Dietary Supplements

HL Deb 25 May 1999 vol 601 cc843-60

7.26 p.m.

Earl Baldwin of Bewdley rose to ask Her Majesty's Government what steps the Department of Health is taking to preserve the public's access to a full range of safe dietary supplements.

The noble Earl said: My Lords, I believe this Question is timely. From the speakers' list it also seems to be popular. A number of issues are coming to a head, as we shall see in the course of our short debate this evening. There are many worries about the future of vitamin, mineral and herbal supplements, and I hope the Government will be able to give us some reassurances about their intentions.

In the time available I cannot hope to cover the whole field. I speak from the patient's perspective, as befits a patron of the Natural Medicines Society and an admirer of the work of Consumers for Health Choice, two organisations which I believe represent the patient's interests on this subject more closely than does the Consumers Association. I do not have to tell the noble Baroness who is to reply what a depth of feeling there is in the country. She will know that a march to Trafalgar Square has been planned for 20th June. Her department will not have forgotten the tidal wave of protest that struck when herbs came under threat in 1994. The Vitamin B6 debate may have gone off the boil since last summer, but it is still simmering.

This last issue, with its involvement of expert committees under both the Department of Health and MAFF, illustrates the heart of the difficulty we face. We have come a long way since Hippocrates said: Let your food be your medicine".

When the medical press publishes trials on broccoli and garlic, it makes a mockery of the distinction between medicines and foods; yet this is the situation we have, where each substance is assigned to its legal category alongside thyme or thalidomide. All substances along this continuum have a physiological effect. I am not of course arguing that drugs such as AZT should not be assessed with the utmost rigour, and that something different is not needed for vitamin A. But it is the middle ground that causes trouble, and the spur for my Question today is the proposal of the Medicines Control Agency to amend regulations concerning the borderline area under the consultation document MLX 249, whose final format we expect in the very near future. Perhaps the noble Baroness will be able to give us a date for this. Together with the implications of MLX 249 we need to look at the longer-term future of supplements in the European context, and how the Government see the interests of patients being best preserved. And the picture is not complete without some consideration of the work of the new ad hoc expert advisory group on vitamins and minerals.

I am not one of those who sees the MCA's latest proposals as a prelude to the wholesale destruction of the vitamin and mineral market through their reclassification as medicines. I accept that that is no one's intention. Nevertheless, there are serious concerns about MLX 249, which the noble Baroness is aware of and which I hope other speakers may have a chance to develop. These centre on the powers proposed for the MCA in its enforcement role, which may add clarity and openness but which do place manufacturers at an unfair disadvantage in terms of burden of proof and challengeability on the merits in a court of law, while at the same time giving the agency the powers of policeman, judge, jury and Court of Appeal. On that last point I can see no good reason why the MCA should constitute the appeal panel since it is not merely technical expertise that is needed on appeal: the requirement is for independence and transparent justice (with of course technical advice available if needed). The worry is compounded by the agency's recent tendency to reclassify formulations as medicines whose individual elements have already been accepted as foods. There have been hints that the Government may be rethinking the MCA's powers in the light of comments received, and it would be good to know if this is the case.

I have two further questions about MLX 249. In a helpful response by the MCA to the concerns already voiced, it is stated that, the proposals would not change the status of products which are correctly classified now as food supplements". The importing of that word "correctly" rather begs the question, for the MCA has only to decide that a supplement is incorrectly classified for us all to be back at square one. The phrase sets alarm bells ringing, and it would be good if the noble Baroness could switch them off for us. My second and more fundamental question is that, while recognising that complaints and pressure from Europe lie behind these proposals, I wonder in fact why they are necessary, since I believe it can convincingly be argued that the MCA at present has all the powers it needs to enforce the law in this area. The Government may simply be making a rod for their own and everybody else's back.

Before turning to Europe let me refer to the work of the ad hoc expert group. This was set up last year, following the battle over the appropriate doses of B6, to consider safety levels for all vitamins and minerals. In contrast to many countries in the EU, this country has a tradition, supported by government, of being guided by safety considerations rather than perceived need based on a low-level recommended daily allowance, and for this we can be grateful. But within that there are some quite restrictive attitudes at work, as we saw with B6. I persist in my belief, which I have expressed in a number of Oral and Written Questions in your Lordships' House, that the composition of our expert advisory committees is largely to blame, and that until the balance of medical/pharmaceutical interests is redressed among their membership, we shall continue to have problems. It is less the financial links than the culture of unfamiliarity with the workings of natural, unpatentable products that is worrying, and I believe we need further and more urgent steps in the direction of finding places on bodies such as the Committee on Toxicity, the Food Advisory Committee and the new ad hoc group for people from a different scientific as well as lay background.

I mentioned that most European countries saw things differently. This is not the place to go into the broadly similar worries over herbal remedies caused by the demands and definitions of European law, but I do want to pay tribute to the noble Baroness for the initiative she has taken to bring interested parties together to thrash out an agreed UK position as a basis for persuading the EU to harmonise along liberal rather than restrictive lines. This is most heartening. But I also want to point out that unless we do the same exercise with dietary supplements we may be in similar trouble. Revised proposals for European legislation are expected at any time. We can keep up the pressure from the UK to have these classified according to upper safety levels, which is not proving an easy task. But we need more than this.

At the moment, unless a supplement is clearly a food it is in a vulnerable position. Neither under existing regulations nor under MLX 249 is there any certainty how a product will be categorised, for although this may be a matter of "law, not policy" as the Government emphasise, it still comes down to the MCA's interpretation. If the agency says it is a medicine, the costs of licensing are usually more than an industry which deals in unpatentable products can bear. What is more—I believe the noble Baroness is sympathetic to this argument—to keep within food law you cannot use any medicinal language at all. You cannot, for example, say, "Do not drive or use heavy machinery when taking these"; you cannot even say of vitamin C, "Helps to prevent vitamin C deficiency"! Patients are thus in many cases denied information they need.

When we discussed this briefly earlier in the year the noble Baroness said she was keen to work with the Parliamentary Group for Alternative and Complementary Medicine (which I chair) to find a solution. We have been doing some thinking and consulting, particularly in the area of creating a possible "third way" for supplements and perhaps traditional remedies which can demonstrate safety without needing to go through the hoops of a full medicinal product licence. There are a number of ideas in the field. I speak for the responsible and representative end of complementary medicine when I say that we give no credence to the ideas she may have seen put forward by the Institute for Complementary Medicine, which, with its associated practitioners' council and register, has always been a body more concerned with self-promotion than genuine dialogue, and whose views on matters of policy command little respect. We must look elsewhere for solutions. Australia, Canada and the USA have developed licensing policies which are worth studying. I would urge the noble Baroness to take the lead, obviously in conjunction with her colleagues in MAFF, in bringing the players together in the way she has so admirably done with herbal medicines. There is much work to do, and if we are to persuade our European partners—we all know this will not be easy—we need to get moving soon.

This Government are well placed to steer us through these difficult questions. They have shown a welcome appreciation for public health and preventive healthcare. They have a public who are little short of passionate about so-called natural remedies. They owe it to them to encourage and not undermine self-reliance in health matters, and to show the way in Europe. They have made an excellent start with herbs. Will they now do the same with supplements?

7.36 p.m.

Lord Colwyn

My Lords, in view of the severe time limitations this evening I had hoped I would not have to thank the noble Earl, Lord Baldwin, for introducing the debate this evening, but he covered the subject with great skill and posed some interesting questions. Before I start I declare an interest as president of the Parliamentary Group for Alternative and Complementary Medicine and president of the Natural Medicines Society.

At present, vitamins, minerals and other food supplements are classed as foods and are currently regulated under food law by the Ministry of Agriculture, Fisheries and Food. The debate about whether they should be regulated as medicines is not only taking place in the UK, but also in the rest of Europe.

Food supplements are a convenient way of safeguarding our intake of essential nutrients to maintain good health. They can contain vitamins, minerals and a range of other ingredients such as herbs, herbal extracts, essential oils, certain enzymes and amino acids.

People take supplements for different reasons, but the main one is to maintain good health as a form of health insurance. In an ideal world it should be possible to obtain optimum nutrition from the food we eat. A diet as near to that which existed before industrialization—avoiding refined and processed foods—would be ideal, but is not always possible to achieve. For many years it has been suggested that good health depended on being able to eat five servings per day of fruit and vegetables. This is possible for your Lordships in the excellent outlets of the Refreshment Department, but not possible for others whose diet may not include the correct amount of vitamins, minerals, enzymes and amino acids. Food supplements are a simple solution.

As supplements are considered to be foods in the UK, they must conform to all food law and contain safe levels of vitamins, minerals and other substances. The limits from nutrients are established by the Council for Responsible Nutrition, which represents manufacturers. But that does not work within the European Union, where varying national laws create an enormous barrier to trade, conflicting with the role of the European Commission, which is to ensure free trade. That has been discussed in Europe since 1988 without any decision, a final paper being issued in 1997 which addressed the issues for a European-wide policy.

One of the primary aims of the Natural Medicines Society has been to work for appropriate evaluation criteria for natural medicines. Although vitamins and supplements do not fall into that category yet, it does appear that present moves from the Medicines Control Agency will remove them from food law and put them in the position of needing a medicines authorisation.

I hope that the Government will seek full consultation with the health industry and consumer representatives in order to develop what used to be called borderline product legislation but is now being termed a "Third Way" option. Consumers' rights to have access to all forms of natural health products must be protected. It is important to realise that medicine and healthcare are not one option but that there are many choices for the treatment and prevention of illness.

7.39 p.m.

Lord Addington

My Lords, I wish to change tack slightly in this debate and try to concentrate on the types of food supplement which generally come under the heading "sports medicine" and are used within that field. A great deal of time, money and indeed misinformation is being pumped into the general public that tells them that if they take something which always has something like "anabolic" in the title at the back or the front, but never "steroids" with it—steroids might come into another product but are actually the same thing—they will get bigger, stronger and faster.

Most of the information which I have acquired from the various sports medicine bodies suggests that most of the claims are false. Sports medicine is an area which has become incredibly fashionable. Indeed, the male part of our society has suddenly been barraged with advertising with which the female part of society would be much more familiar. For instance, these products are advertised in magazines with words like "Fitness and Health" or "Health and Fitness" worked into the title, and a picture of somebody parading a six-pack stomach on the front and smiling. Most of the products do not work. They are telling us lies. The Government should be trying to get a handle on this type of promotion.

Most of what has been said, and undoubtedly will be said in this debate, will concentrate on such things as vitamin supplements. Everybody I have spoken to on this subject has said that vitamin supplements are a safeguard for the vast majority of the population who can eat properly. For people who have a deficiency either through ill-health, accident or bad diet they can be a life-saver. They can change the way you think. For most people they are a guarantee. For athletes who are pushing themselves to the limit they may well be a necessary support issue. If you are pushing your body to the limit it is close to breakdown: that is a fact. For most of the area which we are talking about here those types of supplements do not work. Indeed, as Professor Maughan of Aberdeen University put it to me, if it works and builds up muscle—and definitely it is muscle-building where most of these claims are made—it does not work. The new product keratin, which has been explained to me, is a distillation of meat, does work if you happen to be doing power events, but you cannot ban it unless you are going to ban meat eating, although one or two might be in favour of that. The farming lobby may have a word or two to say on that subject.

What we are talking about here is a situation where a large section of society is being fed a steady diet of misinformation. I do not have the time to go into this. Like everybody else here, I had a much longer speech, but I hope that we will have the opportunity to go into this question further later on.

7.42 p.m.

Earl Kitchener

My Lords, we suffer from too many rules but some are more objectionable than others. In the context of this debate the objectionable ones are those which make it a criminal offence to sell something against which there is no strong evidence of danger. The unobjectionable ones are those which force informative labelling about dangers, as is already done with tobacco. Contra-indications could also be shown.

There is a reluctance to accept the idea that any increase in minerals or vitamins beyond the recommended dietary allowance may be beneficial; but unless they are allowed we shall never learn their effect. It is sometimes said that one should consult one's doctor before taking supplements. That would be true if there were more doctors and a better established body of knowledge about our nutritional needs, and also of course if the doctors knew all the established knowledge.

An important question is, is there a body which might be called "the establishment" which is unwilling to be seen to be linked to anything unorthodox, particularly when it goes against what they or their colleagues have said in the past? When I first became interested in supplements I was unwilling to think this, but there does seem to be a reluctance to do research into the effect on health and behaviour of diet even when there is considerable anecdotal evidence in favour of a supplement. I therefore echo the words of the noble Lord, Lord Colwyn, and urge Ministers to consult widely before making decisions in this area.

Vitamin B6 is a case in point. The danger from high doses only justified a warning and a repeat of the work of Dalton and Dalton which was about the only evidence against it. In the event much effort was needed to get the proposed ban dropped or at least delayed.

I see I have not exhausted my time, so I will add a rather different sort of supplement, which is fluoride and its supposed good effect on dental decay. That is a very well established and orthodox opinion, but I recently read an article from New Zealand which pretty well convinced me that it was not so. I have written to the Dental Association asking if they have any countervailing arguments, so I hope to learn something about it. That may turn out to be an example where entrenched opinions have been very slow to change.

7.46 p.m.

The Countess of Mar

My Lords, I am grateful to the noble Earl, Lord Baldwin, for tabling this Question. I should declare an interest. I am chairman of the Environmental Medicine Foundation and I have been prescribed dietary supplements by a registered medical practitioner for several years and believe that the restoration of my health after I suffered the effects of exposure to organophosphates can be attributed in the main to the supplements.

It is clear that there is an impelling need for the legal standing of dietary supplements to be clarified. There is a great deal of disquiet about the present activities of both the MCA and the Expert Group on Vitamins and Minerals. I know the noble Baroness the Minister is aware of the United States' Dietary Supplement Health and Education Act of 1994. If we can overcome the over-riding desire for more stringent legislation from the European Union and the dictatorial tendencies of the Medicines Control Agency, I can see no better model for legislation. It defines dietary supplements; it has a mechanism for dealing with the safety issues; it regulates health claims and labelling; it provides for good manufacturing practices, and has established new government entities to review regulations and encourage research on dietary supplements. When he signed the Act, President Clinton said: 'After several years of intense efforts, manufacturers, experts in nutrition, legislators—acting in a conscientious alliance with consumers at grass roots level—have moved successfully to bring common sense to the treatment of dietary supplements under regulation and law. The White House press release concluded: In an era of greater consciousness among people about the impact of what they eat and how long they live, it is appropriate that we have finally reformed the way government treats consumers and supplements in a way that encourages good health We have seen from the outrage expressed by consumers following the proposal to limit general sales of vitamin B6, and the alliance which has been formed between consumers and manufacturers of dietary supplements in this country, that consumers neither want nor see the need for what they regard as excessive control in this area. They perceive that it is the pressures from the pharmaceutical industry creating a situation which led to the issue of the now notorious statutory instrument by the Medicines Control Agency.

I have given the Minister a copy of the summary and analysis of the American Act by the US Council for Responsible Nutrition. As time is short I will ask her to consider it with her usual diligence and, most importantly, to insist that good sense prevail in her department and in the Ministry of Agriculture, Fisheries and Food in its dealings with the proposed EU, as well as domestic, legislation. It would also be helpful to align the UK with the Codex in this field.

7.49 p.m.

The Earl of Clanwilliam

My Lords, I must declare an interest as a director of Culpeper. We have shops selling herbal products and aromatherapy oils. I am also a patron of the Herb Society and president of the Association of Traditional Chinese Medicine, for which your Lordships will be grateful.

As can be imagined, with that background I am very concerned, as is the whole alternative arid complementary medical fraternity, at the proposed MCA statutory instrument labelling herbs as medicines by virtue of their very existence. Will the Minister first, confirm whether that is the real intent, and secondly, that under EC law it is the responsibility of the UK Government alone to make such decisions as are necessary to implement that law?

My main concern revolves around the composition of the MCA. That the members are all experts in their field is beyond doubt. The field in which they exercise the greatest expertise comprises the products of the pharmaceutical industry and the clinical trials that prove the products deriving from the extremely expensive research in which the industry invests. But—dare I say it?—they do not have any great expertise in the many fields that comprise the alternative and complementary healing and curing disciplines. For instance, the concoctions and decoctions supplied by the practitioners of herbal medicine, as approved by the National Institute of Medical Herbalists, do not respond to clinical trials as practised in the pharmaceutical industry. To that extent, therefore, we are not represented in the thinking and the decisions of the MCA as it is presently instituted; nor with the ad hoc expert advisory group. In what fields, may I ask, are the members of that group expert?

In the meantime, the Committee on Toxicology has shown itself to be unfamiliar with the subject of vitamin supplements, as other speakers have said. Therefore, it seems to me that there should be a new and separate committee chaired by the same officer and containing only peer group representatives of these alternative and complementary disciplines, thus leaving the present organisation to continue with its interest in the pharmaceutical industry.

I recall the now famous remarks of the Select Committee on resistance to antibiotics. Its opening conclusion was: This has been an alarming experience, which leaves us convinced that resistance to antibiotics and other anti-infective agents constitute a major threat to public health, and ought to be recognised as such more widely than it is at present". That can hardly be called an encomium on the work of the MCA. We have only to recall some of the post-war disasters to realise that none of them could be laid at the door of alternative and complementary disciplines and that they were the product of modern medicine. Surely, there is a case to separate the warring factions and look at alternative and complementary medicine from the standpoint of the practitioners.

There is a wealth of knowledge accumulated over centuries which is available in text and evidence and should be considered by a committee composed of the peers of the disciplines involved. Many of the products and materials defy scientific analysis and their effects are beyond the comprehension of the scientific-based mind.

In answer to a question from the noble Earl, Lord Baldwin of Bewdley, on 19th May, the noble Lord, Lord Sainsbury of Turville, made this very point in suggesting that there was a difficult problem in finding experts of a scientific background to judge the processes of the alternative and complementary industry. Perhaps I may point out to the Minister that she has only to look at the committees of alternative complementary therapies to find these experts. These disciplines have been in use for hundreds of years in Europe and, in the case of herbalism and acupuncture, for thousands of years in China. As noble Lords will know, for I have said it before in this House, modern Chinese medicine involves three disciplines—modern, herbal and acupuncture. Every hospital case is reviewed in the light of the treatment or combination of the three treatments that would be suitable for each individual case.

We should take a leaf out of their book and broaden the approach to alternative and complementary processes and materials. I hope that I have made a case for a new approach to alternative and complementary medicine. I urge the Minister to press for a reform of the investigative procedures of the MCA.

7.53 p.m.

Lord McNair

My Lords, I, too, am most grateful to the noble Earl, Lord Baldwin, for giving us the opportunity to debate this subject which I feel is of crucial importance. It is of crucial importance from a human rights perspective. It is about freedom of choice and the right of people to make their own decisions and take responsibility for their own health. It is also about big business breathing in the ear of big government.

The purpose of the moves to reclassify, which other speakers have mentioned, is quite simply big business seeking to get more big business. What I am going to describe to noble Lords next casts serious doubt on whether the pharmaceutical companies, which are behind these moves, can be trusted to behave in an ethical fashion. Only last week, two very large European drug companies were fined a record 725 million dollars in the United States and a Swiss executive was sent to prison for participating in a nine-year, world-wide conspiracy to control the market in vitamins. Roche of Switzerland agreed to pay 500 million dollars—the largest criminal fine in the United States—and BASF was fined 225 million dollars for their joint roles in the market-rigging cartel. A third conspirator, Rhône-Poulenc of France, escaped criminal punishment under an amnesty deal by supplying US prosecutors with the evidence that cracked the cartel.

A few years ago, I remember being lobbied by Rhone-Poulenc, which took the trouble to write a letter to me—indeed, I am sure the company wrote to many other noble Lords and Members of the other place—claiming that soggy white bread was just as wholesome as wholemeal bread. I have to say that I was not convinced.

When one considers that BASF was one of the members of the IG Farben cartel that funded Hitler, spied for him and manufactured chemicals with slave labour at Auschwitz; when one considers that the German Government, with the World Trade Organisation, sponsored the conference of major drug companies in 1995 that created the Codex Alimentarius that is behind the moves to which the noble Earl and others have referred, it really makes one ask whether the leopard—or the panzer—has changed its spots.

This issue is a test of the democratic credentials of the new Europe. If governments buckle and capitulate in the face of such pressure, there is little hope that the promises and hopes of a better life for Britons in Europe will be fulfilled.

I sincerely hope that my noble friends will take this issue on board. We are the only party that has seriously confronted the democratic deficit in Europe. We are absolutely right to do so. The issue which the noble Earl has raised this evening is exactly the sort of issue on which the European institutions seem powerless to protect Europe's citizens.

7.56 p.m.

Lord Lucas

My Lords, I urge the Minister to take courage and adopt self-belief. This is exactly the sort of situation where politicians count and where they make a difference. There is no firm line between food and medicine. Red wine is one of the great medicines of the world and some things sold as medicines do us remarkably little good, except to provide a little bit of energy. Political judgment and commonsense judgment are what counts. Behind its monopoly barriers and protection of patents, the great pharmaceutical industry operates a system in which it has to invest a great deal of money into a product; it then gets a great deal of money in return. It naturally does not chime with unpatentable products, but that is what we are dealing with in this area.

We cannot even think of imposing the sort of controls on this area that we impose on the pharmaceutical industry. However, at the same time there are abuses. There are people who are taking advantage of the situation to sell the public products which do absolutely no good at all. I quite agree with the noble Lord, Lord Addington: anything that makes him bigger, stronger and faster ought to be banned.

It is important that advisory committees contain an element of common sense. Collections of scientists are inevitably connected with the industry but, beyond that, they do not have enough experience of the outside world. I was in MAFF long enough to see committees made up of excellent people who knew their subject extremely well. But I can remember seeing some of those people running around in panic, like chickens faced with a fox, because they were being asked to take political decisions, which should not have been theirs to take. Such committees are advisory committees and they should be treated as such by Ministers.

However, beyond anything else, there should be justice. There should be a system whereby if a company is adjudged to have stepped on the wrong side of the line and a product is effectively banned—that is what happens if the product is made to go through all the hoops in terms of proving its safety, which it cannot do commercially—there should be a sensible and convenient method by which that decision can be appealed to someone independent. That is what has concerned us most about the MCA approvals. I hope that the Minister will have some words of comfort for us this evening.

7.58 p.m.

Lord Thurlow

My Lords, we see the Minister as a warrior campaigning and fighting on two separate fronts. The problem without is Brussels; the problems within are the limitations and the flaws that have been ventilated this evening in the context of MCA advice.

I should like to focus my few remarks on the proposed MLX 249 regulation. The litany of criticism of the MCA adds up to a serious threat to the liberties of small producers. They are liable to be forced out of business for no reason of public interest and, as has been pointed out tonight, this is basically due to the unremitting pressures, both in Brussels and at home from the pharmaceutical companies. I am sure that there are other ways of dealing with the legitimate interests of harmonisation without pursuing the present proposals. I ask the Minister to delay matters with regard to MLX 249 and to require the matter to be given further thought.

MLX 249 is seriously flawed. The reversal of the burden of proof with regard to the nature of a product is itself contrary to natural justice. The MCA itself admits that the required proof would be almost impossible to obtain. There is the question of procedures for appeal that have been mentioned. The idea of asking small specialist firms—who are often the best producers—to pay licensing costs of between £5,000 to £87,000 is atrocious.

I was interested in the recent publication of Australia's proposals. I hope that the department will consider those carefully. In conclusion 1 ask the Minister to delay the matter of MLX 249 to arrange serious reconsideration to seek a quite different approach. We are all behind the Minister in her work, which vie greatly admire.

8.1 p.m.

Viscount Falkland

My Lords, so far we in this country have been fairly relaxed in our attitude towards supplements of the kind that we are discussing this evening. I say this against a background of fairly imminent legislation from Europe and the proposals of the Medicines Control Agency. As the noble Earl has already said in his introduction to this debate, foods of these kinds must be safe as foods, and of course it is not permitted to include any medicinal claims which make labelling difficult. However, these products are becoming increasingly popular and many people are making a great deal of money out of them. Far be it from me to say that they are doing no good at all. What concerns us on these Benches is whether some of them may be doing harm. The noble Countess, Lady Mar. has spoken of the benefits that she has derived from the products which she has tried.

I refer to a consultation paper by the European Commission on dietary supplements and proposals by the MCA to put the decision of what is or is not a pharmaceutical or herbal supplement on to a statutory basis. There is also the row about Vitamin B6—which is on hold at the moment—which concerns the safety of vitamins. The MCA is also reviewing herbal medicines exemptions which the noble Baroness may mention. We on these Benches take a fairly relaxed view on these matters. We pose the question as to what level of consumer protection is needed. In the light of the fears expressed by other noble Lords, are the proposed new regulations necessary or do they constitute unnecessary interference? I detect from this debate a feeling that we are in danger of facing unnecessary interference in this area.

The code of practice of the Food and Drink Federation on health claims of food contains an interesting and, I think, positive suggestion; namely, to make a distinction between foods which try directly to prevent illness and those which are termed "health foods" and offer a possible reduction of risk. That seems to us to be a sensible suggestion. I understand that the Government have sought a legal opinion based on human rights legislation as to the position in cases of appeal where producers are judged to be producing medicines rather than health food supplements. Can the Minister tell me what stage this legal consultation has reached?

8.5 p.m.

Lord McColl of Dulwich

My Lords, one of the problems with this whole subject is that there is far too much pontification by people who make extravagant claims from their rather poorly founded research work. There are also too many people who are obsessed with controlling too many aspects of our lives. Some of the homeopathic medicines have been found on good scientific research to be of real value. Liquorice, foxglove and all kinds of others spring to mind. However, the problem with many homeopathic medicines is that they are not subject to any controls and it is possible that some of them may be harmful. On the other hand, it can be argued that they do probably less damage than some of the powerful orthodox drugs.

So far as food supplements are concerned, we certainly want to resist the temptation to start controlling vitamins. There was a scare over Vitamin B6 which has been mentioned but that scare was based on research which has now been shown to be defective. The water soluble vitamins on the whole are safe, even in high doses, because they are quickly eliminated from the body and are not stored in a harmful way. But the fat soluble vitamins, A, D, E and K, on the other hand, if they are taken to excess, can undoubtedly cause problems.

The history of Vitamin E is an interesting and rather sorry tale of claim and counter-claim. In the 1940s the Shute brothers on the American continent published work showing that Vitamin E was good for patients with cardiovascular disease. However, this was debunked a few years later and the official view became that Vitamin E was good only for sterile rats! As it has turned out now, many years later, Vitamin E has been found to be of value in preventing and treating cardiovascular disease. There are a number of good studies which show that it will produce a 45 to 50 per cent reduction in heart disease. In those patients who have established heart disease, treatment with it for nine months will improve symptoms and produce a 70 per cent reduction in cardiovascular deaths.

As has already been mentioned, there is a plan from the Medicines Control Agency to classify such products as "medicinal in function". The task of the MCA is to determine whether a product is or is not a medicine and to ensure that products which are classified as medicines are safe. If the MCA decided to classify such products in this manner, stricter controls would have to apply to their usage. The food supplements and homeopathic medicines would have to overcome an efficacy hurdle and it would have to be proven that there were at least some beneficial effects of using them; and satisfying this criterion would, in some cases, be costly for the manufacturers. I am sure that everyone believes that safety of customers must be the paramount consideration. Any substance, no matter how it is classified, should be subject to removal from open sale if it is proved to be harmful. But any such judgment must be based on sound science, not on anecdotal evidence.

It is, of course, essential that consumers should be protected from any harmful effects of homeopathic medicines or food supplements, but their regulatory framework should not have the effect of removing from sale products that, first, are perfectly safe, secondly, make no unjustifiable claims about effectiveness, and, thirdly, are widely used and popular. The present proposals, I am sure, are well intentioned, but they may be in danger of using a sledgehammer to crack a nut. The regulatory burden regarding such products must be proportionate to the risk, and should be implemented with as light a touch as possible.

We question whether the MCA should be effectively judge, prosecutor and jury in its own causes, and whether it is sensible to classify everything either as a food or as a medicine. I look forward to hearing what the Minister has to say about this.

We must make it clear that we support the view that when claims of therapeutic efficacy are made for food supplements they must be justified.

8.10 p.m.

Baroness Hayman

My Lords, I should like to add my congratulations to the noble Earl, Lord Baldwin, on obtaining the opportunity to debate these issues. I am very well aware of the depth of concern about the subject of dietary supplements, on which people throughout the country, as well as Members of your Lordships' House, have very strong views. Were it not for the noble Lord, Lord McColl, I think the whole debate would have been conducted between hereditary Peers. It is obviously, therefore, a matter of particular interest to them. I am sure that there is a Ph.D thesis to be written on the connection, but not by me.

I am truly grateful to the noble Earl, not only for introducing the topic, but for doing it in such a considered and very generous way, and for giving me the opportunity to restate clearly the Government's policy towards dietary supplements. I hope also, as he suggested, to give some reassurance on some specific areas and to correct some of the very widespread misconceptions that there have been, particularly around the consultations on the document on MLX 249.

I should say at the beginning, in response to points made by several noble Lords, but particularly by the noble Earl, Lord Kitchener, that the Government are in no way opposed to the use of dietary supplements. On the contrary, for example, we actively encourage women who are planning to become pregnant to take folic acid supplements in order to reduce the risk of neural tube defects in the developing foetus, and we recommend that the elderly, and in particular those who are not exposed to adequate sunlight, take vitamin D supplements.

We also recognise that supplements can provide a useful function for those who do not eat a balanced diet—a point that has been made in tonight's debate, although, in practice, research shows that those most likely to take supplements are also those least likely to need them. That is an issue that we have to look at. Nor would we wish in any way to destroy the market for supplements. However, we have a duty to ensure that the law regulating their sale is properly enforced. More importantly, we need to be satisfied that the ever-increasing range of supplements now appearing on the market does not pose a risk to consumers. We must maintain the balance between the Government's responsibility to ensure that public health and public safety are protected and their responsibility to ensure that there is adequate choice and freedom for those who wish to use such products.

Dietary supplements, are not, of course, defined in law. Food products which are not covered by medicines legislation are subject to food law and are regulated for the Ministry of Agriculture, Fisheries and Food by the trading standards departments of local authorities. I advise the noble Lord, Lord Colwyn, that the Government's policy is that consumers should continue to have access to the full range of safe dietary supplements. We have stated very clearly on numerous occasions, as I wish to do again tonight, that we have no plans to shift the borderline between foods and medicines. We believe that the level of vitamins and minerals in supplements sold under food law should be limited only in cases where this is necessary to protect public health, and that any limits should be based on safety considerations. We have made this view very clear to the European Commission and other member states within Europe.

I turn to the issue of herbal medicines and herbal remedies. The noble Earl, Lord Baldwin, referred to what I think is a growing consensus among those operating in the natural health sector about the need for a new approach on herbal products, one which balances consumer safety and consumer choice, is tailored to reflect the particular characteristics of herbal medicines and avoids the over-regulation to which some noble Lords referred. I am very aware of the question that has been raised about the potentially very large licensing cost were we to subject herbal remedies to exactly the same medicines regime as other pharmaceutical products.

I believe that it is possible to take this work forward, consulting widely with the interested organisations, and to reach a solution that balances the need for safety, which has been acknowledged throughout the House, without imposing on those involved in the production of herbal medicines an inappropriately rigorous licensing regime.

We need to avoid wrongly classifying any product, whether herbal or otherwise, as a medicine. But equally we have a duty to protect consumers and public health by ensuring that all medicines are appropriately classified as such so that the licensing and other legal controls can be applied. In contra-distinction to a dietary supplement, a medicinal product is defined in legislation and, as the law stands, products which are not clearly foods or cosmetics are medicinal products if claims are made for the treatment or prevention of disease, or if they may be administered with a view to restoring, correcting or modifying physiological functions. Such a product is subject to UK and EC medicines legislation and normally requires a marketing authorization—that is, a licence—before it can be sold or supplied.

The noble Lord, Lord Addington, referred to sports medicines or supplements. Such products are borderline. If they merely make a health claim that they will make one fitter, they will be not a medicine, but a food. If the claims go further and are medicinal in nature, they should be regulated as medicines. That illustrates some of the difficulties in making these distinctions. But I assure the noble Lord that the MCA would certainly consider any such products brought to its attention if there were particular concerns, although once again I am very aware of the concern that we are being over-zealous in terms of enforcement.

The MCA has a duty, on behalf of the licensing authority, to implement and enforce the provisions of medicines legislation. Part of that duty is to decide whether a product is or is not a medicine. The criteria by which the MCA makes those decisions are a matter of European Community law. The MCA's purpose is to protect public health, and specifically to make sure that medicines are safe, of high quality and effective. The proposals in the document on MLX 249 are intended to ensure that the agency gets those decisions right, and in a transparent, open and fair way. As the Minister with responsibilities in these areas, I am of course aware of the concerns generated by the proposals, but much of the criticism has, I believe, misrepresented the aims and effects of the proposals and has been an unwarranted cause of worry to many people.

Perhaps I may say clearly to the noble Lord, Lord McNair, that there is no connection between the MCA proposals and the Codex Alimentarius Commission; nor is there any truth in the statement that those proposals were prompted by the pharmaceutical industry.

I should like to say also that the consultation has been genuine. The Government have listened and I am determined to meet the genuine concerns which have been expressed about some aspects of the package not only during the consultation process but this evening in your Lordships' House.

I was asked specifically by the noble Earl, Lord Baldwin, about timing. I hope that we can have a clear set of decisions by the end of June; and develop guidance and constitute the review panel with a view to laying regulations in the autumn. The reason for that timing is to make sure that we do not run into the difficulty of laying regulations during the Recess which I do not believe would be regarded as satisfactory.

As I said, we have been listening. The noble Viscount, Lord Falkland, asked about legal advice in that area. I can say to him that the legal advice is unequivocal: the proposals made are compatible with European law and with the European Convention on Human Rights. However, that does not mean that we should not look to see whether there are ways to meet some of the genuine concerns which have been expressed, if we can do so without compromising our objectives.

For example, I can confirm this evening that the MCA will give full reasons for its decisions at each stage of the process. I am looking also—I know that this is a matter of concern to many noble Lords—at how we can ensure that the members of the review panel who consider representations about provisional decisions should be independent of the Medicines Control Agency. I hope that that will be reassuring to noble Lords.

Equally. I assure the noble Lord, Lord Thurlow, that I want to look very carefully at the proposal that the MCA's decisions would be deemed to be correct in any subsequent court proceedings unless the manufacturer could show that the decision was unreasonable. That is another area in which I hope that we can find a way forward.

I should say to the noble Earl, Lord Clanwilliam, that in classifying medicines, the MCA will ensure that all relevant disciplines are involved. As I suggested earlier, the panel will be independent and will include representatives from relevant expert and lay backgrounds.

Reference was made by the noble Countess, Lady Mar, and several noble Lords to the different regimes in other countries existing in relation to the regulation of dietary supplements. The legislation for dietary supplements in the USA, and initiatives being pursued currently in Australia and Canada, have been held up as possible models for the development of such a regime. Although we have no plans to review the way in which supplements are regulated in the UK, we are following developments on those initiatives with interest. There are indications that the USA example allows some potent products—for example, herbal ephedrine—on to the market with very little control. Details of the new regimes in Australia and Canada have yet to be finalised, but it appears that both will involve pre-market assessment and licensing of products. Indeed, in Australia all supplements will be classed as medicines. If that is the case, the controls could be more restrictive than those which apply currently to supplements sold as foods in the UK but less onerous than those which apply under medicines legislation.

Any such change would require action at the European level. The legal position on border-line products is governed ultimately by the definition of "medicinal product" in EC Directive 65/65. There are no proposals to change that definition either by member states or the Commission. Should such a debate begin, I can guarantee that the UK would consult widely and participate fully in that.

The EC Commission has given no indication that it intends to review the definition of a "medicinal product", but it is considering the need for harmonisation of controls on vitamin and mineral supplements sold under food law. It issued a discussion document on that issue in June 1997.

We made it clear in our response that we should be prepared to support the introduction of harmonised controls if they could be justified on safety grounds to protect the public. We made it very clear also that any maximum limits on the vitamin and mineral content of supplements should be based on safety considerations and not on arbitrary multiples of the recommended daily allowance (RDA). Noble Lords have referred to that matter. We have emphasised the point in subsequent discussions with the Commission and representatives of other member states and will continue to do so whenever suitable opportunities arise. The Commission has not made any commitment to legislate in that area and it remains to be seen whether it will issue formal proposals.

The debate has covered a great deal of ground and I hope that I have been able to answer most of the points raised. If I have not, I shall certainly write to noble Lords.

I conclude by saying once again that the Government have no plans to change their policy towards dietary supplements. We are committed to protecting public health and protecting consumers with regulations which are proportionate and fair and which better enable the MCA to meet its regulatory and enforcement obligations. I assure the House that the Government have no intention of introducing regulations without first considering whether the proposals can not only meet their purpose but also address the legitimate concerns raised by those affected.

I give a further undertaking that our final proposals will go no further than is required by our obligation as the licensing authority to protect public health. Our aim to promote, both in the UK and in Europe, the regulatory environment in which safe supplements are widely available; the public is not put at risk or misled; and the law is effectively and promptly enforced. On that basis, I hope that noble Lords will feel reassured about the Government's policies in that area.