§ Motion made, and Question proposed, That this House do now adjourn.—[Mr. Dowd.]9.33 am
§ Mr. Mark Todd (South Derbyshire)
I am glad to see such a healthy attendance so early in the morning.
My motivation in choosing this subject for debate stems from two concerns. First, two companies in my constituency are manufacturers of herbal remedies, vitamins and minerals. One, a very small company, is worried about the potential impact of regulation of the sector that might affect its business. The other company is much larger, but its anxieties are real too.
Secondly—like, I am sure, many other Members—I have been lobbied by consumers in my constituency about last year's proposed reduction in maximum permitted levels of dosage of vitamin B6. I think that we all remember the postbags that we received then. As vitamin B6 was classed as a food at the time, the Select Committee on Agriculture, of which I am a member, reviewed the Government's proposals. Our firm view was that the proposed regulation of the dosage was unjustified. Such evidence as there was that excessive consumption might pose a risk had been heavily criticised by scientists. No one taking vitamin B6 had complained of ill effects, despite the massive publicity given to the subject for several months—and, internationally, for longer.
If, as was claimed, the issue was purely one of safety, there was no real evidence to support intervention. There are two possible grounds for intervention: safety and need. Is the product effective in meeting a person's requirements? Does anyone need it? Are unjustified claims being made about the need for it? Let us begin with safety, however. As the Committee's report observed, as a society we allow many items to remain readily available, their availability being restricted only by often ineffective measures to protect children from products that carry known risks, such as alcohol and tobacco. It has been clearly demonstrated—possibly even in the personal experience of some Members—that excessive consumption of alcohol can damage health; yet we still allow it to be freely available in shops, with no suggested dosage levels.
A doctor with whom I conducted a debate on the radio this morning ventured to express the view that sales of alcohol and tobacco should be banned. I suggested that such a programme might enjoy limited support among the electorate. We must make judgments about what is practical and also about what should be left to individual citizens to decide for themselves, on the basis of reasonable information that is available to them.
280 We also allow the sale of salt without warnings, although excessive consumption of it can do significant damage, and we do not try to restrict the size of packets available in supermarkets.
We need to consider the concept of risk. We all take risks, in almost everything that we do. We take risks when we eat and when we consume drugs prescribed by doctors. We take risks when we cross the road. Which of those risks is it our responsibility to judge, and in which cases should the Government try to help? One of the problems has been the failure to establish the philosophy on the basis of which we should make decisions. Should the Government decide what people ought to consume when they are feeling ill, or should individual citizens make judgments based on their own perception of their health needs?
We should measure relative risks. We should be clear about the kind and level of risk that we expect citizens to weigh up for themselves, the cases in which clear warnings are justified, and the cases in which society should expect Government intervention in the form of either restriction or a total ban. Because we have engaged in no proper analysis or debate, we act in an ad hoc and reactive fashion featuring glaring inconsistencies of approach.
The Government's response to the Select Committee report is directly relevant to today's debate. Let me quote some key passages. The Governmentaccepts the Select Committee's view that action on vitamin B6 should not be taken in isolation but in the context of the wider review of the safety of dietary supplements which is to be undertaken by the Expert Group on Vitamins and Minerals. The government recognises that the Expert Group will be considering the establishment of principles on which controls for ensuring the safety of vitamin and mineral supplements can be based.
§ Mr. John Hayes (South Holland and The Deepings)
I note what the hon. Gentleman has said about the expert group, although many in the health food industry are concerned about it. Will he, however, dissociate himself from the words of the Minister of State, Ministry of Agriculture, Fisheries and Food, who said that these were "drugs masquerading as foods"? Surely that compromises the work of the expert group before it has even begun.
§ Mr. Todd
My right hon. Friend the Minister for Public Health will have a chance to reveal the Government's position for herself. I will not be drawn into defending or otherwise a statement that I have not seen in context.
The response continued:The government agrees that there is a delicate balance to be drawn in this and other areas between regulation to protect the public and the desire to determine such issues on the basis of personal choice.It is for this reason that the government accepted the Select Committee's recommendation that action on vitamin B6 should be deferred pending the report of the Expert Group on Vitamins and Minerals.Essentially, the Government said that we have to understand the philosophy of how we should intervene in the sector before we take an isolated decision on one particular product. They accepted the argument that I have set out.
There is scepticism among many consumers and those in the vitamins and minerals industry. Our discussion on B6 showed an unhappy relationship between that sector 281 and the "official" health sector. There is considerable suspicion that drug companies wish to undermine the position of those providing alternative products.
§ Mr. Desmond Swayne (New Forest, West)
Do not large drug companies have a motivation to use increased regulation and licensing requirements as an enemy of economy of scale that they can exploit to exclude smaller firms that feature largely in the market?
§ Mr. Todd
The hon. Gentleman may have a point. On a slightly different subject, but related to it, consumers in my constituency have complained to me about changes in the price regime for the purchase of simple analgesics following changes in dosage levels. There is a suspicion that some companies in the sector find ways in which to raise prices, based on Government intervention that has just happened.
In recognition of that scepticism, the Government made an extremely welcome and positive step, which was to allow direct representation by consumers and representatives of the industry on the expert group. After it considered the Government's response, the Select Committee applauded both those steps: the recognition of the need for a clear philosophy and for proper representation in the decision making that would lead to a regulatory framework.
One might therefore assume that any new proposals for intervention will be founded on that report, when it finally emerges, and there is probably still another year or so to go before it concludes its evidence. One would be wrong. The Medicines Control Agency is proposing to take additional powers in the sector after a brusque consultation that even another Government Department, the Department of Trade and Industry, has commented on:We share your concerns that the consultation period was very short.… There are a number of pieces of legislation affecting these proposals in the 'borderline area' and we are concerned that the proposals from the MCA do not make any reference to these or require the MCA to consult with ourselves and other government departments with a responsibility for these areas.That is scarcely a ringing endorsement of the consultation.
The MCA has proposed that it should have sole powers to decide whether any health product should be classified as a licensable medicine, requiring it to be tested for efficacy. Those tests carry massive costs for small companies. I think in particular of Surepharm, a small company in my constituency, which was built up from scratch by an individual entrepreneur, employs 30 or 40 people and specialises in the sector. It could not carry the regulatory cost that would be involved in securing clearance for particular products through the MCA.
That company had never imagined that it was manufacturing something that might be described as a medicine, yet someone could make that claim to the MCA and it could make that judgment. One recognises that most minerals, vitamins and herbal products could be described as either a food or medicine, and lie within that borderline classification. If the sole basis for classification is whether a product has a physiological impact, most foods and drinks would fall within the MCA's compass.
§ Mr. Richard Allan (Sheffield, Hallam)
I am grateful to the hon. Gentleman for raising the subject. On the key 282 subject of classification, my constituent, Mr. Ralph Pike of the National Association of Health Stores, has referred to the problem of the definition "medicinal by function" which appears in the consultation. Does he share my concern about its being a strange and subjective definition in deciding such important issues?
§ Mr. Todd
Indeed; I share exactly that concern. I have also been contacted by health food proprietors near my constituency; as my constituency is not blessed with one of those shops, people have to go to Derby to buy the products. They are concerned about precisely those points, so I recognise the point that the hon. Gentleman makes.
An individual would only have to complain and say, "Yes, I believe it is a medicine," for the MCA to be involved in the process. There is no review of any MCA judgment in which the industry or other consumers might be involved.
As the MCA is likely to be reactive to individual contacts, its involvement will be incoherent. A comment will be made about an individual product, the MCA will make a judgment on whether it is a medicine, and then apply the necessary regulatory framework to it if that be so. Essentially similar products may be treated differently. That is why the Government wisely referred the issue of B6 to the expert group to provide a coherent framework within which decisions might be made.
That takes us to the second possible reason for intervention. On the B6 study, did taking B6 actually help anyone? The evidence on that was inconclusive. I am not a scientist or a consumer of the products, so I have no way of making a personal judgment on the matter. One could go only by the number of people who claimed positive effects. There are many reasons why someone might claim a positive effect for consuming a particular product. We are all reasonably well aware of the fact that consumption of particular items may make people feel good, but may not have any medical or physiological impact at all, although they feel better for having taken it.
§ Mr. Peter Luff (Mid-Worcestershire)
The hon. Gentleman plays a distinguished part in the Select Committee on Agriculture. I thank him for his contribution. Does he recall that two members of the Select Committee claimed benefit from such products?
§ Mr. Todd
I thank the hon. Gentleman for his compliments. Indeed, one member of the Select Committee did a trial run on B6, taking it in measures that were in excess of those suggested by the Government. She then consulted her family and they all said that she seemed much the better for it. I personally think that she is very nice just as she is now, but that was just one individual's subjective judgment.
§ Dr. Jenny Tonge (Richmond Park)
I am horrified by that exchange. The medical profession would say that a double-blind, crossover trial must take place on any substance before we draw any conclusions. I would hate anyone to go away with the impression that one person feeling a bit better according to her family after taking something should be the basis for a judgment.
§ Mr. Todd
I take the hon. Lady's comment. In a way, it exposes exactly the point that I am making, which is 283 that many individual judgments are made on the matter. The scientific evidence is inconclusive. Select Committee members will bear me out: the information that we were able to obtain showed no clear judgment in favour of consumption of vitamin B6 for particular purposes.
§ Mr. Todd
Or against. Therefore, people could simply make their own judgment. That is what hundreds of thousands of people did.
We heard no complaints. We were assured by the industry that it was careful not to attribute powers to the product that were not demonstrable. However, one cannot stop other people—in magazine articles, for example— suggesting the use of a product to deal with a particular problem. That often happens in the sector. People read a piece in a magazine that says that consuming a few more vitamins of a particular sort will do them a lot of good, and they go into a health shop and buy them. Perhaps the product does make them feel better—although we do not know whether they feel better because of the product. However, quite often, endorsement and marketing of products are effected by such informal means.
One cannot stop informal advertising. Moreover, we already have laws against misleading advertising. The MCA has also recently sought powers to control advertising claims for licensed medical products. There is an argument that such controls exist already. However, I am prepared to accept the view that there may be abuses that are best dealt with by the MCA. There is already such a proposal in an earlier MCA regulation that has not yet received parliamentary approval. However, that is not my specific concern today. The MCA would be applying the rules on advertising within the licensed sector, on products that have been licensed as a medicine—not the products that we are discussing today, unless the MCA chose to classify them as medicines through the process that I described earlier.
There is a third strand of regulatory activity, at European Union level. Since 1991, the European Commission has sought harmonisation of regulations for the sector. So far, the United Kingdom Government have rightly said that any regulation should be based on safety rather than need. Therefore, using the distinction that I drew earlier, the UK Government maintain that it should be a matter of whether a product is harmful, not whether it is demonstrably good for people. Although that is the correct view to take, it is not exactly the view that is taken in all other European countries—which is why the issue has been batted around for quite some time already.
The issue of efficacy should not be the determining factor in deciding EU regulation. However, the MCA's proposed involvement in the matter may make efficacy precisely the determining factor. Surely one should argue that there is inconsistency in the Government's approach to the matter. I believe that, provided manufacturers or marketers of the products make no medical claims for them, consumers should be left to make their own judgments.
The issue of dietary supplements evokes strong passion. Since becoming involved in it, I have discovered that people write extremely passionate letters on the benefits of the products that they have been consuming, and that, when they get on the telephone, they tell one about the products at considerable length.
284 One person told me: "Do not prevent us from taking responsibility for our own health." There is a broader philosophical issue—which we could debate at much greater length—on the balance between reliance on the medical profession to tell us about our health and reliance on individuals to make their own judgments on how they themselves should manage their own health. The person who told me that individuals should assume responsibility for their own health made an important and profound point. Individuals should own the issue of their own health—on which they, too, should make some judgments.
Furthermore, I do not think that it benefits the United Kingdom medical profession to regard itself as the sole arbiter of how health should be provided to individual citizens. Going down that route will lead only to overload and a complete lack of individual responsibility for what one consumes and how one lives one's life—all of which are much more critical factors in determining good health than whether one regularly visits the doctor.
§ Dr. Tonge
Does the hon. Gentleman agree that, recently, the Government have shown some inconsistency on those issues? We are not allowed, for example, to make judgments for ourselves on beef on the bone. We have absolutely no chance of making a judgment on genetically modified foods, as substances that have been genetically modified are already in the food chain. Does he agree that the Government have to get their act together and decide just where they will stand on the issues?
§ Mr. Todd
The hon. Lady is dragging a very large red herring right across a debate that could engage us for quite some time. However, I should briefly deal with the two points, which deserve a quick response.
On the beef on the bone ban, I should say—for the benefit of Conservative Members who do not know me so well—that I am not by instinct a regulator, but have always taken the view that individual citizens should make judgments for themselves. Therefore, I took some persuading that the Government's action on beef on the bone was the correct course to take. However, the main persuader in the issue was the overriding objective of lifting the beef ban. A critical factor in attaining that objective was the Government's stance on bovine spongiform encephalopathy and on the possibility of Creutzfeldt-Jakob disease among human beings.
The need to deal with the critical factor of credibility led me to believe that the beef on the bone ban was necessary, to ensure that our European partners—with whom we were, and still are, negotiating to lift the ban— were persuaded of the seriousness of our intent. That was the justification for the ban.
On genetically modified foods, I take the view that the Government are very seriously engaged in ensuring that consumers have, by means of proper labelling, proper information on what they are purchasing. We are operating on that issue within an EU framework, in which we must try to persuade others of the validity of our point of view. Fortunately, we have greater sympathy within the EU on that matter than we would if we were negotiating with the Americans, who take a much more cavalier approach to the subject.
Certainly within the EU, we have been forcefully defending the position of providing greater information, both in labelling products themselves and in stating on 285 labels the fact that GM-derived ingredients may be involved—or the fact that enzymes have been used that are not left in the food ultimately, but that nevertheless have a GM link. Currently, all those elements are subject to Government action.
I therefore believe that the Government are responding properly to the concerns mentioned by the hon. Member for Richmond Park.(Dr. Tonge).
I believe that consumers should be left to make their own judgments on dietary supplements. It simply should not be the Government's business to prevent someone from taking a product that is not known to be unsafe if they feel that it does them good. Let us establish a clear framework of how to regulate those products. If further regulation is needed, we should consult the public on their perceptions, and then act. Without such action, I believe that we shall risk taking incoherent action that is damaging to businesses and totally inexplicable to many consumers.
§ Mr. Philip Hammond (Runnymede and Weybridge)
I congratulate the hon. Member for South Derbyshire (Mr. Todd) on securing this important debate and am grateful for the opportunity of stating the Opposition's view on the issue. I am grateful also to you, Madam Speaker, for allowing me to speak early in the debate. I apologise to the House and to the Minister for the fact that I shall have to leave before the debate ends, so that I may attend a Standing Committee. It is only one of the drawbacks of being somewhat short-handed on the Opposition Benches.
The British approach to dietary supplements, both by the current Government and the previous Government, has always been safety focused, concerned with the safety of consumers rather than with their dietary need. We strongly support that position. Although the direction in which the Medicines Control Agency is travelling has caused the industry some concern, the line taken in principle by the Government seems to be—as the Minister of State, Ministry of Agriculture, Fisheries and Food said, and as my hon. Friend the Member for South Holland and The Deepings (Mr. Hayes) quoted—that dietary supplements are "drugs masquerading as foods".
The British approach now has to be placed within the European context. Within the European Union, there is clearly a significant interventionist tendency focusing on dietary need—which often is expressed in terms of multiples of recommended daily allowances—rather than on safety. The European Union is therefore moving towards developing medicines standards in which not only safety and quality, but efficacy, have to be proved.
Safety must be the paramount consideration. Any substance, however it is classified, should be subject to removal from open sale if it is harmful. However, any such judgment must be based on sound science. We must have no repeat of the B6 fiasco. Therefore, the regulatory framework governing dietary supplements has to be the servant, not the master, and ensure that only safe products are on sale and that only justifiable claims for those products are made. It must not have the effect, however unwitting, of removing from sale products that are perfectly safe, that make no unjustifiable claims and that are widely used.
286 The great fear, which the hon. Member for South Derbyshire has expressed, is that extending medicines legislation to cover products that common sense tells us have little similarity with complex pharmaceutical compounds—the Medicines Control Agency has already publicly acknowledged that it is taking that action by embarking on action against products that are "medicinal in function", even if there is no concern about their safety—with all the associated costs of satisfying medicines standards, and introducing an efficacy hurdle, will effectively remove the products from sale by administrative action. Such a move would be a sledgehammer to crack a nut.
We must ask ourselves whether there is any evidence of serious safety risks from these products. Is any damage being done to consumers? Is the NHS suffering a burden of additional cost in treating ill effects caused by the products? Quite the opposite, I suggest, even if in some cases, as I think the hon. Member for South Derbyshire suggested, the benefits of taking them may be as much psychological as physiological.
I should like to suggest two possible ways of dealing with the problem. First, I question whether it is sensible to define everything as either a food or a medicine. Might it not be sensible to create a third category for supplements, with no requirement to prove the efficacy of the product—in other words, no requirement to prove need—but with a streamlined procedure for dealing with any science-based safety concerns? Secondly, if there is to be greater regulation of supplements, might we as a minimum consider introducing some grandfather rights so that products not hitherto subject to an efficacy test but on sale in substantial amounts throughout the country can continue to be sold unless they are demonstrated to be unsafe?
§ Dr. Peter Brand (Isle of Wight)
Is the hon. Gentleman aware that many prescribed drugs are on the pharmaceutical register only through grandfather rights? Digitalis and aspirin never went through the rigorous tests that are now mandatory, and they probably would not have passed them.
§ Mr. Hammond
I take the hon. Gentleman's point. It is with that analogy in mind that I suggest that if the regulations are tightened it will be appropriate to protect the existing industry and consumers, where there is no suggestion of a safety hazard, by introducing a system of grandfather rights that would allow products to remain on sale.
The burden of proof in relation to an established product must lie with the accuser, in line with the long tradition of British justice. In any regulatory regime, the Medicines Control Agency cannot act as policeman, prosecutor, judge and jury in its own case. The consultation document MLX 249 takes a worrying step in that direction. That, as the Minister will be aware, seems to be part of a trend. Amendments to the Medicines (Advertising) Regulations 1994, which have also been laid and are due to be considered by a Committee of the House, appear to be headed in the same direction. They would extend the powers of the MCA and give it the right to act as judge and jury in its own case.
Other European Union countries operating under the same directive have managed to allow sales of supplements and herbal products either as foods or 287 medicines, with a simplified regime. Any licensing regime in the United Kingdom must be appropriate to the products involved. The objective must be the safety of the consumer, not a constraint on his, or perhaps in this case I should say her—it often is a woman—buying only what she needs as opposed to what she wants. If we adopted that test, we would ban half the goods on sale in the high street today.
The regulatory burden must be proportional to the risk, and so far I have seen little evidence of any risk. Action can be justified only to protect the public, not to conform to what, for most of us, is an alien concept of state intervention to allow us to do only that which is good for us, as opposed to preventing us from doing that which is positively harmful.
We need as light a touch to the regulatory regime as is consistent with the safety of consumers. I think that the Government recognise that principle. As always, within the limits of the paramountcy of public safety, we should support an established industry which has many valuable small firms within it that make an important contribution to the economy. Above all, any regulatory change must ensure continued access to existing products from a diverse range of suppliers in a competitive marketplace, unless there is clear and compelling scientific evidence that demonstrates that they are unsafe.
The expert group on the safety of vitamins and minerals established after the B6 fiasco has only just begun its deliberations. As the hon. Member for South Derbyshire said, it has probably another year or 18 months of work ahead of it. I urge the Government to allow the group to consider the wider issues, and to withdraw the proposed regulatory changes outlined in MLX 249 until that group has finished its work and reported its conclusions so that the Government may come to an informed decision.
In among all the talk of medicines, supplements and dosages, it is clear to me that what is most urgently needed in the debate on dietary supplements is a dose of common sense. I hope that the Minister will deliver that when she replies to the debate. I am only sorry that I shall not be able to hear that reply in person, but I shall read it with great interest in Hansard.
§ 10.6 am
§ Dr. Brian Iddon (Bolton, South-East)
I congratulate my hon. Friend the Member for South Derbyshire (Mr. Todd) on his timely Adjournment debate. I have nothing to declare other than an interest in the topic that has been created by workers in a factory in my constituency who make health products and by hundreds of constituents who wrote to me during the B6 saga. I do not use health products myself, although I must confess to having been brought up during world war two on a lot of spoonfuls of cod liver oil and rosehip syrup. I made a lot of pocket money by collecting rosehips from hedgerows in the fields where I used to play as a young lad.
It is worth reminding the House that the B6 saga was a long struggle and I congratulate the Minister of Agriculture, Fisheries and Food on referring the subject to the group that has already been mentioned by other hon. Members. I had intended to go over the history of B6, but in view of the time, I shall go to the crux of the debate.
I pointed out during the Adjournment debate on vitamin B6 that, whereas medicines and foodstuffs are closely regulated, the group of products that we are discussing 288 this morning fall into a regulatory no man's land and attempts to use medicines law or foodstuffs law to regulate them will cause and have already caused problems.
MLX 249, which is partly causing the present controversy, is a proposed amendment to the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994. It was issued recently by the Department of Health. A consultation letter was sent out on 6 November last year by the Medicines Control Agency and responses were requested by 31 December 1998. Note the very short time for consultation over one of the busiest holiday periods of the year. I shall come back to that in a moment. The proposal was to put the regulation in place by statutory instrument by 1 April. The MCA claims that it wants to make the decision-making process more transparent and put the classification process for medicinal products on a statutory basis.
MLX 249 relies for its existence on European directive 65/65, which was incorporated in UK law in 1995. That led to MAL 8, which is the MCA's interpretation—I underline that word—of the directive. Other countries have interpreted the same directive differently. Although the directive excludes foodstuffs, it has produced a broad definition of a medicine, which supersedes that given in the Medicines Act 1968, causing panic throughout the health food industry. The definition is:Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying"—I underline the next word—physiological functions in human beings or animals is likewise considered to be a medicinal productaccording to directive 65/65. Note the use of the word "physiological" instead of "pharmacological". The definition could classify water as a medicine, along with many other substances.
In a court action last year, the MCA used directive 65/65 and MAL 8 to remove melatonin from the shelves of health product stores and supermarkets. The industry is very worried that many other products will follow suit.
In a letter to me dated 2 February this year about MLX 249, my noble Friend Baroness Hayman, Under-Secretary of State at the Department of Health, said:The proposed legislation has no bearing on herbal remedies exempt from licensing".She goes on to say thatall the current exemptions from licensing for medicinal products will continue to apply.However, at a meeting in Committee Room 18 on 19 February this year, John Neale, manager of the borderline unit at the MCA, took an apparently contradictory view when he said:The proposals will improve the MCA's prospects of success in courtandmake it extremely difficult for a manufacturer to prove a product is not a medicine".He also said:We already have all the powers we need to do our job".The health products industry regards such remarks as a threat to their business.
289 In response to a parliamentary question on 18 January this year, my right hon. Friend the Minister for Public Health admitted that at that time her Department hadreceived 69 letters from hon. and right hon. Members and 278 representations from other interested bodies and individuals. Three representations broadly support the proposals. The remainder are critical of the proposals to some degree."—[Official Report, 18 January 1999; Vol. 323, c. 380.]In the time available for the debate, I am not able to refer in equal detail to the MCA's other proposed new regulations, MLX 239, on advertising, and SI 267, which was laid subject to negative resolution.
§ Miss Melanie Johnson (Welwyn Hatfield)
I have a registered interest with a pharmaceutical company in my constituency. I am concerned about the lack of a satisfactory appeal mechanism to an independent body under SI 267. Companies could be in the invidious position of committing a criminal offence, on the judgment of the MCA, without being able to appeal to a higher court. I should like my right hon. Friend the Minister to address that.
§ Dr. Iddon
I fully endorse that point, which I was going to make in my next few sentences.
If all the proposed regulations are accepted, the health food industry will be far more complicated to run. Many small firms will not be able to afford the costs involved. The MCA is a quango. As my hon. Friend the Member for Welwyn Hatfield (Miss Johnson) has just said, there is no right of appeal against its decisions. That is an important point that needs to be emphasised.
The 1997 Labour party manifesto made a commitmentto monitor the scale and quality of regulatory activity".As a result, the deregulation unit in the Cabinet Office, established by the previous Administration, became the better regulations task force. One of its first jobs was to produce a very important document, which many hon. Members may not have seen, called "The Better Regulations Guide and Regulatory Impact Assessment", which was published in July last year.
On consultation, the document says on page 9:Above all, allow enough timeIt goes on:Lack of time is one of the most frequent complaints about Government consultation. Eight weeks should generally be the minimum period.On page 34, it says:Always consider the option of 'do nothing' or 'do minimum' as it may not be possible for Government to improve matters, or the costs of doing so may outweigh the benefits".I have written to Lord Haskins, chairman of the better regulation task force, suggesting that some Departments are not taking much notice of the good advice given in the Government's booklet.
Vitamins, minerals, dietary supplements and herbal products are clearly not foodstuffs or medicines, but as I have tried to show, two Departments—MAFF and the Department of Health—have tried to regulate them. We are in a regulatory mess. Indeed, that is why the debate is being held.
290 What should the Government do? Clearly, there is a need to do something. The two Departments that I have mentioned have rejected the "do nothing" and "do minimum" options. The Government could try to make the existing regulatory frameworks work, as they appear to be doing, but they are clearly having great difficulty. I agree with the hon. Member for Runnymede and Weybridge (Mr. Hammond) that a third way is needed. I suggested that at the recent annual Health Food Manufacturers Association conference in London. The Government should consider establishing a separate regulatory framework to cover the substances in question. The principles of safety, quality and efficacy, based on bibliographic evidence and traditional usage, should be the key drivers for the regulations, as they always have been.
There is nothing new about this idea. Canada and Australia have tried it already. Following a letter from the Canadian Health Minister, dated 13 November 1997, the Canadian House of Commons Standing Committee on Natural Health Products published a document entitled "Natural Health Products; A New Vision" in November last year. It contains 53 recommendations. Health Canada was recommended to set out an appropriate definition of natural health products in conjunction with a new separate natural health product expert advisory committee. The relevant food and drugs legislation would then be amended accordingly. There were also recommendations to create a new regulatory authority for such products, to build appeal mechanisms into the processes, to seek advice from those involved in the production of natural health products and, importantly, to promote research on their efficacy and safety.
We have reached the critical stage in Britain at which we need to review the existing regulatory procedures and seek a third way. We could refer the matter to the better regulation task force or, like the Canadians and Australians, we could set up a commission to look at the quagmire that we appear to be getting into. I look forward to the response of my right hon. Friend the Minister for Public Health.
§ Dr. Peter Brand (Isle of Wight)
I congratulate the hon. Member for South Derbyshire (Mr. Todd) on allowing us all to appear so liberal this morning—even if only with a small "1". Citizens of this country can expect the Government to protect them in two ways: from being poisoned and from being ripped off. We are talking about substances which, in high concentrations, may well be poisonous, and substances for which claims are made that would make the average snake oil salesman blush. It may be that those claims are not made by the manufacturers, but they somehow find their way into advertising.
I am concerned that large sums of money are being spent by vulnerable people who are hoping to improve their lives. We must strike a balance, and I like the third way that seems to be breaking out all over the place—it is obviously catching.
The important issue is who decides what should be referred to the MCA. It is wrong that the agency has the power to trawl around to see what else might be within its remit. It is important that the shady line between what is a drug and what is food be addressed. I was disappointed that the draft Food Standards Agency 291 legislation does not address the issue of who determines what should be treated as a pharmaceutically active and dangerous drug, and what is a food. Physiological functionality includes everything that we breathe, do and take in.
I made myself extremely unpopular in my party by supporting the Government's line on B6—and then they caved in. B6 was an extremely good example; in itself, B6 can be a beneficial substance, but taken in high doses, it can be harmful. I thought that the compromise of allowing it to be freely on sale at a reasonable, rather than high, dose was a good safety measure—rather like selling aspirins only in packages of 30.
§ Dr. Brand
That is not a debate for this morning.
The same issue can arise in terms of herbal remedies. As a GP, I am much more relaxed with people using herbal remedies. It is cheaper to use the natural product, and it is extremely difficult to take a pharmaceutically active substance in high enough doses to do oneself much harm. I am worried about the relentless drive to try to identify the active ingredient in whatever herbal tea we might be drinking, so that it can be concentrated and flogged off at a high price.
I am surprised that we have not had more support from hon. Members concerned about the debate on herbal cannabis and cannabinoids, as there is a similarity. It is dangerous to say that we need to identify every active ingredient in everything. That means we deny people a substance which may have some benefits—even if it is only as a placebo.
I urge the Government to set up a mechanism where we can identify what needs to be considered by the MCA. The FSA should have a responsibility in this area, and we need to work much more closely with the Advertising Standards Authority, which has a major responsibility in sorting out what is and is not a reasonable claim.
It is perfectly proper for any food or substance to be able to claim that it may be good for your health in general. "A Mars a day" helps whatever it is you want to do—that is a perfectly reasonable claim. It can be believed or not, and most people are not fooled. However, I would be extremely worried if it were claimed that a Mars could cure colitis, or stop cancer. There is a problem about claims being made for substances, as vulnerable people may be taken in. They may not help themselves by spending money that they do not have, and by taking substances in high doses—or to the exclusion of a more balanced diet—which may be harmful.
I urge the Minister to rethink. There is an opportunity to set up an agency with an overarching responsibility for food safety and nutrition. If we include the third category of substances, and align them more closely to food than to drugs—the link with drugs has already been established in terms of the FSA—we may find a way forward, provided we are prepared to be patient and to let the status quo carry on for the time being.
§ Mr. David Tredinnick (Bosworth)
I congratulate the hon. Member for South Derbyshire (Mr. Todd) on obtaining this debate. He mentioned the B6 saga last year, 292 and history seems to be repeating itself. The MCA's proposals on borderline substances have all the hallmarks of the proposals for B6. The Minister's hair should be standing on end, because those proposals caused enormous problems for the Government. If this proposal goes through, it will be devastating for consumers, manufacturers, and practitioners of herbal remedies and vitamins.
If Uncle Joe Stalin had been going through his red box in the Kremlin and this proposal had come up, he would have said, "I like it very much. It is good. It is disempowering the people. It is giving one of my Government agencies the opportunity to be judge, jury and de facto executioner." Does that really fit in with the Government's philosophy? It is bad luck for the Government that they have chosen 1 April to implement the measure—April fool's day. It is hardly a good omen.
The pressure on the Minister resulted in the extension of the consultation period, which was widely welcomed. However, as the hon. Member for Bolton, South-East (Dr. Iddon) said, that consultation period included Christmas; it was woefully short and quite inadequate.
When the MCA circulated proposals for the revision of the so-called 1994 regulations on medicines for human use last November, a flood of correspondence came into the offices of Members of Parliament—not least mine, as I am the treasurer of the parliamentary group for alternative and complementary medicine, a position that I have been proud to hold for three Parliaments. I have been doing the job for 10 years, and I regard it as valuable.
§ Mr. Tredinnick
I thank the hon. Gentleman; perhaps it is because I take a few supplements. Many complementary and alternative practitioners in this country are scared out of their wits by the proposal. An experienced traditional Chinese medical practitioner—a qualified UK physiotherapist and acupuncturist—said to me, emotionally, last week that the proposal, if it goes through, will make her a criminal. The hon. Member for Richmond Park (Dr. Tonge) may look askance, but the facts do bear that out.
The document would give the MCA new legal powers to allow it to decide, unilaterally and virtually without reference to anyone other than its own officials, whether a so-called borderline substance—one of the vitamins or supplements—was a medicine or not. The decision would be binding in any criminal or civil proceedings, unless shown to have been made unreasonably. Do the Government really believe that that is fair?
On 19 January, the parliamentary group of which I am treasurer met John Kneale, the manager of the policy and borderline unit at the MCA. I pay tribute to him for coming along—he did not have to. We were grateful to him for speaking to representatives from the industry and colleagues. He said:I do not believe that the MCA would be able to review products that have been on the market for a long time.He tried to reassure us that the MCA was not taking powers that it did not already have, but he went on to say:The manufacturer would have to seek to show through the court that the MCA's decision was unreasonable. It improves the MCA's possibility of success in court.293 The burden of proof is transferred from the accuser to the accused, which gives the MCA too much power and will result in the criminalisation of a practitioner through an MCA decision made without the necessary element of natural justice required to safeguard basic constitutional rights. Power is transferred to a prosecuting authority to adjudicate without accountability. Such a power exists nowhere in any other democratic society and if granted will unquestionably be open to abuse.
The current UK legal system operates to protect the innocent as well as to convict the guilty, placing the burden of proof on the state. That one simple aspect of British justice helps to prevent a large number of miscarriages of justice. If the proposal goes through, there will be widespread injustice, because arbitrary decisions will be taken, they will be disputed by those affected and there will be little recourse.
How does that sit with new Labour's so-called philosophy of open and accountable government? I suspect that the Government were hoping to slip the proposals through. They certainly were not checked by their spin doctors. Someone slipped up, however. If the proposals go through, it will be highly damaging for the Government's image and credibility in both the short and the long run. My hon. Friend the Member for Southend, West (Mr. Amess) may castigate me for trying to tip off the Government about these problems and may say that we should let them ride it out.
Why is all this happening? The whole exercise is being carried out not to protect or benefit consumers, health manufacturers and practitioners, but to make life easier for officials in the UK and to appease the bureaucrats in Brussels. At the meeting of the all-party group on alternative and complementary medicine, the borderline unit manager said:We are bound by European legislation.However, we have exemptions, as in many other matters. We are fighting to maintain those exemptions, while the European Community as a whole is revising its position.
There is every indication that there will soon be new legislation on herbal products from the European Commission, as it tries to homogenise the law in Europe. The great concern is that the UK Government will try to pre-empt what is happening in Europe and introduce a draconian measure at a time when the whole process is being thought through at a more leisurely pace on the continent.
Herbal remedies are traditional medicines whose therapeutic use has been tried and tested over hundreds, or even thousands, of years. Such plant medicines invariably comprise many chemical components whose overall effect cannot simply be assumed by reference to perceived active constituents. Apparently unimportant fractions of a plant may act in vivo to buffer or amplify its principal pharmaceutical characteristics.
The essential features of herbal medicine have important implications for their assessment and licensing, but current European Union medicines licensing procedures are generally designed to evaluate and validate single chemical entities—not several chemical entities— as medicinal products.
§ Dr. Howard Stoate (Dartford)
I am rather concerned by the assertion that a medicine must be safe simply 294 because it has been around for hundreds or thousands of years. All medicines require the rigour of full medical examination.
§ Mr. Tredinnick
The hon. Gentleman may have the opportunity to make his own speech later on. Most medicines used by traditional Chinese medical practitioners have been used for a very long time.
Plant medicines cannot be patented, so the enormous sums required to bring a new product to the market cannot be recouped. The cost of licensing compound herbal medicines would be so high as to be unrealistic for all but the largest companies. The smaller companies referred to by the hon. Member for South Derbyshire and others would be put out of business.
It seems entirely wrong—this is borne out by all the letters that we have received—to classify pharmaceutical drugs in the same category as herbal medicines derived from natural sources, including many foods, such as cardamom, cinnamon, garlic, ginger, Chinese dates, peach kernels, orange skins, borage, celery, parsley, rhubarb and all spices.
At a presentation to the all-party group by the Association of European Self-Medication Industry, known as AESGP, we were told that the European Commission was considering issues concerning the internal market and herbal medicine. The association stressed that there is a wide divergence of opinion in the European Union but that strenuous efforts are being made to develop a sensible pan-European policy.
The Minister would be well advised to wait and see. Products not classified as medicinal products belong in most cases to the food and cosmetics category, even though they sometimes contain plants with pharmacological properties. In Ireland, Spain and the UK there exist preparations defined as medicinal products that are exempt, under specific conditions, from licensing requirements. We have to protect that position in the short term.
It will be the role of the European Commission to evaluate and assess the consequences of possible divergence in the legal position and/or the assessment of herbal medicinal products, and to agree a plan on how best to safeguard public health while allowing the free movement of herbal medicinal products throughout the European Union.
At a time when every country in the European Union has its own specific problems, it is not appropriate for the Government to take the arbitrary action that they propose. The issue is under debate and we do not need these draconian measures.
I offer the Minister the hand of friendship in finding a way out of this maze. There are three possible solutions. She could back off and leave everything as it is, which would satisfy most people, because nobody really wants the change. The second honourable way out would be to wait and see what happens in Europe; so much is going on that it seems foolish to pre-empt it. What is the third option? Several hon. Members have mentioned the third way. Having been a great fan of Mrs. Thatcher, I have not always been keen on the third way, but in this instance it is probably the right way forward.
The all-party group has consulted widely among our large membership to ascertain whether that idea should be pursued. In the United States, the Dietary Supplement 295 Health and Education Act 1994 defines dietary supplements as a special category between foods and medicines. They are defined as products that aresafe within a broad range of intake",and for whichsafety problems within the supplements are relatively rare.Such supplements include all the medicines that we have been discussing.
The way forward is not to allow the proposals through at this time. The Minister must back off or, perhaps better still, wait for Europe or consider the third way.
The Government should not rush into any legislation that would harm the future of herbal medicines, food supplements and vitamins. The B6 fiasco last year, followed by the present proposals, have raised great fears in the industry. That fiasco should have served as a warning to the Government that all European countries treat such products differently. This is not the time to classify celery and beetroot as drugs, or to break well-established principles of English law. The Government should agree to consider a third, new category between foods and pharmaceutical drugs, thereby getting themselves off the hook and making consumers and producers happy.
§ Mr. David Amess (Southend, West)
I congratulate the hon. Member for South Derbyshire (Mr. Todd) on the way in which he introduced the debate. He has certainly given the House an opportunity to explore all the various issues. He was right to represent the producers of the products in question in his constituency. If I had such producers in my constituency, I would have done the same. Sadly, I do not, but I have many constituents who use the products and a number of health food shops that supply them.
I pay tribute to Consumers for Health Choice, which has done a splendid job in educating Members of Parliament such as me on the various issues. Until the row about vitamin B6 last year, I knew precious little about the issues. I may regret what I am about to say, but I am not a natural pill taker. I would try anything to cure hay fever and have done so over the years. I was told that I would grow out of it, but I am taking a long time to do so.
I have been overwhelmed with letters and petitions on the matter from my constituents. Given that, in terms of the number of senior citizens who live there, Southend, West is 33rd out of the 659 constituencies, I can only conclude that those people are doing extremely well on those products so far.
Before the Minister responds, I simply want to draw attention to three pieces of information that I have received from constituents. One lady wrote that she used these productsdaily to try and stay healthy so as not to burden the state … I understand the Government is now trying to sweep vitamin products off health food shop shelves, by trying to licence them as medicines.That lady wants the Government to tell herwhy these proposals are being rushed through with such urgency (1st April 1999)".She points out:The only people that would benefit at the end of the day would be the pharmaceutical companies",296 who, according to her, apparently already make "vast profits."
Another lady mentions the fact that 1 April is April fool's day and says:it is no joke for the many independently minded people who wish to take responsibility for their own health and avoid as long as possible being without any free choice of health therapy.She asks me toprotest against this underhand plan to tack on the power to restrict … liberty by avoiding free debate on this vital issue.She continues:We want nutrition to be our first line of health defence and we want freedom of choice in medicine.Finally, one supplier of such products in my constituency believes that the Medicines Control Agency wantsto include far more than is necessary under their control umbrella and once they have gained the changes in the law will become judge, jury and executioner in the removal of anything they see fit from our shelves without consultation.The letter continues that, as regards health food shops,there is in place effective control on products under the Medicines Act that has worked well for years. Freedom of choice is again in jeopardy".I entirely agree with my hon. Friends the Members for Bosworth (Mr. Tredinnick) and for South Holland and The Deepings (Mr. Hayes). I do not want to cause trouble between the Department of Health and the Ministry of Agriculture, Fisheries and Food. However, it was unfortunate that the Minister responsible for food suggested, when he gave evidence, that these products were somehow masquerading as food or were foods masquerading as drugs.
If the hon. Member for South Derbyshire achieves anything today, I hope that it will be to persuade the Minister for Public Health to adjudicate on the difference between the two Departments and to put the fears of all our constituents at rest.
§ The Minister for Public Health (Ms Tessa Jowell)
I shall begin not exactly by registering an interest, but by pointing out that my brother is a senior executive in Glaxo Wellcome. For that reason, I do not take part in departmental discussions or decisions about pharmaceutical licensing. I am responsible for complementary medicine, but I want the House to be aware of that fact in the context of my responding to this debate on a matter that would normally be handled by my noble Friend Baroness Hayman.
I congratulate my hon. Friend the Member for South Derbyshire (Mr. Todd) on taking this opportunity to raise a matter that is of great cross-party concern. I hope that, in the time available, I can generate a little more light than heat and put the record straight on a number of important issues for those hon. Members here today and for the many people who are enormously concerned about the issue.
First, let us deal with the facts of the current controversy. I am concerned that much of the criticism of the proposals has been an unwarranted cause of worry and worse for manufacturers, retailers and consumers alike. I say that as someone who has ministerial responsibility for complementary medicines and who recognises the 297 enormous public interest in this new and developing area of medicine, which is of potential benefit. We should be clearer and more systematic about the evidence for the benefits that many people anecdotally report. I approach this debate by making clear my sympathy for complementary medicine in general and my understanding of many people's enthusiasm for and reliance on methods of complementary medicine.
As has been clear throughout the debate, the problem is the lack of a legal definition of the term "dietary supplement". Many of the products described as such inhabit an increasingly grey area between foods and medicines. As the law stands, those products for which claims are made for the treatment or prevention of disease, or which are administered to restore, correct or modify physiological functions, fall within the definition of a medicine and are subject to the requirements of the Medicines Act 1968 and the appropriate European directive. Such products normally require a marketing authorisation—that is, a licence—before they can be sold or supplied.
Products that are licensed as medicines are excluded from the definition of food in the Food Safety Act 1990. Products that are not licensed are automatically regarded as foods and are subject to the general provisions of the 1990 Act, which effectively requires that they should not cause harm, and to the Food Labelling Regulations 1996, which control the labelling and advertising of food. Among other things, the regulations prohibit claims in labelling or advertising that a food has the property of preventing, treating or curing a human disease, and lay down conditions for the use of nutritional claims and certain descriptions that may mislead.
As regards policy, the Government have stated on a number of occasions that we believe that the quantity of vitamins and minerals in supplements sold under food law should be limited only in cases in which it is necessary to protect the public. Any limits should be based on safety considerations, judgments about which are made on the basis of expert scientific advice.
I would not pretend for one moment that such advice might never give rise to controversy, but the boundary between categories of product can be difficult to determine. Garlic, evening primrose oil and vitamins in general may be dietary supplements or medicinal products. The determining factor is whether they are sold with claims to treat or prevent disease. If they are, and if the manufacturer wishes to continue to make those claims, he must apply to the MCA for a licence for the product.
It may be helpful to remind the House of the responsibilities of the MCA. The agency has a duty, on behalf of the licensing authority, to implement and enforce the provisions of the Medicines Act 1968 and other medicines legislation. It does so to protect public health, and specifically to make sure that the medicines that sick people use are safe, of high quality and effective. The MCA has a very important role in protecting consumers.
Part of the MCA's duties involve deciding whether a product is or is not a medicine. The criteria against which it makes those decisions is a matter of European Union law.
§ Ms Jowell
I do not accept that point. The routes by which matters of concern are raised with the MCA are many and varied. Many of the grounds on which inquiries are raised about products that are in a grey area are identified by public concern or by general practitioners, such as the hon. Gentleman himself, on behalf of their patients.
Unless EU law changes, there will be no change in the status of products sold as food or as herbal remedies exempt from licensing. Those products will continue on open sale without the need for licensing. It is claimed that if the consultation proposals became law, the MCA would sweep supplements and herbal remedies from the shelves unless they were licensed. Those claims are completely unfounded.
What would the proposals do? They would make the process by which medicines are classified more transparent, consistent and credible among the wider public. That is important because the present purely administrative arrangements for classifying medicines are sometimes criticised by manufacturers on the ground that they have not had a full and fair hearing. It is the Government's view that decision-making processes should be as open as possible. We believe that introducing a new statutory process, on top of the agency's present administrative arrangements, will make for greater clarity and transparency.
The Government also believe that if manufacturers are given greater access to the classification process, they will be able to have faith in decisions under it, and it is important that they should have that faith. We believe that introducing a statutory right for manufacturers to participate in the process and put their arguments and cases to a review panel would effectively address the criticisms sometimes made about the alleged secrecy of the present classification arrangements.
At the same time, the proposals would improve the effectiveness of the MCA's compliance and enforcement processes by reducing the scope for delay and evasion. In that way, we would demonstrate the UK's commitment to full implementation and enforcement of medicines legislation. We believe that introducing a new offence of non-compliance with a final decision will bring greater precision to compliance and enforcement activity. The proposed presumption in favour of the MCA in any subsequent proceedings should also strengthen the effectiveness of enforcement activity.
Let me say something about what the proposals do not do. They do not give the MCA a new and unaccountable power to decide whether or not a product is a medicine. The MCA already has that power, as the Court of Appeal confirmed last year. The MCA exercises its powers in accordance with EU and UK law, legal precedent and its published guidance. The MCA also has the power, on behalf of Ministers, to seek to enforce its decisions in the courts.
I want to deal with some specific criticisms levelled at the proposals. It is suggested that the consultation exercise is too short and secret. In fact, the initial eight-week timetable was within the MCA's normal six to eight-week limit. We have extended the consultation period for an 299 additional month, and implementation of the proposals is not tied to a target date of 1 April. We have already said that we are prepared to listen further, and so we should.
A second criticism is that the statutory review procedure would not be independent of the MCA. We propose that the members of the review body should be officers of the MCA. As the Court of Appeal has recognised, the MCA is a specialist body with accumulated experience in relation to medicinal products, which has had to develop a consistent policy for similar products. Under EU law, it is the licensing authority's duty as the competent authority to make final decisions on classification.
The third criticism is that the proposal to introduce a new offence of non-compliance with a final MCA decision is unnecessary. In any subsequent legal proceedings, the MCA's decision would be deemed correct, unless the manufacturer could show that it was unreasonable. The proposals are said effectively to prevent a manufacturer having any chance of a successful defence in court, but that is not the case. The European Court of Justice has recently agreed that the courts should not have to reassess the merits, as distinct from the legality and reasonableness, of the MCA's final decisions. Accordingly, we do not accept that it should be necessary for the courts to reassess the merits of MCA decisions.
If the MCA were to take proceedings because a manufacturer would not comply with a final decision, our proposed change would shift the burden of proof to the manufacturer, who would have to prove that the decision was unreasonable. We believe that that is justified. The decision would have been arrived at only after thorough and open assessment and review. Manufacturers will have repeated opportunities to make their case.
Perhaps the most alarming claim has been that dietary supplements will have to be licensed from 1 April as prescription-only medicines. That is emphatically untrue. The proposals will not affect the status of dietary supplements, and the idea that they would be available only on a doctor's prescription is equally unfounded.
We will consider carefully the criticism that the shift in the burden of proof in proceedings is oppressive and lacking in natural justice. We recognise that manufacturers would find it extremely difficult to prove a final decision by the MCA to be unreasonable. We are sensitive to the need to show that justice is done. Consequently, we will look particularly carefully at this part of the proposals, to ensure that they go no further than our obligations as the licensing authority require.
In conclusion, we want the people of the United Kingdom to have confidence—
§ Mr. Deputy Speaker (Mr. Michael J. Martin)
Order. We now come to the debate in the name of the hon. Member for Totnes (Mr. Steen).