Select Committee on Science and Technology Fifth Report


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".[380] 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.[381] 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
Cycles Population Cycles/

million

ART deliveries ART infants National births ART infants (%)
Denmark 9,6825.29 1,8302,457 2,45767,081 3.7
Finland 7,4895.18 1,4461,184 1,29356,742 2.3
France 56,75459.08 9618,357 10,334744,791 1.4
Iceland 3640.28 1,300102 1664,315 3.8
Netherlands 15,06215.93 946N/A N/A
Norway 4,3404.47 971860 1,22359,234 2.1
Sweden 9,2058.87 1,0381854 2,25390,441 2.5
Switzerland 4,6447.21 644783 80978,458 1.0
UK 34,63459.76 5805,553 7,677679,029 1.1
All 142,174166.07 856

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.[382] 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".[383] 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".[384] 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.

Success rates

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.[385] 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.[386] 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.[387] 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 bottom".[388] 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.[389]

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 results".[390] 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.[391] 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.[392]

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.[393] 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.

INTERNATIONAL COMPARISONS

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.[394] 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.[395]Table 16: Number of embryos needed to achieve a live birth across Europe.
Country Number of Embryos
Iceland 5.6
Finland 6.2
Sweden 7.1
Norway 8
Denmark 8.5
Europe 9.6
UK 10.6

Source: see Arne Sunde

297. Despite 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".[396] 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". [397]

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 and organised".[398] He suggested that "there is a good case for making economic incentives rather than raising regulatory hurdles if you want to improve treatment".[399] 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".[400] 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.[401] 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 standards.

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[…]A strict law and strict regulation is not necessarily beneficial in this respect".[402]

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.

NICE Guidelines

302. The National Institute for Clinical Excellence (NICE) published guidelines on Fertility: assessment and treatment for people with fertility problems in February 2004.[403] 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.[404]
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 recommendations.[405]


380   para2.4 Back

381   HCDeb,26Jan2005,Cols96WH-115WH Back

382   MedicalResearchCouncil:Assistedreproduction:asafe,soundfuture,2004 Back

383   Ev367 Back

384   Ev428 Back

385   Ev377 Back

386   Q4 Back

387   NICE,Fertilityassessmentandtreatmentforpeoplewithfertilityproblems,February2004 Back

388   Q26 Back

389   Ev398 Back

390   Q12 Back

391   Qq4-7,12,14 Back

392   Ev425 Back

393   Ev377;seealsopara269 Back

394   Q1175 Back

395   Q1286 Back

396   RoyalCollegeofObstetriciansandGynaecologists,ClinicalStandards:AdviceonPlanningtheServiceinObstetricsandGynaecology,July2002 Back

397  Q1176 Back

398  Ev372 Back

399  Asabove Back

400  Q1212 Back

401  Ev369 Back

402  PresentationtoRoyalCollegeofObstetriciansandGynaecologists,8October200Back

403  ClinicalGuideline11,February2004,DevelopedbytheNationalCollaboratingCentreforWomen'sandChildren'sHealth Back

404   "HealthSecretarywelcomesnewfertilityguidance",DepartmentofHealthpressrelease2004/0069,25February2004 Back

405   HCDeb,26January2005,Cols96WH-115WH;NHSFundedIVF:IsItReallySoNiceOutThere?,DrBrianLieberman,StMary'sHospital,Manchester,BioNews,14February2005 Back


 
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