§ Order for Second Reading read.
§ 3.24 p.m.
§ Mr. Peter Emery (Reading)
I beg to move, That the Bill be now read a Second time.
If one were to have in Victorian fashion a couplet at the head of a chapter, the head of the chapter of this Bill could well bePoisons there are that cure, and poisons there are that kill;Whilst some are just remedial.Quite obviously, this Bill is concerned with all three, but it is to see that drugs and poisons shall be only used, prescribed and administered after the most thorough check in all ways for safety.
Safety with drugs is a matter of degree. It is relative, and not absolute. It is very important for the public to know that they cannot be completely protected by any form of legislation. The only absolute protection, as has been said many times in the last fortnight on the Floor of the House, would be to have no chemical tests and no distribution of any new drug. This, quite obviously, must be wrong and can in no way be the will of the public.
What is necessary is that in this country. as in every other country of equal or somewhat similar standards of living or technical advance—indeed, in many countries more backward than ourselves—there should be a board or committee charged to investigate and consider that every step has been taken to protect the public. To ensure that, as we are all human, every known precaution or the fullest consideration must have been given before a new drug is freely available for use by the medical profession or by the public. That, ultimately, is what my Bill is all about.
It should be made clear to the House what is the present position in any drug consideration and how this has altered since my Bill was read a First time on 21st November. Instructions well before that were given by the Minister of Health to the Standing Medical Advisory Committee which formed a Joint Sub-Committee, with its Scottish counterpart, under Lord Cohen.
The Cohen Report was presented to the House on 4th April, and I am certain that 1767 all hon. Members here today would want to thank Lord Cohen and his Committee for the great considerations they have given to these very wide problems. The first stage, however, was reached when the Minister of Health accepted the first two recommendations of the Report of the Cohen Committee on 6th November. These were on page 5 of the Report:
This is of extreme importance, for no one at any time should get the idea that there is from this House or from any informed opinion an attack on the pharmaceutical industry. In my view, 90 per cent. and probably 95 per cent. of that industry is completely and absolutely above reproof. It is an interesting fact that this industry which, in 1958, was employing about 58,000 people is today employing nearly 66,000 people. There are about 250 companies in the industry and its total output in value is about £218 million. What to many hon. Members is of supreme importance is that the exports of the pharmaceutical industry have risen since 1938 from £3.3 million to £15.8 million in 1948—not a very large rise—but to £50.2 million in 1961. Probably, they are among the ten largest of all our exporting industries.
- "(1) The responsibility for the experimental laboratory testing of new drugs before they are used in clinical trials should remain with the individual pharmaceutical manufacturer.
- "(2) It is neither desirable nor practicable that at this stage of their evaluation the responsibility for testing drugs should be transferred to a central authority."
What makes the story even better is that the importation of pharmaceutical and chemical products has decreased since 1954 from £9.6 million to only £5.3 million. Another factor of great importance for the ordinary public is that in 1962 over £10 million was spent on research in this country, and a number of companies associated in some way with sister or parent companies elsewhere have been able to benefit from about £150 million worth of research. It is important to remember the contribution which the pharmaceutical industry is making in our country today.
I turn now to the final Report of the Cohen Committee. In paragraph 10, we read:We think that a Committee on the Safety of Drugs should be established.1768 In paragraph 7, it is said:These arrangements themselves would obviously be more effective with legislative sanction than without…I ask my hon. Friend the Parliamentary Secretary to take particular note of that. The Committee goes on to say:We are satisfied that legislation on the whole subject is urgently requiredMy Bill would meet that.No interim measures should be regarded as a justification for delaying this essential task. We recognise, however, that legislation would probably involve a comprehensive review of the whole field and that this is a major undertaking. Yet there is a specially urgent need to take whatever steps are immediately possible to improve the safety testing of drugs".It is obvious that my Bill is immediately possible.
The Minister has accepted this Report, taking the view that it would be possible to introduce a voluntary scheme without legislation, and in this he is supported by the last two sentences of paragraph 7 of the Cohen Report:The scheme we suggest can be introduced, if desired, without waiting for legislation. In the absence of legislation, it will only be effective to the extent that the industry and the medical profession are prepared to cooperate in implementing it but we hope it is reasonable to assume that this co-operation will be forthcoming.It is only fair to state that this co-operation has been forthcoming, but, nevertheless, it is necessary only if there is not legislation. I suggest that the Bill would do for my right hon. Friend a great deal in furthering the suggestions of the Cohen Committee.
But let there be no doubt that the Minister is to be congratulated on the action which he has taken in the last twelve months not only in appointing the Cohen Committee but in immediately acting, as he saw fit, on the recommendations. Obviously, the Minister of Health would be somewhat limited in producing a small Bill, and he must feel that a comprehensive Measure immediately would be impossible.
It is important that the House should realise how involved this subject is. There is no comprehensive legislation or legislative code to provide protection on drugs. Various Statutes deal with different aspects, mainly incompletely, and responsibility is scattered among a number of 1769 authorities. The Statutes are the Pharmacy arid Poisons Act. the Dangerous Drugs Act, the Therapeutic Substances Act, the Cancer Act, the Venereal Disease Act, the Merchandise Marks Act and the Food and Drugs Act.
The authorities with powers under these Measures include the Ministry of Health, the Department of Home and Health for Scotland, the Home Office, the Advisory Committee under the Therapeutic Substances Act, the Poisons Board, the British Pharmacopoeia Commission, the British Pharmaceutical Codex Committee and the British National Formulary Committee.
That is a pretty large number of organisations and authorities with duty or power of enforcement include the Health Ministries, the police, the local authorities and the Pharmaceutical Society. It is, therefore, against this background, together with the appointment of Sir Derrick Dunlop as chairman of the Committee on the Safety of Drugs, which has already been made by the Minister, that my Bill must be considered.
Clause 1(1) of my Bill would appoint a Drugs Advisory Board. I think that from what I have said already, it follows logically that I believe it imperative not to give the public the belief that any committee or board can make all new drugs absolutely safe. Therefore, the title "Drugs Advisory Board", as opposed to the title of "Committee on the Safety of Drugs" would be much better.
Clause 1(2) says that, in discharging its duties, the board would be required to consider certain things. These would include (a) whether such drugs mentioned in subsection (1) were toxic,(b) the results of chemical trials of such drugs,(c) the therapeutic efficacy of such drugs,(d) whether such drugs react adversely upon those to whom they are administered.Then it states that the board must report its finding to the Minister of Health as quickly as possible.
I should add that Clause 2 fits in closely with the suggestion made in the Cohen Report for three sub-committees dealing with toxicity, clinical trials and adverse reaction. The Clause goes on to designate that the board would consist of a chair- 1770 man, and up to six members, and that it would be a corporate body. We do not yet know whether the Minister's own Committee will be a corporate body.
The Clause sets out procedure and gives power to keep accounts and records and to appoint officers. In subsection (1)(f) there is provision for an annual report from the board to the Minister. This report would be published and laid before Parliament, so that this House could debate it. This is of considerable importance.
Being particularly human, I gather that paragraph (g) is a lawyer's way of saying that the Minister can make certain regulations to make the operation of the board in a sensible and businesslike manner possible if there is anything that I have forgotten.
Clause 3 deals with the financing of the board. My hon. Friend the Parliamentary Secretary knows that we are entirely in the dark about how his committee is to be financed, but we have heard that it will be financed from public funds. My Bill removes the responsibility from the taxpayer and allows the board to levy fees. I heard an hon. Gentleman opposite say "Shame". I wonder whether he will follow me closely through my reasoning to see whether he cannot agree with me about this matter.
The whole concept of the board is not that it should do all the toxicity testing and clinical trials itself, but that it should consider the trials and tests done by the manufacturer and the importer of a drug to see whether these have been adequate to give the public full and proper coverage. This is done fully and comprehensively by most pharamceutical firms. I mention no names, but Burroughs Wellcome and Smith, Kline and French are firms which have the highest reputation for doing everything in their power to ensure that drugs which they produce are properly tested for toxicity and are given proper clinical trials.
However, the Cohen Committee, on page 8 of its Report, said:The high, standards of leading firms are not necessarily reproduced throughout the industry.There are perhaps 5 or 10 per cent, of the firms in the industry which do not have this reputation and there may be 1771 importers who are willing to sell drugs from other countries in the United Kingdom without checking the toxicity or considering clinical trials carried out overseas.
If such firms or importers ask the board to consider a drug and report upon it, there will not be the closely documented brief which a leading firm would produce, and the board might be put to considerable expense to make a check or an examination. If it has to go to outside opinion—and it will be seen that my Bill will allow the board to go to other specialists and agents—to get the views and considerations necessary for clearance by the board, that might cost a large sum of money. While a well documented brief might cost the board only 50 or 100 guineas to test, testing an unreliable brief from an unreliable importer or manufacturer might cost more than £1,000.
Why should the taxpayer be asked to finance the less reputable firm? I believe that if the board is able to charge fees according to the amount of work that is necessary, this will be fairer both to the firms in the industry and to the taxpayer.
§ Mr. Richard Marsh (Greenwich)
Does not the short answer to the hon. Gentleman's question, "Why should the taxpayer bear this burden?" lie in the fact that we do not allow judges' salaries to be paid by those whom they are trying?
§ Mr. Emery
There is no doubt that people tried by judges have no option, but to be charged by the police. Indeed, those applying for a certificate of clearance do not have to do so. If one believes that the Minister will appoint to any form of Board or committee people who are not absolutely reliable, the certificate will not be worth the paper on which it is written.
I have an inherent belief that the people appointed will be fair and unbiased. That being so, I cannot see why the taxpayer should be taxed for the sake of the unreliable chemical manufacturer or importer, as opposed to the firms being able to obtain a clearance certificate on a fee-paying basis.
If the Minister thinks that a large amount of money is available in the Ministry of Health, and if he is gener- 1772 ously inclined towards this industry, I should have thought that he could best have provided assistance by establishing a number of chairs of clinical therapeutics at different universities throughout the country, because whatever one may say about the Bill there is no doubt about the need for this kind of research professorship in universities.
An important and somewhat newer aspect of my Bill is outlined in Clause 1(3) which deals with other activities of the board, and I should like to take the House back to paragraph 7 of the Cohen Report which said:There are several other aspects of drug safety which are of considerable importance, e.g., the control of quality of drugs, control of sale over the counter, labelling of containers, use of improved names, regulation of therapeutic claims, etc. These matters, new arrangements for which would require legislation, are outside our terms of reference.Anybody reading that must realise that the Cohen Committee was concerned about these things, and although it could not report on them, it did in fact suggest that legislation was needed. My right hon. Friend's Committee would be unable to do all these things, and if the House would bear with me—
§ The Joint Parliamentary Secretary to the Ministry of Health (Mr. Bernard Braine)
I am sure that my hon. Friend would not wish to give the House the wrong impression. Surely he will recall that, speaking in the Committee of Supply last Wednesday, my right hon. Friend made it clear that he did not dissent from this view expressed by the Cohen Committee that we would have to legislate in this wider field? I hope that my hon. Friend will not create the impression that the Government exclude the possibility of such legislation.
§ Mr. Emery
I apologise to my hon. Friend. Certainly, my right hon. Friend the Minister of Health said more than once, when speaking to the industry, that he does not preclude legislation to deal with this matter. However, he takes the view that it should be overall legislation. My point is that the committee which he now suggests would not be able to do these things. It would not have the power to consider the items that I have listed, whereas my Bill would give him those specific powers.
1773 Clause 1(3) provides thatThe Minister may from time to time request the Board to consider and report to him on any other matter related to the manufacture, distribution, marketing, advertising and naming of drugs or any other related matter not previously considered by the Board".Clause. 4 deals with those drugs which are unsafe, and lays upon the board three duties. First, if a drug cannot be safely administered the board shall inform the manufacturer or importer of the drug:and shall notify all persons permitted to prescribe, dispense or administer drugs that the drug concerned should, in the Board's opinion, not be prescribed and should be returned forthwith to the manufacturer or importer.The Board is also required to report this to the Minister, and to make its decision public. My right hon. Friend has not been willing to accept this duty in respect of his own Committee. It is imperative that if an adverse report is made by any committee or board—a report which could have a financially detrimental effect upon the manufacturers or importers—that report must be made available to the public in order that the persons concerned may discover the reasons which have led the Committee to an adverse conclusion.
In this respect the Cohen Committee does not agree with me. On page 10 the Report says:We do not think that the Committee itself should be expected to bring these facts directly to the attention of the medical profession since this might lay the Committee open to action through the Courts. In our view, the Committee should advise the Health Ministers whenever such instances occurred so that the Ministers might take whatever action they thought fit to bring the facts to the notice of the profession.This is understandable in respect of a voluntary scheme, but if my Bill became law set powers would be given to the board, and no problem of the kind envisaged by the Cohen Committee would arise.
The Bill is not the complete comprehensive review which the Minister might feel it necessary to introduce in the field of drugs or poisons. Obviously that is beyond the scope and resources of an individual back bencher. It may be that the Bill does not go as far as the Government would like, or that it is not in the form which the Minister thinks best. 1774 That is understandable, since it is my Bill. The Minister cannot be blamed for that. The Minister may think that it can be strengthened by Amendment. I am willing to provide every possible assistance in making whatever Amendments he may deem necessary.
Perhaps when Government action is finally taken this Bill as an Act would be supernumerary. This I do not mind, but I believe that in the interregnum it would do some good. What is not in any doubt is that if the Minister wanted to back the Bill it could be on the Statute Book during this Session, probably before August, and provide some of the legislation recommended by the Cohen Committee.
I know that my hon. Friend the Parliamentary Secretary will get up, make some friendly noises, pay charming compliments, make reference to some interesting ideas and pay regard to all that has been said, saying probably that it will be taken fully into account. This will be done in a manner that my hon. Friend can do as ably as any member of the Government, probably better. But what I fear is that he is under instruction to have this Bill "still-born". I plead with my hon. Friend, as he has listened so closely and so kindly to what I said, "Forget your compliments and your healing balms, overcome your brief and allow yourself to be entirely non-committal. Do not foully poison this Bill at birth. Let it go to Committee. You can still ensure that it does not become law if you want to, but consider with your Minister, my right hon. Friend, who I realise unavoidably cannot be here this afternoon, what I have had to say. This Bill can do no harm to your cause; but only good. Do not let the Minister of Health be a broken thermometer, Surprise us all, surprise even yourself, by allowing this Bill, the Drugs Advisory Board Bill, 1963, to obtain a Second Reading".
§ 3.57 p.m.
§ The Joint Parliamentary Secretary to the Ministry of Health (Mr. Bernard Braine)
I have very little time in which to resist the blandishments of my hon. Friend the Member for Reading (Mr. Peter Emery). While I think that we would all wish to commend him for giving us an opportunity to consider once again this important question of the safety of drugs, I must make the 1775 Government's position quite plain in the time available to me.
I think that it says a great deal for the thoughtful and constructive way in which my hon. Friend has proceeded in the matter that the proposals which he brings before the House bear a very close resemblance indeed to those of the Cohen Sub-Committee, but, I am bound to say, they offer no greater protection. It is, after all, with protection that the House must be concerned.
Since my hon. Friend first announced his intention to introduce a Bill of this kind a great deal of water has passed under the bridge. The Government have accepted the recommendation of the Cohen Committee that an advisory body should be set up in order to advise on the adequacy of toxicity tests before clinical trials, to advise on the adequacy of the clinical trials themselves, and to enable the collection and evaluation of data about the effects of new drugs. The Government are implementing this recommendation.
As I made clear in my intervention, my right hon. Friend does not dissent from the view that legislation in the wider sense is necessary. But we feel that we should not delay implementing the Cohen proposals on that account. My hon. Friend made light of the task of introducing such legislation. It will have to be detailed and comprehensive. We are proceeding with our study of what is required as quickly as possible.
I am bound to say, as I think the House will recognise, that this is not a subject suitable for a Private Member's Bill, however eloquently and ably it is introduced into the House. I cannot, therefore, in these circumstances, advise the House that facilities should be given for the progress of my hon. Friend's Bill. This does not mean to say that we do not recognise the necessity for proceeding as speedily as possible in regard to the implementation of the recommendations of the Cohen Report—I do not think my right hon. Friend can be accused of dragging his feet on that score—or the need to press ahead with the wider subject of comprehensive legislation.
§ It being Four o'clock, the debate stood adjourned.
§ Debate to be resumed upon Monday next.