Authorisation of Human and Veterinary Medicines

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Mr. Tredinnick: Will the Minister assure us that she will do everything that she can to make sure that the numbers of herbs available on the market remains the same? Will she focus on the need to maintain the existing market and not allow availability to be severely restricted?

Ms Blears: The hon. Gentleman is aware that the positive list that is being drawn up of herbal substances will set out the parameters for the use of medicines, dosages and formulations. I have to draw a line, however, at the mix-and-match approach suggested by the hon. Member for Bosworth. He said that we need the right to mix and match herbs, vitamins and minerals to make sure that there is a range of products. I draw a line at the mix-and-match approach because we must be sure that substances are safe. We must be sure that issues about safety and effectiveness are properly covered.

The hon. Member for Oxford, West and Abingdon, who usefully has a medical background, set out the way in which substances taken in combination can have a different effect from individual substances. When substances are taken in different formulations, the way in which they are ingested can have a different effect on the body. We have to be very careful and not simply jump to the conclusion that because one ingredient is deemed to be safe and acceptable, a range of combinations involving that ingredient would have the same safety and effectiveness. We have to insert a note of caution about going down that path. As I stated previously, there is support for the directive from companies involved in the field. Those companies have both licensed and unlicensed medicines, and it is important to stress that the issue is not simply about protecting their market.

On a wider issue, the hon. Member for North-East Hertfordshire asked about the role of the advisory committee, which will be part of the European Agency for the Evaluation of Medicines. It will have two main functions: it will be responsible for establishing herbal monographs to look at the bibliography and background for drawing up a positive list of substances; and it will also be responsible for setting up and maintaining the list of substances for which applicants do not need to demonstrate safety and traditional use. It will provide a support mechanism, search out evidence and provide the positive list. I understand that each member state will nominate a member of the committee. The term of office will be three years and will be renewable.

Mr. Heald: The explanatory memorandum states:

    ''Due to the dissimilar situation of herbal medicinal products in the Member States, which cannot immediately be harmonised in its entirety by the new provisions, the mutual recognition procedure . . . cannot be applied to registrations of traditional herbal medicinal products.''

Why is that, and what does it mean?

Ms Blears: There was a proposal for a mutual recognition procedure so that substances that had been registered in one member state could be mutually recognised across the EU. However, because of the background and the way in which products have emerged, it will not be possible for that to take place.

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There is a precedent with homeopathic medicines, for which a register has been established. Again, there is a problem with mutual recognition of homeopathic medicines because of the different traditions in which they have emerged. Therefore, although the UK will have a registration system for products, mutual recognition will not be possible because of the different ways that the industry has emerged in different member states.

Mr. Heald: Does that mean that the product must be registered in each individual state? That seems awfully burdensome.

Ms Blears: Yes, that would be the case because, obviously, the field is very unregulated. We are just beginning to take the first steps towards regulation. Therefore, to preserve safety and protection, mutual recognition will not be possible at present. A substance may be registered here, but the way in which the industry developed in another member state may have resulted in entirely different products, formulations and combinations.

It took a long time for traditional pharmaceuticals to receive widespread recognition. We started the Europe-wide mutual recognition scheme in 1995 for pharmaceutical medicines, but we are at the early stages of recognising herbal medicine. It will be some time yet before we are in a position to have the same degree of trust in alternative medicines, whether homeopathic or herbal, which would enable Europe-wide mutual recognition.

Hon. Members asked how the products will be labelled. Traditional herbal medicines that are registered under the directive will have a clear, agreed label stating that the medical indication is based on traditional use. My hon. Friend the Member for Bolton, South-East mentioned the interesting precedent of Canada, which has a borderline regulatory regime. Other Members indicated that at some point a borderline would have to be drawn and that we would argue about the parameters. We are genuinely concerned not to generate more bureaucracy in this process. Having to make yet more decisions about where a separate regulatory regime would interface with this one would create even more complication.

The hon. Member for Teignbridge asked us to ensure that we take a minimalist approach to the changes that appear in the regulations. I assure him that, as the regulations go through the process, we will make the point very clearly that we envisage a strong role for member states. We shall resist the move to centralisation and the resultant bureaucracy. The overall objectives are about competitiveness—it is very important for us to pursue that. The hon. Gentleman gave an example of a do-it-yourself remedy. I just point out that do-it-yourself remedies from the garden are very different from the remedies of a company marketing a product with therapeutic claims. I hope that the hon. Gentleman has recovered his vigour and is feeling well.

The hon. Member for Oxford, West and Abingdon referred to the necessity of ensuring that there is evidence of efficacy in medicines. We are trying,

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through the traditional-use route, to give people an alternative to the randomised trials to which he referred, recognising that there are different ways of looking at such matters. However, we must always be conscious of the need for an evidence base, so we want to set up dossiers and obtain expert reports, bibliography, information about the background of herbal literature and so on, and to trawl as widely as possible to find out which products can make a difference to people.

The hon. Member for Westbury expressed concern about the time for consultation. The proposals emerged in November last year and will certainly not be implemented before the end of 2003, so the period is fairly lengthy. If people, whether small retailers, to which my hon. Friend the Member for Bolton, South-East referred, or whatever, have views or particular concerns, we would welcome their representations. We want as much information as possible to ensure that our negotiations in Europe are made from the right base. If there are further representations to be submitted, I would welcome them.

I think that I have covered most of the points raised by hon. Members. The debate has been interesting and provided an opportunity to consider some of the difficult balances and choices that must be made to ensure that we protect public health and maintain competitiveness and innovation. I genuinely believe that our proposals will give the traditional medicine sector the chance, at long last, to come into the main

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stream so that the public can have confidence in it and to gain an increase in its standing in the medical field. Provided that we negotiate the directives and regulations robustly and rigorously, I genuinely believe that they will be useful in the future.

Question put and agreed to.


    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 establishing a European Agency for the Evaluation of Medicinal Products, and draft Directives amending Directives 2001/83.EC and 2001/82/EC on the Community codes relating to medicinal products for human 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.]

Committee rose at three minutes to Seven o'clock.

The following Members attended the Committee:
Chidgey, Mr. David (Chairman)
Cunningham, Tony
Havard, Mr. Dai
Henderson, Mr. Ivan
Hesford, Stephen
Jack, Mr. Michael
Ladyman, Dr.
Luke, Mr.
Murrison, Dr.
Smyth, Rev. Martin
Swire, Mr.
Wright, Mr. Anthony D.
Younger-Ross, Richard

The following also attended, pursuant to Standing Order No. 119(5):
Blears, Ms Hazel (Parliamentary Under-Secretary of State for Health)
Caplin, Mr. Ivor (Hove)
Hall, Mr. Mike (Weaver Vale)
Harris, Dr. Evan (Oxford, West and Abingdon)
Heald, Mr. Oliver (North-East Hertfordshire)
Iddon, Dr. Brian (Bolton, South-East)
Mitchell, Mr. Austin (Great Grimsby)
Morley, Mr. Elliot (Parliamentary Under-Secretary of State for Environment, Food and Rural Affairs)
Swayne, Mr. Desmond (New Forest, West)
Tredinnick, Mr. David (Bosworth)
Ward, Ms Claire (Watford)

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Prepared 18 June 2002