6 Provision of infertility services |
291. There has been a rapid growth in the number
of people in the UK seeking assisted conception since the HFE
Act was passed. The HFEA reported in 2000 that 50,000 babies had
been born using IVF since 1978 and that a third of these had been
in the previous three years. The Warnock Committee decided against
considering this approach in the light of increases in world population
as "the number of children born as a result of techniques
to assist in the treatment of infertility will always be insignificant
in comparison with the naturally increasing population".
Given that population growth in developed countries, where most
IVF, is undertaken, is modest, this seems a reasonable position,
although it should be noted that in some countries IVF accounts
for more than 3% of live births (see Table 15). Despite being
responsible for the first IVF birth, the UK is by no means a leader
in its provision. Figures from abroad suggest that demand will
become greater as a result of the NICE guidelines since IVF is
responsible for a higher proportion of babies born where there
is widespread state funding.
Table 13 provides figures for the rest of Europe.Table
15: Assisted reproduction in 2000 in those European countries
where all clinics reported to the national register
||ART infants (%)
Number of reported cycles, deliveries and infants
in relation to the population and the national number of live
born. ART = assisted reproduction technologies.
The fertility "industry"
292. While 75% of UK IVF provision is currently in
the private sector, this can give a slightly misleading impression,
since some IVF patients in the NHS are self-funded and some centres
in the private sector offer treatment at similar rates to the
NHS. In addition, some primary care trusts (PCTs) have contracts
with private sector clinics. In 2000-01 there were about 25,000
ART treatment cycles in the UK, each costing between £2000-£5000
per cycle. Professor
Margaret Brazier from Manchester University argues in her written
evidence that regulation should be extended to cover the market
in infertility services: "Fertility treatment is a highly
lucrative business. Patients/clients are willing to mortgage their
homes, forfeit their lifesavings and borrow thousands of pounds.
Just as financial services such as pensions and life insurance
need specialist regulation so does the fertility industry".
The Department of Health has rejected a role for the HFEA here,
declaring that "the Government does not see the role of the
HFEA as being that of a financial regulator".
We have heard
concerns that some of the services being offered to patients in
IVF clinics are not justified by evidence of their value. We believe
that clinics, private and NHS, must make it clear when they are
offering services and treatments that lie outside the NICE guidelines.
Practitioners need to be aware that their patients are desperate
for a child and vulnerable to exploitation. We recommend that
the Healthcare Commission prioritise its activities in this area.
293. Section 8 of the HFE Act 1990 obliges the HFEA
to provide information to the public about 'services provided
in pursuance of a licence' and to provide information and advice
to persons who are receiving treatment services'. The HFEA has
taken this to include outcome data from all licensed clinics.
The professional bodies have been critical of the policy. Dr Richard
Kennedy from the British Fertility Society argued that IVF procedures
were standardised in Western Europe and North America and cited
evidence from the US that concluded that the single most important
factor was variation among the patients rather than differences
in individual practices.
We heard during our visit to Guy's and St Thomas' Hospital that
it had three PCT contracts yet despite the fact that all patients
received the same treatment, there were significant differences
in the success rates for each contract. It is well established
that maternal age is a major factor in the success rate and cultural
and financial factors may have a bearing in the age at which infertility
treatment is sought.
Dr Sue Avery of the Association of Clinical Embryologists told
us that the results from the vast majority of clinics are not
statistically different from each other, but that "You have
outliers at the top and the other concern is the outliers at the
Professor Alison Murdoch, Chair of the British Fertility Society,
has expressed concern that the league tables that were inevitably
produced created competition between clinics which was not conducive
to collaborative clinical trials.
294. However undesirable Dr Richard Kennedy, Secretary
of the British Fertility Society, thinks it is for league tables
to be published, it will take place and as Dr Simon Thornton from
the Park Hospital in Nottingham told us, "One of the main
issues that patients do look at when they are selecting clinics
- both in the independent sector and in the state sector - are
The important issue is that patients are not misled by the information
presented to them and it is presented in such a way as to drive
good practice rather than bad practice, as Dr Kennedy suggests
they do at present.
We see a clear role for the regulator in providing useful data
that help patients make choices. If all clinics were the same
then we could understand Dr Kennedy's argument, but the presence
of "outliers" in the data does not bear him out. Furthermore,
we fail to see any merit in withholding this information from
patients. The British Fertility Society should share everyone's
concern that some centres are not performing and not seek to protect
them. Robert Winston, Professor of Fertility Studies at Imperial
College, London is concerned that the HFEA seems to have no explanation
for why some centres are obtaining very good results ("is
this because some clinics are giving untruthful statements or
because some clinics are surprisingly skilful at what they do?")
and why others are much worse.
295. The HFEA has made a welcome recognition of the
concerns of professionals and set up a Clinical Information Working
Group, consisting of representatives from centres, the professional
bodies, patients and counsellors. This group decided that publishing
outcome data should be continued, but that a single unified comparator
(a 'success rate') should not be calculated for 2004 because it
would reflect the wide range of embryo transfer practice before
the introduction of the two embryo transfer policy.
The issue to be resolved is
not whether there should be league tables but how to ensure that
the data are sound and provide useful information to patients.
Not all of the factors that influence the success of IVF are clearly
understood but we see an important role for the regulator in developing
metrics. We welcome the HFEA's work on developing better comparators
but it should resist publication of success rates for different
clinics until it is satisfied that they are not misleading.
296. Table 16 shows the number of transferred embryos
needed to achieve a live birth using data from the European Society
of Human Reproduction and Embryology's European IVF Monitoring
programme. This measure is commonly used as a "parameter
of excellence". It shows that despite having tight regulatory
regime, IVF in the UK is not the market leader. One can argue
whether live births per embryo transfer would be a more meaningful
measure or that the data from other countries may not be complete.
However, the picture may be slightly misleading since it would
be reasonable to expect larger clinics to have better success
rates (since they would have a greater body of expertise and ability
to train staff) and the UK may have a larger number of small clinics
by virtue of the fewer number of cycles being undertaken. We have
also heard that the inconsistency of reporting standards and criteria
vary across Europe, but the overall picture, particularly in relation
to the Nordic countries, is undeniable.Table
16: Number of embryos needed to achieve a live birth across Europe.
||Number of Embryos
Source: see Arne Sunde
being a pioneer in IVF, the UK lags behind many of its European
neighbours in quality of the treatment it offers. We believe that,
while regulation is not necessarily an appropriate tool to improve
standards, the Healthcare Commission has a role in identifying
the reasons why some other countries perform better than we do
as a means of underpinning changes in UK practice.
298. We have concluded that one of the most important
rationales for the regulation is the protection of the patient.
This has two inter-related, elements to it: protection from dishonest
practitioners and unsafe procedures; and promotion of the highest
clinical standards. In other words, eliminating the bad and promoting
the good. While there is a danger that undue attention is given
to the first of these, it is not clear what regulation can do
to promote best practice. The RCOG defines clinical standards
as "standards of clinical care which the College would expect
units and hospitals to adopt in relation to the quality of patient
services, training opportunities and participation in national
data gathering of relevance to clinical accountability and effectiveness".
Dr Kennedy told us that "it is up to the professional bodies,
such as the Royal Colleges and other professional organisations,
to ensure that the clinical standards and laboratory standards
of practice are such that they strive to produce the highest standards
of care and the best possible results of practice". 
299. National comparisons paint only a crude picture
of the state of assisted reproduction across Europe, not least
because of the variation that is likely to exist within countries.
It is reasonable, however, to ask what external mechanisms could
be employed to close this perceived gap. Dr Arne Sunde, Chairman
of the European Society of Human Reproduction and Embryology,
told us that "you cannot use regulation to achieve excellence.
Regulations can of course determine what type of treatment is
available, prevent the worst cases of malpractice, and define
a minimum standard of treatment. To discover the reason for the
relative success in countries like Belgium and the Nordic countries,
you will have to look at the way infertility treatment is funded
He suggested that "there is a good case for making economic
incentives rather than raising regulatory hurdles if you want
to improve treatment".
An alternative perspective is to look at what regulation might
be doing to obstruct the promotion of good practice. It is hard
to find examples of where the HFEA has been obstructive. Professor
Allan Templeton said that there had been "inappropriate inhibitions"
on egg freezing but that in general the response to new techniques
has "been fair and has been balanced".
This is not the same as saying that the regulatory environment
is conducive to the introduction and spread of good practice.
The Code of Practice has become the practitioner's "bible"
prompting concerns that by being provided with such explicit guidance,
the profession has become passive in its outlook, waiting to be
told what to do. Another perspective is provided by the RCOG,
which suggests that Code has strayed further into technical matters
to fill a void left by the professional bodies.
These are not mutually exclusive concerns. It seems likely that
in this new area of medicine, assisted reproduction practitioners
initially lacked the confidence to push forward change in what
was, and still is, a controversial area. The HFEA, in turn, was
only too keen fill the gap, and thus inhibited the profession
from developing a proactive approach to best practice. There are
welcome signs that this is changing. The HFEA has asked the British
Fertility Society and the Association of Clinical Embryologists
to develop technical standards as a basis for accreditation and
comprehensive draft standards have now been drawn up. We
welcome the increased responsibility taken by professional bodies
to draw up and maintain guidelines on clinical and laboratory
300. One should be cautious in drawing a link between
the regulatory regime and the standard of medical practice, since
cultural differences between patients and the medical professions
could contribute to perceived differences. However, the UK has
tighter regulation than many other countries and yet it appears
to have failed to match the best practice of neighbouring countries.
Of the Scandinavian countries only in Sweden is the practice of
single embryo transfer formally promoted through regulation. According
to Dr Arne Sunde from the University of Trondheim and Chairman
of ESHRE, "To my opinion, there is a correlation between
success parameters and the legal situation in the country[
strict law and strict regulation is not necessarily beneficial
in this respect".
301. This does not necessarily reflect badly on the
HFEA. Nowhere in the HFE Act does it indicate explicitly that
the Authority should work to improve clinical standards. Section
8(c) states that the HFEA should "provide, to such extent
as it considers appropriate, advice and information for persons
to whom licences apply" and Section 25(1) stipulates that
its Code of Practice should give "guidance about the proper
conduct of activities carried on in pursuance of a licence".
It could be argued, however, that the Authority's obligation to
consider the welfare of the child should require it to promote
the highest medical standards. As we discussed above, in Finland
the move to single embryo transfer has occurred without direction
from a regulator or funder. In these cases practitioners, possibly
responding to the well-informed demands from their patients, have
taken the decision themselves. In the UK too, it is possible that
the professional bodies could have encouraged further change unilaterally.
The reasons for their failure to do so may be complex but it may
be attributable to the culture that has developed in an emerging
sub-specialty as a result of the heavy regulatory burden and intense
public interest. Professionals took a passive role in setting
standards as everything that governed their practice was contained
in their "bible", i.e. the Code of Practice.
302. The National Institute for Clinical Excellence
(NICE) published guidelines on Fertility: assessment and treatment
for people with fertility problems in February 2004.
The report identified seven "key priorities for implementation",
and four of these relate to IVF provision (see Box 11). The first
of these, that within certain criteria, women should be offered
three cycles of IVF on the NHS, is the most significant. This
has clear resource implication and, in responding to the guidelines,
Secretary of State of Health John Reid, stated that he wanted
all PCTs to offer at least one cycle of treatment by April 2005
but that he wished the NHS to make progress towards full implementation
of the NICE guidelines.
|Box 11: NICE Guidelines on provision of in vitro fertilisation
o Couples in which the woman is aged 23-39 years at the time of treatment and who have an identified cause for their fertility problems (such as azoospermia or bilateral tubal occlusion) or who have infertility of at least 3 years' duration should be offered up to three stimulated cycles of in vitro fertilisation treatment.
o Human menopausal gonadotrophin, urinary follicle-stimulating hormone and recombinant follicle-stimulating hormone are equally effective in achieving a live birth when used following pituitary down-regulation as part of in vitro fertilisation treatment. Consideration should be given to minimising cost when prescribing.
o Couples should be informed that the chance of multiple pregnancy following in vitro fertilisation treatment depends on the number of embryos transferred per cycle of treatment. To balance the chance of a live birth and the risk of multiple pregnancy and its consequences, no more than two embryos should be transferred during any one cycle of in vitro fertilisation treatment.
o Embryos not transferred during a stimulated in vitro fertilisation treatment cycle may be suitable for freezing. If two or more embryos are frozen then they should be transferred before the next stimulated treatment cycle because this will minimise ovulation induction and egg collection, both of which carry risks for the woman and use more resources.
303. We welcome the more equitable availability of assisted reproduction
services and the promotion of best practice in this area by NICE.
Comment on the nature of the guidelines is beyond this inquiry
but there are implications for regulation. It has been estimated
that implementation of the NICE guidelines will result in an 80%
increase in the number of live births resulting from IVF (5,400
births) and substantial changes in the IVF industry. However,
we note concerns that many PCTs will not be able to meet the NICE
397 Q1176 Back
398 Ev372 Back
399 Asabove Back
400 Q1212 Back
401 Ev369 Back
402 PresentationtoRoyalCollegeofObstetriciansandGynaecologists,8October2004 Back
403 ClinicalGuideline11,February2004,DevelopedbytheNationalCollaboratingCentreforWomen'sandChildren'sHealth Back