Previous SectionIndexHome Page


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

8 Dec 1999 : Column 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

8 Dec 1999 : Column 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

8 Dec 1999 : Column 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.



 IndexHome Page