure that as an organisation we are as
patient focussed as possible. Our aim is to ensure that we are making a practical difference to
patients’ experiences. We are using a variety of channels to hear patients’ views, including
routinely surveying patients’ experiences as part of inspections and through our new online
patients’ panel, Fertility Views. We want to empower patients so they have greater knowledge
and involvement in selecting the right clinics and treatments for them. Our 2005 Guide to
Infertility with its online clinic search was developed following extensive research and
involvement from patients and has been widely welcomed by patients.
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Working with stakeholders and the public has been a feature of the policy work we have
undertaken during the year. We launched a major dialogue with the public and stakeholders on
PGD (Pre-implantation Genetic Diagnosis) for late onset, lower penetrance treatable conditions
which has given us valuable feedback to support the development of a policy. We also launched
a major review on the issue of multiple births and embryo transfer and convened a working
group of clinicians, patients, PCTs, neonatologists and international experts to develop policy
proposals for the authority. These issues will subsequently be consulted upon.
We have actively collaborated with the newly established Human Tissue Authority over the year
including setting up joint working and providing services to HTA where appropriate.
All this has been achieved by prudent resource management and within the monetary and
headcount reductions required by the Department of Health Arms Length Body Review targets
for budgetary savings.
HFEA staff and authority members have been at the heart of delivering this very demanding
programme of work and we are very grateful to them for their dedication and hard work in
helping the HFEA improve further in regulating fertility treatment and embryo research in the
UK.

Suzi Leather Angela McNab
Chair Chief Executive
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Management Commentary
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
The 1990 Human Fertilisation and Embryology Act 1990 (HFE Act) provides for the regulation of
centres offering assisted conception involving the manipulation of sperm, eggs or embryos
outside the human body (e.g. In Vitro Fertilisation –IVF, Donor Insemination - DI), the storage of
sperm, eggs or embryos and research involving human embryos. The HFEA aims to safeguard
the interests of patients, children, the wider public and future generations, and will:
(cid:120) Provide efficient, effective, economic and fair regulation of centres to promote good
practice and maintain the highest ethical standards of patient safety
(cid:120) Provide centres with clear and comprehensive guidance to promote high standards in the
services they offer
(cid:120) Provide relevant information and advice to centres, people receiving treatment services,
gamete and embryo donors and members of the public in an open and accessible way
(cid:120) Assist centres to tackle and resolve any difficulties which may arise in relation to patient
safety and care, and to ethical procedures
(cid:120) Identify the ethical and social implications of developments in research and treatment
and to develop policy accordingly
The statutory responsibilities of the HFEA are to:
(cid:120) License and monitor clinics carrying out IVF and DI
(cid:120) Regulate storage of eggs, sperm and embryos
(cid:120) Provide information and data about the services, treatments and techniques that clinics
provide
(cid:120) Keep a register of treatments to enable people born as a result of IVF or DI to obtain
information about their origins
(cid:120) License embryo research to ensure science can progress in a responsible way
(cid:120) Advise government on all aspects of assisted reproductive technology
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(cid:120) Produce a Code of Practice to help clinics comply with the requirements of the HFE Act
(cid:120) Publicise the services the HFEA provides
Current position/context
The HFEA continues to operate in a fast moving, complex and ethically challenging area of
science, with a very high level of public interest in its activities. The organisation is constantly in
the media spotlight and is continually required to adapt to changes in the external environment.
The policies developed take into account the disparate and often conflicting view of the public.
The organisation recognises the importance of engaging well with a range of stakeholders and
with the fertility sector itself. Maintaining public confidence in fertility treatment and embryo
research are paramount and ensuring safety for patients, embryos and children born as a result
of Assisted Reproductive Technologies (ART).
The HFEA leads the establishment of the European Assisted Conception Consortium (EACC) to
bring about closer international links between ART regulation and service providers in
anticipation of and preparation for the European Tissue and Cells Directive (EUTCD).
The Directive extends the HFEA’s remit to include the regulation of all treatments involving the
use of human gametes, such as IUI, for example. It will reinforce the need to focus on a quality
system approach for clinics.
During 2006, as the government conducts its review of the regulation of infertility treatment and
embryo research, the need to ensure that the patient’s voice is heard is more important than
ever. The HFEA has a prominent role in this.
The organisation has demonstrated how well it has adapted to changing expectations over the
years and is now taking a rigorous approach to the requirements of the Department of Health’s
Arms Length Body Review agenda, specifically more targeted, proportionate and risk-based
regulation, which can be demonstrated in the following achievements within the regulation
function during 2005/06.
Longer term goals
The following goals are contained within the Authority’s Strategic Plan for the next five years as
follows:
(cid:120) Strengthening our regulatory role
(cid:120) Being an open organisation through excellent communication and working in partnership
with stakeholders
(cid:120) Working closely with other regulators and international agencies
(cid:120) Strengthening the process of policy development
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(cid:120) Developing an information base, which meets the needs of the offspring, stakeholders
and the wider regulation and public health functions, and supports the delivery of
services to required standards
(cid:120) Supporting the development of research in assisted conception and its application
(cid:120) Developing an organisation that will fulfil these goals supported by strong corporate
governance
Ministerial performance targets for 2005/06
(cid:120) A continued rigorous approach to inspection and regulation, including the development
and implementation of a risk-based inspection process
(cid:120) Completion of the Register Project, including the Historic Audit (verifying HFEA register
data against information held in clinic records) by 31 March 2006
(cid:120) Preparation for the implementation of the requirements of the EUTCD
(cid:120) The development of arrangements with the Human Tissue Authority (HTA), including the
provision of back office functions and systems that can be easily integrated on the
establishment of the Regulatory Authority for Tissues and Embryos (RATE)
Meeting Key Challenges
The HFEA delivered on all its 2005/06 business plan activities and below are selected
achievements under each objective:
Continue with the HFEA’s strategic modernisation drive, to provide more
proportionate, cost effective, efficient, targeted and streamlined regulation.
(cid:120) Fully implemented a risk-based approach to licensing, inspection and incident
management, which will ensure that centres performing well against the Code of Practice
receive less intervention
(cid:120) Engaged with the fertility sector by setting up a consultative Licensed Centres Panel,
composed of staff from clinics, which met twice during the year
(cid:120) Carried out a fundamental review to streamline the inspection process, incorporating all
changes suggested by the Licensed Centres Panel which resulted in a 20% efficiency
saving in the type and number of information requests to centres as part of the inspection
process
(cid:120) Improved information and training for Persons Responsible for licensed clinics and
introduced more rigorous assessment of applicants
(cid:120) Strengthened the independence, accountability and consistency of inspection by
recruiting and training a team of full-time inspectors to develop greater in-house expertise
(cid:120) Produced thematic reports on centres’ performance and developed pre-inspection
analysis to ensure more focused inspections
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