§ Motion made, and Question proposed, That this House do now adjourn.—[Mr. Jamieson.]11.50 pm
§ Mr. Tim Collins (Westmorland and Lonsdale)
I wish to raise a matter that is of great concern to a number of my constituents in south Cumbria, although I am sure that, like me, they would have been happy to wait for a few more minutes if another matter of great concern to them, the future of the beef industry, had been the subject of a statement.
My first, and much happier, duty is belatedly to congratulate the Minister of State for Health on her much deserved promotion. I am sure that it is only a matter of time before she finds herself in an even more elevated position on the Government Front Bench.
The Minister might be wondering why I applied for the debate, given that, as she will know, the Government announced in July some concessions on the most controversial issue concerning the Medicines Control Agency, namely, the consultation document MLX 249. I say straight away that I very much welcome the concessions that Baroness Hayman announced in her press release of 15 July. None the less, there remain some ambiguities in the Government's position, and I know from representations made to me and to hon. Members on both sides of the House that some concerns remain. There have been a number of developments since July which may prove to be significant. Accordingly, I would like to press the Minister for whatever clarifications she may be able to give.
Perhaps I should also explain to the House that I have never, to my knowledge, used or consumed herbal remedies. Given that I have a number of close relatives who are general practitioners, nurses or surgeons in the national health service, my background is one that makes me much more sympathetic to, and understanding of, conventional rather than alternative medicine. However, I believe strongly in the principle that consumers should be able to decide these matters for themselves.
I welcome the statement that was included in the letter that Baroness Hayman wrote to hon. Members on 16 July. She said:The Government is committed to ensuring that consumer choice and the availability of health products are not restricted".I hope that tonight we may be able to shed a little light on what the Government mean by that in practice.
I shall begin at the beginning. MLX 249, the Government's consultation document, appeared on 6 November last year. It included the Medicines Control Agency's letter proposing that the classification process for borderline substances be put on a statutory basis. Those are substances on the borderline between foods, which are regulated by the Food Safety Act 1990, and medicines, which are regulated by the Medicines Act 1968. A new statutory instrument was proposed to put the handling of those substances on a new basis.
There are serious implications for the reclassification of a health food as a medicine. Unless otherwise exempt, a medicinal product may not be placed on the United Kingdom market without a marketing authorisation or a product licence. That is granted by the licensing authority 963 when it is satisfied that the product meets the prescribed standards for safety, quality and efficacy. The point is that there is no way in which the efficacy of many of those substances can be demonstrated, at least not by conventional medical means. Yet there are many people in my constituency and throughout the country who swear by many of those products and testify in great detail about the dramatic improvements in the quality of life that they have had since they began taking them.
At present, most of those products are classified as foods. As such, they are required by the Food Safety Act 1990 to be safe. Ironically, that is not a requirement which applies to a medicinal product, where frequently quite serious side effects may be contingent upon them. Furthermore, as they are classified as foods, those making and selling them are not permitted to make any claims on the packaging or in the advertising that they will improve people's health. In those circumstances, it seems that there is a strong argument for allowing consumers a continuing freedom of choice. However, if the MCA deems that something is a medicine, a licence is required. My hon. Friends tell me that the cost of obtaining one can sometimes be up to £150,000. That is a huge sum for the very small companies that are often involved in the health food business.
The original document caused widespread concern, among not only the health food industry but from many consumer groups. Perhaps at this point I should pay tribute, and express my gratitude, to Consumers for Health Choice, and Mr. Christopher Whitehouse in particular, for whose help in briefing me I am most grateful.
I was visited at one of my advice surgeries by Elizabeth Kan of Kan Foods of Kendal, by Penny Seeds of Living Well, which has a shop in Milnthorpe and another in Grange-over-Sands, and by others on a number of occasions. A large number of my constituents in south Cumbria also wrote to me on the matter and signed petitions in health food shops and elsewhere.
The concerns at that time related to the lack of an independent appeals body, the possibility that the burden of proof would be placed on the accused, so to speak, and the fact that the consultation period was too short. There were also fears about how the legislation would be interpreted. My hon. Friend the Member for Bosworth (Mr. Tredinnick) raised the matter in an Adjournment debate in February this year. In July, when Baroness Hayman announced that the Government were shifting policy, she said that they would do so in three major areas: the review panel would be genuinely independent and would have statutory provision; the burden of proof would not, after all, be reversed; and the MCA would have to give full reasons for its decisions. That has been widely welcomed. I pay tribute to the effectiveness of the campaigns that were mounted, and to the fact that the Government have, however belatedly, shown a willingness to reflect on these matters and take a fresh look in the light of public representations.
However, some possible difficulties remain. I shall put to the Minister the fears of some of my constituents, with which I hope that she can deal relatively easily. Some people continue to believe that there is an implicit agenda to reclassify most or all herbal and health food products as medicines. They fear that lobbying by powerful 964 pharmaceutical companies has led to steps designed to damage the growing health food sector, and that the Medicines Control Agency has a vested interest in redesignating health foods as medicines because it secures income each time an application must be made for a medicinal licence. I hope and believe that the Minister will be able to give firm reassurances to lay those fears to rest, and I would welcome her placing on the record a clear denial of those suggestions.
In July, the Government undertook to table a new statutory instrument to reflect the changes that they had agreed to make. I would be grateful if the Minister could tell us tonight when that measure is likely to be published and when she would expect it to take effect. There remain a number of concerns about the possible content of the new statutory instrument.
Given the great importance attached to the Government's assurances earlier this year about the composition of the new statutory review panel, can the Minister give the House a specific assurance that the composition, role and functions of the new statutory review panel will be written into the statutory instrument, not simply left to later guidance notes? Can she also assure us that the review panel's composition, role and functions will not be amendable simply by a change in guidance notes, but will also require amendment to the statutory instrument? Naturally, there will be guidance notes for quite a complicated measure. Will they be made available at the same time as the statutory instrument?
Will the statutory instrument make it clear that the statutory review panel is the final decision-making body, or will it leave the MCA as the final judge and jury in its own case? If the MCA is to be given the residual power to make a final determination in extreme circumstances on clear public safety grounds—which I and many in the industry believe is a perfectly reasonable position—will that condition be written into the statutory instrument? In other words, will the circumstances in which the MCA may make a final determination be made explicit, and will it be clear that the MCA would be expected to overrule the review panel only in a small minority of cases?
Given that health food manufacturers are small companies, will the Government re-examine the original provision in MLX 249 for a mere two-week period to be allowed for a reply to be made to a provisional determination by the MCA that a substance is a medicine? The Minister will understand that, for many of the small companies operating in the sector, a fortnight's notice is unfair. If there is only one person dealing with compliance or regulation issues, as may be the case with some small health food operators, that person may be away on holiday, ill or travelling on business. A two-week period for a response is a tight timetable.
Can the Minister shed any further light on the answer given by the Under-Secretary of State for Health, the hon. Member for Birmingham, Edgbaston (Ms Stuart), on 2 December to parliamentary questions tabled by my right hon. Friend the Member for Penrith and The Border (Mr. Maclean)? Those answers established that the Government are considering new regulations to cover herbal remedies following European Directive 99/83 EC, which was passed in September this year, and also that the MCA is to review its current list of specified and toxic herbs. Does the Minister expect those two processes to expand or reduce the range of herbal products available to consumers in the UK?
965 Will the Minister say a word about a matter that has caused great concern in my constituency? Penny Seeds of Living Well mentioned it to me earlier. The MCA has just written to food manufacturers to inform them that it proposes to designate as a medicine St. John's wort, the most popular herbal remedy in the UK at the moment. St. John's wort has been around in this country for many decades and has been used with success for a long time.
I am told that, ironically, the catalyst for the MCA's decision to seek classification of St. John's wort as a medicine was research published in the British Medical Journal, which established that the remedy's effectiveness in tackling depression may not be an old wives' tale after all, and may be medically provable. I hope that the Minister agrees that it would be the greatest irony of all if it turned out that the provision of scientific proof of the effectiveness of a herbal remedy led directly to the imposition of costly and difficult procedures, resulting in far fewer people gaining access to it than were able to do so when there was no scientific proof of its efficacy. What reassurances might the Minister be able to give?
I know that the Minister will appreciate that many of the problems stem from the fact that some of the products—whether we call them herbs, dietary supplements or health foods—are not easily classifiable, as either a food or a medicine. She will be aware that the industry believes that its future lies in the fast-growing sector of blended products, in which vitamins, minerals and, perhaps, amino acids are rolled together with a herbal remedy such as St. John's wort. If the herbal remedy element has to be licensed separately as a medicine, the whole range of multi-blend products have also to be licensed individually.
Would the Minister be prepared to consider seriously the suggestion floated earlier this year by my hon. Friend the Member for Runnymede and Weybridge (Mr. Hammond), the shadow Health Minister, that a new category should be created in which supplements could be grouped? She will know that the industry feels strongly on that point, too.
In such a category, there would be no requirements to prove the efficacy of the product, as there are at present, but instead a streamlined procedure for dealing with legitimate and important safety concerns. The proposal would ensure that the hundreds of supplements now available—their properties are often questioned by some, while others swear by them—would be protected and would remain available.
I know that the idea has been supported by many in the industry, and by many consumers too. It was also supported earlier today in conversations that I had with both consumers and sellers of such products in my constituency. Would not a new category of natural remedies, falling between food and medicine, be more accurate, lead to better regulation, and encourage the growth of a burgeoning sector that is much supported by people throughout the country? I invite the Minister to recognise the merits of something that we might both agree is the third way.
§ 12.3 am
§ The Parliamentary Under-Secretary of State for Health (Yvette Cooper)
I congratulate the hon. Member for Westmorland and Lonsdale (Mr. Collins) on having obtained this debate and on his speech, in which he 966 detailed very clearly a list of very important questions about MLX 249 and developments under way in the Medicines Control Agency. I shall try to deal with the issues that he raised in turn. Rather than responding to all of them in sufficient detail, I shall also write to him on many of the matters to confirm the points that I have made and to clarify in further detail some other issues. I should point out that this area is the responsibility of my noble Friend Lord Hunt. I shall certainly pass the hon. Gentleman's comments on to him, as he considers these matters further.
The Medicines Control Agency is responsible for ensuring that medicines available to United Kingdom citizens are safe, of appropriate quality and effective. It regulates medicines in accordance with UK and Community medicines legislation through a system of granting and maintaining product licences, post-licensing surveillance, licensing and periodic inspection of manufacturers and wholesale dealers, and enforcement action against those who break the law.
The hon. Gentleman referred in particular to the MCA's MLX 249 proposals, whose purpose is to protect public health. They are intended to ensure that the agency gets its decisions right—in a transparent, open and fair way— and I welcome the points that he made about the aims and intentions of MLX 249. Of course, we need to avoid wrongly classifying any product as a medicine, but equally we have a duty to protect consumers by ensuring that all medicines are classified as such, so that the appropriate controls can be applied. The MCA is responsible, on behalf of the licensing authority, for implementing and enforcing the provisions of medicines legislation. That includes deciding whether a product is a medicine or not.
Like the hon. Gentleman, I am well aware of the concerns that were generated originally by the proposals, but much of the criticism misrepresented their aims and effects and was an unwarranted cause of worry to many people. Many of the responses at that stage were based on a fear that the proposals would change the status of dietary supplements and herbal remedies. That is simply not the case, and I shall return to the specific points that the hon. Gentleman made about herbal remedies. Allegations that vitamins and popular food supplements would become "medicines" overnight were, and are, emphatically untrue. The Government are committed to ensuring that consumer choice and the availability of health products are not restricted, so people will have a wide range of choices to make for themselves.
The definition of a medicinal product and the criteria against which the MCA must make such decisions are matters of European Community law. The proposals would not alter in any way the definition of a medicine or the criteria for deciding whether a product is a medicine or not. As the law stands, a product that is not clearly a food or a cosmetic is a medicinal product if claims are made that it can treat or prevent disease or if it may be administered with a view to restoring, correcting or modifying physiological functions. Such products are subject to the requirements of UK and EC medicines legislation and, as the hon. Gentleman said, normally require a marketing authorisation—a product licence— before they can be sold or supplied.
The consultation undertaken by the MCA has been genuine and the Government have listened to the concerns that were expressed. I welcome the hon. Gentleman's 967 comments in that respect and on the Government's response. As he said, my noble Friend Baroness Hayman was able to announce on 16 July that three important changes would be made to the proposals: first, full reasons would be given in writing for MCA decisions; secondly, the advisory panel to review MCA provisional decisions would be independent of the MCA; and thirdly, the burden of proof in any court proceedings would be borne by the MCA, not the defendant company, as was originally proposed. It has been possible to make those changes without prejudicing our commitment to protect public health and consumers.
The hon. Gentleman made a series of points and I shall try to answer as many as I can, but I hope that he will forgive me if I come back to him on those that I do not cover this evening. He asked when the relevant statutory instrument would be put before the House and what its content and composition would be. I must refer him to my noble Friend Lord Hunt for further details, although the matter is being considered by Ministers and I can tell him that we intend to introduce the final legislative package later this month.
The hon. Gentleman mentioned the review panel. The MCA is inviting nominations to it from interested organisations and will shortly begin discussions with trade associations and consumer groups on the draft guidance that will support the legislation. He also referred to the two-week timetable for notice of wish to review. I can tell him that that has changed to four weeks, following representations from the trade associations. He also mentioned St. John's wort, which has been classified as a medicine in the UK for at least two years. It is widely available as an exempt herbal remedy. There is no intention to change the status of herbal remedies. So long as there is nothing on the packaging about promoting health or about their efficacy, they will retain their current status as a herbal remedy.
The hon. Gentleman asked whether the independent review panel or the MCA, on behalf of the licensing authority, will have the final say. The MCA must have the final say. If it cannot accept the review panel's advice, as the competent authority, it must retain the right to make the final decision. Although that may hardly ever happen, it could be challenged by judicial review. The final decision must rest with the MCA.
The hon. Gentleman asked whether there could be a third way, as he described it, and whether dietary supplements and herbal remedies, or combinations of both, could be described as neither foods nor medicines, but as something in between. That has been suggested. I am aware that the legislation for dietary supplements in the USA, and initiatives currently being pursued in 968 Australia and Canada, have been held up as possible models for the development of such a regime. We have no plans to review the way in which supplements are regulated in the UK, but we are following developments on those initiatives with interest.
There are indications that the USA legislation allows some potent products, such as herbal ephedrine, on to the market with very little control. Details of the new regimes in Australia and Canada have yet to be finalised, but it appears that both will involve pre-market assessment and licensing of products. Indeed, in Australia all supplements will be classed as medicines. If that is the case, the controls could turn out to be more restrictive than those that currently apply to supplements sold as foods in the UK.
Any such change would require action at the European level. The legal position on borderline products is ultimately governed by the definition of a medicinal product in EC directive 65/65. There are no proposals to change that definition either by member states or by the Commission. Should a debate begin, the UK would consult widely and participate fully.
§ Mr. Collins
The hon. Lady rightly refers to the original European directive 65/65, which dates back to 1965. It is about as old as the hon. Lady and me, so perhaps it is time to have a look at it. Will she make the case in the Council of Ministers for at least considering these matters 34 years on, because much has changed in this field in that time?
§ Yvette Cooper
The hon. Gentleman is right that much has changed since then, and I shall reflect on the points that he has made.
As for food or dietary supplements, the Government have made it clear that any maximum limits on the vitamin and mineral content of supplements should be based on safety considerations.
I am aware that I have not responded fully to many of the points that the hon. Gentleman made, and I shall write to him. I shall also pass on his comments to Lord Hunt. We have ensured that our final proposals go no further than our obligations as the licensing authority to protect public health. Our aim is to promote, both in the UK and Europe, a regulatory environment in which safe supplements are widely available, the public are not put at risk or misled, and medicines law is effectively and promptly enforced. We want to encourage consumer choice in these areas. The Government will take note of the views expressed by the hon. Gentleman.
Question put and agreed to.
Adjourned accordingly at fourteen minutes past Twelve midnight.