HL Deb 04 July 1968 vol 294 cc512-45

5.25 p.m.

LORD KENNET

My Lords, this Bill is really no more and no less than a measure of consumer protection. We have recently had the Health Service and Public Health Bill, and within the last few days I have repeated a Statement in this House which the Minister of Health made in the House of Commons about the Sainsbury Report. So it may clarify a complex situation if I say, first of all, what the Medicines Bill does not do. It is not about the Health Service; that was the other Bill. It is not about the price of drugs; that was in the Sainsbury Report, and the Minister's Statement has said what he proposes to do about it. What it is about is the safety, efficacy and quality of drugs, and the descriptions and advertisement of drugs, whether the drugs are prescribed or consumed within the Health Service or without and in both human and veterinary medicine. It is also about the incorporation of medicines in animal feeding stuffs.

My Lords, as we all remember, the thalidomide tragedy gave us a severe jolt about the arrangements we had for protecting people against inadequately tested drugs. After that we had the Report of Lord Cohen of Birkenhead, that there ought to be a voluntary system for seeing that new drugs were safe and that, in time, a statutory system should be devised. And this is what happened. For four years we have had the Safety of Drugs Committee under Sir Derrick Dunlop, and on the animal side we have had the Voluntary Veterinary Products Safety Precautions Scheme. This Bill, which follows a White Paper published late last year, now moves the whole thing over on to a statutory basis. I do not think anybody has doubted that it would be right to go statutory as soon as we had enough experience of the voluntary arrangements to know we were on the right tack. The voluntary arrangements have worked well, but we cannot leave it at that, for two particular reasons. First, although the great bulk of the British pharmaceutical industry has conducted itself responsibly and has been amenable to this voluntary system of control, yet there have been one or two fringe firms which make the Government feel that it would be safer to have a Statute up their sleeves; and secondly, we are among the few technically advanced countries in the world which have no statutory controls, and this poses certain problems in talking to other countries about this whole field of medical safety.

Part I of the Bill, accordingly, establishes a Medicines Commission and provides for establishment of certain other expert committees. The House is bound to want to know why the Bill does not give the Medicines Commission all the executive powers which the Sainsbury Report recommended it should have. Let me take this opportunity, which is the first I have had since I started talking about health matters in this House, to add my thanks to those expressed by everyone else to my noble friend Lord Sainsbury for chairing the Committee which drew up the Report bearing his name. The answer to this question is that as we are dealing here with statutory compulsions with the underlying threat—which I am confident will always remain underlying but it just might not—of criminal proceedings, the Government have thought it better to abide by the British tradition that the making of statutory regulations should be in the hands of a Minister responsible to Parliament. So far as the exercise of these powers go, therefore, the Commission is to he advisory, as are the specialist committees to which the Minister will be able to turn for advice on particular categories of this immensely wide and complex technical field.

Part II of the Bill says that new medicinal products may not be marketed or imported without a "product licence", and may not be subjected to clinical or field trials, which normally precede marketing, without a clinical or field trial certificate. And not only this, no firm may manufacture or sell by wholesale medicinal products without being licensed in general to do so. Part II also provides for transitional arrangements to bring medicinal products, which are already on the market, within the licensing system as time goes on. The Minister may not refuse a licence for any product on grounds of safety, efficacy or quality without referring the matter to the appropriate expert committee, though he may, and will, as the expert committees build up a body of doctrine, which will be available to him, grant licences without referring. When he proposes to refuse a licence, there is provision for a hearing or written representations. And finally, of course, there is appeal to the High Court on points of law. This Part of the Bill incorporates suggestions made by the Council on Tribunals.

Parts III to VI, inclusive, of the Bill amend and codify the existing law of medicines, which is at present scattered about among many Statutes, and particularly those of 1933, 1941, 1955 and 1956, and the corresponding Scottish and Northern Irish legislation.This Bill applies to the United Kingdom. The basic premise of these Parts of the Bill is that it is no longer enough to treat drugs and medicines as simple commodities like any others which can be left to ordinary commercial pressures, except in the case of certain ones long established as dangerous. Among the revisions in these Parts, I am glad to be able to say that the ordinary chemist in the chemist shop is no longer to be known to the law as an authorised seller of poisons, but will become "a person lawfully conducting a retail pharmacy business", which sounds a bit nicer. Certain drugs, which people normally and properly buy for themselves when they feel like it, will be able to be sold in any shops. They will be listed in a general sale list Order. There are corresponding provisions for veterinary medicines. The Bill will confer powers on the Minister to regulate the labelling of medicines as sold or dispensed, a power which is wide enough to cover the labelling of dispensed medicines.

Part VI of the Bill deals with advertising and makes it a criminal offence to advertise a medicine in a way which is false or misleading. One of the most important clauses in the Bill is Clause 89. This deals with advertising and promotion aimed by the pharmaceutical industry at doctors, dentists and vets. Under them, no manufacturer may address an advertisement or send a promotion representative to a doctor, dentist or vet. about any given medicine that is the subject of a product licence until he has already sent to him a data sheet. The form of this data sheet will be laid down by regulations, and it will be required to set out objectively the basic particulars of the substance as; regards its composition, its therapeutic purpose, its side effects, and any necessary warning. If it does not do so, it will not be a data sheet under this Bill and the manufacturer will be in breach of the law if he advertises the product or promotes it to the doctor or vet. Clause 90 says that the Minister may call for copies of any advertisement to be submitted to him.

Part VII of the Bill gives the Medicines Commission the responsibility of producing future editions of The British Pharmacopoeia and enables them to publish from time to time material about medicines and things used in medicine. I should not like this provision to go by on Second Reading without remarking that the General Medical Council, under the chairmanship of the noble Lord, Lord Cohen of Birkenhead, agrees with this change of responsibility. The Pharmacopoeia has been produced under the aegis of the General Medical Council for over 100 years, during which time it has earned a remarkable standing throughout the whole world of medicine.

Part VIII of the Bill contains the enforcement provisions, which we can examine in Committee, and provision for extending the Bill to cover devices of one sort or another used in medicine and surgery and products which are not normally medicines but which may be promoted for medicinal uses, such as medicated toilet articles, antiseptics, and so on. Health foods, unless they are promoted as medicines, do not come under the Bill. In this Part, too, is a provision to bring, for instance, antibiotics used in horticulture or as food preservatives under statutory control where there is a risk to human or animal health.

I do not think that I need detain the House with any account of the Minister's intentions with regard to appointments to the Medicines Commission or to the expert committees. We have at present a voluntary system which is working well, and it is the purpose of the Minister to preserve that full and frank dialogue between the professional staff of the Departments and the industry which has characterised our arrangements so far. His appointments will be made after full consultation with appropriate parties and will be made in the desire to continue that atmosphere of co-operation and at the same time to provide the increased degree of protection to the consumer; namely, to the sick of this country, which it is the purpose of this Bill not so much to achieve, since in a great measure it already exists, but to consolidate beyond all doubt.

The Bill was in Committee in the House of Commons for 20 Sittings, and I should inform the House that as a result of this constructive examination certain Amendments are still being drafted, which I shall put down in good time for our later stages. I beg to move that the Bill be now read a Second time.

Moved, That the Bill be now read 2ª —(Lord Kennet.)

5.36 p.m.

LORD NEWTON

My Lords, I am sure that the whole House will be grateful to the noble Lord, Lord Kennet, for the succinct and clear manner in which he has explained the main provisions of this Bill, which is a pretty long and complicated one. The noble Lord did not say very much about the background of it—there was no reason why he should—but I would emphasise that the need for new drugs legislation has been recognised, certainly by Government Departments, for many years.

As long ago as 1958, the Ministry of Health were seeking the reactions of interested parties to a proposal to coordinate the existing legislation on drugs and to add some stricter controls. In 1959 the Poisons Board expressed concern about the lack of control over some potent medicines, and it was already suspected that the Therapeutic Substances Act of 1956 would soon become inadequate for its purpose. But, of course, as the noble Lord said, it was the thalidomide tragedy of 1962 that clinched the matter, if I may put it in that way. At that time it fell to me to announce to your Lordships' House the setting up of a joint sub-committee of the English and Scottish Standing Medical Advisory Committee, under the chairmanship of the noble Lord, Lord Cohen of Birkenhead, to look into the situation. Later it again fell to me to announce the recommendations of the noble Lord and his colleagues, and the Government's decision upon them; and still later to announce the appointment of the Dunlop Committee on the Safety of Drugs.

Contrary to fears expressed at that time, the latter part of 1962—fears, I may say, expressed by some noble Lords and Ladies: but no names, no pack drill!in practice, the voluntary vetting system operated by the Dunlop Committee has worked remarkably well, as the noble Lord said, thanks largely, I believe, to the full co-operation of the pharmaceutical industry. The noble Lord made a qualifying observation about what he called one or two "fringe" firms. I am bound to say that I did not know about that, and although I naturally accept what he says, on the whole I think that the industry has cooperated pretty well with the Dunlop Committee and ought to receive credit for it.

Nevertheless, it has been accepted all along—at any rate, ever since 1962—by the Minister, by the noble Lord, Lord Cohen of Birkenhead, and his colleagues, and by the Dunlop Committee, that a voluntary system of vetting patent medicines could be only temporary, and that there would have to be new legislation dealing with the safety, efficacy, quality, prescriptions, advertisements, and all the other relevant matters. Indeed, in the last few months before I left the Ministry of Health, at the end of March, 1964, I was given the task of struggling through a whole forest of paper in order to try to think up a framework or a policy for a new Bill. So obviously I cannot be anything but benevolent in general towards this Bill; and I feel pretty sure that a Bill on these lines would have emerged at this time, or at about this time, whatever the Government of the day.

It is an extremely comprehensive Bill—I doubt whether it could have been more comprehensive—and I think it right that it should be. But, of course, the implementation of all its provisions will entail a considerable extension of bureaucratic activity, and that is something which in principle is to be regretted, at any rate, by me. Unfortunately, I cannot see how one can mount a massive protective operation of this kind—and it is a massive protective operation—except in a bureaucratic setting.

I suppose that the fundamental necessity for legislation of this nature springs from the attitude of the general public towards the National Health Service. The public seem to feel that, as they have a right to the medicines, appliances and services supplied by the National Health Service, they are going to have them if they want them, even if they do not need them. I heard recently from a friend of mine who is a dentist an example of this attitude, at any rate in the field of medicine, of wanting something because you have the right to it. I think this example is a good illustration, although the anecdote refers to a time before the commencement of the National Health Service. It was a few years after the war.

A patient came to this dentist and said: "I have just been demobilised from the Navy. Under the terms and conditions of my service, I am entitled to a free set of dentures, and I have come to you for them." The dentist said: "Very well; let me have a look at your teeth." Apart from a few holes that needed filling, he found that the man had a pretty good mouthful of teeth; and he told him so. The man said: "Never mind about that. I am entitled to a new set of dentures, and I want to have them." There was a certain amount of argument, and then the dentist in the end said: "You go away and think about it, and then come and see me again." The man went away, but he returned and said: "I have thought about it, but I am going to stick up for my rights. I want my dentures."

LORD KENNET

He wanted them to keep coal in.

LORD NEWTON

I do not know what he wanted to keep in them. Anyway, reluctantly the dentist pulled out all his teeth and gave him new dentures.

BARONESS SUMMERSKILL

He was a very bad dentist, then.

LORD NEWTON

I do not know about that. I must say that if I had been the dentist I should probably have let him keep his own teeth and given him any old pair of dentures to take hone and keep in a paper bag. But perhaps that might have been unethical.

It has often been said before, my Lords, and I believe it to be true, that we are something of a nation of hypochondriacs. To the casual expression: "Hello; how are you?", too often one finds one gets a pretty lengthy reply, going into all the symptoms. I think we are a nation of medicine drinkers and pill swallowers, and perhaps over-medicated. If we are, then I should have thought that for this state of affairs the medical profession must accept some responsibility. At any rate, I am sure that a good many doctors would agree that it can be easier and quicker to prescribe a bottle of coloured liquid or a box of pills than to explain to the patient that he does not need treatment at all and that it would be wiser to leave it to Nature.

It seems to me that the public not only expect modern medicines to be available and efficacious for almost any malady or ailment that they can contract, but expect that these modern medicines should be absolutely safe. This, I suppose, is really crying for the moon, because, as I understand it, if a drug is absolutely 100 per cent. safe, and there is not the smallest risk of any undesirable side effects, then that drug is probably not a very potent one. So I suppose the most that one can hope for is to ensure by all reasonable means that all drugs produced are made to be as safe as possible. This, after all, is one of the main purposes of this Bill, and I do not see why the Bill should not achieve it.

I do not know how many noble Lords present have read right through the Bill —it certainly took me a long time to do so—but if one does, one is immediately struck by the fact that it contains a great deal of enabling power. I wish that it did not contain so much enabling power. But, even so, I think that here again quite inevitably there is a mass of detail, some of it fairly small. I do not propose on Second Reading on a Thursday afternoon to go into the details.

I would conclude by saying that I wish this Bill well. I think it goes a long way in following the recommendations of the Sainsbury Report, but not the whole way. I shall look forward to hearing what the noble Lord, Lord Sainsbury, has to say about that. It is undoubtedly a better Bill than it was when it was introduced into the other place. Very sensibly (and the noble Lord, Lord Kennet, mentioned this) the Minister in the other place made a number of concessions; and I gather from what the noble Lord said that we may have a few more here. It seems to me that in the end the success or failure of the Bill will turn on the regulations and orders that will flow from it, and on the manner in which those regulations and orders are interpreted and exercised. So we shall just have to hope for the best, also keep a wary eye open.

5.49 p.m.

LORD SAINSBURY

My Lords, I am speaking in the debate on this Bill because a Medicines Commission was one of the main recommendations of the Committee of which I had the honour to be Chairman. I should like to take this opportunity, on behalf of the Committee, to thank my noble friend Lord Kennet for the tribute he paid to the work of the Committee. I should like also to apologise for not being in the House when the noble Lord moved the Second Reading, but I was attending a Committee of the House in a Committee room.

As is clear from its Report, the Committee attached great importance to the establishment of such a body as the Medicines Commission. It felt very strongly the need for the supervision or control of the introduction, promotion and marketing of ethical pharmaceutical products. I welcome the fact that the Bill provides for such supervision. As Sir Derrick Dunlop has said: Modern medicines are such potent weapons —like atomic energy, powerful for good but also powerful for evil—that the responsibility for their safe production and use can no longer be left entirely to the manufacturer or prescriber. I am bound to point out, however, that my satisfaction is somewhat tempered by my reservations about the status, structure and duties of the Medicines Commission as proposed in the Bill.

During the course of its work, the Committee was greatly impressed by the evidence of some sections of the medical profession, which showed that on the whole doctors would have far greater confidence in the Commission if it was independent, and seen to be independent, of the Government in its day-to-day working. Although we accepted that, for constitutional reasons, the licensing authority should be the Minister, we recommended the setting up of a strong independent Commission which, apart from advising the Minister on licensing and other matters, would have a number of clearly defined executive, as opposed to advisory, functions, such as the control of advertising and the classification of medicines. These functions would be performed independently of the Minister and the Commission would have its own powers of enforcement.

The Medicines Commission proposed in the Bill follows closely the White Paper (Cmd. 3395) published before the Sainsbury Report. It is an advisory body with very little statutory independence. It has no powers of enforcement and all its functions are exercised through the Minister of Health, who takes responsibility for them. I recognise that there is room for difference of opinion, that these differences are strongly held and that there are powerful arguments for both points of view. I appreciate that critics of the Commission proposed in our Report fear that it might be excessively bureaucratic, which could lead to undue delay in clearing new medicines, and that its independence could result in the exercise of power without responsibility to Parliament.

However, having given consideration to everything that has been said in favour of the Medicines Commission proposed in the Bill, I still feel that there are two reasons why an independent Commission would be preferable. The first is because it would probably find it easier to gain the confidence and co-operation of the medical profession, which is so vital for its success. The second reason is because I feel that decisions relating to medicines should be taken by a body with professionally qualified people, in the best interests of the health of the nation.

Another important difference between the Minister's Medicines Commission and that envisaged in our Report concerns the status and duties of committees serving the Commission. We recognised that because of the heavy duties of the Commission, expert committees to advise on specific aspects of its work—such as the safety of drugs, their classification and so on—would have to be set up. Such committees, we felt, should be appointed by the Commission, should work in close co-operation with it and should provide it with the assistance necessary to enable members of the Commission to make the right decisions.

According to the Government proposals, however, these committees, of which there will be a very large number, will be appointed by the Minister in consultation with the Commission. The advisory committees, such as those concerned with licensing and the general sales list, will work more or less independently of the Commission and will send their recommendations direct to the Minister. The Commission itself will be concerned with these problems only if there is an appeal against a decision by the Minister. In these circumstances it seems inevitable that what influence there will be outside the Ministry will lie with the committees. In paragraph 334 of our Report we said: We have been struck by the absence of any co-ordinated structure for dealing with matters concerning medicines. No doubt these committees will be highly expert in their field, but they will not be in a position, even with the heir of the Commission as envisaged in the Bill, to provide such a structure.

I welcome the clauses of the Bill which deal with controlling advertising and sales promotion, for I am convinced that there is an overwhelming case for some statutory control. In paragraph 228 of the Sainsbury Report, dealing with promotional literature sent to G.P.s by pharmaceutical firms, we stated: The British Medical Association told us that the main disadvantage to doctors was the absence of any 'independent medical control or scrutiny over the literature'. I stress the word "independent". I am, therefore, a little surprised that the Bill does not specifically appoint this task to the Commission or to one of its committees.

No doubt the Minister of Health will be able, under Clause 3, to consult the Commission on this and related matters, but I feel that it is an important enough problem to be made the responiibility of a separate committee. In any case, I hope that the new controls will be strictly enforced, for only if this is done will doctors take promotional literature and advertising more seriously, which may in time lead to a reduction the volume of material pushed through the G.P.'s letter box.

As noble Lords will no doubt know, there has been in existence for some years a standing joint committee on the classification of proprietary preparations which is now known by the name of its present Chairman, the MacGregor Committee. I am sure all noble Lords will agree that it is only right that I should add my tribute to that which has already been paid to the valuable work done in an earlier period under the chairmanship of the noble Lord, Lord Cohen of Birkenhead.

I am disappointed that the Government have not yet reached a final decision as to whether the activities of the committee will be brought under the ægis of the Commission. Its work in classifying medicines according to their efficacy has an important role in helping doctors to prescribe to the best advantage of their patients, and I, and the committee over which I presided, were strongly of the opinion that this work should be continued. The classification of medicines is of great value, and in my view it should be done in complete independence by the professionally qualified Medicines Commission. In conclusion, in spite of these reservations I welcome the Bill. It is a much needed measure and I hope that it will have a speedy passage through all its stages in your Lordships' House.

6.2p.m.

LORD SHAWCROSS

My Lords, I must, at the very outset of the remarks I am about to address to your Lords-ships' House, declare an interest. I have associations with the pharmaceutical industry. In particular I am the Chairman of a pharmaceutical company operating in this country and in the United States of America. In view of some of the things that were said by the noble Lord, Lord Sainsbury, perhaps I ought to say that I by no means apologise for my connection with the industry. Although the pharmaceutical industry is one which appears to arouse great emotions in the minds of those who like to regard themselves as members of the intelligentsia,and who appear to think that it ought to make more discoveries and no profits at all, in fact no industry—and I proudly include my own company in this —has made a greater contribution to the wellbeing of mankind than the privately conducted pharmaceutical industry.

If the noble Baroness, Lady Summerskill, will cast her mind back over thirty years she will agree what a dramatic change in the health of this nation, and in large parts (although not yet of all) of the world has taken place in that time. Thirty years ago I believe tuberculosis was killing off over 30,000 people in this country alone. Unfortunately, it still is killing great numbers in other countries not yet so fortunately placed. In this country the death toll from that disease has now become exceedingly slight. Thirty years ago, I think diphtheria probably accounted for 4,000 or 5,000 deaths each year; nowadays it accounts for none. Endocarditis was uniformly fatal; infantile mortality was about three times what it is to-day.

A little while ago a very distinguished Member of your Lordships' House, and a distinguished leader of his profession, the noble Lord, Lord Platt, in the Harveian Oration that he delivered this year, pointed out that the major contribution to the dramatic advance which has been made in these matters in the field of chemical therapy since the war had been made by these much-abused pharmaceutical companies.

LORD SAINSBURY

My Lords, I do not want to interrupt the noble Lord, but I was not clear, when he referred to me in his opening sentence, whether he was suggesting that due and appropriate tribute had not been paid in the Sainsbury Report for the advances of the pharmaceutical industry over the last 30 years. In fact we clearly stated that in an industry where there is innovation and research the profits have to be appropriate to the research.

LORD SHAWCROSS

My Lords, I was referring not to the Report of the Sainsbury Committee but to the noble Lord's speech. If I may say so, with great respect to him, the noble Lord seems to have become something of an advocate for the Report of his Committee. Different views are held about this. An older school of thought considered that it would perhaps be wiser, where there was a Committee of this kind, or a Royal Commission (and this is the view that I myself have taken), that once the Report had been made the Chairman and members of the Committee should remain a little outside the battle and leave others to judge whether or not the Report was right. However, I was criticising nothing in the noble Lord's Report; I was referring to what I am sure was not intentionally a disparagement of the industry, but at any rate a slight implication which I thought I felt in the noble Lord's speech. I would add that it was always the view of the Medical Research Council, certainly when I was the Chairman of that body, that the pharmaceutical industry was the best placed to undertake the direct research for new drugs and, of course, to undertake the consequential development work.

Having said that, I am the more glad to be able to welcome, almost without reservation, this important new Bill. I think it was desirable to bring the hitherto perhaps rather obsolete and, in some respects, rather fragmented legislation relating to medicine up to date, and to this extent to consolidate it. And although we all, I think, recognise that the Dunlop Committee—and I should like to pay a warm tribute to that Committee, and in particular to its; Chairman, Sir Derrick Dunlop—achieved in its informal and voluntary procedures very great success in promoting its objective of securing the safety of drugs. We have rather a genius, perhaps, in this country for doing that kind of thing in a way that is voluntary, informal and often illogical, yet successful. Although one must recognise the success of the Dunlop Committee I think that on balance it was right to fall into line with the procedures followed in other countries and to adopt a statutory system. It may well be that in the course of time that may lead to some degree of reciprocity in the international arrangements in regard to these matters.

I am glad, on the other hand, that the Minister has not thought it right at this time to include within the strict procedures of the new system medicines intended for export. That does not mean, of course, that we shall export to foreign countries products which we do not think are safe for this country. It means merely that this very useful export trade—I mean useful economically to us, and from a health point of view to other countries —will not be exposed Ito double standards in the country of production and the country of use.

I personally welcome the constitution of the Medicines Commission and the status which this. Bill gives to it. I am not able to follow the noble Lord, Lord Sainsbury, in the views which he ex- pressed about this aspect of the Bill. I think it was right to establish a Commission, highly powered, containing, I have no doubt, people of the greatest distinction, but in the end responsible to Ministers who themselves are responsible to Parliament, rather than to establish a new and independent body, inevitably bureaucratic and exercising power without responsibility. Tie confidence which the Commission enjoys with the medical profession or with the industry will depend much more upon the composition and membership of the Commission than upon its technical status.

Nor am I going to follow the noble Lord in his animadversions on advertising. I am quite sure that the provisions of the Bill are appropriate and that the Minister, with the advice of the Commission where this is called for, will deal in a sensible way with the matter. I sometimes think that in all this talk about advertising of pharmaceuticals we underrate the intelligence of the doctors who receive the advertisements.

I believe that the Medicines Commission can play a most important part in all these procedures, provided always (and here I draw on my earlier experience in the Medical Research Council) that the Commission is not only conscious of its function of exercising the regulatory and therefore restrictive powers in dealing with drugs, important as this function no doubt is, but also seeks to exercise a positive and active role in encouraging and helping the development of new and improved drugs: drugs which may prove of incalculable advantage to mankind and, I am sure, will some day, perhaps before too long, conquer the still dread diseases which have so far not been overcome by chemotherapeutic methods.

I am very glad to see that the Commission, being constituted in the way it is, is entitled to be consulted by Ministers—in other words, that Ministers are obliged to consult it in some of the matters to which the noble Lord, Lord Sainsbury, referred, such as the establishment of the various expert committees, and also in regard to matters of subsidiary legislation. I am glad also that under this Bill the interests likely to be affected must also be consulted. I am quite sure that the Minister recognises that not only in the medical profession but also in the industry—and I speak with some inside knowledge of the industry—there is a great body of expertise which, if the system is to work at all, must be brought into active co-operation with the Government in framing the detailed controls for which the Bill provides.

But having said all this, and paying, as I do, the warmest tribute to the Minister and to the general purposes of this Bill, and even to the machinery it establishes, I must add that there remain some points which ought to be examined in Committee, and I was glad to hear the noble Lord, Lord Kennet, say that there are some matters on which it is intended to be put down Amendments. I do not propose to deal with any but one of these matters, for they are in the main matters of detail—drafting, clarification, and the like.

One of those matters, however, is a matter of principle, not indeed for this Ministry, and not affecting in the least the purpose of this Bill, but of importance from a much broader and constitutional point of view. We who are lawyers, or concerned with the machinery of government or with constitutional matters, have a growing anxiety about the way in which the rights of the citizen are increasingly interfered with otherwise than by judicial procedures. I beg noble Lords on the Government Benches to believe that in saying this I am not in the least making a partisan point. Noble Lords on the Government Benches as individuals are just as much concerned with the maintenance of individual rights and liberties as anyone else. The trouble is that, collectively, Governments—and I am using the word in the plural and not the singular—too often sacrifice this concern for the individual on the altar of departmental expediency.

In recent years the policies of Governments have shown a growing tendency towards authoritarianism; and one aspect of this Bill illustrates, I do not say in a glaring or vicious way, the pattern to which in this country, over a number of years now, we have gradually become, or are becoming, conditioned. Decisions affecting the private rights of a particular citizen are taken secretly, without reasons being given, by some faceless member of the bureaucracy, and with no appeal. This pattern looks unjust, and quite often it is unjust.

Then, of course, there is this growing tendency, this technique of imposing this policy or that policy on the mere ipse dixit, the say-so, the dictat, of some Minister without legislative authority at all. One is becoming painfully familiar with the system of some ministerial pronunciamento, "Do this, or else…". This is government by intimidation and whether these methods relate to planning or to patents, to passports or to pharmaceuticals, they are a form of dictatorship. As I said, I do not suggest for a moment that this Bill contains any particularly vicious example of that, but the time has come to call a halt to it. And this Bill presents an opportunity to get back to the rule of law in regard to some of these matters, and without detracting in the slightest degree from the purpose of the Bill itself.

Under the Bill, as your Lordships will have seen, the licensing authority—which is a grandiose expression euphemistically describing the Ministers—may grant licences for clinical or field trials, or for marketing. They may vary licences; they may revoke licences in regard to medical products. This power may, of course, involve a drastic interference with the rights of private people; and it may also interfere with the rights of the public to have access to particular medicines. One remembers a very famous instance of this being debated in this House some years ago. I do not dispute that a power of this kind ought to exist and is necessary. Certainly it is. But the producer and the public are entitled to know the reasons for its exercise and to have a right of appeal.

The procedure under this Bill is quite elaborate. It may involve going before a Committee, then going before a Commission, and perhaps subsequently going before a person appointed by the Minister to hear representations. That is the old familiar device of appointing an inspector to report on the matter and then disregarding his report—as in the case of Stansted the other day, except that here the inspector's report is not to be published at all, so that nobody except the Minister and the licensing authority knows what is in it. It may be said that these procedures contain a kind of inbuilt system of appeal. Not so, my Lords. The public are entitled to know the reasons behind the advice given and the eventual decision made. At no stage in the procedures laid down by this Bill (and here perhaps the noble Lord, Lord Sainsbury, will agree with me —though I do not know, because he favours greater power for the Commission than I do) is any opinion given by an expert Committee or a Commission binding upon the Minister; nor is the report of the person who hears the representation binding upon the Minister. At no stage is there any right of public appeal.

This business of administrative decisions taken wholly or partly behind closed doors, and with no reasons given, is really not good enough; and it is not in the least necessary in this Bill. There should be a right of appeal to the courts on known facts and stated reasons. These cases will depend greatly upon expert evidence, and of course the courts have a special expertise in assessing the weight to be given to expert evidence. It may well be that only one case in one hundred would go to appeal. All the less reason, I venture to say, for not allowing the ordinary processes of law, openly conducted, to operate. The establishment of an open and public right of appeal, either to the High Court or even, if it were thought better, to an independent tribunal—if one must have another of them, although the court is there—from decisions given under Clause 20 of this Bill would in no way impair its operation when it becomes an Act, and would leave those concerned with its administration at least to feel satisfied that, although the decision may have gone against them, the rule of law was operating. I hope that the Minister will give consideration to an Amendment on those lines on the Committee stage.

6.22 p.m.

LORD FRASER OF LONSDALE

My Lords, I declare an interest, being a director of a pharmaceutical company. In another place there was an amiable Second Reading debate upon this Bill. The Minister of Health made a speech in which he gave substantial and strong assurances as to the moderation which would be exercised in carrying out the great powers which the Bill confers upon him and upon his opposite numbers in Scotland and Northern Ireland. But we ought to be aware how great these powers are.

There is the power to appoint a Commission, and the requirement that it should be consulted; but obviously no requirement that its advice should be taken. That would not be possible, I suppose. But if the Commission continues to give him adverse advice which he does not like, then what does he do? He can reduce its numbers; he can increase its numbers; he can alter its terms of reference—all without coming back to major legislation. He has to lay an Order, and it is an Affirmative Order. But everyone of us knows how difficult Orders are: what a small safeguard they are for liberty, or even for good sense, because they have to be taken or left; they cannot be amended. I hesitate to use the word, because I am sure Mr. Robinson would not do this, but the Minister can "pack" this Committee if he just does not like it. He just fixes it, by reducing its numbers, or increasing its numbers, or altering the personnel, or the rules. He takes an Order down to the House, and the majority in another place, which now has the ear of about one-third of the voters, can make sure that it becomes the law. This is not right, and I hope that support may be found for some Amendments which will deal with this matter in Committee.

My other objection is the one which has been voiced so exceedingly well by the noble Lord who has just spoken. He has said it so much better than I could have done and therefore I shall not go over the ground, except to say that I, too, think there should be a right of appeal. Probably there will not be justice in some case here and there; and certainly justice will not be seen to done unless there is provision for an appeal. In particular, I would stress the point made by the noble Lord, that the fact of the existence of this appeal machinery would require that the reason for the rejection of a licence or the amendment of a licence would have to be stated. I think that is most important.

Finally, with the noble Lord, Lord Newton, I would say that we in this country are getting into the habit of setting up the most enormous pieces of bureaucratic and governmental machinery. I am not saying that there are not some mistakes made in the pharmaceutical business, as in every business. I am not saying that a watch must not be kept upon quality, claims and methods of manufacture and selling. But the fact is that we are going to have an enormous machine imposed upon us; and we have not been told by the Minister in either House what it will cost. One of its effects will be to slow up the process of bringing useful drugs to patients who need them, to slow up the whole business of manufacturing and selling, thereby impeding business at home and harassing export business.

I think it was the noble Lord, Lord Shawcross, who said that he was glad exports were excluded. I am not sure quite how to read this clause or this aspect of the Bill. It is true that exports are in one sense excluded from licensing. A product can be refused a licence here to be sold in the United Kingdom but it cannot be refused a licence to be sold overseas. But it cannot be sold overseas if it has no background market here. So it is not quite true to say that exports are not affected. They will be affected by the slowing up process, as well as by the interfering process; and the taxpayer will pay. I wonder whether a better system of control might not be to prosecute where faults occur rather than to try to foresee them in every case. Caveat emptor was a pretty good rule. I wish I could commend it to civil servants and to noble Lords on the Front Bench opposite.

6.28 p.m.

LORD CHORLEY

My Lords, I should like to apologise for not being in my place at the time when my name was reached on the list of speakers. I had an engagement of a public character in another part of the Palace which I had to fulfil, and which prevented my getting here in time. I do not want to say a great deal in this discussion this afternoon. This is not a matter with which I have been a great deal concerned. Looking through the Bill, I find myself much in sympathy with its objects and I am quite sure that it will be an improvement, indeed a landmark in the progress of social medicine in this country. We in this country have been much worried over these last years by thalidomide and other matters of that kind, which have, I think, brought it home to the great mass of the people that much tighter control, indeed control of the kind which is envisaged in this Bill, is necessary. But I do not really wish to discuss general problems of this kind.

There is one aspect of this matter which I think has not been touched upon, so far as I have been able to gather, in the speeches which have been made this afternoon, that is, the tremendous power which this Bill will put in the hands of the Pharmaceutical Society in many ways. A very important part of the Bill, of course, is the control which it entrusts to the Pharmaceutical Society in the shape of powers of inspection and administration of much of the machinery which is established by the Bill. I have no doubt that the gentlemen who run the Pharmaceutical Society will do their best to carry out their duty in a way which respects the rights of the shopkeepers and others over whom they will be given a good deal of power, but it may be that lower down in the ranks that duty will not be observed in the same kind of way.

I have been interested for quite a long time in herbalists. I suppose you could say that it is from the herbalists that the modern pharmacist has grown; but in growing out of the herbalist the pharmacist has departed a good long way from his original forbears. Certainly in some parts of the country there has been a certain amount of hostility between the two. I have myself come across instances where herbalists have not been altogether fairly treated locally as a result of interventions by pharmacists.

I am not at all satisfied with the safeguards which exist in the Bill at the present time. Herbal medicine is a very valuable part of medicine. Years ago the local herbalist used to have his part to play in the general pattern of medicine. He has to some extent died out. I remember as a young man coming from a rather old-fashioned part of the country where the local "bone-setter" was something of a surgeon; and out of his work, of course, the modern science of orthopædic surgery has to a large extent grown. The famous Sir Herbert Barker's family were famous "bone setters" in South Westmorland, and in the small towns there was always a herbalist whose herbal remedies were highly thought of and formed part of the pattern, so to speak, of medicine in those country districts. There, too, it was a business which had often been handed on from father to son. The man I have in mind was a very wise man with a considerable knowledge of these valuable remedies, and a man who was trusted, and trusted with justified confidence by his patients.

One of the encouraging features in recent times in this country has been, to some extent, a return to herbalism, and one meets people—rather like the "composters" in agriculture who object to chemical manures and insist on vegetative manures—who will take only herbal medicines. I do not belong to this fanatical brigade in any sort of way and have enormous admiration of the chemical medicines which have been built up with such skill over the years.

I do a good deal of travelling abroad, and I have been very impressed by how, in many parts of the Continent, particularly, perhaps, in Germany, Austria and parts of Switzerland, the herbal remedy is still tremendously used and has its place, so to speak, in medicine which it has rather lost in this country. At the same time, in the present generation the herbalists in our country have been building themselves up again. The modern herbalist is highly trained in his profession, and certainly I think has not received sufficient attention in the Bill which is before your Lordships this afternoon. I gather that the Government themselves realise that this is so, and some Amendments have already been accepted in another place which go some distance to improve the position, and that other Amendments may be moved at a later stage in the passage of this Bill through your Lordships' House. However, I have no doubt that a good deal further alteration is needed in order that the position of the herbalists may be effectively safeguarded. I felt that it was only right that I should make these points on the Second Reading in order to be in a position to move the necessary Amendments when the Committee stage is reached.

6.36 p.m.

LORD SEGAL

My Lords, I feel I ought to confess at the outset that I have no interest to declare. I have not been engaged in medical practice now for something like close on thirty years, and have long ago passed the statutory retiring age. I feel that there is little prospect, even if I had the desire to do so, of my being able to return to medical practice in the future. All that one can perhaps claim to do is to be available sometimes in an emergency, for better or for worse, if one happens to be on the spot anywhere when one's services may be needed. I am sure that I am voicing the feelings of a good many other Members of this House when I say that we listened with rather doubtful approval to the intervention of the noble Lord, Lord Shawcross, when he took exception to my noble friend Lord Sainsbury standing before your Lordships' House as an advocate on behalf of his Committee's Report.

LORD SHAWCROSS

Would the noble Lord forgive me. If I used language which suggested that, I was mistaken. I do not think I took exception to it; I said that I regretted it. I think this is entirely a matter of personal taste. I regret it because I think it is sometimes counter-productive for a Chairman of a Committee to become an advocate for his Report. The good Report is really its own best advocate, that is all. I did not intend to take exception or suggest that there was any impropriety in it.

LORD SEGAL

My Lords, in fully accepting the noble Lord's intervention, may I say that I am sure he is absolutely right in his approach to the Report of the noble Lord, Lord Sainsbury, from a legalistic point of view. I will not refer to his own declaration of interest in the subject we are discussing because again, as we all realise, it was made in absolute good faith and with a genuine desire to assist the work of this House on the eve of its approaching the Committee stage.

We are dealing here with a problem which cannot be approached exclusively on a commercial or a legalistic or governmental basis. We are dealing here with the unassessable elements of human suffering, of the unpredictability of human illness. I confess that I believe from his appearance the noble Lord, Lord Shawcross, may have been singularly fortunate in the rare occasions when he has had contact, not with the pharmaceutical industry but with the medical profession. I feel we ought to pay tribute, the highest possible tribute, to my noble friend Lord Sainsbury just precisely because he approaches this problem with a depth of feeling, with some degree not only of profound human understanding but, let us admit it, also of human emotion, which one cannot divorce entirely in dealing with the subject of human illness and the development of drugs to alleviate it.

It would be a very sad day for this country and for the interests of patients in this country if medical research were left exclusively in the hands of the pharmaceutical industry. We ought to give due recognition to the fact that medical research in its most outstanding achievements has been initiated simply by the strivings and the inquiries of the human mind, especially of the professionally-trained human mind, without any regard to commercial advantage or material gain. We ought to recognise this as an absolutely essential factor in dealing with a subject like the Medicines Bill. In America the whole industry has become highly over-commercialised, and severe restraints have had to be imposed on allowing the commercial aspect of the industry there to be given too free a rein. Therefore, I welcome this measure as a first major attempt, and a long overdue attempt, to rationalise the industry and to bring to bear some badly needed measure of control so as to avert human tragedy which could easily be involved if commercial interests were allowed to operate unrestrained.

I should like briefly to refer to a very important recommendation, No. 13, of the Sainsbury Committee on branded pharmaceutical products. It is generally admitted that branded products, where they already exist, should remain under their branded names, not only for the maintenance of the export market, but also for the enormous amount of good will which is attached to them. But a clear case has yet to be made out for any new pharmaceutical products licensed by the new licensing authority appearing under new branded names. The facts for and against their adoption should be carefully weighed. New goods appearing under new branded names may be more convenient for doctors to prescribe, though this is very doubtful, but we have to agree that this is not necessarily the case; and nor does it follow that new goods appearing under an ap- proved name would necessarily be more inconvenient for doctors to prescribe. They need not appear under their full pharmaceutical name, nor need they necessarily be given in a conveniently abbreviated form. What type of name is desirable for any new product to be given, while retaining it in a convenient form for prescribing, and ensuring that it does not suffer in its export sale, has yet to be decided. It is most important that the manufacturer's name should be retained, whether in full or whether by initials, if only to make it easily identifiable and easily dispensed.

A highly satisfactory answer could be found if the licensing authority were to revert to an old custom of giving any new product the name or initials of the manufacturer and following it by a designated number. Instances could be multiplied from Salvarsan 606 in the early days for the treatment of syphilis by chemical agents, to a more recent example in our own times the M and B 693 brand of sulphonamide, which was the pioneer of its group. These numbers become fixed almost at once in the mind of the prescribing doctor, and the initials of the manufacturer ensure that only a drug of proved efficacy, prescribed by a firm of repute, should be handed out to the patient.

This also preserves the anonymity of the drug, in certain cases where its identification ought to be withheld from the patient. I see no reason whatever why a licensing authority should not revert to this practice for any new drug approved by it for prescription by a doctor, or for exporting, to the fullest extent, without detracting in any way from the convenience of the doctor, in the best interests of the patient, and to the fullest advantage in the competitive export markets. I should like to ask the noble Baroness in her reply to state specifically the objections against reverting to the formerly well-established practice of designating drugs—certainly new drugs —by a number. I conclude by saying that this Bill is long overdue and, apart from certain minor adjustments, ought to receive the warmest approval from all sides of your Lordships' House.

6.47 p.m.

LORD AUCKLAND

My Lords, generally speaking this Bill must command a wide welcome, though I would register a mild protest at its having reached this House so late in the Session. I certainly do not blame those concerned with the Bill this evening, but this is a very complex Bill, with 128 Clauses and 8 Schedules, and I should have thought it would have been an ideal Bill to start in this House. I hope that in future consideration will be given to starting legislation of this kind here, because this House is uniquely qualified to give much more detailed attention to the very technical implications of this Bill than is likely to be possible at this stage of the Session.

It seems to me, as a layman in these matters (I am not a director of any pharmaceutical company, though I have visited a number and seen the various processes), that Clause 2, which sets up the Medicines Commission, is one of the mainstays of the Bill. There were long discussions in Committee in another place on this matter, and at this hour I shall not go into it at length. But we should like to know—and in Committee we shall have to go into this more thoroughly—what are to be the powers of this Commission. According to the Bill, the composition of the Commission is to be not less than eight, and there is no specified maximum. Amendments were put down in another place in an effort to achieve some specified number, but they were withdrawn.

The anxiety which many people may reasonably feel is about what the Commission is going to do. The Report of the Sainsbury Committee, which is a model of clarity, even if some of its recommendations do not universally commend themselves, seems to me to recommend very wide and sweeping powers for this Commission. They range from the safety of drugs to marketing, sales promotion and so on. I am not suggesting for one moment that the present ethics of marketing and sales promotion are anything like perfect, but I am not at all sure, having seen some of them carried out, that they are quite so bad as certain people have tried to suggest. After all, our export record in the pharmaceutical industry, as has been shown by the recent Report of the N.B.P.I., is second to none. And that would not be the case if the marketing of those involved in it were as bad as has been suggested in some quarters. I hope—and perhaps the Government can give some indication on this, if not to-night then during the later stages of the Bill—that at least the present terms of reference of this Commission will be limited to safety and quality, rather than include the very much more technical implications of marketing. It seems to me that this requires a much more expert set-up than I understand to be envisaged from the terms of reference of the Medicines Commission.

My Lords, I fully support the idea of having a Commission of this kind and I am sure that the Minister, who is well-respected and experienced in the medical profession, will insure that men—and, I hope, women—of the right calibre will serve on it. But I am a little concerned that the chairman is to be appointed from within the members. I wonder whether this is not a case for an independent chairman, particularly as it seems that the Commission's terms of reference may well be very wide. However, those are matters which can be probed during later stages of the Bill.

There are one or two other points that I should like to raise at this stage. First of all, there is the question of the general sale list. How is that list to be compiled? I am rather worried at the numbers of drugs which can be obtained from slot machines. Possibly "drugs" is too strong a word for some of the items, but there are a number of commodities, such as cascara, which appear to be readily obtainable, and which ought not to be, particularly if children, or even teenagers, get their hands on them, because they can be ill-used. Such commodities as aspirin may well be a different matter. But not being a doctor, I shall certainly avail myself of any correction which may be offered on that remark. However, as a vice-president of ROSPA, I am naturally particularly concerned with safety matters, especially at a time when we have a problem of drug addiction, although when we talk of "addiction" we usually have in mind other drugs. But some kind of guidance as to the types of drugs on the general sale list could be of some help.

This Bill is necessary. The powers contained in it are very wide, and I hope that we shall be accorded ample time for its remaining stages. I also hope that, in the very technical implications of this Bill, we shall have the benefit of the advice of noble Lords who are versed in medical drugs.

6.56 p.m.

BARONESS ELLIOT OF HARWOOD

My Lords, I do not propose to take up more than a very few minutes of your Lordships' time. I speak to-night as Chairman of the Consumer Council at the time when the Sainsbury Report, in which the Council took a keen interest, was published, and I should like to add my support to the Bill which we are discussing to-night. When I was Chairman, the Council welcomed the Report and also welcomed the Bill which is largely based on that Report. But there are one or two points that I should like to mention in this Second Reading debate to-day.

The first is that in the membership of the Commission, and of the Committees which are being set up under Clauses 2 to 5, there should be someone who represents the users of medicines. If all the other interests, including the pharmaceutical industry, are to be represented on the Commission, I think that someone who represents the consumers of the medicines should also be included. A list is given of interests which the Government are to consult and Government Departments are included. But I should like to suggest that, when the Minister is consulting such organisations and Departments, he should consult either the Consumer Council or the Patients' Association. They might be considered useful organisations, not only for consultation but for providing membership of the appropriate committees—such committees as deal with labelling or advertising—for I believe that the Government would get valuable help from representatives of those bodies.

Advertising brings many complaints to my office from consumers, often complaints of a medical or quasi-medical nature. The Council is very glad that the Minister will have power under this Bill to deal with those complaints. There was a suggestion in the Sainsbury Report that the Commission should have power to monitor advertisements. I am sure that that would be helpful and it would prevent the abuses which can arise through exaggeration in advertising.

The only other matter that I want to mention is the question of clinical trials. There have been occasions, no doubt very rare, when patients have been the subject of clinical trials without being consulted. I have had one or two letters suggesting that such trials were made without the knowledge or consent of the patient. I am sure that that rarely happens—indeed, doctor friends have assured me that it happens very seldom—but it should always be the policy to get a person's consent before any trial of that kind takes place. Therefore, speaking purely and simply for those who are, as it were, on the receiving end of this Medicines Bill, I hope very much that the noble Lord and the Government will remember, when they are setting up the machinery of this Bill, that the people I have mentioned can make a valuable contribution and consider whether there should be some representative on the committees of the consumer end of the product.

6.59 p.m.

BARONESS SEROTA

My Lords, this Bill has had a gratifying reception from all parts of your Lordships' House this evening—warmer, possibly, from some sections than from others. But there appears to be general agreement on the need for some control and regulation at this stage in the development of the pharmaceutical industry. All noble Lords have agreed that, although this is a complex, difficult—and indeed a very long—piece of legislation, it is a necessary one to which we attach very great importance, and one to which we shall need to give very careful consideration in its other stages as it proceeds through the House.

As I listened to the debate, I thought there was one possible exception to this general agreement; namely, the noble Lord, Lord Fraser of Lonsdale, with whose views I must confess I could not find myself in agreement. The principle of waiting until disaster occurs has surely been illustrated to be highly dangerous in this field, where human life and happiness are clearly at risk. Reference has already been made by the noble Lord, Lord Newton, and others to the thalidomide tragedy in 1962. The noble Lord, Lord Fraser of Lonsdale, has no doubt seen and tried to help the children who now live to bear witness to the results of that tragedy. We see them in our children's homes; we see parents having to cope with the upbringing of severely handicapped children. Surely we cannot wait until we have other similar tragedies before providing a full and comprehensive statutory framework for the control of the safety, efficacy and quality of the drugs supplied, as the noble Baroness, Lady Elliot, so rightly said, to all of us who are the consumers of drugs throughout this country.

The noble Lord, Lord Newton, reminded us at the outset of this debate of the history of events leading up to this Bill and of his particular part in its development. He was a member of the Government at that time; and it is very pleasing to the Government to know that the Opposition is with us in this particular endeavour and will support the Bill through its various stages. Almost every noble Lord who has spoken made some reference I and quite naturally so in view of its importance for the future) to the status, standing, powers, composition and functions of the Medicines Commission. We all of us listened, with the greatest interest, and indeed with the greatest respect, to the remarks of the noble Lord, Lord Sainsbury, who chaired the Committee whose valuable Report we have all read with such very great interest. There is, I think, between him and my right honourable friend, a genuine difference of opinion on this matter. None of us would wish even perhaps to attempt to persuade Lord Sainsbury to change the view that he came to, together with members of his Committee after a very long period of careful consideration.

My right honourable friend, and indeed Her Majesty's Government, for the reasons given in another place and also here to-day by my noble friend Lord Kennet when he introduced the Bill, consider that the Medicines Commission as constituted and as provided for in this Bill should be an advisory body to the Minister responsible to Parliament and therefore answerable to Parliament for its actions. I have no doubt that the points that were made in this debate on different aspects of its powers and functions, and on the way in which it will work in relation to the expert committees that are to be set up, will be fully explored on Committee stage; but on this general point of principle of the standing and status of the Commission I myself join with those noble Lords, including the noble Lord, Lord Shawcross, who took the view that ultimately its standing will depend on the quality of its membership. I am sure it is the intention of my right honourable friend, when appointing the Commission, to bear in mind all the comments that have been made on its composition; both here and in another place.

The noble Lord, Lord Sainsbury, apart from the one particular reservation which he made very clear to us, gave his support to the Bill, particularly in relation to advertising and sales promotion. But I am afraid I could not myself agree quite so warmly with the comments of the noble Lord, Lord Shawcross, as I could with those of the speaker who preceded him, particularly when he made what I thought were some somewhat sweeping generalisations about the procedures which the Bill provides for representations against proposed decisions under the licensing scheme. Here again, we shall be able to deal in greater detail with this particular point of his concern in Committee. I am sure the noble Lord is aware, having real the Bill, that the conclusions of the Commission have to be given to the applicant for a licence under Clause 21(6); that the reasons for the final decision by the licensing authority also have to be given under Clause 20(5), and that the appeal in Clause 99 to the High Court on the points of law also exists if there has been non-compliance with the requirements of the Bill. It is the view of my right honourable friend that these are adequate safeguards against the misuse of the procedures embodied in the Bill, and we can discuss them further in Committee, when there will be proper opportunity to ventilate the concerns of the noble Lord, Lord Shawcross, in some greater detail.

My Lords, the noble Lord, Lord Chorley, expressed his concern about the position of those who place their faith in the use of herbal medicines—which, after all, were traditionally the predecessors of modem medicine. There are, as we know, some people who still believe in the value of these traditional remedies, and the Bill makes special provision for them. I am sure the noble Lord will agree that when this Bill was proceeding through its various and somewhat lengthy stages in another place considerable attention was paid to this particular sphere of interest. A number of Amendments were introduced which improved the Bill in this respect. Consultations are still proceeding, and the Government intend to put down further Amendments as a result of further consideration of this particular aspect of the Bill. I hope that the noble Lord, Lord Chorley, will participate fully in those considerations when we come to the appropriate clause at the Committee stage.

The noble Lord, Lord Segal, also welcomed this Bill, and, from his distinguished experience in the field of medicine, touched on the question of branded products, suggesting that we might move instead to a numbering procedure. He probably knows (although one quite appreciates why he wished to air the point at this particular stage) that the Medicines Bill which we are considering to-day does not cover the question of branded names. This particular point was dealt with by my noble friend Lord Kennet in a Statement he made in the House on June 24, and no doubt the noble Lord, Lord Segal, will bear that in mind when he comes to think further on these matters. I would make only one point to him in passing: the very number of drugs that exist in this country to-day would be a cause of considerable difficulty if we started using numbers rather than some other form of identification. I understand that some 600 to 900 new drugs are produced each year, and those of us who have difficulty with decimals, and who are in any event fearing the onset of decimal coinage, might have even greater difficulty if his proposal were introduced.

LORD SEGAL

My Lords, will my noble friend forgive me? I hesitate to interrupt her. What I suggested was that the number attributed to the drug should be combined also with the initials of the firm which was marketing it.

BARONESS SEROTA

The noble Lord, Lord Segal, is far more familiar with these matters than I am, and I am sure that he will find adequate means to ventilate this particular suggestion, since it is not really a subject that falls within the confines of this Bill.

My Lords, I hope that I shall not be accused of being biased, but I confess that I found the speech of the only noble Baroness to speak in this debate, Lady Elliot of Harwood, one of the most interesting of all, because, as usual, she went right to the heart of the problem leading us back to the intitial remarks of my noble friend Lord Kennet when he opened this debate—namely, the position of the consumer. The primary object of this Bill is to protect the consumer, and, in addition, to give him confidence in the drugs which are prescribed to him or are available on the open market. The noble Baroness suggested that means should be found of involving consumers in the work of the Medicines Commission. There are a number of ways in which this could be done, and she suggested that my right honourable friend might possibly wish to consult certain consumer bodies in this field—the Patients' Association, for example.

We are all consumers of drugs at some time or another, and in regard to the point made by the noble Lord, Lord Newton, at the outset when he mentioned his fear that we are becoming a nation of pill-takers, I can only say that the true answer here probably lies not in negative control but in positive health education. We listened to the suggestions of the noble Baroness, Lady Elliot of Harwood, with great interest and I am sure that my right honourable friend will read this debate and take note of her comments. I do not pretend that it will be easy to find appropriate consumer representations in this field; but the point has been made most effectively, and due note will be taken of it.

My Lords, I hope that I have covered the matters raised in this general debate. We shall be able to continue our discussions on this difficult and complex Bill further, and in greater detail when we reach the Committee stage. To the noble Lord, Lord Auckland, I would say that, as is the practice of this House, we hope to have adequate time to consider it in all its detailed clauses. There will be no attempt, even if such a thing were possible in this House, to rush it through. The main purposes of the Bill have been ventilated in this debate. It is a measure that will bring our medicines legislation up to date without restricting new developments in the future. It has been generally welcomed, and all are concerned to improve the nation's health and to develop new means of doing this, while at the same time ensuring the public safety. The Medicines Bill will embody in a statutory framework the successful practice which has been built up through the voluntary system that has been developed in recent years.

On Question, Bill read 2ª, and committed to a Committee of the Whole House.