Food Supplements Directive

– in the House of Commons at 7:30 pm on 20th January 2003.

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Photo of Alan Haselhurst Alan Haselhurst Chairman of Ways and Means 7:30 pm, 20th January 2003

I must advise the House that Mr. Speaker has selected the amendment in the name of the Prime Minister.

Photo of Liam Fox Liam Fox Shadow Secretary of State for Health 7:43 pm, 20th January 2003

I beg to move,

That this House
notes that the Food Supplements Directive includes a list of nutrients and nutrient sources that may be used in supplements and that there are nearly 300 safe nutrient sources on the UK market which are missing from the list;
further notes that unless full safety dossiers are submitted for consideration by the European Scientific Committee for Food by July 2005 these nutrients will be illegal;
observes that the cost of commissioning research to include within a dossier, and the compilation of such dossiers, makes the task prohibitively expensive and that some 270 safe and popular nutrient sources will be lost to the UK industry and its consumers;
and declines to approve the proposed statutory instruments implementing the Directive unless and until the Government secures an amendment to the Directive so as to allow to remain on the national market those products which would otherwise fall outside the Directive's technical restrictions;
further notes that the Traditional Herbal Medicinal Products Directive would require dossiers to be submitted to the Medicines Control Agency and would impose costs of tens of thousands of pounds per product on manufacturers;
regrets that it would not allow any overseas product which had not been on the European market for 10 years even if it were demonstrably safe;
and urges the Government to renegotiate the main provisions of this flawed Directive.

It is fair to say in the House that it sometimes comes as a surprise that a certain subject should produce a very large mailbag for Members on both sides of the House, and this is one of those issues. Indeed, the concerns expressed have prompted the support of hon. Members on both sides of the House through early-day motions that were tabled in the last Session and this Session. Tonight, we all have an opportunity to reinforce those concerns in a real debate in Parliament, with a real vote and a real motion reflecting those early-day motions.

The directives are important for two reasons, the first of which is specific to the directives themselves, and the second relates to the general burden of regulation. The directives will have specific effects on consumers' freedom of choice and on United Kingdom manufacturing and retail business. On the general burden of regulation, as my right hon. and learned Friend the shadow Chancellor pointed out recently, 4,642 new sets of regulations were introduced in the United Kingdom last year—one for every 26 minutes of each working day. That is not only a record, but an increase of nearly 50 per cent. on the number introduced in 1997. As well as the general burden of over-regulation, those directives reflect the European Union's increasing intrusion into areas of our national life and legislation where it has no place.

I shall first turn to the background to the two directives—first, the food supplements directive. In May 2000, the European Commission published a directive on food supplements, which was finalised in the spring of 2002 and published in the Official Journal on 12 July 2002. Its main provisions will be implemented over the next seven years. Although presented as essential to ensure consumer safety, the food supplements directive has been designed to standardise the different regulatory regimes for vitamin and mineral supplements across EU member countries. That may cause a slight liberalisation of the market in France, Germany and some other countries, but it will mean the loss of a substantial number of products in the existing liberal markets—the United Kingdom and the Netherlands in particular—where millions of consumers have been using higher-dose vitamins and minerals for several decades. In March 2002, Conservative Members of the European Parliament voted against the food supplements directive.

The second directive is that on traditional herbal medicinal products. Under Community legislation governing pharmaceuticals, no medicinal product may be placed on the market without having obtained a marketing authorisation. The draft directive on traditional herbal products provides for a new special procedure to apply to the authorisation of traditional herbal products. Products to which the proposal applies would be identified in a positive list, subject to their meeting certain conditions, including the need for safety to be demonstrated, a requirement to show a history of 30 years' use, the use of agreed medical indications and the need for labelling to include a clear statement that product efficacy is not proven, as well as other information on the safe use of the product. On 21 November 2002, the European Parliament voted for that directive at first reading, backing numerous amendments tabled by the Conservatives designed to protect individual choice as much as possible.

Photo of John Redwood John Redwood Conservative, Wokingham

I am grateful to my hon. Friend for highlighting this crucial issue. Many of my constituents are angry that they will not be able to buy their normal products in the usual way, and shops are worried about the damage to their business. Does my hon. Friend agree that the fact that the Government cannot stop the EU doing such enormous damage to something that does not need fixing shows that they have absolutely no influence at all in Brussels?

Photo of Liam Fox Liam Fox Shadow Secretary of State for Health

It would be reassuring for me to tell my right hon. Friend that the Government have no influence—I imagine that that is true—but I am not sure whether they tried to use any influence in this instance, so I am not sure whether we can draw any inference from their inactivity.

We have some specific reservations about the food supplements directive. The first threat is that the directive introduces a system of maximum permitted levels for nutrient content. Those levels are expected to be set substantially lower than the scientifically assessed upper safe level. That process will start with a cautious assessment of the safe level by the EU Scientific Committee for Food. That level will then be further reduced by the European Commission to take into account risk management factors, such as nutrient intake from other dietary sources and population reference intakes. Political considerations at the relevant EU Standing Committee will then come into play, with probably the Governments of France, Germany and other countries seeking to block everything, except the lowest possible dose levels in line with their existing markets.

Millions of British consumers regularly use higher-range vitamins and minerals. Removing those products from general sale will not stop consumers wanting them. A good example might be the generally high doses of vitamin C available in this country. If we harmonise down to the sort of level used in countries such as Italy, we might find that a couple of fruit smoothies from the House of Commons canteen gives us a higher does than recommended by the EU. What is to stop the outrageous and incredibly creative step of consumers taking two tablets instead of one? That directive is complete bureaucratic nonsense. As Consumers for Health Choice has put it,

"such action would raise a very real moral hazard by forcing consumers to seek"— these products—

"from unregulated outlets such as overseas mail-order companies and the Internet, putting consumer safety at risk."

In addition, if high-dose nutrients are lost, the entire market will be genericised, putting a question mark over the future of all natural health care and alternative therapies, and putting at risk the livelihood of specialist retailers and manufacturers. Of course, UK manufacturers could take advantage of some of the loopholes. They could move abroad or go somewhere as close as the Isle of Man to continue to manufacture and market the same products to the same consumers through the internet. What is much more likely, however, is that they will simply disappear, sacrificed needlessly on the altar of European harmonisation.

Photo of Mark Todd Mark Todd Labour, South Derbyshire

Will the hon. Gentleman set out how British manufacturers such as Peter Black in my constituency currently have access to the German, French and Austrian marketplaces, to which he referred as liberalised in this process? Currently, I believe that they are not able to sell into those marketplaces satisfactorily.

Photo of Liam Fox Liam Fox Shadow Secretary of State for Health

I referred to the United Kingdom and the Netherlands as liberalised. I referred to France and Germany as much more restrictive, which is entirely in line with what the hon. Gentleman says. I fear that, rather than liberalising and allowing German and French consumers access to the products currently available to UK consumers, the exact opposite process will occur, with greater restriction of the markets in the United Kingdom to bring them into line with the restricted availability in other countries. The directives will be designed to suit the already restrictive practices in other countries, not the liberal trading environment of the United Kingdom. It will be against the interests of British consumers and British manufacturers.

The practical effect of the detailed proposals in the second directive on herbal medicines would remove many safe and popular products from the marketplace, as some products have not been on the market for the necessary period. The imposition of the extraordinarily arbitrary 30-year period would jeopardise the position of products introduced over a period of nearly three decades and prevent all future innovation. No new products could be brought to market, even if they had been available for many years in another non-EU country with a good safety record. The directive would not allow products that were combinations of otherwise legal ingredients—for example, existing mixtures of herbs with nutrients such as vitamins and minerals—leaving some of those products, which represent an important section of the UK market, in a regulatory vacuum.

On top of all that, the cost of the new framework would be completely beyond many small manufacturers, forcing them out of business. What do we want the Government to do?

On the food supplement directive, the Government must immediately use every opportunity to persuade the Commission and the Governments of other EU member states to allow the most liberal possible interpretation of the legislation. The Government must also force an early review of the procedures of the EU Scientific Committee on Food so that the requirement to submit dossiers for nutrients currently not on the permitted list is not overly burdensome and expensive. Above all, the Government must work now for an amendment to the directive that would allow those safe supplements, which would otherwise lie outside the directive's technical restrictions, to remain on the UK market. As the Health Food Manufacturers Association put it

"What is needed is a system whereby the SCF can accept minimum data requirements for such products, based on their history of safe use. The UK Government should be arguing for this in Brussels."

Photo of Angela Browning Angela Browning Vice-Chair, Conservative Party

Is it not the case that if the Government do not use their influence in the way that my hon. Friend suggests before we receive the final directive to be considered in Standing Committee, it will not matter what Members of the House think about it, or what representations we make? It will be a done deal, and we will have no power to amend it.

Photo of Liam Fox Liam Fox Shadow Secretary of State for Health

As ever, my hon. Friend is absolutely correct. I shall come to the democratic deficit that that represents in just a moment.

What do we want from the Government in relation to the second directive? The directive's scope is currently restricted to herbals alone, thereby making many safe and popular products that combine herbals and food nutrients ineligible, as well as excluding many important combination products used in traditional Chinese and Ayurvedic medicine. That needs to be addressed.

The second area is cost. There are two ways in which the impact of registration costs could be ameliorated: first, by ensuring that registration fees are kept as low as possible; and secondly, by encouraging the early development of a national positive list made up of products with a long tradition of safe use in the United Kingdom, for which minimum regulatory assessment will be required. Those are not huge steps for the Government to take, but they will take some energy in pushing them forward, given the state of play that the Government have allowed to develop.

There is more to this debate, however, than the specific directives. We suffer in this country, as I said at the outset, from an increasing burden of over-regulation. Digby Jones, the director general of the CBI has said:

"our flexibility has been steadily eroded by ever increasing regulation and there is still more to come onto the statute book. We now face a real danger of our advantage being destroyed and there are clear signals that firms will go elsewhere if they are burdened with more legislation."

That is exactly what is happening in this arena. A survey of 600 members of the Institute of Directors showed that 84 per cent. feel that the problem of excessive bureaucracy has got worse under the Labour Government. Much of it, however, originates in Europe. On the burden of legislation, it is worth pointing out to the House that the Lord's prayer has 59 words, the Ten Commandments have 297, the American declaration of independence has 300, and these two directives together have 10,038. That makes the point clearly.

Time after time, the EU extends its influence though the spurious use of directives, and we in this House, as my hon. Friend Mrs. Browning said, can do absolutely nothing about it. Time and again, control over whole areas of our national life is abandoned with little more than ministerial whimpering. Specific directives such as those under discussion may be small issues in themselves, but they amount cumulatively to the castration of this Parliament. I cannot stand the nanny state telling us how we must live our lives. If I hate one thing more than the British nanny state, however, it is "Euro nanny" running amok. It is time that Members on both sides of the House stood up for those who elected us to protect and not surrender their interests.

Photo of Hazel Blears Hazel Blears Parliamentary Under-Secretary (Department of Health) 7:57 pm, 20th January 2003

I beg to move, To leave out from "House" to end of the Question, and to add instead thereof:

"recognises, in relation to the Food Supplements Directive, the Government's firm commitment to the view that the law should allow safe and properly-labelled food supplements to be freely marketed;
welcomes its intention to take advantage of flexibility, secured by the UK, to permit continued use of substances not on the permitted lists where products comply with existing UK food safety legislation;
notes that the impact on the long-term availability of products currently on the market will depend upon future developments on maximum limits and lists of permitted nutrients;
supports the Government's efforts to press the case for any maximum limits which may be established at EU level to be based on thorough scientific risk assessments;
further recognises that the proposed Directive on Traditional Herbal Medicinal Products would introduce regulatory arrangements to set safety and quality standards for unlicensed herbal remedies, and introduce systematic consumer information about the safe use of products and permit companies to make claims;
further notes that the proposed Directive is supported by most interest groups, who believe it will protect public health and boost consumer confidence in herbal medicines;
further welcomes the progress of the Government in negotiations for more flexibility to take account of valid evidence of traditional use from outside the European Union and to permit herbal nutrient combination remedies;
and further welcomes the stated willingness of the Herbal Forum, representing all UK manufacturers' trade associations in the sector, to work with the Medicines Control Agency to minimise regulatory impact, consistent with the need to protect public health."

I do not think that these are small issues but ones of great importance to people up and down the country. I am therefore delighted that we have the opportunity tonight to debate these two European directives: the food supplements directive, which has already been passed, and the directive on traditional herbal medicinal products, which is currently under negotiation.

I want to make it clear at the outset that we support the right of consumers to have access to a wide range of safe remedies and supplements. We understand the anxieties that people have about the possible effects of the directives, but the discussions have also included a great deal of misinformation, which has caused consumers some unnecessary anxiety.

It is absolutely vital that we get the right balance in this area of policy. Dr. Fox rightly mentioned the views of consumers, the important issue of freedom of choice and the effect on manufacturers, which I will deal with in my remarks. I am absolutely amazed, however, that he did not once mention public health in relation to the important area of food supplements and herbal remedies. We must get the right balance between consumers having freedom of choice and access to a wide range of safe supplements, while making sure, crucially, that we protect public health.

Photo of Anne McIntosh Anne McIntosh Shadow Minister (Transport)

Does not the hon. Lady subscribe to the fundamental principle of European law that once a product has been accepted for free movement in one member state it should be generally allowed in every other member state? By excluding these products, the French and Germans are therefore acting illegally.

Photo of Hazel Blears Hazel Blears Parliamentary Under-Secretary (Department of Health)

No, what is important is that products are able to demonstrate their safety, quality and efficacy. I will be amazed if Conservative Members depart from that principle. The proposal for the herbal sector is for a simplified registration process so that the products do not have to go through the even more lengthy and expensive process of obtaining a specific medicines authorisation. The proposal is designed to try to make sure that those products can get to market in a way that recognises their traditional use.

Photo of Michael Weir Michael Weir Scottish National Party, Angus

I am interested in the Minister's remarks, but can she explain, if supplements have been on sale perfectly safely in this country possibly for generations, why the European directive will effectively take some of them off the market? Where is the evidence that public health requires some of them to be removed from the market?

Photo of Hazel Blears Hazel Blears Parliamentary Under-Secretary (Department of Health)

The hon. Gentleman raises an important question and I intend to deal with it in relation to both the food supplements directive and the herbals directive. In both cases, there are important public health issues, so I shall deal with that point in some detail.

Photo of Liam Fox Liam Fox Shadow Secretary of State for Health

The Minister is right to suggest that public safety should be paramount. However, is she suggesting that the current legislation is insufficient to protect the public? If she thinks that some of the products that are currently available might be adversely affected by the directive, why will they be on sale until 2009?

Photo of Hazel Blears Hazel Blears Parliamentary Under-Secretary (Department of Health)

The hon. Gentleman is certainly well aware of the significant concerns about a whole range of herbal products. For example, in Westminster Hall, we have debated aristolochia, which has been found in traditional Chinese remedies and has led to serious health problems. We have also seen recently how prescription-only steroids have been used in traditional Chinese eczema remedies. We placed in the Library last year a whole dossier relating to the concerns about such products. It is generally accepted—among manufacturers as well as consumers—that getting proper quality standards into the sector is a top priority. I shall come to the views of manufacturers in due course, because they are important.

Photo of Desmond Swayne Desmond Swayne Opposition Whip (Commons)

Given the Minister's concerns—which I do not share—will she answer the question of my hon. Friend Dr. Fox as to why the products will remain on sale for many more years?

Photo of Hazel Blears Hazel Blears Parliamentary Under-Secretary (Department of Health)

If the hon. Gentleman is referring to the food supplements directive rather than to the herbals directive, he might like to know that it makes provision for a transitional phase. We need also to introduce quality into the herbals sector, because some of the products are pretty dangerous. On food supplements, we have to make sure that people recognise the findings of the dossiers that prove that products are safe. There is a long way to go on food supplements. We have not yet had any negotiations about maximum permitted limits, and there is a great deal to play for in getting the best deal for the products that are on sale in Britain. Much of what the hon. Member for Woodspring said was speculation about what might happen in the future. The important thing is that the Government are engaged actively in the debate and are not simply throwing our hands up and saying that there is nothing that we can do.

Photo of Mr Hilton Dawson Mr Hilton Dawson Labour, Lancaster and Wyre

Late on Thursday, I become the latest Member of the House to present a petition, and this time it was on behalf of 437 of my constituents who have expressed a great deal of concern about the two directives. Can my hon. Friend assure me that the views of the hundreds and thousands of people who have been represented in the many petitions that have been presented to the House are being taken into careful account in all the work that she is doing on this issue?

Photo of Hazel Blears Hazel Blears Parliamentary Under-Secretary (Department of Health)

I certainly can give my hon. Friend that assurance. The allegation has been made that the Government have failed to use their influence on this important issue. I absolutely reject that. The Government have been able to exercise considerable influence on the food supplements directive and on the herbals directive. I will come to the details of that, because we are absolutely determined to engage actively in putting forward the interests of the people of this country. We will not abdicate our responsibility.

Photo of Hazel Blears Hazel Blears Parliamentary Under-Secretary (Department of Health)

I have given way lots of times. I now intend to make a little progress.

As I said, it is important to get the balance right between protecting public health and promoting honest and informative labelling so that people can make informed choices. It is for consumers to choose what to eat. We are not in the business of the nanny state—whether it is a British nanny state or a European one. We know that consumers welcome a wide range of choice and we are determined to make sure that that is sustained. The rationale of our approach applies as much to food supplements as it does to other foods. We know that many consumers value the range of food supplements that are currently available on the UK market.

Our current position on the food supplements directive is the one that we took in the negotiations. They were difficult negotiations. It was not a case of our not engaging; we were in there arguing the case for our position. The negotiations were carried forward with great vigour and in full consultation with all interested parties. The negotiations are now over and the supplements directive is a fact of life, but the Government were positively engaged in achieving the flexibility that enables us to have transitional provisions from 2005 to 2009 and in securing a commitment in the directive that the maximum permitted limits, which is the crucial issue for most consumers, will consider not just nutritional need, which was the view taken by most other members states, but safety, which was the view taken by the Government, and dietary intakes. We achieved in the negotiations a broader base of factors to be taken into account in setting maximum permitted limits than we would otherwise have done had we taken the view of the hon. Member for Woodspring and opted out of the negotiations.

Photo of Angela Browning Angela Browning Vice-Chair, Conservative Party

If I heard the Minister correctly, she said a few minutes ago something about safety, which suggested that she believes that some products on the market contain dangerous components or ingredients. She mentioned a Westminster Hall debate on one of them. Before statutory instruments appear before the Standing Committees of the House, will she place in the Library a list of all products on the market in this country that she believes contain dangerous ingredients or components? If she has the medical and scientific evidence to show that dangerous products are on the market, the House deserves to know what they are and why they are dangerous.

Photo of Hazel Blears Hazel Blears Parliamentary Under-Secretary (Department of Health)

That is exactly why, following the debate in Westminster Hall, we did just that. We placed in the Library a dossier compiled from reports from all around the world about substances that had given rise to health concerns. If any further items have given rise to concern since the dossier was placed in the Library, I shall gladly include them on it.

I have already referred to aristolochia. In addition, digitalis causes serious irregular heart rhythms. That was reported in the United States following the accidental substitution of harmless plantain with digitalis. Synthetic drugs have been adulterated. For example, fenfluramine, a prescription-only medicine, was banned globally on health grounds in 1997, but has been identified in traditional Chinese weight-loss remedies. Steroids have been found in skin creams, and there are herb and drug interactions with St. John's wort.

There have also been quality issues. Analysis has been carried out on echinacea, and lots of leaf and ash have been found in the product even though it should be made from the root if people are to obtain the benefits that they think they are buying. A lot of information is available and the dossier is in the Library. If further matters have arisen since the dossier was produced—the debate should be based on proper evidence—I will gladly place information about them in the Library.

Photo of Brian Iddon Brian Iddon Labour, Bolton South East

Why does it take a far more adverse reaction to remove a pharmaceutical product from the shelves than it does a herbal product?

Photo of Hazel Blears Hazel Blears Parliamentary Under-Secretary (Department of Health)

Herbal products are only just starting to be regulated. That is why it is important to support the directive. We need a proper regulatory framework for the herbal sector as well as our framework for traditional medicines. Herbal medicines are becoming more accepted in different medical environments, and Mr. Tredinnick has been pressing their case for a long time. As they become more widely used and demanded, the requirement for them to be properly regulated becomes even more intense.

Photo of Hazel Blears Hazel Blears Parliamentary Under-Secretary (Department of Health)

I want to make a little progress. I have given way many times, and I now want to describe our current position on the food supplements directive.

We have taken a robust position in the negotiations. The directive establishes the positive list that defines the range and form of vitamins and minerals that can be used in food supplements. It sets the principles for defining the maximum permitted limits; it does not go into specific limits but sets a framework. It also provides for mandatory labelling on nutrition information, warnings about keeping the product out of the reach of children and a statement making it clear that supplements are not a substitute for a balanced diet. We welcome those provisions.

Photo of Dr Jenny Tonge Dr Jenny Tonge Liberal Democrat, Richmond Park

I thank the hon. Lady for her generosity in giving way. I have not seen the dossier in the Library—I have been concentrating on other dossiers recently—but what is the directive's position on qat, which is classified by the Government as a herbal substance and is chewed mainly by people in the north African community? It is a great concern to the elders of that community, who have been to see me, because it is a powerful tranquilliser, then stimulant, causing young people in particular to do nothing with their lives. Can the Minister advise us whether the directive will cover that substance?

Photo of Hazel Blears Hazel Blears Parliamentary Under-Secretary (Department of Health)

I am not in a position to do so at the moment, but I undertake to look into the matter. I shall get back to the hon. Lady about the important matter of where that substance falls in the regulatory framework.

The directive contains a provision enabling member states to require notification of new products when they are developed. We will not activate that provision because it will involve unnecessary regulation. We are anxious to keep regulation to a minimum, but commensurate with the protection of public health—we want to get the balance right. It is fair to say that, if the Government and the Food Standards Agency had not engaged actively in the negotiations, the directive would have gone through and we would not have won flexibilities. Nor would we have broadened the base on maximum permitted limits, which is an important gain.

The directive must be implemented by 31 July this year. Draft regulations have been prepared and are out for consultation. The first effect of the directive, on labelling, bites on 1 August 2005. Reports of the imminent withdrawal of swathes of products are misleading. I am concerned that, in the motion, the Opposition talk about 300 products being taken off the shelves—[Interruption.] Well, they talk about 300 but mention 270 later in the motion. I am not sure whether they know which figure is correct—perhaps it depends on which briefing they are citing.

The food supplements directive contains two positive lists. The first deals with vitamins and minerals that can be included in food supplements, and lists all the vitamins currently used in food supplements and all but six minerals in those supplements. The controversy arises in relation to the second positive list, which deals with sources of nutrients, not nutrients themselves. The distinction is important. This is not about taking products off the shelves, but about the fact that 270 sources of vitamins are not included in the positive lists. Both lists remain open for amendment—they will not be closed—and new sources can be added to them.

The second positive list in the food supplements directive includes 32 sources of vitamins, nine of calcium, 11 of magnesium, 11 of iron, eight of zinc, eight of sodium and nine of potassium. A range of nutrient sources are included in the positive list, so consumers have been caused unnecessary alarm. It is simply not the case that the products on which they rely will be withdrawn.

Photo of Nicholas Winterton Nicholas Winterton Conservative, Macclesfield

Is the Minister saying that our brief from Holland and Barrett, a reputable company, is grotesquely inaccurate and dishonest? It says:

"The Directive, when transposed in UK law will still . . . lead to the banning by August 2005 of several hundred nutrients and nutrient sources which are currently permitted, affecting potentially thousands of UK products".

I have a retail outlet in my constituency. I like the shop, go there and use its products from time to time. Is it being dishonest?

Photo of Hazel Blears Hazel Blears Parliamentary Under-Secretary (Department of Health)

Many of us have such outlets in our constituency—I have myself. I have not seen the letter, but it refers to "nutrients and nutrient sources", thus making the point that I have been making—that the vast majority of things that are not on the positive list are not vitamins and minerals, but combinations and formulations of those ingredients. I am informed that the vitamins that people want to take will be available in the formulations—the nutrient sources—on the positive list. However, companies may be required to reformulate their products or submit dossiers if they want to carry on with a specific formulation.

I have just said that there are a number of formulations for all minerals and vitamins on the positive list, so it is unlikely that a whole range of products will be wiped out. Both lists include a wide range of vitamins, minerals and formulations. Admittedly, other formulations and nutrient sources are not included in the lists at present, so it will be a matter for industry and manufacturers to decide whether they want to submit dossiers on those nutrients or provide products derived from nutrient sources included on the lists. They therefore have many choices to make. I have received letters from constituents who think that echinacea and garlic will be banned. That is not the case—there is no substance in those allegations.

Photo of Angus Robertson Angus Robertson Shadow SNP Spokesperson (Defence), Shadow SNP Spokesperson (Foreign Affairs)

I am grateful to the Minister for giving way—she has been generous in accepting interventions. She will appreciate that many hundreds of thousands of people in Scotland, as throughout the rest of the UK, are concerned about the measures, but I have heard nothing about joined-up government and devolved Administrations. Matters such as food hygiene, composition labelling and advertising are devolved. What discussions has the Minister had with her counterparts in the Scottish Executive? How many times has her opposite number in the Scottish Executive, Malcolm Chisholm, who is Minister for Health and Community Care, attended the Council of Ministers to battle for a Scottish interest on that important subject?

Photo of Hazel Blears Hazel Blears Parliamentary Under-Secretary (Department of Health)

The matter is clearly of concern and interest to consumers up and down the country, and the proposed regulations have been consulted on in other countries. On the second question, I am not in a position to give the hon. Gentleman the exact details.

On the future of food supplements, the next big step is maximum permitted limits, which will be of great interest to consumers. Substances can be added to the list so long as a dossier is submitted by 12 July 2005. Member states may allow continued use until 31 December 2009, so there is a lengthy transitional period for manufacturers and retailers to take steps to ensure compliance. I welcome the fact that manufacturers using substances that are not on the list are co-operating in the preparation of dossiers, which clearly reduces the costs and regulatory burdens on them.

The directive does not set maximum limits, but establishes a framework for them. The House should be aware that other member states take a view of food supplements that is very different from ours. They regard them much more as medicines and, initially, have taken a more restrictive line than the one that we take. We have been able to achieve a wider framework for the setting of permitted maximum limits that looks at safety and thorough scientific risk assessments as well as nutritional need. We shall to continue to press those key considerations. Our efforts will focus on getting a good deal for the UK on implementation. I accept that many consumers value the high-dose products on the UK market, but we are actively pressing for thorough scientific risk assessments. There is still a great deal to play for.

Photo of Mark Todd Mark Todd Labour, South Derbyshire

Can I return to the point that I raised with the Minister's opposite number, who wilfully ignored it? From the perspective of a UK manufacturer seeking to enter the European marketplace, is not the attempt to break down restrictions in currently restricted markets good news?

Photo of Hazel Blears Hazel Blears Parliamentary Under-Secretary (Department of Health)

Indeed, it could well be in future. We are speaking of a different viewpoint from that of our country. The Netherlands shares our view, but other member states take a much more restrictive view. It is important, therefore, that we have been able actively to engage in those negotiations to make sure that we can retain UK consumers' rights to the supplements that they value, and ensure that we make those goods more widely available in future.

We set up an expert committee on vitamins and minerals, which is preparing a report and has consulted widely. The report is likely to be published this summer. It will then go to the European food safety agency and will form the basis of our negotiating position on the maximum permitted limits. I can promise the House that that will be robust, and that we will argue the case as strongly as we can.

Photo of Brian Iddon Brian Iddon Labour, Bolton South East

Is my hon. Friend aware that the European Union committee on food safety has set a maximum daily dose of 25 mg on vitamin B6, without taking into account factors such as dietary intake? The dose recommended by the committee may be less than 25 mg. It is traditional in this country for consumers to take more than 100 mg of vitamin B6. What will happen if there is such a wide disparity between the UK and the EU figures?

Photo of Hazel Blears Hazel Blears Parliamentary Under-Secretary (Department of Health)

I am aware that vitamin B6 is taken by many thousands of people in this country, and that there are concerns about the consumption of very high levels of vitamin B6 and the effect on the nervous system. At this point, it is not right to speculate about the European food safety agency's view on these matters. That is why it is important that we have succeeded in widening the framework within which the maximum limits will be set, rather than simply on the basis of nutritional need. Safety is the primary concern and must be taken into account.

On the directive on traditional herbal medicines products, there is agreement across almost the entire herbal sector that current regulatory arrangements for unlicensed herbal remedies are unsatisfactory. We do not set quality standards, we do not set safety standards, we do not require consumer information about the safe use of products, and we do not allow companies to tell consumers what the product is for. We have had repeated examples in the UK and across the world of unsafe or poor quality unlicensed products, or products containing illegal ingredients. I have already set out some examples of the wrong herb being used, contamination and poor labelling. We have placed the summary of evidence in the Library. The Medicines Control Agency has undertaken several successful prosecutions in relation to herbal remedies found to contain illegal ingredients, but the real issue is the lack of systematic quality controls to prevent those illegal ingredients from getting into the products in the first place.

The House of Lords Science and Technology Committee examined the issue of complementary and alternative medicine and reported in November 2000. The all-party group took evidence from various sources and was clear on the case for regulation. It stated:

"We are concerned about the safety implications of an unregulated herbal sector and we urge that all legislative avenues be explored to ensure better control of this unregulated sector in the interests of the public health."

The House of Lords Committee realised that public health was an important consideration, as well as consumer choice and the rights of manufacturers.

The proposed directive will put in place systematic arrangements to protect consumers. Ministers, including myself, have had meetings with people from the sector—manufacturers, herbalists and consumers. The clear majority of interest groups broadly support the directive. Groups representing practitioners, manufacturers, pharmacists, doctors and toxicologists, and the Consumers Association have all indicated their support. They believe that the directive will protect public health and, importantly, boost consumer confidence. The herbal manufacturers want a regulated regime, because they want their sector of the market to have the confidence of consumers, so that they will want to buy the products and feel that they can rely on their efficacy and quality.

Unlike Consumers for Health Choice, which has campaigned and issued hundreds of thousands of leaflets, and which is funded by some large companies in the field, including Holland and Barrett, Solgar and Biocare, many other groups do not have the resources to engage political lobbyists, but they are passionate in their support for the directive.

The European Herbal Practitioners Association, which represents 1,200 herbal practitioners in the UK, states that the EHPA now supports the proposed directive,

"recognising that it represents the best chance to safeguard the public by ensuring reliable quality and safety standards for herbal products."

The EHPA states that in its judgment, failure of the proposed directive to pass into law

"could potentially jeopardise the supply of herbal medicines to the public since in the absence of agreed quality and safety standards for herbal medicines throughout the EU, there would undoubtedly be a loss of confidence in the sector".

The Herbal Forum, which represents all 10 manufacturing trade associations, recently stated that it sees the need for the directive and that it wants to work closely with the Medicines Control Agency. Such views are held not only in this country. The draft strategy of the World Health Organisation on traditional medicines was published last year and recommends support for all countries to establish effective regulatory systems for registration and quality assurance of herbal medicines.

In our European negotiations, our main aim has been to press, as in the case of food supplements, for increased flexibility as regards the scope of the directive. We are very hopeful of progress. We understand from the European Commission that the next version of the proposals, which is due out shortly, will extend the proposed simplified registration procedure to herbal/nutrient combination remedies. The hon. Member for Woodspring raised the issue, and consumers and others in the field have been raising it for some time. The combination products, which at present do not have authorisation, would currently be required to go through a full market licensing procedure, but they may well be able to come under the simplified procedure of the directive. That would be an extension of consumer choice, rather than a limitation of it. We look forward to the next draft. If that development is confirmed, it will be an example of the Government's creativity and the Opposition's lack of imagination on the subject.

We have also pressed for the directive to be amended so that more account can be taken of valid evidence of traditional use from outside the European Union. The Medicines Control Agency, with the support of many groups across the UK herbal sector, has fought long and hard in Europe over several years to get wider recognition of non-EU traditional remedies. We welcome the possibility of progress. We think that the next draft of the directive will give the European herbals committee power to reduce the requirement for a minimum 15 years' EU usage where valid evidence is supplied. On those two issues, combination products and traditional non-EU usage, we are hopeful of progress.

The thousands of leaflets issued by Consumers for Health Choice will have frightened many consumers. Last year, we extended the public consultation process and asked people who were worried to send in examples of products likely to be ruled out as a result of the directive. We referred 200 substances for examination. The results showed that three or four of them might have been excluded. That is the extent of the issues with which we are dealing. To frighten consumers by talking about hundreds, if not thousands, of products being ruled out is not a responsible course of action.

We are keen to ensure that Chinese and Ayurvedic medicines can be incorporated in the category of traditional non-EU use. We shall continue to press for that.

Manufacturers large and small are supporting us in this cause. They are concerned that some of their competitors are short-changing the public with lesser quality products. Why should the public have to accept patchy, second-rate standards merely because a medicine is made with herbal ingredients rather than chemical ones? None the less, we attach great importance to trying to keep the regulatory requirements to a minimum, so we are keen to engage with the industry in that regard. The MCA and the Herbal Forum have launched a detailed programme of discussions about the dossier process, in which they are asking how those requirements can be streamlined and how they can ensure that companies collaborate so that they are not all starting from scratch, perhaps by enabling them to refer to each other's evidence.

The hon. Member for Woodspring proposed the idea of a national positive list. We are certainly sympathetic to that idea, but we think that many of the practical issues could be dealt with by co-operation between those in the industry, who should use each other's information. We are not unsympathetic to the idea of a national positive list as well as a European one, and we will continue to explore it.

Photo of Mark Lazarowicz Mark Lazarowicz Labour/Co-operative, Edinburgh North and Leith

I am glad to hear about the consultation that my hon. Friend is promising to continue to hold with the industry. Will she assure the House that she will not allow any directives to pass through the European Union legislative process unless the industry's concerns are taken into account?

Photo of Hazel Blears Hazel Blears Parliamentary Under-Secretary (Department of Health)

From the outset, the Government, the MCA with regard to herbals and the Food Standards Agency with regard to food supplements have been engaged with the industry, including large and small companies, manufacturers, retailers and the whole field to try to ensure that we advance the views of the people whom we represent and to protect consumers and public health by getting the balance right.

On the food supplements directive, our focus is now on good implementation, ensuring that we maximise consumer choice and pressing for a safety-based approach to maximum limits. On herbals, we want to enhance the status of herbal medicine and maintain consumer choice, and our initiative is widely supported in the sector.

It is crucial that we get the balance right between protecting public health and ensuring that consumers have a wide choice of safe and effective food supplements. I suppose that I can do no better at the end of my speech than to quote from the brief that the Consumers Association—an independent and challenging organisation—has given to hon. Members for this debate. It states:

"There is potential for harm in relation to both herbal medicines and food supplements, where there is inadequate quality control and insufficient information. These two EU Directives will establish regulatory frameworks that ensure consumers can take full advantage of these products in the secure knowledge that they are using them safely and that they contain what they say they contain."

The Government are ensuring that that happens. As usual, the Opposition motion is cynical, short-sighted and opportunist. It exposes their inability to take mature and responsible decisions on behalf of the people of this country. Our amendment sets out our plans actively to engage on all these important matters with other member states and the Commission to get the best possible deal for consumers in this country, as well as adequately illustrating the difference between us. I ask the House to support our constructive amendment.

Photo of Evan Harris Evan Harris Liberal Democrat, Oxford West and Abingdon 8:31 pm, 20th January 2003

The Liberal Democrats welcome this debate and applaud the Conservative party for raising on one of their Opposition days a subject that features heavily in hon. Members' postbags and which has attracted much cross-party support as the subject of early-day motions. It has also been the subject of petitions submitted by many of my hon. Friends and, indeed, hon. Members on both sides of the House. The Under-Secretary was uncharacteristically harsh in her closing remarks in claiming that the Conservative party's motion was cynical, short-sighted and opportunistic. That might embarrass some Labour Members who support at least some of the sentiments underlying the concerns that have been expressed. Generally, the debate has been detailed rather than partisan, and I hope to continue in that spirit.

The Under-Secretary was right that there is an issue of public health, and it has to be balanced with choice. She has my sympathy in grappling with the difficulties of finding that balance. I think that the main principle should be that people should be allowed to consume products where it is safe to do so and where they are not being misled into doing so. In some cases, we are dealing with vulnerable consumers who are seeking specific health effects, even if they are not advertised as such. Another principle that should be established is that the greater the health claim, the greater the potential vulnerability and the need for safety. In that respect, information is very important.

The labelling aspects of the directives have not been stressed enough. They will provide for proper labelling. Yes, there will be a cost to the industry and retailers in providing it, but we support it with regard to food and licensed medicines and it is right that we should support it with regard to an intermediate group of products. The directives are good in that respect. I know that people who feel that there should be freedom to consume also recognise that that must exist in the context of adequate health information. For example, very few hon. Members would ban smoking, but most of us insist that a significant amount of information should be given to people who are especially vulnerable, as they are addicted in many cases.

Photo of Roger Gale Roger Gale Vice-Chair, Conservative Party

The hon. Gentleman is a medical practitioner, as is my hon. Friend Dr. Fox and Dr. Iddon. Dr. Harris referred to smoking. The European Union promotes and subsidises the production of a leaf—tobacco—that is known to cause harm, yet we are considering banning substances that humans have used for many years and have not been proven harmful. What is the logic of that?

Photo of Evan Harris Evan Harris Liberal Democrat, Oxford West and Abingdon

I agree that it is morally outrageous that the European Union subsidises tobacco crops. Many hon. Members feel strongly that such subsidies should end because they cannot be justified, especially when the products are marketed in the developing world. It is therefore consistent, and the hon. Gentleman is consistent, to raise anxieties about that and to be worried about some of the directives' unintended—or, indeed, intended—effects on products that are currently available. I hope to deal with some of those concerns.

Although I generally agreed with the speech of the hon. Member for Woodspring, he went further than I would go in decrying regulation. I shall revert to that shortly. He was inconsistent when he argued that the directives would send people and users underground and that they would double their dose, go abroad or seek black market sources, because that argument also applies to some softer drugs. He praised the Netherlands, but it is important that hon. Members realise that some countries are consistent in their liberal approach of allowing consumer choice, provided that adequate information exists about a product's safety or health risks. There are health risks associated with, for example, cannabis.

I do not believe that over-regulation is the problem. We support the principle of regulating food supplements and herbal products, but there are valid concerns about the detail. The directives aim to improve the single market. Mr. Todd pointed out the difficulties that manufacturers in this country experience in marketing products in other European countries that are stricter. That is the problem with a single market, which the Conservative party supported in the past.

Safety, information, labelling and public health also need to be tackled. We must take a balanced view, and I am therefore worried about scapegoating the pharmaceutical industry. Although there are problems with pharmaceutical companies, they are not the baddies with regard to the directives. As we have heard, significant commercial resources back those who lobby against the directives or some of their provisions. That does not invalidate their concerns, many of which I share, but the pharmaceutical industry does not have a monopoly on lobbying.

It is pleasing that some progress has been made in amending the food supplements directive in the European Parliament. My Liberal Democrat colleagues in the European Parliament supported a move to extend the 18-month period for submitting evidence for the harmless nature of a food supplement to at least 36 months. It is regrettable that it is not longer. If the derogation allows the products to be used until 2009, it is strange to set a cut-off date of 2005. The evaluation would not require four years.

I agree with those who tabled the motion, Consumers for Health Choice and others, that up to 300 nutrients or nutrient sources that are currently in use may not be available, and that that is unsatisfactory. I do not believe that the Minister disputes the numbers. It is worrying that the maximum allowed dosage may not be based on an upper safety threshold. I believe that all hon. Members would support such a basis.

It is unclear whether the positive list remains open in the way in which the Minister implied when she spoke about the amendment. The positive list remains open only with the provision of the dossier. That places a significant burden on smaller companies, and there is a valid concern that it will be more difficult for established small companies to ensure that their products are included on the positive list. It would be useful if Ministers cleared up the part of the amendment that implies that the positive list remains open without qualification.

The suggestion that there should be a British positive list could only result in support being given to smaller companies to enable them to work with other people to establish the safety of their product. There is an argument for at least some kind of framework for helping those companies, if not for Government intervention, given that they will be put in a difficult competitive position by the regulations, which will have been difficult for them to foresee when they first marketed and established their product.

The Government have made progress. They have obtained—or, at least, they claim to have obtained—a derogation to allow the use of existing products until 2009. Their approach goes in the right direction with regard to the maximum permitted safety levels, and there is therefore much to be welcomed in their approach. It could have been worse: they could have taken a very narrow line on these issues. It is, therefore, appropriate to give them our support and wish them luck in future negotiations on these matters.

A series of amendments to the directive on traditional herbal medicinal products has been tabled in the European Parliament. Again, the position is not as bleak as had first been thought. Liberal Democrat colleagues have supported the amendments to allow the inclusion of non-herbal ingredients such as vitamins and minerals—I suppose that Conservative MEPs will have done so too—and to modify the definition of a herbal medicinal product to mean those products containing pharmacologically active ingredients.

Photo of Liam Fox Liam Fox Shadow Secretary of State for Health

Those were Conservative amendments.

Photo of Evan Harris Evan Harris Liberal Democrat, Oxford West and Abingdon

I shall put on record that I accept that the hon. Member for Woodspring claims that they were Conservative amendments, but the Conservative party—and its colleagues, such as they are—does not have a majority in the European Parliament and requires the support of other groups to pass such amendments. There is a greater spirit of co-operation, and more recognition of the need to form such coalitions, in the European Parliament than we have here. Amendments tabled to clarify the border between food and herbs and to ensure that the directive does not apply to food supplements or cosmetics were also successful.

It was regrettable, however, that there was no success in amending some other parts of the directive, and those areas give rise to some concern. First, it needs to be clearly established that combinations will be allowed under the directive, and I hope that the Minister will clarify that point. During an earlier debate of a European Standing Committee, it was not entirely clear that the Government had been reassured on that position. Indeed, it was not clear that the Government even supported the concerns raised by, among others, Mr. Tredinnick about whether such combinations would be permitted. It would be useful if the Minister could put his views on that matter clearly on the record.

It is also regrettable that there is inequality between the amount of traditional use allowed in other parts of the world—where there has been traditional use for longer—and in the European Union, and that we require the passage of a measure through the Council of Ministers even to make progress to 10 years rather than 15 years of European use. An early review will be required to see how the measures are working, but it is not clear that that is to be delivered. It is, therefore, reasonable to suggest that we expect a lot of the Government in regard to the traditional herbal medicinal products directive, which has not yet been published and is therefore not yet in force. The Government claim to seek flexibility on the years of European use necessary, and I would be grateful if the Minister would clarify exactly what his aspirations are in that respect, and what level he would consider unsatisfactory.

The Government also claim to be trying to reduce the regulatory impact burden on smaller producers of these products, but more substance needs to be put on the bones of that claim. Otherwise, people whose business depends on such action may not believe them. Like the Consumers Association—I, too, shall quote selectively from its briefing—we recognise that

"there are positive benefits . . . from both of these EU directives"— but, in both cases, there is still more work to be done.

Several hon. Members:

rose—

Photo of Michael Lord Michael Lord Second Deputy Chairman of Ways and Means

Order. Before I call the next speaker, I must tell the House that a number of hon. Members are clearly seeking to catch my eye, but there is a limited amount of time left. It would, therefore, be helpful if Members could make their remarks as brief as they feel is reasonable.

Photo of Alan Simpson Alan Simpson Labour, Nottingham South 8:44 pm, 20th January 2003

If any Members in the House tonight were medical students in China, they would be given a simple message in the first lecture of the first part of their course: food is our first and strongest medicine. It has the power to cure us and make us well, but it also has the power to kill us. The importance of that in medicine lies in understanding the significance of thresholds and appropriate intakes. Even in this country, a large number of members of the medical profession will happily repeat part of that message. They will tell people that if they were to drink even water in sufficient quantities, it could kill them. For me, the sad thing is that that common ground between our conventional medicine and the traditional medicines of our own country and of the east seems to end there.

Our medical culture is dominated by a view of medicine written largely by the pharmaceutical companies. As such, we have a medicalised model that addresses, by and large, not health, but ill health. We have a culture that is resistant to the idea of people taking responsibility for their health. No matter how much we say that we want people to be responsible for their health, we increasingly throw up all sorts of obstacles in their path to doing so.

In some ways, tonight's debate has managed to capture the contradictions of where we are, although it is further complicated by a number of disparate and different interests, which we are trying to encompass in one discussion. We are dealing with two directives involving some common ground, but lots of differences of interest. Also, two Ministries are involved as are, at European level, two different views as to the place of nutritional supplements and traditional herbal remedies in the pattern of health culture.

In addition, there are two clear political tendencies with interests in the debate. One, which seems to exert a disproportionate influence in the European Union, is pro-standardisation and pro-regulation while the tendency in our country is much more pro-choice and pro-information. I can understand that the negotiations involve genuine differences of view that have to be argued and fought out between those different perceptions.

As if that were not complicated enough, there are two clearly different sets of lobbying interests—the pharmaceutical industries and some large herbal product suppliers and, on the other side of the equation, members of the public who just want more extensive choices that they are empowered and trusted to make. We have to try to navigate our way between those sets of competing interests.

For Ministers, the final complication is that, within our advisory system, different views are taken by the Food Standards Agency and the Medicines Control Agency. Members should remember that throughout our debates on nutritional supplements, the MCA has consistently sought to medicalise the health model that applies to traditional herbal remedies and food supplements. We need to try to hold off those interests as separate from and in competition with those being put to us by members of the public and our constituents.

Let me make it clear that it would be crass for the House not to support the Government amendment. A good amendment has been tabled and, even as a sceptic, I think it incumbent on us to support and understand its importance, because it reflects the negotiating position that the Government seek to occupy. In particular, it is worth supporting because, as I must say for the record, the robust negotiations involving Lord Hunt have presented a formidable challenge to many of the inclinations that people wanted to be written into the first draft of the directive.

It is important for us to recognise the lobbying and negotiating role played by the Food Standards Agency. A former Minister in this House, the noble Lord Rooker, had the sense to kick some of our earlier debates into touch. He put together a Joint Committee, which is due to report to the Government and to the House this spring. It would be naive and politically dishonest of us to try to pre-empt that. It may turn out that it puts forward a strong position, and most of us who support nutritional supplements and public choice may find it an ally in our negotiations, not a limitation.

I want to focus on my concerns, which I hope the Minister will heed. The food supplements directive raises issues about potency that we must address. The wording that has so far been used stresses the notion of safe levels. It is important for us to recognise that what some other European countries mean by that is minimum levels. The references to vitamins C and B6 show how problematic that could be. The idea of a safe level of 25 mg of vitamin B6 would be a sad joke to the thousands of British women who regularly take vitamin B6 to maintain their well-being as part of their informed health choice.

The Minister referred to the adverse effects of an intake of large amounts of vitamin B6—four times the current safe level recommended by the EU, or even eight or 10 times that level. There is no medical evidence to support that claim. People in the Department advise the Minister on the basis of one study alone, the Dalton and Dalton study. It is worth going through that study if one wants to read a piece of hocus-pocus research. The authors have persistently refused to allow their peers to review the data on which they based their recommendations. It is astonishing that researchers have made such far-reaching claims but have refused to let their peers examine the basis on which they were made. I understand that there is one study that may offer a crumb of comfort to them, but as it was a study on dogs rather than people, I suggest that any investigation of its significance should be carried out with caution.

The Medicines Control Agency has attempted to bounce successive Governments into a medicalised view of regulating these supplements, because it suits its needs and those of the pharmaceutical industry, which would make an awful lot of money out of the process if it were able to capture that market. It would give the agency monopoly control, and it would allow the industry to charge monopoly prices. The vast majority of women who campaigned in opposition to the initial proposals to set ludicrously low limits on the availability of vitamin B6 knew what game they were playing and what was at stake.

Whatever figure we choose to put on it, there is a problem with having a limited number of nutrients allowed to be registered under the directive. I think that it would be crass of us to say that some of the nutrients that are currently available in the UK would not automatically be covered by the new directive. To go down that path would be to take a serious step backwards, with no medical evidence on which to base our contention.

I also caution the Minister and other colleagues about going down that path, because it does not make any sense, even in pragmatic terms. In today's globalised information market, if we set foolish, prohibitive and restrictive rules, consumers who have looked into this issue and made their own health choices will go through other channels. They will use mail order or the internet to do so. A more open and regulated market will always be better than the present market, which is prescriptive and pushes more people into making choices outside a formal market framework.

Photo of Chris Grayling Chris Grayling Shadow Minister (Health)

The hon. Gentleman has voiced many of the anxieties that lie behind our motion, and indeed behind early-day motions signed by many Members. Does he not realise that this motion gives him, and others on both sides of the House, an opportunity to make their point robustly?

Photo of Alan Simpson Alan Simpson Labour, Nottingham South

I do, and the terms of the motion certainly presented an initial attraction. The more I read the Government's amendment, however, the more I saw a compelling case for Members on both sides of the House to support it. We are talking about negotiations that are currently in progress, and our debate should send Ministers a message about where we want the progress to end up. That will, I think, strengthen their position. The message is clear: if we as a Government fail to meet demands made by Members on both sides of the House, Members on both sides of the House will not give their support.

Let me say something about the proposed directive on traditional herbal medicinal products. I urge the House to be cautious about the catalogue of criticisms that we are offered in relation to the dangers of herbal products. It would sit more easily on my conscience if we had a similar list of the problems associated with manufactured pharmaceutical drugs. The catalogue of health disasters foisted on people by an industry that appears at times to be able literally to get away with murder is scandalous.

In that context, it is outrageous for us to allow ourselves a distorted debate that fails to recognise the thousands of years of knowledge—especially in the east—of the use of traditional herbal remedies. The issue is not the use of the herb involved, but an understanding of dosage. That has always been the basis of the application of such remedies. The House must not become trapped in a caricature of a debate—an exchange in which scare stories are thrown around, suggesting that if Ayurvedic medicines or different herbs are used there will be terrible consequences for us all. Using such herbs in an informed fashion is arguably one of the best ways of giving people more responsibility for and control over their own well-being, and all parties in the House should welcome that.

We would like the Minister to return from his negotiation with affirmative answers based on the need to address the existence of products that have been on the market for some time, and ought not to be outside the loop of existing or proposed legislation. We should oppose the suggestion that no new products should be brought on to the market even if they have been available in another EU country and have a good safety record. We should recognise that the standards for manufacturing of such products must relate to food safety rather than medicinal standards. We should allow more emphasis to be put on labelling, rather than on the restriction of dosages.

One question relating to how the markets will function after the two directives are agreed on and become operative will concern the number and nature of suppliers. The costs of compliance will have a profound effect on the range and character of the choices that the public face.

Therefore, I hope that the Minister will agree tonight to commit the United Kingdom to five clear points at the negotiations. The UK must reserve a position that gives it the right to derogations, otherwise the consensus would be for a market that was so restricted that it was diametrically opposed to everything that the UK has built up. We must emphasise upper safety levels rather than minimum risk restrictions. We must have a commitment to abolish the arbitrary period that a herbal product must be on the EU market before it is allowed to register. We must press for maximum rights to clear information about product labelling, and minimum presumptions that positive health choices need to be medicalised rather than just publicised. Finally, we must try to set the lowest possible price hurdles for product registration in each of the respective markets.

Consumer choice will depend not on the assurances of agencies or Ministers but on the freedoms, derogations and choices that end up being written into the legislation or directives. The UK is committed to a strong negotiating position. The message that must come from the House is that we must deliver on that position if the House eventually is to offer any support to the final directives that come through.

Photo of David Tredinnick David Tredinnick Chair, Statutory Instruments (Joint Committee), Chair, Statutory Instruments (Select Committee) 9:01 pm, 20th January 2003

My hon. Friend Dr. Fox is to be congratulated on his choice of debate this evening and on the eloquent way in which he set out his stall and explained in great detail some of the problems that we face. I will try to add a little colour to what he said.

Talking of colour, I straight away refer to the Minister's speech. She presented an amazingly rosy picture of the Government's approach and what they have done in the past few months. I am astonished to hear her blame organisations such as Consumers for Health Choice for scaremongering, and others for distributing leaflets when it is the very fact that they generated interest among the public that brought the Government to their senses and got them to act in the first place.

If the Minister casts her mind back to the spring of last year, the Department of Health was in disarray on the matter. It was impossible for any of the manufacturers such as the ones to which Mr. Todd referred to see a Minister to put their case. It was not until her Department agreed to meet me, my hon. Friend Sir Nicholas Winterton, and industry experts on 17 June to discuss the problems that the Department became aware of what was going on. The only reason why the Minister and Lord Hunt agreed to meet us then was that the next day they were going before Standing Committee C and they were going to get a right grilling.

In the Minister's defence, she had just taken over the brief from, from memory, Yvette Cooper. It was not easy to go before that Committee at that time but she did and she defended herself in an honourable way, on the basis that she had very little knowledge of the subject; that is a slightly double-edged compliment.

We have many specific concerns about the directive and they have been listed this evening: unreasonably requiring 30 years' continuous medical use; unreasonable demands for compliance; the exclusion of safe and popular products; and leaving many combination products outside the directive's remit. I should like to look at some of those in turn but, to give an example of how wrong the Government got it, they had to extend the consultation period on the herbal directive. It was not an achievement to extend the consultation period; it happened because the Government were behind the game. That was the problem. On 18 June, the Minister appeared before the Standing Committee and had a pretty rough time of it. It was only then that we saw some action.

The Minister has given a typically upbeat, new Labourish presentation. [Interruption.] She shakes her head—perhaps she is part of old Labour, but she has given such a presentation. However, I do not want to get her into any trouble. In her rather clever debating style, she managed to focus on the few rogue problems that have occurred in the herbal industry. She referred to aristolochia, as I knew she would. We have surely been round that track before: the mis-prescription of a wrongly labelled drug by the wrong practitioners at the wrong time for the wrong purposes, and the resulting problems. She has gone on about the hoary old chestnut of steroids in creams—yes, we know all about that—and one or two other matters.

The Minister has tried to distract us from the issue. No one on this side of the House wants unsafe remedies on the market, and it is a good thing that two professional committees, under Professor Pitillo and Lord Chan, are looking at herbal medicine and Chinese acupuncture, and trying to draw the strands together in this country. No one is suggesting for one second that we want unsafe products on the shelves. The real problem is that the shelves will be denuded if this Government do not get their act together. I am very relieved to hear that, almost at the last fence, the Minister has got some good news on combination therapies.

Alan Simpson mentioned the dangers of herbal medicines when compared with other products, as did Dr. Iddon. I nearly described the latter as my hon. Friend—perhaps because we once led a march together. I have looked up the figures. In 1997, the last year for which figures were provided, 562 people died from taking paracetamol, and 51 died from taking aspirin. In his winding-up speech, the Minister who is to reply might like to tell us how many people in this country have died from eating parsley, or from taking most of the other herbs that are obtainable in stores such as Holland and Barrett. The Minister made much of this issue, but the fact is that the number of herbs that have caused health problems is very small indeed. Generally speaking, such problems have occurred because of incorrect labelling and rogue marketing. We obviously welcome a tightening up in that regard, but we do not want this Government to be rolled over and knocked about by members of the Commission or the European Parliament because they failed to present Britain's case effectively.

The really big issues that we are considering through the motion are borderline products and the combination products of herbs, vitamins and minerals. The Minister made much of the positive lists, which she says are still open, but she has said little about the costs that manufacturers will have to incur if they are not on those lists. Even if they are on those lists, they will still have to produce complex dossiers—[Interruption.] I note that the hon. Member for Nottingham, South is nodding. They will also have to clear the hurdles set by the Medicines Control Agency. That will of course result in restriction of choice—my party stands for choice, not restriction—and it will prove damaging to the industry as a whole. Are the Government really in favour of monopolies in this field? What will happen to the small producers? I am slightly suspicious of the position taken by the hon. Member for South Derbyshire, because I have a feeling that he is representing only the larger manufacturers, such as the one in his constituency. We should focus much more on the little people. We do not want them to be wiped out.

I was pleased to hear today from the Minister about the new negotiations on simplified procedures. That announcement conveniently slipped out today in order to take the wind out of our sails, and having seen what happened in the Department before the Minister participated in Standing Committee C, I have no conscience about offering such criticism. We have all called for simplified procedures, and we want vitamins, herbs and minerals to be sold in this country as they were in the past. This has been a bone of contention, and although the Minister says that everything is wonderful and that they have been on top of the situation the entire time, that simply is not the case. She must accept that fact—[Interruption.] I do not know whether she is smiling or blushing, but it would not surprise me if she were upset at thinking about what happened in the past.

My hon. Friend the Member for Woodspring and the hon. Member for Oxford, West and Abingdon (Dr. Harris) referred to the work of MEPs. The Government are not responsible for the amendments to the traditional herbal medicines directive; that responsibility lies with John Bowis, MEP, the former Member for Battersea. I spoke to him on the telephone at some length this afternoon. I said, "Put me straight. What have the Government actually done?" He replied, "Precious little. They let it coast along. They did not intend to do much." Only the pressure that has been brought to bear on them has caused them to take any action at all. The amendments are nothing to do with the Government. They were produced by the Conservatives in the European Parliament and include amendment No. 1, which concerns easier registration, and Nos. 9 and 11, which are about combinations. Some of them are supported by the Liberal Democrats—I will give them that.

The awful truth is that the letters sent out by Lord Hunt in the summer were intended to lull us into a false sense of security, but it is possible that the amendments will be rejected and that we will be in a worse situation than we were in the spring. Perhaps when he winds up the debate the Under-Secretary will tell us whether there is a guarantee that the amendments will be accepted. In this case, the big gun wheeled out by the Government was inertia. They let the issue drag on. It is only the determination of certain groups to bring the subject to people's attention and to needle the Government about it that has brought them kicking and screaming to the point where they take the issues seriously.

The Council of Ministers, which is made up of national representatives, will have an impact on the matter, and the Under-Secretary of State for Health, Ms Blears, should get in there and make strong points. We want to see a little fire in her belly and a little action. We do not want to hear from our representatives in Europe that nothing much is going on. The former Member for Battersea is a very honourable man, and in our conversation earlier we were not trying to make political points. I asked him what line I should take in this debate, and he said that not much has been done about the matter. It is not very good.

The Minister still has time to effect change. The Government should introduce proposals that would allow the UK to set national rules to permit the continued sale of products that are safe and appropriately labelled, but which may lie outside the restricted code. They should abolish the completely arbitrary period for which a product must have been on the EU market before being allowed registration. That period has no relation with the availability of safe data. Finally—the Government can certainly do this—they should end the attempts by the Medicines Control Agency to regulate herbal medicines as if they were pharmaceutical drugs, thus reducing compliance costs. We are talking about the third way, which has been referred to in the past. That was part of earlier legislation but it was never implemented.

I turn briefly to the food supplements directive. We have already heard about the problem of minimum dosage levels, and the hon. Members for Nottingham, South and for Bolton, South-East have spoken about the pressure in Europe to reduce the maximum permitted levels of vitamins. If the Government do not stand up and sort this out, it will simply be a tax on poor people. They will buy the amount that they want—they will buy on the internet and get the products from abroad—but they will have to pay three times as much. The Government must stand up and be counted. It is wrong that we should be forced to reduce the levels of vitamins when 20 per cent. of the nation are using supplements and complementary therapies. It is time for the Government to be tough.

The possible effects of the directives include the loss of thousands of safe, popular herbal products, completely unnecessary restrictions on consumer choice, substantial job losses in the retail sector, the bankruptcy of several specialist manufacturers and retailers, an adverse impact on public health and a substantial increase in the number of visits to general practitioners.

The Government's approach to the directives has been the most appalling example of inertia, muddle, late action, refusal to consult, defensiveness and, if not deception, at least sleight of hand. We are often told, as we have been tonight, that everything will be all right in the end, but the amendments could be thrown out and worse could come. We shall not avoid problems in the future. The Government have done far too little, far too late, but I hope that some good may come out of it.

Photo of Brian Iddon Brian Iddon Labour, Bolton South East 9:15 pm, 20th January 2003

I want to make a few new points.

The pharmaceutical industry has been accused of being behind the directives and promoting them for its own benefit. I do not believe that. The pharmaceutical industry was born from natural products. Many of the drugs that we use nowadays are derived from plants, roots, berries and tree bark. Salicylic acid, for example, comes from the bark of the willow tree, and then turns into acetyl-salicylic acid or aspirin. Many of our modern drugs follow similar pathways.

I should like to tell the House a funny story about a late friend of mine, Dr. Michael Scrowston, who used to lecture in my subject at the university of Hull. Over many, many years, he collected a large number of beautiful plants from all over the world, potted them and nurtured them in his greenhouse. He gave lectures on how the modern drugs industry was derived from the plants described in little books such as the one I have in my hand. On one occasion, he set out a wonderful display of plants on the lecture bench in front of him; there were beautiful flowers such as the autumn crocus and some extremely rare plants. When he had finished his lecture, the lady from the Women's Institute who had invited him said, "Dr. Scrowston, how wonderful of you to bring all those amazing plants for the raffle", and he lost the lot.

I do not want the Government to underestimate the public reaction that always occurs when new legislation is introduced in this policy area. If the public were not fully behind the natural health products industry, how could it have achieved such growth? Mr. Tredinnick has just referred to ML" 249. When it was under discussion a few years ago, there was a march from Hyde park and a rally in Trafalgar square. I still cannot believe that the hon. Gentleman and I stood on the plinth of Nelson's column talking to a large gathering about ML" 249. Probably, nobody had ever heard of it, apart from the people in Trafalgar square on that day. Thousands of people came from all over the country because they were annoyed about a European directive that has long since passed into law.

As my hon. Friend Mr. Dawson has pointed out, more than 20 Members, including him, have presented petitions to Parliament expressing concern about the directives relating to the UK health products industry that we are debating. Altogether, there are more than 1 million signatures and the petition is one of the largest presented to Parliament in modern times. Just before Christmas, I presented six boxes, which alone contained 350,000 signatures. Those petitions are still coming in and they show that people in every corner of the country—in all our counties and nations—are extremely concerned about what is going on. The Government should not lose sight of that fact.

As of today, 165 hon. Members have signed my early-day motion 278 on the food supplements directive and 164 Members have signed early-day motion 279 on the traditional herbal medicinal products directive. That, too, demonstrates the concern expressed to us by our constituents.

Photo of Brian Iddon Brian Iddon Labour, Bolton South East

I have little time, so the hon. Lady will forgive me. If my constituents cannot purchase health products from a local shop, they will not blame the European Parliament but the Government. They may be tempted to purchase such products on the internet or from mail order catalogues that may not be manufactured to the standards that they have come to expect. My hon. Friend Mr. Hoyle tells me that he has seen health products on sale at car boot sales. Not much regulation there.

Many people, myself included, like to keep as far away from our doctors—with the greatest respect to Dr. Harris—as possible and self-medicate minor ailments. If popular over-the-counter products are removed by legislation, there is a slight possibility that general practitioners and even hospitals will be under greater pressure.

The food supplements directive is almost set in stone. It appeared in the Official Journal of the European Commission in July 2002 and must be implemented by our Government in July this year. I am glad that the Government have stressed safety as the important factor. Government representatives have worked hard on putting their arguments across in the Council of Ministers and its working parties, where people from less liberal regimes on the continent are pressing for topping up the nutritional requirement a little.

The European Union Scientific Committee on Food has already published a list of recommended daily doses to be enshrined in the final directive. My hon. Friend the Minister referred to the ad hoc committee on vitamins and minerals that was established following the vitamin B6 fiasco which has now become part of the Food Standards Agency. In May, it will report its own recommended levels. I have already indicated the disparity that might exist, particularly in respect of vitamin B6. The European recommended level is 25 mg but people in this country are taking 100 mg and up to 200 mg per day—most of them without any adverse effects. In any event, if they exhibit peripheral neuropathy, it is reversible if they lower the dose or stop taking B6.

We can all adhere to the safety requirements that are enshrined in the directive on herbal remedies but it requires manufacturers to adopt pharmaceutical processes that will add costs, because it requires each batch of herbal remedy to be tested. Industry estimates may be over the top but I have been given a figure of £2,000 per batch. Smaller organisations prepare about 10 batches of the same product every week, so a lot of money would be added to the cost of producing a particular product. Some companies handle 100 products, so that requirement could soon mount up to £200,000 of extra costs for a small or medium-sized enterprise.

This afternoon, some of us put that concern to the Minister in the other place with responsibilities for the herbal remedies directive. He assured us that he does not want any small or medium-sized enterprises going out of business as a result of imposing such regulations on the industry. I am sure that manufacturers will be pleased with that news, as we were.

However, there are other costs. The cost of registering the product may also be about £2,000 per product. The industry has set a figure of £15,000 on the cost of preparing the dossier on each product because specialist advice will have to be taken. I accept that those ballpark figures are over the top, but nevertheless, if they are imposed on small and medium-sized enterprises, they may be the straw that breaks the camel's back.

We do not want those small and medium-sized enterprises to go out of business. We want to preserve the competition that exists in the industry. We do not want the large concerns—Holland and Barrett has been mentioned, but there are many others—to begin to attain monopoly positions. I, too, am concerned about the extra costs that both directives, particularly the herbal remedies directive, will impose on the industry.

I will vote for the Government amendment because, as my hon. Friend the Member for Nottingham, South has suggested, it clearly enshrines words that tell us that the Government are still manoeuvring on both directives, particularly on the herbal remedies directive. I wish the Government a fair wind in achieving what the British people expect them to achieve, so that our consumers do not suffer from a reduction in the wonderful choice that they already have in health product shops.

Photo of David Amess David Amess Conservative, Southend West 9:26 pm, 20th January 2003

I congratulate my hon. Friend Dr. Fox on his speech. He echoed many of my concerns on these issues, but I particularly want to congratulate my hon. Friend Mr. Tredinnick, because there is no doubt at all that, although people might smile gently as he gets to his feet, he has done all constituents and hon. Members a great service in bringing this very important subject to our attention.

The Minister has popped out of the Chamber briefly, so I hope that the Under-Secretary of State for Health, Mr. Lammy, will pass on my remarks. In her speech, she sought to charm and reassure the House. There is no doubt at all that she succeeded in charming the House, but I have to tell her that she did not reassure hon. Members.

I should also like the Under-Secretary to pass on to the Minister the fact that I had not realised until now that she was a highly accomplished joke teller. In fact, so good were her jokes that I shall include them in after-dinner speeches in the future. She told the House that the Government are not about the nanny state. Well, I had to scrape myself up off the floor. For goodness' sake, if the Government are not about the nanny state, they are not about anything. They interfere in anything and everything. That is why the country is such a mess, and the sooner my colleagues get their act together and replace them with a good Conservative Government, the better for all of us. The Minister then had the nerve to talk about the Government's creativity. We all applaud their creativity in reannouncing things time after time and in duping the general public, but she certainly did not reassure the House.

Unless the food supplements directive is changed, it will result in the loss of up to 300 currently available safe nutrients. That is certainly causing great distress to my constituents. Unless the traditional herbal medicinal products directive is changed, it will result in the loss from the United Kingdom market of a wide range of safe and popular herbal remedies, as the hon. Members for Bolton, South-East (Dr. Iddon) and for Nottingham, South (Alan Simpson) said. That is a very serious matter, and many of our constituents our worried that a large number of products that are mixtures of nutrients, vitamins and herbs could be lost.

I would like a derogation from the food supplements directive so that the United Kingdom may continue to allow products to be sold, provided that it is satisfied that they are safe and appropriately labelled, even if they fall outside the technical restrictions of the directive. Furthermore, there should be added to the list of 300 permitted nutrients and nutrient sources those that are currently missing but that are accepted as safe by the UK authorities prior to the deadline of July 2005.

On the first of the directives, my hon. Friend the Member for Bosworth has blown the Government's position out of the water, following his conversation with one of our representatives in the European Parliament. I would like active lobbying by the Government to ensure that maximum permitted levels for nutrients are set at acceptable levels, not the restrictive ones preferred by France and Germany.

On the traditional herbal medicinal products directive, I would like a derogation from the directive to allow the United Kingdom to introduce national rules to permit the continued sale of products that are safe and appropriately labelled, but which may otherwise lie outside its restrictive scope. Furthermore, the completely arbitrary period for which a product must have been on the European Union market before being allowed registration should be abolished. Finally, I want an end to attempts by the Medicines Control Agency to regulate herbal remedies as though they were pharmaceutical drugs, thus reducing compliance costs.

Photo of Mark Todd Mark Todd Labour, South Derbyshire 9:32 pm, 20th January 2003

First, I want to set out one principle: consumers in the perfect world—at the moment, we have something close to this—should be free to purchase food supplements and herbal remedies that are not harmful or marketed dishonestly. In my view, the issue of scientific efficacy should be largely irrelevant to that process, provided that no claims are made to that efficacy.

As a result of a liberal regime run roughly on that principle, we have an extremely diverse marketplace, in which there are small, niche retailers and one can also purchase many of those products in large supermarkets. There are manufacturers who design and develop specific products for very narrow marketplaces, and bulk manufacturers—I have been criticised for having one in my constituency, but I am delighted to have it and to argue for its interests, among others—who supply the supermarket sector and other sectors.

However, we must strike a balance. We seek a free European marketplace and a position in the provision of those products in which some of our citizens can visit another European Union country, receive broadly the same treatment when they get there and buy goods on the same terms. We should all share that aspiration, but it is not a process in which our view can be imposed unilaterally on our colleagues. That was made clear in a wise speech by Alan Simpson, who dwelt on the different cultures and perspectives in relation to this subject. We cannot impose our will; compromise is required.

I have spoken on these topics previously, and I compliment the Government on making substantial progress on this issue. It is undoubtedly true that more remains to be done, but we should be positive about what has been done so far and recognise that the balance of these goals—between individual choice, our liberal values and the requirements of a free market—requires compromise. That balance will undoubtedly affect our marketplace, and it is important that we recognise that. It is particularly likely to affect—I take the point made by Mr. Tredinnick—small niche players, both as retailers and as manufacturers. By eliminating some of the higher dose and more marginal products to which some of our European partners are particularly averse, we may remove the competitive advantage in the marketplace of some smaller players. That would be true in any other industry; it must be true in this. It will aid consolidation and maturity in the market—that would probably happen anyway—but I am not sure that that is the role of Governments.

We may also impede new product development, and I will listen to what the Minister has to say about that in winding up. In particular, we may impede the development of products that use familiar ingredients in novel combinations. It is important to have greater clarity about how we deal with the development of the marketplace, because we cannot freeze the products in aspic and suggest that that is all that consumers will want in the future. It is a fast-developing sector, with new demands from consumers, and we need a clear framework by which new products can be added to the marketplace for our consumers and those of other European Union states to enjoy and use. If we do not do that, we will inevitably encourage the use of the internet to purchase the products.

Many manufacturers, such as Peter Black in my constituency, seek to make more formal claims for their products than heretofore. In a maturing marketplace, one should not expect people simply to rely on recommendations in magazines or informal endorsements. It should be possible for a manufacturer to make clear endorsements of a product and statements of its effects. Manufacturers such as Peter Black wish to do that and recognise that it requires a tougher regulatory framework if they are to do so. They would welcome that.

Manufacturers also recognise—we should commend this aim in any case—that we need tighter quality controls. My hon. Friend the Minister referred to notable examples of poor quality control that exposed consumers to risk. We need to recognise that, as consumers become more demanding, they expect the highest possible quality and we should aid them in that goal.

What should Ministers do in the remaining negotiations? First, we need to ensure that we set for ourselves the lightest possible touch for our regulatory activity. I particularly point the finger at the Medicines Control Agency, which, as several Members have said, does not have a track record of sympathy for the sector. It is important that it understands its responsibility not to crush innovation and stifle consumer choice through the dead hand of an institution that is used to dealing with very large companies.

Secondly, we need continually to review the effect of the framework on the way in which the industry and marketplace operate, so that innovation and learning from experience are permitted. We should not stifle that process. Finally, we need to make sure that negotiations aim at safety as the prime goal but with the widest possible choice. To stray down the route of seeking proof of medical effect that some of our European counterparts may suggest to our negotiators would be dangerous. We have taken a consistent intellectual path until now, and we should persist in that.

Photo of Chris Grayling Chris Grayling Shadow Minister (Health) 9:39 pm, 20th January 2003

This has been a timely and important debate on an issue that has prompted a million people around the country to lobby their Members of Parliament, sign petitions and otherwise express their great concern about something that affects many people.

The debate provides the House with an opportunity to make its views clear to the Government. Many Members on both sides have signed early-day motions both in this Session and in the last expressing their concerns about these matters. Indeed, the motion on which the House will vote tonight reflects the views of more than 160 Members from all parties, including 88 Labour MPs, who signed two of those early-day motions.

Our debate began with a spirited attack by my hon. Friend Dr. Fox on the flaws in the two directives. He also made telling points about the torrent of regulation from Brussels and its impact on our manufacturing firms. The Minister unsurprisingly defended the directives on public health grounds. More worryingly, she said that many of the products in the health sector were "pretty dangerous". If that is the case, the Government ought to take urgent action under existing legislation. Why are products that the Minister regards as pretty dangerous on sale in this country? She also admitted that many companies would have to reformulate their products, but appeared not to understand the cost to manufacturers. In their amendment, the Government make a disingenuous claim about the list system, implying that it will still be possible for products to remain on an exclusively British list. There is no formal evidence in the wording of any of the legislative documents on the measure to suggest that that is true.

Turning to the contributions of the hon. Members for Nottingham, South (Alan Simpson) and for Bolton, South-East (Dr. Iddon), the wording of tonight's motion is drawn from two early-day motions that they signed. Indeed, the hon. Member for Bolton, South-East proposed tabling them. Will he vote tonight against the very words that he suggested and, if so, what message does that send to the community outside that is concerned about the measures, and what will that do to his credibility in those circles? I very much hope that he will reflect on what he has said and join us in the Lobby.

My hon. Friend Mr. Tredinnick accused the Government of painting far too rosy a picture. If anyone in the House knows about that, he does, and I pay tribute to all the work in this area that he has done over the months and years. My hon. Friend Mr. Amess talked about the distress in his constituency about the likely impact of the measures. That distress is shared across the country, as the two directives will have stark effects. The food supplements directive creates an approved list of nutrients which the European Commission will permit for use in foodstuffs. Almost 300 ingredients, however, will disappear even though they are currently deemed safe in the UK. In 2005, those products will become illegal. We may get an extension to 2009, but people who swear by those products to treat illnesses like osteoporosis, ME, digestive disorders, stress and bronchitis will lose the right to buy them.

The only way for those products to remain legal is for manufacturers to submit, at a cost of many tens of thousands of pounds, a dossier to the European Commission, effectively applying to allowed to keep on the market the products that they are selling today. In a written answer to my hon. Friend Mr. Heald last year, the Government admitted that the initial cost of the dossiers would be between £80,000 and £250,000, which would result in an additional cost to the industry of £24 million to carry on selling products that are sold legally and safely today. That point was recognised by Mr. Todd, who said that small manufacturers who cannot afford the cost of the measures will suffer.

This morning, I walked down the aisles of the Holland and Barrett store in Epsom past product after product that will become illegal under the two directives. However, they are popular and are selling well and safely. That is the absurdity of the current situation—a small manufacturer of a perfectly safe nutrient that has been on sale for years will lose the right to sell it in future unless he pay tens of thousands of pounds for the privilege. In my view, that is a scandal. If that were not enough, the directive sets maximum permitted levels for vitamins and minerals. At first glance, that appears sensible, but the maximum levels bear no relation to safety—they are simply a compromise with the norm in other countries. In Italy and Germany, there has traditionally been a different approach to the use of vitamins. Almost every one of the vitamin tablets that I saw when I walked around the store this morning will have to be modified if it is to continue under the directive.

When hon. Members walk into their supermarket next weekend, they should look at the vitamin C tablets on the shelves. The vast majority of the vitamin C tablets sold in this country will become illegal under the new directive. There is no suggestion that they are dangerous. There is a long tradition of using vitamin C in those doses in this country, so what on earth is the rationale for turning those tablets into an illegal product?

Even the Government admit that the restrictions will be a disaster for the industry. The former Health Minister, Yvette Cooper, stated in a written answer last year:

"Setting unnecessarily low maximum permitted levels for nutrients in food supplements is likely to have a detrimental impact on the viability of the United Kingdom's specialist food manufacturers and on UK consumer choice."—[Hansard, 30 April 2002; Vol. 384, c. 765W.]

She is right and we agree with her. Why are the Government not taking tougher action to deal with the matter?

Even the European Commission, in the small print to the directives, admits that the measures will have an adverse effect on small and medium-sized enterprises—the manufacturers. Surely it is not right that, for no reason, we are placing a burden on those businesses that may make it difficult for many of them to survive. It is not good legislation, and it is not too late for the Government and the House to reject it.

The food supplements directive is only part of the story. The traditional herbal medicinal products directive could have an equally serious impact on smaller manufacturers. The Government say that their goal is to provide a proper regulatory framework for herbal medicines, and to provide improved protection for the public. No one on either side of the House would disagree with the desirability of maintaining public safety, but the measure is tantamount to using a sledgehammer to crack a nut, like so many of the regulations introduced by the Government since 1997.

Once again, the improvements that the Commission and the Government seek will be achieved only at the expense of the manufacturers—literally. They face bills of thousands of pounds to secure approval for products that have been selling in the UK for years, and possibly even decades or longer. Many smaller manufacturers cannot afford to pay the bill. As a result, their businesses may disappear. Even if the manufacturers can afford to pay the bill, they may not be given the opportunity to do so, because the directive requires manufacturers to prove that a product has been on the market for 30 years, and for 10 or perhaps 15 of those years in Europe, in order for it to be eligible for licensing in the future. If it has not, it will be banned in perpetuity. As a result, many products that have been introduced over the past few years will disappear.

Let me share with the House the words of one of the constituents of my hon. Friend Mrs. Gillan, who wrote:

"I know of many people who cannot find a cure for their particular ailment through the NHS and opt for self-help using natural remedies. To deny them is to deny them their health."

I know that those anxieties are shared in the constituency of every hon. Member. I suspect that there is not a Member in the Chamber who has not received representations on the issue. The wording of the motion has been carefully chosen to reflect those representations and the concerns expressed by hon. Members in all parts of the House. It has been designed to give Parliament the opportunity to state its view—to allow us to act on behalf of a huge number of the people whom we represent, which is, after all, what we are here for.

The two measures will do real damage to businesses around the country. They will do little to improve public safety. The authorities already enjoy the power to tackle areas of concern quickly and effectively. When the measures become law—which I hope they do not—people who have used the products for years and believe that they have made a difference to their lives will find that they are no longer able to buy them in their local health food shops or their supermarket. Do Ministers honestly believe that that means they will stop buying them? Instead, they will buy products from overseas by mail order or via the internet, from suppliers in countries where the rules do not apply—countries where health and safety and quality checks are not present, and where the contents of the products cannot be guaranteed.

I believe that some simple principles should underlie legislation in this area. Consumer choice should not be reduced unless there are genuine safety reasons for doing so. No manufacturer should have to pay thousands of pounds to continue to sell a product that they have been selling safely for years. We should not ban safe and legitimate products in the United Kingdom simply to achieve harmonisation across Europe.

Opposition Members believe that the two directives fail on all those counts. I know that that view is shared by many hon. Members in all parties. I believe that the measures do not have the confidence of the House, and tonight presents us with an opportunity to send them back to the drawing board. I very much hope that the House will take that opportunity.

Photo of David Lammy David Lammy Parliamentary Under-Secretary (Department of Health) 9:50 pm, 20th January 2003

I warmly congratulate all hon. Members who have spoken in a very good debate on this very important subject. We have heard some excellent speeches delivered with passion and conviction. In particular, strong speeches were made by my hon. Friends the Members for Nottingham, South (Alan Simpson), for Bolton, South-East (Dr. Iddon) and for South Derbyshire (Mr. Todd).

The debate started with the speech of Dr. Fox[Interruption.] Indeed, he is an hon. Member. It is fair to say that he set the tone for the contributions made from the Opposition Benches. His speech was perhaps the most animated contribution that I have heard him make, I suspect because it was not about health, but about Europe. We know from his speech and his suggestion that we live in a Euro-nanny state that his sentiments are shared by the majority of those on his Benches and that his speech must have been written by a nanny with a handbag in another place.

Photo of Desmond Swayne Desmond Swayne Opposition Whip (Commons)

Sir John Krebs states in his letter to us of 17 December that 300 sources are currently omitted by the directive. Nevertheless, we will be able to continue to use them until 2009 should evidence of their safety be presented by July 2005. If evidence of their safety will preserve their use until 2009, why will we have to do without them thereafter?

Photo of David Lammy David Lammy Parliamentary Under-Secretary (Department of Health)

The hon. Gentleman refers to 300 sources; the motion refers to 270.

Photo of David Lammy David Lammy Parliamentary Under-Secretary (Department of Health)

What we need from the Opposition is some clarification. As my hon. Friend—

Photo of Desmond Swayne Desmond Swayne Opposition Whip (Commons)

The hon. Gentleman asked for clarification.

Photo of David Lammy David Lammy Parliamentary Under-Secretary (Department of Health)

The hon. Gentleman is clearly in need of some supplements.

Photo of David Lammy David Lammy Parliamentary Under-Secretary (Department of Health)

If the hon. Gentleman will permit me to answer the question, I can say that the issue is about nutrient sources and not the nutrients themselves. I shall go on to explain that issue further.

Dr. Harris made a slightly rambling contribution, as expected, in which he took a number of different positions. Presumably, they were assigned to different audiences. None the less, he asked a couple of important questions. He asked whether combinations were permitted. Yes, of course they are. He also asked for clarification about positive lists and whether they were still open. Indeed, in order to add substances to the positive lists, safety dossiers will have to be submitted. They need to be submitted by 12 July 2005. That is the position and we are clear about it. It sits alongside the derogation that we obtained leading up to 2009.

My hon. Friend the Member for Nottingham, South made a very measured and reflective contribution in support of the Government. He expressed his concern about nutrients that may be prohibited and may no longer be available in the UK. There is an important difference between nutrients and nutrient sources. My hon. Friend listed several sources, which may continue. However, time is available for contributions to the list.

Photo of Liam Fox Liam Fox Shadow Secretary of State for Health

The Under-Secretary avoids the crucial point. As my hon. Friend Mr. Swayne said, if a dossier is presented before 2005, and a substance is subsequently made available, why should it become unavailable again after 2009? That is ludicrous.

Photo of David Lammy David Lammy Parliamentary Under-Secretary (Department of Health)

That is not ludicrous. We are considering public safety—[Interruption.] The hon. Gentleman did not use the term "public safety" when he opened the debate. We are considering public safety in the absence of regulation. That is why we are having the debate.

My hon. Friend the Member for Nottingham, South also mentioned traditional use. The consultation period was extended to allow contributions on that, but few were forthcoming. There are serious issues to consider about herbal remedies outside Europe. There have been unfortunate instances of contamination, for example, metal and other substances have contaminated Chinese and Indian medicines.

Mr. Tredinnick made a rambling contribution in which he made familiar points about his favourite single issue. [Interruption.] Indeed, he took 10 minutes to say little. [Interruption.]

Photo of Michael Martin Michael Martin Chair, Speaker's Committee on the Electoral Commission, Speaker of the House of Commons

Order. Mr. Swayne is becoming very excited. In fact, he may need some medication because he is out of order. I advise him to try to listen to the Under-Secretary calmly. It helps.

Photo of David Lammy David Lammy Parliamentary Under-Secretary (Department of Health)

Doom and gloom pervaded much of the speech of the hon. Member for Bosworth.

My hon. Friend the Member for Bolton, South-East made an excellent contribution. As a chemist, he brought considerable experience to the debate. Mr. Amess also spoke. However, his jokes were poor. My hon. Friend the Member for South Derbyshire made a helpful contribution in his usual reflective manner.

Hon. Members will remember that, after the general election, Mr. Duncan Smith pronounced that his party should be quiet about Europe. He is also keen to portray the Conservative party as the party that will help the vulnerable and champion the needs of children in our inner cities. Just as the Christmas decorations were coming down in homes all over the country, and children were preparing to return to school, the Opposition did a U-turn on that issue.

Photo of David Maclean David Maclean Shadow Chief Whip (Commons)

rose in his place and claimed to move, That the Question be now put.

Question, That the Question be now put, put and agreed to.

Question put accordingly, That the original words stand part of the Question:—

The House divided: Ayes 196, Noes 309.

Division number 57

See full list of votes (From The Public Whip)

Question accordingly negatived.

Question, That the proposed words be there added, put forthwith, pursuant to Standing Order No. 31 (Questions on amendments):—

The House divided: Ayes 347, Noes 151.

Division number 58

See full list of votes (From The Public Whip)

Question accordingly agreed to.

Mr. Speaker forthwith declared the main Question, as amended, to be agreed to.

Resolved,

That this House recognises, in relation to the Food Supplements Directive, the Government's firm commitment to the view that the law should allow safe and properly-labelled food supplements to be freely marketed; welcomes its intention to take advantage of flexibility, secured by the UK, to permit continued use of substances not on the permitted lists where products comply with existing UK food safety legislation; notes that the impact on the long-term availability of products currently on the market will depend upon future developments on maximum limits and lists of permitted nutrients; supports the Government's efforts to press the case for any maximum limits which may be established at EU level to be based on thorough scientific risk assessments; further recognises that the proposed Directive on Traditional Herbal Medicinal Products would introduce regulatory arrangments to set safety and quality standards for unlicensed herbal remedies, and introduce systematic consumer information about the safe use of products and permit companies to make claims; further notes that the proposed Directive is supported by most interest groups, who believe it will protect public health and boost consumer confidence in herbal medicines; further welcomes the progress of the Government in negotiations for more flexibility to take account of valid evidence of traditional use from outside the European Union and to permit herbal nutrient combination remedies; and further welcomes the stated willingness of the Herbal Forum, representing all UK manufacturers' trade associations in the sector, to work with the Medicines Control Agency to minimise regulatory impact, consistent with the need to protect public health.

Photo of Liam Fox Liam Fox Shadow Secretary of State for Health

On a point of order, Mr. Speaker. The motion relating to the previous debate was taken from two early-day motions, 278 and 279, from the last Session. That was done with the intention of allowing Members of Parliament to vote in the House for something that they had put their name to on paper. Yet bizarrely, several members of the Labour party actually voted against the early-day motion that they had put their name to in the House.

We do expect Members to act consistently, although we understand that all are free to change their minds. However, would it not be only honourable for Members who have actually voted against their own early-day motions now to withdraw their names from them? [Interruption.]

Photo of Michael Martin Michael Martin Chair, Speaker's Committee on the Electoral Commission, Speaker of the House of Commons

Order. Perhaps I can answer the point of order, if Mrs. Gillan will allow me. As the hon. Gentleman said, hon. Members are free to change their minds. [Interruption.] Order. Of course, that is why we have debates: so that hon. Members can be swayed by persuasive words.