Authorisation of Human and Veterinary Medicines

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Dr. Evan Harris: There is an argument for the hon. Gentleman's proposal, but separate legislation will still create a borderline between medicines legislation and his proposed legislation. The creation of a new category does not solve that problem. The key question is whether something that makes medicinal claims is thoroughly tested.

Dr. Iddon: Traditional herbal products have been tested for far longer than any modern pharmaceuticals. Some of them have been used for centuries, and we have not seen large numbers of people dying as a result. I was brought up in a village in the 1940s, and the number of pharmaceuticals that were available then could be counted on two hands, and they had to be paid for. In every village, there was somebody who knew how to deal with a physiological condition using a herbal product. Those traditions go back hundreds, sometimes thousands, of years, and their safety and efficacy have been clearly demonstrated.

I can understand why we have the 30-years rule and why the word ''traditional'' is in the directive. However, the directive appears to carry sway on the word ''products''. I think that we should use the term, ''herbal ingredients''. In the past few decades, a range of innovative products have been put on the market that fall outside the scope of the 30-years rule—they contain traditional herbal ingredients but in new products, which will be caught by the legislation. The directive will fly in the face of innovation, for which the industry has become well known, especially over the past decade.

Another problem is the regulatory impact assessment that was applied to the directive. The industry representatives who have come to me have greatly criticised the way in which that assessment was carried out. They argue that there are many flaws in it and say that they have not been properly consulted. Other hon. Members have referred to the lack of consultation with the industry—with the people actually manufacturing the products, not the trade representatives of the industry. I put it to the Ministers that there has been a lack of consultation with the companies producing the products, rather than with the trade organisations.

I would frankly prefer the legislation to be deferred for a few months, or perhaps a year, so that we can look at it again, consult the industry properly and ensure that what we are introducing is watertight. Three kinds of companies operate in the industry. First, there are companies that are not large. I mention Potters of Wigan, in an adjacent constituency to mine, because I happen to know it quite well. It has been manufacturing such products for decades. It has

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licenses for that, which it obtained under quite different legislation many years ago. It is not going to be caught and it is quite small. Secondly, there are many companies such as Holland and Barrett that have bottom lines that could probably withstand the impact of such directives.

I am most concerned about the third group of companies: small specialist companies that will be trapped in the middle and hit hard by this directive and the others that are coming at them. I repeat my request to the Ministers that we get down to much better consultation than has so far taken place. When we reach agreements in Europe, we must ensure that we carry the whole UK industry with us, so that we do not get people marching down Park lane and I do not have to turn up in Trafalgar square again.

6.07 pm

Dr. Evan Harris: I am grateful for the opportunity to participate in this debate. I want to focus on the matters about which I have intervened because my hon. Friend the Member for Teignbridge (Richard Younger-Ross) will be speaking on some of the general issues and because some of the concerns clearly held by the Liberal Democrats have been expressed in the European Parliament. They include concerns about the scope of the regulations and such particular issues as whether two ingredients that are both herbal, or two herbal products taken together, will gain exemption—a point that the hon. Member for North-East Hertfordshire made well.

I want to say a word on safety and efficacy in products that make medicinal claims. Let me make it clear again that my concerns about that extend not just to herbal, or what are called complementary, medicines but to pharmaceutical products. The same arguments apply to them and they must not be let off the hook. The first thing to say is that safety is an issue and the normal way of testing for safety as best one can is to indulge in human volunteer trials, at least at the end of the process. That is where safety problems are sought because, when using a product for general use, one does not submit oneself to a battery of blood tests, liver function tests, scans and symptom questionnaires. Safety problems are very difficult to detect until they are huge, unless they are specifically sought in a well-designed research trial. That is why the hurdles for safety are high.

Everything in life carries some risk but, as a society, we put a higher premium on safety when products are marketed as having medicinal benefit because they are being marketed to vulnerable people, many of whom are desperate for a cure or for symptom relief. One can argue that extra protection in the pharmaceutical industry is provided by the barrier to access that is the requirement of a prescriber and by a second barrier—although the Committee might be discussing this in the future—which is the current ban on direct-to-consumer advertising.

However, in areas such as those that we are discussing, where, for historical reasons, there is less safety data, there are far fewer restrictions on advertising to consumers who are just as vulnerable. We must therefore be clear, when we talk about safety,

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that we not only talk, but say what we mean. That means asking those seeking to market a product and profit from it, in both sectors—orthodox and so-called complementary—to ensure that safety trials are done. That is a different issue from efficacy. I think that there was, towards the end of the otherwise very interesting and sensible remarks of the hon. Member for North-East Hertfordshire, a confusion between the question of efficacy and safety.

The problem is that many products turn out not to be safe in the long run. They are always on the front page of the newspapers as scandals, and we should accept that it will always be that way. As legislators, we have a responsibility to ensure that we put as many barriers to unsafe products coming on to the market as possible.

On efficacy, to a certain extent it does not matter when marketing some products whether they work or not. There are issues of advertising and trading standards, but when it comes to products that make therapeutic claims, as opposed to food supplements that do not, it is reasonable to insist on some evidence of efficacy. I question whether experience alone, even over many years, is in itself sufficient evidence of efficacy. Bleeding was used for hundreds of years in this country—it was used more recently when I was a junior doctor taking blood, unintentionally—as a potential treatment for various maladies. Of course, we know that often the patient died not from the illness, but from lack of blood due to the treatment. Simply counting the years without doing trials of effectiveness, and looking for those trials, preferably randomised double-blind control trials where possible—a little hobby horse of mine—will make it very difficult to show that there has been efficacy.

Clearly, there is a difficulty because consumers have been using a product that they find helpful, which may be because it is helpful, or because they think that it is. The placebo effect is valid, and modern medicine relies on it to a certain extent in the non-complementary field. Therefore, the proposal is a compromise. When there has been safe use for many years of products that make medicinal claims, one can say that they are efficacious enough to be advertised to vulnerable consumers as having a medicinal effect. However, we have to accept that that is a compromise.

As I mentioned in my questions, the Consumers for Health Choice document is concerned that the regulations would end all product innovation and development, including the introduction of any safe new ingredients—presumed safe, it ought to say—that pharmaceutical companies should state for their products, even if such products were able to comply with pharmaceutical standards in the directive. I received that letter only recently, so I was not able to explore with CHC what exactly it meant. I have heard the argument used, and it says in a further document that

    ''the manufacturing and testing standards proposed are inappropriate for herbal remedies which should not be treated in the same way as pharmaceutical drugs.''

However, it had previously stated that, even if companies were able to comply with those standards, it would stifle innovation.

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The CHC has not explained to me why that is the case. I do not know whether the CHC is funded by the industry. The Under-Secretary felt that it was. It does not say so it is on its letterhead, and I take issue with groups lobbying on pharmaceutical products that are funded by the pharmaceutical industry but do not make that clear. I am assuming that it is not. I would like the Under-Secretary to clarify whether she or other Members have received representations showing why the matter referred to by the CHC would be a problem.

I have debated with the hon. Member for Bosworth, who is concerned that if one puts standards on complementary areas of therapy, which do not have the capital of the pharmaceutical companies to carry out safety and efficacy trials, one creates insuperable barriers to innovation or retesting. I am not sure whether that is necessarily true because of the size of the market in some of the areas. Some of the companies are major players. Of course, the molecule has already been identified, particularly for existing products, so a limited number of efficacy trials is needed, which can be afforded. The Government should say whether they are willing, as they have done in other areas of industry, to work with players in the field on a partnership basis, perhaps with match funding or support for infrastructure, to allow such trials to proceed. It is very difficult to enter an area in which there is no tradition, because infrastructure, experience and indemnity are important.

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