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Traditional Medicines Directive

1.30 pm

Mr. David Tredinnick (Bosworth): I am most grateful to you, Mr. Winterton, for that kind introduction. I cannot say that I have caught your eye—we all know that these debates are balloted—but I am grateful to have this opportunity to debate such a vital issue at this important time. It is also a pleasure to see the Under-Secretary of State for Health, the hon. Member for Salford (Ms Blears), in her place.

Many herbal products are sold in the United Kingdom under section 12 of the Medicines Act 1968 as medicines not requiring a product licence. Those products are regarded by some regulators as technically illegal under European Union law, but I shall not go down that route today. The proposal for a traditional medicines directive would allow a product licence to be given to herbal medicines without proof of efficacy, provided that they are safe, have been traditionally used for 30 years—the current proposal suggests that at least 15 of those years must have been in Europe—and that they are produced to good manufacturing practice standards.

I suggest that regulation on the subject should aim to establish a new system that provides the consumer with assurance on the safety and quality of the products that they purchase, and enables information on the purpose of the products to be given. However, individuals and organisations in the UK, including the Health Food Manufacturers Association, the European Herbal Practitioners Association and the Consumers for Health Choice—umbrella bodies that represent many interests—are concerned that the directive no longer does what it set out to do.

The problem is that, as the directive has developed, it has changed direction. Its criteria now rule out many safe and popular products that are on the market. That leaves many products in limbo, because although they are regarded as medicines they are unable to meet the criteria for registration. The consequence will be that many valued products will be removed from the market and thus denied to the consumers who wish to use them.

The traditional medicines directive is now in its third informal draft. The first formal draft is due to be published by the Commission soon. If the Minister is to act, it is vital that she does so speedily. The title of the latest draft is significantly different. What earlier drafts called the "directive on traditional medicinal products" is now entitled the "directive on traditional herbal medicinal products". Thus the new directive will not accommodate those traditional medicines derived from mineral or animal sources. Traditional medicines from India, China, Pakistan and Tibet that use natural products of animal or mineral origin will therefore have no place—especially if we do not use them now. That does not seem to be a scientific decision, and the Commission needs to redraft the directive so that it can include traditionally used medicinal products of non-plant origins. The decision whether to include such products should be taken on scientific grounds alone.

The directive has become very Eurocentric. In its present form, it runs the risk of being branded Eurocentric because it will prevent a full range of

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traditional medicinal products from ancient medical traditions—Chinese and ayurvedic—from being placed on the European market.

Another problem is that there must be evidence of usage for 30 years, of which 15 must have been in the European Union. Furthermore, many companies have gone out of business or changed hands, and many new companies marketing old products have not been around for 15 years, let alone 30. That problem will be overcome if we apply that qualification not so much to the product but to the active ingredients—the constituents of the product.

Thirty years is a long time, so it will be difficult for manufacturers to meet that requirement. As a result, it will be impossible for other traditional medicines to enter the United Kingdom market, as they will not qualify under the 15-year rule. I fear that many traditional products—we may not know about some of them—will be blocked, which is highly unsatisfactory. As drafted, the directive applies to traditional products. The industry's view is that it should refer to traditional ingredients because, although data will support a long history of use of ingredients, they are less likely to be available for products. There are also concerns that the directive is drafted in such a way that it could not be used to register products from non-EU traditions.

Although the current draft is called the "traditional medicinal products directive", its scope will probably be restricted to herbals. I cannot see what else could happen. At a stroke, that would make the many products that combined herbals with food nutrients ineligible and would rule out many important and popular combinations produced in traditional Chinese and ayurvedic medicine.

There are concerns that the standards proposed for registration under the directive will be too difficult for manufacturers to meet. That issue needs to be addressed, as there will be serious problems if the industry simply gives up trying to register products that are already saleable.

The directive should be a major step forward, but it no longer looks as though it will help. Indeed, it now seems to threaten many herbal remedies. It would require natural herbal medicines to comply with strict pharmaceutical testing procedures that are completely inappropriate for such naturally occurring substances. Especially at risk are blends of herbs with vitamins and minerals, which the Medicines Control Agency argues should be classed as medicines requiring a full licence if the herbal ingredient is at therapeutic levels.

One expert said to me in a written submission:

If such a measure could not be implemented, the effects on industry in terms of employment, survival and growth, and on the consumer in terms of restriction of choice, would be extremely serious.

Another expert told me:

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If ever there was an amber light for a Minister, and if ever a Back Bencher fired a Verey light to alert the Government to a problem, surely this is it.

You were generous in your remarks, Mr. Winterton, about the interest that I have shown in the subject in the House during the past almost 15 years. I warn the Minister to take great note of what I say, as the subject is worrying.

The consultation exercise by the Medicines Control Agency on a proposal to extend the list of potent or toxic ingredients that are not permitted in unlicensed herbal medicines has an indirect bearing on the directive. We need to educate the Department and the agency on the fundamentals of Chinese medicine. It works by combining as many as 15 herbs. It is nonsense to test one herb to see whether it is safe, because others are often included in a recipe to counteract side effects. It is meaningless to test in isolation a herb that is part of a prescription. I gather from one source that formulating

Usually, between four and 15 herbs are used. Practitioners believe that it is fortunate that their ancestors have left them so many effective formulae, which have been tested over thousands of years in clinical practice. Doctors in this country have been regulated for more than 100 hundred years, but Chinese medicine is based on thousands of years of experience. When people say that there is no evidence to support such remedies, I ask, "What about the anecdotal evidence?" Are we so misguided as to adopt an imperious, if not imperial, attitude towards countries that have used such remedies for such a long time?

Why must herbs be used together to treat a disease? A single herb usually cannot resolve a complex disease, so to do so Chinese medicine must combine several herbs with similar or different therapeutic effects. The basic principles behind combining herbs are co-ordination and mutual restriction. In co-ordination, two or more herbs with similar therapeutic functions or two or more herbs with different therapeutic functions are combined to strengthen their curative effects. Mutual restriction is quite technical, but important. It means that one herb inhibits or relieves the side effects or toxicity of another. Combining herbs is, therefore, the art of selecting two or more herbs with a clinical purpose—that is the crux of the matter. Mutual restriction means that one herb can inhibit or relieve the side effects or toxicity of another, but well-known Chinese herbs that should be used only as part of specific combinations are now being taken off the market in Britain, and will be taken off elsewhere in Europe, too. A senior Chinese practitioner told me last week, "David, it is so sad. It is a disaster for us. We simply cannot treat some conditions. The Medicines Control Agency foolishly banned substances on the ground that they were toxic if used on their own. But they are not toxic if used as we use them."

Traditionally, there are four methods of combining herbs in Chinese medicine. It is a pity that the Minister is not a former Whip because the language involved might have appealed to her. Generally, practitioners talk of using a chief herb, a deputy chief herb, an assistant herb

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and an envoy to achieve curative results. That would go down well in the Whips Office, where there is a Chief Whip and a deputy. The chief herb is used to produce the leading effects in treating the cause. The deputy herb has two purposes: first, it helps the chief, just as the deputy does in the Whips Office; and, secondly, it is used to produce the leading effects in the treatment.

The assistant herb strengthens the therapeutic effects of the chief and deputy herbs, and treats less important symptoms by itself. It is also used to prevent the possible toxic side effects of the chief and deputy chief herbs—the very side effects for which the MCA has banned these herbs. Finally, the assistant may possess opposite properties to those of the chief herb, and may be used to deal with possible adverse reactions in serious cases where the herbal tea has too potent an effect.

The fourth constituent is the envoy, which we do not have in the Whips Office, although there are perhaps such things in the diplomatic service. The envoy herb works in two ways, as the medicinal guide and as the conductor. As the guide, it leads the other herbs in the formula—the chief, the deputy and the assistant—to the affected parts of the body. As the conductor, it harmonises them, co-ordinating the effects of the various herbs. I do not think that anybody on the expert panels—except, perhaps, one person—is capable of making such assessments, and that is a fundamental problem.

The easy way out is to say that all the herbs should be tested on their own. However, as I hope that I have shown by giving the House the benefit of this briefing from one of the leading Chinese medical institutions, that policy is nonsense and must be looked at again. I have been through the problems that we face with the medicines control directive, not least because it has been renamed, because the 30-year period is beyond reason, and because if we do not address the issue now, products will be removed from the shelves in many shops and pharmacies across the country at a time of public demand for greater access to them. The blame will lie fairly and squarely at the door of the hon. Lady and the Government.

1.46 pm

The Parliamentary Under-Secretary of State for Health (Ms Hazel Blears): I am grateful to the hon. Member for Bosworth (Mr. Tredinnick) for having raised the important matter of the proposed European directive on traditional medicines. This is an opportune time for the debate because we are expecting the European Commission to make formal proposals. As the hon. Gentleman said, several unofficial drafts of the directive have already been issued.

I should like to pay tribute to the work of the hon. Gentleman. I have not been in the House for 15 years, but I am aware that he has raised such issues regularly and he brings to the subject great knowledge and expertise. I have learned some things today that I was not aware of before the debate. I should also like to record our appreciation of the helpful contribution of the many herbalists, manufacturers and people involved in the industry to the preparation of the directive. It is important for us in the Department of Health to look outwards to the industry, to consumers and to the range of people with direct experience of how medicines work.

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There has been a constructive dialogue between the industry and consumers and the Medicines Control Agency. I understand that there are tensions, but it is important for dialogue to continue, otherwise we shall be operating in isolation from each other. I hope that today's debate will contribute to the effort to identify both the weaknesses of existing arrangements for regulation and what might be done to improve the regulatory framework for herbal medicines. As a result of the dialogue, and of the information that we have, the UK has been able to play a prominent role among member states in arguing the case for the reform of European law to provide a secure regulatory home for traditional herbal medicines.

It is widely acknowledged that the current, unlicensed system is a very weak legal basis for regulation, and there has been a search for a more secure regulatory framework. To give a simple example of the problem, a consumer might find two apparently similar, unlicensed herbal remedies at a local health store. One might be made to high standards, following good manufacturing practice, and the other might be a low-quality product. However, the consumer has no way of knowing which is which. Product information can vary widely between two apparently similar products. The consumer cannot tell which is the more reliable and effective product.

The hon. Gentleman gave examples of unlicensed herbal medicines that contain products that pose a risk to public health. The Government must be mindful of striking the right balance and ensuring that the public are protected. By implication, he mentioned the ingredient aristolochia, a toxic herbal ingredient used in traditional Chinese medicine. It has been known to cause renal failure and cancer. I understand that there is documented evidence of that. It has happened not just here but elsewhere in Europe and, indeed, in China.

Mr. Tredinnick : The Minister makes a valid point. That ingredient was over-prescribed in Belgium, but one case does not necessarily make good law. The Minister must consider my explanation, which described how proper Chinese practitioners often use ingredients that can be toxic in one situation but are beneficial in another. That is the real issue.

Ms Blears : The hon. Gentleman's explanation about the chief, the deputy, the assistant and the envoy gives a clear picture of the complex interaction of herbs, and I understand his point. However, the Government have a responsibility, when serious public health issues arise, to protect the public from toxic ingredients. I expect that the hon. Gentleman would accept that.

Another example of what I am concerned about involved Chinese skin creams that were found to contain prescription-only steroids. That is a serious matter. They were being used on children, and I do not think that any hon. Members would want such a state of affairs. I do not say that that is typical, but cases arise in which the Government need to take action.

I reassure the hon. Gentleman that the traditional Chinese medicine sector will have every opportunity to contribute to discussions about the ingredients that should be licensed and regulated. There is no intention

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of making the process exclusive, and one in which the Medicines Control Agency adopts a "we know best" attitude and imposes its views. We want to be inclusive and to consult people, because we want to reach the right result. That is the most important thing for the public, including people who want access to traditional herbal medicines.

The directive is being developed to provide a secure regulatory framework, so that consumers can be assured on quality, safety and a history of use. Those factors will enable them to have trust and faith in a product, and reassure them that it is not completely untested and undependable. We are keen to ensure that people representing all the traditional sectors are represented in our consultations. Responsible herbalists are concerned that proper standards should be built into the system. For the sake of their reputations and the conduct of their business, they want standards to be raised to enable the public to depend on the products in question.

We have three main aims. We want the public to have continued access to a wide range of safe, good quality, traditional herbal remedies; we want consumers to receive systematic information to enable them to take the right decisions; and we want the regulatory framework to be established, so that we can safeguard the long-term future of various herbal traditions, which are greatly valued by many people. We should not underestimate that.

As to the requirement for 30 years of traditional use, the United Kingdom has pressed strongly for account to be taken of use outside the European Union as well as within it. Remedies must be safe and meet the normal quality standards, and people need information about them, but it is important to draw on the experience of other cultures and the use of herbs outside Europe. I understand that some European countries have good, well-documented histories of traditional use. In France and Germany there is a good base of information on which we should be able to draw.

We also want to ensure that as well as traditional Chinese medicines, ayurvedic medicines, which, I understand, originated in India, should be available. The idea is to find the right balance and, without compromising on safety or quality, to permit access to a wide range of traditional remedies that might help people to improve their health.

We are aware that many people in the industry would like the directive to extend further than it does at present. The hon. Gentleman raised the issue of combinations of herbal and non-herbal items. The difficulty is that consensus across the European Union about extending the directive to cover that would be unlikely. Our prime objective is to find a safe regulatory framework for traditional herbal medicines. Combination products cannot be sold as an unlicensed medicine, although many can be sold as a food if they contain vitamin and mineral supplements, and we should ensure that they can continue to be sold in that way. However, we should focus on what we can achieve within the confines of the directive, which has widespread support, although I accept the concerns expressed by the hon. Gentleman.

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Mr. Tredinnick : What the hon. Lady says will be reassuring if combination medicines can be sold under existing legislation. If she can assure us that that is the case, she will remove many of the concerns expressed by the representative groups.

Ms Blears : Some of the combination products can be sold as foods under the legislation, as I said, and that position will continue. I can also give an assurance that, as the Commission's proposals proceed, the Medicines Control Agency will continue to consult the herbal sector. Last week, a useful meeting took place with representatives from the industry's herbal registration forum. We have established a group considering specifically ethnic medicines, and we also have an ethnic medicines forum. Plenty of discussion and consultation is taking place, which is key to getting the maximum benefit from the directive to secure the future of traditional herbal remedies in this country. People rely on those remedies and value them for improving their health.

There should be many more such meetings, which will help to inform our negotiating position when we go to Europe, and will enable us to speak from a position of strength, based on evidence in the field. We look forward to keeping in regular contact with those groups.

We are cautiously optimistic that the directive and the proposals will achieve the objectives that we have set for safety, quality, information and a good regulatory framework. Many in the herbal sector have been hoping for such an approach for a long time. Those operators who fail to operate systematic quality standards will have to raise their sights considerably to meet the requirements of the new scheme, which is good because it will bring consistency into the industry. Consumers will be able to rely on the quality of the products that they are purchasing, which will benefit the public and the many responsible operators. It will make for a good regulatory framework, and could lead to greater

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stability in the industry and increased public confidence in the products on offer. The industry has little to fear because setting up a proper regulatory framework will mean that the products have a standard of guaranteed quality on which people can rely. We should take the best scientific advice that we can find.

The hon. Member for Bosworth raised interesting issues about the combination in which some products are provided. I undertake to do more work on those issues, because it is important that we consider matters not only in isolation but across the piece. I will take those issues away with me for consideration, and acquire some further information.

Mr. Tredinnick : I am grateful for that assurance. Will the Minister also consider the proposed 30-year role, which may restrict the number of companies that can register their products?

Ms Blears : I understand the hon. Gentleman's concern about the 30-year rule, but persuading Europe that 30 years is not an appropriate period may be difficult, to say the least, so we must consider what we can reasonably hope to achieve. A 15-year rule exists for use in the European Union, and there is a possibility of looking outside the European Union to make up for the 30-year rule. Trying to make the period shorter than that would pose severe difficulties, especially in achieving a consensus on the directive across Europe. It is difficult to achieve consensus within the European Union, but we are anxious to do so in the interests of consumers, the public and the industry to ensure that quality products are available on which people can rely for their traditional value. We must provide a good regulatory framework to sustain products that have been of such great benefit to so many people.

Question put and agreed to.

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