Authorisation of Human and Veterinary Medicines

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Ms Blears: We are trying to set up a registration scheme that, as far as possible, meets the key balance between maintaining confidence and safety, and choice and access to remedies that people value. Inevitably, it will be a balance. In setting up any regulatory scheme, lines must be drawn.

The proposal is that the period should be 30 years for traditional remedies, and we have said that up to 15 of the 30 years can relate to use outside the EU. I understand that in negotiating the terms of the directive, it may be possible to press for more regard to be given to non-EU use. I am very conscious of the fact that traditional Chinese and ayurvedic medicines have a long and respectable history of developing remedies, and that may well be an issue. Clearly, if medicines are to be regarded as traditional, a period must be set in which a tradition can be established for people to be able to rely on that traditional use.

Mr. Heald: In the comments of the Under-Secretary of State for Health that were given to the European Scrutiny Committee, she expressed some concern about the general shift in the legislation from a balanced approach, with centralised procedure and mutual recognition procedure being seen as pretty much even, to a strong movement towards centralised procedure. Some concerns have been expressed about that, and I should be grateful if the Under-Secretary would outline a little more fully exactly what is going on.

Ms Blears: Yes, that is right. As I understand it, that was one of the main reasons why the Committee was concerned to have a closer look at some of the provisions. I think that they relate to several areas. The Commission requires that all new active substances be authorised under the centralised procedure. At the moment, centralised procedure covers only 2 per cent. of existing medicines, which is a tiny proportion. It is more cumbersome than the mutual recognition procedure because the centralised procedure requires that there be two member states with a rapporteur and a co-rapporteur, who carry out the scientific assessment, which provides a licence for everywhere.

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The companies may not want to market some substances in particular areas. That will be a commercial decision depending on the development of the market, the needs of a particular community, cultural differences and all those sorts of issues. We therefore oppose any proposal that all new active substances should come through the centralised procedure. We think that companies should continue to have the choice of the mutual recognition procedure, which is less burdensome and allows an incremental approach by granting approval in specific areas where new substances can continue to be developed. There is that shift to the centre.

We are also concerned about the make-up of the committees that will oversee the matter. At the moment, we have two representatives from each member state on the European committee, which makes 30 members from member states, and there is a proposal to reduce that to just four members from member states. We feel that is far too small a representation. We must not forget that the system is based on member states doing the scientific analysis and bringing their particular view to the centre, which co-ordinates the analysis. However, it is not the centre that carries out the work, and we want to resist that sort of shift.

There are also proposals for representation of industry on the board, which again causes us some concern. Of course we want to get wider views, but we do not feel it is appropriate for the industry to be on the board of the regulatory body that regulates it. The Government have several concerns; we shall press to retain the choice of routes, and to retain a more inclusive representation for member states in the machinery that approves the medicines through the process.

Dr. Harris: Consumers for Health Choice, which the Under-Secretary abbreviates to CHCs—rather alarming, given her record on CHCs—in its letter dated 7 June raised the concern that the traditional herbal medicines directive

    ''would end all product innovation and development, including the introduction of any safe new ingredients in the future: even were such products able to comply with the pharmaceutical standards in the Directive.''

Will she explain what she thinks lies behind that concern, and what is her response to it? The organisation says that the proposed manufacturing and testing standards are inappropriate for herbal remedies, which should not be treated in the same way as pharmaceutical drugs. That is one point, but it has also said that, even if the industry were able to comply with the pharmaceutical standards, they would stifle innovation and development. That is worrying. Does the Under-Secretary know what that is about?

Ms Blears: As I have attempted to say, the standards have been specifically designed with herbal medicines in mind. They seek to ensure purity of ingredients, lack of contamination, suitable premises and appropriate equipment. I do not understand how the directive will stifle innovation. It will ensure that products are produced to a high quality, and will end the almost perverse incentive by which those who do not comply with basic quality standards can still get

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their products into the market. In future, they will have to comply with basic quality standards. That is not about stifling innovation, but ensuring that those with good ideas introduce them in a way that meets proper and necessary standards. I reassure the public that efficacious innovations will have the same access to the licensing procedure as any other product. I am concerned that the campaign has sought to raise unjustified worries among the public.

Mr. Jack: In one of the two explanatory memorandums issued by the two Departments, doubt is expressed about the legal base of the regulation, and, under the heading ''subsidiarity'', about the

    ''balance between the Community and Member States''.

Can the Ministers tell the Committee how they propose to resolve questions over the legal base, and over an appropriate balance under the terms of subsidiarity?

Ms Blears: As I understand the position, there are questions about amending the legal base. We are consulting lawyers and other Departments about the full implications of the changes. We therefore reserve our position on the negotiations pending further legal clarification. If any other details become available, I will gladly write to the hon. Gentleman.

Mr. Tredinnick: I am grateful for another chance to ask the Under-Secretary of State for Health about the various hoops that suppliers will have to go through to provide to the market without so-called proof of efficacy—a euphemism for huge costs. The danger is that if many herbal remedies are not able to meet the requirements because they have not been in use in the EC for 30 years—or for 15 years in the EC and for 15 years elsewhere—it is inevitable, despite her reassurances, that without continuation arrangements they will fall and will be subject to a new regime which will be so tough that many will not pass the test.

Ms Blears: I understand the hon. Gentleman's concerns. The purpose of the directive, however, is to provide to herbal remedies an alternative route to the traditional medical model of efficacy, which involves double-blind randomised controlled trials, to allow them to gain widespread standing. That is why the directive includes a traditional element. Although some products may not be able to prove themselves effective in the traditionally hard and detailed way, it must still be recognised that herbal remedies are often effective and that their effectiveness could be based on the traditional element of their usage. The compilation of the dossier, the bibliography, an expert report and its background are all important.

A product that can prove efficacy neither in a normal medical way nor in a traditional way will struggle to prove that it is of value at all or able to meet the needs of consumers. It is right that products have to prove that they are useful. We have promoted that to ensure that herbal remedies can find an alternative route through the system, which recognises their different background and the way in which they have evolved. The element of tradition is therefore important.

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Mr. Heald: One concern with the directive relates to a case in which two traditional medicinal products may individually comply with the directive and be exempt, but when they are combined they may cease to be exempt and require a marketing authorisation.

Ms Blears: Yes, the traditional herbal directive relates to exactly that subject—herbal ingredients. Non-herbal ingredients will fall outside its scope.

Mr. Heald: In the notes, the Minister herself raises the same concern about the combining of two traditional active herbal ingredients.

The Chairman: Does the Minister wish to respond?

Ms Blears: Yes. I must have misheard the hon. Gentleman. I thought he was talking about a combination of herbal and non-herbal ingredients.

I understand that the combination itself must be traditional. The way in which different ingredients react with each other could be an issue, because the ingredients will not be seen in isolation: any medicine will be a combination of different ingredients. It is the combination that must be traditional if the alternative route of authorisation is to be followed.

The Chairman: Order. That brings us to the end of the time allotted to questions.

Motion made, and Question proposed,

    That the Committee takes note of European Union Document No. 13361/01, Commission Report on the experience gained as a result of the operation of the procedures for granting marketing authorisations for medicinal products; and No. 14591/01, draft Regulation laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and veterinary medicinal products; supports the Government's position of broad agreement to the proposed amendments, and the overall aims of the Review; supports the Government's ongoing work with Member States to build on the current system of medicines regulation to ensure it continues to contribute to the protection of human and animal health, also to promote the further development of a single market in pharmaceuticals, prepare the regulatory regime for enlargement, and provide a competitive environment for the pharmaceutical industry; notes European Union Document No. 6240/02, draft Directive amending Directive 2001/83/EC as regards traditional herbal medicinal products for human use; and supports the Government's position of broad agreement to the proposed amendments in order to achieve a regulatory regime for traditional herbal medicines which improves public health protection while maintaining consumer choice.—[Mr. Morley.]

5.31 pm

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