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Parliamentary briefing
Issue 2 - December 2005
- Infertility and its treatment ? a public concern
- Thousands affected in each constituency
- Protecting society, enabling science
- Providing confidence to patients through regulation and inspection
- Trusted source for NHS professionals
- Public concerns over safety
- Making regulation a benefit not a burden
- Looking to the future
- Upcoming events
- Infertility and its treatment ? a public concern
In the UK today, 1 in 7 couples have some problems in conceiving naturally. It may be twenty-seven years since the first IVF birth in this country but the issue remains at the forefront of public health. Infertility is the single biggest reason for women aged 20-45 going to see their GP, apart from pregnancy itself.
In 1991, Parliament established an independent regulator for the sector -from ensuring safety in treatment to permitting ground-breaking scientific research - the Human Fertilisation and Embryology Authority (HFEA).
The HFEA's remit covers the UK making it one of the few health bodies whose statutory role involves England, Wales, Scotland and Northern Ireland.
Doctors predict that health and social changes could lead to a rapid increase in demand and fertility treatment in the coming years, due to the trend for putting off pregnancy until later in life; an increase in obesity and the higher rate of sexually transmitted infections. Professor Bill Ledger from the Centre for Reproductive Medicine in Sheffield has said the UK will experience a ?fertility timebomb' within ten years.
The HFEA's role is to ensure safe and appropriate treatment in the 85 licensed clinics in the UK ? we have no role in scrutinising the level of provision of treatment. Even though assisted reproduction has been in existence for many decades and steps are being taken by Government to improve NHS availability, the provision of treatment on the NHS remains limited: roughly 20% is carried out by the public sector, with 80% in the private sector.
Rapid developments in science underline the need for a regulatory framework that protects society and reflects mainstream opinion while at the same time enabling the scientific community to continue groundbreaking research.
The HFEA recognises that the public are cautious over the long term consequences of IVF treatment and the ethics of embryo research. Parliament must set out the framework and the regulator must adhere to these principles to ensure that safeguards remain in place and freedoms are not abused by the scientific community. Striking a balance is key and the HFEA works hard to provide a dynamic research environment for researchers while taking heed of the public's views.
Thousands affected in each constituency
In an average constituency, roughly 10,000 couples will have concerns over their infertility. It is clearly growing as a health issue:- in 1991, almost 10,000 patients were treated in the UK resulting in the birth of 1,443 babies
- in 2004, nearly 30,000 patients went through the process of fertility treatment in the UK resulting in 8,000 babies
- Causes of infertility relate to both men and women. While many perceive that infertility is a ?woman's problem', male causes are identified in 49% of cases of infertility.
Patients have said that one of their biggest concerns is the need for clear, reliable independent information. In meeting this need, the HFEA recently produced the HFEA guide to infertility and directory of clinics 2005/06.
Empowering patients with straightforward information on the sector manages their expectations of treatment and gives them more confidence to ask informed questions and generally feel reassured.
The issue of most importance to patients is the chance of getting pregnant. The HFEA has published success rates for each of the 85 licensed clinics in the UK to give patients an accurate view of a clinic's overall performance.
Protecting society, enabling science
Making decisions to permit licences for research is a detailed process and the HFEA considers carefully each application it receives. There is detailed scrutiny to determine whether the research is necessary and desirable? factors which Parliament laid down as being central to permitting the research.
We have recently strengthened the process by increasing the number of internationally renowned experts that are called on during the peer review stage.
We have also reduced the time taken to assess each application?90% are now considered within four months of receiving the peer review. People's views on embryo research are finely balanced between those who believe the benefits outweigh the risks and those who hold the opposing view.
For science to progress, it must stay in step with the mainstream of public opinion. We recognise that the public should continue to play an important role so that our decisions are wellinformed and in line with the prevailing view in society.
During major policy reviews, we hold wide reaching consultations to ensure that people's views are taken into account. A key factor in explaining why we, in the UK, have been able to develop a fertile environment for embryo research is the public confidence in the system of regulation which we have had in place for more than fourteen years. This has been central in building a consensus that has allowed the UK to become a world leader in this area.
Research by MORI into public attitudes earlier this year shows that there is an engagement in research and its regulation:
on the positive side, we found that one in three people associate embryo research with finding cures for diseases or stem cell research.
They therefore recognise the benefits to society
in fact, the benefits are seen by 43% to outweigh the risks and 73% believe that embryo research can improve the quality of life for future generations with inherited disease.
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Providing confidence to patients through regulation and inspection
The HFEA has worked hard with fertility centres to establish a streamlined process that gives patients reassurance that fertility clinics meet the highest standards.
The focus is now firmly on risk. Examples of this include:
- there is a system of unannounced inspections to ensure that effective safeguards are in place on a consistent basis
- the Incident Alert System alerts all centres across the UK about any incident that HFEA investigations have identified as potentially compromising
- the safety of patients or clinic staff. This ensures all clinics can learn from best practice and minimise risk
- inspection reports are available to the public and feedback from patients is included as part of the inspection process.
This approach enables patients to be reassured about the standards of treatment and ensures consistency across the UK. The diversity of the sector - with the mix of public and private provision - means it is the job of the regulator to provide confidence for all patients going through treatment, irrespective of the financial considerations.
Trusted source for NHS professionals
MORI research earlier this year found that 80% of patients rely on GPs for infertility information. However, 2 out of 3 GPs said they felt they did not have enough information on the condition.
Therefore, reliable, verified information is essential for NHS professionals to provide guidance and enable clinicians to give better-informed advice to patients. We are working closely with GPs to ensure that they have sufficient information to help patients during consultations.
Reliable information is also required by bodies making NHS spending decisions. Primary Care Trusts benefit from information held by the HFEA on outcomes, treatment and research so there is an important role played by the regulator in meeting this need.
The HFEA is increasingly working with commissioners in assessing information requirements while ensuring the burden of information reporting is kept to a minimum for the clinics. NICE guidelines advise that up to three cycles of treatment should be made available on the NHS (to women aged 23-39) and we are ensuring that NHS commissioners have detailed and accurate information to use for their decision-making process regarding funding priorities.
Public concerns over safety
According to a recent survey by MORI, just under half (48%) of people say that consequences of treatment are unknown.
The HFEA's own online panel of patients ? Fertility Views, has revealed
some of the factors that reassure concerns over safety and build trust:
- regular inspection of fertility clinics was the most important factor in commanding confidence among patients in the UK (91%)
- three quarters of patients (75%) felt that producing effective information on fertility treatments was important in reassuring patients
- according to the HFEA's own research, just under 75% of patients felt that being able to read clinic inspection reports would lead to greater
- confidence in the UK fertility sector.
There are no doubts that the public need reassurance and effective regulation and reliable information is essential.
Making regulation a benefit not a burden
The HFEA has been working to ensure that clinics and patients benefit as much as possible from the regulatory process. We are focussing on those centres most needing improvement. This has been achieved through careful analysis of risk factors, striking a balance between well performing centres who receive a lighter touch style of regulation and those who merit more close and thorough inspection.
More effective use of HFEA held information, means that inspections are now less burdensome for clinics and inspection teams can spend their time more effectively during site visits by speaking to staff and patients. This gives a greater insight into the efficient running of a clinic and brings benefits to all concerned.
The more widespread use of Electronic Data Interchange means that information can be exchanged much more quickly and efficiently. Clinics across the UK will be adopting this system during 2006, which will improve the accuracy and quality of information and allow better feedback on performance?a crucial resource for all fertility centres bringing benefits to patients and clinicians.
Looking to the future
The fertility sector is about to undergo its biggest changes in two decades as the Government carries out a review of the Human Fertilisation and Embryology Act.
New legislation in the coming years must set a foundation for the sector for the next generation. This is a real opportunity for parliament to bring in a clearer and stronger framework, fit for the years to come.
Changes in the last decade in human reproductive technologies mean that regulation in this field has had to adapt to become more flexible, more responsive and more efficient. We believe that Parliament plays the most fundamental role in setting out the framework and boundaries to which we work and establishing a sound basis for regulating crucial areas such
as treatment and research.
We are confident that the work carried out by the HFEA since 1991 has been valuable in protecting the public, ensuring the highest standards of treatment for patients and encouraging a fertile environment for researchers ? we look forward to continuing this work and building on the foundations that were laid down in the UK twenty seven years ago.
Upcoming events
- The HFEA Open Authority Meeting will be held in central London 15 February 2006
- The HFEA Annual Conference will be held in central London 29 March 2006
Infertility - the real issues (638.22 Kb)
Issue 2 - December 2005
Freedom of Information