Authorisation of Human and Veterinary Medicines

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Mr. Jack: What does the health Minister expect to happen to products that are a combination of otherwise legal ingredients, but are outside the scope of the directive?

Ms Blears: I understand that it will still be possible to sell some products that are currently sold as food supplements. It will not be possible to sell combinations of active ingredients—herbal and other ingredients—unless they can be shown to be medically efficacious. That is the position now, and it is the position I described at the beginning. We are not talking about a new directive that outlaws a sector of the market. Some products on the market do not fall within the current framework because they contain a combination of herbal and other ingredients, but as the ingredients are active, those products do not fall within the definition of a food supplement.

I found it hard to envisage such products, but I have been given some examples of combinations that would not normally be regarded as medicines—products that have no physiological effect and can be sold as foods provided that no medicinal claims are made: garlic and nutrients, artichokes and nutrients, and saw palmetto and nutrients. Nothing in the traditional herbal medicines directive would change the classification of those products.

Examples of combination products that the MCA would currently normally classify as medicinal on the basis of the medicinal nature of the herbal ingredients are echinacea plus vitamins, horse chestnut fruit plus vitamins, and St John's wort plus vitamins. Those products would currently require a marketing authorisation, because they contain active herbal ingredients that have a physiological effect, so we are imposing no extra burden on them. In future, however, producers using some of those ingredients, if they are registered, will be able to claim that they are beneficial and therapeutic, and will therefore be able to market their products more robustly. Manufacturers look forward to some aspects of the directive: they know that, as long as they conform to the licensing framework, they will be able to take a step they have wanted to take for a long time and bring herbal remedies from the periphery into the mainstream.

Dr. Evan Harris (Oxford, West and Abingdon): The hon. Member for Westbury asked whether the Minister knew of any health problems caused by traditional herbal medicines. Medical literature refers to case studies and examples, but it is not easy for Members to gain access to the information. If this is an important part of the justification for regulation in the area, as I believe it is—especially when claims of health benefits are made—will the Minister and her Department put that information into the public domain, and conduct a literature search in both that area and the area of food supplements, which is also coming down the line? Will she ask her Department to produce such a study, which would not take long given the Cochrane library and other facilities, and place it in the Library?

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Ms Blears: I was going to say to hon. Members that although I have not got wide-ranging information at my fingertips, I do have some examples. I have been told that in Belgium more than 100 women suffered renal failure after taking aristolochia, and many of them are now developing cancer. There have also been concerns about creams containing steroids, and I am happy to write to members of the Committee about that.

I understand that guidance on the MCA website gives general advice to consumers on specific safety issues. There is a long section on kava kava, which is currently under consideration after reports of liver damage associated with its use. Indeed, there is information about aristolochia, St. John's wort, side effects and interactions when herbs are used with other medications and the mistaken identity of herbal ingredients to which I referred earlier with regard to the substitution of gentian for podophyllum and digitalis for plantain. Extensive information is already on the MCA website, and Members will obviously have access to it.

Mr. Heald: Does the Minister accept that the way in which she has outlined her view of the law on combination products has not given us the full picture? One of the proposals before us is the Commission's intention to change the definition of medicines

    ''to avoid any doubt as to the applicable legislation, when a product whilst fully falling within the definition of a medicinal product may also fall within the definition of other regulated products.''

Is it not true that she and the Commission seek to bring under the medicinal umbrella many products that have been regulated under other jurisdictions? What she has said about the existing law not being changed in any way is contradicted by the proposed new paragraph in article 2(2).

Ms Blears: Indeed, I have previously said that we strongly oppose the effect of those provisions when taken together because they will create a hierarchy of medicines, whereas everything that is a medicine has to be regulated as such. We believe that, where items are properly regulated elsewhere, the regulatory framework ought to apply. When we have good law that provides public safety and confidence, we should rely on it. At the moment, we do not have sufficiently robust quality standards to give the public the confidence that they need.

Rev. Martin Smyth: The word ''effective'' was used; many folk find placebos effective.

I want to press the Under-Secretary of State for Environment, Food and Rural Affairs, who kept speaking about national standards and national issues. As I understand the briefing notes, the devolved Administrations in Scotland and Wales will have authority for legislation there, as will the Northern Ireland Assembly, except it will not have control of the implementation of the legislation. What will happen if any of the devolved Assemblies do not implement the legislation? Can we assume that the negotiations with Europe will be carried through by the Westminster Parliament, and implemented and perhaps enforced in

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the United Kingdom with a degree of alacrity and effectiveness that will not be seen in other kingdoms?

Mr. Morley: I hope that I can put the hon. Gentleman's mind at rest. This is, of course, an EU directive, and as such it is a reserved matter for the Westminster Parliament. EU directives, of course, have a national remit. In that respect, what we are talking about applies across all the devolved Administrations, although they are of course closely involved in discussions in which they give their views, which consist of an agreed position that we take from the UK to negotiations of that type. The devolved Administrations know all about the directive. They have fed in their views directly to the UK team, and we shall negotiate on the basis of the directive applying across all countries, but in some cases being administered in the regions.

Mr. Mitchell: My hon. Friend has made much of the fact that the British Herbal Medicine Association supports the directive. In the words of Mandy Rice-Davies, ''They would, wouldn't they?'', as producers of licensed medicines already have licences.

The Chairman: Order. I ask hon. Members to keep their questions short, please.

Mr. Mitchell: Does my hon. Friend accept that, as the holders of licences for medicines, they would be keen to have a measure that puts competitors out of business?

Ms Blears: I have tried to be fair in my comments. There are many different interests: manufacturers, retailers, consumers and public health officials. We have tried to get the balance right. The directive is not in the business of outlawing products that can be shown to be useful and effective and that should be made available to the public. The directive is not about a closed shop; it is about ensuring that herbal medicines are widely available to consumers in a safe, proper manner.

I understand that many members of the British Herbal Medicine Association produce unlicensed as well as licensed medicines. The association does not represent a vested interest, because its members produce the whole range of medicines.

Dr. Murrison: We are getting closer to finding the evidence base for the regulations. I am grateful to the Under-Secretary of State for Environment, Food and Rural Affairs for producing evidence. May I ask about the UK Government's ad hoc group on vitamins and minerals in the context of setting safe upper limits, because that is very important work, without which it is difficult to consider the directive. I understand that the group will be reporting soon—I am not sure when—and it seems that we are putting the cart before the horse by discussing the directive before we have the results of its deliberations.

Ms Blears: I am not entirely sure whether the hon. Gentleman is referring to food supplements. Negotiations are taking place about the maximum limits that can be supplied in such products. If he is, I am happy to tell him that we are pressing hard for

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maximum limits, on the basis of safety, rather than the lower levels that many other member states want. We are pressing positively to ensure maximum consumer choice while still providing adequate health protection. The maximum levels of vitamins and minerals in supplements sold under food law should be limited only if it is necessary for safety reasons. We agree with consumers in that respect and are pressing very hard to ensure that the position is maintained.

Mr. Tredinnick: The hon. Lady is trying to reassure us in many ways that things will not change too much and that we will not see the shelves denuded of products with which we are familiar, but how does that square with the 30-year qualifying period for products without proof of efficacy? The proposal is that products must have been used in the EU for 30 years or for 15 years outside the EU plus 15 years inside. What about products that have been in use for 29 years, or new traditional products that are developed? There will be new herbal products. Where will they fall? What will happen to new products?

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