MEDICINES BILL

HL Deb 18 July 1968 vol 295 cc504-80

6.30 p.m.

THE PARLIAMENTARY SECRETARY, MINISTRY OF HOUSING AND LOCAL GOVERNMENT (LORD KENNET)

My Lords, I beg to move that the House do now resolve itself into Committee on this Bill.

Moved. That the House do now resolve itself into Committee.—(Lord Kennet.)

On Question, Motion agreed to.

House in Committee accordingly.

[The LORD ROYLE in the Chair.]

Clause 1 agreed to.

Clause 2 [Establishment of Medicines Commission]:

LORD DONALDSON OF KINGS-BRIDGE: I beg to move Amendment No. 1:

Page 2, line 28, at end insert— ( ) The Ministers shall also appoint at least one member capable of representing consumber and welfare interests.

The reasons for this Amendment were well stated by the noble Baroness, Lady Elliot of Harwood, in the Second Reading debate. There are I think only two conceivable arguments against it and it would probably be less discourteous for me to state them and refute them rather than wait for my noble friend to state them and then refute him.

The first argument is that the Commission is a technical body and there is no room for laymen on it. This is refuted by the fact that at the Report stage in the Commons an Amendment was agreed that the words "except so much of it as relates to retail sale" should be deleted from paragraph (e) of subsection (3) of Clause 2 as the retail trade would not necessarily be represented under paragraph (c). It was made clear by the Minister that it is certainly his expectation that the retail trade will be represented on the Commission. The Amendment accepted was put forward on the ground that a large part of the Bill relates to advertising, labelling and marketing. If the retail trade is to be represented on the Commission we think the consumers, the buyers, should be represented too, and at any rate it does prove it is not a technical body.

The second argument is that it is impossible to select people who are generally representative of the consumer interest in this sort of subject. We have no less than three bodies professionally engaged in this work, the Patients Association, the Consumers Association and the Consumer Council. If your Lordships do not like any of those, it is quite easy to select any worthy citizen unconnected with any vested interest, who is not a nature cure addict or herbalist, and appoint him or her as representative of consumers. There is no difficulty about this, but the bureaucracy is in league with business to keep the customer out because he can so easily and properly be a nuisance. We think the consumer should be represented on this Commission. I beg to move.

LORD KENNET

I think it might be of help to the Committee if I were at this stage to say what course the Government urge upon it in respect of this Amendment and the next two Amendments, because they hang together. First of all, let me assure my noble friend that bureaucracy is not in league with business—at least, if my right honourable friend or I come across any who are, they will hear about it. This Amendment says that the Minister shall appoint a consumer person (to use shorthand) to the Commission. The next Amendment, No. 2, says that the Minister shall consult with appropriate consumer organisations about membership of the Commission, and the third Amendment says, in effect, that the Minister shall consult with consumer organisations about membership of the committees.

To put it in a nutshell, the Government's view of the best solution to this is that there should probably—and I emphasise probably—not be a consumer person on the Commission, became the Commission's work will in the main be directed towards purely scientific and technical questions of a pretty abstruse nature in which the advice of a consumer person, however valuable it will be elsewhere, will not be of the foremost relevance. The view of the Government is that on the other hand the specialised committees, the Clause 4 committees—or some of them, the relevant ones—could contain consumer persons. The committee concerned with labelling will probably be one that should; probably the one concerned with the general list should, and possibly if there is one concerned with unconventional medicine, herbals and so on, maybe this also should contain a consumer person. It is the intention of my right honourable friend to consult with relevant organisations in this field before making appointments to the specialised committees.

To sum up, the policy that the Government think it would be right to adhere to would be no consumer representative on the Commission itself, but consumer representatives on those specialised committees which are relevant to this field; and that there is no need to amend the Bill to achieve the latter part of this purpose, for they will consult and will appoint without amendment of the Bill. This is an assurance I can give the Committee, and I would urge the Committee to invite the movers of these Amendments to withdraw them all in view of the assurance I have given.

LORD AUCKLAND

I think that on balance the Government's case here is probably the right one. I yield to no-one in my belief that the consumer should be represented on any body of this kind in some form or other. As Vice-President of the Royal Society for the Prevention of Accidents I believe that anything involving pharmaceutical products and any other products which are dangerous if ill-used or mismanaged should have the maximum protection available. What rather worries me about this Amendment is the very wide terms in which it is drawn and the equating, as I read it, of welfare and consumer interest. When it comes to medicine and medicinal products we are of course all consumers, whether we manufacture the product, market it, retail it or anything else.

Therefore I feel, and I think I probably speak on behalf of most of my noble friends, that rather than have the actual Commission itself represented by consumer interests, to quote the words of the Amendment, it would seem probably better either to have co-opted members —because I presume this Commission has powers of co-option, but another clause may deal with this—or what the Government suggests may well be the right solution. What does rather worry me about the Amendment, as I say, is the equation of consumer and welfare interests. It would seem to me that the welfare interests would presumably deal more with the safety side, whereas the consumer interests would deal with pricing and that kind of thing. It seems to me questionable as to whether one representative, so to speak, or one body of representatives, could represent both interests, which are, so far as this particular matter is concerned, as I see it, rather widely divergent. I hope, for my part, that the Government's case will at least be fully considered.

LORD DONALDSON OF KINGSBRIDGE

I thank my noble friend for his full and sympathetic reply. We are very used in the Consumer Council to getting rather less than we ask for. We are pleased to get something, and the concession made is I think considerable. If we can have consumer representatives on the committees a great part of our case is met. I beg leave to withdraw the Amendment.

Amendment, by leave, withdrawn.

Clause 2 agreed to.

Clause 3 agreed to.

Clause 4 [Establishment of committees]:

On Question, Whether Clause 4 shall stand part of the Bill?

THE MARQUESS OF LOTHIAN

I wonder whether the noble Lord could answer one short question on Clause 4. This concerns the special expert committees which are to be set up. I feel that it would be useful if one of these committees could deal specifically with animal feedingstuffs. This is a point that I do not think he mentioned when he was speaking just now, but I think that it forms such an important part of the Bill that it would be better to have a committee dealing specifically with this matter, rather than have it jumbled in with some other committee.

LORD KENNET

As the noble Marquess knows, the Bill leaves the Minister free to set up such committees as seem to him appropriate. But after consultation with the Commission the way he proposes to go about this is, as Mrs. Beeton would say, "First get your Commission"; then consult it on what specialist committees should be set up. He has done this simply because the point of having the Commission is that this will give expert advice on the whole field, and he feels that he should not go ahead to specify what specialist committees there will be until the Commission itself is set up. But he will take note of what the noble Marquess has said. This certainly seems to be a candidate for the kind of specialist committee which might be set up.

Clause 4 agreed to.

Clause 5 [Supplementary provisions as to Commission and committees]:

6.42 p.m.

LORD AUCKLAND: I beg to move Amendment No. 4:

Page 5, line 11, at end insert— ("Provided that the functions so conferred or varied shall be concerned with medicinal products or related matters.")

This is not intended to be in any way a wrecking Amendment, because as I said on Second Reading of this Bill, I, and I think the whole House—in fact both Houses of Parliament--have recognised the need for some form of Medicines Commission, since this is largely a consolidating Bill, serving as it does to carry out the well-needed action of consolidating medical legislation over the years.

The real purpose of this Amendment is to draw your Lordships' attention to what could be interpreted as the wide powers which this Medicines Commission has. We do not yet know the numbers of those who will serve on the Commission, and I certainly do not intend to press the Government to give this figure this evening because quite clearly it may well be that a Commission of this kind may have to add to, as well as to subtract from, its numbers. We do not know. But as I indicated on Second Reading, my own view is that the Commission, initially at any rate, should be concerned mainly with the safety and quality of drugs and pharmaceutical products, rather than with some of the far more wide-ranging matters which Part V of the Report of the Sainsbury Committee advocates, such as the control and marketing and sales promotion of drugs.

I am not saving that in the future there may not be a case if, by any chance—and I think it is a slender one —these particular aspects of the pharmaceutical industry do get out of hand, for having some kind of Commission to look into this matter. But I think it is fair to say that there are already powers to deal with any serious shortcomings in this particular aspect of the industry. I am not a lawyer, so this is a point which rather baffles me, even though I have studied this Bill closely. Will the particularised powers given to the Medicines Commission be subject to Affirmative Resolution by both Houses of Parliament, particularly if any new powers, such as those I have mentioned, are added? I think this is most important, because we are embarking here on a new and novel procedure. As I said earlier, I do not say that it is in any way unwelcome, but I think that careful scrutiny should be given to the powers of this Commission so that it manages to cover properly and within a reasonable scope of time and energy the most important aspect of this matter; namely, to ensure the safety and quality of the products which they control. I beg to move.

LORD OGMORE

Before the Minister replies I should like to ask him a question. If this Amendment is passed, would it cut out from Clause 5(4)(b) any relation to veterinary products? As I read it, this Amendment refers only to medicinal products or related matters. It occurs to me, having regard to the wide scope of Clause 2 and also of the first Schedule, that it might well halve that effect, in other words to cut out any reference to veterinary products and matters. This would be most unfortunate.

LORD KENNET

That is exactly the sort of thing that we should like a little time to look into. It was only, I think, on Tuesday morning that we were first able to see Lord Auckland's Amendment. At first blush, I do not think it would cut out veterinary products because they are also described as "medicinal" elsewhere in the Bill. It is a general principle, accepted by the courts and by Parliament, that any changes effected by regulation or by order under the Bill shall fall within the four corners of the Bill; and there is no doubt that any changes proposed by the Minister in regard to the functions of the Commission would do so in the case of this Bill, as with others.

I am, incidentally, grateful to the noble Lord for not having raised the spectre which was raised in another place: that since one of the Ministers concerned with the appointment of the Commission is the Secretary of State it was thinkable that the Commission should at r later stage be empowered to declare war. This I believe is not so, and I believe that any power between the declaring of war and continuing to be concerned with "medicinal products or related matters", in the noble Lord's words, is also unlikely to be conferred upon them. But of course, having said that, I have deprived myself of any grounds for arguing against the noble Lord's Amendment, since, if that is the situation, he may well say: why not write it into the Bill? What I would say to him is, that if he will withdraw this Amendment we will have a good look at the situation and see whether there are any objections to writing into the Bill something having roughly this effect, so as to make it perfectly clear that these extra functions must be related to the subject matter of the Bill.

LORD AUCKLAND

I am most grateful to the noble Lord, Lord Kennet, for his most courteous and reasoned reply to this Amendment, which I am quite prepared to admit is not perhaps as specifically drafted as it might be. With the assurances which he has given I have pleasure in withdrawing the Amendment.

Amendment, by leave, withdrawn.

On Question, Whether Clause 5 shall stand part of the Bill?

LORD OGMORE

Before we leave this clause may I draw to the attention of the noble Lord one point which was touched upon slightly by the noble Lord, Lord Auckland. I should like to have a further assurance from the Minister in this respect. He will notice that in Clause 5(5) these words appear: No order shall be made under this section unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament. I wonder whether the noble Lord can assure us that those words mean what they say. In other words, if we in this House, in our wisdom, wish to reject or refuse to give an Affirmative Resolution then we may do so, but shall not be told that in about the year 1832 the House of Lords abandoned, or was held to have abandoned, or by effluxion of time is considered to have abandoned, these rights. I myself feel that if Parliament, instigated by the Government of the day in this Year of Grace, 1968, gives a House of Parliament certain powers, that House of Parliament should be able to use them if it thinks fit and should not be faced by some huge constitutional crisis, and be threatened with oblivion or extinction, if it acts in accordance with the powers which have now been given it.

I raised this point on another Bill, also affecting the Health Service, on Tuesday night. I am glad to say that on that occasion the Minister, the noble Baroness, Lady Phillips, with her usual great charm, assured me that the powers in the Bill would be exercised by the House of Lords if the House so desired after consideration, and that it could reject the Resolution if it considered it proper to do so. I ask now for a similar assurance from the Minister in relation to Clause 5(5) here.

LORD KENNET

If Parliament passes this Bill those words will become law and will remain law until they are amended by another law passed by Parliament.

Clause 5 agreed to.

Clause 6 agreed to.

Clause 7 [General provisions as to dealing with medicinal products]:

6.52 p.m.

LORD KENNET: I beg to move Amendment No. 5: Page 5, line 39, leave out ("field trials") and insert ("medicinal tests on animals").

This Amendment paves the way to an Amendment to Clause 23 and to the introduction of the new clauses after Clause 30, and to a very large number of consequential Amendments thereafter. I would ask the Committee to agree to consider the whole nexus of the changes at this point, rather than later. If your Lordships are content with the rather extensive revisions brought into the Bill by the Government let us say so at this point, and let us then either carry in or not carry in the later ones, however bulky they themselves may be, without debate. Let us have the debate now. I think the Committee will agree with me this is the orderly way to do it.

This Amendment, the Amendment to Clause 23, and the five new clauses after Clause 30 which replace the present Clause 31, are introduced in the light of some very constructive criticisms and suggestions which were made in Committee in the House of Commons. One of the principal points of criticism of Clause 31 in its present form has been that it did not sufficiently distinguish between the different factors affecting the use of new drags in trials in human beings and in tests on animals. So far as trials of drugs for human use are concerned, control under Part II of the Bill is first imposed when a new drug is to be used in a "clinical trial", that is, therapeutically, in circumstances where there is a doctor-patient relationship.

The "field trial", on the other hand, in Clause 31 of the Bill as it stands was envisaged as the equivalent therapeutic trial in animals, and under Clause 31 control was likewise first imposed at this stage. However, animal tests even at the pre-clinical stage can in some circumstances give rise to hazards to human or animal health if there are inadequate safeguards. Such risks can arise, for example, from undesirable residues left in animal products sold for human consumption. After full consideration my right honourable friends the Ministers of Health and Agriculture, Fisheries and Food have concluded that further safeguarding provisions should be included in the Bill. In the proposed new clauses control of tests in animals is not limited therefore to those tests which have a therapeutic purpose, and the expression "medicinal tests on animals" has been substituted throughout the Bill for the expression "field trial" which is too narrow in its connotations to cover all the extended kinds of tests which ought to be covered.

Another criticism of Clause 31 as it stands—and this applies to both clinical and field trials; that is, in relation to both human and animals—is that in requiring only the importer of the drug or the person "responsible for its composition" to hold the certificate, it does not go far enough and would allow an entrepreneur, or even the manufacturer himself, acting through a third party, to conduct trials without a certificate. In the new clauses, the way to which is paved by this Amendment, this possible escape route is blocked. If the Committee will agree, I will leave it at that and move this Amendment, and ask the Committee to bear in mind that it carries a great deal of material after it throughout the Bill. If there is any further explanation or clarification I can give to the Committee I shall, of course, be happy to do so. I beg to move.

LORD OGMORE

Do I take it from the Minister that we are not going to discuss at a later point the lengthy Amendments he has put down, and that he wants us to discuss the whole matter now? Is that what he proposes?

LORD KENNET

The Committee will, of course, do what they like, but I would urge that this is the moment to discuss the matter, because, supposing the Committee do not like the later clauses, and supposing we have carried this paving Amendment into the Bill and the Committee then wished to throw out the later clauses, we should be in a muddle. So it would be better if we could have the substantial discussion at this stage.

6.58 p.m.

LORD OGMORE

As the Minister has indicated, this is from many points of view one of the most crucial parts of the Bill after Clause 2. Your Lordships probably know that various stages have to be gone through before a product can be put on the market. First of all there is a very lengthy research programme, which is conducted in the laboratories in the pharmaceutical company concerned; or it may be in a university, or financed by the Medical Research Council. That is the research stage. Then, of course, comes a very important stage. At that time there have been probably a number of experiments on animals in the laboratory, and after that there comes another stage where there has to be a far more extensive application of the research principle. Finally, one has various development processes to go through, so a number of expensive and very lengthy processes have to be gone through before a product can be put on the market.

In this lengthy series of processes the trials to which the Minister has referred play a most important part, and whether those trials are held in the laboratory of the company or whether they are held, as is often the case, in a hospital or in a research institute, they are of vital importance. I should like to ask the Minister at what particular stage he envisages these licences will be applied. Will they be applied at the first stage, when there is research in a pharmaceutical company's laboratory, or will they be applied at a research institute, medical school or university? Or, again, will they be applied when the process has moved forward from that preliminary stage to the next stage, what used to be called a "field trial," when very much more extensive trials have to be entered into?

When one is dealing with medical products rather than with veterinary products, there comes a time when one can no longer experiment with rats, mice, guinea pigs, rabbits or similar animals, and one has to begin to experiment on human beings. That is a very testing time indeed. That is when the pharmaceutical industry has to apply to the various hospitals, to the professors of medicine, and the like, to help them to conduct their trials. This is an important matter for the industry. Nothing should be done that might affect proper and reasonable powers of the pharmaceutical industry to experiment. I should like to quote what was said on this matter by Sir Derrick Dunlop, Chairman of the Committee on the Safety of Drugs, which is now being replaced by the Medicines Commission. He said: The pharmaceutical industry has made enormous contributions to our society. Professor Chain of penicillin fame recently recently reviewed the 66 most valuable compounds introduced to medicine since aspirin in 1889. His analysis showed that only nine of these came from universities and research institutes; the rest came from scientists in the pharmaceutical industry. I have not consulted the industry on what they think about this particular series of clauses because, frankly, I have not had time. I received the Marshalled List only this morning, and there has not been time to get in touch with them. However, I imagine that they would want to be quite sure that nothing shall be done which would unduly restrict and hamper the research scientists in the pharmaceutical industry, or the researchers and scientists in the medical schools and hospitals who so often collaborate with the industry. When the company of which I am a director has a product which it wishes to put on the market, a product which has been carried through all its stages in our own laboratory, our own research centre, we look around to try to get the best possible research organisation, hospital, or whatever it may be, to assist us in the next stage.

I should not like to think that something was being imported into this process—which is a difficult, tedious and sometimes expensive process for the industry—which would be harmful in preventing the industry from making great advances. I am quite sure that the Minister will be sympathetic, for I know his interest in health matters. I am quite sure that he would not wish to see anything being done which would impede the pharmaceutical industry. It is a new and exciting industry, an industry developing new processes, new medicines, new drugs which will completely revolutionise the lives of the sick in this country in the next few years.

Already, as Sir Derrick Dunlop has said, the pharmaceutical industry, in conjunction with the medical research institutes and the hospitals, has been able to invent processes and patent new medicines which have had enormous effect. I am quite sure that in the next ten years or so that process will go on at an ever-increasing pace, and that many hospitals which are now full may be then emptied, or half-emptied, of their patients —in the same way that many tubercular hospitals have been closed because of the new pharmaceutical products, and that mental hospitals have been able to discharge many of their patients because of the new drugs which enable them to live practically normal lives at home. In this way the hospitals will be greatly relieved.

Although in principle I have no objection to this elaborate series of Amendments, I hope they will not unduly impair or hinder research practices and projects which the industry may desire to carry out in the future.

LORD KENNET

I am sorry that the noble Lord did not see this complicated series of Amendments until this morning. They were printed and distributed to Members of the House on Tuesday morning. I always try, as I think do most members of the Government, when introducing Bills and Amendments, to see that they are available two or three days before they are discussed, certainly if they are substantial Amendments.

LORD OGMORE

I have been a Member of this House for a good many years and if I can I always wait until I get the Marshalled List. One gets many bits of paper coming in every morning, not only in regard to the Medicines Bill but a whole host of things, such as the Gaming Bill, the Theatres Bill and one thing and another. I feel that it is dangerous to pay too much attention to Amendments until one actually sees the Marshalled List; one can then see exactly in proper sequence what one has to deal with. Even if they were available on Tuesday, that is not very long. I was here on Tuesday quite late in the evening on another Bill, so I cannot see that one has had a great deal of time. Some of us, of course, have other things to do. We are not solely concerned with matters in this House.

LORD KENNET

I mentioned the point only because I should not like any members of the Committee to think that the Amendments appeared only this morning. That was not the case; they were available in printed form on Tuesday morning. The Marshalled List, of course, appears only on the morning of the Committee.

I fully admit that this is a very complicated matter and I will do my best to explain to the noble Lord at what stage the controls come in on each side of the fence—by "each side of the fence" I mean as regards human controls and animal controls. On the human side of the fence, trials on human beings, the matter becomes subject to control and certificate at the point where the doctor-patient relationship comes to an end. When doctors carry out a trial, that is the moment on the human side when controls come in. On the animal side of the fence it comes about earlier for the reason (this is contained in the Amendment) that the carcases of the animals concerned, which have been part of the population coming into the trials, may be sold for human consumption. Since there is no relationship or confidence or contract between a man and a beast of any sort, it appeared to the Government a good plan to bring these trials under control, in other words to ensure that if these animals had been subject to a trial they should not be sold on the market just like any other. That is where it comes in on that side.

Of course, there is no question of subjecting to control by this body of Amendments research in the sense of "set it down and work it out on paper", or research in the sense of pure chemical work in a test tube. As to the labs., I am sure the noble Lord will have noticed that in these Amendments certain animals—guinea pigs, mice, rats and so on—are exempt from control, for the simple reason that they are common laboratory animals and that nobody eats them. One is simply seeking to subject to these controls cattle, sheep and so on which people do eat, and which ought to be subject to them.

On the general point that one dies not want unduly to restrict and hamper the development of the pharmaceutical industry's own research programmes, I of course agree and I am sure every Member of the Committee agrees, that it would be very bad to do this, but I think there is a danger of lapsing into a mode of thought which suggests that one is talking about whether or not to forbid a certain class of activity. Of course, we are not: we are talking about whether or not certain activities ought to be subject to permission, ought only to be lawful with the holding of a certificate to be issued by the certifying authority; namely, the Ministers, after this Bill is passed. Of course, they will not use their duty to certify what is safe to impede the development of the pharmaceutical industry's research programme. I think that is implicit throughout the Bill and throughout all the discussions at every stage so far. In conclusion, may I say that I was glad the noble Lord said he had no objection in principle to the bulky Amendments which we are introducing at this stage.

On Question, Amendment agreed to.

Clause 7, as amended, agreed to.

Clauses 8 to 11 agreed to.

Clause 12 [Exemptions in respect of herbal remedies]:

On Question, Whether Clause 12 shall stand part of the Bill?

VISCOUNT BARRINGTON

shall not detain your Lordships for mo e than a moment. I am completely ignorant on this. I hope I shall not be accused, as a Member sitting on the Liberal Benches, of jumping on a bandwagon, because all I want to do is to clarify my own mind about one phrase on which the noble Lord, Lord Chorley, said he might introduce an Amendment. He has not done so, and I am quite sure he has looked into it. This clause deals with exemptions in respect of herbal remedies. Like the noble Lord, Lord Chorley, I am not a herbalist, and I know nothing about herbalists, but there is one phrase that I do not entirely understand. I know that the noble Baroness, Lady Serota, said that during the Report stage in another place some concessions had been made to herbalists, but at the bottom of page 9 and the top of page 10 this clause says that the restrictions imposed by Clauses 7 and 8 do not apply in certain cases, among them being where, the person carrying on the business sells or supplies the remedy for administration to a particular person after being requested by or on behalf of that person and in that person's presence to use his own judgment as to the treatment required". The only phrase that worries me at all is, "in that person's presence". I am not quite sure what that applies to. I understand it means that the person who requires a prescription, rightly or wrongly, has actually to be present—not on the premises, necessarily, if whoever is prescribing it can come to them—when it is given. What I should like—and I would be absolutely satisfied by a word from the noble Lord, Lord Kennet, that this is either correct or will be looked into—is to make sure that this is not a law which would operate against people who, through no fault of their own, could not be present. Whether they are cranks or not is quite irrelevant to this. We have heard in debates on other Bills about one law for the rich and another for the poor. I want to be satisfied that this is not one law for the bedridden and one for the unbedridden. That is the only question I have to ask: whether a person has to be present; and, supposing that person is in a state of health such as to make him incapable of being present, what is the position?

LORD KENNET

The only thing that the herbalist has to do on his premises is to manufacture or assemble the remedy. He does not have to have the consultation on his premises. He can certainly go to the bedside of the sick person.

VISCOUNT BARRINGTON

Then I am right in believing—this is what I hoped—that a herbalist can manufacture things on his own premises, but in order to prescribe them, as it were, or in order to deliver them to the patient, he has to go to the premises of the patient? Am I right?

LORD KENNET

No. The effect of paragraph (b) of subsection (1) of Clause 12 is only that the consultation, or the event which one might call diagnosis in the context of conventional medicine, should take place in the presence both of the herbalist and of the patient; that they should be together. It does not matter where.

VISCOUNT BARRINGTON

Provided that the patient has actually been seen by the herbalist who is prescribing the remedy then that is correct. I thought this was a point worth raising.

Clause 12 agreed to.

Clauses 13 to 15 agreed to.

Clause 16 [Transitional exemptions]:

7.18 p.m.

THE MARQUESS OF LOTHIAN

I beg to move Amendment No. 6: Page 11, line 21, after second ("description") insert ("sold, supplied or manufactured by, or assembled to the order of, that person") This Amendment covers a fairly small point concerning transitional exemptions, and it is designed to limit the benefits of the transitional exemptions to those persons already selling, manufacturing or supplying products of the description in question. It seems to me that under the Bill as it stands it would appear that any person will now be able to introduce a product which was effectively on sale on the appointed day without recourse to a product licence if it is of the same description as some existing product. I myself feel that this is opening the door a little too wide. In any case, I foresee difficulties in finding out whether a product is manufactured to the same specification as an existing product. There may be difficulties in finding out what the specification of the existing product is, for example; and I think there will inevitably be a timelag which may prove very difficult considering that this is only a transitional question. Therefore, I really feel that it would have been better to limit the exemption in the way that the Amendment sets out. I beg to move.

LORD FRASER OF LONSDALE

I support this Amendment. The very word "transitional" implies that this is a concession to cover a limited period between the time when the idea is promulgated and the Act becomes operative. There seems to me to be a genuine risk here that during that period new products, untried, unproven, and entirely without the safeguards which apply to medicines even now, and which will apply much more under the Bill in the future, could slip in. Therefore, it seems to me that the words my noble friend moved are advisable and perhaps even necessary. It was said in another place that there was no intention to open the door to any risk of this sort. We in the trade think the risk is here and ask the Committee to accept this Amendment.

LORD KENNET

It is true that in the House of Commons my right honourable friend resisted a suggestion of this sort, for reasons which he explained then and which I need not go into now: they will be familiar to all noble Lords in this field. But since then he has had more arguments laid before him, and these arguments, together with another matter brought to his attention by the Committee on the Safety of Drugs, have underlined the potentially dangerous situation which could arise if a manufacturer were to launch a new product during this transitional period with the licence granted on the basis of his own claims that his product is of the same description as another which was already on the market. So my right honourable friend, the Minister of Health, has decided that it would be right to accept this Amendment in principle. There are certain drawbacks in the present wording, however, and if the noble Lord will withdraw the Amendment I will propose at Report stage a form of words which I hope will meet his purpose.

THE MARQUESS OF LOTHIAN

I am grateful to the noble Lord. In the circumstances I beg leave to withdraw my Amendment.

Amendment, by leave, withdrawn.

Clause 16 agreed to.

Clause 17 agreed to.

Clause 18 [Application for licence]:

7.23 p.m.

LORD COLERAINE: I beg to move Amendment No. 7:

Page 12, line 45, at end insert— ( ) The appropriate Ministers may by order designate classes of persons to whom a general licence may be granted for the manufacture, sale or supply of medicinal products specified in the order.

As the Committee know, I have an interest in some of the subject matter of this Bill as the director of a pharmaceutical company, one which also operates a considerable chain of pharmacies. This Amendment is one that I have beer asked by the Pharmaceutical Society to put forward. Its purpose is to make a little more flexible the licensing power under the Bill and to increase the flexibility without in any way detracting from the final authority of the Minister.

The present position, without tie Bill, is that any pharmacy in the country can make up—I was about to say "manufacture", but that is perhaps an elaborate word for what they do—familiar remedies such as Gee's linctus, zinc ointment, glycerine and thymol or glycerine and rose-water. These are not proprietary patent medicines; they are medicaments for which there is a demand and which, until now, the chemist has been free to manufacture in lots of two, three, four or half a dozen, and put them on his counter for sale.

Under the Bill, the chemist who does this and who has done this—for I suppose this practice has been going on for a century or so—would be obliged to go through all the procedure in Clause 18(1). That is to say, an application to make, say, Gee's linctus, must be made to the licensing authority and it must be made in such a form and manner as may be prescribed. There are probably 15,000 chemist's shops in this country and all are accustomed to making up these preparations. It would be an intolerable burden on the licensing authority if they were obliged to go through all this process for each one of the hundreds, perhaps, of pharmacists who might have to make them up. It may be that, apart from pharmacists there are others in a similar position who now make up simple preparations of one kind of another without doing any harm to anyone. They too would have to go through this elaborate procedure. If the Minister can accept this Amendment they, as well as the pharmacists for whom I have spoken, would be covered. I beg to move.

LORD KENNET

I have a great deal of sympathy with what the noble Lord has said. The Minister of Health agrees that there may be an advantage in arranging for licences to be available, as it were, ready-made for small-scale manufactured pharmacies of a limited range such as the noble Lord has outlined. I do not know if this meets the noble Lord's point. Rather than give a blanket exemption, which, anyway, one would have to define, it would be a better arrangement administratively to have these ready-made licences for small-scale manufacture which would be issued more or less on demand to persons of the right qualification, such as pharmacists. If this were so, these arrangements could be introduced without amending the Bill. I can assure the noble Lord and the Committee that, subject to the advice of the Medicines Commission, the Minister intends to work out this sort of arrangement as and when the licence scheme comes into force. If that covers the noble Lord's point, I hope that he will agree to withdraw his amendment.

LORD COLERAINE

I am grateful to the Minister; I think it covers the point; but I am not absolutely clear. Do I take it that this would be a licence not for the product but for the manufacturer—for the chemist?

LORD KENNET

Those persons in general who want to manufacture something have to get a special licence for that something. That something must be defined in how it is composed and in what it is hoped to do. Persons like pharmacists who are qualified to manufacture simple things should be able to go along and ask for a licence to manufacture familiar, traditional, products. Such licences would be given more or less on demand, without further examination, provided that the Medicines Commission agrees (when it comes into existence) that this should be done. I can inform the Committee that it can be done under the Bill without the Amendment.

LORD FRASER OF LONSDALE

Before the noble Lord withdraws his Amendment—I am not without sympathy for the withdrawal—I should like to inject this thought. It may not be a simple, familiar product; it may be an entirely new one—simple perhaps, but new, and not familiar. A good many of the medicines which are now familiar were first started by a little chemist who sold to his neighbours in the village or town where he lived, and who then built up a local business and eventually became a manufacturer of considerable products with a great deal of value. I hope the Minister of Health will say, when he takes the advice of the Commission, that he will take account of this and will not stifle the initiative of the little man who may invent a new simple product—let us say a new cold cream—which somebody may find very useful.

LORD COLERAINE

In the light of what the Minister has said, and in spite of the argument of my noble friend, I beg leave to withdraw the Amendment.

Amendment, by leave, withdrawn.

Clause 18 agreed to.

Clause 19 [Factors relevant to determination of application for licence]:

On Question. Whether Clause 19 shall stand part of the Bill?

7.30 p.m.

THE MARQUESS OF LOTHIAN

I do not want to take up the time of the Committee, but I should like to know whether the licensing authority is empowered in any way to inquire into the cost of research into a particular product. It seems to me that this is obviously something which would interest the general public just as much as the cost of promoting and publicising the product. I am not suggesting that the authority should have this power; I am trying to find out whether they in fact have it. Nor am I suggesting that the efficacy of a product bears any relation to the cost of the research.

LORD KENNET

Under this clause the authority inquires only into the safety, efficacy and quality, and not into the cost.

Clause 19 agreed to.

Clauses 20 to 22 agreed to.

Clause 23 [Special provisions as to effect of manufacturer's licence]:

LORD KENNET

I beg to move Amendment No. 8: Page 18, line 7, leave out ("or field trial certificates") and Insert ("trials and medicinal tests on animals") This is one of the Amendments we discussed with Amendment No. 5. I beg to move.

On Question, Amendment agreed to.

Clause 23 as amended, agreed to.

Clauses 24 and 25 agreed to.

Clause 26 [Scope of licence of right in different cases]:

THE MARQUESS OF LOTHIAN

I beg to move Amendment No. 9: Page 22, line 25, leave out "section 99" and insert "sections (Appeal) and 99". This Amendment and Amendments Nos. 44 and 82 hang together, and with permission I should like to speak to the three of them together. They cover an important point raised on Second Reading by the noble and learned Lord, Lord Shawcross, who, I am sorry to say, is unable to be present to-day. Briefly, the point is that there should be available to persons who are aggrieved by the refusal of the licensing authority to grant or renew a licence, or because a licence has been revoked or suspended, a right of appeal to an independent tribunal presided over by a judge appointed by the Lord Chancellor.

I am sure that the licensing authority will be guided by the advice of its expert committees, because that is why they were set up. It is also probable that the individual members of the Medicines Commission may be drawn from the same sort of professional ranks as the experts who advise them and whose advice they will have to take into account. These will be dedicated, levelheaded and unbiased men who will do their duty to the best of their ability, but there may be no one among them who is professionally trained in the techniques of weighing and assessing expert evidence. I think this is a role for a legally qualified person. It is also true that the successive stages through which an application for a licence will have to pass will constitute a valuable safe- guard for any applicant. Nevertheless, as the noble and learned Lord, Lord Shawcross, pointed out, these stages will be conducted behind closed doors and among experts who are involved professionally in the matter.

I have heard it suggested that the Parliamentary Commissioner might be called in to deal with any question of injustice, but in addition to that being a rather cumbersome procedure involving Members of Parliament, I do not believe that it is quite what the Parliamentary Commissioner's job was intended to be. In my view, what is needed is the tight of appeal to an independent legally qualified tribunal. It is a right which I feel would seldom be used, but I think it should be in this Bill as it is in many other Statutes. It would in no way interfere with the smooth operation of the Act.

No doubt I shall be told—and I am perfectly prepared to admit the fact—that my Amendments are defective in some way. But even if they are, I suggest that without some sort of provision on the lines I have suggested the Bill would be even more defective. I therefore hope that the noble Lord will consider this suggestion sympathetically. I beg to move.

LORD FRASER OF LONSDALE

I should like to support this Amendment. If a person who applies for a licence is turned down or another person has his licence revoked, they are bound to feel that the Minister has been judge and advocate in his own case, because the Minister is the licensing authority. The Minister appoints the Commission; the Commission appoints the expert committees, and one of the gentlemen appointed to these bodies will be the chairman and there will be a committee advising the Minister. It is upon that advice that the Minister will have turned down the application, and the applicant is bound to feel that the Minister has been judge and advocate in his own case. On a general principle of law, quite apart from the rights of the individual whose application has been turned down, I feel it is a good thing that we should try to make sure that the operator or manufacturer—the citizen, whoever he may be — has some right of appeal against arbitrary acts of Ministers.

Earlier in this Bill it was shown that the Minister has very great powers which may be extended at his will. If he does not like the advice of the Commission he can change the composition of the Commission at his will; he can increase or decrease its numbers. All these reasons make me think that justice would be done and, above all, would be seen to be done, were there this modest and simple method of appeal.

LORD ROWLEY

I have a measure of sympathy with the noble Marquess who moved this Amendment, but I think its acceptance would put a difficult qualification on the powers granted to the Minister. It is true that in some Acts of Parliament provision has been made for a right of appeal, but on looking at this clause I doubt whether it is necessary to go to the trouble of appointing a tribunal to hear appeals from an act of the Minister. The Minister has to assess the pros and cons of arguments put to him by experts, and it may be that some power of assessment is requisite. Although I should not be prepared to go so far as the Amendment proposes, I should like to ask my noble friend whether he can satisfy the Committee that the Minister would have a legal mind at his service, someone trained to assess the arguments that are put for and against the granting of a licence or whatever it might be. Without going so far as to say that I would support the Amendment, I should be grateful to my noble friend if he would satisfy me that there is no case for a tribunal, because in difficult cases the Minister would have legal advice at his behest.

LORD KENNET

I can satisfy my noble friend on that point at once. Of course the Minister would do so. In every case legal advice is available and in cases which look like difficult ones he would rely heavily on this advice. The procedure in the Bill, without a tribunal but with various references to specialised committees and a Commission at different stages, has been carefully considered and constructed with the special field of medicines in view. It has been discussed with the Council on Tribunals, who are content with it. Although the Government admit that it is unusual, it appears appropriate in the circumstances.

Let us go through what happens. The decision of the licensing authority is the final stage, but only after the applicant or licence holder has had two, or even three opportunities of making oral or written representations about the matters on which he is most likely to disagree with the final decision—that is to say, matters involving considerations of safety, efficacy or quality—first to the expert committee concerned, and then to the Medicines Commission as regards what he regards as adverse advice from the committee; and after that, if the licensing authority proposes to disagree with the advice of the committee or commission, he can be heard by a person appointed or have further representations considered by the licensing authority on this aspect. Where the grounds for proposed refusal are not connected with safety and so on, there is also a right to make written or oral representations. Not until then is the formal decision given.

If at the end of this he is disposed to do so, he would not find it difficult, if he did not wish to appeal to the High Court on a point of law, to have the matter raised in Parliament, to which the licensing authority is responsible. There is also the possibility that he would get the Parliamentary Commissioner to look into it. Although the noble Lord said that that was cumbrous, it: would not be half so cumbrous as appeal to a tribunal on top of what I have been describing.

Clause 99 of the Bill gives a right of appeal to the High Court on the ground that the licensing authority's act was ultra vires or that the requirements of the Bill relating to the matters in question had not been complied with. These cover the non-specialised and procedural aspects of such cases, but not the merits, which are scientific matters. The merits are concerned with judgments about safety and efficacy of the product, which if they are embodied in a decision regarded by the promoter of the product as "unfavourable" could, of course, affect the prospects of marketing the product very considerably.

The licensing authority is given the last word, because it is the Government's view that in matters of drug safety and efficacy the decision ought legally to be by a Minister answerable to Parliament. The whole purpose of the licensing scheme is to ensure that the medicinal products marketed for use by practitioners, pharmacists and the public have been scrutinised by persons of authority and standing in their special fields, independent of the promoters and in whom the industry, the professions and the public have confidence.

The matter at issue would be the relative importance, in relation to the proposed use of the product, of safety, efficacy and quality as indicated by the data available at the time of examination. These are inherently difficult considerations to measure where there is no objective test and the decision would hinge on the weight to be attached to subjective professional opinions as to how certain facts should be interpreted in reaching a relative measurement of these three factors. This is a field regarded by professional opinion as a difficult one, even for experts. It is difficult to see how these can be appropriately decided by means of a judicial or quasi-judicial contest in which the appellant submits all the technical evidence afresh and calls his expert witnesses, and on the other side the Ministers as respondents call members of the expert committee or the Commission as witnesses, each side being no doubt expected to defend its own judgment with advocacy and rebut the other's judgment. The legal chairman and two professional or technical assessors, as proposed by the noble Marquess's new clause, trying to arrive at the best solution between the conflicting testimonies would have a most difficult task. Moreover, if the Ministers have done their duty in finding the best people to serve on the expert committee and the Commission, it is improbable that the assessors would be better qualified to advise the legal chairman on the merits of the opposing testimonies than the expert committee who have advised the licensing authority in the first place.

My noble friend thinks it right that the last word on the specialist scientific matters should rest with the Commission or the expert committee, as the case may be. It seems to be a field of such technical difficulty that the added wisdom which could be brought to it by a legal chairman, after it has been threshed out lower down by the top people in the professions concerned, is very doubtful, and much as I sympathise with giving everybody a go, it seems to the Government that the provision in the Bill is adequate.

7.48 p.m.

LORD OGMORE

I feel that what the Minister has said has some force, in that I believe that in the last resort, in every case possible, the Minister should be responsible to Parliament. I have always fought for that. But I am not entirely satisfied that the noble Lord has made a case for the situation up to that point. He has said that there are three safeguards. First of all, there is appeal to the High Court on a point of law. It is highly unlikely that any of the matters referred to in this new clause would constitute a point of law, because they are points on medicine and science. So that is out. Then he said that there was the Ombudsman, the Parliamentary Commissioner. He is out, too, because he is not concerned with such things as the safety of drugs but with whether civil servants have been obstructive or have done something to the detriment of the citizens.

So we come back to the third safeguard, Parliament. But Parliament, after all, is not a suitable body for discussing the matters referred to in this new clause. How could we in this House, and still less those in another place, argue technical points about the efficacy of some drug of which none of us have ever heard before and probably cannot pronounce anyway? That is the situation. You have to look at this from a practical point of view. We want to do something to meet the very real point of the noble Marquess, that is that people should feel that there is some sort of appellate situation, and that they can go to appeal. One must realise that in many cases the person or the company concerned has spent a great deal of time, and a great deal of money, in producing this new product—a vast amount of money. Their prestige, to some extent, and their good will would be involved. There is the standing of their research scientists, especially. It is once more a question not only that justice must be done, but that it must be seen to be done by everybody, not only by the public, but by those in de industry itself.

I do not think in this case justice will be seen to be done, because whatever the Minister likes to say, the chap whose product has been turned down will have the feeling that it was turned down by the people who themselves were appointed by the Minister. That is true enough, because they were appointed by the Minister, and they are not independent people in the sense of an independent tribunal, they are there for a period of years; they will get into the way of dealing with matters for the Ministry, and for industry. In other words, they will become part of the Establishment. They will be Establishment figures, and will be regarded by the industry, especially by that part of the industry which has been turned down, as being part of, as it were, the Ministry's field of influence and responsibility, and that will be the case. No doubt people will say, "Oh well, we know so-and-so, he is looking for a knighthood". Somebody else is looking for an O.B.E.; somebody else is hoping for a job at a university. All these things may be said; no doubt they will be entirely wrongly said, there will not be an ounce of truth in them, but they will be said.

I think it would be better if one could spatchcock the two, and I should like to make a suggestion which might meet the noble Marquess and the Minister—interpose this appellate tribunal before the Minister's final say. In other words, that there shall be an appeal from the particular body which is dealing with the licences or certificates, as the case may be, and then if the applicant is dissatisfied with the result of his application for a licence, he can appeal to an independent tribunal. This can be either set up in accordance with the suggestion of the noble Marquess or in some other way. The point is they will be independent, looking at it from a broader point of view. They will not be concerned with day-to-day applications for licences; they will be specifically and especially brought into being for this particular purpose. Then the matter will go to the Minister, and he will be answerable to Parliament.

I should have thought—and I only make this suggestion as it has occurred to me while sitting here listening to the debate—that that would meet really everybody's just feelings in this matter, and would be a very practical way of that it has a right of appeal and at the dealing with it; enabling industry to feel same time the Minister would have, in effect, subject to Parliament, the final word.

VISCOUNT COLVILLE OF CULROSS

I have not got the fertility of the noble Lord, Lord Ogmore, to think of an answer to this. I am not sure that I agree with him that it is so difficult to get matters before the High Court on points of law in these sort of cases, as he may perhaps have thought. I should like to ask the noble Lord, Lord Kennet, if he can tell me this. I heard him say he had discussed the existing appeal procedure in the Bill with the Council on Tribunals. I think that is standard practice now with any new tribunal of this sort that is going to be set up. Could he tell me whether the hearing will be subject to the Council on Tribunals, and whether it is necessary to make an Order, if that is going to be done, and also whether a member of the Council on Tribunals, either in England or Scotland, will be able to go and listen to these hearings if they want to, in the way that they very often do? I do not know whether he has the answer to those points now; perhaps he would at some stage be able to tell me.

LORD KENNET

If the noble Lord agrees, I would like to write to him about the relation between the Committees and the Commission, and their hearings with the Council on Tribunals. I would just like to make one point. Nobody who has spoken in favour of this proposal has drawn any analogy with any existing procedure.

There is no appeal on merits from a decision of the Planning Ministers. There is an appeal on grounds of law to the High Court, but there is no appeal on merits from a decision of the Minister of Education about the local education authorities' plans. There is no appeal on merits from a decision of the President of the Board of Trade on an industrial development certificate, or an office development permit. Very often there is not even a hearing, and on none of these is there an appeal to a special tribunal on merits. I think we should be introducing a very odd animal indeed if we did so in the context of this Bill. In all of them there is an appeal on grounds of law, as there is in this Bill, and in all of them there is provision for hearings and representations on merits to the Minister or persons appointed by him, and in the relevant ones there is provision for going to the Parliamentary Commissioner, and this Bill will be subject to him, too.

LORD OGMORE

I do not understand that reply at all. Does the noble Lord mean that because it has never been done before we should do it now? It seems to me to be a very odd sort of theory to put up. It is a completely new animal; we have not had one like this before, and, therefore, there should be completely new provisions. There is nothing like it in planning law affecting town planning. and things like that, drains and so on, and you are dealing here with a completely new product of a highly scientific nature, on which a great deal of time and money has been spent. As he said, it could be very much an expert examination, and in these circumstances I should have thought the suggestion I put up—I do not ask for it to be decided now—could be put to the responsible Minister, if the noble Marquess agrees. I would like to see whether the Minister would consider it, and at a later stage the noble Lord could let us know the result.

I do not think the noble Lord can reject something off the cuff because it has never been done before. It is a most extraordinary theory for a Left-Wing Government to put up! I should have thought the thing they ought to say is, "As it has never been done before, we will look at it". The Left-Wing Government's sole objection to a new idea, that it has never been done before, is, to my mind, quite extraordinary, and it only goes to show that the Labour Government are getting more and more conservative as they carry on!

LORD KENNET

If I might interrupt for one moment, the noble Lord's reasoning is really most engaging. If I said that I thought it was a good idea to do this, and the only reason against it was that it had never been done before, I should have been caught on the wrong foot. I did speak for about 15 minutes giving all the reasons why I thought it would be a bad plan in itself to do it; the fact that it has never been done before is simply an addition to all those reasons.

THE MARQUESS OF LOTHIAN

I am very grateful to the noble Lords who have taken part in this debate, particu- larly to the noble Lord, Lord Ogmore, for his suggestions. I hope, the Minister may consider these seriously, and discuss them with his right honourable friend. I should like to thank him, too, for his very full and frank reply to my original speech. He has gone some way to convincing me that this Amendment is not quite so necessary as I thought it was. He has not gone the whole way. I should like if I may, to read more carefully what he said. There was a great deal of information and fact in his speech, and as I have been fortunate enough to have one Amendment accepted, I feel it would be very churlish of me to press on with this one. I beg leave to withdraw.

Amendment, by leave, withdrawn.

Clause 26 agreed to.

Clauses 27 to 30 agreed to.

8.0 p.m.

BARONESS SEROTA

I beg to move Amendments Nos. 10 to 14: After Clause 30, insert the following new clause:

Clinical trials

"—(1) Subject to the following provisions of this Act, no person shall, in the course of a business carried on by him,—

1. (a) sell or supply any medicinal product for the purposes of a clinical trial, or
2. (b) procure the sale or supply of any medicinal product for the purpose; of a clinical trial, or
3. (c) procure the manufacture or assembly of any medicinal product for sale or supply for the purposes of a clinical trial,

unless one or other of the conditions specified in the next following subsection is fulfilled.

(2) Those conditions, in relation to a person doing any of the things specified in he preceding subsection, are—

1. (a) that he is the holder of a product licence which authorises the clinical trial in question, or does it to the order of the holder of such a licence, and (in either case) he does it in accordance with that licence;
2. (b) that a certificate for the purposes of this section (in this Act referred t) as a 'clinical trial certificate') has been issued certifying that, subject to the provisions of the certificate, the licensing authority have consented to the clinical trial in question and that certificate is for the time being in force and the trial is to be carried out in accordance with that certificate.

(3) Subject to the following provisions of this Act, no person shall import any medicinal product for the purposes of a clinical trial unless either—

1. (a) he is the holder of a product licence which authorises that clinical trial or imports the product to the order of the holder of such a licence, and (in either case) he imports it in accordance with that licence, or
2. (b) a clinical trial certificate has been issued certifying as mentioned in subsection (2)(b) of this section and that certificate is for the time being in force and the trial is to be carried out in accordance with that certificate.

(4) The restrictions imposed by the preceding provisions of this section do not apply to a doctor or dentist in respect of his

1. (a) selling or supplying, or procuring the sale or supply of, a medicinal product for the purposes of a clinical trial, where either he is the doctor or dentist by whom, or under whose direction, the trial is to be carried out or he acts at the request of that doctor or dentist, or
2. (b) procuring the manufacture or assembly of, or importing, a medicinal product for the purposes of a clinical trial, where the product is specially prepared to his order, or specially imported by him, for the purposes of that trial and either he is the doctor or dentist by whom, or under whose directions, the trial is to be carried out or he acts at the request of that doctor or dentist.

(5) The restrictions imposed by subsection (1) of this section do not apply to anything which is done in a registered pharmacy, a hospital or a health centre and is done there by or under the supervision of a pharmacist in accordance with a prescription given by a doctor or dentist; and those restrictions do not apply to anything done by or under the supervision of a pharmacist which consists of procuring the preparation or dispensing of a medicinal product in accordance with a prescription given by a doctor or dentist, or of procuring the assembly of a medicinal product.

(6) The restrictions imposed by subsection (1) of this section also do not apply to anything done in relation to a medicinal product where—

1. (a) it is done by the person who, in the course of a business carried on by him, has manufactured or assembled the product, where he has manufactured or assembled it to the order of a doctor or dentist who has stated that it is required for administration to a patient of his or is required, at the request of another doctor or dentist, for administration to a patient of that other doctor or dentist, or
2. (b) it is done by the person who, in the course of a business carried on by him, has manufactured or assembled the product to the order of a pharmacist in accordance with a prescription given by a practitioner, or
3. (c) consists of selling the product by way of wholesale dealing where it has been 536 manufactured or assembled in the circumstances specified in paragraph (a) or paragraph (b) of this subsection.

(7) For the purposes of this section a product licence shall be taken to be a licence which authorises a particular clinical trial if—

1. (a) the trial is to be a trial of medicinal products of a description to which the licence relates, and
2. (b) the uses of medicinal products of that description which are referred to in the licence are such as to include their use for the purposes of that trial.

(8) A clinical trial certificate may certify as mentioned in subsection (2)(b) of this section without specifying the doctor or dentist by whom or under whose direction, or the patient or patients on whom, the trial is to be carried out.

(9) In this Act 'clinical trial' means the administration of a medicinal product of a particular description by, or under the direction of, a doctor or dentist to one or more of his patients, where there is evidence that medicinal products of that description have effects which may he beneficial to the patient or patients in question and the product is administered for the purpose of ascertaining whether, or to what extent, it has those or any other effects, whether beneficial or harmful."

After Clause 30, insert the following new clause:

Medicinal tests on animals

".—(1) Subject to the following provisions of this Act, no person shall, in the course of a business carried on by him,—

1. (a) sell or supply any medicinal product for the purposes of a medicinal test on animals, or
2. (b) procure the sale or supply of any medicinal product for the purposes of such a test, or
3. (c) procure the manufacture or assembly of any medicinal product for sale or supply for the purposes of such a test,

unless one or other of the conditions specified in the next following subsection is fulfilled.

(2) Those conditions, in relation to a person doing any of the things specified in the preceding subsection, are—

1. (a) that he is the holder of a product licence which authorises the test in question, or he does it to the order of the holder of such a licence, and (in either case) he does it in accordance with that licence;
2. (b) that a certificate for the purposes of this section (in this Act referred to as an 'animal test certificate ') has been issued certifying that, subject to the provisions of the certificate, the licensing authority have consented to the test in question and that certificate is for the time being in force and the test is to be carried out in accordance with that certificate.

(3) Subject to the following provisions of this Act, no person shall import any medicinal product for the purposes of a medicinal test on animals unless either—

1. (a) he holder of a product licence which authorises that test, or imports the product to the order of the holder of such a licence, and tin either case) he imports it in accordance with that licence, or
2. (b) an animal test certificate has been issued certifying as mentioned in subsection (2)(b) of this section and that certificate is for the time being in force and the test is to be carried out in accordance with that certificate.

(4) Subject to the following provisions of this Act, no person shall, in the course of a business carried on by him, administer any substance or article to an animal by way of a medicinal test on animals, or procure any substance or article to be so administered, unless either—

1. (a) in the case of a medicinal product, there is in force a product licence (whether held by him or by another person) which authorises that test and the product is administered in accordance with that licence or in accordance with any instructions required by the licence to be communicated to the person carrying out the test, or
2. (b) whether the substance or article is a medicinal product or not, an animal test certificate has been issued certifying as mentioned in subsection (2)(b) of this section and that certificate is for the time being in force and the substance or article is administered in accordance with that certificate.

(5) For the purposes of this section a product licence shall be taken to be a licence which authorises a particular medicinal test on animals if—

1. (a) the substance or article to be administered in the test is a medicinal product of a description to which the licence relates, and
2. (b) the uses of medicinal products of that description which are referred to in the licence are such as to include their use for the purposes of that test.

(6) In this Act 'medicinal test on animals' means any of the following, that is to say—

1. (a) the administration of a medicinal product of a particular description to one or more animals, where there is evidence that medicinal products of that description have effects which may be beneficial to, or otherwise advantageous in relation to, that animal or those animals, and the product is administered for the purpose of ascertaining whether, or to what extent, it has those or any other effects, whether advantageous or otherwise;
2. (b) the administration of a medicinal product to one or more animals in circumstances where there is no such evidence as is mentioned in the preceding paragraph, and the product is administered for the purpose of ascertaining whether, or to what extent, it has any effects relevant to a medicinal purpose;
538
3. (c) the administration of any substance or article, other than a medicinal product, to one or more animals for the purpose of ascertaining whether it has any effects relevant to a medicinal purpose, whether there is evidence that it has effects which may be beneficial to, or otherwise advantageous in relation to, that animal or those animals or not."

After Clause 30 insert the following new clause:

Exemptions in respect of medicinal tests on animals

".—(1) The restrictions imposed by subsections (1) and (4) of section (Medicinal tests on animals) of this Act do not apply to anything done in relation to a substance or article for the purposes or by way of a medicinal test on animals if—

1. (a) the test is, or is to be, carried out in circumstances where there is no evidence that the substance or article has effects which may be beneficial to, or otherwise advantageous in relation to, the animal or animals to which it is, or is to be, administered, and
2. (b) the arrangements for the test ate such as to secure that no animal to which the substance or article is administered in the course of the test, and no carcase or part of the carcase or produce of any such animal, will be sold or supplied for human consumption.

(2) Subject to the next following subsection, the restrictions imposed by subsections (1) and (4) of that section do not apply to a veterinary surgeon or veterinary practitioner in respect of his—

1. (a) selling or supplying, or procuring the sale or supply of, a medicinal product for the purpose of its being administered to one or more animals which are under his care, or
2. (b) procuring the manufacture or assembly of a medicinal product where the product is specially prepared to his order for the purpose of its being administered to one or more such animals, or
3. (c) administering a substance or article to an animal which is under his care, or procuring a substance or article to be so administered.

(3) Subsection (2) of this section shall not have effect so as to exempt from the restrictions in question anything done—

1. (a) in relation to a vaccine specially prepared for administration to poultry, or
2. (b) in relation to any other vaccine, unless the vaccine is specially prepared for administration to the animal from which it is derived,
3. (c) in relation to plasma or a serum, unless the plasma or serum is specially prepared for administration to one or more animals in the herd from which it is derived.

(4) Subject to subsection (6) of this section, the restrictions imposed by subsection (1) of that section do not apply to anything which is done in a registered pharmacy and is done thereby or under the supervision of a pharmacist and consists of dispensing a medicinal product in accordance with a prescription given by a veterinary surgeon or veterinary practioner, and those restrictionse do not apply to anything done by or under the supervision of a pharmacist which consists of procuring the preparation or dispensing of a medicinal product in accordance with a prescription given by a veterinary surgeon or veterinary practitioner or of procuring the assembly of a medicinal product.

(5) Subject to subsection (6) of this section, the restrictions imposed by subsection (1) of this section, the restrictions imposed by subsection (1) of that section also do not apply to anything done in relation to a medicinal product where—

1. (a) it is done by the person who, in the course of a business carried on by him, has manufactured or assembled the product to the order of a veterinary surgeon or veterinary practitioner who has stated that it is required for administration to an animal or herd which is under his care, or is required, at the request of another veterinary surgeon or veterinary practitioner, for administration to an animal or herd which is under the care of that other veterinary surgeon or veterinary practitioner, or
2. (b) it is done by the person who, in the course of a business carried on by him, has manufactured or assembled the product to the order of a pharmacist in accordance with a prescription given by a practitioner, or
3. (c) it consists of selling the product by way of wholesale dealing where it is has been manufactured or assembled in the circumstances specified in paragraph (a) or paragraph (b) of this subsection.

(6) The exemptions conferred by subsections (4) and (5) of this section do not apply to a vaccine specially prepared for administration to poultry, and do not apply to any other vaccine or any plasma or serum prepared or dispensed for administration to an animal or herd unless—

1. (a) in the case of a vaccine, it is specially prepared for administration to the animal from which it is derived, or
2. (b in the case of plasma or a serum, it has been specially prepared for administration to one or more animals in the herd from which it is derived."

After Clause 30, insert the following new clause:

Restrictions as to animals on which medicinal tests have been carried out

" .—(1) Subject to the following provisions of this Act, no person shall in the course of a business carried on by him sell or supply for human consumption an animal to which in the course of that business a substance or article has been administered by way of a test to which this section applies, or the carcase or any part of the carcase or any produce of such an animal, unless—

1. (a) at the time when the substance or article was so administered there was in force 540 an animal test certificate issued in respect of that test, and
2. (b) all the provisions of that certificate relating to the carrying out of the test and the disposal of the animal or its carcase or produce are, and have at all material times been, complied with.

(2) This section applies to any medicinal test on animals which is carried out in the course of the business of the person who has manufactured the substance or article administered in the test, or is carried out on his behalf in the course of the business of a laboratory or research establishment carried on by another person, and (in either case) is so carried out on one or more animals kept in the course of the business of the person carrying out the test."

After Clause 30, insert the following new clause:

Supplementary provisions as to clinical tests and medicinal tests on animals

" .—(1) The restrictions imposed by section 7 of this Act do not apply to anything done in accordance with a clinical trial certificate or an animal test certificate.

(2)The restrictions imposed by section 8(2) of this Act—

1. (a)do not apply to the manufacture or assembly of any medicinal product for the sole purpose of its being administered by way of a clinical trial, or of its being sold, supplied or exported for the sole purpose of being so administered, and
2. (b) do not apply to the manufacture or assembly of any medicinal product for the sole purpose of its being administered by way of a medicinal test on animals, or of its being sold, supplied or exported for the sole purpose of its being so administered, unless the product falls within a class of medicinal products specified in an order made for the purposes of this paragraph by the Agriculture Ministers.

(3) No class of medicinal products shall be specified in an order for the purposes of paragraph (b) of subsection (2) of this section unless it appears to the Agriculture Ministers to be requisite to do so for securing that the exemption conferred by that paragraph does not apply to medicinal products consisting wholly or partly of substances the purity or potency of which cannot, in their opinion, be adequately tested by chemical means.

(4) The restrictions imposed by subsection (1) of section (Clinical trials) of this Act do not apply to anything done exclusively for the purpose of a clinical trial which is to be carried out wholly outside the United Kingdom; and the restrictions imposed by subsection (1) of section (Medicinal tests on animals) of this Act do not apply to anything done in relation to a medicinal product for the purposes of a test which is to be carried out wholly outside the United Kingdom, unless the product falls within a class specified in an order made for the purposes of subsection (2)(b) of this section.

(5) Where the holder of a manufacturer's licence manufactures or assembles any medicinal product for sale or supply for the purposes of a clinical trial or a medicinal test on animals, and—

1. (a) a clinical trial certificate or animal test certificate has been issued and is for the time being in force in respect of that trial or test, and the trial or test is to be carried out in accordance with that certificate, and
2. (b) the product is so manufactured or assembled as to comply with any requirements of the certificate relating to the products to be administered in the trial or test,

then, if the conditions specified in subsection (1) of section 23 of this Act are not fulfilled in relation to the product, that section shall have effect in relation to it as if those conditions were fulfilled.

(6) Without prejudice to subsection (5) of this section, section 23(1) of this Act shall not have effect in relation to the manufacture or assembly of any medicinal product for sale or supply for the purposes of a medicinal test on animals, where the product falls within a class specified in an order made for the purposes of subsection (2)(b) of this section.

(7) For the purposes of sections (Clinical trials) and (Medicinal tests on animals) of this Act a person shall not be treated as doing anything, or procuring anything to be done, for the purposes of a clinical trial or of a medicinal test on animals if—

1. (a) the trial or test is, or is to be, carried out under arrangements to which he is not a party, and
2. (b) he has not been informed of those arrangements.

(8) The appropriate Ministers may by order provide—

1. (a) that subsection (1) or subsection (3) of section (Clinical trials) of this Act shall have effect subject to such exemptions (other than those for the time being having effect by virtue of subsections (4) to (6) of that section and subsection (4) of this section) as may be specified in the order;
2. (b) that section (Medicinal tests on animals) of this Act shall have effect subject to such exemptions (other than those for the time being having effect by virtue of section (Exemptions in respect of medicinal tests on animals) of this Act and subsection (4) of this section) as may be so specified.

(9) Any exemption conferred by an order under subsection (8) of this section may be conferred subject to such conditions or limitations as may be specified in the order.

(10) The appropriate Ministers may by order provide that any of the provisions of subsections (4) to (6) of section (Clinical trials) of this Act, or any of the provisions of section (Exemptions in respect of medicinal tests on animals) of this Act, or subsection (4) of this section, shall cease to have effect, or shall have effect subject to such exceptions or modifications as may be specified in the order.

(11) No order shall be made under subsection (10) of this section unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament."

These five new clauses deal with Clinical trials, Medicinal tests on animals, Exemptions in respect of medicinal tests on animals, Restrictions as to animals on which medicinal tests have been carried out and Supplementary provisions as to clinical trials and medicinal tests on animals. They replace the present Clause 31 and have been drafted in the light of the criticisms, comments and suggestions made in Committee stage in another place. These were the consequential Amendments referred to by my noble friend Lord Kennet at an earlier stage of our discussion. By leave of the Committee, I will move the Amendments en bloc. I beg to move Amendments Nos. 10 to 14.

On Question, Amendments agreed to.

Clause 31 [Provisions as to dealing with medicinal products for purposes of clinical trial or field trial]:

On Question, Whether Clause 31 shall be agreed to?

LORD KENNET

I beg to move that Clause 31 be deleted.

On Question, Clause 31 disagreed to.

Clause 32 [Application for, and issue of, certificate]:

BARONESS SEROTA: I beg to move Amendments Nos. 15, 16 and 17.

Page 28, line 18, leave out ("a field trial") and insert ("an animal test").

Page 28, line 26, leave out ("field trial") and insert ("medicinal test on animals")

Page 28, line 29, leave out ("field trial") and insert ("animal test")

Amendments Nos. 15 to 43, inclusive, are all consequential to the new clauses after Clause 30 to which the Committee have just agreed. If it is for the convenience of the Committee, I propose to move them en bloc, but clause by clause. I beg to move.

On Question, Amendments agreed to.

Clause 32, as amended, agreed to.

Clause 33 [Transitional provisions as to clinical and field trials]:

BARONESS SEROTA

I beg to move Amendments Nos. 18 to 27: Page 28, line 32, leave out ("31") and insert ("(Clinical trials), (Medicinal tests on animals), (Restrictions as to animals on which medicinal tests have been carried out)")

Page 28, line 35, leave out ("section 31") and insert ("sections (Clinical trials) and (Medicinal tests on animals")

Page 28, line 36, at end insert ("and the restrictions imposed by section (Restrictions as to animals on which medicinal tests have been carried out) of this Act do not apply where the substance or article in question was administered before that day")

Page 28, line 38, after ("day") insert ("(a)")

Page 28, line 40, leave out from beginning to ("the") and insert ("by way of a clinial trial, or

(b) substances or articles have been administered by way of a medicinal test on animals")

Page 28, line 41, leave out ("31") and insert ("(Clinical trials) or section (Medicinal tests on animals)")

Page 28, line 42, after ("description") insert ("or (as the case may be) in relation to similar substances or articles")

Page 29, line 5, leave out ("field trial") and insert ("an animal test")

Page 29, line 9, leave out from ("administered") to ("in") in line 10 and insert ("by way of a clinical trial or (as the case may be) substances or articles so specified were administered by way of a medicinal test on animals")

Page 29, line 17, leave out from ("a") to ("such") in line 18 and insert ("certificate")

On Question, Amendments agreed to.

Clause 33, as amended, agreed to.

Clause 34 [Duration and renewal of certificate]:

BARONESS SEROTA

I beg to move Amendments Nos. 28 to 31:

Page 29, line 42, leave out ("field trial") and insert ("animal test")

Page 30, line 19, leave out ("field trial") and insert ("animal test")

Page 30, line 28, leave out ("field trial") and insert ("animal test")

Page 30, line 32, leave out ("field trial") and insert ("animal test")

On Question, Amendments agreed to.

Clause 34, as amended, agreed to.

Clause 35 [Suspension, revocation or variation of certificate]:

BARONESS SEROTA

I beg to move Amendments Nos. 32 to 41:

Page 31, line 9, leave out ("field trial") and insert ("animal test")

Page 31, line 19, leave out from ("contravened") to end of line 22

Page 31, line 23, leave out ("such description") and insert ("description to which the certificate relates")

Page 31, line 25, leave out ("in pursuance of the certificate") and insert ("for the purposes of the clinical trial or medicinal test on animals to which it relates")

Page 31, leave out line 32 and insert ("any substances or articles to which the certificate relates")

Page 31, line 33, leave out from ("that") to ("which") in line 34 and insert ("any such substances or articles can no longer be regarded as substances or articles")

Page 31, line 36, leave out ("field trial") and insert ("medicinal test on animals")

Page 31, line 37, leave out ("medicinal products of any such description") and insert ("any such substances or articles")

line 42, leave out ("field trial") and insert ("animal test")

Page 32, line 4, leave out ("field trial") and insert ("animal test")

On Question, Amendments agreed to.

Clause 35, as amended, agreed to.

Clause 36 [General provisions relating to medicated animal feeding stuffs]:

BARONESS SEROTA

I beg to move Amendments Nos. 42 and 43:

Page 32, line 15, leave out ("field trial") and insert ("animal test")

Page 32, line 38, leave out ("field trial") and insert ("animal test")

On Question, Amendments agreed to.

Clause 36, as amended, agreed to.

Clause 37 agreed to.

BARONESS SEROTA

I beg to move Amendment No. 45: After Clause 37, insert the following new clause:

Supplementary provision as to incorporation of substances and articles in animal feeding stuffs

" .—(1) Where in the course of a business carried on by him a person incorporates a substance or article, other than a medicinal product, in any animal feeding stuff with a view to—

1. (a) feeding it, with the substance or article incorporated in it, to one or more animals, or
2. (b) selling, supplying or exporting it with the substance or article incorporated in it,

and the substance or article is so incorporated by him for a medicinal purpose, sections 36(3) and 37 of this Act shall have effect in relation to the incorporation of that substance or article as if it were a medicinal product

(2) Where in the course of a business carried on by him a person proposes—

1. (a) to sell or supply a substance or article, other than a medicinal product, to persons who for a medicinal purpose may require to incorporate it in animal feeding stuffs to be fed to one or more animals, or
2. (b) to manufacture a substance or article, other than a medicinal product, for sale or supply as mentioned in the preceding paragraph,

he may, if he so desires, apply for a product licence in respect of that substance or article, and the licensing authority (subject to the provisions of sections 19 to 22 of this Act) may grant to him a product licence in respect of it, as if it were a medicinal product and he were proposing to sell or supply it in circumstances to which section 7(2) of this Act applies; and a product licence so granted may he renewed, suspended, revoked or varied accordingly.

(3) Where a person proposes to sell, supply or manufacture a substance or article, other than a medicinal product, in the circumstances specified in paragraph (a) or paragraph (b) of subsection (2) of this section, any person who proposes, by purchase or otherwise, to obtain from him a supply of the substance or article with a view to incorporating it for a medicinal purpose in any animal feeding stuff may, if he so desires, apply for a product licence in respect of that substance or article, and the licensing authority (subject to the provisions of sections 19 to 22 of this Act) may grant to him a product licence in respect of it, as if it were a medicinal product and he were proposing to procure the sale or supply, or the manufacture for sale or supply, of that product in circumstances to which section 7(2) of this Act applies; and a product licence so granted may be renewed, suspended, revoked or varied accordingly.

(4) On the grant, renewal or variation (whether by virtue of subsection (2) or subsection (3) of this section or otherwise) of a product licence, in so far as it relates to any substance or article which is to be incorporated in animal feeding stuffs, the licence may (without prejudice to the generality of section 20(1) of this Act) include provisions as to the manner in which the substance or article in question may be so incorporated, whether by the holder of the licence or by any other person to whom those provisions of the licence have been communicated.

(5) Without prejudice to the operation of section 117(6) of this Act, a substance manufactured, sold, supplied or exported as an animal feeding stuff shall not be taken to be a medicinal product for the purposes of this Act by reason only that any of the preceding provisions of this section has effect in relation to a substance or article incorporated in it.

(6) The appropriate Ministers may by order provide that any of the provisions of section 36 of this Act or of subsections (1) to (5) of this section shall cease to have effect, or shall have effect subject to such exceptions or modifications as may be specified in the order.

(7) No order shall be made under subsection (6) of this section unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament."

This new clause, which hangs together with consequential Amendments to Clauses 39, 40, 96 and 117, has been introduced in the light of the discussions and comments made during the Committee stage in another place, and as a result of further consideration by my right honourable friend. It was generally accepted during those discussions that any substance or article added to an animal feedingstuff for medicinal purposes should be the subject of appropriate control. The object of this clause is to treat any substance or article as a medicinal product for the purposes of Clause 36(3) and Clause 37 if, although it is not a medicinal product, it is incorporated in an animal feedingstuff for medicinal purposes.

On Question, Amendment agreed to.

BARONESS SEROTA

I beg to move Amendment No. 46: After Clause 37, insert the following new clause:

Extension of section 7 to certain special circumstances

".—(1) Where in the course of a business carried on by him a person sells or exports a substance or article for use wholly or mainly in either or both of the ways specified in section 117(1) of this Act, and the substance or article, not having been—

1. (a) manufactured or imported for such use, or
2. (b) previously sold or supplied for such use,

does not constitute a medicinal product before that person so sells or exports it, then (subject to subsection (2) of this section) subsection (2) of section 7 of this Act, if apart from this subsection it would not so have effect, shall have effect in relation to the sale or exportation of the substance or article as if he were selling or exporting it is circumstances to which that subsection applies.

(2) Subsection (1) of this section shall not have effect in relation to a person selling a substance or article by retail in the course of a business carried on by him unless in the course of that business the substance or article has been assembled for the purpose of being sold by him.

(3) In any reference in this Part of this Act to the provisions of, or the restrictions imposed by, section 7 of this Act, the reference to that section shall be construed as including a reference to subsection (2) of that section as extended by the preceding subsections.

(4) Where in the course of a business carried on by him a person proposes to sell or export a substance or article for use as mentioned in subsection (1) of this section, where the substance or article will not constitute a medicinal product before he so sells or exports it and he will not be selling or exporting it in circumstances to which section 7(2) of this Act applies, he may, if he so desires, apply for a product licence in respect of that substance or article, and the licensing authority (subject to the provisions of sections 19 to 22 of this Act) may grant to him a product licence in respect of it, as if he were proposing to sell or export it in circumstances to which section 7(2) of this Act applies; and a product licence so granted may be renewed, suspended, revoked or varied accordingly.

(5) In subsection (2) of this section the reference to assembling a substance or article in the course of a business carried on by a person is a reference to doing in the course of that business anything which (in accordance with section 118(1) of this Act) would constitute assembling it if it had been a medicinal product when sold or supplied to him."

This is another new clause which has been tabled as a result of further consideration. The purpose of the new clause is to provide that a product licence should be held to enable the person concerned to apply for a product licence under subsection (4) of the new clause. Subsection (2) puts the retailer in the same position as the wholesaler when he is consciously setting up to sell the substance as an additional product.

On Question, Amendment agreed to.

Clause 38 [Provision of information to licensing authority]:

BARONESS SEROTA

I beg to move Amendments Nos. 47 and 48.

Page 33, line 38, leave out ("field trial") and insert ("animal test").

Page 34, line 10, leave out ("field trial") and insert ("animal test").

Amendments Nos. 47 to 52 inclusive are consequential to the new clauses put in after Clause 30, and again for the convenience of the Committee I will move them en bloc clause by clause. I beg to move.

On Question, Amendments agreed to.

Clause 38, as amended, agreed to.

Clause 39 [Offences tinder Part II]:

BARONESS SEROTA

I beg to move Amendments Nos. 49 to 52.

Page 35, line 3, leave out ("31") and insert ("(Clinical trials), section (Medicinal tests on animals), section (Restrictions as to animals on which medicinal tests have been carried out)").

Page 35, line 8, leave out ("31") and insert ("(Clinical trials), section (Medicinal tests on animals)").

Page 35, line 16, leave out ("field trial") and insert ("animal test").

Page 35, line 30, leave out ("a field trial") and insert ("an animal test").

On Question, Amendments agreed to.

BARONESS SEROTA

I beg to move Amendments Nos. 53 and 54.

Page 35, line 30, leave out ("medicinal product of a description") and insert ("substance or article").

Page 35, line 35, leave out from ("of") to end of line 36 and insert ("that substance or article in animal feeding stuffs, or any instructions required by the licence to be communicated by him to persons to whom the substance or article is sold or supplied for that purpose").

Amendments Nos. 53 and 54 are consequential to the new clause which the Committee has just accepted after Clause 37 dealing with supplementary provisions as to the incorporation of substances and articles in animal feeding stuffs. I beg to move the two Amendments.

On Question, Amendments agreed to.

BARONESS SEROTA

We now come to a group of Amendments which hang together, Amendments Nos. 55 to 61. I beg to move Amendment No. 55. Page 35, line 38, leave out ("field trial") and insert ("animal test").

On Question, Amendment agreed to.

Clause 39, as amended, agreed to.

Clause 40 [Special defences under section 39]:

BARONESS SEROTA: I beg to move Amendments Nos. 56 to 61 inclusive.

Page 36, line 20, leave out ("field trial") and insert ("animal test").

Page 36, line 21, leave out from ("any") to ("been") in line 23 and insert ("substance or article which has been manufactured (or, in the case of a medicinal product, manufactured or assembled) to his order by another person and has").

Page 36, line 25, leave out ("them") and insert ("it").

Page 36, line 36, leave out ("field trial") and insert ("animal test")

Page 36, line 43, leave out ("field trial") and insert ("animal test")

Page 37, line 6, leave out ("field trial") and insert ("animal test")

On Question, Amendments agreed to.

8.10 p.m.

BARONESS SEROTA

I beg to move Amendments Nos. 62, 63 and 64:

Page 37, line 8, leave out from ("36") to ("it") in line 9

Page 37, line 12, leave out from ("that") to ("certificate") in line 13 and insert ("another person was the holder of such a licence or")

Page 37, line 14, leave out ("act in question was done") and insert ("substance or article to which the contravention relates was incorporated in the animal feeding stuff")

Amendments Nos. 62, 63 and 64 hang together. The purpose of these Amendments is to deal with the situation where at present the special defence in subsection (3) of Clause 40 relating to a contravention of Clause 36 deals with a case where the person concerned is not a holder of a product licence or an animal test certificate, and the act constituting the contravention was done by the order of somebody else. These Amendments make the defence apply where the person concerned had reasonable grounds for believing that some other person held the licence and that the substance or article to which the contravention relates was incorporated in the animal feeding stuff in accordance with the licence or certificate. I beg to move.

On Question, Amendments agreed to.

BARONESS SEROTA: I beg to move Amendment No. 65:

Page 37, line 15, at end insert: ("( ) In the last preceding subsection any reference to section 36 of this Act shall be construed as including a reference to that section as extended by section (Supplementary provisions as to incorporation of substances and articles in animal feeding stuffs) of this Act.")

This Amendment is consequential on the new clause after Clause 37.

On Question, Amendment agreed to.

Clause 40, as amended, agreed to.

Clause 41 [Standard provisions for licences or certificates]:

BARONESS SEROTA

I beg to move Amendments Nos. 66 to 69:

Page 37, line 22, leave out ("field trial") and insert ("animal test")

Page 38, line 6, leave out ("field trial") and insert ("animal test")

Page 38, line 17, leave out from ("of") to ("to") in line 18 and insert ("substances or articles")

Page 38, line 24, leave out from beginning to ("to") and insert ("substances or articles")

This is another group of Amendments which are consequential to the five new clauses after Clause 30. I beg to move.

On Question, Amendments agreed to.

Clause 41, as amended, agreed to.

Clause 42 [Postponement of restrictions in relation to exports]:

BARONESS SEROTA

I beg to move Amendment No. 70: Page 39, line 33, after ("Act") insert ("but subject to the next following section"). Amendment No. 70 is a paving Amendment for the new clause set out in Amendment No. 71 on the Marshalled List on special provisions in respect of exporting certain products. The purpose of this new clause is to exclude from the postponement provisions under Clause 42 the coming into operation of the licence and provisions of Part II in relation to a limited category of export products. I beg to move.

On Question, Amendment agreed to.

Clause 42, as amended, agreed to.

BARONESS SEROTA: I beg to move Amendment No. 71:

After Clause 42, to insert the following new clause:

Special provisions in respect of experting certain products

".—(1) Nothing in subsection (1) of section 42 of this Act shall affect the operation of any of the provisions of sections 7 to 41 of this Act in relation to any medicinal product falling within a class specified in an order made under this section by the Health Ministers or the Agriculture Ministers.

(2) No class of medicinal products shall be specified in an order made by the Health Ministers or the Agriculture Ministers under this section unless it appears to the Ministers making the order to be requisite to do so for securing that any exemption confer-ed by section 42(1) of this Act does not apply to medicinal products consisting wholly or partly of substances the purity or potency of which cannot, in their opinion, be adequately tested by chemical means.

(3) Subsections (3) to (7) of section 42 of this Act shall not have effect in relation to medicinal products of any description falling within a class specified in an order under this section which is in force immediately before the day appointed for the purposes of subsection (1) of that section.

(4) Subject to the next following subsection, section 7(2) of this Act shall not have effect in relation to a person in respect of his exporting, or procuring the exportation of, medicinal products of any description falling within a class specified in an order under this section which is in force immediately before the first appointed day if, in the course of a business carried on by that person,—

1. (a) substantial quantities of medicinal products of that description (that is to say, quantities exceeding those required for distribution as samples) were exported or procured to be exported during the period of twenty-four months ending with the first appointed day, and
2. (b) during the whole of that period further substantial quantities of medicinal products of that description were available, or could within a reasonable time have been made available, to be so exported or procured to be exported if required.

(5) Sections 17 and 25 of this Act shall have effect in relation to subsection (4) of this section as they have effect in relation to subsections (2) to (5) of section 16 of this Act.

(6) Where a person is entitled to the grant of a licence of right by reason that subsection (4) of this section has effect in relation to him, he shall be entitled to the grant of a product licence; but, subject to the next following subsection, the licence shall be granted so as not to extend to medicinal products of any description other than those in respect of which the conditions specified in that subsection are proved to the reasonable satisfaction of the licensing authority to have been fulfilled, and shall be limited to exporting, or procuring the exportation of, medicinal products.

(7) Subsection (5) of section 26 of this Act (with the omission of paragraph (b) of that subsection) and subsection (6) of that section shall have effect in relation to the grant of a licence of right in accordance with subsection (6) of this section as those subsections have effect in relation to the grant of such a licence in accordance with subsection (1) of that section."

On Question, Amendment agreed to.

Clauses 43 to 45 agreed to.

Clause 46 [Sale or supply of medicinal products on general sale list]:

On Question, Whether Clause 46 shall stand part of the Bill?

THE MARQUESS OF LOTHIAN

I wanted to ask one question concerning this clause, and that is on the position of street traders. Am I right in thinking that subsection (2), which deals with the question of being able to close buildings to exclude the public, would debar street traders from selling goods that are on the General List? I rather feel that this may be the case, and, if it is, that it is perhaps somewhat unfair. I have no doubt that these good people would be anxious to sell such things as aspirin and indigestion tablets, cough lozenges and things of that kind. There is also the question of whether toothpaste would be considered a medicinal product, in that it prevents disease and decay. I am not asking this question in a frivolous spirit, but I know there is some doubt about it, and I wondered whether the noble Lord could throw any light on it.

LORD KENNET

The general effect of this clause as it concerns street traders is to continue Section 12 of the Pharmacy and Medicines Act 1941. That Act is quite specific in saying that a proprietary medicine must not be sold except from a shop, so the Bill now before us is continuing a ban which has been in force for more than a quarter of a century and which has had as its object to prevent the sale of medicines from sources which could not readily be controlled. And, of course, there is the point that it is easier for children to pick up things from a stall in the street than from a shop. The question whether or not a toothpaste is a medicine is something that will appear as the categories are drawn up under the advice of the Commission when it is in existence.

Clause 46 agreed to.

Clause 47 agreed to.

Clause 48 [Exemptions for doctors, dentists, veterinary surgeons and veterinary practitioners]:

LORD COLERAINE

I beg to move Amendment No. 72: Page 44, line 22, at beginning insert "as provided by order of the appropriate Ministers,". This is another Amendment to which the Pharmaceutical Society attach some importance. It is not a very complicated one. Clause 48 provides for exemptions from the requirements that medicinal products should be sold only through pharmacies. The purpose of this Amendment is to empower the Minister to have oversight of the exemptions which are proposed in paragraph (b). At present, from a hospital or a health centre, any medicine requires a particular prescription for a particular patient. The Amendment does not insist that this condition should be continued, but it asks that the Minister should have a general oversight over what is being done. At the moment, with the Bill as it stands, there is a wide gap between the conditions governing the sale and supply of medicines from pharmacies and the conditions in hospitals and health centres.

I notice that the Minister is moving an Amendment which seems to cover the point of my second Amendment on the Marshalled List, No. 74. I hope the fact that he has not included paragraphs (b) and (c) does not mean that he is going to reject this Amendment. I beg to move.

LORD KENNET

I had supposed that the noble Lord would be agreeing that the Government Amendments on Clause 48 and on Clause 50, with the consequential one on Clause 116, would have come close enough to the effect of what he desired to achieve to make it possible for the Committee to adopt those Amendments and not his. If that is the case, I hope he will withdraw both Amendments 72 and 74. If, on the other hand, he feels that the Government Amendments do not sufficiently cover what he was seeking to do, I would ask him whether he would, all the same, withdraw them and allow me to enter into consultations with him between now and Report on those matters which he thinks are covered in his Amendment and are not covered in my Amendments later on.

LORD COLERAINE

I certainly agree that Amendment No. 74 is covered by the noble Lord's Amendments. I am not clear that Amendment 72 is. Does the noble Lord assure me that it is covered? If so, I would accept his assurance.

LORD KENNET

I should not like to assure the noble Lord of a fact which he might, on going into it later himself, not agree with. Whether or not it is sufficiently covered must be his decision, but I would suggest to him that if he would care to withdraw both his Amendments, we can then enter into a discussion, particularly about the effect of his Amendment 72. I say this simply because I am not absolutely dear what it is that he desires to achieve which I do not desire to achieve; and perhaps, for the sake of saving time, we could best discuss this privately between ourselves before Report stage.

LORD COLERAINE

I am most grateful to the Minister, and I certainly beg leave to withdraw the Amendment. If necessary, I will take him up on his offer later.

Amendment, by leave, withdrawn.

THE CHAIRMAN OF COMMITTEES

Before I call Amendment No. 73, I should point out to the Committee that if this Amendment is agreed I cans of call Amendment No. 74.

8.20 p.m.

LORD KENNET: I beg to move Amendment No. 73:

Page 44, leave out lines 27 to 31 and insert: ("( ) Those restrictions also do not apply—

1. (a) to the sale or supply of a medicinal product of a description, or falling within a class, specified in an order made by the Health Ministers for the purposes of this paragraph, where the product is sold or supplied by a registered nurse in the course of her professional practice, or
2. (b) to the sale or supply of a medicinal product of a description, or falling within a class, specified in an order made by the Health Ministers for the purposes of this paragraph, where the product either is sold or supplied by a certified midwife (or, in relation to England and Wales, by a certified midwife or exempted midwife) in the course of her professional practice or is delivered or administered by such a midwife on being supplied in pursuance of arrangements made by a local health authority in Great Britain or by a health authority in Northern Ireland.")

Paragraphs (b) and (c) of Clause 48(1) were inserted by Government Amendments at a late stage in another place to fill a gap in the Bill when it was realised that the supply of a drug to a hospital patient or to the patient of a nurse or midwife technically involved a retail sale or "supply in circumstances corresponding to retail sale". It would not have been reasonable to leave such sale or supply subject to the requirements of Clauses 45 and 46 which were specifically designed to cover sale or supply at ordinary retail outlets such as pharmacies and other retail shops.

The clause as amended in another place has since been criticised, and on reflection my right honourable friend the Minister of Health agrees that these criticisms have some force and that there may be a case at some future time for relating the hospital and health centre exemption more closely to the nature of the pharmaceutical services available to the institution concerned; and also that it would be appropriate to provide for the products which nurses and midwives are to be allowed to supply in the course of their professional practice to be specified. This and following Amendments enable that to be done. I beg to move.

On Question, Amendment agreed to.

Clause 48, as amended, agreed to.

Clause 49 agreed to.

Clause 50 [Power to provide further exemptions]:

LORD KENNET

I beg to move Amendment No. 75: Page 45, line 24, leave out ("this section") and insert ("the preceding subsection").

Amendments Nos. 75 and 76 apply to the same point which was covered by Amendment No. 73.

On Question, Amendment agreed to.

LORD KENNET: I beg to move Amendment No. 76:

Page 45, line 26, at end insert— ("( ) The appropriate Ministers may by order provide that subsection (1)(b) or subsection (2) of section 48 of this Act shall cease to have effect, or shall have effect subject to such exceptions or modifications as may be specified in the order. ( ) No order shall be made under subsection (3) of this section unless a draft of the order has been laid before Parliament and approved by a resolution of each House of Parliament.")

On Question, Amendment agreed to.

Clause 50, as amended, agreed to.

Clauses 51 to 68 agreed to.

Clause 69 [Supplementary provisions as to registration of premises]:

LORD KENNET

I beg to move Amendment No. 77: Page 65, line 20, leave out ("register") and insert ("registrar"). This Amendment corrects a spelling mistake.

On Question, Amendment agreed to.

Clause 69, as amended, agreed to.

Clauses 70 to 88 agreed to.

Clause 89 [Advertisements and representations directed to practitioners]:

LORD KENNET

I beg to move Amendment No. 78: Page 83, line 8, leave out from ("which") to ("(3)") and insert ("neither subsection (2) nor subsection"). Amendments Nos. 78, 79 and 80 are drafting Amendments which do not affect the sense of the provisions in question. I beg to move.

On Question, Amendment agreed to.

LORD KENNET: I beg to move Amendment No. 79:

Page 83, line 12, leave out from ("which") to ("applicable") and insert ("either of those subsections is").

On Question, Amendment agreed to.

LORD KENNET

I beg to move Amendment No. 80: Page 83, line 16, leave out from ("Act") to ("to") in line 17 and insert ("those subsections cease (or, if only one of them is applicable, that subsection ceases)").

On Question, Amendment agreed to.

Clause 89, as amended, agreed to.

Clauses 90 to 95 agreed to.

Clause 96 [Application of Act to certain articles and substances]:

BARONESS SEROTA

I beg to move Amendment No. 81: Page 88, line 32, leave out from beginning to ("and") in line 33 and insert ("a medicinal purpose"). This is a further consequential Amendment to the new clause which we added after Clause 37. I beg to move.

On Question, Amendment agreed to.

Clause 96, as amended, agreed to.

Clauses 97 to 99 agreed to.

Clause 100 [Enforcement in England and Wales]:

BARONESS SEROTA

I beg to move Amendment No. 83: Page 91, line 29, after ("provisions") insert ("and regulations"). Amendments Nos. 83 and 84 are drafting Amendments. They insert references to regulations since paragraph (c) in Clause 100(2) refers both to the provisions in Clauses 86 and 87 and regulations under Clause 88. I beg to move.

On Question, Amendment agreed to.

BARONESS SEROTA

I beg to move Amendment No. 84: Page 91, line 31, after ("provisions") insert ("and regulations").

On Question, Amendment agreed to.

8.26 p.m.

LORD CHORLEY

I beg to move Amendment No. 85: Page 92, line 2, leave out from ("pharmacies") to end of line 4 and insert ("In registered pharmacies the local authority as defined above shall be under a duty, concurrently with the appropriate Minister, to enforce any regulations in paragraphs (g) and (h) of subsection (1) and in subsection (2) of section 59 of this Act. As this Amendment and Amendment No. 86 go together I will, with your Lordships' permission, discuss them together. Indeed, the first of these two Amendments is in a sense consequential on the second, and it is not very easy to follow without an explanation. I am really moving these Amendments for the purpose of removing a possible injustice to herbalists. This Bill, as originally introduced, did very much less than justice to herbalists, a point which I endeavoured to bring out in my speech on Second Reading. In its passage through the other place the case on behalf of the herbalists was most ably put by a number of honourable Members, and the Minister showed himself very receptive to the points that were made and handsomely accepted a number of Amendments, in particular two new clauses, Clauses 12 and 49, for which the herbalists are very grateful.

There is, however, at least one remaining matter on which the herbalists still labour under a sense of grievance and feel that they are not being altogether fairly treated, and I must say that I think they are right in this feeling. The point is that under subsection (5) of this clause the Pharmaceutical Society is given the job of enforcing regulations which are to be made under the important Clause 59, which is concerned with the regulation of dealings in medicine. I do not want to go into the details of that clause. It is a fairly long and important clause, and indeed much of the enforcement of the provisions of the Bill depend upon it.

As I have said, the Pharmaceutical Society is given the job of enforcing regulations made under this clause, including, of course, the dealings of herbalists—medicines which are of a herbal character and which are sold or prescribed by herbal practitioners. If your Lordships will look at the clause, you will see at the end of subsection (5)(a) that the Pharmaceutical Society is given the duty of looking after this matter in relation to medicinal products sold by retail, or which are supplied in circumstances corresponding to retail sale. This gives them, so to speak, power over the herbalist's shop—and not only over the herbalist's shop, but over health food stores and various other types of person who deal in medicines of this kind. The herbalists, of course, feel, and I think very naturally, that pharmacists are their competitors, and indeed not only are pharmacists their competitiors but I understand that the Pharmaceutical Society is on record as wishing to see to t that medicines are only supplied through registered pharmacists.

One can well understand that tie herbalists, the health food stores and other sorts of people who are, as it were, on the black list of the pharmacists feel that even if this duty which is given to the Pharmaceutical Society is carried out with integrity, as one would expect it to be, still there is a sort of bias; and it is not really right that some representative of one's competitors should have a right to go into one's shop and examine what is going on there, look at one's books and really carry out a job of this kind. How far it would go one does not know, but it is quite obvious, is it not, that the herbalist will feel himself very much under a sense of grievance. It is an accepted axiom I think that not only should there be fair play but that it should be obvious that fair play is being done aril that people who may be aggrieved should not be put under a grievance of this kind. I hope your Lordships will agree that there is here a very strong case for seeing to it that this particular job in respect of herbalists should be done by somebody else, and that is really the object of this Amendment.

There is a further point, which is of even more importance in a way. Over recent years the consulting medical herbalist has become really quite an important profession. To qualify as a consulting medical herbalist one has to go through a pretty severe course, which lasts four years, not dissimilar from the course of studies in medicine which a medical practitioner has to go through. And owing to the comparative paucity of herbalist shops, a great deal of the prescribing and making up of the prescriptions advised by the medical consulting herbalist has to be done on his own premises, either by himself, or if he is a professional man of high standing he may have to employ a herbal pharmacist to assist him in the work. It seems to me altogether wrong that men in this position should in effect be subject to visits from representatives of the Pharmaceutical Society empowered under this clause to examine their pharmacies, to look at their books and generally carry out the provisions of this earlier clause.

The suggestion is put forward in these two Amendments that if we delete in subsection (5) the words at the end after "Wales" where they appear in the Clause, that will remove this duty and job from the Pharmaceutical Society. It will be seen that at the end of the Clause if one stops at the words "in England and Wales" it cuts out "at which medicinal products are sold by retail or are supplied in circumstances corresponding to retail sale". That is there for the purpose of dealing with the position of the consultant medical herbalist. That will get rid of the position of the Pharmaceutical Society in regard to this matter in connection with herbalists and consultant medical herbalists and health food stores.

But of course that means that somebody else ought to do the job, because the inspections and the enforcement of the provisions of the important Clause 59 have to be carried out by somebody. Therefore we come back to the first of these Amendments, which your Lordships will see puts the obligation to carry out this work under Clause 59 on the local authority, which already comes into an earlier part of subsection (1) of this Clause. So that the result of it all is to remove the Pharmaceutical Society from this job of inspecting and enforcing the provisions of Clause 59 against the herbalists and people who come under this category and transferring it in effect to the local authority, which would be completely independent and would not leave the herbalists and consulting medical herbalists under this sense of grievance. I hope this makes the object of these two Amendments clear. I beg to move.

8.37 p.m.

BARONESS SEROTA

These two Amendments, which the noble Lord, Lord Chorley, has explained to us very fully, are in fact, apart from the new sentence introduced after "pharmacies" in the first Amendment, completely identical with the Amendments moved in another place at Report stage. As the noble Lord has explained, the effect of the first Amendment would be to give the local authorities a concurrent duty under subsection (2) and also the duty of enforcing under subsection (3) in premises other than pharmacies. The second Amendment, as I think he made clear, would remove the latter duty from the Pharmaceutical Society.

I am sure all your Lordships will agree that at this stage of the Bill any question of redistribution of enforcement functions involves the considered examination and the ascertainment of the views of the enforcement authorities affected or likely to be affected under the provisions of this Bill. My right honourable friend did give an undertaking in another place that he would look into the matters involved and if it appears that the provisions of the Bill should be amended he did agree that Amendments would be moved at an appropriate stage. He has asked me to repeat the assurance in this House and regret that it has not yet been possible to bring this matter to a conclusion in time for the Committee stage in your Lordships' House. I will let my noble friend know between now and Report the result of that particular consideration.

But in any event I am afraid I could not advise the Committee to-night to accept the solution proposed by the noble Lord, Lord Chorley. The local authorities to which his Amendments refer would, in my right honourable friend's view, be for the most part inappropriate to have the duty that the noble Lord suggests should fall upon them as a result of his Amendments, if it were decided that the enforcement of regulations under Clause 59(1) was appropriate for local authorities. They do not include county councils, but on the other hand they do include even the smallest non-county borough, urban or rural district councils. Whatever may ultimately be done about the suggestion made in another place to bring the food and drugs authorities into the enforcement of these regulations, I must advise the Committee against making this a function of the local authorities I have referred to, who are the ones responsible for "sanitary" requirements such as those in Clause 58(1)(g) and (h). I hope that in the light of the points I have just made my noble friend will agree at; this stage to withdraw his Amendment. I have repeated the assurance given by my right honourable friend in another place, and I hope that we can be in touch between now and the next stage of the Bill.

LORD CHORLEY

Naturally, I am glad to beg leave to withdraw this Amendment on those assurances. I have not the slightest doubt that if some authority other than the Pharmaceutical Society can be found upon whom to put this duty, it will be well received by the herbalists. In those circumstances, I beg leave to withdraw the Amendment.

Amendment, by leave, withdrawn.

On Question, Whether Clause 100, as amended, shall stand part of the Bill?

8.41 p.m.

LORD OGMORE

There is just one question I should like to ask the Minister. I should like to have some information about Clause 100, and also Clauses 101 and 102. As I see these three clauses, they are the enforcement clauses of the Bill or of this particular Part of the Bill. The provision is that the appropriate Minister shall do the enforcement. The appropriate Minister is set out for England and Wales in Clause 100, for Scotland in Clause 101 and for Northern Ireland in Clause 102. In Clause 100 the appropriate Minister seems to be in certain respects the Minister of Agriculture, Fisheries and Food, and in all other respects the Minister of Health. So far as Scotland is concerned the appropriate Minister will be the Secretary of State, and so far as Northern Ireland is concerned the appropriate Minister will be the Minister of Health and,Social Services for Northern Ireland.

I want to ask the Minister why it is that the Secretary of State for Wales is not "the appropriate Minister" with regard to the Principality of Wales. After all, we have a fully fledged Secretary of State in the Cabinet. He is not second-rater, but is a first-rater, in that I e has a seat in the Cabinet. He has a large Department in Cardiff and a small one in London, and it seems to me that where there is an enforcement provision local knowledge is necessary. Certainly it would be much more to the convenience of the people of Wales if their Secretary of State, who is located at Cardiff, could deal with any matters that they have to raise.

In those circumstances, if, as is their claim, the Government are serious on administrative devolution, it is quite time that this matter, which so widely 'fleets an important segment of the population in regard to the enforcement of the regulations under this Bill, should be considered and dealt with in Wales by the Secretary of State for Wales and by his Department—a large department of civil servants who understand, or are deemed to understand, the necessities and requirements of the people of Wales. That is my question. I hope I shall get a satisfactory answer.

BARONESS SEROTA

All of t s are well aware, and if we are not well aware we are certainly made aware, of the particular view that the noble Lord, Lord Ogmore, holds on these matters, but I suspect that he knows the answer to this one just as well as, if not better than, I do; namely, that my right honourable friend the Minister of Health is responsible for the Health Service in Wales and therefore falls to be the appropriate Minister to administer this particular piece of legislation. The noble Lord is undoubtedly aware how best to further the point of view he has just put forward, but surely one could not expect in a Bill of this kind to divide the functions of my right honourable friend who is responsible for the administration of the Health Service throughout England and Wales.

Clause 100, as amended, agreed to.

Clauses 101 to 103 agreed to.

Clause 104 [Power to inspect, take samples and seize goods and documents]:

BARONESS SEROTA

I beg to move Amendment No. 87: Page 98, line 24, at end insert ("and where by virtue of this subsection a person exercises any such right as is specified in subsection (4) of this section, he shall be subject to the duty imposed by subsection (6) of this section").

This Amendment No. 87, rectifies an oversight in Clause 104.

On Question, Amendment agreed to.

Clause 104 agreed to.

BARONESS SEROTA

I beg to move Amendment No. 88: After Clause 104, insert the following new clause—

Application of sampling procedure to substance or article seized under s. 104

".—(1) The provisions of this section shall have effect where a person (in this section referred to as an 'authorised officer') seizes a substance or article (other than a document) in the exercise of such a right as is specified in subsection (4) of section 104 of this Act (including that subsection as applied by subsection (7) of that section).

(2) If any person who in accordance with subsection (6) of that section is entitled to be informed of the seizure so requests, either at the time of the seizure or at any subsequent time, not being later than twenty-one days after he is informed of the seizure, then, subject to the next following subsection, the authorised officer shall either—

1. (a) set aside a sample of the substance or article seized, or
2. (b) treat that substance or article as a sample,

whichever he considers more appropriate having regard to the nature of that substance or article.

(3) An authorised officer shall not be required by virtue of subsection (2) of this section to set aside a sample, or to treat a substance or article as a sample, if the nature of the substance or article is such that it is not reasonably practicable to do either of those things.

(4) Where in accordance with subsection (2) of this section an authorised officer sets aside a sample, or treats a substance or article as a sample, he shall divide it into three parts, each part to be marked and sealed or fastened up in such manner as its nature will permit, and shall supply one part of it to the person who made the request under subsection (2) of this section.

(5) Paragraphs 10, 11 and 11A and paragraphs 13 to 25 of Schedule 3 to this Act shall have effect in relation to a sample set aside, or a substance or article treated as a sample, in accordance with subsection (2) of this section as they have effect in relation to a sample obtained as mentioned in paragraph 1 of that Schedule, but as if in those paragraphs—

1. (a) any reference to a sampling officer were a reference to an authorised officer;
2. (b) any reference to a sample included a reference to a substance or article treated as a sample;
3. (c) any reference to the preceding provisions of that Schedule were a reference to the preceding provisions of this section; and
4. (d) any reference to the relevant enforcement authority were a reference to the authority by whom the authorised officer is authorised wor the purposes of section 104 of this Act,

and as if in paragraph 22(1) of that Schedule the reference to a substance or article obtained as mentioned in paragraph 1 of that Schedule were a reference to a substance or article of which a sample has been set aside, or which has been treated as a sample, in accordance with subsection (2) of this section."

On Question, Amendment agreed to.

Clause 105 agreed to.

BARONESS SEROTA

I beg to move Amendment No. 89: After Clause 105, insert the following new clause—

Analysis of samples in other cases

".—(1) A person who, not being a person authorised in that behalf by an enforcement authority, has purchased a medicinal product may submit a sample of it for analysis to the public analyst for the area in which the product was purchased, or, if for the time being there is no public analyst for that area, then to the public analyst for some other area.

(2) Paragraphs 2 to 11B of Schedule 3 to this Act shall have effect in relation to a person proposing to submit a sample in pursuance of the preceding subsection, as if in those paragraphs any reference to the sampling officer were a reference to that person.

(3) Subject to the following provisions of this section, a public analyst to whom a sample is submitted under subsection (1) of this section shall as soon as practicable analyse the sample or cause it to be analysed by some other person under his direction.

(4) If the public analyst to whom a sample is submitted under subsection (1) of this section determines that for any reason an effective analysis of the sample cannot be performed by him or under his direction, he shall send it to the public analyst for some other area, and (subject to the next following subsection) that other public analyst shall as soon as practicable analyse the sample or cause it to be analysed by some other person under his direction.

(5) A public analyst to whom a sample is submitted or sent under this section may demand payment in advance of the prescribed fee, and, if he demands such payment, he shall not be required to analyse the sample or cause it to be analysed until the fee has been paid.

(6) A public analyst who has analysed a sample or caused a sample to be analysed this section shall issue a certificate specifying the result of the analysis to the person by whom the sample was originally submitted.

(7) Any certificate issued under subsection (6) of this section shall be in a form prescribed by the Ministers and shall be signed by the public analyst who issues the certificate.

(8) Paragraphs 19 to 21 of Schedule 3 to this Act shall have effect in relation to a certificate issued under subsection (6) of this section as they have effect in relation to a certificate issued under paragraph 17 of that Schedule.

(9) Any regulations prescribing a fee for the purposes of this section shall be made by the Ministers.

(10) In this section 'public analyst' has the meaning assigned to it by paragraph 1(2) of Schedule 3 to this Act.")

The purpose of this new clause is to fulfil an undertaking given by my right honourable friend in another place. Section 92 of the Food and Drugs Act 1955, and similar provisions in the Scottish and Northern Ireland Acts, provide for analysis by public analysts on payment of a fee of samples of food and drugs submitted by ordinary members of the public. The Food and Drugs Act are to be repealed by Schedules 6 and 8 in their application to drugs, but this provision should not be lost in the repeal. This new clause accordingly re-enacts the provision as part of the medicines legislation and applies relevant parts of Schedule 3 to samples proposed to be submitted for analysis. I beg to move.

On Question, Amendment agreed to.

Clauses 106 to 109 agreed to,

Clause 110 —[Warranty as defence.]

BARONESS SEROTA

I beg to move Amendment No. 90: Page 102, line 35, after ("this") insert ("and the next following").

Amendment No. 90 is a paving Amendment for Amendment No. 91. The new clause reproduces the effect of Section 116 of the Food and Drugs Act (and correspondingly in the Scottish and Northern Ireland Acts) so far as it relates to warranties and certificates of analysis relating to drugs. The clause makes it an offence to misapply a warranty or certificate, or to give a false warranty or certificate. The Amendment to Clause 110 anticipates the new clause by applying the Scottish interpretation provisions in Clause 110(7) to the new clause. I beg to move.

On Question, Amendment agreed to.

Clause 110, as amended, agreed to.

BARONESS SEROTA

I beg to move Amendment No. 91: After Clause 110, insert the following new clause:

Offences in relation to warranties and certificates of analysis

".—(1) If a defendant in any such proceedings as are mentioned in section 110(1) of this Act wilfully applies to any substance or article—

1. (a) a warranty given in relation to a different substance or article, or
2. (b) a certificate issued under section (Analysis of samples in other cases) of this Act, or under paragraph 17 of Schedule 3 to this Act, which relates to a sample of a different substance or article,

he shall be guilty of an offence.

(2) A person who, in respect of any substance or article sold by him in respect of which a warranty might be pleaded under section 110 of this Act, gives to the purchaser a false warranty in writing shall be guilty of an offence, unless he proves that when le gave the warranty he had reason to believe that the statement or description contained in it was accurate.

(3) Where the defendant in, any such proceedings as are mentioned in section 110(1) of this Act relies successfully on a warranty given to him or to his employer, any proceedings for an offence under subsection (2) of this section in respect of the warranty may, at the option of the prosecutor, be taken either before a court having jurisdiction in the place where a sample of the substance or article to which the warranty relates was procured, or before a court having jurisdiction in the place where the warranty was given.

(4) Any person guilty of an offence under this section shall be liable—

1. (a) on summary conviction, to a fate not exceeding £400;
2. (b) on conviction on indictment, to a fine or to imprisonment for a term not ! exceeding two years or to both."

On Question, Amendment agreed to.

Clauses 111 to 115 agreed to.

Clause 116 [Orders and regulations]:

BARONESS SEROTA

I beg to move Amendment No. 92: Page 106, line 19, after ("15(1)") insert ("(Supplementary provisions as to clinical trials and medicinal tests on animals) (2)(b) (Special provisions in respect of exporting certain products)").

This is a further consequential Amendment. I beg to move.

On Question, Amendment agreed to.

8.49 p.m.

BARONESS SEROTA

I beg to move Amendment Nos. 93 and 94:

Page 106, line 19, after ("47(2)") insert ("48(2)").

Page 106, line 19, leave out ("50") and insert ("50(1)").

I think it would be for the convenience of the Committee if I took Amendments Nos. 93 and 94 together. Paragraphs (b) and (c) of Clause 48(1) were inserted by Government Amendments at a late stage in another place to fill a gap in the Bill when it was realised that the supply of a drug to a hospital patient or to the patient of a nurse or midwife technically involved a retail sale or "supply in circumstances corresponding to retail sale". It would not have been reasonable to leave such sale or such supply to the requirements of Clauses 45 and 46 which are specifically designed to cover the sale or supply at ordinary retail outlets such as pharmacies and other retail shops. The amended clause has been criticised on two grounds, and the Government have therefore submitted the Amendment which appears in the Marshalled List.

On Question, Amendments agreed to.

BARONESS SEROTA

I beg to move Amendments 95 and 96:

Page 106, line 20, leave out (` 97 ").

Page 106, line 21, at end insert—

( ) an order made under section 97 of this Act otherwise than as mentioned in subsection (3) of that section, or").

Here, again, the next two Amendments hang together. The provisions listed in Clause 116(3)(a) are those referring to making orders subject to the annulment procedure. Originally this, was correct in referring to Clause 97, but in another place Clause 97 was amended by the introduction of subsection (3) which made orders under Clause 97(1)(b) subject to Affirmative Resolution. It is consequently necessary to qualify the reference to Clause 97 in Clause 116(3). Those under Clause 97(1)(a) remain subject to annulment. I beg to move.

On Question, Amendments agreed to.

Clause 116, as amended, agreed to.

Clause 117 [Meaning of "medicinal product" and related expressions]:

LORD KENNET

I beg to move Amendment No. 97: Page 107, (line 15, at beginning insert ("use"). Amendments Nos. 97, 99 and 102 hang together. I shall, with the leave of the Committee, move Amendments 99 to 102 formally when we come to them. The effect of the three Amendments, which were foreshadowed at Report stage in the House of Commons by my honourable friend the Parliamentary Secretary to the Minister of Health, is to put manufactured herbal ingredients not already covered in 103(b) in the same position as manufactured ingredients for use in pharmacies, hospitals or by practitioners. I beg to move.

On Question, Amendment agreed to.

LORD KENNET

I beg to move Amendment No. 98: Page 107, line 16, leave out from ("for") to end of line 17 and insert ("a medicinal purpose"). This is consequential on the new clause after Clause 37.

On Question, Amendment agreed to.

LORD KENNET

I beg to move Amendment No. 99: Page 107, line 18, leave out from beginning to ("of") in line 19 and insert ("use, in circumstances to which this paragraph applies, as an ingredient in the preparation.").

On Question, Amendment agreed to.

LORD KENNET

I beg to move Amendments Nos. 100 and 101:

Page 107, line 21, leave out ("one or more of those purposes") and insert ("a medicinal purpose").

Page 107, leave out lines 22 and 23 and insert—

("( ) In this Act ' a medicinal purpose' means any one or more of hte following purposes, that is to say").

Amendments Nos. 100 and 101 hang together and are consequential on the new clause after Clause 37.

On Question, Amendments agreed to.

LORD KENNET: I beg to move Amendment No. 102:

Page 107, line 34, at end insert— ("( ) In paragraph (b) of subsection (1) of this section the reference to use in circumstances to which that paragraph applies is a reference to any one or more of the following, that is to say—

1. (a) use in a pharmacy or in a hospital;
2. (b) use by a practitioner;
3. (c) use in the course of a business which consists of or includes the retail sale, or the supply in circumstances corresponding to retail sale, of herbal remedies.")

On Question, Amendment agreed to.

LORD KENNET

I beg to move Amendment No. 103: Page 108, line I, leave out ("trial") and insert ("test"). Amendments Nos. 103 to 107 hang together and are consequential on the new clause after Clause 30. I beg to move.

On Question, Amendment agreed to.

Clause 117, as amended, agreed to.

Clause 118 [General interpretation provisions]:

LORD KENNET

I beg to move Amendments Nos. 104 to 107:

Page 109, line 28, at end insert ("animal test certificate' has the meaning assigned to it by section (Medicinal tests on animals) of this Act").

Page 110, line 1, leave out from first ("trial") to ("of") in line 3 and insert ("and 'clinical trial certificate' have the meanings assigned to them by section (Clinical trials)").

Page 1l, line 31, at end insert ("'medicinal test on animals' has the meaning assigned to it by section (Medicinal tests on animals) of this Act").

Page 114, line 4. leave out ("a field trial") and insert ("an animal test").

Amendments Nos. 104 to 107 hang together, and I beg to move them en bloc.

On Question, Amendments agreed to.

Clause 118, as amended, agreed to.

Clause 119 agreed to.

Clause 120 [Special provisions as to Northern Ireland]:

LORD KENNET: I beg to move Amendment No. 108:

Page 115, line 29, at end insert— ("( ) Section 38 of the Interpretation Act 1889 shall have the like operation in relation to any repeal by this Act of an enactment of the Parliament of Northern Ireland as it has in relation to the repeal of an enactment of the Parliament of the United Kingdom."). This is a Northern Ireland Amendment to attract the provisions of Section 38 of the Interpretation Act 1889. I beg to move.

On Question, Amendment agreed to.

Clause 120, as amended, agreed to.

Clauses 121 and 122 agreed to.

Schedules 1 and 2 agreed to.

Schedule 3 [Sampling]:

LORD KENNET: I beg to move Amendment No. 109:

Page 122, line 44, at end insert— ("11A. Section 114 of this Act shall have effect in relation to supplying any part of a sample in pursuance of the preceding paragraphs as it has effect in relation to the service of a document. 11B. If after reasonable inquiry the sampling officer is unable to ascertain the name of a person to whom, or the address at which, a part of a sample ought to be supplied in pursuance of the preceding paragraphs, lie may retain that part of the sample instead of supplying it.")

This Amendment improves and perfects the provisions about sampling in the Bill. I believe its effects are self evident. I beg to move.

On Question, Amendment agreed to.

Schedule 3, as amended, agreed to.

Schedule 4 [Provisions relating to Northern Ireland]:

LORD KENNET

I beg to move Amendments Nos. 110 to 116:

Page 127, line 12, leave out ("medicinal products") and insert ("substances or articles")

Page 127, line 12, leave out ("a field trial") and insert ("an animal test")

Page 127, line 22, leave out ("a field trial") and insert ("an animal test")

Page 127, line 27, leave out ("field trial") and insert ("animal test")

Page 127, line 32, leave out ("field trial") and insert ("animal test")

Page 127, line 34, leave out ("medicinal products of any description") and insert ("substances or articles")

Page 127, line 40, leave out ("medicinal products of that description have") and insert ("a substance or article to which those provisions relate has")

These Amendments are consequential on the new clauses after Clause 30. I beg to move them en bloc.

On Question, Amendments agreed to.

LORD KENNET

I beg to move Amendment No. 117: Page 127, line 49, after ("15(3)") insert ("section (Supplementary provisions as to clinical trials and medicinal tests on animals), section (Supplementary provisions as to incorporation of substances and articles in animal feeding stuffs) and section 50(3)") The Government's Amendments introducing the new clauses mentioned here and the Government's Amendment to Clause 50 have created new order-making powers of the same character as that in Clause 15(3), and it is appropriate therefore, that such orders should be excluded also from the Northern Ireland Minister's power to make separate provisions. This is the purpose of this Amendment. I beg to move.

On Question, Amendment agreed to.

Schedule 4, as amended, agreed to.

Schedule 5 [Amendments of enactments of Parliament of United Kingdom]:

LORD KENNET: I beg to move Amendments Nos. 118 to 120:

Page 129, line 7, at end insert—

"The Pharmacy and Poisons Act 1933 (c. 25)

.In section 17(2), for the words from 'those poisons' to 'authorised seller of poisons', in each place where those words occur, there shall be substituted the words 'those substances which, where they are non-medicinal poisons, are by virtue and subject to the provisions of this Act prohibited from being sold except by a person lawfully conducting a retail pharmacy business'.

.In section 18, in subsection (1), for paragraphs (a) and (b) there shall be substituted the following paragraphs:—

1. '(a) for a person to sell any non-medicinal poison which is a substance included in Part I of the Poisons List unless—
1. (i) he is a person lawfully conducting a retail pharmacy business; and
2. (ii) the sale is effected on premises which are a registered pharmacy; and
3. (iii) the sale is effected by, or under the supervision of, a pharmacist;
2. (b) for a person to sell any non-medicinal poison which is a substance included in Part II of the Poisons List unless—
1. (i) he is a person lawfully conducting a retail pharmacy business and the sale is effected on premises which are a registered pharmacy; or
2. (ii) his name is entered in a local authority's list in respect of the premises on which the poison is sold',

and in paragraph (c), for the words poison, whether' there shall be substituted the words 'non-medical poison, whether it is a sub- stance'; and in subsection (2), for the word 'poison', in the first place where it occurs, there shall be substituted the words 'non-medicinal poison which is a substance'.

.In section 21, in subsection (1), for the words from 'who not being entitled to sell poisons included in Part 1' to 'such poisons on those premises', there shall be substituted the words as being persons entitled, on premises in respect of which their names are entered in the list, to sell non-medicinal poisons which are substances included in Part II of the Poisons List, and shall enter in the list the name of any person who, having premises in the area of the authority, makes an application to the local authority in the form prescribed by rules to have his name entered in the list in respect of those premises'; and in subsection (3), for the words from on which' to the said Part II' there shall be substituted the words 'in respect of which the name of any person is entered in the list'.

.In section 22, before the word 'poison' there shall be inserted the word 'non-medicinal'.

.In section 23, in subsections (1) and (2), before the word 'poisons' in each place where it occurs (except where the reference is to the 'Poisons Board' or the Poisons List') there shall be inserted the word 'non-medicinal'.

.In section 24, in subsection (2), before the word 'poison' there shall be inserted the word non-medicinal'.

.In section 25, in subsection (1), for the words 'registered pharmacists and authorised sellers of poisons' there shall be substituted the words 'pharmacists and persons carrying on a retail pharmacy business'; in subsection (4), for the words 'registered pharmacists and authorised sellers of poisons' there shall be substituted the words 'pharmacists and persons carrying on a retail pharmacy business', for the words 'premises which are on the register of premises' there shall be substituted the words 'registered pharmacy', and for the word 'poisons', in the second and fourth places where it occurs, there shall be substituted the word 'substances'; in subsection (5), after the word 'steps' there shall he inserted '(a)', for the words 'authorised sellers of poisons' there shall be substituted the words 'persons lawfully conducting a retail pharmacy business', for the word 'poisons', in the second place where it occurs, there shall be substituted the word 'substances', and for the words 'for that purpose' there shall be substituted the words— '(b) to secure compliance with those provisions and rules by persons lawfully conducting a retail pharmacy business, in so far as that business is carried on at premises which are not a registered pharmacy, and for those purposes'; and in subsection (6), for the word 'poisons', in the first place where it occurs, there shall be substituted the word 'substances'.

.In section 29, for the definition of 'pharmacist' there shall be substituted the following:— '"person lawfully conducting a retail pharmacy business" shall be construed in accordance with section 62 of the Medicines Act 196E:; pharmacist" has the meaning assigned to it in relation to Great Britain by section 118(1) of the Medicines Act 1968', after the definition of 'registered dentist' there shall be inserted the words '"registered pharmacy" has the meaning assigned to is by section 67 of the Medicines Act 1968; "retail pharmacy business" has the meaning assigned to it by section 118(1) of that Act,' and at the end of section 29 there shall be inserted the following subsection:—

'(2) In this Act "non-medicinal poison" means a substance which is for the time being included in Part I or Part II of the Poisons List and is neither—

1. (a) a medicinal product as defined by section 117 of the Medicines Act 1968, nor
2. (b) a substance in relation to which, by virtue of an order under section 96 or section 97 of that Act for the time being in force (and whether, in the case of an order under section 96 of that Act, it is referred to in the order as a substance or as an article), the provisions of sections 44 to 47 and sections 62 to 70 of that Act (whether subject to exceptions and modifications or not and with or without other provisions of that Act) have effect as they have effect in relation to medicinal products as so defined.'

The Cancer Act 1939 (c. 13)

.In section 4, in subsection (4)(a)(v), for the words 'authorised sellers of poisons' there shall be substituted the words 'persons lawfully conducting a retail pharmacy business in accordance with section 62 of the Medicines Act 1968'."

Page 129, leave out lines 8 to 11 and insert—

The National Health Service Act 1946 (c. 81)

.In section 39(2), for the words 'authorised sellers of poisons within the meaning of the Pharmacy and Poisons Act 1933' there shall be substituted the words 'persons lawfully conducting a retail pharmacy business in accordance with section 62 of the Medicines Act 1968'.

The National Health Service (Scotland) Act 1947 (c. 27)

.In section 41(2), for the words 'authorised sellers of poisons within the meaning of the Pharmacy and Poisons Act 1933' there shall be substituted the words 'persons lawfully conducting a retail pharmacy business in accordance with section 62 of the Medicines Act 1968'.

The Purchase Tax Act 1963 (c. 9)

.In Part H of Schedule 1, in paragraph 5(1)(a)(i), for the words 'an authorised seller of poisons' there shall be substituted the words 'a person lawfully conducting a retail pharmacy business in accordance with section 62 of the Medicines Act 1968.'

The Drugs (Prevention of Misuse) Act1964 (c. 64)

.In section 1, in subsection (2) in paragraph (f), for the words 'an authorised seller of poisons' there shall be substituted the words 'a person lawfully conducting a retail pharmacy business in accordance section 62 of the Medicines Act 1968', and in paragraph (k), for the words 'the said Act of 1955' there shall be substituted the words 'Schedule 3 to the Medicines Act 1968'; and in subsection (6), for paragraph (a) there shall be substituted the following paragraph:— '(a) for the reference in paragraph (j) of subsection (2) to section 89 of the Food and Drugs Act 1955 there shall be substituted a reference to section 27 of the Food and Drugs (Scotland) Act 1956'.

Page 129, line 13, leave out from ("11") to end of line 28 and insert ("in subsection (2), for the words from 'carrying on business' to 'authorised seller of poisons' there shall he substituted the words 'conducting retail pharmacy business in accordance with section 62 of the Medicines Act 1968', and for the words 'duly registered under Part I' there shall be substituted the words 'which are a registered pharmacy as defined by section 67'; in subsection (3), for the words from 'the sale by retail' to the end of the subsection there shall be substituted the words 'any contravention of the Pharmacy and Poisons Act 1933 or of the Medicines Act 1968 or any rules, regulations or order made under either of those Acts'; and in subsection (4) for the words from 'subsection (2) and (3), to the end of the subsection there shall be substituted the words the reference in subsection (2) to the Pharmaceutical Society of Great Britain, of a reference to the Pharmaceutical Society of Northern Ireland, for the reference n subsection (3) to the Pharmacy and Poisons Act 1933, of a reference to the Pharmacy and Poisons Acts (Northern Ireland) 1925 to 1967, and as if in subsection (2) the reference to a person lawfully conducting a retail pharmacy business included a reference to a person deemed to be a person lawfully conducting such a business by virtue of an order made under paragraph 1 of Schedule 4 to the said Act of 1968'.")

These Amendments, Nos. 118 to 120, hang together. Their purpose is to restrict to non-medicinal poisons the control of sale provisions of the Pharmacy and Poisons Act 1933 and certain related effects. The result is to remove the need for too much registering of pharmacy premises under the two Statutes concerned, the conditions being always identical, and to take the medicines containing poisons outside the ambit of the poisons legislation which at r resent governs them and to put them within the ambit of this Bill. I beg to move Amendments 118 to 120 en bloc.

On Question, Amendments agreed to.

LORD KENNET: I beg to move Amendment No. 121:

Page 129, line 28, at end insert:

("The Trade Descriptions Act 1968 (c. 29)

.In section 2, in subsection (5), after the word 'section' there shall be inserted '(a)' and at the end of the subsection there shall be inserted the following paragraph:— '(b) where by virtue of any provision made under Part V of the Medicines Act 1968 (or made under any provisions of the said Part V as applied by an order made under section 96 or section 97 of that Act) anything which, in accordance with this Act, constitutes the application of a trade description to goods is subject to any requirements or restrictions imposed by that provision, any particular description specified in that provision, when applied to goods in circumstances to which those requirements or restrictions are applicable, shall be deemed not to be a trade description'.

.In section 22, in subsection (2) after the words 'the Food and Drugs Act (Northern Ireland) 1958' there shall be inserted the words 'or the Medicines Act 1968'; in paragraph (b) the word 'and' where it occurs at the end of that paragraph, shall be omitted; and at the end of paragraph (c) there shall be inserted the words 'and (d) in relation to the said Act of 1968, so much of Schedule 3 to that Act as is applicable to the circumstances in which the sample was procured', and at the end of the subsection there shall be inserted the words 'or paragraph 25 of Schedule 3 to the said Act of 1968'.")

This Amendment has the effect of excluding from the operation of the Trade Descriptions Act of this year certain things done in pursuance of the Medicines Bill which would amount to the application of trade descriptions under the Act. I beg to move.

On Question, Amendment agreed to.

Schedule 5, as amended, agreed to.

Schedule 6 [Enactments of Parliament of United Kingdom repealed]:

9.0 p.m.

LORD KENNET

I beg to move Amendments Nos. 122 to 124:

Page 129, column 3, leave out lines 34 to 44 and insert—

		("Sections 8 to 14.
		In section 17, in subsection (2), the words 'of persons who are to be entitled to sell poisons in Part II', and, in subsection (6), the words from 'and in this Act' to the end of the subsection.

		In section 18(2)(a)(ii) the word "registered".
		Section 19.
		In section 23, in subsection (1), paragraph (a), paragraph (b)(ii) and paragraph (i); and in subsection (3), in the reference to paragraphs (a), (b)(i), (c),(d),(e)and (i), the references to paragraphs (a) and (i).
		In section 25, in subsection (1) the words 'Part I of this Act and of section nineteen and', in subsection (4) those words and the word 'registered', and subsection (9).
		In section 29, the definitions of 'authorised seller of poisons' and 'poison' and paragraph (a) of the definition of 'registered'").

Page 130, column 3, leave out lines 2 to 14 and insert—

("The whole Act")

Page 130, line 15, column 3, at end insert—

("In section 12, the definition of 'authorised seller of poisons'")

These Amendments serve the same purpose as Amendment No. 118. I beg to move.

On Question, Amendments agreed to.

LORD KENNET

I beg to move Amendments Nos. 125 and 126:

Page 130, line 33, column 3, at end insert—

("In section 114(4), the words from 'the authority concerned' to 'in any other case'.")

Page 130, line 39, column 3, at end insert—

("In Part I of Schedule 9, in column 2, paragraph (a)(iii) of the definition relating to sections 321 to 325 of the Public Health Act 1936").

The effect of these Amendments is to remove certain additional references to drugs in the Food and Drugs Act 1955. This is to fulfil our intention of removing from that Act the provisions relating to drugs and references to drugs, other than in the expression "food and drugs authority", and also in the interpretation section where one reference has to be retained for interpretation of certain other provisions. I beg to move.

On Question, Amendments agreed to.

LORD KENNET

I beg to move Amendment No. 127:

Page 130, line 56, at end insert—

("1963 c. 9.	The Purchase Tax Act 1963.	In Part II of Schedule 1, in paragraph 5(2), the definition of 'authorised seller of poisons'.
1964 c. 64.	The Drugs (Prevention of Misuse) Act 1964.	In section 1, in subsection (7), the reference to, and the paragraph substituted for, paragraph (k) of subsection (2).
		In section 9 the definition of 'authorised seller of poisons'.
1965 c. 15.	The Dangerous Drugs Act 1965.	In section 11, in subsection (4) the words 'in subsection (1) thereof'.")

This Amendment hangs together with Nos. 122 to 124, which have already been accepted by the Committee. I beg to move.

Amendment agreed to.

Schedule 6, as amended, agreed to.

Schedule 7 [Amendments of enactments of Parliament of Northern Ireland]:

LORD KENNET

I beg to move Amendments Nos. 128 to 140 inclusive:

Page 131, line 8, leave out from ("words") to ("for") in line 13 and insert ("a retail pharmacy business is carried on',").

Page 131, line 17, leave out from ("words") to ("and") in line 19 and insert ("'carry on a retail pharmacy business':").

Page 131, line 21, leave out from ("the") to the end of line 26 and insert ("expression 'retail pharmacy business' has the meaning assigned to it by section 118(1) of the Medicines Act 1968").

Page 131, line 27, at end insert—

(".In section 25 for the word 'poisons' there shall be substituted the words 'non-medicinal poisons'").

Page 131, line 33, leave out from ("retention") to ("of") and insert ("or other fees, or any other sums, paid to him under section 69").

Page 131, line 39, at end insert—

(".In section 30 for the definition of 'poison' there shall be substituted the following definition—

"The expression 'non-medicinal poison' has the meaning assigned to it by section 38(1A) of the Medicines, Pharmacy and Poisons Act (Northern Ireland) 1945".").

Page 132, line 10, at end insert— (".In section 26A(3) for the words from those 'poisons' to 'authorised sellers of poisons', in each place where those words occur, there shall be substituted tie words 'those substances which, where they are non-medicinal poisons, are by virtue of and subject to the provisions of this Act prohibited from being sold except by a person lawfully conducting a retail pharmacy business' and for the words 'and those persons who ate authorised by the local authority' there shall be substituted the words 'or a person whose name is entered in a register kept under his Part of this Act by a local authority (in this Act referred to as a "local authority's register").").

Page 132, leave out lines 11 to 38 and insert— .In section 27, in subsection (1) for paragraphs (a) and (b) there shall be substituted the following paragraphs:

1. '(a) for a person to sell any non-medicinal poison which is a substance included in Part I of the Poisons Schedule unless—
1. (i) he is a person lawfully conducting a retail pharmacy business; and
2. (ii) the sale is effected on premises which are a registered pharmacy and
3. (iii) the sale is effected by, or under the personal control of, a pharmacist;
2. (b) for a person to sell any non-medicinal poison which is a substance included in Part II of the Poisons Schedule unless—
1. (i) he is a person lawfully conducting a retail pharmacy business and the sale is effected on premises which are a registered pharmacy; or
2. (ii) his name is entered in a local authority's register in respect of the premises on which the poison is sold,'

and in paragraph (d) for the words poison, whether 'there shall be substituted the words 'non-medicinal poison, whether it is a substance'; and in subsection (2) for the word 'poisons' where it first occurs there hall he substituted the words non-medicinal poison which is a substance' and in paragraph (a)(ii) of that subsection for the words duly registered person' there shall be substituted the word pharmacist'.

.Section 28 shall cease to have effect. .In section 30, in subsection (1), for the words from 'who, not being entitled to sell poisons included in Part I' to 'such poisons on those premises' there shall be substituted the words 'as being persons entitled, on premises in respect of which their names are entered in the register, to sell non-medicinal poisons which are substances included in Part II of the Poisons Schedule, and shall Enter in the register the name of any person who, having premises in the area of the authority, makes an application to the local authority in the prescribed form to have his name entered in the register in respect of those premises'; and in subsection (3), for the words from on which' to 'the said Part II' there stall be substituted the words in respect of which the name of any person is entered in the register'. .In section 31, before the word 'Poison' there shall be inserted the word 'non-medicinal'. .In section 32, in subsections (1) and (2), before the word 'poison' or 'poisons' in each place where it occurs (except as part of the expression 'the Poisons Board'), there shall be inserted the word 'non-medicinal'; and in subsection (1) paragraphs (a), (b)(ii) and (i) shall cease to have effect, and, in subsection (3), the references to paragraphs (a) and (i) of subsection (1), shall be omitted. .In section 33(2) before the word 'poison' there shall be inserted the word 'non-medicinal'."

Page 132, line 43, leave out from ("effect") to end of line 46 and insert ("; in subsection (2) for the words 'registered persons, authorised sellers of poisons' there shall be substituted the words 'pharmacists, persons carrying on a retail pharmacy business and'; and in subsection (3) for the words 'premises having an annual licence or registered under section 30 of this Act' there shall be substituted the words "registered pharmacy or any premises in respect of which a person's name is entered in a local authority's register,' and for the word 'poisons' there shall be substituted the words 'substances included in Part I or Part II of the Poisons Schedule'")

Page 132, line 48, leave out paragraph 17 and insert— .In section 38, in subsection (1), the definitions of 'authorised seller of poisons', poison', 'premises having an annual licence' and 'retailing' shall cease to have effect, and the following definitions shall be inserted at the appropriate points in alphabetical order— '"person lawfully conducting a retail pharmacy business" shall be construed in accordance with section 62 of the Medicines Act 1968; pharmacist" means a person who is, or is deemed to be, a pharmacist for the purposes of any provision of the Medicines Act 1968; registered pharmacy" has the meaning assigned to it by section 67 of the Medicines Act 1968; retail pharmacy business" has the meaning assigned to it by section 118(1) of the Medicines Act 1968;', and at the end of that subsection there shall be inserted the following subsection— '(1A) In this Act "non-medicinal poison" means a substance which is for the time being included in Part I or II of the Poisons Schedule and is neither—

1. (a) a medicinal product as defined by section 117 of the Medicines Act 1968, nor
2. (b) a substance in relation to which, by virtue of an order under section 96 or section 97 of that Act for the time being in force (and whether, in the case of an order under section 96 of that Act, it is referred to in the order as a substance or as an article), the provisions of sections 44 to 47 and sections 62 to 70 of that Act (whether subject to exceptions and modifications or not and with or without other provisions of that Act) have effect as they have effect in relation to medicinal products as so defined'."

Page 133, line 14, at end insert— (".In sections 1 and 3 there shall be made the amendments to sections 26A and 30 respectively of the Medicines, Pharmacy and Poisons Act (Northern Ireland) 1945 set out above.")

Page 133, leave out lines 23 to 28.

Page 134, line 1, leave out from ("words") to end of line 2 and insert ("'Carrying on a retail pharmacy business'.").

These Amendments, Nos. 128 to 140, do for Northern Ireland what we have just done for Great Britain in Amendment 118. I beg to move.

On Question, Amendments agreed to.

Schedule 7, as amended, agreed to.

Schedule 8 [Enactments of Parliament of Northern Ireland repealed]:

LORD KENNET

I beg to move Amendments Nos. 141 to 143:

Page 134, column 3, leave out line 40 and insert— ("Section 28. In section 32, in subsection (1) paragraphs (a), (b)(ii) and (i), and in subsection (3) the references to paragraphs (a) and (i) of subsection 1) ").

Page 134, line 48, column 3, after ("of") insert ("'authorised seller of poisons ', 'poison',").

Page 136, line 20, column 3, at end insert ("and section 32 of the Diseases of Animals Act (Northern Ireland) 1958.").

On Question, Amendments agreed to.

Remaining Schedule, as amended, agreed to.

LORD KENNET

Before the Motion is put that the Bill be now reported, I should like to take this opportunity to thank noble Lords opposite, and those behind me also, for their co-operation in the progress of what in my experience has been a record speed on a Committee stage.

House resumed: Bill reported, with the Amendments.