Joint Committee on Health and Children debate -
Thursday, 25 Jun 2015

Pre-Pregnancy Folic Acid Supplementation: Discussion

Chairman

I welcome Professor Michael Turner, who is professor of obstetrics and gynaecology at University College, Dublin. He is joined by Mr. Bob McDonnell, Mr. Martin McNicholl, and Dr. Aoife McKeating. I thank them for coming here this morning. As members will know, we have been dealing with the issue of maternity over the course of our programme. Deputy Byrne has raised an issue which we will address in the autumn as part of the national maternity strategy.

I draw the attention of witnesses to the fact that by virtue of section 17(2)(l) of the Defamation Act 2009, witnesses are protected by absolute privilege in respect of their evidence to the committee. However, if they are directed by the committee to cease giving evidence on a particular matter and they continue to so do, they are entitled thereafter only to a qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter of these proceedings is to be given and they are asked to respect the parliamentary practice to the effect that, where possible, they should not criticise or make charges against any person, persons or entity by name or in such a way as to make him, her or it identifiable.

Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against a person outside the House or an official either by name or in such a way as to make him or her identifiable.

I remind all present that mobile telephones should be turned off. They interfere with the sound equipment.

I invite Professor Turner to make his opening remarks.

Professor Michael Turner

Chairman, members of the committee I thank you for the invitation to discuss the pregnancy complication of neural tube defects which is a major public health issue of national importance.

Neural tube defects, NTDs, are a group of serious congenital neurodevelopmental malformations due to the incomplete closure of the neural tube within a month of conception. They are important because they are a serious and preventable cause of congenital malformations. About one in 1,000 pregnancies is complicated by neural tube defect. To put that in context, 80 families every year are touched by the crisis of having a pregnancy with a neural tube defect.

This group of congenital abnormalities includes anencephaly which, as the members may be aware, is incompatible with life. Death before birth is common and survival beyond the first week of life rare. Spina bifida and encephalocoele both have a high peri-natal and infant mortality.

In Ireland, about 80% of infants with spina bifida survive, although the condition is associated with varying degrees of disability. The number of babies live-born with spina bifida in Ireland is higher than in any country with the exception of Malta. That is, in part, because of our legislation on termination of pregnancy. In my view, this means we have a greater responsibility to prevent neural tube defects than many other EU countries do.

NTDs carry a heavy, life-long burden of illness for the individual, parents and families and, incidentally, there is a heavy financial burden for the health services.

Some neural tube defects are genetic in origin but two landmark studies from the 1990s indicate that approximately two thirds are preventable by increasing the mother's consumption of folic acid before and during the early days of pregnancy. There are three possible sources of folate. The first is food, and I have listed in my submission the various foodstuffs. I will not go through them in detail. The bio-availability of folate from food is limited and it is strongly influenced by methods of preparation. For example, boiling degrades the natural form of vitamin but steaming does not. During pregnancy, the demands for folate increase as it is important for the development of the baby. Even if a woman is on a healthy diet and where food is prepared appropriately, it is very difficult for any woman to achieve the necessary amounts of folate through dietary means alone.

The second source of folate is folic acid supplements. Based on scientific evidence over the past 24 years, it is recommended that the optimum dose of supplemental folic acid for the prevention of neural tube defects is 400 micrograms orally per day, which is readily available from pharmacists over the counter. However, with individual women where there is increased risk of neural tube defects, a higher dose of 5 mg orally per day should be taken, and this requires a prescription before it is dispensed. In particular, this applies to women with a history of neural tube defects, women who are obese or with type 2 diabetes mellitus or women on particular medication, such as certain anti-epileptic drugs.

The third source of folate is food fortification, which may be mandatory or voluntary. In North America, food fortification with folic acid is mandatory and this has been associated with a decrease in the incidence of neural tube defects in the United States, Canada and other countries such as South Africa and Chile. In Ireland and the rest of the European Union - with the exception of Sweden - food fortification with folic acid is voluntary. There was a recommendation that went to the Government in 2006 about mandatory food fortification but following a report from the Food Safety Authority in 2008, the Government decided not to mandate fortification.

I will now move to some recent research published in Ireland that is relevant to much of the discussion. Ireland had a high incidence of neural tube defects compared with the rest of Europe and the rate had been falling. However, a recent comprehensive national study was undertaken by my colleagues in the HSE EUROCAT, and I acknowledge the work of Dr. Bob McDonnell and Dr. Virginia Delany in carrying out this detailed national study. It indicates that the incidence of neural tube defects in Ireland had increased significantly from the previous audit in 2005 and 2006; this increase was from 0.92 per thousand births to 1.17 per thousand births in 2009 to 2011. Of the 236 cases over three years, approximately half were due to spina bifida and another half were due to anencephaly. Importantly, of the 94 babies born with spina bifida, 90% survived the neonatal period and the overwhelming majority ended up having spinal surgery in the national centre in Temple Street. Interestingly, the incidence of neural tube defects was higher outside Dublin, and that was significant. The increase in the incidence may be explained by better case ascertainment in the recent study but we believe that is not the case and the incidence has now stopped falling.

With regard to food fortification, an important study was carried out by Dr. Mary Rose Sweeney and her team in Dublin City University, where they audited fortified foods available in supermarkets in the Republic of Ireland. They visited six of the top supermarkets by market share in Dublin and compared folic acid levels with nutrition levels from two previous studies in 2004 and 2008. They found that the voluntary fortification of food has been reduced in Ireland and this decision has been taken by food manufacturers.

A third piece of research was carried out by my colleague, Dr. McKeating, who studied women booking antenatal care in the Coombe. She found that the number of women taking periconceptual folic acid had fallen from 45% in 2009 to 43% in 2013. This fall is statistically significant and at a time one would hope the number of women taking periconceptual folic acid would increase, it is coming down. This decrease was more likely to occur in women who had children before, who were older, who were obese and who were born in Ireland. Some women in our society are more vulnerable than others when it comes to not taking periconceptual folic acid.

A recent study published from the UCD centre of a large series of women in the Coombe indicates that only one in four women takes folic acid for more than 12 weeks before pregnancy, as is recommended. Looking at it another way, three of four women booking antenatal care have inadequate folic acid supplementation at the start of pregnancy. Women who planned their pregnancy or who were having their first baby were more likely to take folic acid. We have just reviewed all the guidelines on folic acid in the European Union that are produced by national bodies. There is inconsistency across national and international guidance about folic acid supplementation, and this must be confusing for the general population and women of child-bearing age in particular.

Based on our research to date, we have recently received a large grant from safefood, an all-island body, and we are planning to look at what exactly are the red cell folate levels in women at the start of pregnancy in Dublin, Cork and Belfast. The Food Safety Authority of Ireland is currently reviewing the issue of food fortification and there is a report due to go to the Minister, so I do not wish to pre-empt that report.

Where does this leave us? We need to update and revise the national guidance that we give to women of childbearing age. In the past we have often told women that if they plan to become pregnant, they should take folic acid. The problem is that a third of pregnancies in the country are unplanned and those figures are similar to other countries. With the two thirds of pregnancies that are planned, in half of those the women conceives within three months of planning the pregnancy, and therefore there is not enough folic acid on board by the time she conceives. We also need to get across a message to women who are at increased risk that they need to take high doses of folic acid, with a prescription required from a doctor.

It is a long time since there was a public health campaign on the subject of periconceptual folic acid. We need to relaunch such a scheme and prioritise those women who are particularly vulnerable. As part of any public health campaign, health care professionals nationally and internationally need to be consistent in their communication and highlight the importance of pre-pregnancy supplementation in addition to that in early pregnancy.

Health care professionals nationally and internationally need to be consistent in their communications and to highlight the importance of pre-pregnancy supplementation as well as that in early pregnancy.

We find from recent studies carried out in the Coombe that women of childbearing age use smart phones extensively to access pregnancy-related information. We suggest that future campaigns should use social media as well as traditional communication tools.

The issue of mandatory food fortification with FA needs to be reviewed urgently by the Government and this has implications not only for the Department of Health but also for the Department of Agriculture, Food and the Marine. As food and food ingredients are now sourced globally this issue would benefit, in my view, from a pan-European approach to the regulation and subsequent monitoring of all food fortification. In the meantime, I recommend that there is an improvement in communications about voluntary FA fortification between the food industry and women and health care professionals. The food manufacturers reduced the amount of fortification in food but they failed to communicate that message to women of childbearing age and failed to communicate it to health care professionals. This reduction in voluntary FA fortification and in supplementation may explain in part why we have seen an increase in the incidence of neural-tube defects nationally in recent years. Thank you.

Chairman

I thank Professor Turner for his very interesting presentation and for raising many thought-provoking statistics, figures and facts. I will not pre-empt the questions but it is important that we join with Professor Turner in a renewed public health campaign. We can talk about that later.

Deputy Billy Kelleher

I thank Professor Turner for his presentation. I am interested in the point that in America there is food fortification but that although the neural-tube defects incidence has reduced that reduction is less than had been hoped. Reference has been made to collating statistics. Professor Turner says there is a higher incidence in Ireland than in Malta, probably because of our abortion legislation. How are statistics on neural-tube defects, and the impact of food fortification on their reduction, collated, given the varying levels of termination around the world and transnational movement of people?

On the broader issue of food fortification, does this cover all food types or are there specific types of food that are more beneficial to women for periconceptual FA intake? There is now an obesity problem in this country. Demographics show that in ten years’ time many women of childbearing age will be obese. How does Professor Turner suggest we plan for that? While the Food Safety Authority is carrying out a review on food fortification is it wise for any country to put the health of the nation into the hands of food manufacturers without there being some form of regulatory oversight?

Senator John Crown

I was trying to find out what was the first paper from Ireland on the issue of FA and neural tube defects because a lot of research was done on this here by Professor Weir and Dr. Scott. Ireland has contributed significantly to this area. I am delighted to see such high quality publications from Professor Turner and others in this area.

I thank Professor Turner. This is very important. Much time is wasted within the walls of these buildings but there is a real chance that something could come out of today’s meeting that could make a difference. Professor Turner refers to people having surgery for neural-tube defects and while I am rusty on paediatrics my clear recollection is that the surgery for patients with neural tube defects does not correct the underlying neurological deficit. If somebody is born with severe spina bifida to the extent of having neurological compromise or paralysis the surgery does not fix that, it closes the defect in the skin and back. There is no treatment for a neural tube defect. What you see is what you get.

What is the cost of FA supplementation? Whenever we attempt anything in public health which can be construed as mass medication there will be a fringe of objectors who will raise concerns about potential side effects and health consequences of the intervention because we are medicating many people who do not need the intervention to bring a great benefit to a small number of people. Is there any credible evidence that there are any side effects from mass medication with folic supplements, either medicinally or through food supplementation? Do we know what was the chain of events whereby the food industry decided to reduce the folic content? Was it just a cost issue? Did it find it cheaper not to do it or were there other considerations? This may not be something Professor Turner has first-hand experience of but I would welcome his speculation on it.

Some of the issues Professor Turner has mentioned about the epidemiology of the decline in the uptake of FA among women presenting for antenatal care had a little ring of being a surrogate for socio-educational status and I presume that is a major factor. In so many issues in public health, be it obesity or cigarette smoking, we find that the burden of preventable illness is falling on the people who can least afford it. I would be grateful for Professor Turner’s insights into that.

What would be Professor Turner’s best guess if we had a folate tsar? I dread to say it because I am sure the Health Service Executive, HSE, will think of appointing one. If we had full compliance with best practice, knowing what we can achieve with maximum folate supplementation, what does Professor Turner think would be the impact of that nirvana-like implementation of health policy on the reduction in the number of cases of neural tube defects?

I thank Professor Turner and encourage him to keep up the good work clinically and in the research arena.

Senator Colm Burke

I thank Professor Turner for his comprehensive presentation. He spoke about the inconsistent guidance nationally and internationally. Is that likely to be resolved and if so when will the information be given out? He said that the decrease over five years was more likely to occur in women who had children before, who were aged between 30 and 39 years, who were obese and who had been born in Ireland. I know we have an obesity problem but is there an increasing number of obese pregnant women? Does that arise more now than it did five or ten years ago? What percentage change has there been in that area?

In regard to social media I agree there has been no campaign on this issue.

Are there discussions on conducting a campaign and what is the timeframe for rolling out such a campaign? Would all the maternity units across the country and-or the GPs be involved in the rolling out of the campaign? The reason I am raising the issue of the involvement of the GPs, is that a person speaking at a recent GP meeting on obesity raised the issue of doctors discussing child obesity with the parents. They responded by saying "No". One GP gave the example of raising it and then the entire family moved from the practice.

How does one get a message across in a very diplomatic way? There are more than 2,500 GPs in the country and they have direct access to more people at an earlier stage of pregnancy than the maternity hospitals.

Deputy Catherine Byrne

I thank Professor Turner for his presentation. Senator Crown summed it up earlier when he said that some people make long statements but in his short statement, Professor Turner was direct and enlightening.

I have young teenagers who some day may become pregnant. Unplanned pregnancy is a major issue, as not everybody plans when she will have a baby; it just happens. Can we identify the age cohorts who would not take folic acid? Let me ask with the greatest respect if people in poorer areas do not take folic acid. Do more people in Dublin than in other parts of the country take it and is there a reason for that?

There is a cost to the HSE when a child is born with spina bifida, but it also changes the lives of families when a child is born with specific disabilities and needs. From my background as a volunteer working with teenagers in youth clubs and schools, particularly with transition year students, I am aware of the need for young people to access information and education as they go from school to college. It is a sad reflection on society that we do not educate people on how to prevent the incidence of such dreadful conditions, and by taking folic acid in tablet form we could prevent spina bifida and other neural conditions.

I thank Professor Turner for his very interesting presentation.

Professor Michael Turner

I thank members for their interest and their appropriate questions. I also thank Senator Crown for his kind professional remarks. Data collection is very challenging. Let me give an example. One might have a baby diagnosed with spina bifida in one hospital being transferred to be delivered in a second hospital and the surgery being carried out in a third hospital. There are a series of sets of data. One of the challenges - this is why this study by Dr. Bob McDonnell and Ms Virginia Delaney was so important - is that they drilled into the detail of individual cases to ensure there was no double counting. Many of the data sets in the past were confined to babies beyond 24 weeks gestation but we have had to drill down and try to get some of the data to which Deputy Kelleher referred. Much of the international data are regionally based. I hope Dr. McDonnell might come in as there are issues nationally in terms of data collection.

Chairman

I invite Dr. McDonnell to join in.

Professor Michael Turner

One of the problems with voluntary fortification in terms of specific food categories is that folic acid was being put into a large range of foods but at variable levels and in a very haphazard way. The recent study is also very enlightening because when one looks at the big six supermarkets in terms of market share, two of the six have entered the market in the past ten years. One of the big German conglomerates fortifies its food. The other does not. They now have 16% of the market share. They have foodstuffs that are very price sensitive and are likely to be availed of by those who are socially disadvantaged. The public is not aware of these facts. It is not aware that a certain food was fortified in the past but is not being fortified now. That is unfair on women who are of child bearing age. The women will often look at the labels and see that it is fortified but when they buy the same food six months later they will not look at the label again to see whether the company has continued to fortify the food. There is a responsibility on the food manufacturers to notify the public in the first instance and the health care professionals and policy makers, who should be aware of such changes, if they propose to make changes in the voluntary fortification of foods.

In terms of specific food categories, it is different when it comes to mandatory food fortification. In general, governments world wide have generally focused on flour. That is what has been done in North America, on the basis that most people eat bread. Again we need to be conscious of the fact that people's food habits are evolving over time and for example a lot of women have changed to eating snack bars on the way to work or for lunch and are not eating bread to the same extent as in the past. With the mandatory fortification programme, one cannot assume that food eating practices are constant and that they are the same for women of child bearing age compared to women or men in other circumstances.

I will address Deputy Kelleher's question on obesity levels. Again Dr. McKeating has recently published a paper in the Scandinavian journal which shows that one in six women booking for antenatal care in the Coombe Women and Infants University Hospital is now obese. The patients attending the Coombe number one in eight of everybody born in the Republic of Ireland, so it is a representative sample. Dr. McKeating's research indicates that the obesity levels in the country are stable. What is worrying is that she also was able to demonstrate that 2% of the population are morbidly obese and have a body mass index of greater than 40. In absolute numbers it has gone up 50% in five years. This is very challenging at several levels and has resulted in a major increase in the number of women with gestational diabetes.

Chairman

Is there any particular reason for the five year period?

Professor Michael Turner

Up until 2009, the women had not been weighed at their first visit. We reintroduced weighing in 2009. There is a lot of good data internationally on obesity levels outside of pregnancy but there is a paucity of information about obesity during pregnancy itself. This has implications not just for folic acid. We know that obese women are more likely to have congenital malformations. We know they are more likely to have babies with neural tube defects. We also know that, technically, because of their obesity it is harder to make the diagnosis of neural tube defects because when one comes to do the scan, the baby is further away from the probe. The obesity crisis is another issue that merits attention.

I will now deal with the cost of supplementation. The costs of fortification for the food industry are extremely low, I read a figure of the order of 19 cent per individual per annum. It is a pittance. One can buy folic acid supplements over the counter. The cost varies from pharmacy to pharmacy and one can get better deals from some pharmacists compared to others.

Again, this is in the order of €4 or €5 per month. My concern about the decrease is that it is a discretionary spend and the demographic of women in their 20s and 30s who should be spending money on supplementation are also those who are struggling to make ends meet with their mortgages and trying to feed their families. They prioritise the nutrition of the children they already have without planning for the children they might have in future. This may explain the regional differences with regard to Dublin. We do not know precisely why there are differences between Dublin and the rest of Ireland, but we know from the Central Statistics Office that people in Dublin spend 20% more on food than people outside Dublin. This highlights the importance of doing national audits. In the past, many of the audits on neural tube defects were Dublin-centric because of the excellent data collection in the three Dublin maternity hospitals. We need to audit outcomes throughout the country and not just in Dublin.

Senator Crown asked about the side effects. There are concerns, and he would probably know more about it than I do, about whether excessive folic acid may be associated with cancer, particularly bowel cancer. I do not find the evidence particularly compelling in terms of risk. It is weak. There is also evidence that cancer is associated with folic depletion. Folic acid may have benefits other than preventing neural tube defects. The evidence suggests that it also prevents cardiac congenital abnormalities and cleft lip and palate abnormalities. It may prevent cardiac disease and stroke in adults. Having lots of folic acid in one's diet and taking folic acid supplements has benefits which go beyond preventing neural tube defects.

All pregnancy outcomes have a social gradient, and this is very important. It is those women who need folic acid supplementation the most who do not avail of it. When it comes to the planning of pregnancy, there is a very strong social gradient. This is important not just in terms of folic acid supplementation but with regard to preparation for pregnancy generally, including losing weight, increasing physical exercise and stopping smoking.

If we had complete compliance with folic acid supplementation - in other words, if every woman took it for three months before she became pregnant - it is estimated that two thirds of cases of neural tube defects would be prevented. To put this in context, approximately 50 to 60 families every year have a baby who must come to Temple Street for surgery, which corrects the defect rather than the neurological issue, so 40 families would be spared this trauma. There is no good data as to the cost to the health services of neural tube defects in Ireland, other than to say that a big review was published four years ago which estimated that each case of spina bifida costs €500,000 over the lifetime of the person concerned. If one takes this €500,000 and multiplies it by 60, it is €30 million. We could do a lot with €30 million in maternity services.

In terms of the consistency of our guidelines, we need to get our house in order nationally. Some guidelines say that folic acid should be taken when one is planning pregnancy, while others say it should be taken one month beforehand and others say three months beforehand. In general, most European guidelines were published after the landmark studies of the 1990s, but the more recent research suggests that folic acid should be taken for three months beforehand. The European guidelines need to be updated. The Canadians and Australians have updated their guidelines and they are advanced. If we get our house in order there is something that could be done at EU level in terms of aligning guidelines, particularly now with women in their 20s and 30s moving more freely between EU countries. We need to have consistency.

The demographic in question uses social media a lot. This has advantages because we know from our work in the Coombe that 95% of pregnant women use their smartphones for pregnancy-related information. Interestingly, those who are socially disadvantaged also use it a lot. It has advantages in that it is inexpensive. We can measure its use, we can archive it, we can update it very quickly and we know what parts of it are used. We cannot do this with traditional communication channels. Not just on the issue of folic acid, but on the issue of providing information to women who are pregnant or contemplating pregnancy, we need to have a national e-health strategy when it comes to maternity services. I am pleased to report that I was at a meeting recently at which I learned that safefood is planning to launch a social media campaign in July on folic acid supplementation.

Senator Burke asked about childhood obesity and whether it was an issue. If a mother or father is obese the child is three to four times more likely to be obese. This is why, when we speak about maternal obesity, we see it not just in terms of the mother; it is a family issue. If mothers have a healthy lifestyle and diet, we hope the fathers will improve. We know that one in six fathers-to-be in the Coombe are also obese. We hope that if the parents have a healthy diet the children will have a healthy diet. There is concern about obesity begetting obesity. Nationally we need a strategy on breaking the intergenerational cycle of obesity.

I agree with Deputy Byrne on the regional differences. Transition year is a great opportunity across the board to educate girls and boys on what they should do to modify their risks subsequently in life. There are huge educational opportunities that we are not taking as a country at present.

Deputy Billy Kelleher

To go back to a few issues, the people who most require public health messages are those least likely to hear them. Professor Turner spoke about socioeconomic groupings in terms of obesity and other health side effects of smoking and poor diet. Many people have poor educational backgrounds. To get the message to people who most require it is often the most difficult element.

Why is there a lower incidence of neural tube defects in Dublin than in the rest of the country? What is the earliest possible point at which neural tube defects can be diagnosed during the gestation period? Professor Turner stated that Ireland had a higher rate of neural tube defects than other European countries, although rates have fallen in recent decades.

Why did the rates fall? Is it possible that the pregnancy would have been terminated in another country? Where do those statistics lie, in terms of trying to build up a base as to the real incidents of neural tube defects in this country? If we are trying to bring forward an educational programme, it is important to target the people who most need it. We know, for example, that terminations are more likely to be sought by those in higher socio-economic groupings as opposed to those in the downwards groupings. What are the statistics based on exactly? Without those statistics, the wrong people might be targeted. I am quite sure all of these things have been addressed in the research.

Professor Michael Turner

It might be appropriate if Dr. McDonnell addresses those issues.

Chairman

Senator Burke has a supplementary question.

Senator Colm Burke

To return to the GP issue and their reluctance to discuss the issue of obesity, it may not be a problem in Dublin but it is a problem in rural areas. The study done by the people who won the Young Scientist competition this year examined the relationship between being overweight and excessive drinking. We seem to have failed to get that message out there that excessive drinking and being overweight poses a risk to one's health. GPs are reluctant to become involved in that debate. Perhaps I am interpreting it wrongly but that is the feedback that I am getting from hospitals in particular.

Professor Michael Turner

I think the Senator is right and I am sorry that I did not give it as much attention in the first round of answers as I should have. It should be part of the routine GP care that young children should be assessed because one of the problems is that parents sometimes do not recognise obesity in their own children. Sometimes they can be very sensitive. When we came to measure the fathers, there were two fathers who would not step on the weighing scale and it was obvious to everybody that they were both morbidly obese. There is a sense of denial when it comes to the obesity issue. As part of the new under six contract, children should be assessed for obesity at certain milestones, because early intervention in childhood is far more productive than waiting until their teenage years. Again, it is linked to dietary policies and physical activity and sports, so it touches on that in terms of national policy. If every GP had to do the same measurements as part of their GP care, people would not move from one general practitioner to another because they did not like what the first GP had to say. I think it is something that needs to be tackled at the level of primary care.

In terms of the statistics, there are some issues nationally that the committee needs to be aware of so Dr. McDonnell might comment on those.

Dr. Bob McDonnell

With reference to Deputy Kelleher's question about the rates and statistics, the numbers of neural tube defects around Europe are monitored by a large network of 40 or 50 congenital anomaly registries that monitor all kinds of birth defects, including neural tube defects, but they also monitor other birth defects. They do this on an ongoing, routine basis - it is regular surveillance. Some of these registries are regional registries within countries and some are national registries. For example, in Scandinavia there are national registries in Norway, Sweden and Finland which monitor, on a yearly basis, the numbers of all congenital birth defects.

The European network, of which there are three Irish HSE member registries, is called EUROCAT. The registries monitor all birth defects, including live and still births, and the terminations within Europe. The Irish registries measure the live and still births. The termination issue is a sensitive one and some mothers will choose to go abroad for a termination for some serious congenital anomalies. We do not have information on that. It is the same in the United States in that they have a network of registries that monitor all the birth defects as well. The statistics are reliable and will provide the actual numbers so we rely on the data from Europe and from ourselves.

In recent years, within the Irish situation, there have been some difficulties in gathering data, particularly in the east. There are three registries in Ireland - one in the east, one in the south-east, and one in the south. They monitor, between them, about 62% of births for congenital anomalies. They were operating fairly efficiently up until about three, four, or five years ago when data protection limitations began to cause some issues. These were due to be addressed in the Health Information Bill, which we have been expecting for some time, which would give cover that would allow the registry to operate efficiently so that there would be accurate data on neural tube defects and all other types of birth defect. At this stage, a couple of the registries are experiencing difficulty in gathering data on birth defects, including neural tube defects and that is why there have had to be special national studies to see what the number of neural tube defects were from 2009 to 2011. It is an issue that needs to be addressed.

The ideal situation would be that there would be a national registry within Ireland that would monitor all birth defects, including neural tube defects so one could see every year what the situation is rather than have to have a special survey in 2005 to 2006 and then another one in 2009 to 2011 and maybe another one later on. There is need for a national registry and this has been part of the recommendations of the folic acid committee that was set up, the Implementation Group on Folic Acid Fortification. In their recommendations, they suggested there should be national surveillance on neural tube defects. So the legislation to allow that to happen needs to be put in place. It is not actually a financial issue because the capacity is probably just about there to do it within the current system - it is a legislative issue. That needs to be done.

Chairman

When Dr. McDonnell says it is a legislative issue, in a hierarchy, is it a priority?

Dr. Bob McDonnell

Yes, it is an absolute priority. Within the east, we have wanted to extend surveillance of neural tube defects to the midlands on an ongoing basis rather than a special survey from 2009 to 2011. We also want to extend surveillance into the north east and other parts of the country, in other words, to cover the other 38% of births within Ireland that are not covered by the three registries. We found that the legislation issue is stopping people from going in and getting the data because the data are very sensitive.

Chairman

What is the role or potential involvement of the HSE?

Mr. Martin McNicholl

I think it is more a Department of Health legislation issue.

Professor Michael Turner

Yes. It is nothing to do with the HSE programme. We support having a comprehensive registry and it is of concern to me, as a clinician, that one in three births in the country is not covered by the HSE registers. It is those parts of the country, when we did the comprehensive audit, that had the highest number of neural tube defects that are not part of the registry. The numbers are higher in the midlands and in the Border counties and they are not being covered by our national register. We need to get accurate data. To return to Deputy Kelleher's point, in terms of the data collection, the data on termination are very difficult to collect in any country, irrespective of what the legislation provides, because a lot of terminations of pregnancy take place in a private health care facility where the information is not collected.

There is an issue around diagnosis and, in particular, the diagnosis of spina bifida, because most cases of spina bifida are diagnosed around 22 weeks gestation. We know that the ultrasound services for diagnostic purposes are far better in the big academic centres than in the 13 smaller units. This may be part of another discussion on the maternity services but the ultrasound services in the smaller hospitals are deficient. The committee has heard a lot of talk about this. It is related to the fact that Ireland has the lowest number of consultant obstetricians and gynaecologists in the European Union. We need to do something about that in terms of improving pre-natal diagnosis.

There are huge advantages to the couple if the diagnosis is made at 22 weeks because they can then plan the rest of the pregnancy, including where the baby is to be delivered and if it is going to be in larger maternity unit where there are foetal maternal specialists. There is a major national issue when it comes to the provision of ultrasound services.

Dr. Bob McDonnell

Reference was made to voluntary fortification decreasing over a few years. Professor Turner cited the recent study which showed it decreased from 2009 to 2013. The recommendation in 2006 from the Department of Health was that there should be mandatory fortification of staple foods in Ireland. As a work up to this, the Food Safety Authority of Ireland did a baseline study of the incidences of neural tube defects, between 2005 and 2007, which was fairly low. The food industry anticipated there would be fortification, and there was a lot of voluntary fortification of their breads, cereals, milks, etc., in advance of this because they knew it was coming down the line. The effect was that it seemed to increase the levels of folic acid in women's blood. When the FSAI actually looked at the amount of voluntary fortification occurring during that period it found that the food producers were over-estimating the amounts required and putting a lot more folic acid into the products that they should have been. In 2008, when the incidences of NTDs had decreased, when women's folic acid levels were quite high and when there was already voluntary fortification happening, it was decided not to fortify. The world food producers were advised that they had a lot of folic acid in their products and they then decreased the amount in their products. That will have decreased the amount of folic acid that women were getting. We did our own survey for the period 2009-11 and we saw that the incidence of neural tube defects had crept back up again.

Professor Michael Turner

The EU regulates food fortification. The Food Safety Authority of Ireland confirmed that there was a scheme in place for folic acid fortification but it was withdrawn in Ireland in 2010 because the EU introduced legislation on the addition of vitamins and minerals, which made the then folic acid flash labelling scheme superfluous. This is being driven at EU level so questions around mandatory food fortification cannot be answered just by ourselves for a number of reasons. Food and food ingredients now cross borders so it is difficult to try to regulate nationally. Regulation and monitoring of mandatory fortification requires an EU approach because there is a big difference between having something on the label and measuring the folic acid in the food. There is an urgency now for the EU to get its act together. The British Medical Association recommends mandatory food fortification but the EU governments are sitting on their hands on this important issue. This is partly due to the fact that, clinically, the issue of neural tube defects is not as important in other countries as it is in this country - they deal with the problem differently.

Deputy Catherine Byrne

We have good primary care centres across the country and GP practices, where there are television sets. My own GP surgery's waiting room shows health promotion videos which cover issues such as obesity and the like. This could provide an opportunity to put a campaign together on this issue. People attend GP practices for many reasons, including younger people who may have children in the future. Knowing my own girls and their friends, I find that many young people, young women in particular, are very conscious of their image and what they eat and they eat healthier. When buying foods they make efforts to get more vegetables and fruit. Much of this goes to the old-fashioned family lifestyle. I no longer see children playing on my street and we rarely see children playing the games we did when we were growing up. Many children now confine their entertainment to social media.

Professor Turner informed the committee on the process of following people from birth, to diagnosis to surgery. I hope he is a fan of the new National Children's Hospital going into St. James's where we will have a new, world class hospital, and a maternity hospital on the site in the future. I live near the Coombe Women and Infants University Hospital and it represents much of my constituency. I have raised this before with this committee and I raise again the possibility of somebody from the Coombe hospital coming to this committee to discuss the issue of babies being born to substance and alcohol abusing mothers. The committee has tried before and the clerk will try again to see if this will be possible.

Professor Michael Turner

I would be confident that the master, Dr. Sheehan, would respond positively to the Deputy's invitation.

I wish to return to the dietary question. Even if one does have a healthy diet it is difficult to get folic acid levels up high enough to prevent neural tube defects. This is why the education needs to focus on supplementation. It is a concern that a recent survey by us showed that many young women did not know they should be taking folic acid and moreover, they did not know why they should be taking it. They had not made the link between folic acid and neural tube defects. I agree that a national education piece needs to be set.

Chairman

I thank Professor Turner, Dr. McDonnell, Dr. McKeating and Mr. McNicholl for coming to the committee this morning and for their presentations. The issue certainly requires further exploration by this committee and a number of suggestions need to be made around this work.

Sitting suspended at 11 a.m. and resumed at 11.10 a.m.