Animals (Scientific Procedures) Bill [H.L.]

HL Deb 12 December 1985 vol 469 cc369-405

4.56 p.m.

The Parliamentary Under-Secretary of State, Home Office (Lord Glenarthur)

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 Glenarthur.)

On Question, Motion agreed to.

House in Committee accordingly.

[The LORD AYLESTONE in the Chair.]

Clause 1 [Protected animals]:

The Deputy Chairman of Committees (Lord Aylestone)

I must point out that if Amendment No. 1 is carried, I cannot call Amendment No. 2.

Lord Glenarthur moved Amendment No. 1: Page 2, line 6, leave out from beginning to end of line 7 and insert ("circulation or the destruction of its brain").

The noble Lord said: I beg to move Amendment No. 1. I hope that the Committee might find it convenient if we discuss Amendment No. 2 at the same time. Amendment No. 2: Page 2, line 6, leave out ("central nervous system") and insert ("brain").

This amendment proposes a change to the definition of the point at which an animal is no longer regarded as living. Our proposals overlap those of the noble Lord, Lord Adrian, in his Amendment No. 2. I should like to take this opportunity of thanking the noble Lord, Lord Adrian, for the very helpful letter that he sent me covering his point and others as well.

Our proposals have two aspects. First, we intend that cessation of circulation alone may be taken as proof of death. This is because the best evidence available indicates that, except in very localised respects, and for a short while, all respiration ceases immediately upon the cessation of circulation. The inclusion of cessation of respiration as a requirement is therefore unnecessary.

Our second proposed change substitutes destruction of the brain for destruction of the central nervous system as a proof of death. The definition of the central nervous system encompasses not only the brain but also the spinal cord. The evidence which we have is that destruction of the brain alone causing the removal of all capacity for consciousness, thought, feeling and instinctual behaviour, means that an animal is no longer alive in any sense which is relevant to the purposes of this Bill even though its spinal cord may still be wholly or partially intact. We have thought most carefully about these changes and have consulted those most expert in this highly specialised and complex field. The alternatives which we propose will not weaken the protection given to animals. I commend the amendment to your Lordships and beg to move.

Lord Adrian

May I say first of all how grateful I am to the noble Lord the Minister of State for having pre-empted, so to speak. Amendment No. 2, which I very willingly withdraw. I can say no more than what has been said already, but perhaps I can point out that there was in the Bill as it is drafted a certain ambiguity and the suggested amendment clears up that ambiguity in that one of the definitions of humane killing—I think the sixth one with respect to cold-blooded invertebrates—might under certain circumstances have left an animal which was killed humanely, but by the definition in Clause 1 still living, a protected animal. It seemed that it was worthwhile with a relatively simple and straightforward amendment to remove this difficulty. I am very much in support of what the noble Lord the Minister has said and I hope that the amendment will commend itself to the Committee.

On Question, amendment agreed to.

[Amendment No. 2 not moved.]

Clause 1, as amended, agreed to.

Clause 2 [Regulated procedures]:

Lord Airedale moved Amendment No. 3: Page 2, line 14, leave out ("cause") and insert ("have the effect of causing").

The noble Lord said: This is only a very small drafting amendment. Subsection (4) refers to: the effect mentioned in subsection (1)". It would seem to be a good idea to make subsection (1) refer in terms to the effect mentioned in subsection (4). The amendment achieves that objective. I beg to move.

Lord Glenarthur

Clause 2(1) states that "a regulated procedure" is: any experimental or other scientific procedure applied to a protected animal which may cause that animal pain, suffering, distress or lasting harm". All references elsewhere in Clause 2 to the: the effect mentioned in subsection (1) above", can only relate to this infliction of: pain, suffering, distress or lasting harm". There is nothing else in Clause 2(1) to which they could refer. However, I appreciate and share the desire of the noble Lord. Lord Airedale, to ensure that the Bill should be clear and unambiguous, and I am quite happy to accept the amendment.

Lord Airedale

I am very much obliged.

On Question, amendment agreed to.

Viscount Davidson moved Amendment No. 4: Page 2, line 16, leave out ("a protected") and insert ("an").

The noble Viscount said: I beg to move Amendment No. 4, which stands in the name of my noble friend Lord Glenarthur. It may also be convenient to discuss Amendments Nos. 5, 9, 10 and 11: Amendment No. 5: Page 2, line 21, at end insert ("; and (c) the animal is a protected animal throughout the series or combination or in the course of it attains the stage of its development when it becomes such an animal."). Amendment No. 9: page 3, line 10, leave out ("a protected") and insert ("an"). Amendment No. 10: Page 3, line 13, leave out ("a protected") and insert ("an"). Amendment No. 11: Page 3, line 18, leave out ("a protected") and insert ("an").

The noble Viscount said: These amendments are linked and are designed to achieve a single and worthwhile objective. The amendment to Clause 2, page 2, line 21, deals with the situation where a procedure is applied to an immature form of an animal (a foetus, an embryo or a larval form) which is not yet a protected animal because it has not achieved the stage of development specified in Clause 1(2). The amendment provides that any procedure applied to such a form of life shall be a regulated procedure, and thus subject throughout to the controls provided by the Bill, if during the course of the procedure it reaches the point at which it would be regarded as a protected animal. At present the creature would receive no such protection.

The other amendment to Clause 2, and the three associated amendments to Clause 3 are all consequential amendments. They reflect the fact that, as a result of the change which we propose to the protection of immature forms, a procedure may be a regulated procedure whether or not it is applied to a "protected" animal.

I believe that these amendments introduce a useful improvement to the Bill and the protection which it affords animals. I commend the amendment to your Lordships. I beg to move.

On Question, amendment agreed to.

Viscount Davidson moved Amendment No. 5:

[Printed above.]

The noble Viscount said: I beg to move.

Lord Melchett

I should like to ask the noble Viscount a question about this amendment, because I must say that I find difficulty in following the English of the new paragraph (c). It says: the animal is a protected animal throughout the series or combination or". and it seems to me that there should then be inserted the word "if", so that it reads: or if in the course of it", and then, it attains the stage of its development when it becomes such an animal". At the moment it does not seem to me to be grammatically correct, but I shall bow to the noble Viscount and his advisers if he is quite sure that it makes sense.

Viscount Davidson

I hope that the noble Lord will be satisfied when I say that we shall have a look at the matter and check on the grammar. I cannot give him an answer directly.

On Question, amendment agreed to.

Lord Adrian moved Amendment No. 6: Page 2, line 28, leave out ("decerebration and any other procedure for rendering an animal insentient").

The noble Lord said: Clause 2 of the Bill sets out what circumstances shall be disregarded in considering what may cause an animal pain, suffering, distress or lasting harm, The first of such circumstances which is enumerated is the use of an anaesthetic or analgesic. That is reasonable enough because an animal may be inadequately anaesthetised or it may recover from it unexpectedly.

However, the second of those circumstances is a process referred to as "decerebration". I wish to argue that there is a quantitative difference—indeed, a qualitative difference—between anaesthetising an animal and decerebrating it, and that difference allows me to say that a decerebrate mammal or bird cannot indeed be caused pain, suffering or distress. That is essentially because in a mammal or a bird the parts of the brain that are concerned with the conscious appreciation of pain, suffering or distress have been irreversibly removed by the process of decerebration—that is, in effect, the removal and the destruction of that part of the brain which is the cerebral hemispheres, the basal ganglia, the thalamus, and part of the mid-brain. It is difficult to see what may be considered lasting harm to an essentially brainless body.

My suggested amendment does not remove the necessity for both a personal licence and a project licence for the actual operation of decerebrating an animal. However, it would allow decerebrate animals, when under an appropriate project licence, to be used in practical classes for university students, for physiology and for medical students as, indeed, they are at the moment used under the 1876 Act. Unless that is allowed I fear that the inevitable difficulties of obtaining and—as I understand it—paying for personal licences for all the undergraduates in such a class, will mean that such practical class teaching will, if not disappear, become very much more uncommon.

I am very well aware that there are difficulties here because, while the removal of the cerebral hemispheres and thalamus makes birds and mammals essentially irreversibly insentient, it may not be quite so sure in the case of fishes and amphibia. It is true that the process of decerebration is hardly used at all in lower vertebrates, but I am aware that that is a potential difficulty. I believe that the practical teaching of doctors is a sufficient reason for giving this matter a good deal more thought and I should like to see the general principle of exempting decerebral mammals in particular and putting them outside the operation of the Act.

I hope that others who are concerned essentially with the teaching of doctors will support me in this matter because I believe that the Bill as presently drafted will inhibit very considerably the practical teaching of medical students. I beg to move.

Lord Somers

I have no wish to oppose the amendment moved by my noble friend, but out of pure curiosity I should be glad to know whether a decerebrated animal can really and truly be called alive, since everything in the way of sensation has gone. Surely the heart and other organs all function from the brain? It would be difficult to know how a decerebrated animal is really still a living animal.

Lord Kilbracken

Perhaps when the noble Lord, Lord Adrian, replies to the amendment he will be able to tell us whether there is any reason why he is content that the word "decerebration" should be left in when it occurs three or four lines further on in the same subsection?

Lord Glenarthur

I have listened with great care to the noble Lord, Lord Adrian. I am well aware, as we all are, of his great experience in the medical field. As he described, at present the decerebrate animal receives no protection from the law. The only point at which the 1876 Act has applied is during the act of decerebration itself and then only for warm blooded animals. The decerebrate animal is undoubtedly alive, but it is rather difficult to describe exactly what "alive" is. It is almost completely intact, it is breathing spontaneously and with intact circulation and its basic physiological processes continue.

Though decerebrate mammals and probably birds cannot experience pain—this the noble Lord said—the position regarding amphibia, as he also said, and fish is much less certain. And irrespective of whether pain is felt or not, they are all intact living animals whose dignity we have a duty to respect and protect as best we can. It is the firm view of the Government that it would be wrong to deny such animals the protection afforded by this Bill. We have the support of many scientists in this. Of course, it is not our intention to refuse to license well-justified work on decerebrate preparations and indeed we shall, as we do now, expect scientists to use this and other means of ensuring that their work is painless instead of doing work which may cause pain or any other kind of suffering.

On this business of whether animals are alive, and perhaps to help the noble Lord, Lord Somers, I understand that as well as breathing spontaneously and having an intact circulation frogs will hop under this condition and evidently birds will perch. But I have to tell both him and the noble Lord, Lord Adrian, that the amendment would prevent the kind of improvement in the position of the decerebrate animal which they need. I sincerely hope that the noble Lord will to some extent be reassured by what I have said, even though there appear to be differences of opinion between scientists on this, and that he will not press his amendment.

Lord Adrian

In reply to the noble Lord, Lord Somers, I think that in some sense, and certainly in the sense that it is put out, even in the amended sense, the decerebrate animal comes within the definition of "living" in this Bill because it has an intact circulation, one that is operating, and it has not suffered a complete destruction of its brain. The reason why I did not remove the word "decerebration" from the second part of the subsection was the operation of decerebration, and I do not, clearly, wish the actual decerebration to be outside the operation of the Act. I only wish the animal to become outside the operation of the Act when it has been decerebrated. I am content to withdraw this amendment, but I hope that what I have said about the teaching of medical students will be taken into account in any further guidelines or deliberations that may be made.

Amendment, by leave, withdrawn.

Lord Airedale moved Amendment No. 7: Page 2, line 35, after ("the") insert ("sole").

The noble Lord said: It occurred to me that a researcher might put an identity ring in an animal's ear and might take the opportunity to impregnate the ring with some irritant substance in order to study its effect upon the ear. If the animal came to no lasting harm the researcher might argue that he did not need a licence for that work because identity rings are specifically exempted by this subsection. I am not saying whether or not that argument would succeed, but the intention of the subsection is totally to separate identity work and research work. If that be so then the inclusion of the word "sole" at this point makes that abundantly clear and would not enable the researcher even to put forward the argument that I think he otherwise might. I beg to move.

Lord Kilbracken

My Lords, arising from that amendment, I wonder whether I might ask the Minister if he would clear up one point. Would the ringing of a bull be covered by this provision? If a bull is rung the purpose is not for it to be identified (although I suppose it identifies the creature as being a bull) but it does not give any indication of its name or number. I have given the Minister no notice of this question so perhaps he could write to me—but if the ringing of a bull is a minor agricultural operation then this subsection should include ringing for that purpose as well as for identification.

5.15 p.m.

Viscount Davidson

My Lords, I hope that I shall be able to answer the noble Lord in about 10 seconds—even quicker it seems. Ringing a bull is an agricultural practice and therefore is not covered in this amendment.

I can reply quite briefly to the amendment. The effect of the amendment proposed by the noble Lord, Lord Airedale, is to emphasise that under Clause 2(5) humane methods of ringing, tagging or otherwise marking animals for identification can only be exempted from the provisions of the Bill where carried out for the single purpose of enabling identification of the animal. The Government believe that Clause 2(5) contains an important exemption. The limits of the exemption must be clear to all concerned and the amendment proposed by the noble Lord, Lord Airedale, emphasises those limits. I am grateful to the noble Lord and as this is my first appearance at the Dispatch Box at the Committee stage of a Bill I am particularly happy that I am able to accept his amendment.

Lord Airedale

I am doubly grateful at being able to provide the opportunity for the noble Viscount to have this happy experience.

On Question, amendment agreed to.

Lord Melchett moved Amendment No. 8: Page 2, line 44, leave out from ("procedure") to end of line 3 on page 3.

The noble Lord said: I hope we have established a precedent which will last for the rest of the Committee stage, but somehow I doubt it. This amendment to Clause 2(7) would ensure that killing would be a licensed procedure by whatever method it was carried out. I understand that in some other countries in Europe, particularly the Netherlands, the view is taken that, even if the methods used is a humane method, it is possible to kill in an unhumane way if it is done by inexperienced persons. I am sure that noble Lords will know that killing an animal is not always an easy matter; it is always possible, even if somebody has been doing it for some time, for things to go wrong. That is the more so if it is being done by an inexperienced person. While the method may be humane, it is necessary for people to have some training and to gain some expertise before they can carry out even a humane method. This amendment would ensure that that was the case. I beg to move.

Lord Houghton of Sowerby

I notice that the word "procedure" is mentioned in this amendment, and I wish to raise a matter of procedure. My noble friend has been very inconsiderate to the Committee in putting down 20 amendments yesterday for the Committee stage today. Those of us who have been following this Bill closely and wanted to devote ourselves to it throughly were at a disadvantage today in not finding these amendments until we saw the Marshalled List at lunch time. That is not good enough. I know we work without rules here, but we shall soon have to have some. Otherwise, I think we shall have an imposition on the patience of the Members of the Committee.

I sincerely hope that my noble friend, who put down one-quarter of the total amendments to this Bill yesterday afternoon, will exercise forbearance towards the Members of the Committee for the remainder of our proceedings. I say this in the kindest way. I have always had the greatest regard for my noble friend. However, it is not as though he had thought about these amendments at the last minute and it was urgently necessary to put them down at a late hour. He knew about them quite a long time ago. In those circumstances, I think I am entitled to a mild protest because we are working very much against time on this Bill and we have a long way to go. When one finds this number of amendments put down at the last minute, and one also has regard to the fact that more than half the total number of amendments at this Committee stage come from two noble Lords, one has some indication of the balance, which I think we should restore in the course of our proceedings.

Lord Glenarthur

As the noble Lord, Lord Melchett, foretold, I have to start by disappointing him. I cannot accept this amendment. As he has described, it seeks to make the killing of a protected animal a regulated procedure in all circumstances. This would have the rather curious effect of requiring personal and project licences for all killing of animals, including, for example, getting rid of the mice behind the skirting-board, or killing poultry or any kind of animal for human consumption. I cannot think for a moment that that is what the noble Lord intended; but, anyhow, that is its effect.

The point about Clause 2(7) is that if an experimental animal is killed by an accepted and humane method the animal is not going to suffer as a result of the procedure and there is no need to license it. Suitable persons, who will not necessarily be licensees themselves—for example, a trained animal technician or a vet—must be in a position to kill an experimental animal lawfully if the circumstances require it. The standard humane methods appropriate to various types of animal are specified in Schedule 1, which has been drawn up with the advice of experts and of people with longstanding experience of laboratory practice. However, if a method not listed in the schedule is used for some reason in killing an experimental animal, then the safeguard of the Bill's protection is clearly desirable.

Clause 2(7), I believe, achieves a proper balance, and the amendment proposed would disrupt this in an unacceptable way. I hope the noble Lord will note that, and that he will not feel it necessary to press this amendment.

Lord Melchett

I certainly shall not press the amendment, and I take note of what the noble Lord says—that the amendment goes much wider than I had intended. I shall study what the noble Lord has said; it would seem to me to contain some good sense. If necessary, I shall come back to it. However, I suspect that the noble Lord has satisfied me.

Perhaps I may trespass on the Committee's indulgence and reply to my noble friend's criticism of the fact that my amendments were tabled rather late. I certainly apologise for that, and in particular I apologise to my noble friend if it has caused him any inconvenience. He will, know that many of these amendments were available to him, as they were to other noble Lords interested in the Bill, some time ago. I think it is fair to say that the noble Lord on the Front Bench opposite had the amendments for some time before they appeared in print. However, I apologise if any inconvenience has been caused.

I must say that I had expected that we should be taking more than one day on the Committee stage of this Bill, as indeed seems to be likely. It is a very important matter. I hope there is no intention on anybody's part to rush through it; and I know that everyone would wish that Parliament should have plenty of time to consider the points. I apologise if I have caused any inconvenience to any Members of the Committee by the fact that the amendments, under my name at least, did not appear in print until today. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 2, as amended, agreed to.

Clause 3 [Prohibition of unlicensed procedures]:

Viscount Davidson moved Amendments Nos. 9 to 11:

[Printed earlier: col. 370.]

The noble Viscount said: I have already spoken to Amendments Nos. 9, 10 and 11 with Amendment No. 4. I beg to move them en bloc.

On Question, amendments agreed to.

Following is the text of the amendments (Nos. 9 to 11): Page 3, line 10, leave out ("a protected") and insert ("an"). Page 3, line 13, leave out ("a protected") and insert ("an"). Page 3, line 18, leave out ("a protected") and insert ("an").

Clause 3, as amended, agreed to.

Clause 4 [Personal licences]:

Lord Beaumont of Whitley moved Amendment No. 12: Page 3, line 29, at end insert— ("( ) The Secretary of State shall not issue a personal licence under this section unless it contains the conditions set out in Schedule (Personal Licence Limitations and Conditions).".

The noble Lord said: My Lords, perhaps it would be for the convenience of the Committee if, with Amendment No. 12, I spoke also to Amendments Nos. 15, 25, 27, 45, 66, 80, 81 and 82: Amendment No. 15: Clause 5, page 4, line 14, after ("programme") insert ("unless it contains the conditions set out in Schedule (Project Licence Limitations and Conditions) and"). Amendment No. 25: Clause 6, page 5, line 33, leave out ("and"). Amendment No. 27: page 5, line 37, after ("purpose") insert (", and (c) unless it contains the conditions set out in Schedule (Conditions of Designated Scientific Procedure Establishments)."). Amendment No. 45: Clause 10, page 7, line 35, at end insert ("in addition to those set out in Schedules (Personal Licence Limitations and Conditions.) (Project Licence Limitations and Conditions) and (Conditions of Designated Scientific Procedure Establishments) to this Act."). .Amendment No. 66: Clause 21, page 14, line 1, after ("conditions") insert ("in addition to those specified in Schedules (Personal Licence Limitations and Conditions), (Project Licence Limitations and Conditions) and (Conditions of Designated Scientific Procedure Establishments) to this Act"). Amendment No. 80: After Schedule 1, insert the following new Schedule—

("SCHEDULE

PERSONAL LICENCE LIMITATIONS AND CONDITIONS

1. Limitations, breaches of which constitute an offence under the Act

1. (1) No licensee shall carry out a regulated procedure for which authority has not been granted in his or her personal licence.
2. (2) No licensee shall use any type of animal not authorised by his or her personal licence.
3. (3) No licensee shall carry out any regulated procedure unless authorised by a project licence.
4. (4) No licensee shall carry out any regulated procedure in public or carry out any such procedure which is shown live on television for general reception.
5. (5) No licensee shall carry out any procedure for the purpose of acquiring or demonstrating manual skill.
6. (6) No licensee carrying out any regulated procedure shall use any neuromuscular blocking agent in place of an anaesthetic.
7. (7) No licensee shall induce muscle paralysis (or relaxation) using neuromuscular blocking agents without authority from the Secretary of State.
8. (8) Licensees shall carry out the procedures for which they have authority only at the place or places specified in their personal licences.
9. (9) Any animal which at the conclusion of a series of procedures for any purpose is suffering or is likely to suffer adverse effects shall forthwith be humanely killed.
10. (10) If it appears to an inspector that the effects of a procedure on an animal are too severe or that the animal is suffering considerable pain or distress, the animal shall be removed from the procedure and be given suitable treatment or forthwith be painlessly killed.
11. (11) The licensee shall not carry out a regulated procedure on any animal previously subjected to a regulated procedure.
12. (12) Where an animal has been subjected to a series of regulated procedures for a specific purpose, and has been given a general anaesthetic for any of those procedures and subsequently allowed to recover, then it cannot later be subjected to another regulated procedure for a different purpose. The only exceptions to this are (a) where the anaesthetic was given solely for the purpose of immobilising the animal, or (b) the procedure performed was surgical preparation of the animal for a subsequent procedure.

2. Conditions of the licence

1. (1) It is the responsibility of a personal licence holder to ensure that all cages, pens or other enclosures are clearly labelled. The labelling must be such as to enable the inspector to identify the project in which the animals are being used, the responsible personal licensee and the principal procedures involved.
2. (2) The licensee shall take effective precautions, including the use of alternative techniques not using living animals, sedatives, tranquillisers and/or analgesics, to prevent or reduce to the minimum level consistent with the aims of the procedure any pain, distress or discomfort in the animals used.
3. (3) If it appears to a licensee that the severity condition or conditions in a project licence may have been, or are likely to be, exceeded, then it is the responsibility of that licensee to notify the project licence holder of the situation as soon as possible, so that he may consider what action may need to be taken.
4. (4) In all circumstances where a licensee is aware that an animal is in severe pain or severe distress which is not at once terminated he will ensure that the animal is painlessly killed forthwith by a method appropriate to the animal specified in the list attached to this licence or by such other method as may be authorised by the personal licence under which the animal is killed.
5. (5) It is the responsibility of licensees to ensure that suitable arrangements exist for the care and welfare of animals during any period when they are not in attendance.
6. (6) It is the responsibility of licensees to ensure that, whenever necessary, immediate veterinary advice and treatment is obtained for the animals in their care.
7. (7) Where a personal licence is issued subject to a condition of supervision the licensee will adhere to the requirements of the supervisor.
8. (8) Before moving any animal undergoing a regulated procedure from one establishment to another or elsewhere the licensee must obtain the permission of the Secretary of State.
9. (9) Before releasing into the wild any animal or groups of animals that have been subject to procedures, the licensee must obtain an appropriate certificate of fitness from a specified expert, normally a veterinary surgeon, or other suitably qualified person.
10. (10) The following condition is to be observed when performing procedures without anaesthetics; no operative procedure more severe than simple inoculation or superficial venepuncture may be performed.
11. (11) The following conditions are to be observed in all procedures performed under an anaesthetic: —
1. (a) all procedures shall be carried out under an anaesthetic of sufficient depth to prevent the animal, during the course of the procedure, being consciously aware of pain arising from it;
2. (b) with the exception of animals on which a procedure is being performed under terminal anaesthesia, the animals upon which procedures are performed shall be treated with appropriate precautions customary in veterinary practice.
12. (12) Where a licensee has applied for the first time for permission to use neuromuscular blocking agents, he will, unless specifically exempted by the Secretary of State, give the inspector 48 hours notice of the performance of any procedure involving use of the relaxants. This condition shall not apply to decerebrate preparations.")

Amendment No. 81: After Schedule 1, insert the following new Schedule—

("SCHEDULE

PROJECT LICENCE LIMITATIONS AND CONDITIONS

1. Limitations, breaches of which constitute an offence under the Act

1. (1) No person shall carry out any procedure authorised by the project licence unless also authorised to do so by a personal licence.
2. (2) Procedures under the authority of the project licence shall be carried out only at the place or places specified in the licence, unless otherwise authorised by the Secretary of State.
3. (3) No person working under the authority of the project licence shall use any neuromuscular blocking agent in place of an anaesthetic.
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4. (4) No person working under the authority of the project licence shall induce muscle paralysis (or relaxation) using neuromuscular blocking agents without authority from the Secretary of State.

2. Conditions

1. (1) It is the responsibility of the project licence holder to ensure that the inspector is notified at the earliest possible opportunity if the severity limit (given in sub-paragraph (6) below and to be included in any project licence at the time of issue) appears to have been exceeded or is likely to be exceeded.
2. (2) None of the following animals shall be used in any regulated procedure authorised by the project licence unless it has been bred at a breeding establishment designated by a certificate issued under the Act: mouse, rat, guinea pig, hamster, rabbit, dog, cat and primate.
3. (3) It is the responsibility of the project licence holder to maintain a record, in a form to be approved by the Secretary of State, of all animals on which procedures have been carried out under the authority of the project licence, showing the names of personal licensees who have carried out the procedures on the animals. The record shall be open to examination by an inspector at any time.
4. (4) The project licence holder shall send to the Secretary of State, within 14 days, at the latest, of the close of each year, a report, in a form approved by the Secretary of State, giving details of the number of animals used and the nature of the procedures performed under the authority of the project licence during the year.
5. (5) The project licence holder shall submit such other reports as the Secretary of State may, from time to time, require. In particular, he shall, if so required, submit, on the expiry of the project licence, a list of publications relating to work carried out under the authority of the licence.
6. (6) In any procedure severe pain or severe distress is prohibited. The degree of severity imposed shall be the minimum consistent with the attainment of the objects of the procedure.
7. (7) Unless otherwise authorised, no animal on which a regulated procedure is performed under the authority of the project licence may, during the course of the project, be used in any procedure authorised by any other project licence.").

Amendment No. 82: After Schedule 1, insert the following new Schedule—

("SCHEDULE

CONDITIONS OF DESIGNATED SCIENTIFIC PROCEDURE ESTABLISHMENTS

1. The establishment shall be maintained substantially as at the time the certificate of designation was granted, except where variations are authorised by the Secretary of State.

2. Unless authorised by the Secretary of State or agreed with the inspector there shall be no variation of the use of the designated room(s) in the establishment.

3. Unless otherwise authorised by the Secretary of State, only the type(s) of protected animals specified in the certificate may be accommodated in the establishment.

4. The establishment shall be appropriately staffed at all times to ensure the well being of the protected animals.

5. The person named in the certificate as responsible for the day-to-day care of animals shall ensure that any protected animal found to be in severe pain or severe distress which cannot immediately be terminated, shall be painlessly killed forthwith.

6. None of the following animals shall be allowed to be used in a procedure unless it has been bred at a designated establishment: mouse, rat, guinea pig, hamster, rabbit, dog, cat, primate.

7. The certificate holder shall ensure that a record is maintained of the source of all animals accommodated in the establishment, and that such a record is available for inspection by the Inspector or for submission to the Secretary of State.

8. All primates, dogs and cats accommodated in the establishment which are used or intended for use in procedures shall be clearly and adequately identifiable by a method of marking approved by the Secretary of State.

9. The certificate holder shall notify the Home Office of any proposed change in:

1. (a) the title of the designated establishment;
2. (b) the name (including forenames) of the certificate holder;
3. (c) the name(s) (including forenames) and qualifications of the person(s) responsible for day-to-day care of the protected animals;
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4. (d) the name(s) (including forenames) of the veterinary surgeon(s).

10. Without prejudice to condition 5 above, the person named in the certificate as responsible for the day-to-day care of protected animals in the establishment shall consult the veterinary surgeon named in the certificate in any case in which it appears to him that the health or welfare of a protected animal accommodated at the establishment gives rise to concern.

11. The designated veterinary surgeon, in any case in which it appears to him that the health or welfare of a protected animal accommodated at the establishment gives rise to concern, shall notify the personal licensee in charge of the animal and the person named in the certificate as responsible for the day-to-day care of animals.

12. All protected animals must, at all times, be provided with adequate care and accommodation appropriate to their type or species, and environmental conditions in all parts of the establishment where animals are kept shall be checked at least once daily.

13. Adequate measures shall be maintained to prevent the escape of animals.

14. Quarantine and acclimatisation facilities shall be provided as necessary.

15. A health record relating to the protected animals in the establishment shall be maintained under the supervision of the veterinary surgeon, and shall be available for inspection by the inspector.

16. Inspectors shall be provided with access to all parts of the establishment where protected animals are accommodated, at all times.

17. Adequate precautions against fire shall be maintained at all times.

18. The certificate holder shall take all reasonable steps to prevent the performance of unauthorised procedures in the establishment.

19. Whenever it is necessary to kill an animal, the killing must be carried out in an approved humane manner.").

I think it has been said in a number of quarters that whereas this Bill is in itself a step forward from the previous Act, nevertheless it is not terribly satisfactory for those who have the welfare of animals at heart unless one takes with it the various codes of conduct. I am delighted to know the draft guidelines have already been published. The draft guidelines contain some very helpful suggestions, and are quite defintely a step forward. Yet, in themselves, they are not subject to either of the usual procedures used for statutory instruments. Thus they can be altered or scrapped at will by the Secretary of State. Also, they are not enforceable through the criminal law.

I think we have an example of how these matters can go wrong in what happened under the last Bill, when, in the first 15 years of its life, a number of experiments were not allowed by the Secretary of State. That was a practice which was soon given up and licences were given practically automatically. It seems to me that we need some statutory backing for these very important guidelines. The various amendments I have put forward in some places actually amend the guidelines as suggested by the Government. However, at the moment I am trying to find the Government's reaction to what seems to me a very useful suggestion. I beg to move.

Lord Glenarthur

During the Second Reading debate the noble Lord, Lord Houghton of Sowerby, described the nature of the Bill in a few characteristically crisp words. He said: It is not a Bill which is full of prohibitions and taboos, but it is a Bill which allows the Home Secretary to have his own prohibitions and taboos and to be accountable to Parliament for the use of them",—[Official Report, 28/11/85; col. 1006.] These amendments, and the suggested new schedules which they support, cut across the whole principle of the Bill being in essence an enabling measure, with the detailed operation of its controls spelt out in guidance notes and codes of practice and available for easy scrutiny and amendment.

In addition to the objections of principle, the proposal would also involve very substantial practical difficulties. Though, exceptionally, Clause 10 contains references to four important licence or certificate conditions, the details of these and all the other standard licence or certificate conditions is not set out in the Bill, but is contained in the draft guidance notes. This is because the standard conditions may be subject to fairly frequent change, to reflect changing circumstances and improvements in scientific standards and public demands for animal welfare, and also, of course, because as conditions they are not intended to have statutory effect, and, of course, the conditions hinge on many complex technical or subjective factors which are not capable of being defined with the precision necessary for the contents of an Act of Parliament.

A further consideration is that the standard conditions are just that: they will not be applicable in every case but inclusion in the Bill would apparently necessitate this; and they will often be supplemented by other conditions tailored to fit individual circumstances.

As to the licence or certificate limitations, these are requirements imposed by the provisions of the Bill. As such they are already contained in the Bill, in the relevant provision. They are set out in the Home Office guidance notes in order to give licensees or certificate holders a concise account of their responsibilities in statute. Thus their repetition in the Bill is wholly unnecessary.

5.30 p.m.

A further point of difficulty is that the Home Office guidance note from which the proposed new schedule is taken is only in draft form. Its final form will not be settled until the Bill has completed its passage. This difficulty points up the importance of maintaining the essential nature of the Bill as an enabling measure. If any change in the standard conditions required a new Act of Parliament going through all the usual stages in your Lordships' House and another place, we should be far better off sticking with the 1876 Act.

I hope that it will be clear from what I have said that the Government view these amendments which grave concern. Their intention goes counter to the spirit in which the Bill was prepared and introduced, and their effect would be to reduce the clarity of the Bill and to hamper the aministration of its controls. I am bound to say that the changes which the noble Lord proposes will do untold damage to the carefully constructed and finely balanced Bill which has been the subject of so much consultation and upon which so many experts are more or less agreed. I hope that the noble Lord will not press it to a Division. If he does, I must ask your lordships to reject it.

Lord Houghton of Sowerby

May I say a few words on this? The noble Lord, Lord Glenarthur, kindly referred to what I said on Second Reading. The noble Lord, Lord Beaumont of Whitley, has raised the fundamental point as to what sort of Bill this is to be. A great deal of consideration has been given to this in the light of the nature of the 1876 Act and all the experience of it, which I think gave us almost the worst of both worlds from the point of view of animal protection; because there was little in the 1876 Act which really did it and it depended entirely upon the administration by the Home Secretary, equipped with little statutory power to do many of the things he felt able to do and the conditions that he felt that he could lay down for the grant of licences and certificates. Now we are trying to overcome those difficulties.

My own approach and that of many of my friends who have been in these consultations is this. Let us get the essentials of the matter in the Bill. Let us get the framework there and then ensure that powers required by the Home Secretary to work it and to administer it are there in his hands and that he is properly accountable for what he does. I say again that this Bill puts animal welfare straight into Parliament because that is where the final judgment is going to rest. It is the body to whom the Home Secretary is going to be accountable to an extent that he has never been accountable before. And he is equipped with the powers to exercise and he submits to the accountability for which the Bill provides. That is the approach to this Bill. The practical side of it is that the more one does in detail on these difficult problems of refinement and definition, of operations and of activities, in this delicate field of technology and the handling of living things, the more complicated the law becomes.

A little later we shall find out how difficult it has been to get clear a practical situation to which there would appear to have been a commonsense answer. When one puts it into the language of the statute law it becomes extremely complicated because almost every supposition, every likelihood of a situation, has to be provided for. I strongly support the approach that we have adopted to the Bill.

My final word on it is this. This has been my passionate desire in approaching this Bill. Let us have a Bill which basically will stand for a long time as the structure upon which change can take place. In this field we want enough flexibility and enough room for manoeuvre and response from the Home Secretary to take heed not only of the changing conditions of scientific research and usage but to take account of public opinion. It has been changing over the years noticeably and I think that it will change noticeably over the years to come. If we can keep the two things in harmony then I think we are set upon the right path.

I urge the Committee to stand by the principles and the framework of the Bill and to reject the idea of going into a lot of detail in schedules which will take hours to get through and we will not be satisfied when we have done so. Let us leave it to guidelines, difficult as they may be to enforce; but the co-operation that we are seeking and must have as a condition of the success of this Bill will surely come more from the voluntary response of the professional people to the guidelines that have been agreed for them and can be amended if they are wrong. Much better do it that way than any other.

The Earl of Halsbury

I rise to support the argument of the noble Lord, Lord Houghton of Sowerby. This agreement betwen myself and the noble Lord, Lord Beaumont of Whitley, is not a new one. It was manifest the whole way through the Select Committee on my own Laboratory Animals Protection Bill. It was again manifest when I saw the Laboratory Animals Protection Bill through a Committee of the Whole House the second time round in the year following its passage on the nod following the work of the Select Committee. I entirely endorse everything the noble Lord, Lord Houghton of Sowerby, says.

We are legislating for the next 100 years. One hundred and nine years have passed since the 1876 Act. All sorts of circumstances that we cannot foresee are liable to take place. The whole question from the start has been: what do you put in the Bill; what do you put on the licence; what are the powers you give the Home Secretary; how do you call him to account in Parliament? What you need is a maximum measure of elasticity to enable this Bill to survive the next 109 years, just as the 1876 Act has survived until very nearly the present moment. I entirely endorse the views of the noble Lord, Lord Houghton of Sowerby. I support the Government rejection of this amendment and I hope that your Lordships will do the same.

Lord Northfield

I wonder whether I may add one or two words. If the noble Earl had not risen, I was going to quote his very eloquent words at Second Reading on this point. They hit me very forcibly when I read them in col. 1026 of Hansard and I am glad that he almost used the same words again today. The other point which has been missed so far is that some of the subsections in the noble Lord's amendment conflict with parts of the Bill. If your Lordships will look at subsection (6) of the new schedule proposed by Amendment No. 80, it reads: No licensee carrying out any regulated procedure shall use any neuromuscular blocking agent in place of an anaesthetic. That is in direct conflict with Clause 17 where such procedures can be expressly authorised by the Secretary of State so that you would have an inconsistency in the Bill if you put that in. Again, if noble Lords will look at page 15 of the Marshalled List, the noble Lord, Lord Beaumont, says that animals in severe pain should immediately be terminated. The Bill says in other parts "alleviated". He is tightening up everywhere and giving no discretion. If you look at the preceding page of the amendment, page 14, in sub-paragraph (6), he says that in any procedure severe pain or severe distress is prohibited. That is a totally new concept to the whole of the remainder of the Bill.

I could give six or eight examples like this where the noble Lord, far from just repeating the statutory guidelines, is so tightening them up as to make a new Bill in very important respects that are in the main text. I hope that even if he returns to this—and I hope for the most eloquent reasons given by my noble friends that he will not do so—at least he will realise that he is challenging the basis of the Bill at several points.

Lord Auckland

There is nothing worse than legislation which contains long and irrelevant schedules. I think the danger of this amendment, as I see it, is that it is making the schedules, if carried, completely unworkable. The first schedule in particular contains details of methods of humane killing. It has been gone through very carefully since the 1876 legislation, and as the noble Lord, Lord Houghton of Sowerby, has so rightly said, if we are going to go into a lot of what is surely irrelevant detail about related schedules we are not going to achieve the purpose of a very desirable Bill at all.

Lord Prys-Davies

I shall be very brief, but it appears to me that the proposed amendment introduces rigidity into the Bill and that ought not to be the aim. Of course we would expect the licence-holder to act within the spirit of the guide and to observe the letter of it; but the point has been well made that with the passage of time and the advances in knowledge it may well be demonstrated that a particular situation will arise which has not been foreseen at this stage. In that event, you would not be able to keep pace with a development without introducing more amending legislation. Therefore we think there are very good reasons why this amendment should be opposed.

Lord Beaumont of Whitley

The reason for the amendment, as I said in putting it forward, is that in fact there is no safeguard in this Bill against the discarding of the very good and important ideas involved in the guidelines. No one is saying that it is something which would happen immediately but I think we should be careful to try to provide safeguards if possible.

I absolutely take the point that noble Lords have been making about the nature of the Bill and the necessity of making it a framework; but within that framework I should just like to see whether there was not some way in which the good intentions which have been put forward in the guidelines could now be preserved. I take absolutely the point made by the noble Lord, Lord Glenarthur, that in fact it would not be sensible to adopt these amendments and put them into the Bill as they stand. There is a real problem, which possibly has not been dealt with in this debate so far, but certainly I have no intention of pursuing this particular set of amendments, and I beg leave to withdraw this particular one.

Amendment, by leave, withdrawn.

Lord Beaumont of Whitley moved Amendment No. 13: Page 3, line 42, after ("person") insert—

1. ("(a) who does not satisfy the Secretary of State that he is competent in the skills of anaesthesia, analgesia, euthanasia and animal care; or
2. (b) who is").

The noble Lord said: With this amendment I think it might be for the benefit of your Lordships if we were to take the amendment in the name of the noble Earl, Lord Selkirk, No. 14. Both amendments are for the same purpose and I certainly have no preference for mine over his. Amendment No. 14: Page 3, line 43, at end insert ("or to any person unless the Secretary of State is satisfied that he has experience in the use of anaesthesia, analgesia and euthanasia, and in the handling and care of animals").

The purpose is quite clear on the face of it. In almost everything important which involves the safety of either people or animals we do ask that competence should be shown. A driving licence is required as a demonstration of competence in the relevant skill; but it is not unknown for scientists without even any of the particular skills which have been spelt out here to become licensed experimenters. If that is so, suffering may then be caused quite unnecessarily to their experimental subjects. This amendment is part of the NSPCA resolution passed at the Society's Annual General Meeting in June 1985, and it is part of NSPCA policy. I therefore hope that in one of its forms the Government will see their way to incorporating it. I beg to move.

5.45 p.m.

The Earl of Selkirk

I am grateful to the noble Lord, Lord Beaumont, for having taken these two amendments together. I would agree with him and I do not really mind which one is adopted. But I want to make the point here that the administration of an anaesthetic is a compicated matter. There are some very powerful anaesthetics available and they need to be understood. I have a relative who was engaged in medical anaesthetics, and it involves a five-year course. That is dealing with human beings of course, but we may take it that the conditions today laid down, which are in Article 28, include the stipulation that the licensee must be 18; and otherwise it is open to the Home Secretary to make up his mind as to whatever conditions he considers appropriate. The noble Lord may wish to put it in the guidelines or he may wish to put it in the Bill. What I would say is this: it is essential that it should stand somewhere.

There are two points I have made here: one is the administration of an anaesthetic and the other is the handling of animals. The handling of animals to some people is quite simple. They know how to do it. But there are many people who do not have a clue as to how to do it. Handling of that sort is second nature in a laboratory in an experimental situation where people are constantly handling animals of different sorts. I think it is necessary that this should be made part of the training, and it should be quite clear that it is an integral part of training for anyone who receives a licence.

Lord Northfield

I wonder whether I might suggest one flaw in the two amendments, apart from the fact that I believe it is better to leave it to the Home Secretary to satisfy himself that the applicant has had an appropriate level of training. As I read the Bill as drafted, the effect of the amendment would be this. If you have someone who is going to be trained under a licensee—I shall take this slowly because it is slightly complicated—he has himself to have a licence. So you would end up, with this amendment, in the rather ridiculous situation that a person who is just beginning to be trained would never be able to have a clearance because he had no experience in anaesthesia, analgesia and so forth. Therefore you would have a self-defeating situation for someone who is about to start training. He would never be allowed to start training because he could not get a licence. In those circumstances, I believe that the amendments are almost a nonsense.

Lord Melchett

If I might try to help my noble friend, I was glad to hear him say that he felt this should be left to the Home Secretary, because presumably he would agree that this fact should appear in the guide-lines which, I think I am right in saying, it does not at the moment—at least explicitly. Also, if I may say so to my noble friend, while his objection may apply to Amendment No. 14 I do not think it applies to No. 13, where what the Secretary of State is required to do is to satisfy himself as to competence and not experience.

Competence, it seems to me, may mean that the person has been adequately trained by somebody with the relevant experience, and so on. It does not imply that the person has actually to have carried out particular procedures. In all of this the Secretary of State, when he deals with an application from someone who has not had practical experience and indeed has not had a personal licence in the past, is going to have to be satisfied by those in authority over that individual that they are competent to carry out procedures which they then apply for a licence to do. That seems to me to be a difficulty the Home Secretary will be well used to facing because it is going to apply to everybody who is asking for a personal licence for the first time.

Lord Auckland

It is common ground, I think, that we all want to see qualified people carrying out these experiments, whether it is the giving of anaesthetics or anything else. I think there are existing provisions in the Bill which ensure this. Clause 4 (3)(b) says: has knowledge of the qualifications, training experience and character of the applicant". Clause 5(2) states that a project licence holder must undertake overall responsibility for the programme specified in the licence. I have myself visited a number of these testing laboratories and have seen the experiments carried out. I think the Committee should take on board the fact that, as I understand it, only registered companies can carry out these experiments. Companies which are not registered are not allowed to do this, which excludes what one might call the "cowboys", who exist in certain other undertakings.

So under those two subsections there is sufficient protection given, to the extent that a person administering an anaesthetic is trained. If perchance somebody was not trained in giving anaesthetics, it must be done under proper supervision. So I think that in both Clause 4 and Clause 5 there are sufficient protections to make this amendment unnecessary.

The Earl of Halsbury

There is some danger here of taking an over-simplistic view of what we mean by an anaesthetist. It covers a very wide spectrum of skills. If you see an anaesthetised pig on the operating table, with its abdominal wall opened in order to remove some of its super-ovulated eggs for the purpose of artificial fertilisation, it is a two-man job. You have to have an anaesthetist as well as a surgeon. But if you are going to operate on a mouse that is a one-man job and the anaesthesia for a mouse is a very simple matter.

You have a large jar with a pad of cotton wool at the bottom soaked in ether. You pick up the mouse by its tail and lower it on to the pad. When it falls over, manifesting unconsciouness, you pick it out, you attach it with rubber bands to the board on which you are going to operate, and you put a puff of cotton wool over its nose and a dropping bottle which sprinkles ether on to it. You just keep the little piece of cotton wool dry, and the operator goes on with the operation and conducts the anaesthesia himself as he goes along.

There is some danger with a very generalised amendment of this kind of making the situation too rigid. It is much best left to the Home Office inspectors and the Home Secretary to satisfy themselves that the individual has the requisite knowledge of anaesthesia for the procedure that he is going to operate.

Lord Adrian

It also seems to me that there will be many procedures under this Bill, if it becomes an Act, which do not require competence in the skills of anaesthesia, analgesia or euthanasia. These are quite mild procedures, many of which are now licensed under the 1876 Act. It is necessary to have a licence to give particular diets or to keep an animal on restricted fluids for a period. I do not see that it is sensible to require competence in the skills of anaesthesia, analgesia or euthanasia for those people who do not need them for the project which they are to be allowed to carry out.

Lord Glenarthur

I respect the concern which both the noble Lord. Lord Beaumont, and my noble friend Lord Selkirk have expressed for the need to ensure that all persons who are licensed to carry out experimental procedures on living animals shall be competent to carry out their work. It is certainly a concern which the Government share. But I am afraid that I cannot agree with the manner which either amendment proposes.

The work which is to be carried out by individual personal licensees varies enormously, and as a result so, too, do the skills required of a licensee vary. For example, many licensees will not have to carry out procedures which require the animal to be anaesthetised. In other situations, a licensee will have a specially trained colleague available to apply any anaesthetic required and will not himelf require to have such skills or the same detailed knowledge of the subject. I think that this was very much the theme which underlay the comments of the noble Lord, Lord Adrian.

It is the essence of the personal licence system that the licences to perform particular procedures will only be provided for applicants who are judged competent to carry them out and who have, where necessary, the associated general skills. In short, the licence will be tailored to fit the applicant and the circumstances.

By contrast, these amendments seek to impose blanket requirements: all licensees will be required to have the specified skills and to the same level, irrespective of whether the skills or the specified level of skills will be required. This would not be an appropriate way in which to manage the system of personal licensing, and would not improve upon the protection which the animal would at the end of the day receive. It would involve much nugatory work for the applicant, any referees he may call on, the inspector, the Home Office and the Secretary of State.

I respect the sincerity and concern of both of my noble friends and the noble Lord, Lord Beaumont, who moved the amendment. But I hope that with the fuller description of how it would in practice work, such as was given by the noble Earl, Lord Halsbury, and others, the noble Lord may feel able to withdraw his amendment.

The Earl of Selkirk

May I ask whether it is implicit in the words in the guidelines that whatever conditions are considered appropriate are brought into consideration when the Home Secretary is giving a licence where necessary?

Lord Melchett

If I may pursue the same point before the noble Lord replies, it seems to me that there is a much stronger argument, and one with which the noble Lord did not deal, for putting a reference in the guidelines, if only to tell people applying for a personal licence or for a project licence that, if they intend to carry out procedures where anaesthesia will be necessary, particularly on primates, cats or dogs in cases which will be complex, then that is something about which the Home Secretary will require some information. Surely that would be useful. In my brief intervention earlier I said that I had not as yet been able to find anything in the guidelines which refers particularly to this, and it would be helpful if there was something there.

Lord Glenarthur

My noble friend Lord Selkirk asked whether it was implicit, and the noble Lord, Lord Melchett, asked whether it could be made explicit. It is certainly implicit, which I think reassures my noble friend. I am certainly quite happy to see whether it is possible to find a suitable form of words to make it explicit in the guidelines. I should not like to be held to exactly what that form of words should be, but I think it is something that can be taken care of. With that assurance, I hope that the noble Lord and my noble friend will be further assured.

Lord Beaumont of Whitley

I absolutely take the point that my amendment as drafted is too comprehensive and too sweeping. The points which the noble Lord, Lord Melchett, and the noble Earl, Lord Selkirk, made are very valid. I am delighted that the noble Lord, Lord Glenarthur, has given an undertaking to look at the possible inclusion of this in the guidelines, and in view of that I am very happy to beg leave to withdraw the amendment standing in my name.

Amendment, by leave, withdrawn.

[Amendment No. 14 not moved.]

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

Lord Auckland

On Second Reading I drew attention to Clause 4(4), concerning the granting of personal licences at the age of 18. Since then I have had consultations with both the chemical and the pharmaceutical industries and have been considerably reassured. But I wonder whether my noble friend the Minister can indicate briefly—or, if it will take time, will write to me—some of the experiments which a person of the age of 18 can carry out. I am still not clear from the Bill what supervision will be required.

This is quite an important point on which we need some reassurance. An 18-year-old carrying out an experiment will want to make his name in the company. He will show the maximum degree of attention and sympathy where needed but it is a young age for some experiments. I wonder whether my noble friend can help the Committee on this point.

Lord Somers

I should like to support what the noble Lord has said. I have felt uneasy from the beginning about this age of 18. A young person of 18 may have very great technical ability but it does not follow—and I think it is highly unlikely—that he or she will have the sensitivity to do the job properly and to observe all the extremely tight regulations. I should have thought that 21 would be a much more appropriate age.

6 p.m.

Lord Glenarthur

I shall certainly try to help my noble friend and the Committee on this point. First, I think I am correct in saying that the age of 18 applies to the existing 1876 Act. The personal licence which this is all about establishes the obligations and restrictions which apply directly to the individual researcher by means of conditions, and above all those conditions will make the personal licensee responsible for the proper care of animals in his charge and for taking appropriate action to prevent and limit suffering.

I share the concern of both noble Lords that those who are inadequate in any way—age being a part of it—should not undertake this kind of work. But somebody of the age of 18 will be of only limited experience, even if technically able, as the noble Lord, Lord Somers, suggests. This will be realised and understood fully by those under whom he is working. I hope it is obvious but I shall spell it out that somebody of that age would undertake only very simple work under the immediate supervision of someone who is much more experienced and who would be a licensee. This is all taken care of in the licensing procedure. I do not think it is necessary to spell out the age of 21 in the way that my noble friend suggests because one could of course have somebody there who may be of that age but may be technically less competent. I hope there is reassurance in what I have said.

Lord Auckland

I am much obliged to my noble friend the Minister. For my part, he has completely reassured me.

Clause 4 agreed to.

Clause 5 [Project licences]:

[Amendment No. 15 not moved.]

Lord Adrian moved Amendment No. 16: Page 4, line 27, leave out ("or secondary").

The noble Lord said: The purpose of this amendment, which is to leave out secondary schools from the list is perfectly clear though I am aware that it is probably contentious. I do not see the sense in preventing the Secretary of State from allowing, if he thinks it appropriate, procedures in a secondary school. I would certainly not anticipate that many schools would wish to obtain the necessary personal and project licences or indeed that the Secretary of State would be often convinced that it was right to grant those licences. But I see nothing in principle against allowing the Secretary of State to make that judgment if application is made to him.

I can well envisage worthwhile procedures, very mild procedures, in schools—such as anaesthetising a fish to immobilise it in order to observe microscopically the capillary circulation in the fins—which could in my view be usefully allowed. But my general point is one which I think has been made already. In a Bill whose essence is to allow matters to be dealt with by the judgment of the Secretary of State, I think it foolish to put unnecessary restrictions on what the Secretary of State may judge to be appropriate in circumstances that may arise.

The Earl of Halsbury

I support the amendment. Do remember that we are talking about sixth form boys who are going on to university where they hope to get degrees in biology, physiology, taxonomy or whatever it may be. Do not put barriers and obstacles in the way of allowing them to gain the qualifications they need to be able to take on this work. I am sure that the amendment will lead to a situation which will be handled responsibly, and I hope that the Government will be able to agree to it.

The Earl of Selkirk

Perhaps I may point out to my noble friend that we are not talking about sixth forms; we are talking about secondary schools, which is totally different.

Lord McGregor of Durris

This is a very important amendment. It is important in principle. Yesterday the House discussed higher education and from the Government Benches the importance of science, natural and applied, and of technologies was heavily emphasised not only for its economic but for its total implications. Here we are, as the noble Earl has just said, putting harriers in the way of the acquisition of knowledge by sixth formers. This is the sort of barrier which affects the attitudes of parents and of people being taught. I am told that undergraduates are already entering medical schools and biology departments without any experience of dissection and that the situation is deteriorating. This is not the way we enter into new educational attitudes and I very much hope that the noble Lord the Minister will accept the amendment of the noble Lord, Lord Adrian.

Lord Melchett

I am afraid that I strongly oppose the amendment. I should like first of all to echo what the noble Earl, Lord Selkirk, said. The amendment does not talk of excluding simply sixth forms or sixth form colleges but all secondary schools—that is children from the age of 11 upwards presumably. Secondly, a number of noble Lords who have spoken in support of the amendment have at least implied that this will discriminate against some children as opposed to others. That is not the case. The Bill will apply to all young people going to university. They will not have had the opportunity of carrying out the procedures which would be governed by the Bill. They will all he in the same position. It will not discriminate against some people as against others.

Thirdly, nobody has yet mentioned the widespread use of alternatives to live animals in schools and in unversities for teaching purposes. We are talking about teaching people at secondary school level, not about people engaged in research, product testing and the rest of it—the areas where the use of animals is most generally and forcefully defended. We are talking about teaching young people, and on the whole even in universities there is a very strong move away from using live animals and towards using a number of other techniques such as films, recordings, models and so on, with which some noble Lords will be more familiar than I.

If the amendment were passed noble Lords who support it would be opening a can of worms. Secondary schools would become the scenes of violent controversy about whether or not live animals should be used. It is wholly undesirable from the point of view of those who support the amendment, let alone from the point of view of the animals which would be needlessly suffering as a result of it. I hope that the Government will not accept the amendment.

Lord Auckland

Since 18 is the minimum age at which project licences can be granted, presumably the number of children to which this amendment would apply is very limited. If you are going to get youngsters into this industry it is necessary that they should start as young as is reasonably possible. Provided that they are not called upon to undertake work that is outside their calibre, it seems to me that secondary schoolchildren—and I come into contact with many of them, as some of your Lordships do—should, if they are suitable, be given the experience of at least seeing how such experiments are carried out. They could then gain some idea about how the pharmaceutical and chemical industries and other industries that need to undertake animal experiments do so, so that when they become qualified or are able to help in such experiments, they will have been able to see for themselves what the atmosphere in an industry is like.

Lord Somers

Those who are opposing this amendment seem to be dividing secondary schools from sixth-form colleges. I remind your Lordships that there are still such things as public schools, which, from the point of view of education, would be looked upon as secondary schools. It would be a great pity to bar the sixth forms of those schools from anything in the way of experiments. After all, the sooner that they learn about these matters the more likely they are to be responsible when they finally come to do the work.

Also, it must be remembered that sixth-formers would be undertaking that work under responsible and guiding hands in the shape of their master. It would be a great pity to place a barrier in their way.

Lord Melchett

Does the noble Lord really mean to say that children, whether in a public school or a state school, would be undertaking such work themselves? The amendment deals with the use of live animals for the purposes of education or training. Unless there happens to be an 18 year-old teacher in a sixth form, it will not be people of that age who will be doing such work—if it is a case of the use of animals in training. The question I hope your Lordships will ask yourselves is this: what will we be teaching children about the importance of animals and about reducing their suffering if we decide that they can be legitimately used by young people of that age, and having the lack of specialisation that sixth-formers would have, in order simply to teach or educate them? I do not believe that that is justifiable.

Baroness Phillips

Speaking as a teacher. I should like to know what is the difference in Clause 5 between "the advancement of knowledge" and "education or training". When I worked in education, I always thought that I was advancing the knowledge of my pupils. There must be some distinction that is not immediately apparent.

Baroness Ewart-Biggs

Perhaps I may add to what was said by my noble friend Lord Melchett. Most of the comments made have been about the education and interests of the children. It goes without saying that it would be of great advantage both to education and to children to have experiments on animals. But less has been said about the precautions and measures taken for the well-being of the animals in those schools. I have no doubt that the masters would be in charge but they might be under some great stress. I cannot see that adequate precautions would be taken for safeguarding the well-being and care of animals if they were used in secondary schools.

Lord Glenarthur

I note the concern that has been expressed by the noble Lord, Lord McGregor of Durris, and by others, about the need to ensure that children are equipped for life and are properly taught. The noble Baroness. Lady Phillips, queried the difference between paragraphs (d) and (e); that is, between "the advancement of knowledge" and "education or training". When I looked at the subsection as she spoke, I began to wonder myself. However. I believe that the "advancement of knowledge" is intended to reflect increasing or developing techniques from a particular existing base and is not directly relevant to children, whose case is covered specially by paragraph (e).

I have to say that the proposed amendment would contradict paragraph 2 of Article 25 of the proposed Council of Europe convention, which states: Procedures shall not be permitted in secondary schools or other institutions of education and training or equivalent or lower level except where the course of education or training concerned is specifically directed at preparing for a career involving the performance of procedures or the treatment or care of animals and the procedures entail no severe or enduring pain or severe or enduring suffering". 6.15 p.m.

It has always been the Government's intention not to allow procedures of that kind in schools. At present, experiments on living animals conducted under the Cruelty to Animals Act 1876 are not permitted in schools. The most that can be done in schools is removal of the brain in cold-blooded animals. The best-known example of that is the pithing of frogs. I myself certainly remember being instructed on that particular procedure; not on the pithing itself but on what was done with the frog afterwards. I remember that there was an elaborate series of wires and levers connected up to a pointer that indicated that the frog's heart was beating. The fact that one could see that the frog's heart was beating was neither here nor there; it was expanded on a large scale.

That adds to the point made by the noble Lord, Lord Melchett. In point of fact, it is the person doing the instructing who would carry out the procedure and not the young pupil concerned. I have to say that under Clause 5(3)(e) of the Bill, even the pithing of frogs in schools would not be permitted.

I wonder whether the proposition of this amendment does not go contrary to the point made earlier by my noble friend Lord Auckland. We feel that 18 is young enough for anybody to join in such experiments and carry out the work, which is what we are talking about. Experimental animals need to be treated with dignity and I believe that they need to be treated by adults. The noble Lord, Lord Melchett, put his finger firmly on the point when he suggested that there were perfectly good alternatives nowadays to carrying out such experiments. There are marvellous videos available, which are probably much easier to make sense of than the kind of work that I watched being carried out not all that long ago. Furthermore, the equipment now available to demonstrate the effects of, for example, the beating heart of a frog, by the use of electronics and so on, has changed out of all recognition. I suggest that such alternatives are perfectly acceptable.

The amendment would alter the position considerably. It would allow painful or distressing experiments on living animals to be conducted in secondary schools. For the guidance of the noble Lord, Lord Somers, secondary schools, for the purposes of this Bill, include public schools. That would be a damaging and retrogressive change. The present restrictions on work in schools and our proposals to tighten them up further are based on the important idea that impressionable schoolchildren (and many of them will be impressionable) should not witness the deliberate infliction of pain on animals and procedures capable of causing pain or suffering, even if it is for their instruction in science—particularly when knowledge can be obtained using some of the techniques that I have just described.

At this of all times, when we are concerned about people picking up the wrong ideas from watching the wrong kind of work being done on animals, it would be a risk if we were to go the other way. I do not believe the amendment is necessary. I do not believe, either, that it is desirable, although I fully understand the points that have been made about the need to ensure that young people are thoroughly taught and that they gain everything they can from the techniques they are studying. My point is that that can be achieved in other ways.

Lord Adrian

Faced with the greater guns of the European Convention, I do not propose to press this amendment. However I should like to say that my point in raising it was not only because of my deep concern about the education of medical students and biologists, which I believe begins in school and certainly in the sixth form, but also to make the point that I would regard the Secretary of State's judgments and powers in this Bill as entirely adequate to take care of all the points raised by the noble Lords who opposed the amendment.

In general, I am very much in favour of alternatives, and so on, fur use in schools. I certainly would not advocate the use of painful experiments in schools, but I find it sad that no procedures of this kind will, if the Bill is passed, be either demonstrated or used in schools. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Lord Airedale moved Amendment No. 17: Page 4, leave out line 29.

The noble Lord said: This is a probing amendment. I take the words "forensic inquiries" to mean inquiries relevant to the administration of the criminal law. It is a rather imprecise phrase. May we have one or two examples of the kind of work that is contemplated under this heading? The Committee can then judge whether a project licence ought to be granted for such work and perhaps see whether we can narrow down paragraph (f) to be more precise than just referring to "forensic inquiries". I beg to move.

Viscount Davidson

After agreeing with the intention of the noble Lord, Lord Airedale, in his previous two amendments I regret to say that the honeymoon is now over—temporarily, no doubt—and that I must disappoint him by opposing this amendment I appreciate that it is a probing amendment and I shall endeavour to give a few examples of what he wished to know.

The skills of the Forensic Science Service will be known to us all. Forensic inquiries are a vital part of our weaponry in the unceasing struggle against criminal activity. Without forensic evidence many crimes would go unsolved. Many criminals, some of them guilty of the most appalling crimes, would go free. The effect of the amendment proposed by the noble Lord, Lord Airedale, would be to make it illegal to use living animals in any regulated procedure under this Bill if the work in question was for the purpose of forensic inquiries.

This is not an amendment which a responsible Government could view with enthusiasm. We cannot accept that this Bill should be used to hamper the fight against crime—for that would be the effect of accepting this amendment. Ours is not a new or novel view. It was the view taken by Parliament when it passed the Cruelty to Animals Act 1876. Section 12 of the Act empowers a judge to licence the conduct of an experiment on a living animal for the purpose of inquiries in a criminal case, and not the Secretary of State. Therefore, our experience of the work is second hand.

However, I can give the noble Lord three examples. The first is placing an animal in an area where there is good reason to suspect environmental contamination and where physical detection methods are not adequate and have yielded no information. Secondly, the testing of a possible poisonous substance by the administration of the substance to the animal is only done if physical methods of analysis have failed to identify the substance or its effects. The third example is producing from an animal antiserum against biological fluids from a suspect source. However. I emphasise these are very rare occasions. The power has been used only once every few years, but where it is needed it is essential.

Nor is this solely a British view. The Council of Europe Convention for the Protection of Vertebrate Animals used for experimental and other scientific purposes also includes forensic inquiries as a purpose for which experimental procedures may be performed on a protected animal. The Government believe that this is an entirely correct position and one which should be reflected in the Bill. I am sure that it is one which the vast majority of the population would support.

I know that the noble Lord is keen to root out unnecessary work on animals but I must tell him that forensic inquiries will be used only for a very important and special purpose and all the normal safeguards will apply. I hope that I have satisfied the noble Lord and that he will now feel able to withdraw his amendment.

Lord Melchett

The noble Viscount said that this procedure was used only very rarely—I believe "once every few years" were his words. Can he tell us when a judge last granted a licence, or whatever it is a judge grants, so that an animal could be used for forensic purposes? Can the noble Viscount also indicate how long before that a licence was granted? Is it every two or three years, every seven or eight years, or how long?

Viscount Davidson

I confess that I have no idea of the answer, but I will write to the noble Lord.

Lord Airedale

If it is a question of letting a criminal go free every few years balanced against the welfare of animals I do not know what answer one arrives at, but I am grateful to the noble Viscount for his reply and I am sure that the Committee will be glad of the information. I do not wish to spend further time on this, and therefore I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Lord Airedale moved Amendment No. 18: Page 4, line 31, at end insert— (" ( ) A project licence shall not be granted for the study of wounds inflicted by weapons.").

The noble Lord said: I think almost everyone views with repugnance the cold blooded infliction of wounds on animals in a laboratory by using a weapon. If the human race was more sensible there would not be any weapons. Unfortunately, in this wicked world not a day passes when nations are not at war with one another somewhere in the world.

I should have thought that there was such abundant evidence of the effects of wounds caused by weapons upon human casualties from military hospitals all over the world that this information could be collated—perhaps with the help of the Red Cross and the World Health Organisation—and made known to the medical profession worldwide. Surely this information on the effect of wounds on human casualties is vastly more valuable than information about the effect upon animals, who do not always react to experiences in the same way as human beings do. I should have thought that a good systematic collation and distribution of medical knowledge taken from the battlefields would be so vastly superior that we could dispense with this abhorrent business of inflicting wounds on animals in cold blood. I beg to move.

Viscount Massereene and Ferrard

I support this amendment. I raised this matter on Second Reading. As it is not possible to wound a carcase presumably these experiments are carried out on live animals, and they would have to be fairly large live animals. I understand that many of the experiments are carried out on pigs, presumably by the Army and perhaps by the police: but I do not know who does them.

If it is true that animals are fired at to wound them on purpose, that is fiendishly cruel. Of course, it is presumably done to find out how a certain velocity of bullet affects animals. But I too do not understand why they cannot get sufficient information from human beings who have been wounded in their hundreds of thousands in the course of war, as the noble Lord, Lord Airedale, has said. When I heard that this was being done—people deliberately wounding animals—I was astounded. Actually, I find it very hard to believe. I wonder whether the noble Lord has his facts right because I am amazed.

It is true that when an animal is shot with a high velocity bullet and is not hit in the right place—the heart—then of course the bullet paralyses the nerves of the animal, for a time which is dependent upon the size of the animal and velocity of the bullet. I sincerely hope that, when my noble friend the Minister replies, he will tell me that such shooting of live animals in order to judge the effect of wounds made by certain calibre weapons or velocity of bullet does not in fact happen.

6.30 p.m.

Lord Monson

Much as one acknowledges the good intentions of the noble Lord. Lord Airedale, I for one oppose this amendment. The basic purpose of this Bill, as I understand it, is to eliminate pain in animal experimentation and not to eliminate death. Most of us are prepared to see animals killed for food, even though we can survive perfectly well without animal protein. If we are prepared to see animals killed for food, why are we not prepared to see them killed in order to save the lives of our servicemen, provided that the animals are fully anaesthetised, humanely killed afterwards and feel no pain at any stage?

Lord Glenarthur

The first thing I ought to make quite clear—and I endeavoured to make it perfectly plain at Second Reading—is that animals are not used for the performance-testing of any sort of weapon. I hope that is perfectly clear to the Committee. I endeavoured to stress it before, but it is just possible that I did not stress it sufficiently.

This amendment is about the study of wounds and not the infliction of wounds by a weapon. It is the study of the actual wound. What the noble Lord's amendment would do is to prohibit all scientific work using live animals in the study of wounds inflicted by weapons, which I fear would be quite unacceptable. I take it that my noble friend Lord Massereene and Ferrard was referring to the effects of a weapon to see whether one particular weapon was better than another weapon, and not to the actual study of the wound concerned.

In moving his amendment, the noble Lord has made it clear that he is referring to the work undertaken by the Ministry of Defence. The Ministry undertakes wound studies to increase knowledge of their effects. That will contribute to the improvement of treatment. While alternative means are used wherever possible, some use of animals remains essential, as it does in most other areas of medical science.

Wound studies are permissible under the 1876 Act as they are directed to saving or prolonging life or relieving suffering and would fall naturally under the "permitted purpose" in Clause 5(3)(a) of the present Bill. All the Ministry's work on animals is licensed by the Home Secretary and is subject to inspection—and rigorous inspection—in exactly the same way as other work governed by the legislation. I can assure the Committee—and the noble Lord, Lord Monson, brought this point out—that of course the animals concerned are anaesthetised before that sort of work is done and there is no chance whatsoever of any suffering to the animals.

It is essential work. I know that wounds can occur. This was vividly demonstrated to all of us on our television screens during the Falklands War, when we saw the sort of injuries that sadly happened at that time, and a very great deal was learned from them of course. However, there are times when techniques cannot be fully explored by the wounds that the battlefield inevitably produces, and the fact is that the benefits which extend from the other work go not only to servicemen but to civilians who may suffer appalling injuries as a result of war or acts of terrorism.

We cannot neglect our duty to provide the best possible treatment and care. Of course I realise that the whole subject is an emotive one and perhaps to some people causes distress, but I can assure your Lordships that I have looked at it in considerable depth and learned of the sort of procedures that go on. I can assure the Committee that I have the utmost respect for those who carry out this work and their wish to see no suffering caused whatsoever. But I am also left with the very clear impression that the work that goes on, in limited numbers, is essential work and the nation would lose a great deal of benefit if this work were to fall through.

I hope that the noble Lord, Lord Airedale, will accept that explanation and will feel able to withdraw his amendment.

Lord Airedale

I did not think I would want to press this amendment to a division. I raised this matter because I know that it is of tremendous concern to people all over the country who have an abhorrence of the idea of the deliberate shooting of animals with weapons. I should not like people outside to be able to say. "The House of Lords completed a whole Committee stage without even referring to this horrible business of cold-blooded shooting at animals". It will now be possible for them to say, "Well, at least the matter was raised, they argued it out and they came to a decision".

I think that it has been useful from that point of view, if from no other, to have this debate, and I am prepared to withdraw the amendment.

Amendment, by leave, withdrawn.

Lord Melchett moved Amendment No. 19: Page 4, line 36, at end insert— ("( ) The Secretary of State shall take into account the availability of products with similar or identical effects in determining the benefit likely to accrue as a result of the programme to be specified in the licence.").

The noble Lord said: I beg to move this amendment. We are in a part of the Bill where I appreciate that we are treading on dangerous ground, in the sense that the Government, and those who have agreed with them in the way the Bill has been drafted, have taken the view that specific procedures which cause great offence to the general public should nevertheless not be ruled out on the face of the Bill but that we should rely on the guidelines and implementation of the guidelines and the licensing system—if this is what happens in practice—gradually to reduce the number of experiments or indeed to eliminate altogether certain types of experiments which are unnecessary or are unnecessarily cruel to the animals involved.

I am well aware of that general background and I am quite prepared to go along with it, but I think that there are one or two areas where there is sufficient and quite legitimate public concern, which I believe would not be opposed by scientists in the terms in which it is put, and where Parliament might be justified in giving the Home Secretary some general guidance. That is why I have tried to draft the amendment in this way: to ask the Secretary of State to take into account the availability of products with similar or identical effects. The idea that very large numbers of animals are used for testing new products which simply mimic those which are already available—the "me too" products as they are called—is one which causes very widespread public concern, and concern not just among the public. Very large numbers of animal experiments, the majority, are carried out to develop and test new drugs and appliances—nearly 2 million in 1984.

As I understand it, the vast majority of new drugs—and I shall be grateful to the noble Lord if he can tell me whether this is right—are not new formulations but new versions, duplications or combinations of existing products. In a survey of medical products marketed between 1971 and 1981 in the United Kingdom, the Medicines Division of the Department of Health and Social Security concluded that even these new chemical entities, have largely been introduced into therapeutic areas already heavily over-subscribed … for conditions which are common, largely chronic and occur principally in the affluent Western Society. Innovation is therefore largely directed towards commercial returns rather than therapeutic need".

I am well aware that that is disputed by the pharmaceutical industry. I do not think that there is a need to try to resolve that dispute during this Committee stage, even if we were able to, which I doubt. It seems to me enough for us to agree that for large numbers of animals to be treated simply to develop products where perfectly reasonable alternatives are already available and where the new product does not offer any significant advance is unacceptable, and that is something which the Home Secretary should take into account—I have put it no higher than that—in deciding whether to grant a project licence under the Bill when it becomes law.

As I say, I have tried deliberately to draft the amendment in the spirit in which the Bill has been produced and to offer guidance to the Home Secretary in an area where there is a great deal of legitimate concern which is shared by scientists. I think that the answer that would come from the pharmaceutical industry or from scientists is that the products which are defensible are new products, which offer some new advantage or benefit that is not currently available. I do not think that those would be covered by my amendment, and so it does not seem to me that that is an argument against it. On that basis, I hope that the amendment would find favour with the Government. I beg to move.

The Earl of Selkirk

I have an amendment following which I think has substantially the same objective, but it is badly drafted and I accept that the amendment of the noble Lord, Lord Melchett, is much more to the point. I have very little doubt that this amendment will put a thought into the mind of the Home Secretary; indeed, I have little doubt that it is there already. But I believe that there is considerable advantage in letting it be seen in the statute that where things can be done by other means they should be done by other means and that the Government accept that that is the right principle. I have no doubt that the Home Secretary is aware of the matter and will take it into consideration, and I think that substantially it is covered by the conditions laid down in the guidelines. But—

Lord Glenarthur

May I clarify in my mind whether my noble friend is speaking to Amendment No. 20?

The Earl of Selkirk

I am speaking to Amendment No. 19. I apologise if I did not make myself clear. I said that my amendment was badly drafted and I was trying to support the noble Lord, Lord Melchett, in what he said. If I have said something amiss, I apologise. Let us be frank. We want the Bill to be accepted.

Lord Beaumont of Whitley

Can the noble Earl tell us which amendment of his is badly drafted? I cannot see it. His Amendment No. 20, together with my Amendment No. 24, deal with a totally different point. Does he have another amendment which we have not seen?

The Earl of Selkirk

I must apologise for being so confusing. I was seeking to be as clear as I could be. What I said was that I was not moving Amendment No. 20 because it was badly drafted for various reasons, and I was trying to support the noble Lord, Lord Melchett. If I have failed to make that clear to the noble Lord, I deeply apologise. I was explaining why I thought that it was useful to have the provision in the Bill so that it could be seen that that was the intention of Parliament. I doubt very much whether in his decisions the Home Secretary will vary from that, but I think it is worth putting it forward clearly. To many people it is an important element for all to see, whereas people cannot see exactly what is in the mind of the Home Secretary. I hope that the noble Lord will give this serious consideration.

6.45 p.m.

Lord Somers

I should like to support both amendments, or either, whichever one is moved. The reason is this. We all know that alternatives to experiments at the moment are few and far between, but we all hope that with research they will grow and become more numerous; and when they do so we should make provision for it being compulsory to use them.

Lord Melchett

I think that we are in danger of getting confused. With respect, the noble Lord is not supporting my amendment but Amendment No. 20, which is on a different point. My amendment does not cover alternative means of experimentation or investigation. It deals with experimentation or investigation which is designed to produce a product where an alternative product already exists. I suggest that it is quite a different point from the point covered in Amendments Nos. 20 or 24.

Lord Somers

I apologise to the noble Lord. He is very good at making things completely incomprehensible, as is usual in politics. But I entirely agree with the point of his amendment: I also agree strongly with what the noble Earl said.

Lord Northfield

I wish to make one or two remarks. On the face of it no one can complain that my noble friend wants to put this matter clearly in front of the Secretary of State, but the sort of thing that he talked about gives a false impression. It is too bad of him to say that some of what he calls the "me too" drugs are sought for by an irresponsible industry trying to woo or to look after rich patients. That is an exaggeration which now that it is on the record must be counteracted.

Let us take a specific example of where similar—to use the word in the amendment—drugs are available. Let us consider arthritis. Many poor people have arthritis, just as many rich people do. Anybody looking for more drugs to treat arthritis, for a start, is not necessarily looking for drugs for rich people. Secondly, many patients respond differently to similar drugs for arthritis, and so it cannot be said that the existence of a similar drug means that it is unsatisfactory to produce yet another one. The same patient may also vary in his response to a drug throughout the course of treatment. He may get used to one, and a similar drug may give him the relief when the effect of the first has worn off. No single product can treat all the symptoms and underlying causes of the disease.

Let me try to put the record a little straight on another point too. The industry would be crazy to be as irresponsible as my noble friend suggests. As I said at Second Reading, it frequently takes a minimum of eight to 12 years to develop a new medicine, and it may have taken substantially longer to discover it in the first place. It may often cost over £50 million. The industry is not silly enough to develop "me too" drugs just for the sake of it, at a huge cost and with the risk that the patients will find the new drug no different from those available already. The industry is not mad. I understand the reason why my noble friend has put down the amendment, but I beg him not to exaggerate the situation.

Lord Glenarthur

I am responding to Amendment No. 19. Although my noble friend has referred to Amendment No. 20 and says that he does not intend to propose Amendment No. 20, which, I agree with the noble Lord, Lord Melchett, is essentially on a different subject, I take my noble friend's point. I do not know, of course, whether the noble Lord, Lord Beaumont, will move his amendment, Amendment No. 21.

Lord Ponsonby of Shulbrede

Amendment No. 24.

Lord Glenarthur

I apologise. I mean Amendment No. 24—just to prevent things becoming more confused.

This amendment is concerned essentially with "me, too" drugs. The noble Lord, Lord Northfield, brought out most of the points that I should like to touch upon. I shall touch upon them only briefly. The noble Lord, Lord Melchett, talks about commercial returns set against therapeutic needs. I have to say to him that I do not share, as the noble Lord, Lord Northfield, does not share, the noble Lord, Lord Melchett's hatred, if that is not too strong a word, or at any rate his apparent dislike, of the drug industry.

Lord Melchett

The noble Lord is perpetuating something that my noble friend said. The quotation that I gave—I thought that I had stated this clearly—was from the Medicines Division of the Department of Health and Social Security. I was not quoting my own views. I am quite happy to give the noble Lord the reference to the quotation. It appears in a paper written for the British Journal of Clinical Pharmacology 1981, Vol. 12, pages 453 to 463, by a Mr., Mrs. or Miss Griffin and Diggle. That is what I was quoting. It is my understanding that those individuals work for the Department of Health and Social Security.

Lord Glenarthur

I cannot refer, obviously, to that document now. I shall certainly look it up. Some of the names at least are reasonably familiar. The fact is that it would do a great deal of damage. What the noble Lord suggests, so far as I can tell, is that only one pharmaceutical company in the country should be allowed to produce aspirin, for example, prepared in accordance with the British Pharmacopoeia. That seems to me to point rather in favour of nationalising every British company. I hope that the noble Lord does not feel that way. I certainly do not.

It also seems to run slightly counter to the debates that we had on an entirely different subject—those concerned with the limited list of drugs. And lengthy debates they were. They took place last year or possibly it was early this year. At that time, many of your Lordships expressed grave concern about any damage that that piece of legislation might cause to the British pharmaceutical industry. I remember some of the comments coming from the Benches opposite. I am sure that I cannot add to the words expressed by the noble Lord, Lord Northfield. I hope that the noble Lord will not press his amendment.

Lord Beaumont of Whitley

Not only have we strayed on to a totally different amendment in the debate, but it looks at moments as if people have not even read the amendment which, basically, we are discussing. It merely says that the Secretary of State "shall take into account". It does not say that he shall not issue licences if more than one drug company is producing the same kind of drug. It simply says that he shall take it into account. Knowing the way in which the noble Lord the Minister has been responding sympathetically to the amendments put forward, I was expecting him to say that the Secretary of State will, of course, take this into account, that it goes without saying that he will take it into account and that there is therefore no need to put it into the Bill. But, clearly, from the Minister's reply, that is not the case. If it is not the case that the Secretary of State will not take this into account, that is all the more reason that we should have the amendment and have it on the face of the Bill.

Lord Airedale

As a postscript to what my noble friend has just said, I see envisaged in this amendment a situation in which not every researcher knows all about the work that every other researcher in the world is doing in his particular field. A researcher goes to the Home Secretary and asks if he may have a licence to do this work. The Home Secretary says that the researcher may not know it, but a product has recently been evolved by a colleague of his (they may not know each other) and that he, the Home Secretary, is not prepared to give him a licence because the product that the colleague has evolved is similar to that for which the researcher is seeking a licence. My noble friend Lord Beaumont says that the Home Secretary can surely do that without the need for the amendment. I hope that he can. But if he cannot, let us have this amendment.

Lord Melchett

I should like to make another point before the noble Lord replies. I was rather unhappy about his first reply to the amendment. I share the view of the noble Lord, Lord Beaumont, that he had not taken into account, if I may say so, the words "take into account" in the amendment. I was not suggesting that it would be impossible for someone to produce a similar or, indeed, identical product but simply that this was a factor that the Secretary of State should take into account when weighing the benefit of developing the new product or a similar or identical product, against the disbenefit to the animals that the product will have to be tested on. I should have thought that this was a different point to that on which the noble Lord responded.

To take the argument one step further, the noble Lord rested his case on what my noble friend Lord Northfield had to say. But my noble friend did not actually say that the amendment was wrong. He simply stated that the DHSS had overstated the case for the amendment—or that my quotation from the DHSS, if my noble friend wants me to be precise, had overstated the case for the amendment. It is not possible, surely, to have it both ways. Either this does not happen and therefore the amendment would cause no one any problems or, on the other hand, as the noble Lord seemed to imply in his first answer, it does happen and everyone should be able to produce his own version of an aspirin. If that is the case and if it is the view that the Home Secretary will take when looking at applications for project licences that might involve a "me too" product that he will say, "Yes, certainly, everyone should produce this, that or the other", then I think that there is a genuine concern and worry and an amendment of this sort would be needed in the Bill.

Lord Auckland

Is it or is it not the case that some companies specialise in a certain product for a certain condition, be it arthritis, blood cancer, cystic fibrosis or whatever? I presume that the purport of the amendment is to prevent project licences being issued to companies when a dozen or so companies may be doing research into the same condition. But there are surely some companies which specialise in a certain condition and carry out research into certain conditions, be it arthritis or whatever. Certainly, if that was the case, I should consider this amendment to be unnecessary.

Lord Melchett

That is neither the intention nor the effect of the amendment. The amendment says that the Secretary of State should not take into account what other companies are doing in research but what other products are already available in addition to the product on which the research application is made. So it is quite a different point from the one that the noble Lord raised. In any event, the amendment, if I may repeat myself for the third time, I think, does not suggest that the Secretary of State may not issue licences for that purpose but simply says that the Secretary of State should take into account the availability of already existing products when determining an application of this sort. That is quite a different point.

Lord Hunter of Newington

The starting point of this saga was the noble Lord, Lord Melchett, reading a report from the Department of Health about drugs that had been used over a 10-year period. That was a retrospective study. The report said that a lot of these drugs were "me too" drugs. I do not believe that the people who started out to do the research work—research work tends to be into unknown terrorities—were trying to get "me too" drugs. A large number of generic companies in the world make drugs that they can make. The point being missed here is that people are seriously endeavouring, for very good reasons as well as commercial ones, to get new products. For example, the original valium was introduced by the drug company and some of its cousins were introduced widely in the first 10 years of its life. Now these drugs are being replaced by new drugs with a different kind of action, and a shorter action. If this kind of thing cannot go on, there will not be progress.

Lord Glenarthur

I believe that the noble Lord, Lord Hunter, has expressed the whole thing in a nutshell, and extremely clearly. One of the reasons why my original, prepared speech in answer to the points made by the noble Lord, Lord Melchett, was so short—and I added to it—was that we certainly have not had time to take in every single aspect and to consult with the experts in the way that one would normally like to do.

I know that the noble Lord has explained why it was not possible to put the proposal down earlier, but I still believe that at the end of the day it is not sensible to proceed in the way that he suggests. All that I can suggest to him now is that we read carefully what has been said. I believe myself that there is no ground for giving way on this at all. However, I shall certainly study very carefully all that has been said by the noble Lord and I shall refer to the DHSS document which he and the noble Lord. Lord Hunter, mentioned. I hope that with the assurance that I shall at least read carefully what has been said, the noble Lord will withdraw the amendment.

Lord Airedale

I hope that when the noble Lord looks at this again he will not say that he thinks that the noble Lord, Lord Hunter, has put this in a nutshell; because, with respect to the noble Lord, he has not. If the noble Lord, Lord Hunter, was saying that this amendment would impede a drug company in trying to evolve a drug superior to valium, this amendment would certainly not inhibit that. I feel quite sure about that.

Lord Hunter of Newington

The phrase in this amendment is, in determining the benefit likely to accrue". That is a kind of guesswork. I should have thought that with the advisory systems which are provided for in this Bill the best possible information would be available to the Secretary of State. However, it is not always easy to determine "the benefit likely to accrue".

Lord Melchett

It is not, but this Bill places the duty on the Secretary of State to do just that in the case of every project licence application, a matter which was covered in some detail at Second Reading. The Secretary of State has to weigh up the relative benefits of the proposed research or testing as against the effect on the animals. That is something which I strongly welcomed about the Bill at Second Reading and which I should not want to see removed—as apparently the noble Lord, Lord Hunter, would. I think that that is a crucial part of the Bill and the package that has been put together.

I am very grateful to the noble Lord for saying that he will look at this again, because I appreciate that he did not have very long to look at the amendment and, if I may say so, the noble Lord over-reacted to what I was suggesting. I was simply saying that in making this very difficult judgment—and we all appreciate that it will be a difficult judgment—the Secretary of State should take this matter into account. At the moment there is nothing in the Bill which says that the Secretary of State should take it into account. So far as I know, there is nothing in the guidelines which says that the Secretary of State will take this into account. I should have thought that the general view would be, yes, the Secretary of State should take this into account. I do not think that it should necessarily be a determining factor.

There are many other things which the Secretary of State has to consider as well, but this is clearly an important issue. It is one about which there is very widespread public concern. I know that this is one about which there is a difference of view between the Department of Health and Social Security and the pharmaceutical industry. The noble Lord himself referred to the difficulty that the Government got into about the restricted list of products; but that was a difference of view between the Government of which the noble Lord is a member and the pharmaceutical industry. I had thought that in quoting a Government source in support of my amendment I might have struck a chord with the noble Lord, but apparently I had the reverse effect upon him and I am sorry about that.

However, I hope that the noble Lord will have a look at this again. It may be, as I suspect is the case in a number of amendments to Clause 5, that the Government would prefer to see something in the guidelines rather than on the face of the Bill. I deliberately moved the amendment in a way which I thought would leave that open to the noble Lord to say in response. He did not. I hope that the noble Lord might consider that before Report stage as he said he would, and if he has any further views perhaps he would write and let me know. If the noble Lord would confirm that he would do that, I should happily withdraw the amendment.

Lord Glenarthur

I said that I would willingly read with great care, but without commitment, all that the noble Lord had said. I am not taking anything away with a view to bringing something back at a later stage. What I said is that I shall carefully examine and read the noble Lord's comments, and indeed those of others who have taken part in this debate.

Lord Melchett

I did not ask the noble Lord to bring back an amendment at Report stage. To be clear, I asked the noble Lord whether he would write to me before Report stage if he takes any different view from the one which he has expressed today.

Lord Glenarthur

I am very happy to write to the noble Lord. But before doing so we shall all need to consider very carefully what has been said.

Lord Melchett

I am very grateful to the noble Lord for saying that. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Lord Skelmersdale

My Lords, we seem to have reached a natural break point in this Bill. I should say that it will be appropriate not to return to this subject until 8 p.m.

I beg to move that the House do now resume.

Moved accordingly, and, on Question, Motion agreed to.

House resumed.