Authorisation of Human and Veterinary Medicines

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Mr. Heald: Taken together, the provisions involve a major change in the way in which medicines for humans and for animals are dealt with in Europe. Let us start with the report on the operation of the marketing authorisation procedures, which appears to conclude that the dual system of centralised and mutual-recognition authorisation has worked quite well. The actual conclusion, however, is that major reform is required—that the scope of the centralised system must be extended massively, and that the fast-track procedures and all the committees must be restructured in the way described by the Minister.

This is presented as a method of speeding things up and making them more efficient. The centralised authorisation system, however, is a very cumbersome beast. It is hard to see how the logic has led to the proposals that we are discussing. The effect, surely,

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will be a substantial shift of power from member states to the centre, which I think should cause us some concern. It is heartening that Ministers themselves have expressed concern in paragraphs 3.17 to 3.20 of the report. I know it is difficult to do this when answering questions, but perhaps the Minister could put the position in context when she replies to the debate.

In paragraph 3.18, Ministers express concern about our

    ''ability to maintain effective regulatory bodies''

if the changes are made. They fear that if centralised authorisations are handed out to an enlarged membership of the European Union, each country will deal with comparatively few, and less work of that kind will be contracted to the regulatory bodies, while the amount of mutual-recognition work will also be much reduced. Does the Minister think she should be fighting harder?

Paragraph 3.19 lists various shortcomings that seem quite important. The Ministers' first concern is that

    ''the shortening of the period for assessment''

might affect public health. I will not go into it now, but, as the Minister knows, we have major public health problems in Britain.

The effect on compassionate medicines is also referred to. On such aspects as

    ''product characteristics, patient information and packaging'',

the effect of the proposals may be to fail adequately

    ''to take account of . . . national markets and differences in prescribing habits''.

The Under-Secretary of State for Health will see the other points that are made, which she obviously knows well because they are her concerns.

The Government must more adequately explain what they are going to do about those matters. If they are worried about the shift of power and the other important issues, we need to know how the battle is going with our partners in Europe and try to achieve a better result. That is the first matter on which I would like the help of the Under-Secretary of State for Health. Will she go further in giving us information about it?

My second area of concern is the definitional point that I raised earlier, on what exactly the directive on medicines covers. The Commission's proposal is that there should be a definitional change,

    ''to avoid any doubt as to the applicable legislation, when a product whilst fully falling within the definition of a medicinal product may also fall within the definition of other regulated products''.

It then suggests an amendment to article 2.2, which would drag products that have previously been regulated as foods under the umbrella of medicinal regulation. Will that mean that regulations on both aspects, food and medicines, apply to those products? That is obviously the understanding of the law, for which the Government are arguing, but it has been an area of doubt. Is that area of doubt the basis on which the Under-Secretary of State for Health is confidently saying that all combination medicines are illegal unless

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they have a marketing authorisation? If that is correct, it has not previously been enforced.

Why are those changes in definition needed, if the law is as the Under-Secretary of State for Health has told us? Why is it necessary to change the wording of the actual definition from:

    ''Any substance or combination of substances which may be administered to human beings''

to a modified text that reads

    ''may be used in human beings''?

Is the effect of that to widen the number of products being covered? In what way does it widen that and why? Is it really necessary for the balance, which the Minister mentioned, to be changed so that we undertake more, and much wider, regulation on the medicines side, which is a very expensive procedure? That question of definition is my second area of concern.

The third matter about which I want to ask the Under-Secretary of State for Health is the traditional herbal medicine products directive itself. She mentioned balance. It is, of course, true that if there are huge amounts of regulation, we think that we are very safe, but the effect is that there are fewer medicinal products available because the more we regulate the more it costs to bring a product to market, so the fewer products there will be. That stifles innovation and we end up with fewer medicines than might otherwise be the case, and therefore less safety. It is a foolish argument that very heavy regulation in the medical field is always the answer. However, we need enough regulation to ensure that people are safe, so a balance is needed.

Dr. Evan Harris: I have followed the hon. Gentleman so far and, clearly, the more one regulates, the more that could stifle innovation because it leads to major barriers. That may well reduce people's opportunities to be cured. However, he said that that impacted on safety. Those are two different issues. One can regret a reduction in the number of potential treatments available, but that is different from saying that a reduced number of treatments because of more regulation will inherently be less safe.

Mr. Heald: Rationing health can be a complicated and semantic discussion if we want it to be. The fact of the matter is that the more we regulate—we see examples of that all the time in the health field—the longer it takes for products to become available to patients. More patients are, therefore, not cured and may possibly die. They consider that as a safety issue, but I accept that that means their personal safety. Clearly, if one is injured or dying, one's safety has been impaired. One can make a semantic distinction, and I am grateful to the hon. Gentleman for reminding me about that.

Concerns on the proposed directive have been raised by the Health Food Manufacturers' Association, Consumers for Health Choice, the Health and Diet company, Holland and Barrett, and almost everyone involved in this field, with the exception of those who hold licences for medicines—it would affect their competitive position in quite a

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positive way. The first point is that herbal products alone are quite a limited category. Many traditional Chinese and ayurvedic medicines include food nutrients as well. Is the Under-Secretary saying that there is a good reason why such safe and popular products should not be available to the public and why they should not be dealt with under the proposed directive? Why does it have to be herbals only?

Secondly, if one has to establish that the combination of herbs in the product has been together and in use for 30 years, that is a very long period. Many traditional herbs could qualify under the directive but would seem to be outside the statement of the directive itself, if put in combination with another herb that qualifies under the directive. The Under-Secretary herself has expressed concern about the situation. In paragraph 4.7 of the Scrutiny Committee report, she tells us that she will be seeking clarification on

    ''the proposed positive list of herbal substances, where it appears unclear how the arrangements would work in a number of likely situations (for example, if several ingredients contained separately on the positive list were to be combined within one product.''

Clearly, the Government are saying that they want to seek clarification and pursue the matter. Is the Under-Secretary telling us that that is not the case and that she is not worried that perfectly safe herbal combinations might not be made available? Surely she has a position on that.

Does the Under-Secretary accept that 15 years would be a more promising time limit? That is partly because 15 years is used in other contexts in the European Union, and it is quite a substantial period. She mentioned that she was flexible about periods of use outside the EU. What is her negotiating position? What is she arguing for as regards the length of time outside the Community in which traditional use can be established?

The industry's view is that the ingredients should be covered by the directive, rather than the products, because that method is very inflexible. What detail is available to us about the quality and safety standards that will be put forward for registration under the traditional medicine directive? Do we know whether there will be a light or heavy hand of regulation? Will industry and consumers be listened to? What can the Under-Secretary tell us about that?

There have been several other points. In the UK and other member states, several herbal products were granted full licences under the directive at the time of the herbal review. Will the Under-Secretary explain the interaction between licensed and registered products? How will the consumer differentiate between them? Will we be able to explain to consumers the difference between a licensed and a registered product? Clearly, if the Minister sees benefits, one of them must be that consumers can rely on a registered herbal product. In that context, what will be done to inform the public about the change and what it means for them?

Article 16f deals with the establishment of a positive list of herbal substances that gives

    ''therapeutic indication, specified strength, the route of administration'',

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but the basis for the compilation of the list, which will be extremely important in the practical working of the directive, is not clear. We are told only that it will be set up by a committee referred to in article 16h. Will the Minister tell us about the committee? Who will be on it, where does it come from and where is it going? We would like to know the details. What is it all about?

I hope that the Minister will address another concern, which is about compliance costs. They are referred to at different points in the regulatory assessment as very high, high and medium. The assessment also says that it is too early to say what they will be. Obviously, it is important for business to know the likely scale of the costs that will be involved. What assurance can the Minister give about the costs?

Let us turn for a moment to the agricultural aspects and veterinary medicines. Ministers are concerned that the proposals do not adequately take account of the fundamental nature of animal health markets and that, due to the species-specific regional and often sporadic nature of animal diseases, the markets are, in practice, tiny in comparison with human pharmaceuticals, yet the medicines must be licensed to similar standards of quality, safety and efficacy. They expressed the concern that it would simply not be economically feasible, under such conditions, to bring to market many veterinary medicinal products. The Minister will know that a Conservative spokesman in the European Parliament, Robert Sturdy MEP, also expressed grave concern about the matter:

    ''If we are not successful''

in arguing our case—

    ''we can see that it would be possible to use the proposed definition of a veterinary prescription to allow a suitably qualified person other than a vet under the UK's current arrangements to write a prescription and/or distribute a specific category of POM product. We are still considering this option, which of course is one of the recommendations of the independent review.''

I apologise—that was Lord Whitty's response to him. Perhaps the record could be amended. We said that we saw no justification for the proposal. There is concern about the considerable costs, particularly given the decline in farm incomes, if such medicines are sold only on prescription. Clearly, it would be helpful to farmers if veterinary costs could be kept at a reasonable level.

It would be helpful to have from the Minister an overview and some specific comments about the definition issue and the whole question of traditional herbal medicines directives.

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