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NICE Infertility Guidelines
2 pm
Mr. Kevin Barron (Rother Valley) (Lab): Through you, Mr. Deputy Speaker, I thank the Speaker for selecting this topic for debate this afternoon. Although there are not many Members present in the Chamber, the issue is one that concerns Members of both Houses. I shall put the debate in context by discussing what brought about the referral to the National Institute for Clinical Excellence and its guidelines as well as the work of the all-party group on infertility, of which I am chairman and of which some Opposition members are present.
I am sure that it is clear to many people in this House and outside that one in seven couples in the United Kingdom will experience problems conceiving at some point in their reproductive life. For about two thirds of them, the only way in which they will successfully conceive is through treatment consisting of either the use of ovulatory stimulatory drugs or techniques such as in vitro fertilisation—commonly known as IVF.
Unfortunately, although the World Health Organisation recognises infertility as a public health problem, the condition has not received public funding to allow those with fertility problems to receive treatment on the national health service as patients with other health problems do. As a result, about 80 per cent. of couples have to resort to paying for their own treatment, the cost of which can run to tens of thousands of pounds. Even in areas where funding is available, couples can be on a waiting list for years and might exceed the age limit before they receive treatment. I suspect from the evidence that I have received from my local primary care trust that in years to come there will be a increase in the age of people on the NHS waiting list, who cannot afford the option of turning to the private sector for treatment. Many people are forced into the private sector for treatment because of non-availability of the treatment on the NHS, although I accept that the Government are trying to make the system fairer than it was 12 months ago; I shall come on to the detail of that later.
The all-party group on infertility works closely with the National Infertility Awareness Campaign, which is an umbrella body formed in 1993 as a development of national fertility week. It was established with the support, which it continues to enjoy, of all the major infertility charities, patient support groups, most members of the medical profession dealing with the subject, and the pharmaceutical industry. I am not sure whether I should declare the fact that I also chair the all-party pharmaceutical industry group, although I have no pecuniary interest in that respect.
Most of us are generally dissatisfied with the level of infertility treatment that our constituents receive. I have been an MP for more than 20 years, and I have encountered about six cases in which I have sat with a couple who could not afford to go to the private sector as others can. I have shared both their disappointment with what was not happening in the national health service, and their disappointment as a result of wanting a family but, unlike many of us, being unable to have one without difficulty.
In November 2000, following pressure from NIAC, other stakeholders and, I suspect, from MPs, the Government asked NICE to produce clinical guidance
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on the treatment and management of infertility. The Secretary of State for Health at that time, my right hon. Friend the Member for Darlington (Mr. Milburn), made it plain in a Department of Health press release at that time that his aim was to ensure that
"infertile couples get fairer, faster access to clinically, cost-effective and appropriate treatments."
In May 2003, NIAC approached supportive parliamentarians for their assistance in setting up an all-party group on infertility, both to raise awareness in Parliament of infertility issues and to maintain pressure on the Government to drive forward implementation of the guideline. As I recall, the guidance was at that time in draft form but had been leaked to the press. Some extraordinary claims were made in the press—for example, that the guidance would cost up to £400 million—and some cancer charities were dragged into the debate, saying a choice would have to be made between infertility treatment or dealing with cancer. I thought that was a misguided debate and do not know how it reached the press, but as a consequence of that initial debate, the all-party group was formed.
At first, we put together a report with a group of experts working in the field of infertility in both the public and the private sectors. The report outlined the structures needed to meet the NICE recommendations in full and was timed to coincide with the guideline's publication. Exactly what NICE was likely to recommend in its final report was no secret after the first leak of the draft, and we and the specialist group concentrated on that. In particular, the report recommended ways to achieve cost savings in the investigation and treatment of infertility by streamlining procedures, avoiding the duplication of tests and treatment and reducing the numbers of embryos transferred.
The report also discussed concerns surrounding the commissioning of infertility services and the problems associated with that following the move towards specialised commissioning by primary care trust consortiums. The aim was to demonstrate to PCTs how the guideline recommendations could be met in the most cost-effective way—that refers to what the then Secretary of State said back in 2000. Copies were sent to all PCTs as well as to the Department of Health—my hon. Friend the Minister for Public Health will have received one—and since then the group has continued to raise awareness in Parliament of the plight of infertile couples and the need for speedy and full implementation of the guidance.
It might be useful to say what the key recommendations in the guidance were. They were, first, that all women should be screened for chlamydia before they undergo procedures to check whether their fallopian tubes are blocked; secondly, that women who have no history of problems with their fallopian tubes should be offered an X-ray to see if their tubes are blocked, rather than an invasive procedure; thirdly, that couples with unexplained infertility problems, slightly abnormal sperm count or mild endometriosis should be offered six cycles of intra-uterine insemination; and fourthly that couples where the woman is aged between 29 and 39 who have an identified cause of their fertility problems or unexplained fertility of at least three years' standing should be offered three cycles of stimulated IVF. Our report certainly looked at far more than just
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IVF, but I suppose that IVF took the lion's share of the debate because of its costs and the pressures on the health service to supply it. We might have been remiss in not looking at the guidance as a whole, because the focus is on IVF treatment issues and the deadline of April this year. However, there is a lot more in the guidance that I would have liked the NHS to address, but up to now, according to my information, it has not done so.
Mr. Andrew Lansley (South Cambridgeshire) (Con): I entirely endorse the right hon. Gentleman's remarks. However, does he agree that one reason that we have focused on the number of IVF cycles is because in some areas—my own constituency, for example—the policy prior to the NICE guidelines was essentially for there to be investigation of impaired fertility, but not to the point of going on to support assisted conception through the NHS? Very often, from the patient's point of view, they have been supported by the NHS up until, but not through, the assisted conception that would help them to give birth.
Mr. Barron : The hon. Gentleman is correct. Everybody knows that there were large areas of England and Wales where IVF was never offered—probably the only thing that was not. He makes a fair point: it is likely that people would have concentrated on IVF because, in some parts of the country, that was the piece of the jigsaw that was missing.
The guidelines that I have read out were published by NICE and form its key recommendations. I think that, to some extent, we took our eye off the key recommendations by concentrating on IVF. When the guidelines were published, the Secretary of State for Health, my right hon. Friend the Member for Hamilton, North and Bellshill (Dr. Reid), responded by announcing that
"As a first step, by April next year I want all PCTs, including those who at present provide no IVF treatment, to offer at least one full cycle of treatment to all those eligible."
Moreover, he added, the NHS was to
This was in the Department of Health press release of 25 February of that year.
My right hon. Friend's final comment seemed to be the only criterion that either the Government or NICE were saying was to be used. I always found that point strange. In my own constituency for many years, having a child living with them was one of the hurdles that the local health authority, as was, raised against people having IVF treatment. The child or children in question, however, might have been one of the partner's from a previous marriage or relationship. It was effectively a denial of a person's right to become a mother or a father through that technique. I do not want to use up today's debate on criteria, however, because we could go on for many hours about how criteria have had different impacts in areas throughout the United Kingdom.
Mr. Lansley : Although the hon. Gentleman said that that was one of the criteria that were related to the NICE guidelines, social criteria as such were outside the scope
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of the NICE guidelines. The only real guidelines in that respect were, for example, the clinical characteristics or the age of the woman, but not that social criterion.
Mr. Barron : That is correct. The Secretary of State is not with us, and the Minister for Public Health probably will not know the answer to this question, but it would be interesting to ask why that criterion was put in the Department of Health press release at that time. There were many others that could have been in there that would operate locally as well.
Although NIAC and the all-party group welcomed the Secretary of State's announcement as a starting point for full implementation, there was a degree of disappointment about the lack of any clear time frame for the remaining two IVF cycles to be put into place. As is now well-known, one cycle offers approximately a 25 per cent. chance of conceiving, compared with a 70 per cent. chance of success over the recommended three cycles. Waiting lists tend to consist of women who are getting near to the age cut-off, and my local PCT is saying that it will treat women who were under 40 when they started treatment until they are 42 years old, and then the cycles will be over. That is very important.
On 25 February, the same day that the announcement was made, I actually rose at Prime Minister's Question Time and asked him directly when he expected full implementation of the guidelines. He responded to me, saying that he hoped that
"over the next couple of years we shall see at least very substantial progress towards implementation of the full NICE guidelines".—[Official Report, 25 February 2004; Vol. 418, c. 278.]
Of course, "the next couple of years" is substantial progress from the Secretary of State's less forthcoming
That was also in the Secretary of State's press release of 25 February. That phrase, "in the longer term", was reiterated last year by my hon. Friend the Minister for Public Health when she addressed the June 2004 national infertility day conference.
It has been nearly a year since the NICE guidelines were published, and the PCTs should have the necessary structures in place by now to meet the April deadline for providing at least one full cycle of IVF to all eligible couples. I alluded earlier to the fact that I have kept in touch with what is happening in my locality, primarily through the good offices of Dr. John Radford at the Rotherham primary care trust, whom I have known for many years and who is leading on commissioning for a group of PCTs. Last week I received a draft paper that sets out the criteria for access to NHS-funded specialist fertility services for patients who are the responsibility of 13 primary care trusts. I am sure that this time last year I would have been very happy that people were looking at commissioning infertility services in that way, particularly in areas where there was no cover for issues such as IVF, as the hon. Member for South Cambridgeshire (Mr. Lansley) said earlier.
The 13 PCTs in question cover the North Derbyshire, South Yorkshire and Bassetlaw commissioning consortium—Bassetlaw being north Nottinghamshire from a geographical perspective. The consortium is
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known as NORCOM. Two of the PCTs cover my constituents in Rotherham. The paper sets out the draft minimum entitlement across the consortium to NHS in vitro fertilisation, intracytoplasmic sperm injection and intra-uterine insemination. There are currently significant differences between the NORCOM PCTs in respect of existing specialist fertility treatment policies, and phased introduction will be required to bring them all to one common policy. It is envisaged that each PCT will adopt at least the minimum eligibility criteria, and it is not intended that any of them will adopt a more restrictive policy than their current one. The present policy in Rotherham is to offer two cycles, so I am glad the consortium has addressed that issue. I have had anecdotal evidence, which I will not use in this debate, that there has been a reduction in the IVF treatment on offer. I would be interested to know if my hon. Friend the Minister has any evidence of that.
The NORCOM document continues:
"Initial investigation of patients is usually carried out by a network of specialist gynaecologists at District General Hospitals throughout the NORCOM area".
The report published by the all-party group on the day that the guidelines were published considered whether specialist centres were needed. I understand they operate in Scotland. I would be interested, if my hon. Friend has time today, to hear whether she thinks we should consider that option. The document continues:
"In any healthcare system there are limits set on what is available and on what people can expect. Primary Care Trusts are required to achieve financial balance; they have a complex task in balancing this with individuals' rights to health care. It is the purpose of the criteria set out here to make the limits on fertility treatment fair, clear and explicit. Nationally this is undertaken through the work of the National Institute for Clinical Excellence and this paper reflects this. The paper should be read in conjunction with the NICE Fertility Guidance.
"The NICE Guidance places NHS assisted fertility services firmly in the mainstream of NHS provision".
I think everyone, no matter where we are at this stage, should be pleased about that. I certainly am. The paper then states:
"Patients as a result will expect the NHS to provide this. This document includes recommendations for the first part of the phased introduction of the Guidance. Further phases of the implementation will be defined in the light of future Department of Health requirements and the prioritisation and availability of resources".
It goes on to list a series of criteria the that will be used in that commissioning area. What is interesting about the "mainstream" comment is that from now on, I assume, the PCTs in my area will be looking to central Government for direct guidance about what they should do next, and when they should do it. One issue has been dealt with, because it was centrally driven, so PCTs will expect direction from the centre on what should happen next and when.
In her speech to the national infertility day conference last year, the Minister said that the April deadline was "a starting point" to support PCTs in meeting the first stage of implementation and the subsequent implementation of the guidelines in full. The Department of Health agreed a broad programme of action last June, and last year the Minister answered
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parliamentary questions that I and other hon. Members tabled on this issue. Part of the programme was that the Government would
"look to strategic health authorities (SHAs) to work with PCTs to ensure that they have effective arrangements in place for the provision of services, to investigate the barriers to implementation of NICE guidelines and to help ensure that the barriers can be overcome."—[Official Report, 4 October 2004; Vol. 424, c. 1978W.]
The programme also included advice from NICE on the development of resource templates to enable PCTs to estimate the resources needed.
The Minister will realise that a number of key questions remain about PCTs' progress toward meeting the April deadline. In part, that is what this debate is about. Are PCTs being monitored, are strategic health authorities playing their part and are they and NICE providing assistance? Does NICE have a further role to play? NIAC and the all-party group are keen to learn what support the Government are providing to PCTs, given that no additional funding has been provided either to meet the April deadline or to assist with the implementation of the guideline in full. What will be the repercussions for PCTs that fail to meet the guidelines? That question is relevant at this stage in the countdown to April.
The next issue is the old chestnut of NHS waiting lists. Will there be action by the NHS centrally to measure and, we hope, reduce waiting lists for couples needing infertility treatment? Now that the Government have gone so far as to ask for the delivery of one IVF treatment cycle by this April as part of the start of implementation of the guidelines, we could not accept people having to be on waiting lists for months, if not years, to get that first IVF intervention. I would be grateful if the Minister had any comments on that.
It must not be forgotten that even if PCTs meet the deadline to provide at least one full cycle of IVF, there will still be postcode provision of infertility services in the United Kingdom. People in Scotland can access up to three cycles: I am led to believe that in the constituency of the Secretary of State for Health, for example, couples have been entitled to three cycles for a number of years. That is unlike the position in my area, although the position there is a vast improvement on that in some areas of England and Wales, in which there has been no offer of IVF treatment under any criteria for many years past.
Access to infertility treatment on the NHS is well known to be patchy—indeed, treatment by postcode remains an intolerable feature of the NHS. We called for the debate to stress to the Government the need for full implementation of the guideline to ensure that couples have access to the most effective treatment, regardless of where they live. Fair and equal access for all those with an established need is the only way to tackle the unacceptable postcode lottery of treatment.
It is crucial that the NICE recommendations are implemented as fully and as quickly as possible throughout the country to ensure fair and equal access for all. As the Secretary of State said last year, we cannot expect all areas, particularly those that have never
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offered any IVF treatment, to achieve that overnight. I think that we all accept that. However, 12 months have elapsed since publication of the NICE guideline. I hope that, by now, we are in a position to have an idea whether the 5 April deadline for the single IVF treatment cycle will be met and—given that we are now looking at implementing the second phase—an idea of the timetable for the second and third IVF intervention if other fertility services have failed the couples involved.
2.25 pm
Mr. Paul Burstow (Sutton and Cheam) (LD): I congratulate the right hon. Member for Rother Valley (Mr. Barron) on securing the debate. I share his disappointment that others cannot be present to take part in it, but I pay tribute to him for his work as chair of the all-party group on infertility and for giving us the opportunity to explore how far the Secretary of State's undertakings in respect of the NICE guidance have been implemented.
I would like clarification of the two phrases that were used by the Secretary of State and the Prime Minister: what is the difference between long term and substantial progress in the next couple of years? The debate should be about getting some idea of the timelines involved. The right hon. Gentleman posed some important questions that I want to take up; I also have a few questions of my own for the Minister.
The issue is charged with emotion; it is about the fundamental desire that very many of us have to have children. Infertility frustrates that desire, which is further frustrated if a person does not have the financial means necessary for private sector provision and as a result has to go on an NHS waiting list. Prior to the NICE guidelines, about 70 to 80 per cent. of couples paid for private treatment. It is not long since the NICE guidelines were published and the Secretary of State expressed the desire that at least one cycle of IVF be available to couples in each PCT area. Can the Minister say how much she expects that to change? Will there be a reduction in the number of couples who will need to pay privately to have the treatment as a result of the guidance being implemented?
The right hon. Gentleman has already given some of the figures but it is worth repeating one or two of them: approximately one in seven couples in the UK need help in conceiving a child and rely on treatment, either ovarian stimulatory drugs or IVF. Figures available up to 2001, supplied to my hon. Friend the Member for Shrewsbury and Atcham (Mr. Marsden) in June last year, suggested that 28,076 patients had received IVF in that year, which was an improvement on 1997, and that 2,718 had received donor insemination in the UK, which was down from 1997. It puzzles me that more up-to-date figures than those for 2001 are not available. I hope that the Minister can shed further light on the matter and update the figures, so that we can see what progress has been made.
The NICE recommendations have been described in detail by the right hon. Gentleman, who is absolutely right to draw attention to the fact that most press reporting of those guidelines and the Secretary of State's response to them tended to dwell more on the number of cycles of IVF than on other aspects of the guidance. It is right to reflect that the guidelines referred to a host of
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other issues, not least that of screening, which is an important safeguard. At the time, the chief executive of NICE said:
"Implementation of our guidance will take time. We have therefore suggested to the Department of Health and Welsh Assembly Government that they consider giving advice to NHS organisations on how they should approach putting our recommendations into practice."
The debate is about the Secretary of State's advice and to what extent it should be just that; should it be about social considerations and how they affect the criteria formulated by the PCTs in framing their approach to implementing the NICE guidance? The Secretary of State said on 25 February:
"As a first step, by April next year I want all PCTs, including those who at present provide no IVF treatment, to offer at least one full cycle of treatment to all those eligible."
The Minister later emphasised that that is the starting point. However, it is not clear from anything that has been published or said to date what the subsequent steps will be. What is the timeline for getting us from where we are now, which is patchy provision of IVF and of NHS fertility services generally, to the ideal that the NICE guidelines set out? What progress has been made in achieving that first step?
Mr. Lansley : I rise to endorse the hon. Gentleman's argument. The NICE guidelines said that there should be implementation resource assessments and that a timeline should be established by PCTs. However, on what basis did the Secretary of State intervene to say that the assessments had to be conducted by means of focusing on delivering one cycle of IVF by April 2005, with no target date thereafter? Was there not a case for saying that progress should be made, but giving every PCT the obligation to set out by some point how it would implement the guidelines in full?
Mr. Burstow : I agree entirely. It would be wrong of PCTs to interpret the Secretary of State's comments in last year's press release as relieving them of their obligation to set out their plans for implementing the NICE guidelines. I hope that the Healthcare Commission will look carefully and critically at the extent to which PCTs have done that. It should also evaluate whether the April deadline in the arbitrary timetable set out by the Secretary of State is a sufficient response to the NICE guidelines.
I will go one step further and say that it would be useful if the Minister confirmed the status of the Secretary of State's statement. Does it have any formal force in terms of what PCTs should be doing? In particular, what is the status of his comment about giving
Surely in an NHS where the balance of power is shifted to local providers to make decisions of that sort, the Secretary of State should not give that sort of instruction, or implied instruction, to the NHS.
There are a number of concerns about the Secretary of State's recommendations, some of which the right hon. Member for Rother Valley itemised. First, the
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NICE guidelines come with a price tag attached, but exactly how much will they cost to implement? No additional resources were provided to allow the services to be developed; it is therefore incumbent on the Government to set out how they will assist PCTs and how they expect PCTs to plan for the implementation—not what they should do, but the mechanisms that they might wish to follow.
As the right hon. Gentleman said, the anecdotal evidence seems to point to a timeline that runs at least six years into the future. It would be useful if the Minister said whether that is a realistic assessment of how long it will take to implement the NICE guidelines fully. In answer to the right hon. Gentleman's question, the Prime Minister said that it would be a couple of years before we saw substantial progress. Yet when one looks at the NHS figures between 1997 and 2001, one sees that although the number of women having access to a cycle of IVF increased, the average number of cycles per woman decreased, and some people are concerned that access to more than one cycle will decrease further. The PCTs that already offer access to more than one cycle will take the opportunity of following the Secretary of State's advice from last year to level down, rather than to maintain their service at its current level. It is therefore important to monitor the situation at local level to ensure that that does not happen. As the right hon. Gentleman said, there is a 25 per cent. success rate from one cycle, but that rises to 70 per cent. with three.
I believe that Lord Winston expressed some concerns about the policy of offering one cycle, describing it as "half-baked" due to the financial and emotional costs of investigating whether a couple is suitable for treatment. There is a huge emotional commitment to going down that road, yet after making that commitment couples could be told, "You've had your one chance," even if they are reaching the age where they will no longer be able to gain access to the treatment. Infertility treatment is a huge investment for a couple, which is more than just financial.
There is also concern about specialised commissioning—tertiary commissioning and tertiary fertility services—and to what extent the roll-out of such commissioning is occurring. There is concern that the still patchy nature across the country of PCTs engaging with specialised commissioning will again slow the process of implementing the NICE guidelines. I would welcome the Minister's comments on that matter.
Can the Minister say whether the Department has assessed the cost of implementing the NICE guidelines in full? I should be surprised and stunned if the Department had not made some assessment. Does the hon. Lady plan to share the Department's figures with us? I hope that she does. Is the figure of about £50 million, which was the assessment made by the all-party group, a realistic assessment of the true cost of full implementation throughout the country? What discussions have taken place with Scottish Ministers, who are already supporting a three-cycle policy in Scotland?
There are financial pressures in the NHS; we need only read the Health Service Journal from one week to the next to learn about those pressures and their consequences. At present, there is a £500 million deficit in the NHS, which I am sure will disappear magically by 31 March until 1 April of the following financial year.
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However, there is a real financial problem that the PCTs must grapple with. They have to find the resources to achieve the targets that are set by Whitehall, and everything else for which there is no target becomes a lesser priority. The NICE infertility treatment guidelines might fall into the second category, and we doubt whether the necessary resources will be delivered.
As we have heard, the anecdotal evidence suggests that progress is patchy. There are concerns that having one IVF cycle as a first step will give a green light to some PCTs to reduce the number of cycles that they provide. I hope that the Minister can tell us today what the plan is beyond the first step, whether that plan is on course, and when it will deliver. Will it be in six years, or in a couple of years? There are thousands of people outside the House who want the answers to those questions because they matter to them and their lives.
2.39 pm
Mr. Andrew Lansley (South Cambridgeshire) (Con): I join the hon. Member for Sutton and Cheam (Mr. Burstow) in congratulating the right hon. Member for Rother Valley (Mr. Barron) on securing this debate. I also thank the right hon. Gentleman for the work that he has done as chair of the all-party group on infertility; as vice-chairman of that group, I have seen that work at close quarters and I know what a close and dedicated interest he has taken in the work of the group. He has also secured influence over the subject, which I hope is reflected in the context of the debate. I do not disagree with anything that has been said. However, I shall elaborate a little on some points and try to capture some of the questions that I am sure that the Minister is expecting to answer. I hope that there will be ample time for her to do that.
This debate is not the first occasion on which we have discussed infertility—indeed, the history of debates on the subject goes back further than the right hon. Gentleman took it. On 6 May 1998, the Minister's predecessor, the right hon. Member for Dulwich and West Norwood (Tessa Jowell), responded to an Adjournment debate in which I participated. Agreeing with the comments of my hon. Friend the Member for Meriden (Mrs. Spelman), I said
The then Minister said that the Government's policy objective was to ensure national consistency. At that point, it was intended to achieve that through national service frameworks and the National Institute for Clinical Excellence; subsequently, it has been done through NICE guidelines. We are therefore more than six and a half years past the point when the Government signalled their intention of getting rid of the postcode lottery for infertility treatment.
As the right hon. Gentleman said, the then Secretary of State for Health asked NICE to undertake the preparation of guidelines in November 2000. What happened then is a classic illustration of one of the key policy issues. While NICE was preparing the guidelines, there should have been a sense of what the developing consensus was likely to be, because work did not start from a blank sheet of paper: eminent bodies had already been examining the issue. Between November 2000 and February 2004, primary care trusts and others working
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in the field should have made themselves aware of what capacity would be needed to supply the infertility treatments that were likely to be recommended as both clinically effective and cost effective. That is what should happen when NICE does its work in future, but there is little evidence that it happened in the present case until the NICE guidelines were published in February 2004. NICE activity was a reason for there to be, in effect, planning blight in the system: services were not being developed. Therefore, in November 2000 the policy of some PCTs, including in my area was to provide assisted conception only in exceptional cases.
That illustrates something that has always depressed me since back in 1998, which is that the NHS is investing time, quality effort and resources into the investigation of infertility, but only those patients who are able to afford assisted conception are able to have treatment. That was certainly the case in my constituency, and my constituents justifiably regarded it as deeply unfair that they were unable to access assisted conception when in other parts of the country they would have been able to do so. We are trying to get rid of that. We want to establish a degree of consistency and a good standard of service. There is a special irony in relation to my constituency: the Bourn Hall clinic is in South Cambridgeshire. It is where the IVF treatment was conducted that led to the birth of the first test-tube baby, Louise Brown, in 1978. Bourn Hall was at the forefront of the provision of those services. It was deeply frustrating that people who lived in the same area as Bourn Hall could not access its services unless they were able to pay for them.
I am keen to achieve consistent delivery of infertility services. From time to time there are debates about the relative priority of IVF and infertility services. I have had them with constituents and colleagues in the House, and PCTs and health authorities have debated where the priority lies. Should resources go to infertility as distinct from other pressing health needs? Such judgments are always invidious.
We are now reaching the point where it can be seen that the job of the NHS is not simply to deal with the problems of physical ill health, but to achieve, wherever possible, a sense of well-being in the community and to promote positive public health. We should not underestimate the psychological and social harm that can result for couples who desperately want to have children but who are unable to do so. Equally, we should not underestimate the social benefit and enormous good that can result from enabling such people to have the opportunity of parenthood; the children would be loved and wanted. As it would depress us to discuss them, I will not go into the circumstances of unwanted children, children who are unloved by parents and not looked after by them, and the number of pregnancy terminations.
If the NHS should, for the reasons I mentioned, provide infertility services, what does it make sense to do? The question of providing one cycle of IVF was touched on by the hon. Member for Sutton and Cheam. The point of the debate is that NICE examined what was not only clinically effective, but cost effective for the NHS to provide. The evidence, which I do not think is disputed, shows that to provide three cycles of IVF broadly speaking gives one, in each of those first three cycles, a good chance of conception; The figures
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vary but let us say it is a 20 to 25 per cent. chance. That number falls off dramatically after three cycles. Subsequent cycles are much less likely to have a positive result. The same is true of age. Beyond a certain age—35—the chances of conception diminish; the balance that the NICE guidelines struck was 39. The same would also be true for body mass index. There are clinical criteria, so we can avoid the NHS pushing resources into the provision of treatments that have much less chance of success.
Having said that, the object of NICE was to produce a sound evidence basis on which treatment could be provided across the NHS. I hope that NICE will have the opportunity to do much more such work. Its work should establish a standard that patients, their clinicians and GPs should be able to access and that the NHS knows it should be gearing up to provide.
The hon. Gentleman was kind enough to allow me to intervene during his remarks to highlight something that happened in February 2004. There ought to have been a straightforward process: even if PCTs had not prepared for the NICE guidelines, at least in the subsequent local delivery plans they should have set out a process, which, according to the NICE guidelines in paragraph 3.1 would have been straightforward. PCTs would look at the template and set up the kind of implementation process that is required; in a local delivery plan, they would show their timetable for delivery of the service. Such a process does not require them to do it tomorrow, nor does it set a rigid timetable, but it would have enabled every PCT to be accountable for how and when it will deliver the standard. I cannot see what purpose was served by the Secretary of State intervening to say, "Oh, by April 2005 you should have delivered one cycle of IVF," but not giving any indication of what would happen thereafter or to what timetable it should happen. Would it not have been better simply to have said, "We know what standard we are aiming for"?
I hope that it is not true that some PCTs are reducing the service that they provide simply in order to meet the aim of providing one cycle of IVF. That is not true in my area because we are, in a sense, gaining services from a very low base. I also hope that the situation does not mean that there will be primary care trusts that make no provision and establish no plans to go beyond April 2005 and meet the NICE standard. The object is to meet that standard and to know when that will happen.
It would be instructive if the Minister could tell us precisely what steps the Department, or the strategic health authorities on behalf of the Department, will take to ensure that PCTs show how they will meet the standard. It is not clear, for example, how the Healthcare Commission will do that. It is to inspect against core standards only. The performance rating that the Healthcare Commission will construct for primary care trusts will reflect those core standards, but we do not know whether it will embrace developmental standards in 2005–06, and to what extent this particular aspect of NICE guidelines will be included in that. None of that is set out yet, and it is not in the Healthcare Commission's consultation, which is too vague to enable us to establish whether there is any requirement on PCTs to show how they will meet the guideline. Clearly, that is an area that needs to be considered.
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What we seek is an explanation of what the Secretary of State intended by his intervention in February 2004. We also want to know how the Department will achieve the delivery of services to the standard set out in the NICE guidelines, on which I hope we all agree. As I see it, there are two possible explanations why the Secretary of State referred to one cycle of IVF. The implication at the time was that it had to do with available capacity, not cost. Members of the all-party group had a number of discussions with those involved in the provision of infertility services; it seemed perfectly clear to me that although there are some capacity constraints, they are not such that they would require service provision to be restricted to one cycle of IVF. In many parts of the country, it would be perfectly possible to provide access to three cycles of IVF, and generally across the country we can scale up services to that level quite quickly. There is a passing difficulty associated with some of the smaller units, which might have been affected by the introduction of new European Union directives, which had implications for them, but they would reduce capacity only temporarily.
If the ability to access services is the problem, the Department can publish the evidence on which it based its judgment. If, however, the issue is not capacity, it must be cost. The hon. Gentleman asked about that. The all-party group looked into the costs and benefits associated with changes in infertility services, and we reached a conclusion that seemed balanced and reasonable to us. If the Department reached the same conclusion, it raises the question why one cycle of IVF was the constraint placed upon such services. In terms of expenditure and the reduction of cost to PCTs, that is much more drastic a constraint than would have resulted from dividing £50 million among 300 PCTs across the country. The sort of costs implied to PCTs were not so great.
The third point relating to the Secretary of State's intervention is where the additional social criterion came from. As the right hon. Member for Rother Valley said, it raises serious questions about the impact on couples if, for example, the children in the home are those of either partner's previous marriages or partnerships. It can therefore place mothers and fathers in a difficult situation in which they are deprived of their access to infertility services and their chance to be a father or mother by the application of a rather arbitrary criterion. Where did it come from and why was it necessary?
As everyone who has spoken in the debate has stressed, can the Minister say precisely how the Government envisage the timetable from now to the full implementation of the NICE guidelines? The review of the guidelines is probably due in about 2008. I hope that well before we reach that point, we will have had the chance to see how the standards are being met throughout the NHS and the benefits that are flowing from them, so that another review does not happen a few years down the line. We do not want to be here again debating why people are subject to a postcode lottery and, in particular, why expensive resources in the NHS are being used to support investigations and why only those who can afford it subsequently receive treatment.
I cannot tell hon. Members the number of times that I have been castigated by the Government, whose inaccurate view is that my party is somehow not
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concerned about access to services being based on need, rather than ability to pay. We believe in NHS services that are based on need. We are discussing an NHS service that is intended to be provided but which, at the moment for many people, is available only if they have the ability to pay. We know what service the NHS ought to provide. I hope that that will be achieved and that the Minister will tell us how and when.
2.57 pm
The Parliamentary Under-Secretary of State for Health (Miss Melanie Johnson) : It is with great pleasure that I rise to respond to my right hon. Friend the Member for Rother Valley (Mr. Barron) and to congratulate him on securing the debate. I recognise the work that he and the hon. Member for South Cambridgeshire (Mr. Lansley) have done with the all-party group and the progress that it has made.
In July 2001, we took the first step towards removing an historical postcode lottery, to which reference has been made by several hon. Members, by commissioning NICE to produce clinical guidelines. That was on the back of the establishment of NICE in 1999, which the hon. Member for South Cambridgeshire said had, at one time, caused planning blight as new developments were made. However, NICE has speeded up its work considerably, and the response of the NHS to the work undertaken through NICE is more accepting than it was when NICE was set up and in the years immediately afterwards. Progress has been made.
NICE worked with stakeholders in fertility matters. All the key organisations were involved, including NIAC, the British Fertility Society, Infertility Network UK and the Human Fertilisation and Embryology Authority. As hon. Members will know, the guidelines were published in February 2004. The Government, who commissioned the guidelines, obviously welcomed them. They are a useful tool by which to achieve consistency in the way that PCTs and health professionals approach the provision of fertility treatment, which means that wherever in the country they live patients will have some access to IVF. That will be a first. My right hon. Friend's constituency is at the upper end of the range of provision in that it currently makes two cycles available. It has done so for some time, whereas many other areas, such as the constituency of the hon. Member for South Cambridgeshire, have made no such provision.
The guidelines go wider than IVF, setting out the clinical side and the cost-effectiveness of a range of assisted reproduction treatments. NICE recognises that it is not feasible for the NHS to implement the guidelines in full immediately. It is, in fact, for PCTs, as hon. Members have noted, to build them into their plans, taking into account local population needs and health care priorities. We are aware of what is happening throughout the country. I will deal with one of the points raised—the stage that different areas have reached—and then come on to the detail of the monitoring arrangements. I will deal with the question of a reduction in existing provision.
Where existing provision is greater than one cycle—that is, two, as in the Rother Valley constituency—we expect provision to continue at least at that level. I have
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been informed of only one report that a PCT was reducing its provision. The Department wrote to the PCT concerned, which confirmed that it was not reducing the number of cycles. That is the only information I have pointing in the opposite direction; I can assure my right hon. Friend that that is the best information I have.
Mr. Barron : I am grateful for that. I thought that my information was anecdotal.
I am happy to listen to what my hon. Friend has to say about monitoring, but the issue for me is that the target for the first phase of implementing the guideline is now being set centrally. The likelihood of my PCT going from two to three cycles will depend on central targets from the NHS, as opposed to a service being provided locally because of patient need. Will there be a change in thinking inside PCTs? We are saying nationally that they must do x and y by April of this year.
Miss Johnson : Perhaps it is time to come to why we issued the guideline, to some of the other comments on that, and to what will happen beyond April 2005.
Mr. Burstow : If the PCT to which the Minister referred had written back saying that it was minded to reduce provision to one cycle, what would the Department have done?
Miss Johnson : Although there are no formal means of instruction, there are informal means of conveying messages. Strong messages would have been sent.
There are questions about the implementation of the guidelines. I will come on to monitoring, the structured arrangements surrounding that and the amount of contact that there has been.
First, the guidance covers an enormously sensitive subject. Infertility causes huge distress. Because of that and the historical postcode lottery, the Government felt that this was a worthy area on which NICE could produce a guidance, one with a commitment on implementation. The definition of infertility is given as a failure to conceive after regular unprotected sexual intercourse over two years, in the absence of a known problem. Implementation has priorities, such as screening for chlamydia and assessing tubal damage. Nobody mentioned chlamydia in the debate, but it is enormously important in this context, because it is increasingly causing infertility, and we are storing up a problem in the longer term. We must put the questions together—hence the huge investment in the whole area of sexual health and sexually transmitted infections.
There are six cycles of intra-uterine insemination for couples with mild male infertility problems, unexplained fertility or minimal to mild endometriosis. Contributions to the debate have mainly concentrated on the couples qualifying for up to three cycles of IVF. The guidance provides a consistency of approach across the health service. In welcoming that, we looked to PCTs to meet, by April this year, a national minimum provision of at least one cycle of IVF for those who meet the clinical criteria in the guidance. Our purpose was to put down a landmark to show that progress had begun to be made.
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My right hon. recently wrote to me on behalf of the all-party group, suggesting that the group's estimate of the costs involved was about £36 million. We believe, on the basis of the work done by NICE, that the cost of full implementation will be about £80 million. A number of Members have asked about the figures. They are already in the public domain; certainly, I wrote to my right hon. Friend about them.
Mr. Barron : Although we did not agree with the Department on the final figures, its final estimate was a great reduction on what had been suggested by the media, which said at one stage that the cost would be £400 million. Our figures take account of measures to avoid multiple births and how much they would save the national health service, and of the full range of infertility services, as opposed to the cost of IVF treatment, which everybody acknowledges is quite expensive.
Has the Department conducted any study on the overall costs of the guidelines—all the other treatment prior to IVF? Does that show that savings could be made? That was the issue in our report.
Miss Johnson : Not that I am aware of, but if that is incorrect, I will write to my right hon. Friend on the matter. I entirely accept the point: there has been a lot of investment in procedures to investigate a problem, without any follow-up for the remedy. There is no doubt that that is an issue.
Our costings are based on the best available estimates. It is difficult to work out what they will be because the costings per cycle range from £2,000 to £4,500. The investigation costs vary hugely, depending on the history and medical condition of each patient; a variable amount of money can be invested.
Mr. Lansley : Before we move away from the point, the Minister said when she began her explanation that it was not feasible to implement the NICE guidelines, and she has referred to the cost of doing so. However, as I mentioned, there is also the question whether there would be the capacity to achieve the standard of three cycles of IVF.
Is the Minister saying that implementing the guidelines is not feasible because that would cost £80 million, according to the Department's best estimate, or that, as the implication was at the time, the Government are prepared to accept the cost of implementation, but it is not feasible because the capacity is not available? Which is it?
Miss Johnson : I was talking about the practical, rather than monetary, feasibility. Different areas start from a different base; one of the issues in developing this policy is that some areas start from zero and others start from two cycles—some may start from three cycles, although I am not aware of any that do. Certainly, many areas have got to two cycles. That is a huge variation in the starting point, the numbers of people, the provision and, ultimately, the money and weighing-up of local priorities.
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Perhaps this is the time to say something about how this fits with local priorities and about the question of devolution versus guidelines and targets.
Miss Johnson : I would like to develop my argument, but I shall give way to the hon. Gentleman one more time.
Mr. Lansley : The Minister is generous with her time. The Department has a sense that the capacity does not exist. In South Cambridgeshire, a PCT was commissioning IVF treatments only in exceptional circumstances, but that was a question not of capacity—Bourn Hall has capacity; local providers have capacity—but of the treatment not being commissioned.
If the Department set a central minimum standard related to the capacity to deliver IVF treatments throughout the country, did it undertake an exercise, which we could see, that estimated what capacity would be available? The HFEA could have assisted with that, because it knows well, through its licensing process, what capacity is available. Is there such an exercise? Can we see it?
Miss Johnson : Advice on those matters would certainly have come to Ministers, but I am not sure that there is any formal report or study of the kind that the hon. Gentleman is looking for, or anything that would be published.
We expected PCTs to give priority to those in greatest need. Hon. Members have referred to couples with no children living with them and those who have children, or a child of one or other of the couple, living with them. It was felt that if PCTs had to prioritise, some help should be given to them on how to do that, and it was fairest to prioritise those who had no children living with them. Hon. Members can disagree with that if they want to, but we had to look at a difficult situation and make some difficult choices rather than leave PCTs without any advice from the centre about how they prioritised those choices. That is not to say that couples with children living with them are not to be considered at all. I am talking simply about a ranking of priorities and a reflection of advice to PCTs.
We rely on the NHS locally, through the PCTs, taking account of the needs of the local population and discussing proposals with patients and the public. That debate is happening in the context of the resources that are allocated to the health service rising to record levels, from £69 billion in 2004–05—the financial year just ending—to £92 billion in 2007–08. The sums that we have been discussing should therefore be seen in the context of a lot of extra money that is going to the health service. Overall, the national average increase over that time is nearly 31 per cent. in cash. There is a real-terms increase for Rotherham PCT of 6.5 per cent. in 2003–04, 7 per cent. in 2004–05 and 6.6 per cent. in 2005–06. That is only a sample, but it is typical and representative of the increases across the wider NHS.
My noble friend Lord Warner, who speaks on health matters in another place, wrote to the NHS on 14 June 2004 to set out a programme of action to support the implementation of the NICE guidance and set that in
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context with the Government's overall policy for national standards in the NHS. He made it clear that broad partnership in local health economies is needed to ensure that patients get access to the quality of care that is recommended by NICE. However, that entails strategic health authorities working with PCTs to ensure that they have effective arrangements in place, are investigating barriers to implementation and are making sure that those barriers can be overcome. Lord Warner's letter referred to the Department's consultation on national health care standards for the NHS in England, which is now published as "Standards for Better Health" and includes a standard for patients to receive effective treatment and care that conforms to nationally agreed best practice, particularly as defined in NICE guidance. There is a direct link between the NICE guidance, the standards for better health care and the work of the strategic health authorities.
In relation to the NORCOM consortium arrangements, I am delighted that there is a wide consortium of 13 PCTs in my right hon. Friend's area that has developed a local commissioning policy based on the NICE guidelines. We are pleased to see that sort of local co-operation and partnership. To some degree, such arrangements answer the point raised by the hon. Member for Sutton and Cheam (Mr. Burstow) about specialist commissioning and people working together across PCTs. There are a lot of specialist commissioning arrangements for different services, including infertility services: they are growing in sophistication and effectiveness and we welcome and encourage them.
What progress are PCTs making towards implementing the NICE fertility guidance? The NHS has needed time to take account of the guidance and draw up its plans, but we know that PCTs are working together. The evidence that we have says that they are working hard to implement the guidance and are focusing on moving in the right direction, for example, by offering one cycle of IVF where previously they offered none and maintaining services at least at the current level where they offer more than the minimum. If any hon. Member has anecdotal evidence to the contrary, we shall be happy to consider it, but we have no such evidence other than that which I mentioned earlier, which we investigated.
I agree that monitoring implementation is important. Overall, SHAs are responsible for overseeing PCTs' performance. If a PCT fails to implement the guideline, SHAs will explore the reasons and work with that trust to overcome the barriers. The independent Healthcare Commission, which reports directly to Parliament on the state of health care in England and Wales, will use the standards in assessing health care provision. The chief executive of the Healthcare Commission has confirmed that assessing the implementation of NICE guidance is one of the commission's priorities. It is currently consulting on the assessment process that it will apply.
I note that the NIAC is conducting a survey of PCTs, in partnership with the all-party group, I believe. We shall be interested to see the results of that survey. If barriers to implementation are identified, we shall bring them to the attention of the relevant SHAs. The basic principle is that PCTs, in liaison with local health bodies
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and patients' groups, take resources and priorities into account when deciding how best to implement the guidance.
On devolution versus standards and targets, I have to argue a little with the hon. Member for Sutton and Cheam. I am sure that his comments on the subject were entirely well meaning, but they were somewhat muddled. There cannot be complaints about instructions and, at the same time, complaints that we are not tackling the issues. We must balance the need to give guidance and advice, to steer and to provide frameworks that drive progress with local commissioning and local production of services. One could argue that giving instructions works against local commissioning, but local commissioning might lead to ongoing postcode lotteries if developments do not take place within the right framework. We must achieve the right balance between putting a framework in place and local decision making on priorities and how to achieve them. That is what we have sought to achieve.
I have already mentioned that we put the costs of full implementation at about £81 million. We know the standard that we are aiming for: to achieve full implementation of the NICE guidance. We recognise that PCTs are starting from different places, which means that we are not in a position to give a formal plan beyond this year, but I am sure that we shall consider that after this year's implementation phase. We shall be look to see what the future holds, but I am sure that there will still be some PCTs on two IVF cycles and others that have only just achieved one. We need to work on that and allow what are felt to be the most appropriate choices to be made in local health economies.
My right hon. asked about waiting lists and other hon. Members raised questions about sanctions. Before I address those points, however, I should like to say that our estimate of the effectiveness of cycles is slightly different from my right hon. Friend's. Our estimates are that the pregnancy rate is about 25 per cent. for one cycle of IVF, about 33 per cent. for two cycles and about 50 per cent. for three cycles, which is slightly lower than the figures he quoted. I am sure that the figures vary according to the population on which they are based. However, those figures are the best that we have and are the ones to which we are working.
The hon. Member for South Cambridgeshire is right to say that there comes a point at which there is a fast-diminishing return. That is something that NICE considered. Hard as it might be for many couples to accept, we must recognise the problem and the advice that NICE gave us.
Mr. Lansley : I am surprised by what the Minister said. The figures are curious, because they appear to imply that the second cycle of IVF is significantly less likely to secure a positive result than the third cycle. Broadly speaking, the first cycle is the most likely to secure a result, and there is a slightly diminishing likelihood of success in each of the two subsequent cycles. One can argue about whether the figure is 50 or 70 per cent. at the end of three cycles, and the estimates
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vary, but I cannot imagine why the Minister would argue that the second cycle has less prospect of success than the third.
Miss Johnson : I entirely understand the hon. Gentleman's point, but that was not what I was arguing. Those are the figures that I was given, and I am not in a position to argue the point further.
On monitoring and sanctions, the Government have two main methods of monitoring: through the Healthcare Commission and through the strategic health authorities. The Commission's developmental standard D2, which is set out in the consultation document, says that patients should
"to nationally agreed best practice, particularly as defined in National Service Frameworks, NICE guidance, national plans and agreed national guidance on service delivery".
That is the formal basis of the monitoring arrangements.
My right hon. Friend the Member for Rother Valley asked about waiting times. The NHS improvement plan has established a target of a maximum wait of 18 weeks from GP referral to the initiation of treatment, which is to be met by December 2008. That maximum waiting time refers to all GP referrals to hospital consultants, including in respect of fertility services. However, IVF is not usually the initial treatment referral made by the GP, and the need for it is usually diagnosed later, so it will usually take longer than 18 weeks from GP referral to IVF treatment. The same applies to other treatments that involve a series of investigations and prior treatments, so it is not true only of IVF. Once an individual patient has been diagnosed as needing IVF, however, it is intended that a guaranteed waiting time will be set for them, although the details are still being developed.
Mr. Barron : That seems to be a crucial point, because the chances of success of treatment of women with infertility problems diminishes with age. We do not want many of the women who are waiting for treatment at the upper end of the age scale falling off the waiting
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list because their birthdays have come along. Given that potential demographic problem, it is crucial that they are considered separately from the generality of NHS waiting lists.
Miss Johnson : I understand my right hon. Friend's point. When we came into government, waiting times in some cases were 18 months—and that was only for in-patient admissions, including the out-patient wait. Now, the process will last a maximum of 18 weeks from start to finish, and given that that is the maximum waiting period, some people will be coming in earlier. To hit our target, we shall probably need to hit about 10 to 12 weeks for most patients—we shall need to bulk them in the middle of the period to achieve the maximum wait target—so we shall be able to offer a substantial improvement across the board. In so far as it can, the strategy will encompass patients who are experiencing infertility problems and a number of other patients who have complicated diagnostic and treatment schedules.
The hon. Member for Sutton and Cheam asked about the need for private treatment. I find it difficult to answer his question, however, because we do not know how many people on NHS lists are already going for private treatment or will go for it at some point. It is very difficult to know how great the double-counting element is, and we do not necessarily have access to all the figures from the private sector.
On the number of people receiving treatment, the HFEA will fairly soon be updating the figures that the hon. Gentleman mentioned, which were from 2001. That follows work on its database of treatment services. It generates the figures, because it collates them nationally.
I think that that deals with all the points that have been raised. The debate has been useful and has raised useful issues. We are committed to an improvement in the services offered to infertile couples and particularly to progress towards full implementation of the NICE guidelines as soon as NHS services can achieve that. We are committed to ensuring that the implementation due in April 2005 takes place. We welcome feedback on issues or difficulties, which we shall take seriously, and we look forward to the channelling of some of our huge investment in the NHS into improvements to fertility services.
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