Authorisation of Human and Veterinary Medicines

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The Parliamentary Under-Secretary of State for Health (Ms Hazel Blears): May I first say that I am pleased to be here, for my first scrutiny debate on these issues? I am delighted to have the opportunity to answer hon. Members' questions.

I am very well aware of the campaign conducted by Consumers for Health Choice. It has issued, I think, 1 million leaflets to constituents up and down the country and has obviously been in contact with manufacturers and retailers on the issues. There is perhaps a misconception over the matter that the right hon. Gentleman highlighted. There is nothing in the traditional herbal medicines directive that would change the classification of products that currently should not be available. Where there is a combination of active herbal ingredients and other active ingredients, they should have an authorisation as a medicine because they have a physiological effect.

The new directive seeks to provide a better and more stable legal framework for traditional herbal medicines so that consumers can properly rely on them as safe, of the right quality and containing ingredients that are not contaminated. The directive, however, does not affect the status of products currently on sale. Those that the MCA is seeking to take away from sale, it is seeking to take away now because they do not fall within the licensing regime. The new directive does not affect their status. The issues have been slightly confused by the campaign, if it says that products that are not currently within the regulatory framework, so should not be on sale, are going to be outlawed by this directive. That is not the case. The

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directive is about providing a more stable legal framework for traditional herbal medicines, to bring them further into the fold rather than to exclude them from the variety of products that can be sold in this field.

Mr. Austin Mitchell (Great Grimsby): I am reassured to hear that, because many of us are worried that the directive is going to be more restrictive. On that point, I have a question for my hon. Friend the Under-Secretary of State for Environment, Food and Rural Affairs. As I understood it, he said that the Government were concerned about the safety of some mixed herbal remedies and that that was leading them to support regulation. He gave an instance of a Chinese herbal remedy that carried dangerous ingredients. Have such cases happened frequently, or is that a fairly small-scale one-off incident that should not incline us to the sort of eccentric regulation set out in the document? My understanding of the case mentioned was that the ingredient that concerned the Government was illegal anyway.

Ms Blears: There have been several examples of ingredients being used that have been found to be unsafe. The example to which my hon. Friend the Under-Secretary referred is that of aristolochia, which is a species known to cause cancer and renal failure. Sometimes, that has been accidentally included in traditional Chinese medicines instead of clematis or stephania, which should be included. That problem has occurred in the UK and other countries. An ingredient called teucrium has been used instead of scutellari. Teucrium is apparently linked with liver toxicity. The trade in unlicensed herbal remedies and ingredients is international.

Other examples include digitalis, which has been used instead of plantain in the United States where they have had reports of cardiac arrhythmia. In Hong Kong, there have been reports of podophyllum root being used instead of gentian, which can cause serious toxicity and may be fatal. Japanese star anise is known to have convulsant effects and has been used instead of Chinese star anise. There have been some cases of creams with undeclared corticosteroids and heavy metals in them. I do not want to be alarmist and say that the issue is huge, but those ingredients have been used and have caused problems. The case for safety, quality and regulation is quite well made.

Richard Younger-Ross (Teignbridge): The Under-Secretary of State for Health seemed to be describing mistakes that were made in the original preparation. I am not too sure how regulation will stop mistakes being made. If those ingredients were illegal in the first place, why are we not making some things illegal to improve safety, rather than taking what the industry considers a rather heavy-handed approach?

Ms Blears: I do not think that it is simply a matter of mistakes. The regulation will deal with quality standards, manufacture and the avoidance of contaminants. There is a suggestion that the manufacturing and quality standards that have been introduced by regulation are suitable only for

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pharmaceutical drugs. The CHC leaflet states that the directive will force herbal remedies into a regime that is suitable only for pharmaceutical drugs. I would take issue with that. Manufacturing standards are necessary to protect the public. They are appropriate and have been designed specifically with herbal medicines in mind. They are designed to ensure that ingredients are not contaminated by other ingredients, and that they have the purity necessary for any medicinal product. I believe that they are achievable.

We have had submissions from a range of small and medium manufacturers, which supported the directive. If they felt that the burdens were too great for them, they would have expressed those concerns to us. Small manufacturers in the herbal sector have said that they welcome the directive, and feel that it is important that it comes forward. The standards are necessary, appropriate and achievable.

Rev. Martin Smyth (Belfast, South): I wonder whether the Under-Secretary of State for Health is happy with the proposed widening of the definition in article 1. It currently reads:

    ''Any substance or combination of substance which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting, modifying physiological functions in human beings''.

That proposition has now been changed to

    ''a combination of substances which may be used in human beings''.

That is so wide it would also cover five vegetables and five pieces of fruit a day. Surely we should not be extending medical matters to deal with everyday food issues, never mind genuine substances that have been used in the past to aid people's health.

Ms Blears: The UK position on that is that we strongly oppose the effect of the provisions. We feel that, when products can be properly regulated, whether under food supplement or other regulations that are already in place, that is the correct way to deal with the matter. We do not want to create a hierarchy of medicines where everything that has a physiological effect must be regulated as a medicine. The proposals would catch items such as herbal teas and coffees, which is plainly ridiculous; there is also the prospect of them including tooth-whitening toothpaste. We want to ensure that the regulations are implemented sensibly. Borderline products should be identified so that they can be regulated if necessary, but we do not want unnecessary regulation. Our priority is that the Commission's proposals as drafted do not succeed, which we will ensure through negotiations.

Dr. Andrew Murrison (Westbury): I have never come across a patient who has been harmed, affected or who has lost anybody as a result of traditional and herbal remedies. Does the Under-Secretary of State for Health have any idea of the levels of morbidity and mortality that can be ascribed to those products?

Ms Blears: I have no hard statistical information of the kind to which the hon. Gentleman refers. Clearly, we are only beginning to regulate traditional herbal medicines. For many years, a wide variety of products has been available, with very little hard evidence of their effects. The hon. Gentleman has highlighted the need to consider relevant regulation because we have

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little substantive evidence. I quoted some of the examples of ingredients that have been found to be unsafe and incidents that have occurred, but I do not have widespread general information on morbidity in the population related to the use of herbal remedies.

Dr. Brian Iddon (Bolton, South-East): Legislation in this area has clearly been unsatisfactory for a long time. Vitamins and minerals have slanted towards food legislation, while herbal products have slanted towards medical legislation. Some of us have been arguing for an equally long time that borderline products should be legislated on separately; herbal products should not be shoehorned into medicine legislation or vitamins and minerals into other legislation. I admire the example of Canada and others. Why have the UK Government not promoted special borderline legislation? It would avoid mismatches like these proposals.

Ms Blears: We think that the best way forward is to try to support the proposed provision in the directive, which includes a proviso for a subsequent review of its extent. At the review, it may be possible to consider traditional medicines that contain other non-herbal ingredients. The right way forward is to use the proposals to achieve what we want for the UK and for the many people who have been involved for a long time in the manufacture of such products. We need to get a more sustainable and solid legal base for those products to establish the industry firmly, and to ensure the protection and safety of the public who depend on standards. There is no chance to achieve unanimity, or even widespread consensus, on an extension of the areas that might be covered under the directive, so we should press ahead with what we have and look to the review in due course.

Mr. David Tredinnick (Bosworth): The Under-Secretary of State for Health laid great store by the support from the British Herbal Medicine Association. Is she aware that its own members are criticising it for not taking into account their views? Is she also aware that there are many other organisations that she should consult because the BHMA represents only holders of products that are already licensed? She should consult half a dozen other organisations that are much more concerned about the proposals, particularly about the fact that herbs and nutrients in a blend will be removed from the market. Can she explain why she has relied so much on the BHMA, and address the worry about mixed herbs and nutrients coming off the market.

 
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