HC Deb 19 December 2001 vol 377 cc389-96

Motion made, and Question proposed, That this House do now adjourn.—[Mr. Caplin.]

10.1 pm

Mrs. Helen Clark (Peterborough)

I am very glad to have obtained this opportunity to speak on this long-running and important issue. I have to tell the House that it is not a festive topic. I must also say that the reason why I have sought this debate is that I am very unhappy about the long delay and Government inaction that I shall be forced to detail.

The headquarters of the Association for Spina Bifida and Hydrocephalus—ASBAH—is situated in my constituency. Since I was elected in 1997, I have sought to advance the case for the fortification of flour with folic acid, on which the association had already been campaigning for several years. In its view, the Government's delay is "inordinate" and the failures by the Department of Health even to reply to correspondence are "unprecedented".

Spina bifida is one of the most common congenital malformations. It occurs very early in pregnancy, at about four weeks, when the spine and brain are being formed. It is a fault in the development of the spine, which fails to close properly, and it often results in paralysis below the fault. A major secondary complication is hydrocephalus—excess fluid in the brain—which, if it is not treated properly, can cause brain damage. Neural tube defects, or NTD, affect about 1,000 pregnancies a year, and the numbers of births of severely handicapped children have mainly decreased because of terminations of pregnancy. At present, NTD affects about 0.13 live births out of every thousand. It is only abortion that prevents the number from being 10 times higher.

There is a direct relation to the intake by mothers of folates, of which I understand that folic acid is the most easily ingested. Poor diet certainly increases the risk and probably accounts for the higher incidence of NTD among poorer women—perhaps those who are socially excluded. Even with a good diet, however, it is virtually impossible to obtain sufficient quantities of naturally occurring folate. The average daily intake is 200 micrograms.

In 1991, an international study led by our own Medical Research Council found that if all pregnant women who had had a previous spina bifida pregnancy took four milligrams of folic acid a day from three months before conception to the end of the third week of pregnancy, the incidence of NTD could be reduced by 75 per cent. That finding was accepted by many authorities, including the then Government. A subsequent health campaign in 1996 increased knowledge among women about folic acid, with the result that 91 per cent. said that they had heard about it, compared with 9 per cent. before that. However, as we know, 35 to 50 per cent. of pregnancies are unplanned. A survey carried out in 1996 found that only one in 10 mothers took a supplement before conception, so that is not the answer either.

In 1996, the United States centre for disease control recognised that health education and tablets would never lead to a significant reduction in NTDs. The United States legislated to make fortification of flour and some other staple foods compulsory. Of course, the United Kingdom must make its own decisions, but our rates of NTD pregnancies are among the highest in the world. We also have precedents for additives such as calcium in flour and iodine in salt. They are accepted as a means of protecting health.

Representatives of ASBAH met Ministers from the previous Administration more than once. They were told that increased intake of folic acid should be a matter for the individual, not public action. The new Labour Government immediately and rightly put public health at the top of their agenda, and appointed a public health Minister. We have made great strides in recognising the link between social and geographical circumstances and health conditions, and in taking measures to tackle that.

In 1996, ASBAH met the Labour Opposition health spokesperson, who gave an undertaking that the Committee on Medical Aspects of Food and Nutrition—COMA—would investigate the fortification of flour with folic acid, should a Labour Government be elected. In September 1997, as the newly elected Member for Peterborough, I met Andrew Russell, executive director of ASBAH, Professor Nicholas Wald and a member of COMA for a briefing on the matter. I was impressed by the strength of the case in general, including the claim that no other single public health measure could prevent as many serious birth defects, and especially by arguments against concerns about the health of the rest of the population if fortification were introduced.

There were two such anxieties. First, folic acid might interfere with the diagnosis of vitamin B12 deficiency. Secondly, people with epilepsy would risk their condition becoming uncontrolled. The evidence showed that folic acid might improve the anaemia associated with B12 deficiency and thus mask its symptoms. However, it does not cause the deficiency, which can be diagnosed by means other than anaemia. Even higher amounts of folic acid than the target 0.4 milligrams would not affect existing epileptics.

Once a fortification policy had been implemented, newly diagnosed epileptics would be controlled on already supplemented flour. I accept that a more cautious position was subsequently adopted on the latter. However, in 1998, a study of 60 epileptic women who were given 0.8 milligrams in multivitamin supplements, found no side effects. That remains the case. When COMA reported in January 2000, it reached the same conclusion. However, I shall revert to that point shortly.

After my meeting with ASBAH, I sought and later obtained a meeting with the then public health Minister. That happened in November 1997, although the Minister was unavoidably absent and was represented by her parliamentary private secretary. Again, it was attended by Professor Wald, Andrew Russell, Professor Wiseman of the Department of Health and officials.

In the meantime, I had tabled the first of three cross-party early-day motions on the topic and, with Lord Ashley of Stoke, organised a reception in the House of Lords in December to publicise the issues. At the meeting, we were told that COMA was considering the subject and that in principle, there was no opposition to the fortification of flour, but the Government would be guided by medical and scientific evidence. That is fair enough. ASBAH and I were encouraged that that was a change compared with the position of the Conservative Administration.

Professor Wald said that he would favour an amount of 0.4 milligrams a day but that less would be acceptable. Professor Wiseman mentioned some other possible benefits of folic acid supplements such as a possible protection against cardiovascular disease. He said that although the research was inconclusive, that should not be a barrier to fortification on the ground of preventing neural tube defects.

The reception in December gained an unexpected boost. In the weeks that immediately preceded it, Bianca, a central character in the popular soap "EastEnders", played by Patsy Palmer, discovered that she was expecting a spina bifida baby. With her partner, Ricky, she agonised about whether to have an abortion. In the end, she did. Patsy Palmer attended our reception.

At that point, we were very optimistic that a favourable Government decision would be taken, and taken soon. We were led to believe that COMA would report within a year or so and expected a subsequent Government decision. We had to wait another year. ASBAH was extremely disappointed, as it expected the Government to take "a more socially inclusive"—we always talk about that—"and responsible view" than their predecessors. ASBAH and I wrote separately to inquire about progress. We waited several months for a response. COMA reported in January 2000: On scientific, medical and public health grounds, the Committee concluded that universal folic acid fortification of flour at 240 micrograms per 100 grams in food products as consumed would have a significant effect in preventing NTD-affected conceptions and births without resulting in unacceptably high intakes in any group of the population. It said later: The Committee has identified a level of fortification that would provide significant benefit in reducing the incidence of pregnancies affected by NTD without exposing any section of the population to risks. That was good news. I tabled a second early-day motion that welcomed it, but it also called for the forthcoming consultation to be as brief as possible, given the long delays. A few weeks later, I asked a parliamentary question on how the consultation on the report's practical and legal implications would be conducted. I was told: A public consultation will be undertaken shortly inviting comments on the report's conclusions."—[Official Report, 27 January 2000; Vol. 343, c. 338W.] Several weeks later, ASBAH received another letter stating the Government's intention to issue a consultation document shortly, which would inform future policy. Twelve weeks were to be allowed for responses.

On 24 May, I tabled a parliamentary question asking when the consultation document would be published. Again, I was told "shortly". On 25 July, in response to yet another parliamentary question, I learned that the document had been published and that the consultation was to run until 31 October 2000. I am sorry if this is becoming tedious, but it is essential to understand the frustration experienced by those of us who have been involved in the issue for a long time. I am afraid that I have not finished.

For the past year, ASBAH and I have been trying to obtain a response from the Department of Health to the results of the consultation. I shall not list all the dates and I certainly shall not identify the Ministers concerned, but I will say that three ASBAH letters went unanswered and that it was erroneously claimed in a letter to me that a reply had been sent. I wrote to the Secretary of State at the end of August, saying how disturbed and concerned I was by such delay and discourtesy and that I had to agree with chief executive Andrew Russell that the delay looked rather like a "substitute for decisiveness". Those are his words, not mine.

I also said that I was, as I remain, concerned about the monetary and human costs of the delay, including those of the many avoidable pregnancy terminations that occur each year due to neural tube defects. It is traumatic for a woman to have a termination. The Department of Health letter to ASBAH dated 19 November said that the majority of responses were in favour of fortification, but again raised the issue of B12 deficiency. The good news was that apparently crucial research on the prevalence of that condition had just been completed. Another issue related to the technical aspects of fortification and, apparently, the Food Standards Agency will engage in detailed discussions with industry representatives to see what might be feasible.

In my first meeting with ASBAH in June 1997, I was assured that there were no technical obstacles, but that the industry had naturally said that it required a directive from the Government before implementing fortification. I tabled a third early-day motion on 9 November to draw attention to some of the facts, noting that the Department's deadline for consultation responses had passed more than a year ago and urging an early announcement of its intentions.

I agreed with ASBAH that, if we had heard nothing by spring, we would go ahead with yet another function in the Commons, but that, hopefully, we would not need to do so. I still hope that that may be the case, or that the function will go ahead, but that we shall be celebrating and not endlessly calling for action. I was horrified, therefore, when very shortly afterwards an article appeared in the British Medical Journal calling for further delays on the ground of the masking effects of folic acid on B12 deficiency and yet more research.

As will be apparent from what I said earlier, the article is based on no new evidence. The reservations expressed by its authors, Professors Wharton and Booth, were dismissed by COMA two years ago. Worst of all, the call for field trials—a rather peculiar phrase in itself—is, I understand, a non-starter, as it would involve millions of participants. In any case, the experience of fortification in the United States already provides the necessary evidence. As I have said, flour fortification has been established there since 1998, with full public acceptance. It has involved minimal cost, and no hazards have emerged. We are talking about a population of a quarter of a billion, which strikes me as quite a large field sample on which to base any conclusions.

Surely enough is enough. We have the evidence; the precedents are there; the practical barriers can be surmounted. Please, please, at Christmas time, may I have an assurance that the Government will follow the recommendations of their own Committee—as they promised they would five years ago—and recommend the fortification of flour with the suggested and agreed amount very, very soon?

10.16 pm
The Minister of State, Department of Health (Jacqui Smith)

I congratulate my hon. Friend the Member for Peterborough (Mrs. Clark) on raising this issue. I assure her that the Government take it very seriously, especially given that—as she pointed out—about 100 births are affected by neural tube defects each year, and spina bifida is the most common of those defects.

We have not been resting on our laurels since the consultation exercise; a significant amount of work has been done. I realise that my hon. Friend and others who have campaigned in favour of fortification would like to see faster progress—particularly organisations such as the Association for Spina Bifida and Hydrocephalus.

Let me record the Department's apology to ASBAH for the delays in answers to correspondence. Although those oversights are regrettable, I hope that I can reassure my hon. Friend that they were purely administrative, and not due to an unwillingness to communicate. No doubt it will be appreciated that the issue is complex, and that the universal fortification of any food—mainly bread, in this case—is a major public health issue that requires the fullest consultation and consideration.

As my hon. Friend said, during the 1960s it was suggested that the risk of a woman's bearing a child with a neural tube defect might be affected by her intake of the vitamin folate. In 1991, definitive evidence was established in a trial by the Medical Research Council which showed that supplementation with folic acid—the artificial form of the naturally occurring vitamin folate—significantly reduced the risk of NTDs in women who had already been through a pregnancy affected by NTD.

Following that, the then Government initially issued guidance about supplementation with 5 mg of folic acid to prevent the recurrence of NTDs. The guidance was then expanded to cover the prevention of first-time NTDs, with the recommendation that all women planning pregnancies should take 400 mg as a daily dietary supplement from the time when they began trying to conceive until the 12th week of pregnancy. They were also advised to consume folate-rich foods.

In 1995, the Health Education Authority began a nationally integrated campaign aimed at increasing the average daily intake of folate and folic acid. The key objectives were to increase awareness of the importance of additional folic acid before conception and 12 weeks into pregnancy in the general female population and in health professionals, to encourage fortification to increase the availability of fortified breads and breakfast cereals, and to make fortified products easily identifiable by promoting the use of a logo—the folic-acid flash—to highlight foods rich in folic acid.

As my hon. Friend suggested, the campaign achieved some success. Spontaneous, unprompted awareness among women increased from 9 per cent. in 1995 to 49 per cent. in 1998, and prompted awareness rose from 51 per cent. to 89 per cent. The percentage of women claiming to take folic acid when trying for a baby had also risen from 24 to 38 per cent.

As my hon. Friend said, although the campaign was generally successful, it had its limitations, as about half of all pregnancies in the United Kingdom are unplanned. Moreover, by the time that a woman knows that she is pregnant it may be too late for folic acid to be effective. Reaching those women remains a challenge. That is why there have been calls for food fortification.

The Department asked its advisory committee—the Committee on Medical Aspects of Food Policy—to consider the dietary intakes and nutritional status of the population with regard to folic acid, with particular reference to its contribution to preventing disease, and to make recommendations.

The Government decided to consult on the recommendations in the report, as a number of other options were also outlined. Consultation took place between July and October 2000. Views were sought on whether universal fortification of bread or flour was desirable, whether any such fortification should be mandatory or voluntary, and the practicalities of fortification. That consultation also sought views on wider issues, such as the impact of the recommendations on consumers and consumer choice, food labelling and technical issues for the industry.

A summary of responses to the fortification consultation was posted on the Department of Health website in July 2001. There were 167 respondents to the consultation, including people from academia, consumer and expert groups, trade organisations and individual companies, health authorities, local government and individuals.

The consultation was complex, and the responses raised a number of issues. Although the majority of respondents—59 per cent.—were in favour of fortification, that was not overwhelming. The most common concerns expressed were about the potential risks of fortification, especially the risk of vitamin B12 deficiency among older adults. A significant number felt that sufficient information was still not available about the possible adverse effects.

Other concerns were about the possible restriction of consumer choice. Almost 80 per cent. of respondents felt that it was important to maintain an element of consumer choice. Another issue was how fortification would be managed, and 85 per cent. felt that there should be restrictions on the level of fortification or the types of foods fortified. Respondents from industry also stated that technical problems may be associated with any mandatory policy.

All those concerns demanded further exploration, and the Department and the Food Standards Agency commissioned relevant research and undertook further work to formulate firm policy options.

As with any public health policy, we need to balance benefits against risks. Although the benefits for women of child-bearing age are well established, it is clear that in the opinion of many the potential risks, particularly the risk of B12 deficiency in older people, are not. Therefore, the Government did not feel that it was right to make a decision without further work on this and other issues. I shall explain what we have done in the intervening period and the stage we are at now.

It is known that high levels of folic acid can make it difficult to diagnose vitamin B12 deficiency. Severe deficiency of vitamin B12 has two main effects: it can cause anaemia identical to that of folate deficiency; and, with prolonged deficiency, it can cause damage to the nerves and the spinal cord, leading to severe disability. The anaemia usually appears first, and thus allows early detection of vitamin B12 deficiency before any nerve damage occurs. Older adults are at greatest risk of B12 deficiency as they are less able to absorb the vitamin from foods. There is, therefore, concern that increased fortification of foods with folic acid could increase the number of older people at risk of undetected B12 deficiency.

The level of fortification suggested by COMA, at 240 micrograms per 100 g, was designed to minimise the number of older people at risk of having high intakes of folic acid. COMA estimated that approximately 0.6 to 1 per cent. of older people could have intakes of folate high enough to mask B12 deficiency if all flour was fortified. However, information on the true prevalence of B12 deficiency was unknown at the time of the consultation, and it is only with that information that we can estimate how many individuals could be at risk of B12 deficiency. I am pleased to say that research on the prevalence of B12 deficiency and its diagnosis among adults over 65 years of age was commissioned by the Department and has now been completed. The work addressed the prevalence of vitamin B12 deficiency in older people, the most appropriate methods to diagnose it, and the feasibility of its routine identification in older people.

That research is awaiting publication and, as a result, I am unable to release exact details of the findings. However, the results are in line with COMA in as much as that fortification would increase the risk of B12 deficiency among a significant number of older adults. To make full sense of the findings on the prevalence of B12 deficiency, a cost-benefit analysis has been carried out by the Department of Health.

Preserving consumer choice was a significant issue for many people—almost 80 per cent. of respondents. Many responses suggested various options for certain types of bread which could remain unfortified. The Food Standards Agency therefore undertook some statistical modelling to look at consumption patterns and what effect those various options might have on folate intakes. The agency has also been addressing other issues of particular concern to consumers, such as the labelling of fortified foods.

Issues have also been raised on the technical aspects of fortification which need consideration. Many responses from industry pointed to the complexity of the technical processes. Folate added to flour is lost to some extent during processing. The amount lost is known to vary substantially between products and, as a result, it could be difficult to achieve a specified target amount in foods as consumed. Respondents from industry also highlighted problems around the fortification of wholemeal flour, to which no vitamins or minerals are generally added at present. To address those concerns, the Food Standards Agency has conducted detailed discussions with industry so as to ensure that any action proposed would be feasible.

In addition, the Food Standards Agency has assessed various legal aspects of fortification. Those include the public health justification under article 30 of the EC treaty; the terms of the notification under the treaty to the European Commission and member states; the use of powers under the Food Safety Act 1990 to control fortification levels; and issues under the Human Rights Act 1998, relating in particular to consumer choice.

The information gathered from that extra work has now been collated and is being considered. As my hon. Friend may know, that has been a UK-wide exercise carried out jointly between the Health Departments and the Food Standards Agency. Ministers from all the UK Health Departments will therefore need to consider the issue. As part of that, there will also be a formal recommendation from the Food Standards Agency board to Health Ministers. My hon. Friend may be reassured to learn that I understand that the Food Standards Agency board will discuss its possible recommendation at a meeting in the new year.

I hope that I have reassured Members, especially my hon. Friend, that we have been taking the issue seriously and have considered the issues in great depth. I am sure that hon. Members will agree that the issue is complex and it is important to make the right decision on a fortification that could have wide-ranging implications, both beneficial ones and ones that should provoke further consideration.

I remind Members that we continue to encourage women planning to become pregnant to increase their folate intake, including the use of supplements. We also support the folic acid flash scheme which helps consumers to identify foods that have been fortified with folic acid. I am pleased that we have had the opportunity this evening to address the issues, to allow the Government to lay out the action that has been taken and to reassure my hon. Friend that we take the issue very seriously.

Question put and agreed to.

Adjourned accordingly at half-past Ten o'clock.