§ 5.14 p.m.
§ Report received.
§ Clause 2 [Regulated procedures]:
Lord Adrian moved Amendment No. 1:
Page 2, line 36, at end insert—
("except that students at universities studying physiological sciences, preclinical medical students and preclinical veterinary students may, under direct supervision of personally licensed instructors authorized by an appropriate project licence, perform the procedures authorized in that project licence on decerebrate mammalian preparations.")
§ The noble Lord said: My Lords, in Committee I moved an amendment which would have placed the decerebrate animal outside the operation of the proposed Bill as, in fact, such an animal is outside the 1876 Act at present. I accept that my argument on that occasion carried insufficient weight but I said that I was concerned about the effect of the Bill on teaching at universities.
§ My present purpose is limited. It is to make possible the teaching of some basic techniques in physiology to students at university who are studying physiology, and medical students and veterinary students. There is, of course, increasing scope for alternative methods in such teaching with the use of videos, and so on, which is being undertaken. However, it is important that such students can carry out limited exercises—strictly limited with a proper concern for the number of animals involved—on living animals and decerebrate mammals. Rabbits have usually been used for this purpose. These exercises form an important part of their experience and training.1191
§ It is true that under this Bill, with an appropriate project licence, a university student could use a decerebrate mammal but it would be at a proposed cost, I gather, of some £60 for a personal licence. A class of, say, 200 students would therefore cost £12,000 in personal licences. In these days of stringency and constrained resources few universities will be able to find such sums.
§ I believe that there are two solutions to this problem, as I see it. One is to adopt the amendment I have tabled and the other to agree that where a university class is concerned an inclusive personal licence can be issued containing a list of the names of the students involved at, one would hope, a reduced cost. In either case such a class would, of course, be directly supervised by experienced holders of personal licences and be authorised by an appropriate project licence covering the exercises involved in the class.
§ I repeat what I said in Committee. A decerebrate animal is an insentient animal that does not experience pain or suffering; nor is it able to recover the ability of experiencing pain or suffering. It is my belief that student exercises have a very real value in the training of young doctors and vets. My own experience of such classes is that they are carried out with all proper seriousness and concern on the part of both the staff and the students. I beg to move.
§ Lord Glenarthur
My Lords, I quite understand the concern which the noble Lord, Lord Adrian, has expressed about the cost to universities and colleges where each individual in quite large classes of students has to obtain personal licences in order to carry out a small number of procedures. Even if only one procedure is carried out during a whole year, the full fee for a personal licensee will be chargeable to the university or college in respect of each student so licensed.
I hope that I can go some way to reassuring the noble Lord on this point. The Home Office is making arrangements for a transfer of the appropriate part of the planned cost of animal experiment inspection to the Department of Education and Science and other appropriate departments so that they will be in a position to make adjustments to grants-in-aid to universities, colleges and other Government-funded research organisations for the cost of fees imposed as a result of this Bill. The detailed arrangements are still in the course of completion but our objective is to ensure that universities, colleges and the other bodies affected do not suffer a disadvantage as a result of the introduction of fees.
I very much hope that the noble Lord, Lord Adrian, and others concerned with university teaching and research will be reassured by what I have just said; but I must point out that the act of decerebration is a regulated procedure and subsequent work on decerebrate mammalian preparations as referred to in the amendment will be a regulated procedure. There can be no exemption granted from the rigours of the projects and personal licensing system for work of this sort. Indeed, we consider that the responsibilities involved in using live animals are emphasised by the requirement to be licensed.
1192 However, as I have indicated, the arrangements which we have in hand are aimed at ensuring that the cost of the necessary licensing arrangements will be refunded to the universities and therefore does not provide an obstacle to the very skilled and valuable work which is carried out in our universities. I do not think that I have gone quite so far as the noble Lord would wish, but I hope that, with the assurances that I have been able to give him, he will be able to withdraw his amendment.
§ Lord Adrian
My Lords, with the leave of the House, may I say that I am partially reassured but I am beginning to learn of the very great complexities that exist in terms of the way in which public funds reach universities, or sometimes do not reach universities. I very much hope that in the relevant departments we shall see the effect of the generosity of the Home Office. With that, as I say, partial reassurance, I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
Viscount Davidson moved Amendment No. 2:
Page 2, line 43, after ("a") insert ("medicinal").
The noble Viscount said: My Lords, I beg to move Amendment No. 2, and it may also be convenient to discuss at the same time Amendment No. 3.
Amendment No. 3: Page 2, line 46, at end insert ("or of an order under section 35(8)(b) of that Act.").
§ Both of these amendments relate to Clause 2(6) of the Bill, which provides that a test on animals conducted under Section 32 of the Medicines Act 1968 is not a regulated procedure provided that it is administered in accordance with Section 32(4) of that Act. The purpose of this exemption is to allow for clinical trials of medicinal compounds which are controlled under the Medicines Act to be carried out without the need for further control under the Bill. Such trials are carried out at a stage when the licensing procedures under the Medicines Act will already have provided sufficient information to show that the product is safe to administer to animals and should not result in any pain or suffering. Since this is the case, the procedures do not fall within the scope of the Bill, and the provision in Clause 2(6) makes it clear that they are exempted.
§ The first amendment is a drafting amendment. As it stands, Clause 2(6) refers to the kind of clinical trial I have described merely as "a test", whereas the term used in the 1968 Act is "a medicinal test". By inserting the word "medicinal" the amendment brings the drafting of the Bill into line with the 1968 Act.
§ The purpose of the second amendment is to provide for a comparable exemption for clinical trials which are carried out for the same purpose as those conducted under Section 32 of the Medicines Act, but which are not subject to the formal requirements of Section 32 because of an exemption granted in an order made under Section 35(8)(b) of the same Act. The purpose of such an order is to permit the trial of medicinal products whose active ingredients have already been incorporated in products licensed under the Medicines Act, without the need for compliance with the restrictions imposed by Section 32 of the Act. In other respects the trials in question will be subject 1193 to close control by the Ministry of Agriculture and applicants will have to demonstrate that the products to be tested satisfy the safety and quality requirements of the legislation. In this way, the effective level of safeguards against such products causing pain or suffering when applied to an animal will be the same as for those trials carried out under Section 32 which are already exempted.
§ The Minister for Agriculture, Fisheries and Food proposes shortly to make an order under Section 35(8)(b) of the Medicines Act 1968 for the purpose I have described. It is logical that the trials to which the order relates should be treated in the same way under the Bill as those already exempted by Clause 2(6). The amendment before your Lordships would achieve this, by extending the exemption in Clause 2(6) to cover medicinal tests carried out under a Section 35(8)(b) order. I beg to move.
The Earl of Selkirk
My Lords, under Section 32 of the 1968 Act there are various licences; product licence; animal test certificate; clinical trial certificate. Are these issued by the Ministry of Agriculture or do they come under the same general category as they do in the rest of the Bill, that is to say, the Home Office? Can my noble friend tell us who issues these certificates and under what circumstances?
§ Viscount Davidson
My Lords, I stand to be corrected, but my understanding is that they come under the Ministry of Agriculture, Fisheries and Food.
§ On Question, amendment agreed to.
§ Viscount Davidson moved Amendment No. 3:
§ [Printed above.]
§ The noble Viscount said: My Lords, I beg to move this amendment.
§ On Question, amendment agreed to.
§ Clause 4 [Personal licences]:
Lord Beaumont of Whitley moved Amendment No. 3A:
Page 3, line 43, after ("person") insert—
§ The noble Lord said: My Lords, I beg to move the amendment standing in my name. The object of putting this amendment before your Lordships' House is to follow up the remarks made by the noble Lord, Lord Glenarthur, in col. 388 of Hansard, at the Committee stage of the Bill. Replying to the noble Earl, Lord Selkirk, and to the noble Lord, Lord Melchett, he said that he would try to find a suitable form of words to make this point explicit in the guidelines. He has had a little time now to look at that and I thought that this would be a suitable opportunity to ask the Minister to tell us how he has got on with that endeavour. I beg to move.
§ Lord Prys-Davies
My Lords, may I also refer to the Minister's words on Second Reading, at col. 1047 of Hansard, when he assured the House that: 1194the important point is that personal licences will be granted only where we are satisfied of the training, education and general suitability of the applicants".
§ Lord Glenarthur
My Lords, in this amendment the noble Lord, Lord Beaumont, has tried very hard to meet the drafting problem with the amendment that he moved on 12th December, which would have required all personal licensees to be competent in anaesthesia, euthanasia, analgesia and animal care, whatever the work they were to be engaged in. This amendment only requires them to be competent in those areas if they are to work in those areas. I readily concede, as I did on 12th December, that there is scope for adding to the guidance notes on these points. The actual rewording of the guidance notes has not yet been completed. It is subject to discussion, as the noble Lord will be aware, but there is that scope available in it.
The amendment, as it stands, still does not work despite the great improvements that the noble Lord has made in the amendment which he has tabled. A licensee might work on a task where an anaesthetic or analgesic needs to be used or euthanasia applied but where there is another competent licensed expert also engaged in the work. Of course, if the licensee were on his own, it is essential that he is competent and, as I have indicated in previous discussions, the whole effect of the system of personal licensing would be to enable the Secretary of State to satisfy himself that people are only permitted to carry out procedures or techniques for which they have the necessary competence.
The guidance note contains an explicit reference to this. Paragraph 32, second sentence, states that:The purpose of the personal licensing system is to ensure that the applicant is competent to perform the techniques he plans to use in procedures under the Act".A personal licence will not be issued unless we are satisfied of this. That, I think, was the point that the noble Lord, Lord Prys-Davies, was getting at when he referred to my earlier remarks at Second Reading. The relevance of the guidance notes is essential here because of the difficulties of placing the necessary detail on to the face of the Bill.
The amendment which the noble Lord has put down adds a requirement which will in many cases be unnecessary and does not improve upon the precautions which will be taken. But I shall once again repeat my assurance that we will add to paragraphs 28 to 36 of the guidance note to bring out the entirely sensible and uncontroversial policy which I believe lies behind the noble Lord's amendment. I hope that he will feel further reassured and be able to withdraw the amendment.
§ Lord Beaumont of Whitley
My Lords, I thank the Minister for his continued reassurance, and I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
§ The Deputy Speaker (Lord Wells-Pestell)
My Lords, in calling Amendment No. 4 I have to draw your Lordships' attention to the fact that there is an error, it should read:Page 4, line 11, at end insert".
§ Clause 5 [Project licences]:
Lord Beaumont of Whitley moved Amendment No. 4:
Page 4, line 11, at end insert—
("( ) A project licence shall not be granted for the performance-testing of any sort of weapon.").
§ The noble Lord said: My Lords, when we were discussing this point at the Committee stage the Minister gave an assurance that no experiments were conducted on any animal for the performance testing of any sort of weapon. This point has come up from time to time and people have strong feelings about it. If this does not happen, and I accept that it does not, it seems to me that it will do nothing but good to broadcast that fact as much as possible. I see no reason why it should not be written into the Bill. I have therefore put down the amendment in order that it should be. I beg to move.
§ Lord Melchett
My Lords, I support this amendment, to which I have put my name. I have been considering carefully what the noble Lord, Lord Glenarthur, told us at the Committee stage. Although I accept that within the terms he used performance testing of weapons does not take place, it seems to me that things are not quite as clear cut as we were led to believe.
There are two reasons for that. First, he said (at col. 397) on 12th December: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".But my attention has been drawn to the Government's reply in another place on 22nd March 1984 (at col. 570) where it is made clear that in experiments conducted at the Chemical Defence Establishment at Porton Down some wounding experiments involve the recovery of the animals. The third paragraph of the Answer says:conditions imposed on licences are complied with and where the Act requires…certificates, these are obtained. For example, this is necessary where animals are allowed to recover from anaesthesia".It says later that some animals will be allowed to recover from anaesthesia in order to trace the course of the wound. I think that there is suffering involved.
The same Written Answer also makes it clear that some rubber bullet and plastic baton round tests have been conducted on animals. A more detailed reply was given in another place on 21st February last year (at col. 501). It was said that the purpose of the tests was to ensure that the rules governing their use were such as to minimise the risk of injury. It seems to me that in that case in particular we are entering a rather grey area between experiments on animals designed to help surgeons deal with people injured by bullets and the performance testing of weapons. I should have thought that tests on plastic baton rounds fell firmly between the two cases that we were talking about at Committee stage.
The amendment may help to clear up the uncertainty that we found ourselves in at the Committee stage, and, as the noble Lord said firmly on behalf of the Government that these things should not and did not happen, it would be a welcome addition to the Bill and make the position much more clear. It 1196 would also reassure a great many people outside Parliament who are concerned.
§ Lord Glenarthur
My Lords, during the Committee stage, as has been indicated, we discussed the issue of the performance testing of weapons in response to an amendment put down by the noble Lord, Lord Beaumont, and also in the context of an amendment by the noble Lord, Lord Airedale. As the noble Lords, Lord Melchett and Lord Beaumont, have both said, I stated then that in the United Kingdom animals are not used for the performance testing of weapons. I made it clear that we allow the study of wounds inflicted by weapons but that is solely in work designed to produce better methods of treatment, and I stand by what I said. I believe that it is quite legitimate and, as I said, the animals are deeply anaesthetised when that work is done.
The noble Lord, Lord Melchett, asks about experiments to test how to treat wounds. That is a different matter from weapon testing. Animals recovering from wounds are given analgesics. They need to recover in order that the recovery from wounds may be studied. The tissue will not react if the animal is dead. The tests on baton rounds are to protect human beings and that must be as paramount as the need to take the greatest care over animals. There is no question of licensing the deliberate infliction of wounds to find ways to improve weapon performance. The noble Lord may feel that it is a grey area but I assure him that there is no question of that happening. Your Lordships will recall that I made that point also during the Second Reading debate. I understand the concern, but I hope that the position has been made plain.
It would not in any case be possible to grant a project licence for the performance testing of any weapon because of the limited purposes for which licences may be granted, as described in Clause 5(3) of the Bill, on page 4. Seven possible purposes are listed and none could be stretched to apply to the performance testing of weapons. I cannot see that the amendment would add to that list.
I recognise the concern. I stand by what I said in Committee and I have repeated it today. The tests that have to be done are for the purposes that I described and not for what others may think they are for. I can go no further than that, but I hope that the noble Lords are reassured.
§ Viscount Massereene and Ferrard
My Lords, can my noble friend the Minister say whether, when the wound heals, the animals are then put down? I hope sincerely that they are not used again for experimentation on the progress of wounds.
§ Lord Glenarthur
My Lords, there are cases, as I have described, of the recovery of an animal from the impact of a plastic baton round being studied in order to determine the effect as the wound heals. The animal concerned will be given analgesics and it will, under some circumstances, recover. I can, however, assure my noble friend that there is no question of animals being used again. It is a once-only experiment. It is unfortunate that we live in times when plastic baton rounds are necessary.
1197 My noble friend may be concerned that some other sorts of weapons may be used leading perhaps to a condition that would not be suitable for recovery. But the sort of bruising that might occur from a plastic baton round leads quite often, I am assured, to a perfectly acceptable condition. After a few hours the animal is eating and behaving quite normally. It is simply bruised. But it is important to study the work. I hope that my noble friend is reassured about re-use.
The Earl of Selkirk
My Lords, now that we are not using poison gas, which was extensively used on animals for some time, there does not seem to me to be the same need. My noble friend says, as I understand it, that because this is not permitted under Clause 5(3) it is therefore excluded. If that is so, we really have in principle the amendment that the noble Lord, Lord Melchett, moved. In fact, it would add nothing to the Bill if it was inserted. If that is correct, why does not my noble friend do it. It makes clear that anything not contained in subsection (3) of Clause 5 would not be permitted. If that is the case, then licences for this purpose—that is, the performance testing of any weapon—are already excluded. Is that the case?
§ Lord Glenarthur
My Lords, I understand my noble friend. I cannot really see, however, that by putting it in—when Clause 5(3) specifically says what the project licence shall be granted for and thatunless the Secretary of State is satisfied that it is undertaken for one or more of the following purposeshe shall not grant, effectively, that project licence—anything will be added. A question of drafting is involved here. It is not the practice to add that one definitely shall not do something in another context. To add to it in another way would not be the sort of thing that the draftsman, or anyone else for that matter, would necessarily approve of.
§ Lord Prys-Davies
My Lords, there is nothing at all, so far as I can see—the Minister will no doubt correct me if I am wrong—in Clause 5(3) to authorise the testing of the wounding effect of weapons. There is nothing at all in Clause 5(3) to authorise the appropriate licence.
§ Lord Glenarthur
My Lords, I suspect that it is covered by paragraph (d), which relates to:the advancement of knowledge in biological or behavioural sciences".I am looking at this quickly. Paragraph (a) refers to diagnosis or treatment, ill health or abnormality. That abnormality, or effects, as the Bill states, will of course be that which we are concerned about when we talk, for example, of plastic baton rounds. I believe it to be covered. If I discover that it is not, I shall immediately rectify the position.
§ Baroness Ewart-Biggs
My Lords, can the Minister give some other examples of what that could cover? This raises all sorts of possibilities in our minds. It has been mentioned that the results of plastic baton rounds would come into that category. What other kind of wound could be inflicted that would be permissible under paragraph (a)?
§ Lord Glenarthur
My Lords, I am not sure how often I can get to my feet on Report stage. However, with the leave of the House, if I may respond briefly to the noble Baroness, I do not think that I can go into the realms of hypothesis on other sorts of issues that might fall within this area. What is clear from the Bill, and what was brought out in the earlier discussion, is that no licence to do anything that is in the least outside the scope of the Bill and does not satisfy the Secretary of State will be granted. That is the assurance. It is an assurance that will be regularly scrutinised by the inspectors and by others. I do not believe that the noble Baroness need have any concern that something untoward will take place.
§ 5.45 p.m.
§ Lord Beaumont of Whitley
My Lords, I am sure that the noble Lord, Lord Glenarthur, is right. We are in danger of slipping into a Committee stage. The House always gives licence to the Minister to come back at least once at Report stage. I believe, however, that we should now wind up the debate. I thank the noble Lord for trying to help as best he can. I do not believe that he has, in fact, put forward a very good answer for not writing this into the Bill. But, obviously, given the goodwill of the Government on this point, it is not worth pressing this any further. I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
Lord Melchett moved Amendment No. 5:
Page 4, line 36, at end insert—
("( ) All project licences shall specify the manner of euthanasia to be employed where animals are to be killed either as part of a project or on its completion.
( ) A project licence shall specify that all personal licensees carrying out procedures under authority of a project licence shall be—
§ The noble Lord said: My Lords, this comes back to a point which we also discussed at Committee stage. Indeed, it raises similar issues to the amendment moved by the noble Lord, Lord Beaumont of Whitley, Amendment No. 3A to Clause 4. I have looked at what the noble Lord the Minister said at Committee stage and also at what he said to me in a letter sent on 6th January, for which I was grateful. The letter contained much helpful information including some corrections of matters that I had misunderstood. I should like to thank the noble Lord and his department for taking the trouble to give me that information.
§ In relation to this point, the noble Lord said, as he has done again today, that he was looking at the possibility—I think, in fact, it is his intention—of revising the draft guidance so that more detail about proficiency in anaesthesia is included. It seemed to me, however, that the debate at Committee stage, as the noble Lord, Lord Beaumont, said, concentrated on the question of personal licences. As the noble Lord, Lord Glenarthur, reminded us, that led to the difficulty that a number of people applying for personal licences would be asked about their proficiency in anaesthesia even though none of them was likely ever to use an anaesthetic or to need that skill.1199
§ It seemed to me therefore that the best way of getting at this problem, or this concern, about proficiency in anaesthesia and other matters such as euthanasia—a matter also discussed in Committee—would be to look at the project licence, and be sure that when a particular project was being licensed it was a condition of the licence that the individuals concerned in carrying out matters that involved killing animals, anaesthetising them, or being involved in other complex and difficult procedures, had the requisite personal skills.
§ I have mentioned euthanasia. The first part of my amendment deals with that subject. Again, this is something that we looked at in Committee. Unfortunately, I put down an amendment which meant that every time someone set a mousetrap they would need a project licence and a personal licence, and that they would no doubt have to get the mouse from a designated supplying establishment. I hope that the amendment now before the House overcomes that fairly substantial problem by making this specific to the project for which the licence application is being made.
§ On the question of killing animals, having looked at what was said at Committee stage, I think that some noble Lords underestimated the degree of skill and expertise needed to do that unpleasant job with the least suffering possible being felt by the animal. But this is a matter where skill has to be developed and where techniques change and develop over the years.
§ I think that some of the matters suggested at Committee stage would not now be done in a reputable laboratory by skilled people. Techniques have changed. It therefore seems to me all the more important that, as each project is applied for, the Secretary of State and his advisers examine the skill of the individuals who will be carrying out that project. I beg to move.
§ Lord Glenarthur
My Lords, the first part of this amendment would require project licences to specify the manner of euthanasia to be employed where animals are to be killed. I well recall that during Committee stage the noble Lord, Lord Melchett, made plain his concern for ensuring that the killing of experimental animals is always properly carried out. I certainly share that concern. But I do not consider that this amendment is a necessary or appropriate means to achieve it.
The Bill already contains comprehensive controls over the killing of animals. Schedule 1 to the Bill details a number of methods of killing which, in tightly defined circumstances, will not be a regulated procedure and thus will not require to be licensed under the Bill. In every other case the killing of an experimental animal either during a procedure or at the conclusion of a project will be closely controlled. That is the combined effect of Clause 2(7), which covers the killing of the animal for experimental or other scientific purposes, Clause 10(5) which deals with killing of animals which do not require to be killed during or as a result of a regulated procedure, and Clause 15, which covers the position where an animal is suffering adverse effects at the conclusion of a series of regulated procedures. In each case, unless a 1200 method specified in Schedule 1 is employed, the method of killing is controlled.
As a regulated procedure forming part of a project it will have to be licensed; and as part of the process of licensing the applicant for the personal licence will have to specify and have authorised the technique to be employed. Where an animal is required to be killed at the conclusion of a series of procedures because it continues to suffer adverse effects Clause 15 requires the method to be one specified under Schedule 1 or a method authorised by the personal licence of the licensee concerned. Similarly, where an animal is killed in a designated establishment otherwise than as a regulated procedure, or under Clause 15, the method of killing must be specifically approved unless it is a Schedule 1 method.
In view of this I do not think that there is any need for this part of the noble Lord's amendment. But I understand the concern of the noble Lord about the importance of this most fundamental act: that of taking life. I shall examine carefully the scope for making clearer in the Home Office guidance note that specific authorisation of methods of euthanasia other than those in Schedule 1 will be required by all licensees who wish to employ such techniques.
I turn now to the second part of the amendment, which seeks to insert in the project licence two requirements which must be satisfied by all personal licensees working under that licence. As I mentioned in reference to the earlier amendment of the noble Lord, Lord Beaumont, paragraph 32 of the draft Home Office guidance note makes the position very clear. It says:The purpose of the personal licensing system is to ensure that the applicant is competent to perform the techniques he plans to use in procedures under the Act".That is what we shall seek to ensure through the personal licensing system. We cannot necessarily ensure that an applicant is skilled in a procedure since this may be his first time of carrying it out. If that is so, we shall require him to work under supervision until he is skilled. However, the whole basis of the personal licensing system will be to ensure the competence of applicants to carry out authorised procedures. A personal licence will not be issued unless we are satisfied with this. Paragraphs 28 to 36 of the draft guidance note are devoted to explaining how this will be done.
The assessment of competence will also include assessment of ability to provide for the care of animals where this is necessary—the nursing care referred to in the amendment. For some personal licensees—perhaps a senior licensee who is only involved in the most intricate procedure—there will be little need for such skills and, of course, much of this work is carried out by technicians.
I should like to take this opportunity to put on record our appreciation of the very high standard of care which technicians provide for laboratory animals. It is something which has certainly impressed me very greatly during the visits I have made to laboratories. The general competence and ability in animal care will therefore be assessed as part of the personal licensing procedure. However, I shall certainly look again at the draft guidance note with a view to inserting an explicit 1201 reference to the assessment of ability to provide nursing care where appropriate.
From what I have said I think it will be clear that I do not consider that this amendment is appropriate. I hope that in the light of the two commitments I have given—to look for scope to improve the draft guidance note—the noble Lord will not feel it necessary to press his amendment.
§ Lord Auckland
My Lords, there are in the schedule various methods of killing, some of which are very simple, and others, such as method No. 7—"exposure to carbon dioxide", etc.—which may need more skill and experience. May I ask my noble friend the Minister whether with the more skilled (if I may use that word) methods of killing the animal humanely a veterinary surgeon, or a doctor, or somebody with medical experience carries out these acts?
§ Lord Glenarthur
My Lords, I think that much will depend upon the technique to be used. Certainly exposure to carbon dioxide—the noble Lord referred particularly to method No. 7—is the kind of technique which I believe will certainly require specialist advice. The answer to my noble friend therefore is: sometimes but not always, and much depends upon the technique that is to be used. I can assure my noble friend that no one will attempt to carry out this sort of procedure unless they are fully competent and trained to do it.
§ Lord Melchett
My Lords, I am very grateful for the assurances that the noble Lord has given, which take us a long way forward. The noble Lord made a long and detailed speech which I should like to read. I was particularly grateful for the two categoric assurances that the noble Lord gave about the guidelines. It may well be that that is the best way of dealing with this problem and meeting these concerns.
I should like to study what the noble Lord said on one point particularly carefully. While I accept that the Government foresee that the necessary competence will be ensured through the personal licensing system, the noble Lord said at Committee stage that there will be some people with personal licences who will never need, for example, to administer anaesthetics and will therefore not need those skills. I agree with the noble Lord that the best way to deal with this may well be in the guidelines, but I want to be sure that the level of personal skill of the people involved matches the skills needed in the particular project. It seems to me that that is what I was looking for with this amendment. However, the noble Lord has gone a long way to meet my concerns and I am very grateful to him for that. I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
Lord Melchett moved Amendment No. 6:
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: My Lords, I beg to move this amendment. This is one which we discussed at Committee stage and which received a rather hostile 1202 reaction from the noble Lord, Lord Glenarthur. Having had a chance to consider this again, I hope that the noble Lord may feel able to go a little further down the road and agree that there is a problem here. Certainly many people outside Parliament believe that many animals suffer unnecessarily in the course of testing and developing products for which there are already perfectly satisfactory equivalents, if not identical products on the market.
§ One respect in which we became rather sidetracked in the Committee stage concerned the suggestion that the amendment is likely to interfere with research. It does not seem to me that that is at all likely, because nobody is very likely to set out on a research programme, and probably not on a development programme, if he is simply looking for an identical product to one already on the market.
§ 6 p.m.
§ However, that does not mean to say that there are not products developed, particularly medical products, with identical or very similar effects to many already on the market and available. Those products will often not involve any basic or strategic research and may not involve very much development, either. They will simply be reformulations, or compounds using different carriers, or the mixing of compounds, or compounds which dissolve where others do not do so, and so on. All of those compounds are likely to have to be tested, and to be tested on animals. Under many legal requirements there may be the necessity to carry out the LD.50 test on them, and so on. It is the use of animals in that area—not as regards research and development but as regards testing—which gives rise to a great deal of public concern.
§ As we discussed in Committee, some companies which make household products have already forsworn the use of animals in safety-testing their products before putting them on the market, and the same is true of many companies which produce beauty products, such as make-up, scent and so on. Nevertheless, there remains very widespread public concern that animals will be used and killed in the process of testing products which are only being developed in order for somebody to get a share of a lucrative market and not to meet any real human need, or medical or other problem which the new product may overcome.
Therefore, I think that there is a need to ensure not that that type of testing is banned by the Bill—I accept that that would be unrealistic, and I accepted that at the Committee stage—but simply that this area of concern is put before the Secretary of State by the legislation when he is considering whether or not a project licence should be granted. That is what the amendment seeks to do. It will ensure that the Secretary of State has to:
take into account the availability of products with similar or identical effects".
During the Committee stage some criticism was aimed at the looseness of the wording:
products with similar or identical effects".
It was suggested that it would be very difficult for the Secretary of State to work out whether something had an indentical effect; that very rarely would one find an
identical effect; and that "similar" was a vague word. It seems to me that if all that we are asking the Secretary of State to do is to take those factors into account when reaching a decision about whether or not to issue a licence, it is quite reasonable to give him guidance couched in those kind of words. If we were laying a duty on the Secretary of State to do something regardless, then I accept that the wording would have to be more tightly drawn.
I draw your Lordships' attention again to Clause 5(4), under which the Secretary of State will be engaged in exactly that type of process. It says:
the Secretary of State shall weigh the likely adverse effects on the animals concerned".
I repeat: "the likely adverse effects". It is not a categoric instruction; it is something about which the Secretary of State will have to make an assessment against the likely benefit which may accrue as a result of the programme. In other words, when this Bill becomes an Act the Secretary of State will be involved in the process of weighing up the pros and cons. In my view that is right. As I said on Second Reading, I think that that is one of the most important advances which the Bill makes over the present law. It therefore seems to me quite reasonable that we should draw the Secretary of State's attention to the availability of identical products when he comes to make this assessment of the likely benefits as against the suffering of the animals involved. I beg to move.
§ Baroness Ewart-Biggs
My Lords, I should like to support the amendment, to which I have put my name. I should like to give a few additional reasons to those which have already been given by my noble friend for including this amendment. There can be no doubt that there are a vast number of unnecessary drugs which are introduced for commercial reasons. One can only wonder whether all of them are necessary.
There has been a great deal of research and surveys have been made about the medicinal products which are marketed. A survey was made of the medicinal products marketed in the period 1971 to 1981 in the United Kingdom. It was made by the medicines division of the DHSS and it concluded that even the remaining new chemical entities:have largely been introduced into therapeutic areas already heavily over-subscribed [and] 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".There has also been a report brought out in France by a health economist. That report revealed that 508 new chemical entities were marketed for the first time during the period 1975 to 1984. The drugs were analysed by therapeutic category and it was concluded that over 70 per cent. of the products were considered to offer no therapeutic advance over existing alternatives. That seems to be very conclusive.
It must surely be felt by a great many members of the public—and my noble friend Lord Melchett has made this point—that if this Bill could discourage the development of duplicate drugs, it would be a very great advance. Many people could even see it as being beneficial to doctors and patients, because it really 1204 must be quite impossible these days for an overworked doctor to be familiar with an ever-increasing number of drugs. Indeed, more in-depth knowledge of fewer drugs would be of benefit not only to the doctor but obviously to the patient as well, particularly in view of the large number—indeed, the epidemic number—of drug side-effects.
As my noble friend has said, he is asking the Secretary of State to take into account the availability of products with similar or identical effects. In view of all the evidence that in many cases drugs are introduced for commercial reasons rather than for therapeutic reasons, surely the amendment is a very good way of ensuring that that does not continue. I very strongly support the amendment.
§ Lord McGregor of Durris
My Lords, there is some public anxiety that this amendment would introduce a most undesirable restriction upon the considerations which the Secretary of State bears in mind in determining whether or not, and on what terms, to grant a project licence. As I understand it, the amendment rests on the assumption that the pharmaceutical industry has been devoting, and is devoting, a large part of its energies to the production of "me-too" drugs.
During the Committee stage the noble Lord, Lord Melchett, quoted at some length from the paper on licensed products in the United Kingdom from which the noble Baroness, Lady Ewart-Biggs, has just quoted a sentence or two and which, together with a paper from a French health economist—which I regret I have not read—she described as "conclusive".
I applied myself to the article which the noble Lord, Lord Melchett, cited at the Committee stage and which the noble Baroness has just quoted. The noble Lord cited its conclusion; he said that the authors concluded that these new chemical entities have largely been introduced into therapeutic areas already heavily oversubscribed. In fact, the conclusion of that paper points in a wholly different direction. The last paragraph of the paper, which the noble Baroness did not cite, reads as follows:The picture for the future is not as gloomy as might appear however from the survey of new chemical entities reaching the market. … For the 1980s it would appear that innovation in the area of genetic engineering is going to represent a major growth area and it can reasonably be expected that insulin, human growth hormone, interferon [and a number of other drugs] produced using recombinant DNA techniques in micro-organisms will reach the market. Innovation in the field of improved pharmaceutical delivery systems is also likely to lead to major improvements in therapeutics.The view which has been presented to us, that the industry is placing greater and greater emphasis on useless "me-too" drugs, manufactured for nothing but commercial reasons, is not supported by any of the evidence which has been cited to us.
§ Lord Melchett
My Lords, I do not think that I or, for that matter, my noble friend either today or at the Committee stage suggested that there was a trend in the industry which was leading to more and more "me-too" drugs being produced. In fact, I would be quite happy to accept that the trend is in the other direction. But surely the paper which we have both quoted makes it clear that there are some cases where 1205 at least some officials in the Government believe that "me-too" drugs have been produced. It does not really matter whether no more than that can be accepted.
§ Lord McGregor of Durris
My Lords, obviously some "me-too" drugs have been produced. What is at issue is the direction and development of the manufacture of drugs. The impression that I was given at the Committee stage by the citing of this article was wholly different from the understanding that I derived from reading it. It is important when laymen are involving themselves in these debates that they should apply themselves with some care to the sources they are using.
There are a number of other points to be made. First, no one can predict what research—which, after all, takes a long time and which may begin on a "me-too" drug—will ultimately produce. Secondly, my lay understanding of "me-too" drugs has been changed considerably by discussing them with experts. I learn that "me-too" drugs are frequently essential for treatment because different people react differently at different times to the same drug. Anyone who has lived with someone suffering from arthritis will know the drift of that. All of us are familiar with someone who has reacted adversely to penicillin. Clearly, it is very desirable that there should be work on "me-too" antibiotics, which may have the effect of making provision for people in such circumstances.
I could continue with this sort of discussion, but it seems to point very importantly in the direction of not restricting the Secretary of State's determination of the considerations involved in giving a project licence in this way. I hope that we shall oppose this amendment.
§ Lord Airedale
My Lords, without wishing to join issue with my noble friend on this, it seems to me that the usefulness of this amendment is that the Secretary of State may be in a better position than the particular applicant for the licence to know whether other similar products are available. There may be some other similar product available from abroad which comes to the Secretary of State's attention but which is not known to the applicant for the licence. That seems to me to be a good reason for supporting this amendment.
§ 6.15 p.m.
§ Lord Swinfen
My Lords, I should like to support what the noble Lord, Lord McGregor of Durris, has said. The benefits in testing relating to this proposed amendment presuppose that they are solely to the human being. What worries me is that drugs which can help to cure and which can be of great benefit to many people very often have very bad side effects on others. It is absolutely essential that we are able to test drugs that give the same curative benefit but which have different side effects on different people or no side effects. There are occasions when drugs that can be beneficial in certain diseases cannot be prescribed because the side effects are so great that they are worse than the disease itself. If the Secretary of State is limited by an amendment such as this, we may well find that we are not in a position to produce alternative drugs.
§ Lord Auckland
My Lords, it has always been my belief that the Medicines Commission was set up to look inter alia into this problem. Surely the fact that it takes a long time to obtain a patent licence on a drug means that the "me-too" drugs have at least been very much decreased. Of course, if one sees the advertisements in some of the medical press one will realise that the medical profession itself, and particularly general practitioners, will deplore a proliferation of "me-too" drugs.
So far as the pharmaceutical companies themselves are concerned, particularly the larger companies, if there was a surfeit of these "me-too" drugs their profits would surely diminish because there would not be the need for these drugs to be used. Of course, side effects are an important consideration. Therefore, while "me-too" drugs are to be discouraged, I believe that, among other pieces of legislation, there is current legislation under the Medicines Act which should take care of the purpose of this amendment.
§ Lord Somers
My Lords, surely the Secretary of State will have enough knowledge of the subject to realise that that is the case. This amendment is not in the least limiting him. It is merely saying that he shall take into account the fact that there are other products. That being the case, I entirely sympathise with the amendment.
§ Lord Glenarthur
My Lords, as the noble Lord, Lord Melchett, said, I indicated that I would carefully consider the subject in the light of our previous discussions; and that I have done. However, I must tell him that I remain of the view that this amendment would not be suitable for inclusion in the Bill. I shall deal first with the paper referred to by the noble Lord, Lord Melchett, and subsequently raised today. This was a paper by two persons employed as senior members of the medical staff of the Department of Health and Social Security, though I understand that the document was not an official production of that department. The paper reviewed the new medicinal products licensed in the United Kingdom during the period 1971 to 1981. Others of your Lordships may not have had the benefit of seeing this paper, so I shall be brief and I shall not go into too many quotations.
The paper indeed notes that the bulk of the new substances licensed were concentrated on a relatively small number of conditions. However, I should say that having read this in context I note that the main focus of the paper is on the small number of new substances licensed each year. During the period reviewed this was in the region of 20 a year. It was these which were clustered in the way that the noble Lord's quotation referred to at the Committee stage.
A large number of other products were licensed, but these were not new chemical entities. The view in the paper was that if there is a low number of new substances becoming available this is a bad thing, and I am bound to say that I agree with that. As Hippocrates said over 2,000 years ago:The life so short, the art so long to learn".We are all aware of the great scope which still exists for developing medical treatment both in dramatic and in more mundane ways. My concern about this amendment is that it does not fully take account of that need.
1207 The amendment is based upon the idea that the decision whether to allow research into the development of a product should take account of the existence of any other product with a similar or identical effect. The noble Lord, Lord Melchett, seems to be of the view that where other products already exist the product to be developed is likely to be of less value because of this, and as a result it should be more difficult to justify issuing the necessary project licences.
There are some important arguments against this view. First, as the noble Lord, Lord McGregor of Durris, said, there are variations in the response of individual patients to medicines. This was a point also brought out by my noble friend Lord Swinfen. There is virtually no medicine which is completely effective in the treatment of a disease in all patients. That seems to me to be the nub of it.
Most medicines have some limitations, and in many cases may be effective only in a limited number of patients. The fact is that there is a benefit to the community in the existance of a range of medicines for a particular condition, each with a similar effect, if this allows the medicine to be tailored to the patient. The idea that we can stop looking for a remedy for a particular condition once we have one remedy to hand really is nonsense; and, of course, progress is often incremental. Treatment for a condition may be improved by the slow addition of unspectacular refinements. The great dramatic breakthrough is by no means the only route to success in this area.
The noble Lord, Lord McGregor brought out another valuable point, and that is that research is an exceedingly long and complex process and the final outcome often cannot be predicted accurately. We have to be extremely careful not to cut off the chance of health or lifesaving advances because of a narrow view of usefulness of the anticipated result.
The third point is that in some senses research does not stop when a product is marketed. Its use in clinical practice over a number of years has to be monitored and evaluated before the therapeutic benefits can be properly assessed. The question of a therapeutic advance is exceedingly complex. The penalties for the community of a wrong judgment made at the point at which a project licence application is considered could be very serious indeed.
As the noble Lord, Lord Airedale, suggested, this amendment would put the Secretary of State in a position of having to take into account the availability of other products. But, as I have tried to show, this really is not a task which the Secretary of State should have placed upon him. The amendment would require the Secretary of State to take account of a factor of a drug, or whatever. To suggest that the Secretary of State might be better placed than applicants to know whether other products are available, which the noble Lord, Lord Airedale, suggested, I do not think is right. The pharmaceutical company is much better placed than the Secretary of State to know whether other products are available. It seems to me to be their lifeblood to know precisely that.
It sounds simple enough, but the Secretary of State would not be able to do it in the way that the noble Lord wishes it to be done without running a grave risk 1208 of damaging the research and production base upon which our future advances in the medicines depend, and also denying the community some of the benefits of continuing developments in this essential area of research which we all want to see go on. I have answered the noble Lord at rather greater length than I had intended, but the result of his amendment would have far-reaching and damaging effects, and I hope he will see his way clear to withdrawing his amendment.
§ Lord Airedale
My Lords, although we are on Report, as I was referred to just now may I simply ask this question? Is there to be absolutely no limitation upon the number of new projects that are to be undertaken when there appears to be a multiplicity of drugs of that character already on the market? People outside Parliament are tremendously concerned about this aspect of the matter.
§ Lord Glenarthur
My Lords, with the leave of the House may I say that I recognise that concern. We return in essence to the fundamentals of the Bill, and that is the need to ensure that project licences are given only in areas where it is essential for the work to be carried out. Obviously I cannot speak for the drug companies, but research will continue, and research that involves the use of animals will be minimised. That is the purpose not only of the drug companies but also of the Bill in the sense of the project licence issue.
§ Lord Melchett
My Lords, I have listened to the comments on my amendment, and again it has aroused considerable interest. I find the arguments raised against this suggestion difficult to follow, not to say contradictory. On the one hand, it is argued that no commercial company in its right mind would develop a "me too" drug because the cost of development is so great that it would not be worth while if there was already something on the market. On the other hand, it is suggested that anything which looks like a "me too" drug is not so really because it may have slightly different side effects on some people who take it than on others—although how it is possible to tell that when development starts I should be interested to know.
As the noble Lord, Lord McGregor, said, there is another limb of the argument which contradicts the first two; that is, that there are some "me too" drugs produced but that the number is decreasing.
§ Lord McGregor of Durris
My Lords, would the noble Lord allow me to intervene? I was simply quoting the article that the noble Lord, Lord Melchett, quoted. It was that article which said that the number of "me too" drugs was decreasing.
§ Lord Melchett
My Lords, I apologise to the noble Lord: I thought he quoted that part of the article because it was a part with which he agreed. If he did not agree with it, he certainly did not say so at the time.
It may well be the case, as the article said, that the number of "me too" drugs is decreasing, and some suggestion that that was the case was made by at least one other noble Lord. But there are examples—and I would say that the enormous proliferation of minor tranquillisers is one—of where a new drug is produced, 1209 there is a large market for it, and on the whole it is not a case of a serious disease with fatal effects being treated.
I am quite sure that if, for example, one pharmaceutical company were to find a drug which counteracted the effects of an alcoholic hangover, there would be no question of other pharmaceutical companies saying, "We must not enter into that market: it has already been satisfied by a drug". Nor would they be worrying about the side effects that the particular drug might have. They would see that here was a huge commercial market, with world-wide sales of billions of pounds, and all of them would be doing research and development from that second to produce their own product to fill that market.
What has not been mentioned by any of those who oppose this amendment is at what cost this is done to the animals involved. The question that none of those who oppose the amendment has addressed themselves to is: are we justified in producing a drug with slightly different side-effects on a small number of people in every case where that has occurred at the cost of many animals being killed, many animals suffering under unpleasant and possibly very painful experiments? That is the question which nobody who opposed this amendment either at Committee stage or now on Report has seen fit to address. That is the question to which I feel we ought to be asking the Secretary of State to address his mind. I am worried at the thought that the Bill will become an Act without that being made explicit in it.
I am conscious that the amendment has had a mixed reception in your Lordships' House. I am not sure that it would advance my case very much to put the matter to the vote. I hope that when the Bill reaches another place they will return to this and they will benefit from the arguments which are being exposed on either side in your Lordships' House. I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.
§ 6.30 p.m.
Lord Beaumont of Whitley moved Amendment No. 7:
Page 4, line 42, at end insert—
("( ) A project licence shall not be granted unless the Secretary of State is satisfied that thorough consideration has been given to the use of alternative methods and the use of live animals is the only feasible means of achieving the purpose.").
The noble Lord said: My Lords, this amendment moves from the question of alternative products to alternative methods in making the necessary experiments and investigations. The amendment that we have put down has taken the requirement from the guidelines and has put it into the Bill. When dealing with this amendment at Committee stage the noble Lord, Lord Glenarthur, said:
The effect of the amendment would be to make the validity of a project licence dependent upon whether any feasible alternative method of research was available at the time the authority was granted, which is something which cannot be determined in any clear-cut way".—[Official Report, 12/12/85; col. 429.]
§ I do not think that that is a good enough argument to put before your Lordships' House. This is a Bill in which we are trying to spell out what the law is. If we agree that the object of this amendment is worth 1210 achieving then we should put it in. I cannot frankly see or visualise the situation in which this could possibly be brought to the courts and therefore have the kind of result which the noble Lord, Lord Glenarthur, seemed to be putting forward as the main objection to this amendment. It is surely absolutely worthwhile that full consideration should be given to the use of alternative methods and that the use of live animals should be the only feasible means of achieving the purpose. That is agreed on all sides. It is written into the guidelines. It seems to me to be a good thing to write it into the Bill, not least because it puts it on the plate of the Secretary of State.
§ When the noble Lord, Lord Airedale, in dealing with the last amendment, said that the Secretary of State had a considerable amount of expertise and knowledge, the noble Lord, Lord Glenarthur, answered—to paraphrase his words—that the large drug companies probably had a great deal more. I do not think that that argument should be allowed to stand unquestioned. To start with, we are not only talking about the experiments that will be done by the large drug companies, but we are considering experiments which will be done in small university departments or similar such resources. To continue and to look at the other side I seem to remember that at an earlier stage of this Bill (I cannot give chapter and verse now) we were assured that the resources at the disposal of the Secretary of State and the advisory committee were enormous, and that all the results and scientific expertise already now flow into the Home Office and are available. If that is so, we should be able to tap it. One of the ways it should be tapped in the defence of animals is by writing this into the Bill. I beg to move.
§ Lord Prys-Davies
My Lords, very briefly, I wish to support the amendment proposed by the noble Lord, Lord Beaumont. Indeed, I endorse all he has said in support of it. As I understand it, one of the objects of the Bill is to reduce, if not to eliminate, the unnecessary use of animals in scientific procedures. This is one way of achieving that end. I do not want to anticipate what is ahead of us, but assuming that Amendment No. 19, which reflects the thinking of the Government, is acceptable to your Lordships' House, it appears to me that this amendment is almost consequential on Amendment No. 19. I support the amendment on the grounds that this is one way, possibly the best way, of ensuring the objects of the Bill. If it is not acceptable to the Government, what real significance do we attach to the objects as set out and as reflected in Amendment No. 19 to which we shall come?
§ Lord Auckland
My Lords, if it were the case that an increasing number of live animals were being used in these experiments, there would then be much substance in this amendment. My noble friend the Minister will confirm or deny whether the number of live animals being used in experiments is on the decrease. I do not know whether he has any figures available.
Also in these amendments an enormous amount will devolve on the Secretary of State. Surely under the very rigid rules for project licences already written into the Bill this is very largely taken care of. If a large 1211 number of new animals were being used in these experiments there would be every justification for an amendment of this kind. But as I understand that fewer are being used I wonder whether this is rather a superfluous amendment.
The Earl of Halsbury
My Lords, I cannot support the amendment of my noble friend Lord Beaumont of Whitley because it springs from a misunderstanding of the definable character of a feasible alternative. Commonsense and economics are what we must rely on to ensure that alternative methods, being much cheaper than the use of live animals, will be used wherever available. But there is no watertight definition of what is a feasible alternative. One has to experiment with alternatives and animals in parallel on the same tests for a very long time to validate the alternative. We are back to the old tussle that we have had from the start about what should be put in the Bill, what is to be put as a condition in the licence and what is to be put in the guidelines.
The conditions of the licence and what is put in the guidelines are elastic. Once the Bill is an Act it is inelastic. If one is to put any firm inelastic injunction into the Bill, into what will always be an elastic and fluid situation, one would be committing a complete and total mistake.
§ Lord Melchett
My Lords, the noble Earl has used that argument and did so on several occasions at Committee stage, sometimes with some force. However, it does not seem to me to be a valid argument in relation to this amendment. The consequence of what the noble Earl is saying is that there may forseeably come a time when he thinks it would be right for a licence to be given when a thorough consideration has not been given to the alternatives to the use of live animals. I do not think any of us believes that we are legislating in this field so that the law will mean that it is possible for a future Secretary of State to dish out licences without any consideration of whether alternatives are available. It may be that to write into the Bill specific requirements about particular tests like the LD50 test and so on poses difficulties, because, if some EEC regulation comes in which requires these tests to take place or which increases the number of animal tests, a specific requirement in the Bill affected by that would be a considerable disadvantage and it would be necessary to change the Act itself.
I really do not think that that is a valid argument in respect of this amendment, unless the noble Lord is prepared to carry his logic through and say, "I am happy to see in the future the possibility of the Secretary of State saying, 'I don't give a fig about the alternatives. I am going to give a licence anyhow in these circumstances, even if valid alternatives are available' ". That is not the case and I do not think it would be within the Secretary of State's powers under the Bill as it is drafted. It seems to me that this sort of provision appearing on the face of the Bill rather than in the guidelines—and it is going to have an effect whether it appears in the guidelines or the Bill; I accept 1212 that immediately—will have the consequence of underlining its importance.
In particular, it seems to me to change the character of the Bill slightly. One of my worries at the Committee stage—and we shall come to this later, so I shall not do more than mention it at the moment—was that the terms of reference of the Animal Procedure Committee were very static in the way they were drawn. They did not envisage any possibility of improvement in the situation. We come to that later. I think that that also to some extent applies to the conditions under which project licences might be granted.
I hope that all of us, without any antagonism, without anybody feeling threatened by it, look forward to the day when gradually fewer and fewer animals are used in experiments and more and more alternatives become available. Some would like to see that process going faster, or believe that it could go faster, than others; but surely we are united in that.
Putting this amendment in the Bill simply reflects what I would have thought and hoped would be a united and unanimous view about the way things are already going and will continue to go in future. Therefore, I support the amendment.
§ Lord Somers
My Lords, one great thing that including this amendment in the Bill might do is to stimulate research into alternative methods, which at the moment are rather few and far between. It is high time that a great deal more research took place, it seems to me. If we include this amendment of course, it will stimulate that approach.
§ Lord Glenarthur
My Lords, I should first say that we attach the highest importance to encouraging and promoting the use of alternatives—a point which the noble Lord, Lord Somers, has just made. It is a factor to which the Secretary of State will give the closest attention in deciding whether to grant project licence applications. If I may anticipate the amendment which was referred to by the noble Lord, Lord Prys-Davies, Amendment No. 19, which we shall consider later, there is further evidence of the importance which we attach to this issue in that amendment. That amendment seeks to insert in the terms of reference of the Animal Procedures Committee a specific requirement to have regard to the protection of animals against unnecessary use in scientific procedures.
However, as I made clear during the Committee stage, this is not a matter which it is appropriate to deal with on the face of the Bill. To that extent, I am grateful to the noble Earl, Lord Halsbury, for bringing up the point. As I pointed out earlier, the question of whether an alternative method of research is feasible is really highly subjective and it would be completely wrong to make a provision of the Bill dependent upon a concept like this which could not be determined in a clear-cut way. I note that the noble Lord, Lord Beaumont, does not like that remark. I quoted what was said and I repeated it. The whole thing boils down to the question of the subjectiveness of the term "feasibility", as I said just now—whether or not it should be on the face of the Bill or in the guidelines.
1213 6.45 p.m.
None of this should be taken as detracting at all from the need for this issue to be considered. I have said that we attach very great importance to the use of alternatives wherever possible; and in that I hope I reassured the noble Lord, Lord Somers. Indeed, the words of the amendment are set out in paragraph 58(b) of the draft Home Office guidance note:whether thorough consideration has been given to the use of alternative methods and the use of live animals is the only feasible means of achieving the purpose".This is one of the most important factors which must be taken into account whenever it is relevant. All applicants for project licences will be required to declare on the application form that they have considered the use of alternative methods. This is a matter which will be vigorously examined, but it is not suitable for inclusion in the Bill.
The noble Lord, Lord Beaumont, suggested that my argument in relation to the Secretary of State's knowledge about drugs was perhaps the argument that I was advocating here. I think he may have got me slightly wrong. I may not have expressed it very well. It is certainly true that the Secretary of State knows better than some applicants whether alternatives are available—not quite the same thing as knowing which drugs are available and how they are developing. I certainly agree with the noble Lord, Lord Beaumont, in what he feels here, but again it boils down to the issue of whether or not it should be contained in the Bill or in the guidelines.
My noble friend Lord Auckland very rightly drew attention to the numbers of experiments. Although broad statistics are available—and I am sure that the noble Lord has a copy of Statistics of Experiments on Living Animals: Great Britain, 1984— in a nutshell, the decrease was from 5.6 million in 1970 to 3.5 million in 1984. We certainly hope that that figure reduces further; and a lot of people are doing a great deal to try to achieve that.
I have indicated why I do not believe that the purpose which this amendments aims to achieve needs, or is suitable, to be included in the Bill. I hope that In the light of the explanation I have given, and the assurance that the guidelines are the best place to put it, the noble Lord will feel able to withdraw the amendment.
§ Lord Beaumont of Whitley
My Lords, I do not pretend to be convinced. As my noble friend Lord Halsbury has said, it is undoubtedly another of these questions as to where you draw the dividing line between what should be in the Bill and what should be in the various other documents. I do not think that the decisions which have been made are necessarily immutable, or that all of them are absolutely the right ones, although I certainly think that the general basis on which they have been put forward is the right one and is the result of good thinking, which is going to be very useful and helpful to the welfare of animals.
I also take the point which the noble Lord, Lord Glenarthur, has made about the new amendment which has been put down to Clause 20; that is, Amendment No. 19. I think that is a very definite step forward. In those circumstances, I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.1214
§ Clause 9 [Consultation.]
Lord Melchett moved Amendment No. 8:
Page 7, line 31, at end insert—
("( ) Where a procedure involves risk of substantial pain or distress the Secretary of State, in addition to consulting an inspector under subsection (1) above, shall consult—
§ The noble Lord said: My Lords, we now move on to Clause 9 and the question of issuing licences and the need for consultation before they are issued. At Committee stage we had a debate fairly late at night—later, I hope, than we shall be debating the Bill tonight—about this matter. In that case the amendment talked about consulting the Animal Procedures Committee and tackled two issues: a licence application for a procedure which would involve the infliction of pain of substantial severity or for the purpose of training in manual skills. The noble Lord told me that at least one aspect of training in manual skills was under review. There were objections raised to the automatic referral to the Animal Procedures Committee of all applications where there was a risk of substantial pain or distress being inflicted on an animal.
§ Another thing the noble Lord said at Committee stage was that we were talking here not about just a very small number of applications (which is what I and a number of other people had assumed) but about applications which would run into hundreds during any one year. The noble Lord very kindly wrote to me, as I said earlier, and one of the things he stated there was that he was not able to give any more precise figure that that. I can understand the difficulty of definition of a procedure where a risk is involved of inflicting substantial pain. Nevertheless, those kinds of judgments will be made when applications for particular projects are received. It seems to me that, given that we are talking here about procedures where anaesthetics will not be used because substantial pain or distress is likely to be inflicted, we are talking about experiments which are likely to cause the maximum amount of public concern. In those circumstances, it seems to me that rather more than simply the standard consultation with a Home Office inspector and one independent assessor is called for and is justified.
§ I considered the arguments against automatically referring all these things to the Animal Procedures Committee. I can see some weight in that but it seems to me, as an absolute minimum, that the Secretary of State should be required to consult two independent assessors rather than one in these cases. I have not just picked the figure two out of the air but I think it will be necessary, at the very least, to consult one person who will be well informed about the particular scientific area in which the procedure is to be carried out—that is, of research, if it is research work, or whatever. It would also be useful to consult at least one person who would have a great deal of expertise in the use of alternatives because this is an area, above all others, in which if an alternative procedure can be used—an alternative involving animals or an alternative involving no animals at all, which would be even better—then of course it should be.1215
§ However, it also occurred to me that there might be some applications which were controversial or likely to become controversial or difficult, or where for some reason or another—I can see this might be very exceptional—it was not possible to find two independent assessors. In those cases, it would be sensible for the Animal Procedures Committee to be called in or for the Secretary of State at least to have that option available to him should he require it. The amendment is therefore drafted to allow that kind of flexibility and indeed for a third possibility, namely, of both the assessors and the Animal Procedures Committee to be consulted if the Secretary of State so wishes. This is discretionary. The minimum, and the only absolute, requirement is that the Secretary of State should consult, as he has to do already, an inspector and at least two independent assessors.
§ Once again, we are dealing with a subject where, quite rightly and justifiably, a great deal of public concern is aroused—procedures involving at least the risk of substantial pain or distress. It seems to me that in those cases, even if they do number hundreds—and I certainly hope that in practice they will not—some rather more rigorous screening should be carried out before a project licence is granted. I have therefore tried in this amendment, in the hope that it will be acceptable to the Government, to set that additional screening at the minimum level I felt it was possible to devise. I have sought not to be obstructive or difficult in this amendment but genuinely to try to find a formula which would be satisfactory to those concerned in operating the system, bath in applying for licences and in carrying out the administrative procedures, and which would also go some way (if only a little way) towards allaying very deep-seated public concern. I beg to move.
§ Lord Houghton of Sowerby
My Lords, I really cannot see that to introduce this new form of institutional surveyors of the administration of the Act is going to serve any useful purpose. The new thing suggested in this amendment is to bring in two independent assessors. Where are they to come from? Find me two independent assessors in this field! We will soon have to have a panel of independent assessors. I think that having got in place the Animal Procedures Committee, which is going to be the substantive body for reference by the Secretary of State, we ought to leave it to work these things out in its relationship with the Secretary of State. I think it can be done in that way; otherwise we are complicating our machinery and we are doing some of the things—all the time, as a matter of fact—which the general framework of the Bill was intended to avoid. Having given the Secretary of State a good deal of discretion, and having imposed upon him a good deal of authority and an awful lot of responsibility, we then seek to limit his discretion or to define its boundaries and thus complicate the Bill with clauses which are meaningless in statute law form.
We have just considered one or two which would have really no meaning in law, because it would be impossible to decide when they had been complied with. Here I think we are tending to go in the same direction of not leaving things alone, having got the 1216 Bill set up and the whole framework of administration within it. I think that if things turn out to be less than satisfactory in administration the Animal Procedures Committee—and it will not be advisory, but will have a higher and stronger status than that—will be there to watch what is going on and to make approaches to the Secretary of State on matters it thinks require its attention or which could be looked into by it with advantage. So I hope that my noble friend will not press this. It is an elaboration, it seems to me, which is unnecessary and which will only add to the problems of administration.
§ Viscount Massereene and Ferrard
My Lords, I should just like to say that I heartily agree with what the noble Lord, Lord Houghton of Sowerby, has just said. With due respect to the movers of some of these amendments, they are really quite unnecessarily complicating the Bill. I should just like to reiterate my hearty agreement with the noble Lord.
§ Lord Prys-Davies
My Lords, with the greatest respect to the noble Lord, Lord Houghton, I do not see that this amendment complicates the Bill. Again, with respect, I do not see that the Animal Procedures Committee will necessarily have a locus in this matter. It will have a locus in this matter only if the Secretary of State refers the matter to the committee for an opinion. It seems to me that the point my noble friend Lord Melchett is making is that whereas the Bill generally deals with pain and suffering, there is another category of substantial pain or distress. If one can foresee that a procedure is likely to result in substantial pain or distress, then one ought to be taking additional safeguards. And one of the safeguards pointed out by my noble friend is that before the licence is granted the Secretary of State should not merely depend upon the inspector but should look either to two independent assessors or to the Animal Procedures Committee for advice. I think he has made out his case.
§ 7 p.m.
§ Lord Airedale
My Lords, I hope it is in order to welcome back to our deliberations in health and strength the noble Lord, Lord Houghton, who returns to us from his recent indisposition.
The Earl of Selkirk
My Lords, I find it difficult to follow the noble Lord, Lord Houghton, in what he said. I was shaken by the words of my noble friend Lord Glenarthur. The original amendment said that the committee should know about the infliction of pain of substantial severity. The noble Lord said that that was not possible, because there were so many; it went into hundreds and hundreds. But this is a Bill for the protection of animals used for experimental and other purposes. Animals are subjected to substantial severity of pain, I think that must be known by the committee, but there was no assurance from my noble friend that it would know anything at all about it. I take it that that is what is wanted, and I do not think it would complicate the issue. It may be that the Secretary of State will refer it, but he may not and we should see that cases of severe pain are examined by an outside authority which is put there for that express purpose.
1217 My noble friend may prefer to do it in a different way, but so far we have no information at all on what the committee will be allowed to see. I have asked that question and have had no answer at all to it; but something of this sort is required. I shall be glad if my noble friend can express a way in which it should be done, but I think it requires a degree of leverage.
§ Lord Beaumont of Whitley
My Lords, I should like to make a point, because I was very struck by what the noble Lord, Lord Prys-Davies, said. It seems to me that this is the moment when we put an extra ethical imperative into the Bill. As a whole, as I have said before, we are all agreed that this is a civilised Bill of which we, as civilised people, approve. There will be less pain suffered by animals, yet the cause of medical research is going on. But where a procedure involves risk of substantial pain or distress, this is the moment when we should put in the extra dimension of saying that this is very serious and that not just the number of animals and the amount of suffering weighed against the amount of good is important, but that it actually matters whether any animal, even rat No. 777 out of a particular batch, suffers unnecessarily. This is important.
If we want to go that extra step—and I think it is something of an extra step—beyond the Bill as we have it at the moment, this is an important amendment. I hope that the Government will understand the seriousness of this; and, as the noble Earl, Lord Selkirk, said, I hope that if they do not like this amendment then they will put down another one which will have much the same end result but which will have the effect of drawing the line and of focusing attention on the individual suffering of the particular animal.
§ Viscount Davidson
My Lords, I, too, should first like to welcome most warmly the return of the noble Lord, Lord Houghton of Sowerby, and to wish him a very speedy recovery, which by the sound of it he has already made.
I understand the general concern which surrounds the work which is the subject of this amendment. The substantial category of severity is the highest category of severity which will be permitted in work carried out under this Bill. Nothing more severe than this will be allowed. It is right, therefore, that we should ensure that applications for work which will involve procedures in this category of severity should be given particularly close scrutiny, and that, of course, is our intention. The House will appreciate that we are in the very early stages of considering the implementation of this Bill. But we are already clear that the assessment by the inspectorate of work of this severity will have to be particularly detailed and rigorous. However, I cannot agree with the spirit of this amendment, which is that in all circumstances where an application for a licence is for work in this severity band my right honourable friend, advised by the professional inspectorate, cannot be trusted to arrive at a sensible decision without further advice from another quarter.
Clause 9 as it stands provides that the Secretary of State must consult an inspector before granting any licence or certificate under the Bill, and that he may consult an assessor, or the Animal Procedures 1218 Committee. This is surely the right balance. Reference to an assessor or to the committee (or to both) is something to be be employed when the Secretary of State or the committee considers that the circumstances warrant it. Even when dealing with work in the substantial severity category, there are likely to be many applications which can be properly decided by the Secretary of State without further reference.
If I may answer the noble Lord, Lord Prys-Davies, the Secretary of State will ask the committee to report to him on the operation of the project licence system, keeping under review the control of substantial suffering if it has to be allowed in licences. To my noble friend Lord Selkirk, I can only say at the moment that the committee will be asked by the Secretary of State to give him general guidance on the handling of applications for licences in the substantial category.
A requirement for further reference in all circumstances where the substantial severity is likely would be wasteful and would impose a great burden, as well as being wrong in principle. The burden of references is likely to be very onerous. Our best estimate is that some 1,000 project licences for work in the substantial category will need to be considered during the transition to the project licence system, and thereafter at least 500 such applications a year will have to be assessed. Under the system envisaged in the amendment, the burden on assessors, the Animal Procedures Committee and the Home Office would be insupportable. In addition, a statutory requirement of this sort would be a very poor reflection on the high level of professional skill of the inspectorate.
I am sure that the advisory committee will pay particular attention to the category of work involving substantial severity, and my right honourable friend will welcome this as a complement to his own particular scrutiny of such work. But, as I have indicated, neither the committee, potential assessors nor he should be subject to the rigidity and burden which this amendment would introduce. I very much hope that the noble Lord will understand that, while we share his sense of the importance of this type of work, we very much hope that he will feel able to withdraw his amendment.
§ Lord Melchett
My Lords, I am grateful to the number of noble Lords who have supported the amendment. I should certainly like to join others in welcoming my noble friend Lord Houghton back to our proceedings, although I must say that his intervention on my amendment was rather less welcome and I disagreed with what he had to say.
First, he suggested that the Animal Procedures Committee is not simply an advisory comittee, but of course it is. What is more, as we discussed at length at the Committee stage, not only is it simply an advisory committee but it is an advisory committee which can give advice only on subjects referred to it by the Secretary of State. It may suggest things to the Secretary of State under the Bill as it is drafted, but it may only give advice if the Secretary of State asks it to do so. The Secretary of State may initiate that himself or do so in response to a suggestion from the Animal Procedures Committee. That is why what the noble 1219 Lord said in response to my noble friend on the Front Bench was particularly welcome. Indeed, I think that of everything he said in his reply that was the only bit that I really welcomed, because it got us over that hurdle which we discussed at some length in Committee.
The fact of the matter is that, without a reference from the Secretary of State, the Animal Procedures Committee does not have any standing in this matter. There is nothing in the Bill which gives it the right to give advice on an area, unless it is referred to it by the Secretary of State. So the assurance that my noble friend was given that this area is one that the Secretary of State will refer to the Animal Procedures Committee is extremely important and very welcome.
I can see that the noble Viscount and his department are concerned about the transitional workload and about the 1,000 or so cases that will arise in the transition from the existing system to the system provided by this Bill when it becomes an Act. I accept that that is a factor. If in every one of those 1,000 cases two independent assessors or the Animal Procedures Committee, or whoever, had to be consulted, then it would involve a considerable workload. I myself believe that it would be a justifiable workload to place on the department and upon independent assessors. As the noble Viscount himself said, we are here talking about the very worst category of pain and suffering that the law will allow human beings to inflict on animals in such circumstances.
I find even less weight behind the suggestion that 500 applications per year would involve too much work if each of them were considered by two independent assessors. After all, presumably a number of licence applications not involving pain of substantial severity will be referred to independent assessors. I find it hard to believe that, except in the most esoteric fields of science, there will not be scientists somewhere around the country who will be independent of the person applying for the project licence. I could not really accept the argument of my noble friend Lord Houghton that there could not be found anywhere independent assessors, particularly if one takes into account the suggestion that at least one of the assessors would need to be, and in most cases should be, an expert in the use of alternative methods, of which there are many in this country now.
However, I accept that the noble Viscount has gone some way to meet my concern, in the assurance he gave that this would be an area at which the Animal Procedures Committee will be specifically asked to look. I still remain extremely concerned, as I believe many people outside Parliament are, about the volume of licence applications that the Government expect in this area. I believe that in cases where pain of substantial severity is to be inflicted, Parliament would be justified in imposing additional requirements on the Government. I do not see why there should not be some provisions in this Bill that are inflexible. There are plenty of provisions that already place duties and requirements on the Government. However, my noble friend has extracted an important further assurance from the Government that is welcome. For the time being, therefore, I beg leave to withdraw the amendment.
§ Amendment, by leave, withdrawn.1220
§ Clause 10 [Conditions]:
Lord Glenarthur moved Amendment No. 9:
Page 8, line 1, after ("(b)") insert ("a termination condition, that is to say,").
The noble Lord said: My Lords, following our discussion in Committee on an amendment put forward by the noble Lord, Lord Melchett, I undertook to find a way of signalling more clearly the nature and importance of the condition that Clause 10(2)(b) requires to be attached to all personal licences. That condition is the termination condition that, as Clause 10(2)(b) says, will specify the circumstances,
in which a protected animal which is being or has been subjected to a regulated procedure must be immediately killed".
§ The effect of this amendment is to identify as the termination condition the condition described in Clause 10(2)(b). Highlighting the provision in that way will give more emphasis to its nature and purpose and will provide a succinct title by which this important condition will be known. We have not used the word "inviolate" or "inviolable" in the amendment, but I should stress that there are no circumstances in which the condition may be set aside. If an animal is in pain or distress beyond a certain degree without hope of alleviation, its suffering must be brought to an end. That requirement will be included in all licences without exception. I beg to move.
§ Lord Melchett
My Lords, I very much welcome this amendment and I hope that those outside Parliament who are concerned with this matter will accept that adding either the word "inviolate" or "inviolable" would make absolutely no difference. I am sure the noble Lord is right about that. This is an important strengthening of the Bill and I am grateful to the Minister for bringing it forward.
§ On Question, amendment agreed to.
§ Viscount Davidson
My Lords, perhaps now would be a convenient moment to break. I therefore beg to move that further consideration on Report be now adjourned. In doing so, I suggest that we do not resume the Report stage before 8 o'clock.
§ Moved accordingly, and, on Question, Motion agreed to.