Authorisation of Human and Veterinary Medicines

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Ms Blears: That view comes not only from the British Herbal Medicine Association, which represents about 36 small and medium companies in the sector, but from the European Herbal Practitioners Association, which represents most of the main herbal practitioner groups in this country. That association has had the view, for a number of years,

    ''that existing European medicines legislation is inadequate to ensure the quality and safety of herbal medicines.''

Thus it

    ''now broadly supports the proposed Directive . . . recognising that it represents the best chance to safeguard the public by ensuring reliable quality and safety standards . . . In our judgment, failure of the proposed Directive to pass into law could potentially jeopardise

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    the supply of herbal medicines to the public since in the absence of agreed quality and safety standards for herbal medicines throughout the EU, there would undoubtedly be a loss of confidence in the sector.''

People involved in the sector, whose livelihoods are at stake, say that they want to see regulation because that will give the public better confidence in the products that they are purchasing, which may open the market to more people wanting to take part.

When products can be registered, people involved in the sector will be able to make claims on what they can do. At the moment, they cannot do that so, again, progress will be able to be made. I take the hon. Gentleman's point, but there is a variety of views on the issues. Of course, the Government will want to hear from everyone who is concerned about them. We certainly do not have a closed mind, but there is a balance to be struck. Much campaigning has been done on specific issues and it is important to get the balance right. That balance must be between providing a proper base for traditional herbal remedies, many of which the public greatly value, and ensuring that access to those remedies is under standards that are safe, appropriate and achievable and that enable the public to have increased confidence in the products that they purchase.

On combination products, which have been mentioned, I made that point at the outset. If combination products cannot prove efficacy or that they have had traditional usage, and if they cannot be sold as food, they currently cannot be sold. This directive does not affect the status of those products. It is misleading that the campaign has merged those two issues. Because the directive does not affect those products' status, it would not outlaw them. If products cannot prove efficacy or traditional usage, it must call into question the reason why they are being marketed and whether it is of any benefit or value for them to be supplied.

Mr. Desmond Swayne (New Forest, West): Given that all animal medicinal products are to be prescription only, can the Under-Secretary of State for Environment, Food and Rural Affairs tell us what investigation the Government have undertaken and what conclusions they have come to on who, in addition to veterinary surgeons, might properly issue such prescriptions? He will be aware that if veterinary surgeons are to have a monopoly on the supply of medicinal products for animals, there will be huge implications for a very hard-pressed livestock industry.

Mr. Morley: I do not dispute that, which is why we do not agree with that part of the proposal: we do not believe that it is necessary for all veterinary medicines to be prescription only. At the present time in this country, there are three levels of control. Prescription-only medicines include all medicines that might have dangerous residue. It is right that those should be under prescription and we have never sought to change that. There is also the pharmacy and merchants' list, the PML, and the general sales list. There is no control on the sale of those medicines. We feel that if some products do not have risks relative to consumers, extending prescription-only status to all veterinary medicines is not justified. We shall strongly

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argue against that and we believe that we have support. We think that the Commission is mistaken in its approach.

On the range of veterinary medicines, the directive proposes to allow additional medicines, particularly for the equine sector, on to the market. There has been a problem with the range of medicines for that sector, and some smaller market medicines will helpfully extend the range of veterinary medicines. We support that idea, but we think that the proposal on prescriptions is far too restrictive, and we shall oppose it.

Mr. Austin Mitchell: What my hon. Friend has just said worries me in part, because such medicines have traditionally been freely available in this country, much more so than in Europe. We were assured by his predecessors that the British Government were negotiating in Europe for maximum availability and freedom, and for an absence of control on that traditional market. However, we are today told that safety is important, although, as the hon. Member for Westbury (Dr. Murrison) put it, there has never been any evidence of danger or illness in this sector. What exactly is the Government's negotiating position in Europe? Are we negotiating to defend availability and freedom of the kind that we have always had in this country or are we accepting the principle of restriction?

The Chairman: Order. May I ask hon. Members to try to keep their questions short and the Ministers to try to keep their replies succinct?

Mr. Morley: Yes, Mr. Chidgey.

In reply to my hon. Friend, of course we want to ensure that there is a minimum of bureaucracy over the availability of medicines. In my case, I am dealing with veterinary medicines; my hon. Friend the Under-Secretary of State for Health deals with medicines for people. I must emphasise a point that she might want to mention later: there is evidence in this and other European countries of people being harmed by unregulated herbal medicines. There are real issues of concern, such as the use of antibiotics in animal treatment. That is already regulated and controlled through the prescription-only system. We do not want to increase risks to consumers over the use of animal treatments. We do not believe that the measures being proposed help in that way.

Although the point is slightly different from that in this directive, we have reached an agreement to allow veterinary nurses to carry out a range of procedures. That is convenient, reduces costs for the livestock sector and has been very much welcomed.

Mr. Hugo Swire (East Devon): I hope that the Under-Secretary of State for Health is convincing herself as she develops her argument this afternoon, because I am not sure that she is carrying the rest of the Room with her. Has she made a study of the economic effect that the regulations, should they come into being, will have on the hundreds of specialist retailers up and down the country who now feel threatened and are writing to us as their constituency

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representatives? They say that the regulations could well result in substantial cuts in the number of people employed in the health food industry.

Ms Blears: As I said at the outset, I am aware that there is a balance of views on the issues from manufacturers, retailers and consumers. Everyone has an interest in the outcome and we welcome consultation from the retail sector as much as from the manufacturing sector. There was an assessment of the effect on the manufacturing sector, but that sector is not operating in isolation. It operates in anticipation of supplying goods to the health food sector. The British Herbal Medicine Association is completely in favour of the directives. I cannot believe for one moment that it would be in favour of regulation were manufacturers' products not then able to be sold by retailers to consumers. That is part of the whole supply chain.

People support the directive because they are, perhaps, taking something of a longer-term view: establishing the safety and reliability of herbal medicines will mean that in future the market will, hopefully, expand. More consumers will want to have access to the medicines because they will be properly regulated. The manufacturers certainly see the benefit of those arguments.

Mr. Jack: On a point of order, Mr. Chidgey. In their remarks, the Ministers have been referring to various medical findings. Is there any error in the documentation pack prepared for Committee members? It should have included evidence-based information on the medical assessments of the dangers concerned, so that we might further understand some of the information now being given to us. I cannot find any reference to that in my pack. Was it an omission?

The Chairman: My understanding is that the documents are circulated by the Departments concerned, and it is entirely up to them what they say. It is not a matter for the Chair.

Richard Younger-Ross: The Minister from DEFRA said a moment ago that he was not entirely happy with part of the legislation, and wanted it changed. The health Minister says that we do not want unnecessary regulation, and that some things need to be changed. We also hear that there is room for review of the regulations once they have come into effect. Why are we bothering? Why do we not say that we want to delay until we have sorted this out?

Mr. Morley: Perhaps I can answer that question. The directive is being discussed in the EU, and has been referred to the European Parliament for its opinion. I know that MEPs are also concerned about some of the aspects that we have raised. It is normal to review and discuss a directive, and to ensure that the Commission is accountable to member states, through national Parliaments, in relation to concerns felt by us as a Government and indeed by individual hon. Members.

When the directive has been agreed, a review period will be provided at an appropriate time, as is right and proper, to take account of changes that may have been

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made. That is exactly the same procedure that we apply to much of our own legislation.

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