COMMITTEE FOR HEALTH, SOCIAL SERVICES AND PUBLIC SAFETY

Departmental Briefing on the Review of Fertility Services

26 March 2009

Members present for all or part of the proceedings:

Mrs Michelle O’Neill (Deputy Chairperson)
Mr Thomas Buchanan
Dr Kieran Deeny
Mr Alex Easton
Mr Tommy Gallagher
Mr Sam Gardiner
Mr John McCallister
Ms Sue Ramsey

Witnesses:

Mr David Galloway )
Dr Miriam McCarthy ) Department of Health, Social Services and Public Safety
Ms Margaret Rose McNaughton )

The Deputy Chairperson (Mrs O’Neill):

Members may recall that we decided to await the outcome of the consultation exercise before being briefed on fertility. The briefing paper from the Department and a press release about the Minister’s announcement of extra funding have been tabled for information. Members also have a copy of a newspaper article about the regional fertility clinic at the Royal Victoria Hospital.

I welcome Miriam McCarthy, the deputy secretary for healthcare policy, David Galloway, the director of secondary care, and Margaret Rose McNaughton, the principal of secondary care specialist services. I invite you to make your presentation, after which members will put questions to you.

Dr Miriam McCarthy (Department of Health, Social Services and Public Safety):

Thank you for inviting us. Given the Minister’s announcement of improved fertility services and additional investment, which has received a fair amount of media attention this morning, the timing is most appropriate.

If the Committee is content, I will provide a brief overview on fertility services, and Margaret Rose will advise on the recent consultation and its outcome. David will pick up on the specifics of today’s announcement. We will be brief in order to facilitate as many questions as possible from members.

I will start by highlighting the significance of fertility issues and infertility in Northern Ireland, and across the UK. The problem affects approximately one in seven couples. It is, therefore, a significant and fairly common problem. It is important not to underestimate the many difficulties that it causes for couples. It gives rise to a range of problems, some of which are psychological. The fear of fertility issues, or the knowledge of infertility, can cause great stress in families.

The problem is possibly increasing as couples tend to delay childbearing until later in life. Many couples now wait until their 30s rather than their 20s before having children. Women’s natural fertility decreases after the age of 35 and again after the age of 40. People who delay having a family are more likely to face a fertility problem and subsequently become highly frustrated at not being able to have children of their own.

We had no publicly-funded service prior to 2001 — anyone who wanted to access fertility services and specialised care had to pay for it. We considered that issue and recognised that it was inequitable. Arrangements were put in place to develop a publicly-funded service, initially on an interim basis. We also developed criteria for access at that time; again, that was initially done on an interim basis. Those arrangements were put in place without proper consideration and consultation, and, therefore, we progressed to full consultation pretty quickly.

The full consultation was a document called ‘From People to Parents’, which was issued in 2003. That consultation was extensive and involved a range of stakeholders. There were workshops with users and people who had suffered fertility problems, some of whom had had successful treatment and some of whom had adopted, fostered or accepted childlessness. They all had a positive input to the consultation, and their input was extremely valuable in shaping the service.

On the back of that, we were able to issue access criteria for consultation. One of the issues on which that access criteria focused was about information for people who had developed fertility problems. We recognised information as key and, indeed, an awful lot of people came forward and sighted the lack of information as a problem.

Counselling was another big issue that we discussed at that time. Counselling for people who attended specialist services was deemed to be necessary at the outset of service delivery; it was seen as often being necessary during the course of the service and at the end, particularly if the person had been unsuccessful in having a family. The consultation also raised other specific questions, such as who should have access to treatment; what the age limit should be for men and women; what the duration of infertility before a person comes forward for treatment should be; and what previous treatment someone could have had and still be eligible.

A key issue that created a lot of discussion was the eligibility of people with dependent children. A criterion that was first introduced stated that people without dependent children would access care — the idea being to give priority to people who had no family. However, there was a lot of discussion about that criterion, and we removed it as a result of the consultation. People with children and people without children now have equal access to the service.

There was a lot of constructive dialogue, and the revised criteria were provided to the service in 2006. It was quite a journey and involved a lot of consultation and discussion with stakeholders. Further to that, the Assembly requested a review of the criteria following a debate in 2007. We embarked on a review of the criteria that had been developed between 2003 and 2006. The consultation process has provided us with a clear outcome, and one which is demonstrated in the improvements to the service — including additional investment — that the Minister announced today.

I have provided some background information. Margaret Rose McNaughton will now provide a flavour of the responses to the recent consultation exercise.

Ms Margaret Rose McNaughton (Department of Health, Social Services and Public Safety):

The consultation ended on 13 January 2009. We received 27 responses — 17 from individuals and 10 from commissioners or organisations representing people with fertility problems. The consultation gave us an opportunity to test the 2006 access criteria, and the responses showed that, in general, the criteria provide reasonable and equitable access.

Our consultation document proposed some minor changes to the current criteria. Respondents were supportive of the proposals, with the exception of the proposal to reduce the age limit from 49 to 39 for women using donated eggs. Most people felt that the age limit should remain at 49, because the age of the donated egg was the issue, rather than the age of the women. That was an important factor in the consultation.

Most people were content with the criteria, and, as well as consulting on that, we also sought views on waiting-list management, particularly on prioritising those who were reaching the upper age limit of 39 for women using their own eggs. Throughout the consultation, there was little support from respondents to prioritise older women. Most respondents agreed that as services improved, and if there were quicker access to the service, women would be given a clearer indication of when they would be likely to receive treatment. Therefore, the risk of breaching the upper age limit would decrease.

We consulted on the proposal to move to one regional waiting list. That was welcomed by all those who were involved in the consultation. That proposal would ensure that there would be no postcode lottery and that women throughout Northern Ireland would be able to access the service without being disadvantaged because of where they lived.

Consultees were also asked about the use of any additional funding. Our document suggests that, if we were to find any such funding, we would use that to reduce waiting times initially and that we would then move to offer additional treatments. In general, the respondents agreed that that would be the best way to use the money.

Finally, a number of respondents raised the issue about the need for clear information to be made available to all those involved in fertility treatment. That would allow easy access to information at an early stage in order to allow people who are not currently thinking about having a family to be made aware of the issues surrounding infertility. David Galloway will talk about one of the measures that we will take forward as part of that. Issues also arose around counselling for prospective patients and the introduction of clear care pathways through primary care and into secondary care.

In summary, respondents were supportive of our proposals. David will explain the decisions in today’s announcement.

Mr David Galloway (Department of Health, Social Services and Public Safety):

As you heard this morning, the Minister announced an additional recurrent investment of £1·5 million in publicly funded fertility treatments. That brings the total recurrent resource that is available to the service to approximately £3 million a year. The service currently provides approximately 400 treatments each year, and we anticipate that in 2009-2010, the service will deliver at least 840 treatments. Therefore, we will see some value for that additional investment, as the throughput of people on treatment will double.

Approximately 600 people are added to the waiting list each year. We will monitor that closely to ensure that we maintain the Minister’s commitment to sustain waiting times of no more that 12 months and to ascertain whether the investment that we are making provides the opportunity to do more than we have set out today.

There was some coverage of the National Institute for Health and Clinical Excellence (NICE) recommendations about the number of cycles that are afforded under the publicly funded system. The NICE guidance was issued in 2004, and, because of that early date, it has never been formally endorsed by the Department of Health, Social Services and Public Safety in Northern Ireland. The guidance recommends that patients should receive up to three cycles of treatment. Even with the £3 million of recurrent funding, Northern Ireland would be able to afford only one cycle of treatment for each couple going through the process.

In the longer term, our aspirations remain to reduce further the waiting times and to increase the number of cycles of treatment that are available. Once we are satisfied that waiting times can be sustained at 12 months and no more, we will then look at the possibility of introducing additional treatments.

As Margaret Rose mentioned, one of the key issues for us was the need to examine the ways in which waiting lists are currently being managed. With our four-board system, there are four board lists for fertility services. Those lists are further subdivided into separate lists for individual types of treatments, thus creating 16 lists in total. We aim to reduce that to a single regional waiting list for Northern Ireland, which will help to ensure that no matter where a patient lives in the Province, they will have better equity of access to fertility services.

We will also be working with the new public-health agency to examine the information available to people who want to access fertility services and those who want to learn about fertility in general. As Miriam has said, one of the messages to arise from the consultation was that people are leaving the choice to have children until later in their lives. As we can all appreciate, that means that it is less likely that those people will have a successful pregnancy. Therefore, there are issues surrounding both the information that we put into the public domain about fertility and the services that the Health Service can provide to help people to achieve a successful pregnancy.

As Margaret Rose said, the review group and the respondents to the consultation found that the access criteria that are currently in place are broadly reasonable and equitable. It is our intention for the access criteria in Northern Ireland to comply fully with the requirements of our equality legislation and the Human Fertilisation and Embryology Act 2008, which received Royal Assent in January.

The Deputy Chairperson:

Thank you very much for your presentation. When will the move from the current 16 waiting lists to the single waiting list take place? There was a suggestion in your paper of an interim position to manage that change.

Mr Galloway:

We are asking the boards to place new patients on a new, single list from 1 April 2009. As the Committee will appreciate, patients still remain on the existing 16 waiting lists, and we have asked the boards for their views on what arrangements could be made to ensure the most equitable transition for those people. We do not want people to feel disadvantaged or perceive that they have been disadvantaged by that change in process. We will try to ensure that people have the opportunities that they believed they were going to have, wherever they are on a current list.

The Deputy Chairperson:

The NICE guidelines, which I referred to in a previous Assembly debate, recommend that three cycles of IVF give a woman the best chance of conceiving. You have suggested in your paper that you want to move to that position when the waiting lists have been tackled. Do you see that happening over the next three years? Can you put that sort of time frame on it?

Mr Galloway:

No. To be honest, I would not want to put a time frame on it. We must wait to see how many people continue to present for treatment, as we have to understand what the level of demand will be. As we increase the availability of resources for the public system, we will undoubtedly find that people who would have opted for private treatment will instead opt for treatment in the Health Service. Therefore, demands may continue to rise, in which case the resources that we have will not be able to deliver additional treatments as soon as we might like. We must learn more about what will happen with the system. We must also ascertain what impact the additional money that we have made available today will have on the service before we can reach that point.

The Deputy Chairperson:

Will you give an assurance that it will be kept under review and that you will aspire to move in that direction?

Mr Galloway:

Yes, very much so.

The Deputy Chairperson:

That is very welcome. Another issue of concern was the article in ‘Andersonstown News’ on 10 March 2009 that expressed concerns about IVF treatment. I am sure you are aware of it.

Mr Galloway:

Yes, we are.

The Deputy Chairperson:

Will you give us some information about what that article was about?

Ms McNaughton:

It concerned issues that the regional fertility centre at the Royal Victoria Hospital had in recruiting and keeping embryologists because of an overall shortage of embryologists. There was also a difficulty in retaining embryologists because of competition in the private sector. The centre recently appointed its seventh embryologist.

At the beginning of the year, the regional fertility centre sent letters to its private patients; therefore, the issue affected private patients at the centre but none of the publicly funded patients. The waiting list might have increased for the private patients, but we were still able to treat the full number of publicly funded patients.

With the appointment of the additional embryologist, the centre hopes to be back up to its normal delivery capacity very shortly — I believe by April. That is because the Human Fertilisation and Embryology Authority (HFEA) also had an issue with the lack of embryologists, and the regional fertility centre would hope to be able to inform the authority that it is back to full capacity from April.

Ms S Ramsey:

It would be remiss of me not to welcome the work that has been done to date on fertility issues. In 2007, there was a motion in the Assembly on fertility services. The Committee must welcome the changes since then and the additional money that has been announced by the Minister.

That said, I will return to some of the issues. In relation to the article in the ‘Andersonstown News’, Margaret mentioned that private patients were affected, which is fair enough. However, at present, a patient becomes a private patient after one treatment. Those patients should be given a copy of the article, because I, for one, would like to know where we stand on some of the suggestions that have been made. As I said, a patient must go private to get a second IVF treatment; therefore, it is not a matter of private versus public.

Although I welcome the additional money, David said that an extra 600 people a year may try to access IVF treatment. Will that money have an impact? The Minister said that he wanted to move towards additional treatment. However, even with that additional £1·5 million, if more than 400 people are accessing the service now, and there is the prospect of another 600 patients coming on board next year, it will not be enough. We are talking about what happens further down the line rather than additional treatment.

We must be totally honest: it is not a matter of there being an additional £1·5 million and the possibility of additional treatment this year and next year. Unless more resources are invested, additional treatment is years away. I am struck by the fact — raised months ago by Dr Kieran Deeny — that some people could not access drugs because they were awaiting clinical guidance from the National Institute for Clinical Excellence (NICE). Now we have NICE stating that people should have extra treatment, but they are not receiving it. Every day, we are battling for people who could access drugs but are not able to do so because NICE has not signed off on them. That is the argument that is put forward.

Therefore, one minute we are being told that NICE is saying one thing about a drug, and the next minute we are being told something else. Where do we stand? If treatment is supposed to be provided, then we must be honest and say that we do not have the money to provide it. If NICE is saying that there should be three treatments, we should strive to provide those three treatments.

I do not want to come across as disingenuous. I welcome the movement on fertility services. However, we should not simply say that an additional £1·5 million is being invested. That additional money must be seen in the light of the 600 patients who will be seeking IVF treatment next year. We could be back discussing the subject next year, with still only one treatment per patient.

Dr M McCartney:

Those points are valid. We look to NICE for expert guidance, and you are absolutely right, it recommends three cycles. The Department has moved from a standing start in 2001, when it had nothing, to developing a service with clear access criteria, to the current situation in which we have a service with clear access criteria and additional investment.

As David said, the first priority for that additional investment is to reduce the waiting time. We heard real frustration about waiting times from people throughout discussions in this and previous consultations. About half of those people were over 35 and were getting to a point in their lives whereby there is not a decade or more available to have a family. They want to move quickly to having children and found that waiting for a couple of years for treatment was unacceptable, which I fully understand.

The first priority is to reduce the waiting time and to meet the demand from people coming into the system. The next priority is to consider the most effective way in which to provide not just one treatment that meets demand, but a second treatment, too.

As David has indicated, we must watch how many referrals come into the system next year, how well we deal with those referrals and the numbers of people who go through the system. We must keep that under close scrutiny so that we make the very best use of the investment and our regional specialised service. We must then try to work towards a system that is even better in future.

Ms S Ramsey:

I am just arguing that there is a need for a substantial investment. The Department chooses to ignore NICE guidelines until it suits — and those are my words. Is there anything that NICE can do about that?

Mr Galloway:

The NICE guideline in this area is a clinical guideline for the whole of the Health Service in England, Wales and Northern Ireland. It is a developmental guideline, not a mandatory one. The drugs issues are typically to do with technology appraisals, which have a mandatory time frame. That is one of the subtle differences in the NICE process. However, we are trying to communicate that our policy intention is that, as resources become available, we want to see the NICE guideline achieved for people in Northern Ireland.

Dr Deeny:

Thank you, ladies and gentlemen. First, we should be glad when good news comes; we should welcome today’s announcement by the Minister, particularly when, as Miriam said, the waiting list was a major problem. I see it in primary care, and for that waiting list to come down is a step in the right direction.

I heard a lady talking about this matter on the David Dunseith radio programme today. She spoke very well about the debate on whether money should be spent on disease prevention or fertility. That is a good and healthy debate to have. She made a good point. I have seen the benefits of IVF treatment as a GP. I have seen two couples who both ended up with three children. She talked about money being spent on creating a healthy life and the positive benefits and spin-offs for the parents, the grandparents and the family circle, who are all much better off as a result. That is a positive development, and I welcome it. It is not always about disease prevention; it is about positive outcomes in health.

My question is about the practical issue of referral. I take Sue’s point, and I will be interested to see, as David said, what the situation will be with regard to referrals in a year’s time. In his statement, the Minister mentioned the need for patients to have discussions with their GPs. As a GP, I think that that is a good thing. I suppose that, up until now, most GPs would have made a referral to a gynaecologist, who would decide whether a patient should be given a full investigation, and so on.

Will there be departmental protocols for GPs? Not that I am expecting it, but we could get a sizeable increase in the number of people coming to us to ask to be referred because that additional money is available. Secondly, will GPs be advised to refer directly to one centre, or will we be expected to refer to a consultant obstetrician or gynaecologist first, who will then make a decision? It is difficult, because a GP knows most of his patients well, and when they come to me, I am not going to say no — I will tell them that I will, of course, refer them to Belfast. To make it easy for us, it might be better for a specialist to say whether a patient fits the criteria and to decide the next step. We used to be advised to tell couples to try for 18 months, and, if that does not work, come back for tests at primary care level. Where does all that fit in?

NICE should update its 2004 guidance; it is almost five years old, and perhaps it is time to write to them. What is the situation at present? I know that England has a three-cycle process; is that the case in Scotland and Wales?

Mr Galloway:

We are aware that some primary care trusts in England are delivering three cycles, but others are not; there is not blanket coverage. I am not quite sure what the situation is in Scotland.

You asked about current GP practice to advise people to try and see what happens and then to come back for primary care. That is still the proper approach to take in the first instance. However, the main point that you raised was about care pathways for people and about GPs and patients clearly understanding what those should be. Having worked through the consultation exercise and with the review group, we recognise that care pathways are beneficial for everyone in Northern Ireland. We intend to develop them in conjunction with the new health board when it comes into being, so that clarity is provided across the system about where people should go and where the points of contact will be.

The Deputy Chairperson:

Thank you very much for coming along today. There have not been too many questions; everyone is generally happy with the direction in which things are moving. I have family members and friends who have accessed fertility treatment; some have been successful, and some have not. I know the joy that it brought to those who were successful and the devastation that it brings to those who are not. I welcome any move that will improve the service or improve people’s hopes — that if one treatment does not work, a second one will be available.