Authorisation of Human and Veterinary Medicines

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Mr. Morley: Let us deal quickly with the veterinary point, because my hon. Friend the Under-Secretary of State for Health has many questions to deal with on the human health factor.

On procedures for scrutiny on the veterinary side, I know that the issue has been referred to the Agricultural and Rural Development Committee of the European Parliament. Indeed, other committees, such as the Environment, Public Health and Consumer Policy Committee and the Industry,

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External Trade, Research and Energy Committee, are considering aspects of it. All parties in the United Kingdom and other member states share those concerns. The matter will be scrutinised in detail, will then go to the plenary session of the European Parliament in October, and the European Parliament will give its opinion and refer it back to the Council of Ministers. I am sure that those concerns are shared with other countries and we intend to press them strongly.

Mr. Heald: I am most grateful to the Minister and hope that he can change the provision because, first, farmers are hard pressed and it would help them if veterinary costs could be kept within bounds and, secondly, we want the products to be available so that animals do not suffer unnecessarily.

Mr. Tredinnick: I was going to make this point during my speech if I am called. The Under-Secretary of State for Environment, Food and Rural Affairs said that he is sure that those on the continent—perhaps I should say in the European Parliament—have similar concerns. I do not believe that that is so, because they live in a much more restricted world with the Code Napoleon and tend to want a more restrictive structure. The French and Germans do not think like us in that respect. A more restrictive code does not sit easily with what we are trying to achieve in this country, where we want a freer code.

Mr. Heald: My hon. Friend makes the important point that the availability of products that consumers want to use and which have a good safety record is an important interest that we should stand up for. It is important that people can use the products they want to use, unless it can be demonstrated that there is real concern about safety.

Had the Under-Secretary of State for Health been able to point to a substantial body of evidence showing that people are being injured or dying as a result of taking complementary medicines, that would be one thing, but she did not. She gave a few anecdotal examples, whereas she could have produced a substantial medical report to the European Scrutiny Committee had she wanted to. Mistakes can be made in any industry. The products of even the best retailers in the land are occasionally found to contain a hair or some other adverse incident occurs.

Mr. Morley: That is unfair. My hon. Friend made it clear that some of the examples were given by the MCA, which is an independent and extremely reputable organisation. Hon. Members can examine its website.

It is worth stressing that, in addition to the fact that many organisations involved in herbal medicines in their own countries support the directive, our own Consumers Association generally supports it. That association is much better known to me than Consumers for Choice, which has strong links with industry and vested interests. I have much more confidence in the Consumers Association on issues such as this than in some of the campaigning groups.

Mr. Heald: It may be that I have not explained my view clearly enough, although I have probably gone on about it for a long time. We are not saying that there

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should not be regulation in this area. We would like it to be the right level of regulation to ensure that products are available and safe. We want the Minister to start to fight for consumers and the hundreds of thousands of people involved in retailing the products in this country in such a way that the widest possible variety of herbal remedies is available without the Code Napoleon approach to which my hon. Friend referred.

Dr. Evan Harris: The point that I am about to make applies not solely to complementary medicines, but also to conventional medicines. All such products have a good safety record until they do not. It is not good enough to say that, unless there is evidence of harm, they can be assumed to be safe. The problem is that health claims are made for the products, which are marketed at vulnerable consumers. Some effort must be made to demonstrate safety as far as possible within limited trials—huge populations cannot be covered in trials—to obtain some support. Like the hon. Gentleman, I am concerned about the extent of the trials, but they provide a let-out for years of experience. The point on which I wanted to take issue with him is the argument that those products have a good safety record; all products have a good safety record until they do not.

Mr. Heald: That is obviously correct, but the Ministers and the hon. Gentleman already accept that if a product has been used safely over an extended period, that is one way in which to show its efficacy. [Interruption.] I shall come to safety, which is important, in a moment. The other way of showing efficacy is to conduct trials, but they are very expensive and if a traditional medicine has existed for a long time, that is one way of proving its efficacy.

As far as medical evidence is concerned, I downloaded the MCA's view from its website, which includes a passage headed, ''additional MCA comment''. It lists a few examples of cases in which products have not been as they should. My point is that nobody would describe that as a detailed medical assessment of complementary medicines, and it is not supposed to be. They are a few anecdotal examples that have been put forward to justify the Minister's case. Those are the areas on which we should like to hear more.

4.57 pm

Dr. Iddon: I shall try to be as brief as possible, although I have a lot to say. My interest in the subject comes from my constituency, in which the Health and Diet Food company has a fairly large presence. It took over a small family business, which occupied one shed on an industrial site, five or six years ago and it now occupies five sheds, which shows how quickly it has developed over the past five years. We can see how popular that industry has become on every high street. I can tell my hon. Friends that a lot of emotion surrounds the products that we are discussing this afternoon. If we dare to take one such product off the shelves, we may not cause a riot but we will create a lot of problems. That takes me back to the fracas that we entered into in the 1997–98 Parliament on vitamin B6. Vitamin B6 took over my life. Later, along came a directive like the one that we are discussing this

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afternoon called MLX249. I never believed that I would talk in Trafalgar square to hundreds of people about MLX249. I would have believed that that could happen on the subject of cannabis, but not MLX249. I was astonished at the number of people who came out to march down Park lane to Trafalgar square on an issue that I thought was not important. If hon. Members feel that the issues are not important, they are wrong.

The industry is growing—I have no other interest in the industry apart from the company in my constituency. The two principles on which the industry bases itself are the safety of its products—I accept that there have been some difficulties, which have been mentioned, but overall it has a good safety record—and choice of and access to products. My concern is that the industry is being bombarded with directives; I have already mentioned MLX249 and the vitamin B6 fracas. Three directives are going through the European Parliament, and experts in the field have told me that there are more to come.

I remind hon. Members that many companies in the industry are not like Holland and Barrett, which could probably withstand the bombardment of directives. Many are small family businesses, and if they have to take on board and implement all the new regulations, they will go out of business; it is as simple as that. Many such companies have hundreds of years of tradition of supplying herbal products and food supplements, and I am therefore concerned about the industry's future.

We have a deregulation unit somewhere in Parliament, and it is supposed to be deregulating. The number of regulations that are flying at the industry—there are more to come—is frightening.

I am worried about the new definition of a medicine in the medicines directive. It is difficult to define a medicine exactly, but the change in article 1 from the words ''administered to human beings'' to ''used in human beings'' is wide, flawed and could result in problems. We know why the European Union has done it: it wants to bring on board many other products.

The new regulations will also bring confusion. Even if a product were on the market under the provisions, for example, of the PARNUTS legislation, the proposed food supplements directive, the proposed addition of nutrients to food directive or other Community food laws, the medicines legislation could in future require it to be considered as a medicine. An enormous swathe of legislation has gone before, and now we are introducing new legislation. How is a small family company to cope with it all? It will be impossible.

We risk the removal of many safe and popular natural health products from general retail sale by requiring them to comply with medicines legislation that demands a demonstration of efficacy. I have always opposed bringing herbal products and medicines under the same legislative procedures and under the Medicines Control Agency. The MCA does a terrific job and is fully conversant with the pharmaceutical industry, its medical trials and

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efficacy, but I maintain that herbal products are not pharmaceuticals. They are quite different. A single active ingredient is involved in trialling a pharmaceutical product, but the trialling of herbal substances with medical properties, if it is required, is much more difficult. I have always argued that we should have separate legislation for borderline products.

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