§ 4.18 p.m.
§ The Minister of Health (Mr. Kenneth Robinson)
I beg to move, That the Bill be now read a Second time.
This Measure is one of great importance for the safety and well-being of the public. I have long regarded legislation on this subject as being an important part of consumer protection legislation, and of course it is a matter that fundamentally affects the health of the individuals to whom medicines are administered. Legislation has become equally necessary in the field of veterinary medicine, but in introducing the Bill I propose to concentrate almost entirely on the human medicine aspect.
The purpose of the Bill is to make new provision with respect to the safety, quality and efficacy of medicinal products for human and veterinary use, the circumstances in which they are sold or supplied, their labelling and description and their sales promotion. We described its general content in the White Paper (Cmnd. 3395), published in September, 1967. Shortly after the White Paper had been completed I received the report of the Sainsbury Committee on the Relationship of the Pharmaceutical Industry with the National Health Service, which not only made some important recommendations with regard to the financial and economic aspects of that relationship, but also others which have relevance to the Bill. The Government entirely share the broad objective of these recommendations, which I will return to later, and consider that the proposals in the Bill are in general harmony with them.
Legislation on this subject has, in a sense, been gestating for a good 10 years. For the past 30 years, and more particularly since the end of the Second World War, there have been revolutionary changes in the development of new medicines, based on the synthesis of new organic chemical substances, some of which have been found to have extremely valuable therapeutic properties. The pharmaceutical industry is, of course, in business primarily to earn profits, but it deserves recognition from the public for having introduced many valuable new 1601 drugs which have served the community well, and in some cases have completely altered the pattern of medical treatment.
However, the appearance of these new and potent medicines has brought disadvantages as well. If it is to be effective a drug must exert an effect on the physiological functioning of the body. Unfortunately not all the effects are beneficial and it is hard to eliminate the others. Thus the new medicines, valuable as many of them are, have carried with them a number of risks. It is to minimise these risks that the voluntary scrutiny by the Safety of Drugs Committee was introduced at the beginning of 1964 and that the proposals for a licensing system in the present Bill are directed. Existing medicines legislation in the main dates from the period between the two world wars, and was never designed to cope with the problems arising from these new developments in pharmaceutical research.
In 1962, as the House will remember, the devastating effects of thalidomide became known and there was great anxiety about the absence of safeguards to ensure that new drugs were not marketed before every possible step had been taken to bring harmful side effects to the notice of doctors, who could then weigh the risks against the expected therapeutic benefit.
An immediate result of the thalidomide affair was the setting up of a Joint Sub-Committee under the chairmanship of Lord Cohen of Birkenhead which recommended by a majority the establishment of a voluntary system of screening of drug toxicity data and the collection of reports of adverse reactions to drugs in clinical use. This led to the appointment of the Committee on Safety of Drugs under the chairmanship of Sir Derrick Dunlop, which has been working since the beginning of 1964.
The voluntary system has had the full support of the pharmaceutical industry and the medical and pharmaceutical professions, but the Government is convinced that the provision of statutory backing for the safeguards should not be further delayed. Indeed the Committee on Safety of Drugs itself in its annual report for 1965 said that whilst the Committee had not been hampered by lack of statutory powers, thanks to the co-operation of manufacturers, it believed that the 1602 arrangements should be given permanence within the framework of legislation. It welcomed an assurance that I gave in Parliament that my aim would be to maintain under future legislation the scope for flexibility and the exercise of professional responsibility which the Committee's experience had shown to be necessary.
I am happy to repeat this assurance. The four years experience of the Dunlop Committee's work has indeed been invaluable in demonstrating the need for a flexible system, and I have no hesitation in saying that if the Medicines Bill had been introduced four years ago without the benefit of this experience, it would have been a less good Bill. I should like once again to pay the warmest tribute to the Dunlop Committee's distinguished service to the community.
I now come to the Bill itself, which is, I am afraid, necessarily long and complex. I am afraid, too, that my speech will be long, but I hope less complex than the Bill itself.
In the first place, the House will see that the legislation applies not only to Great Britain but also to Northern Ireland. It is clearly desirable that standards for safety, efficacy and quality of medicines should be uniform throughout the United Kingdom. The responsible Ministers are the Health and Agriculture Ministers.
Part I of the Bill relates to the establishment of a Medicines Commission whose general functions are set out in Clause 3 and include advice on matters relating to the administration of the Bill and more generally in relation to medicinal products. The Commission will also advise on the pattern and membership of the expert committees set up under Clause 4 to deal with various aspects of the administration of the Bill. I will say more about the Medicines Commission later.
Part II of the Bill provides for a licensing system in respect of the manufacture, marketing and wholesaling of medical products in the United Kingdom. Under Clause 6 the Ministers are the licensing authority but any one or more of the Ministers can act on behalf of all.
The main provisions of the licensing scheme are as follows: Clause 7 requires a "product licence" to be held before 1603 a medicinal product is marketed or imported. Clause 8 requires the manufacturer and the wholesaler to have a licence: such licences will relate only to the manufacturing or the wholesaling function, and not to particular products and Clause 23 provides the necessary link between the two types of licence. Clauses 9 to 15 provide for a number of necessary exemptions from the licensing obligation.
Clause 16 provides for the introduction of the licensing scheme by means of a statutory order fixing the "first appointed day ". After this day no new products may be marketed without a licence or put to clinical or field trial without the appropriate certificate.
Clause 17 provides for existing products and activities to be brought gradually within the scope of licensing by means of licences of right, described in Clause 25, on various subsequent appointed days.
Clause 19 sets out the factors that must be taken into account in the grant or refusal of licences in relation to home-produced and imported products alike.
Clause 20 provides that licences shall not be refused on grounds of price—a safeguard which I think it is wise to express formally, and to which I think that the industry and the medical profession will attach great importance—and that there shall be no refusal on grounds of safety, efficacy or quality except after consultation with the appropriate expert committee, or, in the absence of such a committee, the Medicines Commission. The following provisions deal with the procedure for representations where refusal of a licence is proposed. Thorough safeguards are provided, and I regard these provisions as of major importance. We should, of course, operate these provisions with full regard to our obligations under G.A.T.T. and E.F.T.A.
Part III relates to the sale and supply of medicines principally at the retail stage. It will eventually replace a number of provisions under existing Acts. Clause 43 establishes retail pharmacies as the normal places for the retail sale or supply of medicinal products, subject to exemptions in favour of practitioners, and, in certain circumstances, suppliers of herbal remedies, and Clause 42 provides for 1604 "general sale lists" of medicines which can with reasonable safety be sold or supplied otherwise than by a pharmacist, and which in consequence may be sold at any shop.
Other Clauses in Part III deal with such matters as the adulteration of medicinal products, the sale of sub-standard products, standards laid down in recognised works of reference like the British Pharmacopoeia, and with standards of hygiene at places where medicines are dealt with or sold.
Part IV of the Bill deals with the conditions to be satisfied by those conducting a retail pharmacy business, and for the registration of their pharmacies.
Part V gives powers for regulating labelling, leaflets and containers, and for requiring the marking of medicinal products themselves for the purpose of identification, and replaces existing provisions relating to false labelling and description.
Part VI deals with advertisements and sales promotion. Its provisions apply, broadly speaking, to any form of advertisement except labels and leaflets controlled under Part V and to oral representations made to practitioners and others. Clause 84 makes it an offence to issue advertisements, or make representations about medicines that are false or misleading. Two special defences are provided—an "ignorance" defence, and a defence for advertising agents acting in innocence.
The provisions in the same Clause that advertisements and oral representations are to be consistent with the provisions of the licence is one of the most important features of this part of the Bill. It is the vital link that enables the licensing authority to ensure that any stipulations considered necessary by the expert committee, or the Medicines Commission, in relation to the uses for which a medicine is to be promoted, or any notice that has to he given of any important side effects, are not disregarded when the drug is actually promoted, either to a practitioner or to the public.
These provisions fulfil one of the important objectives in the Report of the Sainsbury Committee. The main difference is that the Committee saw the regulation of advertisements as an independent function of the Commission 1605 based on particulars requested by it from the manufacturers. There are, however, two objections to this. First, in the Government's view, the body responsible for statutory regulations should be answerable to Parliament, and, secondly, the Committee did not fully recognise the close link between the required content of advertisements and the particulars that the applicant will already have furnished to the licensing authority, which must, therefore, form the basis of the enforceable provisions in the licence.
This part of the Bill also gives wide regulation-making powers for prohibiting advertisements for particular classes of products (for instance advertisement to the public of products limited to sale on prescription), advertisements and representations in relation to remedies for specified diseases or conditions cancer, for example—and those containing expressions likely to mislead.
Part VII transfers to the Medicines Commission the responsibility for preparing future editions of the British Pharmacopoeia, and I want to say a word about this.
For over 100 years, the General Medical Council has had the statutory duty of preparing and publishing the British Pharmacopoeia, during which time it has acquired a very high standing throughout the world. Originally, it fell to the General Medical Council to prepare the Pharmacopoeia because doctors—who in those days were accustomed to manufacture their own medicines—needed an authoritative book of standards. Latterly, doctors have come to rely more and more on pre-packed products made by pharmaceutical firms able to produce products of far higher quality than any individual could hope to attain.
The General Medical Council considers, therefore, that the time has come when the duty of preparing the Pharmacopoeia should be handed over to a more appropriate body. The Sainsbury Committee made a similar recommendation in its report, but, as the Bill stands it does not enable the Medicines Commission to perform the broader function contemplated by the Sainsbury Committee of providing practitioners with information about medicines. In fact, Clause 90 enables it to go outside the narrow area of publications containing standards for medicinal substances and to publish 1606 regular compendia of information about actions and uses—for instance, it could produce the British National Formulary. But the power does not extend to monthly or bi-monthly journals about medicines, such as "Prescribers' Journal ".
The Government, however, see no reason why this function should not be broadened and intend to move an Amendment to this effect in Committee. The House will notice that, in these matters, the Minister's function is limited to publishing on the recommendation of the Medicines Commission, which consequently will have complete professional independence with regard to the contents of all these publications.
Part VIII deals with a number of miscellaneous supplementary provisions of which I will only mention the most important. Clause 93 enables appropriate provisions of the Bill to he applied with suitable modifications to medical and veterinary devices, when desired this could include such things as implants, blood transfusion equipment, catheters and so on—or to other products, for instance, medicated toilet articles, antiseptics, dietary supplements, and crude chemicals, which are not marketed primarily as medicinal products but which may at some time have to be brought within the Bill because they are sold for medicinal use. The intention to include such a provision has given rise to some fears in the health food industry that we might use it to bring the whole range of health foods under medicines control and restrict their sale to pharmacies. There is no such intention. The provision would in all cases be operated only after consultations with the interests affected; it would be subject to affirmative Resolution, and it would only be used in relation to products sold for medicinal use.
Clause 94 enables similar provision to be made with regard to ingredients used in the manufacture of medicinal products and substances—such as certain antibiotics used in horticulture or as food preservatives—where unregulated sale would give rise to risks to the health of the community, either human or animal, even though the substances concerned are not in medicinal form.
I should like to refer now to one or two matters of particular interest in rather more detail.
1607 I should first of all say something about the thing that the Bill is all about, in other words, the "medicinal product" as defined in Clause 114. In general, unless a product satisfies the definition of "medicinal product ", the Bill does not apply to it at all. I fear that the definition is rather long and complicated, and it has to be read with the definitions of disease "and" treatment "in Clause 115. Broadly speaking, it means a finished product intended wholly or mainly for medicinal use and ready for administering or for use as an ingredient in dispensing. It does not, therefore, cover crude chemicals, bulk ingredients or toilet preparations, foods, disinfectants and so on, whose primary use is not medicinal. If any of these products reed to be brought within the control provisions of the Bill, it will be necessary to make an order under Clause 93 or 94 far the particular purpose.
The definition has not been easy to draft in such a way as to avoid too wide a definition—by bringing in any substance capable of medicinal use—or too uncertain a definition—for example by making it dependent on evidence of actual use of the substance in question or too limited— for example by linking it with a specific written recommendation for the treatment of a particular disease or condition. The words "manufactured, sold, supplied, imported or exported" for medicinal use in subsection (1) are critical. For instance, the main use of carbon tetrachloride is industrial, and the substance itself, therefore, is not a medicinal product. However, if some of the substance is set aside, further processed and put up for veterinary use for liver fluke, that purpose makes this part a medicinal product.
Let me give one further example. Vitamins are normal constituents of a balanced diet, and, although they can be used to prevent disease or to deal with a condition resulting from a dietary deficiency, this is not the purpose for which, generally speaking, they are wholly or mainly sold. But if a vitamin preparation is Specially made up and sold wholly or mainly for one of the medicinal purposes mentioned in subsection 2 of Clause 114 then that preparation is a medicinal product. No doubt we shall have further 1608 discussions about this definition in Committee.
The normal sequence of events in the marketing of a new medicinal product is that a manufacturer, in his laboratory, synthesises a number of substances which he hopes will prove of medicinal value. These are tested in laboratory animals, and if a particular substance seems promising the next stage may be to see what the human body does to it when it is administered to man. Such trials are often carried out on healthy volunteers, on the responsibility of the manufacturer. With the knowledge so far gained, the firm can make an assessment of whether there is likely to be a beneficial pharmacological effect in man. At this point, it is necessary to establish whether the effect predicted from the tests so far carried out are realised when the drug is administered to a person suffering from the condition that it is hoped to improve. The trial then becomes a clinical trial under the responsibility of a doctor, which will require in advance a clinical trial certificate issued by the licensing authority. This ensures that all the necessary preliminary stages have been gone through and that a clinical trial in patients is justified.
When the results of the clinical trial are known and evaluated the firm may wish to proceed to market the drug. At this stage, Clause 7 requires the issue of a product licence before marketing, and this is the essential safeguard as to the safety, efficacy and quality of the particular product. The manufacturer's licence provided for in Clause 8(2) will normally relate to the facilities, equipment and expertise for the processes that he is engaged in. A manufacturing licence is not, however, required by a doctor, dentist or veterinarian for making up a preparation, nor will a pharmacist require one for dispensing a prescription.
The factors which must be taken into account in determining whether a licence is to be issued are set out in Clause 19. The decision will depend on whether the particulars supporting the application indicate adverse considerations relating to the safety or efficacy of the medicine in relation to the proposed uses that would justify its withholding from sale or supply, and whether the standards 1609 for the product, or the manufacturer's specification, are adequate.
It is not intended that efficacy by comparison with other products intended for the same purpose should be a factor affecting the issue of a licence, but efficacy must be taken into account in relation to the product's toxicity and to the question of whether the evidence supports the purposes for which the product is intended. Thus, a product which might carry with it the risk of serious side effects might nevertheless be licensed if it were a very valuable drug for treating a disease which carried a higher risk to the patient. But a product which might be very effective in treating a relatively trivial condition could be refused a licence, if the side effects were disproportionately serious.
I want to say a word now about what happens where the question of refusing an application for a licence or a certificate arises, or where, when one is in force, it appears desirable to suspend it, revoke it or vary it in a way unacceptable to the holder. Here the Bill contains a number of safeguards. The grounds on which action to revoke, suspend or vary can he initiated by the licensing authority are clearly set out in Clauses 28 and 35. The grounds for refusal of a licence will be that the relevant factors, as set out in Clause 19, are not satisfied.
It might be helpful to describe this from the point of view of the applicant for a licence. The procedure, and the rights of the applicant, are broadly the same in all cases and for the sake of simplicity, I will describe it in terms of a proposed refusal. The first thing to bear in mind is that the procedure takes place before the licensing authority has made a formal determination, that is, at a stage when the refusal is no more than a proposal.
In the first place, Clause 20(3) provides that the licensing authority shall not refuse on any grounds relating to safety, quality or efficacy, except after prior consultation with the appropriate committee, or the Commission. In other words, if the examination in the office of the data submitted by the applicant suggests that there is not a clear case for the granting of a licence, the staff will refer the matter to the appropriate committee. Clause 21(1) ensures that, if 1610 the committee has reason to think that it may be unable to advise the granting of a licence or could do so only on conditions not contained in the application, the committee must, before advising the licensing authority, notify the applicant accordingly and afford him an opportunity of being heard, or of making representations in writing.
The committee then reports its findings and conclusions to the licensing authority, and where the committee advises refusal or granting subject to conditions, the licensing authority is required to notify the applicant, setting out the advice which it has received. The applicant then has 28 days in which to give notice to the licensing authority that he wishes to make representations with regard to the advice in question. If he does so, the licensing authority must arrange for the representations to be considered by the Medicines Commission, and the Commission in turn has to report its findings and conclusions to the licensing authority.
The formal decision on the application is then taken in the light of the advice received. If the formal decision follows the advice of the Commission or —if he did not make representations to them—the committee, the applicant has no further opportunity of making representations. On the other hand, if the licensing authority proposes to depart from the conclusions of the Commission or committee, it has to notify the applicant accordingly and give him an opportunity of appearing before a person appointed for the purpose by a licensing authority or making representations in writing.
In any case where the licensing authority issues a formal refusal, it must send the applicant a notice stating the grounds for the decision, or, if the licence is granted otherwise than in accordance with the application, reasons must be given on request. This decision is then final, in the sense that it cannot be questioned in any other legal proceedings except on the grounds that it is ultra vires, or that any statutory requirements have not been complied with.
In such a case, then, under Clause 96(2), there is a right of appeal within six weeks to the High Court, and the High Court may quash the decision. Such a decision voids the formal decision of 1611 the licensing authority, but the High Court does not itself make a substitute decision; the licensing authority takes the application up again at the point immediately before the formal decision was reached, and, in the light of any observations made by the High Court, makes a fresh decision.
The House will see that we are providing very great safeguards, elaborate safeguards, against arbitrary action on the part of the licensing authority, and giving the utmost reassurance that medicines will not be withheld from the market except on proper grounds. This procedure also carries with it important safeguards for the independence of the advisory committees and the Medicines Commission, to which I will return later. Finally, I must add that another important safeguard comes from the fact that the licensing authority is to be the Ministers, which means that they can he questioned in Parliament.
A further point calls for brief mention here. One relates to confidentiality of information furnished to the licensing authority and the advisory bodies. The importance which we attach to this is stressed by the provisions of Clause 103 and the maximum penalties fixed there-under, supplementing the standard provisions of the Official Secrets Act which apply to any civil servant engaged in this work.
The provisions in Parts V and VI of the Bill covering labelling and advertising requirements are necessarily wide in extent, but they include the provision that before any regulations are made there must be consultation with organisations representative of the interests likely to be affected. I have little doubt that the Medicines Commission will think it appropriate to recommend that a special committee should be established for the purpose of advising the Ministers on the exercise of these powers. All these safeguards, taken together, should go far towards removing any fears that the powers might be arbitrarily or improperly used.
The present law relating to the retail sale and supply of drugs starts from the assumption, which is clearly no longer valid in the context of modern medicines, that drugs and medicines are merely commodities, whose sale can take place any- 1612 where and be left to the ordinary commercial pressures of the market, except where there is risk of accident, abuse, or criminal mis-use, or danger to the community as a whole. Consequently, the basis of the existing law on this subject is legal freedom to sell medicines anywhere, safeguards being applied only to a limited list of specified substances.
This approach, however, pays too little heed to the risk for the individual inherent in uncontrolled medication with modern drugs. It is notable that pharmaceutical manufacturers, of their own volition, now often decide to market drugs, particularly the new potent drugs, only through pharmacies, because they are primarily intended for use on a practitioner's advice, and not for self medication by the public.
The Bill makes two important changes here. First, the provisions relating to the conduct of pharmacies and the circumstances in which medicines are sold to the public are set out afresh in terms which reflect the modern situation. The second important change establishes the registered pharmacy as the normal retail outlet for the sale and supply of medicines. There will, however, be a general sale list of prepacked medicines which can be sold by any shop. The drugs on the general sale list will be listed in orders made by the Ministers, following advice from the appropriate committee and consultation with organisations representative of the interests concerned. They will be products where the hazards to health, the risk of misuse, or the need to take special precaution in handling is small, and where wider sale will be a convenience to the public.
There are somewhat complicated provisions about enforcement which, despite their importance, I do not propose to go into on Second Reading, since there will be full opportunity to discuss them in detail in Committee.
The provisions in Part II look complicated and I will comment on the way in which we intend to administer them. The introduction of a statutory licensing system, with penalties, necessarily involves making detailed requirements, either in the Bill or in subordinate legislation, with regard to the particulars to be supplied, the conditions to be satisfied, the provisions to be attached to licences and, more particularly, with regard to 1613 the circumstances in which representations can be made where there is a proposal to refuse or revoke. Such provisions could quite easily be operated in a rigid and litigious manner, but the intention is to retain the flexible administration that has been so effective under the voluntary schemes, with the formal provisions as statutory backing.
The secretariat of the expert committees will be integrated with the licensing staff so as to enable applications, though technically made to the licensing authority, to be handled by staff serving the expert committees and knowing their views. Under the voluntary scheme there has been easy communication between the staff handling the submission and the staff of applicant firms. This has produced a situation in which applications can be handled without the delay that so easily arises where precise stages of procedure are laid down, and I am sure that mutual respect has been built up in this way. There is no reason why this situation need change or why applications should be handled any less expeditiously than are submissions at present.
The legislation provides unavoidably for offences, legal proceedings and penalties, but with the co-operation and mutual confidence which we expect to continue into the new arrangements provided for in the Bill, legal proceedings should be exceptional. Indeed, I hope that differences of view can be ironed out at a very early stage, and I shall be most disappointed if there needs to be more than very rare recourse to the elaborate provision for representations.
In general, there is a high standard of responsibility in the pharmaceutical industry over these matters and we shall have failed if we move into a situation in which firms try to take every possible advantage of every legal loophole they can find and thus compel the officials concerned with the administration of the Bill to handle applications in an atmosphere of suspicion.
I come to matters which are vital to the success of the legislation as a whole —that is, the provision of adequate expert advice, which will be recognised as both authoritative and up to date. Clearly, with legislation covering so wide a field as the present Bill—human medicine, veterinary medicine, devices, label- 1614 ling, description, advertising, the preparation of works of reference and other publications about drugs—the best possible expert advice is essential, and plainly one could not find it all within the membership of a single body, however eminent.
For this reason Clause 4 provides for a series of expert committees to be set up. But it does not rigidly define the composition and terms of reference of the committees that have to be set up for particular purposes. Here again, the Bill sets out to be flexible, as regards both the initial and the future pattern of committees. The Sainsbury Committee recommended that such functions relating to prescription drugs should be the responsibility of an independent Medicines Commission, which should be advisory in relation to licensing and advice generally about medicines, but executive in some other respects. Differing views have been expressed about this recommendation but the Government's view is that, in matters so closely touching the public interest as these, the fundamental responsibility must rest with Ministers who are answerable to Parliament.
In particular, we consider that the responsibility for making subordinate legislation should not be assigned to a separate organisation, however distinguished, but must reside with Ministers responsible in their turn to Parliament. Consequently, the basic status of the Medicines Commission under Clause 3 is advisory, and the functions which are given to it in later provisions in the Bill are, in the main, also advisory.
But it has important functions which go beyond this. When it is considering representations from applicants and licence-holders against advice from the expert committees, or is arranging for the preparation of the British Pharmacopoeia and other publications, it will be performing much more than an advisory function. The composition of the Commission is bound to reflect a variety of important interests who are concerned with medicines, and, as I have said, it cannot possibly cover within its numbers all the expert knowledge which is necessary for the purposes of the Bill.
The function assigned to it in Clause 3, therefore, of advising on the pattern of special expert committees which will in turn advise the licensing authorities and 1615 the Ministers direct is most important, as are its further powers to suggest suitable membership for such committees. It is also being charged to give advice, on request or on its own initiative, on any question relating to medicinal products and, as suggested by the Sainsbury Committee, will also have the duty to make an annual report which will be laid before Parliament. These are highly important functions and it will be our endeavour, through consultation, to assemble a Commission, and special committees, in whom all concerned will have the fullest confidence.
§ Mr. John Cronin (Loughborough)
There are innumerable admirable safeguards in the Bill, but it seems very much a matter of how these safeguards are interpreted by the people who administer them. There is a danger that advances in medicine might be bogged down by bureaucratic procedures unless the people who interpret the Bill will ensure that they use the maximum celerity and minimum impedance in advances of this type. Can my right hon. Friend confirm that that is the way in which the Bill will be administered?
§ Mr. Robinson
I can give that assurance in unqualified terms. Indeed, I had hoped that some of my earlier remarks would have conveyed the assurance in the explicit form for which my hon. Friend asks. The provision could be interpreted with great rigidity. We want it to be a very flexible instrument and the elaborate statutory provisions to be merely a necessary background to the normal flexible administration of the Bill.
I should like now to discuss the method of appointing the members of the Medicines Commission. The appointments are to be made by the Ministers under Clause 3 after appropriate consultations. The Commission will have complete professional independence, and will be expected to offer the Ministers advice which has regard solely to the professional and technical considerations concerned. What I might call departmental considerations are not to colour its advice at all. The method of appointing members must be such as to secure this basic objective; and it must also be seen to do so in order that it may command 1616 the confidence of the interests most closely affected by the Commission's activities. The same considerations apply to the appointment of the special committees provided for in Clause 4.
What I propose to do is this. Let me take the Commission as an illustration. First, my Ministerial colleagues and I will consider in detail what balance of knowledge and experience we need on the Commission—how many members with medical or scientific knowledge of certain types or with particular experience of the pharmaceutical industry, and so on for the other relevant spheres of activity which will have a part to play in the counsels of the Commission.
We should then consult the interests concerned about our proposals, which could well be modified as a result. Names would then enter into the discussions. My colleagues and I would make suggestions, the bodies we were consulting would make suggestions, and all these suggestions would be discussed between us. By this means we should expect to arrive at a proposed list of members which would be acceptable to all concerned. The aim would be—and I can give a positive assurance of this—to ensure by this very thorough process of consultation that the balance of membership of the Commission and the individuals appointed to serve on it were acceptable to, and enjoyed the confidence of, all interests most closely concerned with the Commission's work. This is a matter which I regard as of major importance, because it is essential that there should be no doubts about the Commission's independence and expertise.
Similarly with the committees provided for in Clause 4. The starting point here will be the pattern suggested by the Medicines Commission under Clause 3(2,a). Consultations would begin as I have just described in relation to the Commission. The names discussed would include those recommended by the Commission under Clause 3(2,b), and so we should appoint a number of committees each acceptable to, and enjoying the confidence of, the interests most closely concerned with the particular committee's sphere of work. These will be the committees on which the Ministers will rely for advice in the day-to-day administration of the Bill, and this fact, coupled 1617 with their standing and acceptability, and the many safeguards in the Bill to which I have referred, is a guarantee that their views as independent professional and scientific authorities will be reflected in its implementation.
Finally, I should like to make some more general remarks about the recommendations of the Sainsbury Committee which they made under the heading of, "The rôle of the Medicines Commission ". Their broad objectives coincide with those in the White Paper, and now provided for in the Bill.
I have already explained why in one or two respects we have departed from the precise methods recommended by the Committee for achieving those objectives. These departures have arisen because of the different approach made by the Committee on the subject of the scope and status of the Medicines Commission. This apart, the Bill substantially embraces most of the recommendations, either specifically or through general provisions that can be applied to the recommended purpose if desired.
There are, however, in this section of the Sainsbury Report, two recommendations which will not be found in the text of the Bill. The first relates to measures for bringing the price of drugs to the notice of the medical profession. We do not consider that this is appropriate to a Bill which is not directly related to the National Health Service. Indeed, as explained earlier, questions of price are wholly removed from the considerations governing the grant or refusal of licences. We consider that this recommendation should be applied by the Ministers as a part of their National Health Service function and should not be a part of the functions of the Medicines Commission or of the committee which is concerned with safety, quality and efficacy.
The other provision which does not appear in the text of the Bill is the Committee's recommendation for the establishment of a "British classification of medicines ". On this the Government have not yet reached a decision. Basically, this is an aspect of the evaluation of the safety and efficacy of medicines, on which information could be prepared for the medical profession, and consequently in principle it is within the ambit of the provisions relating to these matters in the 1618 Bill. On this subject, therefore, the Bill may be regarded as neutral, neither for nor against the Committee's recommendation; but the Bill would not preclude effect being given to the recommendation if that is found to be the right course.
I should like to take this opportunity of expressing once again the Government's appreciation of the work of the Sainsbury Committee, and of the extent to which its Report has supported the Government's own objectives expressed in the White Paper, after many years' study of the subject.
In conclusion, this is a lengthy Bill, because it has to meet such an infinite variety of situations in which many interests are affected. We are convinced that the enabling power must be wide if the complexities of manufacture, sale and supply are to be properly covered. In our view, the Bill contains fully adequate safeguards against the arbitrary use of the powers sought. Our intention is not to impede the industry not to hamper doctors, dentists, veterinarians or pharmacists in the practice of their professions. We are confident that this legislation will enhance the standing of British pharmaceutical products, and that it will operate for the benefit of the consumer, both within and without the National Health Service.
In matters of this sort, it is, I am afraid, impossible fully to satisfy all the interests concerned; but I have been heartened by the reception that the proposals in the White Paper have received, and I commend the Bill with confidence to the House.
§ 5.7 p.m.
§ Mr. Maurice Macmillan (Farnham)
As the Minister said, the Bill is basically about medicinal products. It might have been easier if the explanation which he gave and which I found confusing, but less so than either the Explanatory Memorandum or the relevant Clauses, had been available to us at an earlier stage. It also cleared up a number of points and referred to others which we shall want to raise at a later stage.
I was very disturbed by the reference the Minister continually made to his intentions under the Bill. Although these themselves were reassuring in the extreme, the fact that the Bill has been so drafted that it requires this type of 1619 reassurance seems to me to make the Minister's intentions for the more distant future virtually irrelevant to the powers which he is taking under the Bill. In all this, it is not what this Minister may intend to do that we are putting on to the Statute Book, but the wording of the Bill itself. In practice, the intepretation depends, not on the Minister or the Ministry, but, as the Minister himself said, on the courts.
It is often said nowadays that we live in a very permissive society. If that is true, judged by the Bill and by the Health Services and Public Health Bill, which is now in Standing Committee, the Minister is "with it" and is really a very permissive member of society, if I may use that word in an active rather than a passive sense, for in this Bill, as in the other Bill, the Minister is seeking very wide discretionary powers. He is demanding permission through the Bill to do many things without specifying how he proposes that they should be enforced —to regulate, to control, without much detail as to the circumstances.
In some cases safeguards or exemptions set out in one Clause are apparently nullified by another. To give one example, in Clause 7(3) the Bill saysNo person shall import any medicinal product except in accordance with a product licence.Clause 13(1) lays down in detail specific exemptions to Clause 7(3) but in subsection (2) it saysWithout prejudice to the preceding subsection, the restriction imposed by section 7(3) of this Act shall not apply to the importation of a medicinal product in such circumstances as may be specified in an order made by the Ministers for the purposes of this section.We are reassured in one Clause of the Bill that the exemptions are laid down and approved as in Second Reading, Committee and Third Reading by Parliament, and in another part the Minister gives himself powers to vary them with the utmost freedom.
He has set up a somewhat bureaucratic machine to operate these powers and he is reversing procedures in some cases which have worked well in practice. He is seeking new powers for himself and his servants, some of which seem to go a very long way indeed. The Minister rather coyly decided to leave the ques- 1620 tion of enforcement to Committee stage. Reading the Clauses devoted to enforcement, I am not altogether surprised.
Clause 100 has almost astonishing powers of entry, including entry to a private house without warrant. Admittedly the Minister's appointees cannot enter a private house as of right without warrant except by giving 24 hours' notice, but that does not seem a very great safeguard. Clause 97 extends to the Minister's staff the powers of the food and drug authority and of the Pharmaceutical Society according to which Section of the Act they are enforcing. There is power to exclude hospitals and doctors' surgeries.
The Minister has taken it upon himself to give power of entry which in my estimation seems to exceed that which the police have in the ordinary detection and prevention of crime. Perhaps the Under-Secretary can clear this up when he replies to the debate.
§ Mr. Ivor Richard (Barons Court)
The hon. Member says that the Bill gives greater power than the police have. The police have power to go to a court and get a warrant to enter premises without first giving the occupant notice. The whole object there is to search without notice being given, but in this case 24 hours' notice is given that an inspector is coming. How on earth can the hon. Member say that the Bill gives a greater power?
§ Mr. Macmillan
The hon. Member has not read the Bill. The police have power on a warrant to enter without notice. So it is with this Clause. In this Clause there is the additional right to enter private premises, with the exception of a private house, without notice. I have read this with extreme care.
The only time that it says notice has to be given is when the premises are used as a private dwelling house. That does not include a shop or a factory and private premises of other kinds. They can be entered without notice on a warrant, without even the suspicion that the Act is being contravened, but simply to discover whether there is or has been a contravention. There is nothing to justify a prima facie case. If I have exaggerated, I shall be delighted if the Parliamentary Secretary can clear up the point in reply, 1621 because this is a considerable power even in its most limited interpretation.
For these reasons I have a rather ambivalent attitude towards the Bill. I do not think I can do better than quote the words of my right hon. and learned Friend the Member for St. Marylebone (Mr. Hogg) in reference to the Gaming Bill. He said:It is a very highly complex and, to my mind, an extremely controversial Bill. Unhappily, I should vote for it if it came to a Division, which will, I fear, inhibit my criticism of it."—[OFFICIAL REPORT, 13th February, 1968; Vol. 758, c. 1181–2.]That is the unhappy position in which I find myself over this Bill. What is intended is admirable. It deals with three aspects of drugs and medicines: safety, quality and efficacy; secondly, description and labelling; and, thirdly, sale and promotion. For all these the Minister has set out a vast number of new provisions. I hope that in practice they will turn out to be better and more effective provisions than those which now obtain. Perhaps all of us would agree on the aim which these arrangements should have. It is that everything practicable and reasonable shall be done to protect the general public, but that the right, indeed the duty, of the doctor to prescribe as he thinks best for his patients should in no way be inhibited, that the general public should not be unduly restricted in its protection, and the industry should be able to manufacture and promote its products at home and overseas with a reasonable freedom. Equally, it is that farming and the agricultural industry as a whole should continue improving food production methods and increasing yields without inhibition by the provisions of the Bill.
Those criteria are accepted by this side of the House, but it is difficult, although the Minister appeared to accept those criteria, to see how they will be carried out under the Bill because as an enabling Measure, despite the Minister's explanations, it is still very obscure. It has been left to regulations to decide what medicines are to be freely sold. We are not even told how the laws will be drawn up, or by whom. The Bill gives the extent of the control to some degree, but it gives no limit and no hint of the principle by which that control will be operated. The same can be said to apply to labelling regulations and the extremely full control 1622 of advertising which the Minister is taking power to impose.
I think it was fairly clear before the Minister spoke, and it became clearer during his speech, what the Bill does not do. I was glad to have his assurance that it does not attempt in any way to control National Health Service doctors either in their choice of medicines or on matters of efficacy or price. I was left a little uncertain as to the precise relationship between the MacGregor Committee and the Commission or the expert committees, and whether this Bill enables any statutory or mandatory force to be given to the recommendations of the MacGregor Committee. It is not clear whether some of the Sainsbury Committee's recommendations which at the moment are not applied by the Bill—notably, the recommendations on price—could be applied by regulations subsequently either directly or through the MacGregor Committee. I should like to have clarification on that from the Parliamentary Secretary. Bearing in mind what the Minister said, which implied that he hopes to do more about the Sainsbury Committee's recommendations—I think he said he does not intend to use the mechanism of the Bill to do it—I should like an assurance that it is not possible to distort the intentions of the MacGregor Committee in this way.
I hope also that the Minister will resist the temptation to extend the Commission's powers to implement anything beyond the scope of the Bill. We shall discuss this matter in detail later, but the wording of the Bill as it stands allows the Commission to extend its operation beyond the ambit of the Medicines Bill itself. We on this side would prefer these extra powers not to be there unless there is good reason for them. No such reason has yet been given to us, and we regard it as a matter which must be discussed later.
I have no doubt that, when we discuss the details, we shall talk about whether the Commission should be wholly independent, as Sainsbury and the B.M.A. recommended, or whether it should be as the Minister would have it. There are close arguments on both sides, but the strong argument which I see is that, whatever happens, there ought to be some method for Parliamentary interference, so to speak, and representation.
1623 Before leaving the whole question of profits and prices, I suggest that the Minister takes great care in how he handles the retail side of the trade. I have tried to find comparable figures. Those which I have been able to obtain indicate that, in those countries where the trade margin is fixed either by law or by a professional body and where the sale of medicine is almost wholly restricted to pharmacies—curiously enough, the two categories are the same in Europe—in almost every case the profit margins are higher than in those countries where there is greater freedom. In France, Finland, Sweden, West Germany and Belgium, where, broadly speaking, the sale of medicines is restricted to pharmacies and where the trade margins are fixed by law—except in Sweden where they are fixed by a professional body—the profit margins are higher than in Holland, Britain, the United States or Canada, where there are no such restrictions and where medicines are sold more widely.
Therefore, both on the manufacturing side and on the retail side, the Minister should be very careful in considering the recommendations of the Sainsbury Committee and any other ideas he might have about prices and profits. As he himself implied in part of his remarks when paying tribute to the pharmaceutical industry, there is a clear link between the capacity of a company to make profits and its ability to invest those profits in research which, as the Minister said, can be and has been of great benefit to the public as a whole, producing many new substances on which we all so much depend.
I turn now to Part I of the Bill, which is headed "Administration." It is a curious reflection that administration should come first. When I was in the Army, a long time ago now, I was taught that, in framing an operation order, in order to achieve clarity and efficiency it was essential to put intention first after information available, then to proceed logically from there to method, and to cover administration last. Perhaps it is significant that the intention of the Bill may still remain hidden, the method obscure, and the administration, I hope, not too rigid.
1624 In referring to the Medicines Commission, which is to take over the functions of the Dunlop Committee, I join the Minister in paying tribute to the work of the Committee and to the co-operation which the industry gives it. I shall not discuss the Commission's membership or method of operating in detail. My only comment at this stage is that the B.M.A., like the Dunlop Committee, would prefer it to be completely independent—this appeared in an article in its Journal. On the whole, the balance of my judgment on his point favours operating it the other way round, as in the Bill.
It is not clear to me how the relationships of the Commission, the committees and the Minister will work out in practice. Perhaps this will become clearer when we discuss the Bill in the coming months, and I have no doubt that, when things begin to work, it will be a good deal clearer. However, I am a little worried about the effect on the responsibility of doctors and on the pharmaceutical manufacturers of the need to get a clinical trial certificate, the new procedure under the Bill. There is a danger here both in reducing flexibility and in lessening the scope within which professional responsibility is exercised, a matter to which the Minister himself appeared to attach considerable importance. Some of the Minister's words led one to fear that the degree of bureaucracy which would supplant the Dunlop Committee's operations would make a mockery of his assurance that he would as far as possible retain the flexibility which the Dunlop Committee's operations showed.
In this connection, I cite the opinion of an American medical man, Dr. Joseph Cooper, writing in a professional magazine. He regarded the Dunlop Committee as extraordinarily effective and the sanctions available to it, largely through the dependence of doctors on the Health Service, as effective; and he regarded it as an admirable method which had succeeded in avoiding the worst bureaucratic excesses of the American system under the Food and Drug Administration.
Here again, I have tried to obtain comparable figures. I am not certain of the complete accuracy of these estimates, but I am assured that they are not far out. The British system, that is, Dunlop, employed a staff of nine professional 1625 people and 16 non-professional. Under the American system, the Bureau of Medicine alone, that is, apart from the rest of the Federal agency operating the legislation, employed 180 medical men out of a total of 608 staff, and I understand that those numbers are now being considerably increased.
It seems to me that the difference there is disproportionate to population, and it is even more disproportionate to the actual work load carried by the two organisations. I am informed that in 1964 the Dunlop Committee dealt with 602 submissions, and in the United States the Bureau dealt with 500. In 1965, 875 submissions were dealt with in the United Kingdom, including a backlog of 68 and 99 referred back. By February, 1966, there were about 1,400 applications pending in the United States. I understand, further, that the average processing time in the United Kingdom for a major submission is about three months, and in the United States it is two to three years, going up not infrequently to four years.
Those figures are a clear indication of the danger in trying to be too rigid and allowing too bureaucratic a technique of control to develop. I have no doubt of the Minister's intention to avoid this. But I question whether the mechanism he has devised can do so.
I was tempted to refer to the Commission's publishing activities, but I thought that in the absence of the hon. Member for Buckingham (Mr. Maxwell) it would be more politic for me not to do so. I do not think that I should be interested in the British Pharmacopoeia in any other than a political capacity.
§ Mr. Eric Ogden (Liverpool, West Derby)
My hon. Friend the Member for Buckingham (Mr. Maxwell) cannot be present now, but if the hon. Member inquires in a little while he will find that my hon. Friend had good and personal reasons for his absence.
§ Mr. Macmillan
I was not implying that the hon. Gentleman should be here, but merely that I might have said a little more about publishing if there had been another publisher in the Chamber.
I cannot deal with all the enormous number of points in the Bill, nor do I propose to try to do so. I hope that the House will not regard this as any 1626 indication that we regard them as unimportant. I know that if they catch the eye of the Chair, some of my hon. Friends will try to develop those points, including the Bill's veterinary aspects. I must confess that there are one or two points about which I know so little that I would hesitate even to read out a brief on them. One of my minor disappointments is the number of words in the Bill which I find it remarkably difficult to pronounce accurately. I would not venture to deal with Scotland or Northern Ireland either, and again I hope that my hon. Friends will catch the eye of the Chair on points concerning them.
The licensing provisions seem to me to be both the most precise and to have all the best safeguards. As the Minister said, they take account only of safety, efficacy and quality, but prices are excluded and I understand that the question of efficacy is in relation to the nature, danger and function of a product, and not by comparison with a similar product.
I hope that when the procedure is developed it will be possible to follow the Dunlop procedure for new formulations of the same substances, and that the only evidence required will be the substance used rather than specific clinical assessment of each formulation, which would continue a considerable saving in time and effort. I also hope that it will not be assumed that preparations which are precisely the same in their chemical structure necessarily have the same clinical effect, because I understand that that varies widely according to the methods of manufacture, tableting, encapsulation and so on.
Does the Minister see any possibility, as he should, of withholding certain types of confidential information from disclosure in certain circumstances? This is particularly important when substances are being prepared purely for export for clinical trials. The American practice has led to their not being able to do clinical tests in Canada without going through a full process of validating their drugs for sale in the United States. It is for that reason that a number of British manaufacturers are exporting medicines to Canada for clinical trials. If they lost that advantage by the Bill's being implemented in a way matching 1627 the American practice, I fear that we should lose this manufacture and export, notably to continental manufacturers.
On export generally, I am not sure whether Clause 19(3) has enough safeguards to protect exporters. As I read it, it requires a separate licence for each product for each country concerned. That seems a very cumbersome method, and I am net clear that it is really necessary. I cannot see why it should be necessary that exports should conform in all respects to our regulations as well as those of the country to which they are being exported.
I, like other people, am not at all happy about the procedure for appeals on licences. The Minister said something about that. It seems very much as if the same people involved in discussions and the procedures leading up to an original decision will be operating the appeals machinery in practice, and thus be almost judges in their own cause. There is a similar danger in the use of the Pharmaceutical Society's testing laboratories for analyses done on behalf of the Society acting for the Minister. I hope that the Parliamentary Secretary will deal with that point.
We heard nothing about the question of fees. When we were discussing another Bill earlier today I was interested to know whether the Minister, wearing the little white coat of a drug manufacturer that Clause 30 of the Health Services and Public Health Bill allows him to don, will be subject to the same licensing regulations and fees as he imposes, wearing his bowler hat as Minister of Health, on behalf of the licensing authority on other exporters, importers, wholesalers and retailers, all of which he or his successor may well become in some distant day.
There is also the question of exemptions from licence fees. I have heard it said that these tend to be both too wide and too narrow. The Minister may regard that as an indication that they are drawn just about right, but there are fears that some of the exemptions extend to the point of nullifying quality control, particularly of importations and perhaps also of drugs manufactured outside industry for sale overseas. That is one of the main reasons why the statutory powers can be 1628 said to be necessary, to give protection both to the public and the industry against what might be called fly-by-night operations. Statutory protection with the possibility of a prosecution is stronger than the protection now open to them, which largely depends on civil action in the courts.
I turn to the question of advertising and research. The Minister paid a tribute to the industry. I think that Lord Platt in his Harleian lecture demonstrated that a great deal of the advances in clinical and chemical medication have been made by research undertaken by the pharmaceutical industry. I suggest that there is a correlation between the effectiveness of the research and the drugs so produced and the demands of the market, that it is simply because the pharmaceutical trade had to sell its goods that it was forced into lines of research that produced drugs which doctors really wanted to prescribe for needs which their patients really had.
I think that there is a danger in assuming that the more academic kind of research, because it is made without regard to a future profit motive, is necessarily directed to better social ends. I would approach it the other way round, and say that one of the best tests of knowing what people really want is their willingness to pay for it even if, as in this case, it consists of their paying for it as taxpayers rather than as consumers.
I come now to the whole question of the protection of the public, including doctors. This applies to the whole Bill, which is essentially a protective Measure. So far, licensing provisions, the Commission and the replacement of the Dunlop Committee and the rest have been concerned with protection requiring expert technical and medical knowledge. I want to turn from the more abstract topics to the more ordinary trade considerations.
The protection of the public in this context can be overdone. The Government can be too bossy. Ministers—not the right hon. Gentleman in particular but Ministers in general—are rather apt to be like masters in a not very good boarding school, with a bland assumption of the superiority of their decisions simply because they are masters and regardless of their efficiency or indeed, the relevance of their knowledge.
1629 We must allow people to make their own mistakes and, although one accepts the fact that medicines are very different from other goods in this context, I do not think that they are so different that they should never be advertised, for example. The Sainsbury Committee had a considerable dichotomy. It is unrealistic to assume that all information about drugs can be left to the Commission.
The other side of the question concerns the general sales list. The Bill reverses the present procedure. Now it is the drugs which are restricted which are listed. When the Bill becomes law it will be those which are free which are listed. There are some dangers and complications here. On the facts and figures, I believe that there are some 15,000 pharmacies as compared with about 150,000 other shops selling some form of home remedies and that the value of the retail trade in household medicines is about £ 40 million, approximately half and half divided between pharmacy and non-pharmacy outlets.
Considering that the average retail pharmacist gets only about one-third of his turnover from the National Health Service, I see the force of their case that they have some claim to special economic protection. Indeed, the claim was recognised in the Resale Prices Act. But I hope that there is no question of its having relevance in the context of this Bill and I hope that the right hon. Gentleman ensures that everything that is now freely on sale, with the possible exceptions of one or two products which, since they have come on sale, have been found to be more dangerous than was thought. will stay on the initial list as of right and that new additions are made as occasions come forward— in other words, that the general sale list will follow in practice the same procedure as the right hon. Gentleman has laid down for licensing.
There are many other matters of detail, but now I want to turn to wider considerations. I do not think it possible to consider the Bill coherently in isolation. First, there is the question of what is not in it but which could be put in by regulation. Then there is the scope and effect of the Green Paper and how much the powers the Minister will have under the Bill can be used to implement its recommendations— indeed. how much these 1630 powers are being sought in anticipation of the Green Paper. The same considerations apply to the Health Services and Public Health Bill which is equally widely drawn and comprehensive and just as vague.
The House has heard a lot— and those of us considering that Bill upstairs have heard even more— of the intentions of the Minister, which are magnificently beneficent. I am happy to say that I have no doubts about them at all. But when these two Bills are on the Statute Book, whatever his intentions may be his powers will be formidable indeed and Parliamentary control inevitably not all that effective, owing to the means open to us of negative or sometimes positive Affirmation.
The composition of the Commission is relevant here, as are the decisions that the right hon. Gentleman has made. It seems that he has recognised the need for Parliamentary supervision. I think that, had it been achievable, an independent Commission would have been the better course. It would have been better if the committees had had to work through such a Commission rather than being responsible direct to the Minister. It would be better if the Commission were entirely independent. But I accept that this would be extremely dangerous, as does the right hon. Gentleman, unless there were some form of Parliamentary control of the Commission or at least of supervising it.
In passing, I think that this is a very strong argument for setting up a specialist committee which could send for members of the Commission, take evidence and send for papers. That might he an effective safeguard to the very wide powers the Minister is taking. Without such detailed apparatus, Parliament is not really very effective in dealing with wide delegated powers.
The right hon. Gentleman thinks that I exaggerate. He has said so repeatedly. But he has only himself and his party to blame if we express our fears. Has he gone back on "Signposts for the Sixties "or some of his own writings? If so, what about his party's position, especially those sitting above the Gangway? He can hardly blame us if we fear that at least some elements in the party opposite would like to carry out 1631 their expressed policy and if we find his expressed intentions too vague and too likely to be reversed to be really assuring.
The Minister has repeatedly said that these powers will not be used and that in any case they are for the public good. That is the classic excuse of those more concerned about interfering than about liberty. I am appalled by the sloppy thinking shown by the sort of mixture of fundamental reasoning and arrogant bossiness which does not recognise this danger. Liberties are eroded not by men or evil intent but by good intentions mixed with a fundamental contempt for the ordinary person which such men have for their less gifted fellows. A letter in The Times recently quoted from The Times of 1846. It said:The greatest tyranny has the smallest beginnings. From precedents overlooked, from remonstrances despised, from grievances treated with ridicule, from powerless men oppressed with impunity, and overbearing men tolerated with complacence, springs the tyrannical usage which generations of wise and good men may hereafter perceive and lament and resist in vain.That, in another context is the same sort of thing. This is the way the world ends, not with a bang but a whimper, a id this is the way that I look at this Government. They produce not a proclamation, but about 119 Clauses of turgid prose. Is this an exaggeration? What about these enforcement powers, especially the right of entry, the appeals procedure and the other matters? What about Clause 30 of the Health Services and Public Health Bill, taken in conjunction with the licensing provisions, and all the rest of the apparatus? Why do we have all these powers if they are not to be used?
There are only three reasons that I can think of. Either that our suspicions are justified or that the Ministry is determined to provide for all possible conditions and contingencies, however remote, with a panic that verges on paranoia, or else it is just a blind obedience to Parkinson's Law. Anyway, the result is a very large, cumbersome and doubtfully efficient Measure to achieve a very laudable but very simple purpose, to give permanence within the framework of legislation to the existing arrangements, which as the already working well and which, as the Minister says, have not been 1632 hampered by the lack of any statutory powers.
We agree that these arrangements should have legislative permanence and statutory powers, but we think that it could be done a great deal more simply and a great deal less dangerously and bureaucratically and, in the end, probably a great deal more efficiently. This is what we shall seek to demonstrate in the course of the remaining stages of this Bill.
§ 5.52 p.m.
§ Mr. Arthur Blenkinsop (South Shields)
The feature of the speech by the hon. Member for Farnham (Mr. Maurice Macmillan) which I found most worrying was the apparent complacency about our present situation with regard to drug production, licensing and so on. For many years I have felt that we have needed to move a good deal further forward towards the procedures which have been adopted for some time on the continent and elsewhere. It has been a matter of some sorrow that it has taken quite so long to establish in a satisfactory framework the kind of organisation that we seem to need for the safety of our people and also to encourage the production and development of the drugs that we clearly require.
It was very hard to discover from this rather lengthy and also turgid speech of the hon. Member whether he was supporting the Bill. On balance it appeared to me that, in view of many of his strictures, he was recommending the House to oppose it. I take a different view. 1 welcome this Measure and believe that the wide powers referred to, which the Minister will have available, are both necessary and indeed essential. It seems a pity that there has been no time so far to put this Bill within the background of the needs as I and many others feel they exist.
There is very considerable public anxiety on this question of drugs, their use and misuse. That is not surprising and there are many reasons why this should be so. It is because of this anxiety that gradually a great number of steps have been, quite rightly, taken in a more informal way, non-statutory steps, to try to ensure the proper safeguards. In the view of many of us those steps have been far from adequate, bearing in 1633 mind the growing pressures that today exist.
There are the problems and dangers both of over-prescription of drugs and the dangers of misuse. It is a fact that powerful drugs are prescribed for relatively simple complaints and ailments. This is nothing new, it has been happening for years, but it has reduced the value of the drugs for the conditions for which they were designed. We have recently had a very tragic example of what possibly could arise as a sequel. We had the tragedy on Tees-side, in Middlesbrough, of the death of several very young children, because of resistances that had built up, possibly— I say no more than that— due to the over-use and over-prescribing of drugs over a long period of time. There are some of us who fear that these dangers may well become far more acute unless there is some more adequate understanding of the uses to which modern drugs should be put.
This is essentially a matter for the Ministry and the medical profession, and I realise that they are both well aware of these dangers, and are discussing effective means which can be taken to meet them. This Bill is one step forward along those lines. It makes it more possible to prevent this kind of danger. Today the general practitioner has full liberty, and it is what he has always rightly demanded, the liberty to prescribe what he thinks right for his patients. One has to modify that for the one exception, at any rate, with regard to the case of heroin, where rightly a limitation has been imposed. Apart from that it still stands, although it is true that the general practitioner can be subject to some challenge afterwards to justify what he has been doing, about the level of his prescribing.
We know that there are very great pressures on the doctors all the time, both from the manufacturers who, perfectly naturally, want to sell their products, and also from the general public. This is one of the tragedies, that otherwise adult and responsible people assume that it is the continuing job of the doctor to relieve every minor symptom, never mind the complaint itself.
This is obviously a very important problem, needing continuing education. One must say that the right of the general practitioner, which is retained in 1634 this Bill, to prescribe as he considers right and proper, assumes a degree of responsibility on the part of doctors which, frankly, general practitioners do not always display. I completely agree that the great majority of doctors do show a proper and real responsibility, but there are some, as we know well, who do not. This has been shown recently in many problems that we have had to face. One is referring not only to the more extreme cases, where abuse can occur, but to the problems that arise because of the pressure that the doctor has to face, and the kind of case that I have referred to on Tees-side and the danger of some of the risks of the potent and powerful drugs available today. It seems that a permissive attitude to drugs has been built up among adults, who have been assuming that the doctor should provide, by powerful drugs, relief for these minor ailments. This has spread, in many cases, from the parents to the young.
We face the dangerous, if not critical, possibility of a spread in the misuse of drugs among young people. We should not regard this as the fault of young people alone. The responsibility for this situation is the attitude adopted by so-called responsible adults— the parents themselves. There are few homes which are not overstocked with masses of drugs, and discussion about what drugs should be used for particular purposes is common in families. If this kind of permissive attitude is adopted by the older members of the community, is it surprising that it is being taken advantage of by the young?
The abuse of "hard" drugs is a very acute problem, but perhaps, within certain limits, it can be contained. However, we also face grave dangers from the abuse and misuse by young people especially of what are wrongly called "soft" drugs. This term gives a wholly misleading impression, because the modern form of use by young people of so-called "soft" drugs— some of the amphetamines— can result in as serious a condition as we have known to result from "hard" drugs.
These are some of the problems which are in our minds when we consider the Bill to see what it can do to help us in dealing with this serious situation which might become far more serious unless 1635 action is taken. This is why I found the speech of the hon. Member for Farnham so unsatisfactory. His comments took no regard of the major problems we face and which are likely to become far more acute.
§ Mr. Maurice Macmillan
I was not aware that the Bill had anything to do with the control of drugs in that sense of the word. I thought that that was entirely the responsibility of the Home Office. Indeed, I understand that there is to be a Prayer about it next week. I did not speak about that problem, not because I do not consider it serious, but simply because it seemed to me that under the terms of the Explanatory Memorandum it had nothing whatever to do with the Bill.
§ Mr. Blenkinsop
The hon. Gentleman shows that he does not appreciate the kind of problems we face. We are talking, not about drugs which come within the special list provisions, but about drugs which are regularly prescribed, perfectly properly, by doctors but which are being misused. This is one of the dangers, together with the other danger to which I referred, which can arise from the prescribing habits of doctors which can be dealt with, possibly, through the operation of the Bill and by the better education of doctors on the way in which they prescribe.
This matter has been of real concern to many of us. My hope and belief is that one of the more beneficient objects of the Bill is to ensure that the safety of the public is more securely guaranteed under the Commission which is to be set up than has been possible in the past. Despite the welcome which there has been of the way in which the Dunlop Committee has worked, we know that there has been some anxiety about this matter. Through the Bill the Commission, and the committees who are to follow the setting up of the Commission, will give an added sense of safety and security to members of the public which they very much need. It is right that the Minister should retain responsibility and that the recommendation of the Sainsbury Committee in this respect should not be accepted. It is vital that answers should be given in the House on matters which might arise. We need an independent 1636 qualified judgment on the value of new drugs and eventually of existing drugs.
That raises the question which the Minister dealt with about who are to he the judges. I agree that it is only right that those who are involved should have representation and that everyone concerned in the operation of the Bill should accept the independence and authority of the Commission. That is vital. Representation must equally be seen to apply, not only to the Commission, but to the committees which are set up. It is true that, in attempting to reach decisions about the value of drugs. regard must be had to the immense value which some drugs have been to the community and the lives which they have saved, but we must all the time consider the dangers involved. This is possible of achievement only provided the Commission has real authority to take charge of this matter.
I welcome the provisions about clinical testing. The situation which has developed has been somewhat unsatisfactory, because inevitably the only way in which clinical testing could be achieved would be by the representatives of a firm making private arrangements with a hospital and building up a relationship with an individual specialist in a hospital. This might mean that a smaller firm which might have something of real value to contribute and test has not been able to do so. I hope that it will be possible under the new arrangements to ensure more independent testing.
We need effective control of so-called ethical and non-ethical products. I welcome the provisions for the control of the general sale list which is to be established. However, I have some anxiety about whether the controls are adequate. I do not take the view that the powers are too great. I am concerned that, in view of the dangers which arise, even products which we might think of initially as relatively harmless should not find their way on to the general sale list.
It would be wrong to allow the development, as is apparently suggested. of the use of automatic vending machines for drugs. I know that this already happens in some cases. We should consider whether there is a need for automatic vending machines for drugs. Even 1637 in the case of the more generally used medicines, there is a danger which needs investigation.
§ Mr. Peter Mills (Torrington)
Could the hon. Gentleman tell me the difference — I am not being funny— between a 16year-old girl in a chemist's shop and a vending machine? We hand our money over to both. The girl does not know what she is selling, and the vending machine does not know.
§ Mr. Blenkinsop
I was about to make it clear that I do not accept the whole of the argument put forward by many pharmacists who seem to take the view that there is complete security provided everybody goes into the pharmacy. It depends on who may be serving. There is, nevertheless, an added check. The existence of the vending machines is based on the assumption that these drugs in any kind of quantity are all right. One has to balance the perfectly proper need for some kind of availability to people with the dangers that might arise. I suggest that this should be looked at again.
So far from regarding the provisions about advertising as too onerous, I doubt whether there is a case for advertising. The needs and safety of the public must come first. Advertising adds little or nothing of value. Indeed, it adds some positive dangers. The provisions now made to ensure that doctors can have a regular flow of information about the new drugs that are coming on to the market in the ethical sphere are right. However, on the wider issue of the non-ethical drugs, the general advertising we see today on television, etc., is potentially dangerous. We could spend a great deal of time arguing whether a particular claim is sound, when in fact there is no value in the expenditure on advertising that goes into it. I welcome the fact that the Minister has cut down on advertising of smoking. It is equally right that there should be an attack on the advertising of drugs.
The Minister has on the whole got the balances right in the Bill. He needs the co-operation of all concerned in the medical profession, the pharmacists and, indeed, in the industry to make sure that the scheme works effectively. I welcome the detail that the Minister gave 1638 as to how he intends the whole operation to be carried out. It meets most of the criticisms which have been put up by the manufacturing firms, which include some highly reputable firms with a very good record. I think, therefore, that their justifiable anxieties are met extremely well by the appeal procedure that my right hon. Friend has mentioned. With the assurance that there will be representation from the industry on the Medical Commission and possibly on the committees, too, I cannot see that any further provision need be made.
I welcome the provisions of the Bill. I regret that not sufficient anxiety has been expressed about some of the worries that most of us have about the developing pressures and the dangers that can arise from drug-taking both in our adult and in our younger population. I hope very much that the Bill can make a useful contribution to relieve these anxieties.
§ 6.14 p.m.
§ Colonel Sir Malcolm Stoddart-Scott (Ripon)
The Minister underestimated when he said that this was a complex Bill. I think that it is a very difficult Bill. It is difficult to understand, but admirable in its intentions. It intends to control the safety, efficiency and quality of drugs by two or three methods. First, by the setting up of a Medicines Commission. I congratulate the Minister on taking this under his wing. This is a tremendous step forward. It gives Parliament some little control and some little say by question and answer and by other methods. We may, therefore, in some small way be able to influence this Medicines Commission.
The licensing procedure which we already have will be greatly enhanced and increased. Reading through the Bill I got a little muddled about manufacturing licence, product licence, wholesale dealer's licence, export licence, and licence of right. I suppose we shall have a Register of Phamarcists and there will be a licence for pharmacists. If we have the list of drugs on general sale there will also be a licence to get drugs on the general list. There is also the issue of certificates: clinical trial certificates and field trial certificates. We are to have increased controls to get safety, quality and efficiency. We are to have controls 1639 over conditions of manufacture, conditions of storage, and conditions of distribution; and there are to be controls over labelling of drugs, sales promotion and advertising, and controls over the colour, shape and marking of medical products.
This will require a lot of staff. We have heard nothing about the increase in staff which will be needed at the Ministry for all this licensing, for all this controlling and for all the inspection that is to go on. On 19th January we were told by the Prime Minister that, in order to save £ 50 million a year, there was to be no increase in the numbers of civil servants. When the Under-Secretary comes to reply, perhaps he will tell us how many additional civil servants will be required, not this year, not next year, but by 1970 when the Act, as it will no doubt become, will be operable. What will it cost? We have not been told anything about the cost of carrying out this enormous operation. There is no Financial Resolution down which should give some indication of the cost. There is a Resolution down today, but it refers to the income from the licences; not expenditure. I wonder whether the Minister can tell us whether he expects the income from these licences to cover the cost of administering this Measure. We have heard nothing about the cost of these licences. How much do licensees have to pay at the present moment? Is there to be an increase in the cost of licences? We should have all these figures and facts put before us.
We were told that the restoration of prescription charges was to save the Exchequer £ 25 million a year. I noticed in theFinancial Timestoday that the hon. Member for Falmouth and Camborne (Dr. John Dunwoody) had got it down to £ 8 million. Is that £ 8 million to go on administering this Measure when it reaches the Statute Book? Perhaps the Under-Secretary will tell us about these things, because they should help, especially when we come to Committee stage, in deciding whether we should go on with this expensive procedure.
The drugs on general sale list is most important. I do not know who will draw up the list, whether the Medical Corn-mission or the Minister, but when it is drawn up I hope that it will be made as extensive as possible, because this will be of great use. Drugs to the value of £ 40 1640 million a year are sold by tobacconists and obtained from automatic vending machines. Some of these drugs are also sold in the Tea Room of this House. It saves a lot of work for the general practitioner if these household remedies can be obtained round the corner. Often when the pharmacist has closed down these household remedies can he obtained. If these outlets are to be discontinued the general practitioner will have a greatly increased burden placed upon him. In Germany, where there was no such list and all these household remedies had to be bought from the pharmacist's shop, they found that it did not work, and in 1962 they instituted a system similar to that which we have in this country.
The success of the Bill will depend on two things. First. on what is in the regulations, orders, and the additional legislation which we hope to see in the future. Secondly, on the spirit in which these regulations and orders are applied. I have no fear about the spirit in which the Minister will apply them, but one has a little anxiety about these powers being taken to bring in orders and regulations, because we could have a Minister who has not the same spirit or the same outlook as our present Minister. and he could act adversely.
I would like two assurances before we end the debate. First, I hope that nothing in the Bill will in any way damage what I consider to be our outstanding pharmaceutical industry. This country has always led the world in pharmacy. There have been more worthwhile discoveries of remedies and drugs in this country than in any other country in the world. Over the last 25 years, probably 90 per cent. of the worth-while drugs have come from Great Britain, with the result that we are one of the four great pharmaceutical exporting countries.
A certain amount of damage has already been done by the Sainsbury Report. One American firm which exports from this country bought a piece of land on the Continent with a view to setting up a factory there so that it could export from the Continent rather than from here if some of the things in the Sainsbury Report were put into this Measure. I am glad that they have not been.
1641 This is a useful industry. When it has paid for the raw materials required to manufacture the drugs, and after account has been taken of all the drugs that we import, there is a balance of payments of £ 28 million in our favour.
§ Colonel Sir Tufton Beamish (Lewes)
It is more than that. In 1966, the last year for which I have figures, exports amounted to £ 75 million, and imports were about £ 20 million, so the figure is more impressive than my hon. and gallant Friend suggested.
§ Sir M. Stoddart-Scott
This is a favourable balance of payments, and I should hate to see any of this licensing and the issuing of these certificates causing a delay, an obstruction, or a hindrance lo the progress of this industry.
§ Dr. M. S. Miller (Glasgow, Kelvingrove)
Would the hon. and gallant Gentleman like to expand a little on the question of exports by the British pharmaceutical industry and say how much of the profit is made by British firms and how much by American or American-dominated firms in this country?
§ Sir M. Stoddart-Scott
One of my hon. Friends will deal with that later. He knows much more about it than I do. I do not know the answer to that question.
As I said, I would like two assurances before the debate ends. The first is that no limit will be placed on prescribing by doctors, that they will be able to prescribe whatever they think is necessary for their patients. I think that the Minister expressed that view when he spoke, but his hon. Friend the Member for South Shields, (Mr. Blenkinsop) seemed to think that there was something in this Measure which would limit a general practitioner prescribing for his patients. If the Bill does that, it will be very unpopular with the medical profession. More of them will leave this country if they feel that they do not have the right to prescribe the drugs which they regard as essential for their patients, and if more doctors go abroad the general practitioner service as we know it will come to an end, and it will be a tremendous blow to the National Health Service.
§ 6.24 p.m.
§ Dr. M. S. Miller (Glasgow, Kelvingrove)
I have the reference which I was 1642 seeking in my mind in connection with the question I asked the hon. and gallant Member for Ripon (Sir M. Stoddart-Scott).
§ Dr. Miller
I have the reference, and it shows clearly that there was a favourable balance of payments on international receipts and payments of £ 28. 3 million in 1965. However, it was British firms which had the favourable balance. United States ones had an adverse balance. It seems, therefore, that there is a mixed blessing about the state of the pharmaceutical industry in this country.
When the hon. and gallant Gentleman was speaking I conjured up visions of vending machines with large looking glasses in front of them, with a thermometer and a stethoscope attached, and with suitable instructions telling patients that if they had such-and-such symptoms, or their temperature was above a certain level, they should put 2s. 6d. in the slot and take such-and-such a medicine. I suppose the consultation will he free. I do not want to enter into the pros and cons of vending machines, but I must tell the hon. Member for Torrington (Mr. Peter Mills) that there is a difference between even a 16-year-old girl serving in a pharmacist's shop under the instruction of a qualified chemist, and a vending machine, because the latter cannot refuse to sell a packet of medicine to a six or seven-year-old child.
§ Mr. Peter Mills
There are many occasions on which a 16-year-old girl is in the shop without a qualified man being present.
§ Dr. Miller
I imagine that she would have received general instructions from the qualified pharmacist not to serve any young children who come toddling into the shop.
I hope that the hon. Member for Farnham (Mr. Maurice Macmillan) will forgive me if I congratulate my bossy form master, as he put it, at this Westminster school for delinquents, on bringing in the Bill. I do not know what the hon. Gentleman was getting so worked up about. It is amazing how any talk about freedom can stimulate such an interest.
1643 The hon. Gentleman seems to have a 'lion memory. Perhaps he has forgotten the thalidomide tragedy, which is in the minds of all doctors, and certainly is in my right hon. Friend's mind. Anyone who has seen the tragic results of the thalidomide episode can have no doubt about the necessity of a Measure such as this to bring in a rigid code of safety for drugs.
§ Mr. Paul Dean (Somerset, North)
I am sure that the hon. Gentleman does not want to misrepresent my hon. Friend. My hon. Friend referred to the wide enabling powers given to the Minister under the Bill to be exercised by regulation in some cases, and in others on his sole discretion. He was in no way suggesting that the safety regulations in the Bill were not required.
§ Dr. Miller
I draw the hon. Gentleman's attention to a recent medical publication which says:If the Bill is passed into law, its effect will depend largely on the spirit in which it is applied. Mr. Kenneth Robinson has shown himself to be fair and reasonable in his dealings with the pharmaceutical industry, as with the medical profession, and as long as he is in charge there are unlikely to be any serious problems. But the powers the Bill gives the Minister to make regulations in many areas could be disturbing…I would prefer the Medicines Commission to be independent, and not merely capable of giving advice.
Thalidomide is not the only drug which can have disastrous effects. It made a dramatic effect at the time, but there are many others which can have serious effects. I believe that my colleagues in the medical profession will agree with me when I say that. As a general rule, no one should take any medicine unless it is essential. We believe that the human body has amazing powers of recuperation without taking anything, but human beings will always find solace in some kind of remedy. I therefore think that it is the duty of those who know the dangers at least to make sure that what people take is not harmful, even if it does no: do them any good.
Two examples spring to mind of drugs which are widely used and which can be extremely dangerous. I would ask the House to bear with me if I give two personal cases. Butazolidin is one and the 1644 other is Sulphapyridine, known as M & B 693. Butazolidin is used in arthritic conditions, and I quote the case of a young woman who began to complain of vague pains in her legs. After three or four weeks she consulted her family doctor who prescribed Butazolidin for her. The patient took the drug regularly for about two weeks according to the doctor's instructions and then began to feel ill. She became pale, developed nausea, and in her own words "felt groggy ". She was sent home from work one day and asked the doctor if it was possible that the drug had anything to do with her condition. The doctor said no.
She continued the treatment for a few days more, and since the symptoms worsened she stopped of her own accord. But the damage had been done. The condition continued to get worse. She began to stagger, collapsed and was rushed to hospital and with acute anaemia due to internal bleeding. The drug she had taken had either activiated a duodenal ulcer causing it to bleed, although she had no previous symptoms of duodenal ulcer, or was directly responsible for the bleeding. At any rate the butazolidin was to blame. After two weeks in hospital and four pints of blood the patient recovered.
The second case is of a similar nature, involving sulphapyridine. A young woman who had a mild cystitis, which was not yielding as rapidly as she wished to a conservative form of treatment, was given sulphapyridine and after two days began to develop bleeding of the gums and large haemorrhagic areas over her body. She had developed perpura. The doctor recognised the symptoms and the connection between the drug and the disease, stopped the sulphapyridine, sent her into hospital and after a blood transfusion she recovered in a few days. Even medicines well known to the public as well as to the medical profession can be dangerous, and measures to ensure safety are essential in order to prevent a further development of iatrogenic disease which is all too common at the present moment.
Medicines should not be taken lightly. I remember hearing the story of a patient who complained to her friend that she had to go to the doctor for pep pills to give her the energy to go to the chemist to get her tranquillisers. We believe in the medical profession that masterly inactivity on the part of the doctor is often 1645 the better course of action than giving drugs.
I would like to refer to one or two aspects of the Bill itself. Although as I indicated I think it is a good idea to set up a Medicines Commission, I feel that probably it would be better to make the Commission independent of Parliament. I know that to talk about the necessity for having Ministers responsible to Parliament is a good democratic resounding phrase, but I also fear the situation which might develop if we had Ministers in the future not quite so enlightened as my right hon. Friend.
Before a licence is granted for a particular preparation, the licensing authorities, who will be the Minister of Health, the Secretary of State for Scotland and the Minister of Agriculture, would presumably be almost completely dependent on the advice and recommendations of the Medicines Commission. It might be better therefore if the Medicines Commission were an independent authority with full powers.
In connection with the promotion of sales, Clause 87, there will be— and again I think this is a sound project— the production of a data sheet. I gather this will be prepared for every new product and I imagine will correspond fairly closely with the control document recommendation in the Sainsbury Report. The data sheet will contain all details about the preparation— its uses, its dangers, its contra indications, side effects, etc. It will be seen by all doctors prior to the drug being released. It is essential that this should not wait until there is a risk of doctors prescribing the drug and not knowing about its dangers and its side effects. This is an important point. It is not only essential for drugs to be tested as to efficacy and safety; it is also imperative that every practising doctor must be fully conversant with all the details of these drugs.
Here I may strike a controversial note. It is manifestly impossible for the majority of doctors to be fully acquainted with the details of all the 3,000 proprietary preparations which are available to him at the present time. I would like to refer to this in more detail later.
The drug bill is costing the nation £ 160 million a year, and this is only for prescriptions written by doctors and dispensed 1646 by chemists. It does not take into account medicines which people buy for themselves. £ 160 million is almost 50 per cent. more than the total cost of the family doctor service— this gives one an indication of its enormity. The number of prescriptions over the years 1949 to 1966 rose by only 1½ per cent. per annum but the cost of the prescriptions rose during each of those years by an average of 30 per cent.
As I mentioned a moment ago, there are 3,000 proprietory preparations available to the doctor, and few doctors can know the details of every preparation. I would like to see incorporated in this Bill a method of pruning this list down to preparations which are more easily and capably handled by the average practitioner. In the first place, not all the 3,000 preparations are different one from another. Many are minor variations of others. Is it really necessary, for example, to have 81 preparations for the treatment of high blood pressure and 32 preparations for the treatment of obesity? I believe that the 3,000 products at present available could be cut down to a third of the number, and possibly even fewer, by ensuring that every preparation had some substantial difference from the others, by refusing to license any new preparation which did not have some substantial difference in its makeup from any preparation already on the market.
I am sure that every doctor welcomes any new preparation whose efficacy is proved and whose safety is ensured as long as that new preparation is different and not merely one which adds to the almost ludicrous proliferation of preparations which we have at the moment. The proliferation is dangerous because, by its sheer volume, it prevents a doctor from having a detailed knowledge of all the drugs in his armoury.
I echo the sentiments expressed by my hon. Friend the Member for South Shields (Mr. Blenkinsop) about the drug industry. It is a good drug industry. However, 49 per cent. of all the prescriptions dispensed by chemists in the country are for drugs which are manufactured by companies which are not British companies at all, but American owned companies. Only 27 per cent. of the market is supplied by British companies, with 14 1647 per cent. being supplied by Swiss companies and 10 per cent. by other European companies.
§ Mr. Kenneth Lewis (Rutland and Stamford)
Does the hon. Gentleman think that anyone bothers his head whether a drug is produced by an American, British or European company, when all that he wants is to get well?
§ Dr. Miller
I do not suggest that American-owned companies do not produce drugs which are valuable. However, when hon. Members speak about British industry, they ought to be sure that they know what they are talking about, because there is no reason to assume that British firms could not produce exactly the same medicines.
§ Mr. Tim Fortescue(Liverpool, Garston)rose—
§ Mr. Speaker
Order. Might I remind the House that interventions prolong speeches? Many hon. Members wish to speak.
§ Mr. Fortescue
Surely the same argument would apply to the car industry. Fords make cars in this country, we export them, and they are counted as British exports in everyone's mind. What is the distinction that the hon. Gentleman is trying to make?
§ Dr. Miller
I am not dealing with the car industry. There are many other subtleties associated with that industry. If hon. Members opposite wish to interject some kind of partisan spirit into the debate, I might say that I feel strongly about an industry which this country built up being taken over by the American market. Hon. Gentlemen opposite can shake their heads, but that is the case. I deplore it also in the motor car industry, but I am not dealing with that industry at the moment.
I wish that the Bill dealt with drug prices and, in some way, with what a doctor had the right to prescribe. It is a sad commentary on our procedures in this House that it takes a Bill of 119 Clauses to attempt to achieve the intended objects.
I have dealt entirely with the human aspect of the use of drugs. Perhaps I can leave it to one of my colleagues 1648 to expand on agricultural and veterinary applications.
I have no reservations about what is in the Bill. I am more concerned with what is not in the Bill. In spite of that, I think that the Bill makes a valuable contribution to our present situation and, if its provisions can bring home both to the public and to the medical profession the dangers of medicines as well as their uses, it will have served a very useful purpose.
§ 6.45 p.m.
§ Mr. Nigel Fisher (Surbiton)
In accordance with the conventions of the House, I wish to declare my interest in the debate as a director of one of the leading groups of pharmaceutical companies in Britain. That is a personal and a financial interest, but I have also a constituency interest, because it so happens that the headquarters of my companies is located in my constituency. As a result, I can speak not only for myself but also for many of my constituents who work for my companies.
I hope that I can make a contribution which is based on a certain amount of knowledge. I have spent a great deal of time and effort in trying to understand the complexities of this new, innovating, international industry and the contribution which it makes to our economy.
I do not think that I need stress the contribution that it makes in human terms. The new drugs which it has developed have prolonged life and relieved pain for countless thousands of people, and it is estimated that as many as 6 million people are living in the Western world today who would now be dead but for the pharmaceutical revolution of the last thirty years. It is literally a lifesaving industry.
In the past, some hon. Members opposite have criticised the industry for making money out of sickness. Perhaps the hon. Member for Willesden, West (Mr. Pavitt) will do so again later this evening. In fact, like doctors and nurses, it makes money by making people well. and I see nothing immoral in that.
The Sainsbury Committee says that it makes too much money out of the Health Service. I have read the Committee's Report with care. It starts with the conclusions, goes on to the arguments, and ends with the evidence, such as it is. 1649 I think that that must have been the sequence in which the Report was conceived, because the conclusions do not emerge from the arguments, nor the arguments from the evidence. I am not surprised that the right hon. Gentleman, whom I regard as a very good Minister of Health, has not incorporated many of the Sainsbury recommendations in the Bill. Most of them arise out of the allegation that the Health Service has been overcharged by "several million Es "in the three years 1963 to 1965. That is a damaging and a sensational charge. The whole of the Sainsbury Committee's case against the industry depends mainly on the accuracy of that charge. Yet the "several million pounds" is not even quantified.
How many millions are "several "? I asked the right hon. Gentleman that question on Tuesday, and I am sorry that he is not present as he might now be able to reply. On Tuesday, he said, in effect, that he did not know. Why does he not know? Has he not even asked the Sainsbury Committee? Surely that Committee must know the answer. After two years' work it could have hardly have based its whole Report on a vague sum which it cannot even name. I do not think that it is a very good Report, but I cannot believe that it is as sloppy and slipshod as all that.
I must tell the House that the Committee's evidence is as suspect as its statistics. It says that of the 27 leading companies, three show a return of from 50 per cent. to 55 per cent. on capital over the three years, but it admits— in Table 18, page 110— that for every company with profits of over 50 per cent. there were three with profits of less than 15 per cent. I am quite entitled to make this point because over the same three years my own group of companies earned average profits, before tax, interest and depreciation, of 22— 2 per cent., which is not at all excessive in a high risk, innovating industry.
It would be a good thing if some hon. Members opposite sometimes paid more attention to the wise words of the right hon. Gentleman the Minister of Labour, who said recently:I do wish so many of the comrades would stop equating profits with incest or lechery.'He went on to say: 1650If you have a profitable industry, you have the means of further investment and further development and more jobs.And of course that is true. Profit is the margin which makes progress possible, and the sooner everyone understands that, the better it will be for Britain.
In any event, it was quite unrealistic for the Committee to criticise the profits of a research-based industry over a period of only three years. It is far too short. Each successful new product costs, on average, £ 1 million to develop, and takes seven years to reach the market. Therefore, a new project begun this year will probably not be marketed until 1975, may not make profits until 1977, and may not recoup the cost of its research for many years after that.
A good example is Beecham, one of the companies in the Sainsbury 50– 55 per cent. profit range, and strongly criticised by the Committee for it. It is true that between 1963 and 1965 Beecham made high profits out of its semi-synthetic penicillins, but its research on the product had begun in 1946 and there was no return at all on capital until 1962, when the profit was 1 per cent. In the 16 years before that it had a nil return on the capital employed in its pharmaceutical business, and even now, 22 years after its research first began, Beecham would need to make a further £ 8 million to show an average return on its research investment.
The Sainsbury Committee knew all this; it was given all the figures; yet, nowhere does the Report acknowledge that the three-year profits it criticised were preceded by 16 years of loss. That is so disingenuous that it casts very serious doubts on the validity and, indeed, on the impartiality, of the whole Sainsbury Report.
This is of some importance because the very first of the Committee's recommendations is that the Ministry should obtain from the manufacturer a standard cost return for each product. How can a firm allocate its research costs by products when, as the Committee admits in paragraph 288, the very few successful products have to carry the cost of all the abortive research as well as the successful research?
Research is always a gamble. My own company, which has a good research 1651 record, has synthesised 25,000 new chemical entities in the last 10 years and out of these only six new drugs have emerged. I calculate that at least 70 per cent. of our research expenditure is wasted because no product ever reaches the market as a result of it. Even when a product does reach the market, it may not make money. It may be quickly superseded by a better drug or it may have only very small sales. Indeed, we have drugs on which we make an actual loss and which, commercially, we would like to withdraw from the market but ethically we cannot do so because they are helpful drugs to a few patients who really need them.
The hon. Member for Glasgow, Kelvingrove (Dr. Miller) today and the hon. Member for Coventry, North (Mr. Edelman)— and I am surprised not to see him here today— in a speech outside the House have criticised the American-owned companies. The hon. Member for Coventry, North said that they are milking the Health Service. As my own companies are American-owned, I feel that I ought to answer that charge.
In fact, the five leading American companies which have subsidiaries in this country— and my own group is one— spend £ 58 million a year on research, and their total National Health Service sales total £ 29 million. Therefore, their expenditure on research is exactly double their National Health Service sales. Total research expenditure by American firms is £ 150 million a year, whereas British firms can afford to spend only £ 12 million a year—
§ Dr. Miller
I do not know whether the hon. Gentleman is aware of it, but that figure represents the complete global pattern. He spoke of £ 58 million being spent or research by American firms, but that is the total amount spent, not just the amount spent in Britain. Is he aware that total sales by American firms throughout the world— and the American domination of the market is worldwide; 50 per cent. of the drugs used throughout the world are made by American companies— is £ 1,500 million?
§ Mr. Fisher
I do not see that that intervention has any particular relevance, but I shall develop my argument a little further and I may satisfy the hon. Gentleman that 1652 we have rather a good case. One American firm alone spends £ 14 million a year on research— £ 2 million a year more than is spent by all the British firms put together.
But Britain has the benefit, through the English subsidiaries of these firms, of this vast American research. This is where we get the benefit, and at no cost whatever to our balance of payments. My own company exports to Europe 62 per cent. of its total production and holds the Queen's Award to Industry for this achievement. Our exports are worth well over £ 5 million a year— indeed, they are now running at much nearer £ 6 million— and our imports cost one-quarter of £ 1 million. After allowing for all imports, royalties, interest and dividends to our American parent company, we still show a net £ 2 million a year favourable balance of payments for Britain. If every company in Britain were doing that, there would not be much wrong with our economy.
When an American company establishes a subsidiary in Britain it probably goes to a development area, as my company did, to build its manufacturing plant. It creates employment there. It pays very high United Kingdom taxes, and it creates a very valuable export market for Britain on the Continent. What more can it do? But if, as the Sainsbury Committee suggests, the right hon. Gentleman were to cut prices, weaken patent protection and abolish brand names, could we expect the Americans to go on using Britain as a base for exporting to Europe? Why should they? It would be the other way round. They would use Europe as the base for exporting to Britain.
Then, our exports would fall, our imports would rise, our trade balance would be minus instead of plus, the brain drain would increase, and we should not continue to benefit from the immense American research to which I referred — and, in the end because of imports, which are more expensive, the cost, even to the Health Service, would be higher. So nothing would have been achieved and much would have been destroyed. I was glad to see that the Joint Parliamentary Secretary to the Ministry of Technology said recently that it was Government policy to welcome overseas pharmaceutical investment in Britain; and it jolly well should be!
1653 I mentioned brand names, which the Sainsbury Committee wish to abolish and which could be abolished, I suppose, under the enabling powers in the Bill. To do so, and at the same time to reduce the length and strength of patent protection, which is another Sainsbury suggestion, would be a real killer for this life-saving industry. It would be a bonus for the copyists at the expense of the inventors and the innovators.
The issue quite simply is this: do we want advanced drugs in the long-term interests of the people's health and the British balance of payments, or cheap drugs in the short-term interest of National Health Service prices? Even that might not follow, because, even if the medicine is cheaper, the treatment may be much more expensive if it involves longer hospitalisation.
In any case, what incentive is there to spend vast sums of money on research, if one cannot effectively identify one's product when it is marketed? Many drugs cannot be patented, and for them brand names are the only possible protection. One does not spend money on research if one cannot protect the results of it. It is very unlikely, to take an example, that PAS, which saved the lives of thousands of people suffering from tuberculosis, would ever have been developed if there had been no brand names. At home, the brand name is the doctor's guarantee of quality, safety and consistency, and, of course, of therapeutic equivalence. Abroad, it is what we sell on. The industry exported over £ 80 million-worth of drugs last year, virtually all of them brand name drugs. There is not a developed country in the world which does not use the brand name system in this international industry. France tried to modify it, but gave up the attempt in 1960 when it proved unworkable and bad for research.
To abolish brand names would also conflict with the policy of making our own laws compatible with those of the Common Market countries, and would be a great exporting disadvantage to us. In the last year, my company secured three large orders from Russia for a premium drug simply because the Russians recognised the established reputation of the brand name and wished to buy it. There is no doubt that the 1654 Hinchcliffe Committee was right to state that brand names encourage research and should therefore be retained. The Sainsbury Committee has reversed that finding, mainly to save money for the Health Service, but its Report made no attempt at any cost-benefit analysis.
In fact, only 25 brand name products have cheaper equivalents. The Ministry of Health evidence to the Public Accounts Committee for the 1964– 65 Session showed that, if these equivalent drugs had been universally prescribed instead of brand name drugs, the maximum possible saving would have been £ 442,000, which is well under one half of 1 per cent. of the National Health Service drug bill. And that, of course, takes no account of lost exports or of the value of drugs which would never have been produced if brand names had been abolished.
I referred to PAS, one of the three great anti-tuberculosis drugs. Sir Derrick Dunlop has said that these three alone are saving the nation £ 55 million a year. It is ridiculous, in this context, to talk of £ 442,000. I suggest that the research and export sacrifices are simply not worth the short-term, domestic savings, and I am thankful that the right hon. Gentleman has not included the abolition of brand names in the Bill.
Having been far from complimentary about Lord Sainsbury's Committee, I have no major criticisms of the Bill itself. Indeed, I am inclined to congratulate the right hon. Gentleman not only on its omissions but also on most of its inclusions. I accept, as my hon. Friend the Member for Farnham (Mr. Maurice Macmillan) did, the statutory safeguards for the safety, efficacy and quality of medicines. But I must reiterate what he said, that, mainly owing to the tact and wisdom of Sir Derrick Dunlop and Dr. Cahal, the Dunlop Committee has worked very well indeed on a voluntary basis. I was grateful for the right hon. Gentleman's assurance that this flexibility and co-operation will continue.
I accept the licensing system in principle and I am sure that it is right to establish the Medicines Commission and make it answerable to the Minister and Parliament. That is very important. I hope that it will be an efficient and effective Commission, with a small, high-quality membership. I would far rather 1655 it had eight or ten members than 18 or 20. The Commission and its expert committees should have a fair balance, and should certainly include people with a real knowledge of the industry. I thank the right hon. Gentleman for what I think was his assurance that that would be so.
Like my hon. Friend the Member for Farnham, I am greatly concerned that the Bill provides such very wide enabling powers to cover subsequent Orders and Regulations. That is a convenient way for any Minister to legislate, but it is potentially very dangerous. I do not like the extension of Departmental powers in that way and the corresponding erosion of the powers of Parliament. I am glad that Clause 113(6) provides for consultation before Regulations are made, and hope that the consultation will be full rather than merely formal. That applies particularly to the general list of ordinary products like aspirin and antacids, which I hope will continue to be readily available for the convenience of the public.
A great many other things come within the scope of Ministerial Orders, and there should be genuine consultations on all of these before Orders are made. We can follow up all these points in Committee. However, in principle, I welcome the Bill, because it should ensure the high standards which the best companies already maintain, without killing research.
Of course this industry is not perfect— no industry is— but it is innovating, it is exporting and it is efficient.
Lord Sainsbury's Committee tried to stifle it— I might say to anaesthetise it— and it failed. It tried to destroy, but it did not attempt to build. It tried to save pennies for the Health Service, while the industry is saving £ s for the nation. it is doing much more than that. It is not only saving money; it is saving lives. Tuberculosis and pneumonia are no longer killer diseases, polio is virtually eliminated, diphtheria, scarlet fever and mastoids have disappeared. A child's expectation of life, mainly due to modern drugs, is 10 years greater today than it was 30 years ago.
There is so far, of course, no cure for cancer. One firm has spent more than £ 4 million without discovering a single drug, but a beginning has been made and I believe that a cure for cancer 1656 will be found— provided that there is less carping and criticism and prejudice and hostility towards this industry, particularly— I am sorry to say— from hon. Members opposite, and provided that the industry is allowed to work in a political climate favourable to innovation.
This is an industry upon which the better health of the people and the greater wealth of the nation both in future depend. Let us be thankful that it exists. Let us allow it to prosper.
§ Mr. Speaker
I would inform the House that I can call all hon. Members who still wish to participate if they prescribe themselves reasonably brief speeches. Mr. Richard.
§ 7.10 p.m.
§ Mr. Ivor Richard (Barons Court)
I hope that the hon. Member for Surbiton (Mr. Fisher) will forgive me if I do not follow him into the intricacies of the pharmaceutical industry, of which he obviously has far more acquaintance than I have. I am certain that some of my hon. Friends who still desire to speak will be quite capable of dealing with the hon. Gentleman's arguments.
I should at the outset declare a partial interest in this matter in that I was recently approached by the Pharmaceutical Society of Great Britain, which informed me that it did not have a Member in the House to speak directly on the Bill. It seemed to me that since this was an important Measure and since there are about 15,000 pharmacists in the country who are directly concerned with the way in which the Bill is to be administered, it would therefore be right for me to put some of the points which are concerning that Society.
As my right hon. Friend the Minister said, the Bill is designed to treat medicines as commodities of a special character. This has never been done in English law and English society before and this step is greatly to be welcomed since they are special commodities, varying in degrees of potency, never being entirely safe and may I say that I agree entirely with my hon. Friend the Member for Glasgow, Kelvingrove (Dr. Miller), they can have either a harmful or beneficial effect.
The failure in the past to treat them as commodities of a special character has 1657 meant that the quality, safety, efficacy and selection of medicines have for far too long been left to the pressures of the market. Whatever one may feel about the general application of market economics, it seems to me that in this sphere, where we are dealing with substances which are of such a special character— some beneficial and some certainly harmful— to have developed over the years, a somewhat casual attitude towards medicines engendered by the pressures of the market is wrong and I am, therefore, glad that my right hon. Friend is taking these steps.
The aim of the Bill is to impose control over all aspects of medicines, and thus to remedy the weaknesses of the present law. The intentions of the Bill are to be warmly applauded. It is the result of long study and discussion and, in the main, seems to have achieved the object which any such legislation which attempts to deal comprehensively with the problem of medicines should achieve. It provides a sensible system of control over the dissemination of substances of a special character in English life.
The licensing provisions in Part II are some of the most desirable in the Measure because no manufacturers escape the net. They will now be under an obligation to submit all new products for consideration. However, while the result of that obligation will be to ensure that medicinal products, which are now put on the market, will be subjected to additional scrutiny, is my right hon. Friend totally satisfied that he has sufficient latitude to adjust the net if necessary? Can he, for example, permit a general authorisation to be given to pharmacies to undertake the manufacture of preparations normally undertaken in such establishments? If there must be a licence for the manufacture of drugs, it would be hard on pharmacies which undertake the manufacture of these preparations if they had to get one.
§ Mr. K. Robinson
It may be convenient if I interrupt my hon. Friend to assure him that there is a specific exemption for pharmacies from the manufacturing licence in respect of drugs which they dispense themselves.
§ Mr. Richard
I am obliged to my right hon. Friend for that assurance because I know that it is one of the doubts which the Society has felt.
1658 I come to Part III of the Bill and I hope that the Minister will answer some questions which are causing concern about the general list. As I understand the position, a general list will be prepared and these medicinal products will be freely available in shops other than pharmacies. Is it the intention of the Ministry that one should more or less start from scratch, with the appropriate professional committees, and decide virtually anew what drugs should be permitted to remain in general circulation? I hope so and I was glad to hear my right hon. Friend say that the appropriate expert committee would be consulted before any article was put on the list.
However, I am still doubtful about the desirability of selling such products from automatic vending machines. When this matter was raised, earlier in the debate, the hon. Member for Torrington (Mr. Peter Mills) intervened and said, in effect, "After all, if one goes into a chemist's shop for something one may be served by an unqualified girl of 16 or 17, so what is the difference?" That is true, but the degree of control in a qualified pharmacist's shop must be greater than the control exerciseable over any sort of automatic vending machine. There are dangers in this which I hope my right hon. Friend will consider. Again, what possibility is there of registering the shops in which medicinal products on the general list are to be sold? In other words, if a store is to sell a medicinal product and the shop is not a pharmacy, should it have a licence? I would ask the Government to consider this as well.
Part VI of the Bill deals with the promotion of sales and this clearly touches a subject which has been responsible in the past for more criticism than any other aspect of the supply of medicines. Here, the market pressures have shown themselves most clearly and the need for control has been most in evidence. The provisions of the Bill in this respect seem admirably to cover the ground in the sense of giving adequate powers to the Ministers, but there is one omission which I hope will receive my right hon. Friend's attention. It is whether or not it is desirable, in the public interest, not merely to have the control on advertising set out in the Bill but also to have an absolute prohibition on the advertising of proprietary medicines sold direct to the general public.
1659 It is important, when dealing with medicinal products— which, I believe everyone concedes to be articles in a special category— to ask whether the copywriters of Madison Avenue promote an atmosphere in which drugs are disseminated in the best and most desirable way and also whether the effect on the minds of the people at whom those advertisements are directed is such as to ensure that they use them in the best way. This prohibition would go far to create a greater sense of responsibility in the public mind towards the use of medicines. Advocates of the "market philsophy" will agree that the object and effect of advertising must be to encourage the greater use of the product.
But it does not do only that. It conditions the public mind in such a way as to prejudice the acceptance of advice from a pharmacist on the suitability of a medicine which is requested by the customer. One can imagine circumstances in which a qualified pharmacist would say to a member of the general public, "I do not think that this is suitable for the symptoms you have described to me". The customer might reply, "That may be so, but if only you had watched television the night before last You would have seen an advertisement in which it was made quite clear that this product is designed specifically to deal with exactly my sort of complaint."
Part VII deals with the arrangements for setting standards for medicines and raises the question of the rôle of the Pharmaceutical Society in this connection in future. The work of the Society in this context has been parallel with, and complementary to, that of the General Medical Council. The Society has produced the British Pharmaceutical Codex and the British Veterinary Codex; the General Medical Council— the British Pharmacopoeia, which is now to be produced by the Medicines Commission or a committee appointed by it.
Although the standards of the British Pharmaceutical Codex and the British Veterinary Codex are to be recognised, it appears that, as time goes on, these standards may be superseded by other compendia produced by the Medicines Commission.
If this is so, it seems regrettable that the experience, the reputation and the 1660 general knowledge which the Pharmaceutical Society has built up over the years in setting standards may be lost, or perhaps disregarded. I hope this is not so and that the Minister who replies to the debate may give me assurance about it. It may be that an opportunity is occurring because of the Bill for a merging of the activities which in the past have been carried on independently by the Pharmaceutical Society and the General Medical Council. It is to be hoped that a way will be found to take advantage of the Society's facilities not only in setting standards, but also in publishing them.
My last point concerns veterinary medicines. I understand that the definition of medicinal products covers veterinary as well as human medicines. Consequently, unless there are special provisions relating to them, they do not have a separate mention in the Bill. My right hon. Friend might consider whether they should be mentioned in the Bill because the control of veterinary medicines seems to have lagged far behind control of human medicines.
These are, however, points of detail which can be examined more closely and perhaps better in Committee, and I conclude by quoting from thePharmaceutical Journalof last September which said:The review confirmed the view that the pharmaceutical revolution' of the last 30 years, by introducing powerful and valuable new medicines which have superseded most of the traditional medicines, has given rise to new problems for which our existing legislation was never designed. The need for greater safeguards has been recognised in many other countries too, and controls similar in aim to those now proposed have already been introduced into the laws of Canada and other Commonwealth countries, the United States, France, Germany, the Netherlands, the Scandinavian countries, and others.The Bill has involved the labours of many people over many years and all who have contributed to it can feel gratified at the result, even though they may have some reservations on points in the Bill. My right hon. Friend and his staff are to be warmly congratulated on having tackled in such a thorough fashion a problem of such scope and complexity.
§ 7.23 p.m.
§ Dr. M. P. Winstanley (Cheadle)
Perhaps it is inappropriate that I should speak on this subject when I have a rather severe cold. I mention it so that 1661 hon. Members will understand if I become inaudible before I sit down, and it may also show that doctors are as delighted as anyone else to discuss their own ailments. The hon. Member for Barons Court (Mr. Richard) has acknowledged that many of the points he made are more appropriate for consideration in Committee. He may have raised them in the hope of avoiding being on the Committee, and I am sure he will forgive me if I do not pursue them now.
We all agree that there is no lack of interest in the House generally in health matters. Only recently we dealt in the Chamber with the Health Services and Public Health Bill, which is now in Committee, and now we have another important Bill dealing with health matters. We also accept that what we are discussing is a subject which has changed very much in recent years. We are not discussing the coloured water which cost little and was largely inert and made up the medicines of the past, but substances which are costly, complex and powerful, and which, because they are powerful, are necessarily dangerous.
We all agree that there is need for control and regulation in many ways under this Bill. I am sure that every hon. Member would wish to support the Second Reading. I would prefer to wait for the Committee to explore some of the details and, in view of the shortage of time, I shall content myself now by making a few general observations in relation to matters with which the Bill is concerned in the hope that they may prove useful to hon. Members in their more specific considerations in due course.
The question of safety has been mentioned over and over again. I emphasise, if it is necessary to do so, that we cannot have drugs which are potent and which have a really significant therapeutic effect without at the same time having drugs which have certain dangers. People who campaign for safe drugs and only safe drugs are asking for drugs which will not be very useful. The dangers are part of the price we pay for immense benefits. Penicillin is of immense value. It was discovered during the war and I was one of the first to use it. It has probably saved more lives than were lost during the war. But lives have been lost as a result of the use of penicillin. There have been cases when people who are 1662 hypersensitive or have had an anaphyllactoid reaction have died through using penicillin, but its benefit to humanity is almost beyond calculation. We should remember this when we are talking about safety.
When we talk about testing drugs we should remember that the only finally satisfactory test of the safety of a new drug is by giving it to a patient. If we are never to give a drug to a patient unless it has previously been given to a patient we shall never have any new drugs. The industry and the profession do their best by considering various theoretical considerations to assesss the effect of a drug and they then conduct experiments with animals which are useful, but their use is limited. The final test must be the clinical one of giving the drug to patients. We are then in a situation of some danger, but it is a danger we should not seek to avoid. It is a danger we have to reckon with and control if we are ever to have new drugs of real value.
Hon. Members have also spoken about the cost of drugs. In this aspect of the subject there are some mis-assumptions. There is a tendency for some to think that the cost of drugs in Britain is immensely high and that we spend an enormous amount on drugs. But in comparison with other countries we are very economical. It is some years since the United Nations did a survey on this subject in which they investigated the cost of drugs per head of population among 13 nations. It was shown that the cost of drugs in Britain was lower than all but two of these countries. Although that was some years ago, there is no real evidence that our position in the league table has changed substantially.
We must also remember that we cannot assess the cost of drugs in isolation. We have to assess it against other costs. Drugs which control tuberculosis have been mentioned. The development of new chemo-therapeutic drugs and antibiotics has resulted in virtually the total disappearance of a disease which was the nation's major killer until comparatively recently. Apart from the saving in human life and suffering, the actual saving in terms of money is enormous. It has to be considered in terms of occupancy of hospital beds and so forth. 1663 The same applies over a large field. Many conditions which resulted in long and highly expensive illnesses are now cured comparatively rapidly with drugs, but those drugs cost a lot of money. We must be prepared to pay a lot of money or we shall not get drugs which are of great use. We ought to see the whole matter of cost in perspective.
I am not saying that it is not possible to make savings. Of course it is and hope that we shall be able to make them. In making them we all have a part to play, the public, the professions, the industry and the Minister.
First, a few words about the public. I regret as much as other hon. Members — this point was mentioned in particular by the hon. Member for South Shields (Mr. Blenkinsop)— that there is such a dependency on medicines. This is regrettable. I read an account, and I believe it to be true, by a doctor, of an elderly man who, after the death of his elderly wife consumed what remained of her medicine and tablets before throwing away the bottles and containers. When the doctor asked, "Why did you do that? There is nothing the matter with you, is there?", the man replied, "No, but I thought that it might find a weak spot somewhere ".
This is an attitude which I agree is not to be encouraged, but the medical profession must accept a share of responsibility for this dependency. I have spent many years in general practice. I have to acknowledge that it is sometimes easier to give a patient a bottle of cheap inert medicine than it is to explain to him that he does not need any medicine. A person who consults his doctor about a condition must be examined and the doctor may have to explain, "No. This condition will get better by itself. Leave it alone and wait for a week". But this can take time, whereas the doctor can dish out a bottle of medicine quickly. I, in common with many of my colleagues, have tended to do this, perhaps to a regrettable degree. It is an understandable practice, in view of the severe pressures under which we work. Nevertheless, I acknowledge that my profession must share some of the blame for producing a general habit which is a regret-table one.
1664 The answer lies, not in controls which could be put into this or into any other Bill, but in health education generally. I see the object of health education not as creating a nation of amateur doctors but as getting people to look at health healthily and cultivating a more healthy attitude towards illness. This is not a matter for the Bill, although it concerns matters with which the Bill itself is very much concerned.
I turn from considering the public and how we can reduce excessive expenditure there to considering the industry itself. It can certainly cut costs. I think that it must be recognised that the industry in private enterprise hands, the competitive industry— although sometimes it is not as competitive as I would like it to be— has, broadly speaking, served the nation well. I do not wish to enter into any ideological arguments, but it is important that I should remind hon. Members who sometimes talk hopefully about nationalisation that in the Soviet Union, where very great strides and progress have been made in medicine generally— in general medicine and in general surgery— the drug industry, which is a nationalised industry, has not produced a single significant therapeutic advance. I am not saying that the Russian people live their lives in a total absence of medicines and drugs. What I am saying is that the Russian nationalised drug industry cannot produce the kind of record which our competitive drug industry has produced. Our drug industry has done a good job in its way, but there is certainly room for improvement.
There has been some talk about advertising. I believe that the hon. Member for Glasgow, Kelvingrove (Dr. Miller) has weighed the advertising literature which he has received from the drug industry over a period and that it amounted to more than his own weight. Even so, I believe that there are some wrong assumptions here. For instance, people tend to believe that the literature which general practitioners receive from the drug industry is about new drugs and is aimed at persuading general practitioners to prescribe new drugs. It has often been said by hon. Members opposite that there are dangers in general practitioners prescribing new drugs in this way. I would agree, if they did. However, it must be emphasised that on the whole 1665 the general practitioner acquires his prescribing habits from the local hospital and the local consultant rather than from anybody else. In many ways it is an economy of thought to use one product for one condition. Let us say that a general practitioner refers a patient to the local consultant who uses a particular drug a hypotensive drug to reduce the blood pressure. For other patients whom the general practitioner does not send to the consultant he will tend to use the same drug, rather than a different one so that he has to scratch his head and think about what drug he has given them.
I have done much research into this. It will be found that the range of drugs used by any individual general practitioner is not large. He uses only about 20 drugs. The trouble is that we all use a different 20. The point I want to make very much concerns what the hon. Gentleman said. The literature which a general practitioner receives from the drug firms is concerned with persuading practitioners to continue to prescribe old drugs rather than to embark on any hazardous, adventurous process with a new drug.
The hon. Member for Kelvingrove, on the matter of variety reduction, said that we could reduce the total number of drugs to one-third. I do not accept that, but I agree that it could be reduced in certain ways. I do not share the fears of many hon. Members about the numbers of new drugs. I welcome new drugs. What I do not welcome is the fact that many new drugs, when they are later proved not to be terribly valuable, remain drugs when they become very old drugs. I do not object to new drugs coming forward. What I object to is the fact that we do not seem to see enough of the old drugs disappearing.
For this, the industry is partly at fault, the profession is partly at fault, and the Minister is partly at fault. I name as an example a simple drug such as aspirin, which is immensely valuable for all sorts of conditions. Acetyl salicylic acid, now part of the national langauge as "aspirin ", is a valuable drug, yet we have learned from experience that it has certain side effects. In certain patients it produces gastric irritation, in other patients gastric haemorrhage, and in other patients interference with the ear and other complications. It is also true that 1666 one cannot necessarily predict in advance which patients will be affected in which way. However, it is a fact that these side effects occur in a small number of cases. As a result of recent advances, we now have soluble preparations of this drug which are very much less inclined to give rise to these sorts of side effects. Once we have recognised that something is an improvement, we should say, "This is an improvement and there is no longer any reason for prescribing the old drug which has been superseded ". In short, ordinary aspirin ought now to disappear.
Mention has been made of what was once a unique drug in medicine— sulphapyridine, M & B 693, one of the most powerful of the chemotherapeutic drugs when it was first introduced. It is still on the market, yet it has been shown that it has all sorts of side effects which, beyond doubt, are extremely dangerous. I believe that it borders on the negligent to continue to prescribe this drug. Yet it remains in use, partly because some doctors like to continue to prescribe old things which they used to prescribe a long time ago, partly because the drug industry itself is reluctant to let go anything which is still selling, and perhaps partly because Government policy in a sense has tended to make general practitioners continue with the old rather than to move to the new.
If there was greater use of certain new and expensive preparations, they would then become cheaper, and it would be cheaper still if we could drop an awful lot of the old ones. There are many examples of this. I think that we are moving to the same sort of situation in regard to the birth control pill. There are many different kinds of this pill. Different drug firms are producing them. More and more are coming out. Doctors tend to use them in a sort of arbitrary way— "Try this. Try that. Try the other whereas all these different pills have their own value. They are all likely to be suitable for different kinds of patients.
What we are not getting, either from the Minister or from the drug industry in any concerted way, is a detailed analysis of the relative merits of these different drugs. This is because there is competition between the different firms, each producing different drugs. There should, instead, be co-operation between 1667 these different firms. If they were endeavouring to show us what was the whole spectrum and the whole extent of these different products and how we could make a selection from amongst these products which would be most satisfactory for the patient, we should gradually move to a much happier situation for tie Exchequer, for the patient, and, in the end, for the industry itself.
In the end, machinery of that kind requires a degree of co-operation which we do not have at present. I should like to see us moving towards it. There have been references to this already, and I shall not ventilate that aspect of the matter further now.
I believe that the Bill will change the role of many people, and of the pharmacist in particular. I should like to see the pharmacist's rô le change in many ways. Dispensing has changed. It is no longer a matter of making pills or making up mixtures. Often, it is no more than a matter of reaching up to a shelf and handing down a bottle. There is scope now for a change in the training of the pharmacist so that he will no longer need to learn quite so much about the mechanical side of dispensing but could learn something about diagnosis and the treatment of certain minor conditions. The pharmacist is frequently asked by patients to advise on what they should take for this or that condition. Some kind of training for that could be helpful to my profession, to the pharmacist's profession and to the community as a whole. If we are to manage with our limited resources, we must make more use of ancillary services of that kind. As I say, this is a change to which the Bill could lead.
The Bill may have, and ought to have, an effect on another profession in which I am interested— I call it a profession— the drug industry's representatives. I am associated with what is now called the British Medical Representatives' Association. It is valuable that this body is beginning to regard itself as having certain duties other than merely selling drugs. Yet, before it can carry out the other duties, there must be a co-operative atmosphere within the drug industry so that the individual drug company's representative may increasingly be able to advise the doctor about various different 1668 preparations produced by different companies, giving comparative statistics on their action, on prices, and so on, in a way which is not open to him at the moment while he is operating in a purely commercial fashion. I welcome the formation of the British Medical Representatives' Association because it has as as its object the promotion of codes of conduct which can do nothing but good for the industry and for the whole community in health matters. We shall have to consider these questions further in Committee.
What we are trying to do here, and what I hope we shall do, is to make for a variety of choice in drugs and medicines. We realise that competition can be beneficial provided that it is regulated and controlled as the Bill will lay down. We should realise, also, that the more expensive medicines are not necessarily to be regretted; they may be a positive advantage. I explained this point earlier. It is something which ought always to be borne in mind. In many ways, the hope for medicine in this country lies in spending more rather than less on drugs. I hope that, as the pharmaceutical industry advances and we have new and more powerful therapeutic substances, we shall solve more and more of our hospital problems, our surgical problems, and the manpower problems with which the Health Service has difficulty in coping at present. All this will depend on the growth of the drug industry and on the manner in which the Bill operates, whether it encourages or obstructs it. We all welcome the Bill. We are glad to give it a Second Reading, but we shall look carefully at all these matters in Committee.
§ The Clerk at the Table informed the House of the unavoidable absence ofMr. SPEAKERfrom the remainder of this day's Sitting.
§ WhereuponMr. SYDNEY IRVING, The DEPUTY CHAIRMAN OF WAYS AND MEANS,took the Chair asDEPUTY SPEAKER,pursuant to the Standing Order.
§ 7.44 p.m.
§ Mrs. Joyce Butler (Wood Green)
I speak as a layman in this debate in which so many medical, drug and pharmaceutical experts have taken part, but I have, over the years, been much concerned with the problem of the safety of drugs. On 1669 5th March, 1962, I raised for the first time in the House of Commons the question of the drug thalidomide, and I think that it might be useful to refer to that occasion in order to put in perspective the Bill before us today. I asked the then Minister of Health,what action he is taking to ensure that all flew drugs are submitted to immediate, independent, and reliable scrutiny before use in the National Health Service ".His reply was:I have no powers to do this".I then put the following supplementary question:Is the Minister aware that there is considerable medical and public concern about the number of drugs which recently have been shown to have very dangerous side effects, particularly the 40 abnormal births which are now believed to have been due to the taking of one particular sedative by expectant mothers? I know that this is a recurring problem, but when it comes to a child being born without limbs because the mother took a sedative during pregnancy, should the Minister not consult the Home Secretary to see whether some machinery can be set up to screen drugs before they are made available for public use?The Minister replied:Where side effects are concerned, and that is what the hon. Lady has in mind, the mere scrutiny of a drug would not be enough. What is necessary are clinical tests, and the terms of reference of the Cohen Committee were recently revised to enable it to recommend that there should be clinical tests in cases where it thinks advisable."— [OFFICIAL REPORT, 5th March, 1962; Vol. 655, c. 25— 6.]I can still remember the horror I felt when I said those words in the House. It seemed to me that it was too horrifying to be true, and I fully expected to be challenged by another hon. Member on the facts which I had stated. But the remarkable feature was that there was no challenge. There was no response. It was like dropping a heavy stone into a pool of treacle; it sank without trace, without a splash or ripple. In fact, the House was not aware of the thalidomide tragedy although there were already 40 recorded cases of abnormal births.
It was not until a few days later, when the "Tonight" team repeated the question in its B.B.C. television programme and asked what it was all about and what was being done, that many members of the public who saw that programme became aware of the tragedy. After that, interest grew steadily, until there was a public demand for action to be taken.
1670 I mention that matter because it is important to remember that the thalidomide tragedy, in particular, was what led to the many discussions, the committees, the reports, and the long and painstaking work which went into the production of this Bill. However many safeguards we put into a Measure of this kind, we can never be absolutely certain of the safety of any drug. The thalidomide result was dramatic and immediate— we could see it— but there are many drugs in use which may, in 20, 30 or 40 years, prove to have something in their nature which is harmful in its side effects. Our legislation must, therefore, be as comprehensive and as detailed as it can possibly be.
I welcome the Bill. I welcome the care which has gone into it, and I congratulate my right hon. Friend and his Department on having produced such a Measure. It has to be long, complicated and detailed.
I am very pleased, also, that there are provisions covering veterinary medicines and products used in agriculture. We are all aware of the concern which has often been expressed, notably more recently, about the use of antibiotics in animal feedingstuffs and about other substances which are fed to animals and which, though the side effects may not affect the animals, may well affect human beings. Since the Bill repeals the Therapeutic Substances Act, 1956, I hope that the regulations made on this point will provide much greater safeguards for the consumer in this field, where we are using in a very slap-happy fashion substances which may be dangerous to us.
I have a thing about labelling, and therefore I welcome the Bill's provisions for labelling, which are absolutely essential. I also welcome the provisions covering advertising.
Having said that, I want to put a minority point of view which has not been put so far in the debate. I agree to some extent with the hon. Member for Farnham (Mr. Maurice Macmillan) on the width of the net which my right hon. Friend has cast in the Bill. In his use of the words "medicinal product ", which are defined in Clause 114, my right hon. Friend is going very far afield. It seems to me that if, for example, a mother who wanted to offset the effects of eating refined flour and white bread bought wheat germ and bran, which she then 1671 administered to one or more of her children with the effect that they increased or accelerated a certain physiological function, she would have been sold a medicinal product in the terms of the Clause! I know that it is not my right hon. Friend's intention that such products as wheat germ, bran and so on should be caught by the Bill. But they could be, as the wording stands, unless special arrangements are made to exclude them.
Clause 114 has caused considerable concern to those who manufacture and sell what are commonly known as health foods. There was a specific reference to health foods and dietary supplements in the White Paper, but it is not in the Bill. Under the Clause the Minister could catch such products, although he has assured me and other hon. Members that he does not wish to do so. If any of these products are caught, the Statutory Instrument procedure, and in some cases appeal to the court, will provide some protection. But until we see the general sales list and know what exemptions are to be made for specific substances and articles it is very difficult to be certain that my right hon. Friend has not gone much wider with his net than he needed to go. It would considerably allay many fears on the Clause if the Minister made it clear that he will not catch medicinal products which are not capable of being injurious to health in the recommended dosages or quantities.
It is ironic that when many people have turned to what are known as health foods — have taken the "look younger, live longer" approach— because they are conscious of many of the deficiencies of modern refined foods and because they are doubtful about the safety of some drugs the very products to which they have turned could be caught by the Bill, which is promoted to cover very different drugs of high potency.
Like other hon. Members, I have had correspondence from a number of organisations, including the Institute of Medical Herbalists. I mention it because my right hon. Friend has excluded herbal products. He has recognised that they are harmless in the sense with which he is concerned. I think that he has excluded them because they are fairly easily defined, al 1672 though the medical herbalists state that the definition he has given of a medical herbal remedy is rather old-fashioned and does not cover the modern practice they follow. It is much more difficult to define a health food, dietary supplement, or vitamin supplement or something of that kind so that it can be excluded. We should examine this point when the Bill reaches Committee to see that such foods are effectively excluded, because we are here entering an entirely new sphere.
Tonight's discussion has been on the orthodox medical approach but many people are turning from that. They have a perfect right to do so and to buy the substances they want in the shops of their choice. The important point is that unless these substances are excluded they will be confined to sale by registered pharmacists, which seems utterly absurd when in the main the registered pharmacists obviously do not want to sell them, and when the people who want to buy them would prefer to do so in shops of their choice.
I shall say no more on that point, because a number of hon. Members want to take part in this very important debate. We have had to wait six years for the Bill, which we shall obviously have to amend considerably in Committee. We are establishing a standard which the public expect us to establish. We are not just legislating for experts; we are legislating for the general public, to give them the feeling of security that we are protecting their interests by every means in our power.
While some hon. Members have expressed the view that this is bureaucracy and that we are going too far in the machinery of the Bill, I am sure that the general public, who are concerned about these things and have been very worried about the whole question of drug safety, will welcome the Bill, as I do, and will wish it a speedy course through Committee.
§ 7.59 p.m.
§ Colonel Sir Tufton Beamish (Lewes)
At the outset, I must declare an interest in that for about 10 years I have been a part-time director, without executive responsibility, of a well-known pharmaceutical company. I hope that after hearing my speech the House will feel that this has enabled me to bring some 1673 first-hand knowledge of the industry to the debate. I also hope that I shall not indulge in any special pleading.
I very much regret that the White Paper was published after quite inadequate consultation with the B.M.A. and the pharmaceutical industry, and that there have been only 10 days between the publication of the Bill and Second Reading, which is a quite inadequate time for such a complicated Bill to be studied by all the interests concerned.
I have considerable reservations about the Bill, sharing them with my hon. Friend the Member for Farnham (Mr. Maurice Macmillan). I have them despite the sweet reasonableness with which the Minister so disarmingly spoke. I congratulate the Minister on resisting some of the wilder recommendations of the Sainsbury Committee. Some of these were superficially attractive to certain people but would have been damaging in the long term to the drug industry as well as to the health and prosperity of the nation.
The policy of cheap drugs has an emotional appeal, but I often feel, at a time when the idea of profit is under attack and the word itself is regarded as a dirty word, that more hon. Members opposite should listen to the wise words of the Minister of Labour, who said last August:I do wish that so many of the comrades would stop equating profits with incest or lechery. If you have a profitable industry you have the means for further investment and further development and more jobs.That was good advice from a Labour Cabinet Minister.
The pharmaceutical industry has been too often criticised and threatened, these criticisms and threats often arising out of ignorance, dogma and misconception. The record of the industry is there for everyone to see. It is inevitably imperfect in a number of ways and can be selectively criticised. I have no intention of trying to whitewash it. But, without hesitation, I say that it has a fine record, comparing favourably in most respects with that of similar pharmaceutical industries in other advanced countries.
It cannot be questioned that its prices and profits, taken across the board, are reasonable both as a proportion of the total National Health Service bill and when international comparisons are made. I 1674 regret that the Sainsbury Committee criticised the profits of one of the companies by taking two or three profitable years and failing to put them into the context of many years of expensive research, of which no account was taken. This was a great mistake on the part of the Committee and was a piece of special pleading which made its other recommendations suspect. It is a pity that not one member of the Committee came from a science based industry, although it expected to examine one.
The industry has worked with the Ministry of Health smoothly since the voluntary price regulation scheme was first introduced. We all hope that still further improvement can be made in the scheme as a result of the talks now going on. The industry has also enjoyed excellent industrial relations— something seldom mentioned. I have not myself heard of a strike in it. It has a remarkable export record, showing that its prices are internationally competitive. This means, naturally, that the Treasury and the Board of Trade both have a vested interest in the success and prosperity and expansion of the industry.
Mention has been made of the remarkable progress of the pharmaceutical revolution in the last 25 or 30 years, which has contributed enormously to the health and well being of the nation. I had thought of going into some detail here by way of background but will not do so because I do not wish to make a long speech as other hon. Members wish to speak. There remain, of course, in spite of great victories, many important fields still to conquer. One thinks of crippling and killing diseases like arthritis, cancer and diseases of the heart and one quickly remembers how many more breakthroughs we are hoping to see.
I admit freely that the present Minister of Health has shown himself to be well aware of the industry's success record and that he understands its problems clearly. That is most encouraging and I pay tribute to him. But he is under considerable pressure to follow certain courses with popular appeal in some quarters but which would have disastrous long term implications. I am thinking in particular of three courses.
First, the right hon. Gentleman is under pressure to abolish brand names. But 1675 these are of critical importance to the success of the industry and especially to exports. Secondly, he is under pressure to erode still further the inadequate patent protection which the companies now enjoy. That would be a retrograde step. We have only to look at the example of Italy, where there has been no patent protection. No new drug has been discovered there and drug prices are the highest in Europe. Patent protection is in the interests of the public as well as of the manufacturers.
Thirdly, the Minister is under pressure to introduce rule of thumb standard cost returns on every individual drug. This would be both unworkable and unfair. Indeed, any of these three courses would stifle the industry's ability to carry out the expensive research which is its life blood and would have the effect of driving overseas subsidiaries of foreign parent companies. This would be a consequential loss to the research effort done in this country and would have a bad effect on the British economy, especially on the balance of payments.
There are sensible omissions from the Bill. Nevertheless, I still have serious doubts about it as it stands. It gives immense powers to Ministers concerned. However great our trust in present Ministers, in particular in the right hon. Gentleman, and their Civil Service advisers, we must examine the Bill as a vehicle which could suddenly and quickly fall into less reliable hands. No names, no pack drill, but I can think of several unreliable hands attached to right hon. Gentlemen opposite.
I want to concentrate on one aspect of the Bill and approach the question from several different angles. It is the vital principle of the doctors' freedom to prescribe. Subject to stringent limitations regarding safety, a doctor must be free to prescribe as he thinks best in the interests of his patients. It is right that irresponsible or negligent prescribing, excessive in quantity or unnecessarily costly, Should be checked. This is already done and is widely accepted as necessary. But the doctor alone can and must decide the best remedy for each patient. He bases his judgment on knowledge of the patient, on the patient's former history and treatment, on the advice of other 1676 doctors concerned and on his own experience.
As the hon. Member for Cheadle (Dr. Winstanley) will agree, no two patients respond in exactly the same way to the same treatment or at least it is very rare. One product which may be more effective for the majority of patients may be less so for the minority. Two products may be only marginally, even fractionally, different, yet one will work on a patient and the other will not. But the decision and choice as to which product to use must rest with the doctor. He is the vital link betwen the research scientist and the patient and the real value of a new product can only be fully assessed through doctors' use of it after trial and observation.
This will be widely agreed and I think non-controversial. The British medical profession maintains the highest ethical standards of which it is very proud and these follow from the long and exacting training through which its members go. It is therefore fitted for and entitled to the responsibility of freedom to prescribe. Doctors must be warned to beware of interference with their freedom to prescribe, whether the interference comes from political or academic sources.
What I have been saying may seem to be self-evident, but it does need stating. As the Bill stands the doctors' freedom to prescribe is put at risk in two ways, in spite of the assurances given by the Minister on Second Reading. It is first of all put at risk by the extent of the powers vested in the Minister and secondly by the possibility that cumbersome and frustrating bureaucratic procedures could discourage innovation and slow down the flow of new or improved products in the drug industry. My concern is whether the powers are too wide and too arbitrary. It does not matter whether they are exercised by a medicines commission, by committees, the Minister or anyone else. The question is whether the Bill provides proper safeguards against decisions concerning drug production or prescribing habits being subject to political or economic influences instead of being based solely on the best available medical advice. For example, Clause 20(2) states that the licence shall not be refused on grounds of price. The same Clause, subsection (3) empowers the Minister to 1677 refuse a licence on the grounds of safety, quality or efficacy, provided that he consults with the Commissioner or appropriate Committee.
He can reject their advice. He may refuse that licence on any of those grounds if he considers it "necessary or expedient" to do so. Necessary and expedient for whom? My hon. Friend the Member for Farnham suggested that if Parliamentary control over this great power is to be exercised satisfactorily, there may be a strong case for a specialist committee to study health matters and this is something that I should like to support.
In this context I am thinking of drugs which show only a marginal advance on existing products. A marginal advance or difference may have specially beneficial effects on one patient compared with others, and compared with a superficially similar product. A marginal advance may lead, and sometimes does, to unexpectedly important breaks-through. I hope that the Bill will be amended to take full account of the assurance given us by the Minister. We shall have to look very carefully indeed at this point in Committee to try to ensure that a licence may not be refused on the grounds that it relates to a product held to be less or no more efficacious than another product already available. This is something for doctors to decide. Their collective professional opinion is surely the best guide to the industry about the value of a product.
The industry and the medical profession have already had experience of the working of two committees whose functions are now to be given statutory powers. In the industry there is nothing but praise for the Dunlop Committee, which has worked extremely well and at admirable speed. But there are mixed views about the work of the MacGregor Committee. Some people feel that it has been over rigid and out of touch with the industry and general practitioners. Some people think it has been too apt to condemn products on academic grounds and the views of the Committee have not by any means always been confirmed by the experience of practising doctors.
These factors have a direct bearing on a doctor's freedom to prescribe, and I 1678 see a potential threat to it under this Bill. I hope therefore that the Minister will give the assurance that he intends above all to safeguard this freedom in every possible way. He must ensure balanced representation on the expert committees, and he must limit their terms of reference to matters properly and better decided by them rather than by doctors.
Another power vested in the Minister is that to publish the British Pharmacopoeia which was formerly done by the British Medical Council. I would like to know what the reason is for these powers in the Bill. Why is there power to publish so much more information over and above the Pharmacopoeia? I am thinking of the compendia which are to be published and the promise made by the Minister that in Committee an Amendment would be moved to enable still more prescribing advice to be produced for doctors.
There is one other important aspect of these far-reaching powers vested in the Minister which concerns me. These are in Clauses 83 to 88 to do with advertising and promotion. I hope that the Minister will co-operate with the industry in trying to improve the code of advertising conduct which the A.B.P.I. and the Proprietary Association of Great Britain already have. No doubt some minor improvements can be made. There is something in this of "trying to keep up with the Jones's "which is undesirable. Some firms do not always co-operate and I would like to see them all co-operating and sticking strictly to this code. But proper rules and restrictions should not be imposed without very careful consultation. We must remember that the profit earned in the marketing of a new drug must be substantial to offset the fact disclosed in the Sainsbury Report that only one in 3,000 of the projects embarked upon by the industry ever reaches the market. This, then, is my main criticism of the Bill, the risk that arbitrary powers could be given statutory effect and could be too easily misused with the consequent serious threat to doctors' freedom to prescribe.
I also feel that this Bill can easily and quickly lead to a top-heavy organisation, frustration and too much red tape, thus discouraging research and innovation and the taking of risks that lead to important discoveries. The F.D.A. has been very 1679 much criticised in the United States. We are told that on average it takes nearly three years for a new product to get through, whereas Dunlop takes only some three months: It is important to learn this lesson. We must not have a top-heavy bureaucracy imposed. We have still not been told how many new civil servants this will mean or what will be the cost of administration.
There is a real possibility that because of the powers which the Government are taking through the Health Services and Public Health Bill the Minister can provide services, or produce or manufacture goods required by the hospital services in excess of their requirements:… if he thinks it expedient so to do.There must then be a threat of Government manufacture, of the Government entering into the manufacture and sale of pharmaceutical products. It is only a short step from entering the industry on a small scale to the wider step of large-scale manufacturing. This is something, nationalisation, which the Sainsbury Report flatly rejects. It expresses grave doubts too about State participation in the drug industry at all. The Minister should be congratulated on accepting this view of Sainsbury. State manufacture would be a retrograde action. In the Soviet Union there has not been one major therapeutic advance resulting from strict State control of the pharmaceutical industry, or for that matter in any other country behind the Iron Curtain. There is a very important lesson to be learned here.
State control could lead to political pressures on doctors to prescribe State-produced drugs. In some ways, this is the greatest implicit threat to their freedom to prescribe. There is nothing explicit about it in the Bill. There are immense sums available through the Industrial Reorganisation Corporation and the Industrial Expansion Bill which could be used by the State to take a direct interest in the manufacture and promotion of and research into drugs.
I now sum up. Although it is not the intention of the Opposition to oppose the Second Reading, there is much in the Bill which gives many of us cause for considerable doubts. We shall have an interesting Committee stage and there 1680 will be some hard-fought battles. Everyone interested in the health of the country and the national economy must have a vested interest in a progressive, flourishing and profitable pharmaceutical industry. The Ministry of Health, the medical profession and the drug industry must work together for the good of everyone. This places a high premium on the need for full and genuine consultation whenever important steps are taken in the light of the Bill.
Good intentions on the part of the Minister are not enough. Therefore, I hope that he will see the wisdom of setting stricter limits on his powers in some of the ways I have suggested and will prune in Committee the irrelevant or unnecessary procedures which could lead to top heavy bureaucracy, delays and frustration. Above all, if anywhere in the Bill the vital principle of the doctor's freedom to prescribe is in any way violated, the profession will find that its birthright has been sold for a mess of political pottage.
§ 8.23 p.m.
§ Mr. Michael English (Nottingham, West)
I am a little surprised by the attitude of hon. Members opposite, particularly that of the hon. Member for Farnham (Mr. Maurice Macmillan). He said, among other things, that the profit margin on pharmaceutical products in Europe was greater than it was here or in Canada or in the United States. It may surprise hon. Members opposite, but it does not surprise me. It is hon. Members opposite who want us to associate with Europe in every conceivable way, including this way.
§ Mr. Maurice Macmillan
I was talking about retail pharmacy only. Taking the countries which I quoted in Europe, the profit margins of retail pharmacists, where medicines almost exclusively were sold and where price margins were controlled by State or professional bodies, were higher than in those countries where this was not the case. I was not making any comparison between the United Kingdom and Europe.
§ Mr. English
The countries which the hon. Gentleman quoted were European in the case of those having higher profits and the countries which he quoted against them were Canada, Britain and the 1681 United States. It was precisely because of that that I mentioned the point.
The Bill has been discussed from the point of view of the manufacturing industry. It has been discussed by one of my right hon. Friends from the point of view of the pharmacists. It has not been discussed from the point of view of the biggest single retailer, the headquarters of which is in my constituency. Therefore, I have a constituency interest in this matter.
There is a difference between the purely manufacturing point of view and the retailing point of view. Therefore, I am sorry to see the nature of the proposed composition of the Medicines Commission in Clause 2. Subsection (3) provides that there should be on the Commission representatives of the practice of medicine, of the practice of veterinary medicine, of the practice of pharmacy, of the practice of chemistry other than the pharmaceutical industry and of the pharmaceutical industry, except so much of it as relates to retail sale— in other words, the manufacturing side. Nowhere is it proposed that there should be on it representatives of the people who sell the drugs. This is quite extraordinary in a Bill whose object is to control the sale of drugs to the public.
I know that it might be said that the representative of the practice of pharmacy might be concerned with selling drugs. Equally, they might not be, because many pharmacists are not engaged in selling drugs at all. When the object of the Bill is to prevent drugs which might be harmful being sold to the public, it is extraordinary that there should be no one concerned with the retail side of the industry on the Commission. The Advertising Association has made a similar point, although it is not identical with the point that I am making. It was concerned with the control of advertisements.
I wish to ask the Minister one or two specific questions about later parts of the Bill. What is supposed to happen if a licence is revoked under Part II? The Minister detailed the licensing procedure at considerable length, and no doubt he was right to do so. But I did not notice in his speech any indication of what is supposed to happen when a licence is revoked. May I make an analogy with 1682 the planning permission which are given under totally different legislation? If a planning application is granted provisionally with certain conditions and is then revoked, there is compensation. Is this likely to be the case under the Bill? What will be the procedure if a licence is revoked?
In Clause 28(3), there is mention of a period of two years within which a manufacturer must start to manufacture the items concerned. It is not clear to me what this Clause means. Apparently the intention is that if the item is not manufactured within two years the licence will cease to be applicable to the manufacturer concerned. That is not the actual way in which it is phrased. However, I should like to know what, in the opinion of the Minister, is the intention behind that particular subsection. In any case, two years is too short a time. I am not familiar with the pharmaceutical industry, but I am familiar with a substantial industry which is also a processing industry. It is impossible to say, after one has discovered a particular item, that it can be manufactured within two years. It just is not feasible. If it is to be done on any scale, one has to set up processing plant and so forth. It just is not possible to do this in modern society in two years. One does not manufacture in a test tube these days. One may need to set up a factory to manufacture a particular product if it happens to be really useful and substantial.
There does not seem to be any means by which the two-year period can be varied. If only a small amount of a commodity is to be sold and it can be manufactured in a test tube, two years is reasonable. However, if it requires the setting up of processing plant and so on to produce an item after the discovery and proving of it, two years seems a very limited time. I ask the Minister to look at that again.
In Part III, Clause 43(c), use is made of a famous word that has a long history, "supervision",… supervision of, a pharmacist.Section 43 is slightly different from the existing law on the subject. Again, I ask the Minister to indicate what he thinks "supervision" may mean. Is it sufficient if one has a pharmacy with a pharmacist present on the premises normally? Can one prescribe without the 1683 pharmacist being present? What is meant by the use of the word "supervision" in that Clause?
There are many other points which I could mention. I do not propose to go into them because some are Committee points. I notice, for example, that there is no provision for appeal in Clause 73, which may simply be based on normal customs in other professions. Again one asks, why not?
What is the meaning of Clause 82 in Part V of the Bill? That to me looks as if it is a draftsman's escape route. Subsection (4) says:In any proceedings in respect of infringement of the right to the use of a registered trade mark, or in respect of infringement of a patent or of the copyright in a registered design, it shall be a defence to prove that the act constituting the infringement was necessary in order to comply with regulations made under this Part of this Act.In other words, the law relating to patents, registered trade marks and copyright is excluded from the operation of this Bill. I should be grateful if the Minister would indicate what it means but it seems to me that this subsection has been put in the Bill by the draftsman to avoid amending in any detail patent law, which this Bill greatly concerns. If one can get round the patent, registered trade mark and copyright law because in any action it can he a defence to say that some provision in this Bill is applicable, this is probably the most remarkable Clause in the whole Bill.
In Clause 86 (3,b) power is given to control the form of advertisements. I did not comment the other day on the Food and Drugs Regulations, but I observed them. I can only say that Regulations of that character do not give one any confidence that a power vested in the Minister to control the form of advertisements will be used in a way that might be wholly desirable. As I understand it, advertising interests were not consulted about those Regulations, or, if they were, they were not adequately consulted. It is not possible to lay down by law the size of lettering or the precise point at which words will appear on an advertisement. I say this as one who is in favour of some legitimate degree of control of advertising. However, the nature of those particular Regulations was not such as to give me any confidence that Clause 1684 86 will be used in a reasonable way. Will the Minister give an assurance now, or subsequently in Committee, that if, for example, this Clause stays as it is and he and his fellow Ministers are given power to prescribe the form of advertisements, there will be some Limitation?
I do not see, for example, why this power, like every other power, relates to "Ministers ". I do not know why one brings agricultural drugs into this. However, apparently one does it, like everything else, probably again for the draftsmen's convenience.
§ Mr. K. Robinson
Three Ministers are involved in the question of human medicines— the Secretary of State for Scotland, the Minister of Health for Northern Ireland, and myself.
§ Mr. English
I thank my right hon. Friend for that explanation. I hope that this will not make the position worse. Having seen the effect that one Minister can have on the Food and Drugs Regulations, I shudder to think what can happen with three.
It is quite common in Bills— we saw this the other day in a Bill that went through the House— to say that a power of this kind will be exercised only in consultation with the interests affected. The Bill itself says, in relation to the Commission, that certain types of interests will be represented. With all respect to the Ministers concerned, I say that they are not experts on the form of advertisements, and I hope that at some later stage some provision will be included in the Clause to say that consultation will take place with persons familiar with the industry.
Hon. Gentlemen opposite seem to have endeavoured to damn the Bill with faint praise. I have made a few points which are almost Committee points, but—
§ Mr. English
"Committee points" was the phrase I myself used. I have no major objection to the Bill, nor do I believe that people in my constituency, or outside it, have any. Hon. Gentlemen opposite say that they are not opposing the Bill, but the hon. Member for Farnham gave the House a quotation which implied that, although he did not wish to oppose the 1685 Bill, he was reluctant that this was the case. It seems to be the case that hon. Gentlemen opposite cannot praise the Government for a good action. In my view, and I think in the view of many people in the industry, the Bill is to be welcomed. It will do a valuable job.
My hon. Friend the Member for Wood Green (Mrs. Joyce Butler) mentioned one of the causes of the existence of this desire to protect people. We all desire to protect human being from anything from which it is possible to protect them. As the hon. Member for Cheadle (Dr. Winstanley) said, nothing in this life is certain. We cannot protect everybody from the side effects of certain drugs, but we can do our honest best to help. It seems to me that the Bill will do that, and do it in a way which will not injure the interests of the industry, or retailers, or of consumers as a whole. It is a pity that some hon. Gentlemen opposite have received the Bill with such faint praise. This Measure is to be welcomed. It is welcomed by members of the industry who desire to protect the public. They believe that the Bill will do that without damaging the prospects of having in this country a pharmaceutical industry that is one of the best in the world.
§ 8.38 p.m.
§ Mr. David Crouch (Canterbury)
I think that the hon. Member for Nottingham, West (Mr. English) has done less than justice to what he has heard from these benches this afternoon by saying that we wish to damn the Bill with faint praise. I have been here all afternoon and that is not my assessment of what I have heard.
I have two interests to declare. First, only last Friday I had occasion to feel grateful to the drug and pharmaceutical industry, in that I underwent a minor operation which necessitated my being put out completely in an operating theatre. As I was still conscious for those last few seconds I could hear the anaesthetist say to the surgeon, "You know who this chap is? He is our local M.P." That is the last thing I heard. It was a truly non-party operation.
My other interest which I must declare, as we have all been opening our hearts and hands this evening, is an interest in an advertising agency. I am a director of an agency concerned with the adver- 1686 tising in one instance of proprietary medicines and in another part ethical medicines to the medical profession. I have no intention of making any special pleading this evening, but there are two aspects to which I would draw the attention of the House. One is the question of household medicines, which I hope will be on the general sales list, and the other is the question of advertising, which was touched on by the hon. Member opposite.
I feel sincerely that the intentions of this Bill and of the Minister are good, but there are, as my hon. Friend the Member for Farnham (Mr. Maurice Macmillan) said, loose ends. It is a very open Bill. Like so many Bills which the Government have presented, there are far too many open "swinging" doors. It is an ill-drafted Bill and a very draughty house in which to construct this legislation.
I hope that the Minister, having heard this responsible and serious debate, will later in Committee take note of some of these loose ends and tie up this piece of legislation which has good intentions and could be made so much better if it covered some of the points raised by Members interested in the retail industry and pharmaceutical industry, both in manufacture and in distribution. We have heard a great deal of wise and knowledgeable comment from doctors and Members speaking with knowledge of the manufacture of pharmaceuticals.
I am glad that the Minister is here at this stage. It might be thought that Part III of the Bill— household medicines — is the least important. I listened to the hon. Lady the Member for Wood Green (Mrs. Joyce Butler) retelling the story of the thalidomide tragedy, when one could have heard a pin drop. The tragedy was made vivid again to us all and we realise the need for legislation. But the Minister has assumed a wide responsibility and has stretched his net very wide indeed to include these household remedies. These are simple products for the treatment of minor ailments which do not normally call for the attention of one's doctor. Only recently during the flu epidemic the Ministry of Health advised people by advertisements on the radio, by advice on television and in the Press, not to call their doctor unless they were very ill but to go to bed and 1687 take a couple of aspirins. This was sensible, pragmatic and reasonable advice.
Let us not try to restrict the sale of these household medicines. Let us keep our feet on the ground. We are talking about simple remedies for indigestion, headaches, coughs, colds, constipation, multi vitamin pills and glucose drinks.
There is a tendency for hon. Members opposite sometimes to think of the consuming public as being in need for too much attention from this House in its legislation. We cannot legislate for everything. We should not assume that the consumer is an illiterate person, because he is not. Ordinary people are very wise about certain matters. They have a great deal of common sense about some of the simple things with which they grow up.
These household medicines are well trusted and understood. There are few people who will take more aspirin than they should, just as there are few people who will take a laxative unnecessarily. I suggest that it is a very dull diet, and even I can think of a better stimulant than a glass of Lucozade, though no doubt it would be helpful after a long day spent in this Chamber.
These household medicines are available not in 15,000 chemists shops alone but in the shops of another 150,000 retailers like tobacconists, grocers, newsagents and so on. They are meeting a genuine public consumer need. It is not wrong for it to be possible to buy a bottle of aspirin, a packet of Enos or a tin of Andrews at places other than a pharmacy.
I accept that there are certain medicines which are judged by a special committee appointed by the Minister. I have in mind cough cures containing poisons. Legislation exists to ensure that such medicines are not sold by anyone other than a chemist. It is right that such matters should be under the Minister's eye. However, I want to draw to the Minister's attention the fact that there is a consumer need for a broad scale of availability of the household medicines to which I have referred. We have no evidence of injury suffered by the public as the result of the sale of such medicines by a wide range of shops. They have a 1688 trouble free history. They are trusted and known by the public to be safe.
In approaches made to me by members of the Pharmaceutical Society, it has been pointed out that even aspirin tablets taken in excessive numbers can be dangerous. I am sure that we all know the problem. So many things that we face today are dangerous if taken in excessive doses. It is not for this House to legislate about them by saying they must immediately be taken out of the public's grasp. People already know about the dangers.
The Bill provides that medicines which are referred to as exceptions to the Bill may in future be sold other than at chemist's shops and are to be put on the general sales lists. My concern is that the White paper was fairly strong on this point and that the Bill is less strong in its terms. Paragraph 47 of the White Paper says:Retail sale of drugs to the public will, with some important exceptions, otherwise be limited to registered pharmacies.Clause 42(1) states:The appropriate Ministers may by order specify descriptions or classes of medicinal products, as being products which in their opinion can with reasonable safety be sold… otherwise than by, or under the supervision of, a pharmacist.I hope that the Minister will bear in mind that he has not yet defined the list. It will take time to draw up the list. Who is to draw it up, and on what considerations will it be drawn up? What is to be the machinery of appeal for any product that might at this initial stage not be included in the list? There is no mention in the Bill of machinery of appeal.
There is an under-estimation, at least by the draftsmen, of the size of the business in household medicines, of their general usefulness to the community and their wide availability. We have been told that £ 40 million worth of these medicines are sold each year, only half at present being sold through pharmacists, the rest of the business coming from all these other sources.
After the wise words we have heard today from hon. Members who are almost experts in their field, I suppose I can say that the Minister is getting from me a touch of commercialism, but, as the hon. Member for Nottingham, West has reminded us, the Bill itself has a commercial 1689 aspect, though not a cheap and sordid aspect. The commercial aspect relates to the simple remedies that I call medicines.
Who is coming first in the Minister's mind—the consumer or the legislator? I ask the right hon. Gentleman to remember that the consumers have a very big interest in their own health. Does he not trust the public at all? I am sure that he does, but I believe that the Bill as a hole in it which I hope will be patched up. Does the Minister think that the public really need to have Whitehall's apron strings attached to them, as the Bill tends to suggest?
In suggesting a practical solution for this general sales list, I echo that made by my hen. Friend the Member for Farnham. It is that those products that are currently sold freely outside pharmacies should, for a start, automatically come on the general sales list unless there is some strong protest from the Minister's Committee about any product because of the health and safety factor.
The Pharmaceutical Society features very largely in the Measure, and has given a great deal of support in many Clauses. It is enlarged to a status that is very new to it. The Society is a very responsible body. Its members are not just retailers in the ordinary sense, concerned only with buying and selling at a profit, but people who give wise advice to their customers about the products on sale. I accept that, but the Bill goes somewhat further in building up the Society and its responsibilities in this matter.
For example, the Society has in evidence said that it would like to see all public advertising of these household remedies banned. I do not think that this is the Minister's intention. In those circumstances, the public would be asked to rely entirely on the chemist's recommendation and possibly, in future, on his own mixtures and medicines, and would be denied the opportunities in our modern industrial society of the free competition and massive production of simple medicines under good, safe industrial and clinical conditions. What we are talking about, unless we patch up the hole in the Bill, is the disappearance of the market plate for these simple remedies and the sudden substitution for the 150,000 shops of 15,000, which is a restrictive marketing practice.
1690 I sometimes sense too much woolly thinking by hon. Members opposite about advertising. It is always thought to be bad and hon. Members opposite seem to find arguments in its favour difficult to discover. They all miss the point, that the introduction of household remedies and the better modern brands—soluble aspirin, for example, is a development on the solid aspirin—cannot await the slow process of word-of-mouth recommendation, so advertising, distribution and marketing are necessary. It is this chain which makes production possible. It has been said, in another context, that the advertising and marketing task is the final stage in the production process.
To leave the marketing of household medicines to the chemist's recommendation would be an attempt to return to the ideas of the last century instead of helping the consumer to enjoy the real benefits of modern research and production.
There are already safeguards. Without doing special pleading, I would say that the advertising industry is much more responsible than those outside would think. We already have the independent Advertising Standards Authority and the independent Television Code of Advertising, which is applied by the television authorities. The advertising is seen by them before it is seen by the public, and it can be turned down. Members of the Ministry's Department and representatives of the British Medical Council are represented.
Without such advertising as is necessary for these household medicines, their supply would be curtailed. I do not accept that advertising in this case produces too great a demand and consumption. It is very hard to achieve over-selling of medicines. No one wants to take more laxatives than he needs, and no amount of advertising will encourage him to do so. No cough cure manufacturer can sell it to people without a cough. As I said, aspirin is a very dull diet. Allied to the advertising problem is the question of the Minister and his Department taking a hard look at what is on the label or the package, which I think has gone too far. Is it necessary for civil servants to try to be authorities in the arts of communication and presentation?
Let us bear in mind the real spirit of the Bill and the Minister's intentions in it. Let us say that we are looking all 1691 the time for the safety of the drugs that are to be sold to the consumer, whether they are simple remedies or ethical medicines. I do not believe that it is necessary to establish rigid, common standards for the wording of advertisements and the size of type faces. There are experts in every field, including this one. They know all about the construction, design and presentation of labels and packages. They should be required to observe sensible, but not rigid, instructions from the Minister.
The House has been in a fair mood today and a serious and responsible atmosphere has been engendered. This is an extremely serious and responsible subject and, as I have said, the Bill has the right intentions. I have no doubt that the Minister has the right intentions for it. However, I trust that, in Committee, this Bill of good intentions will he improved because there is general feeling among hon. Members that we should put right the faults that exist in it.
§ 9.1 p.m.
§ Mr. Laurence Pavitt (Willesden, West)
The hon. Member for Canterbury (Mr. Crouch) was right when he said that the background to the Bill is definitely the thalidomide tragedy. if that is my only comment on his speech, I trust that he will forgive me because very little time remains for this debate. Before I reduce some of the results of the two days' of homework I have done on the 119 Clauses of the Measure, may I put this to my right hon. Friend.
Two powerful and cogently argued attacks on the Sainsbury Report have been made in the debate, one by the hon. Member for Surbiton (Mr. Fisher) and the other by the hon. and gallant Member for Lewes (Sir T. Beamish). It will be impossible for the Under-Secretary to deal with those attacks in his reply tonight because he must be concerned with the Bill. I therefore plead with my right hon. Friend to ensure that an opportunity is provided for those attacks to be answered in a complete debate on the Sainsbury Report, when we will be able to rehearse again the arguments against the Report and have them adequately answered.
It has emerged that we are no longer a nation of shop keepers but a nation 1692 of pill takers and medicine pourers. The hon. Member for Cheadle (Dr. Winstanley) was right when he said that it was imperative that the Bill should go forward, when, in his general practitioner manner, he pointed out that, in the last analysis, medical trials must he carried out on people. In other words however much one conducts heart transplants on guinea pigs and other animals, in the last analysis a human patient must be used for clinical trials. Ordinary people must therefore be protected.
This Measure has been essential for at least the last four years. We said long ago when we were still in Opposition that we would put teeth into the Dunlop Report. One of the most knowledgeable persons on this subject, Sir Hugh Linstead, who was a Conservative Member of this House at that time, prepared the minority report of the Commission which led to the Dunlop Committee and I am pleased to note that the Bill now introduces many of his recommendations.
Because this is such a highly technical Measure, it is vulnerable to specialised pressures and interests. That is why I agree with the hon. Member for Canterbury that in Committee we will find a great deal to discuss when we get into Committee. However, the crux of the Bill is the Medicines Commission and I seem to be in a minority position—certainly I agree with my hon. Friend the Member for Glasgow, Kelvingrove (Dr. Miller) —in thinking that the Minister has taken the wrong point of view on this question of whether the Commission should be independent from or responsible to my right hon. Friend. In my view, it is important that, for the Commission's leadership, my right hon. Friend chooses a professor of pharmacology, someone who commands universal respect for it is vital that this body is seen to be independent from politics.
Reference has been made to the need for clinical freedom for doctors. As advisers who will be involved in the work of the Commission, concerned with both pharmacists and general practitioners, it must be seen, and they must be confident of the Commission's independence from the Ministry. We must remember the tendency of the professional man to say, "This is yet another circular from the Ministry" and, "The civil servants 1693 are sending something out again" A high-powered commission would carry more weight with them than the Government Department.
In the establishment of committees is the MacGregor Committee to go into the framework? Will it be married to the Dunlop Committee to make one single committee, or will the MacGregor Committee have the statutory provisions which we should like to see separately? A recent report showed that one third of the drugs being used had no efficacy for the purpose for which they were prescribed. It is imperative that we should make sure we are not prescribing and paying for a lot of worthless medicines. The type of job which the MacGregor Committee could do is precisely that, and this is most important for the taxpayer.
I would prefer that the Commission should be the licensing authority. So many licences have to be issued that I dread to think of the headache that will be entailed for the Minister if he is to be subject to political pressures about licences. If the Medicines Commission has this responsibility that could all be avoided. It would be non-political. It is absolutely wrong to exclude all question of price from the Bill. This is where I cross swords with the hon. Member for Surbiton, and the hon. and gallant Member for Lewes. The licensing authority should have the right to consider price in connection with other things. In regard to Clause 19 I hope to give the hon. Member for Farnham (Mr. Maurice Macmillan) an opportunity of debating in Committee an Amendment which I hope to move to that effect.
In the Bill I cannot see any power to withdraw a licence, but that power should be there. There should also be the possibility of licences being reviewed every three years. If this opportunity is not taken by the Minister now, he will not be able to take it later. If he is to secure the procurement of drugs as "services of the Crown" in general practice in the same way as he is able to do it for hospitals, he must do it in this Bill. He will not find an opportunity of introducing a further Bill on these lines or of amending the Patents Act. The Emergency Laws (Re-enactment and Repeals) Act 1964 is totally inadequate 1694 for the kind of purpose I should like to see covered by this Bill.
There are 10 drugs used in hospitals for which the Minister pays £2 million a year. For halothane alone, £¾ million a year is paid in hospital practice. Good business on behalf of the taxpayer means that we should adopt the same kind of methods as Marks and Spencer adopt in buying. A big buyer can secure the best possible treatment. I hope the Minister will look at the possibility of including this kind of provision in this Bill.
Hon. Members have declared an interest in some companies which has given them a specialised knowledge of the subject. The House appreciates that they speak from knowledge. I cannot speak with so much knowledge when I declare my interest as a member of the Co-op, but I ask for an assurance that there will be no restriction on a corporate body or a publicly owned movement like the Co-operative Movement to provide a pharmacy service for its members, provided that properly qualified men are employed in positions of responsibility.
Part VI deals with the question of promotion. I wonder if it would be the appropriate place in which to put forward the idea of a "Little Neddy" for the drug industry. If not in the Bill in negotiations which the Minister is seeking with the industry, perhaps as a by-product of the Bill we could secure a "Little Neddy" established for the industry.
I congratulate the Minister particularly on Clause 84 and the way in which it deals with the whole question of advertising. This is a most brilliant piece of drafting. I wish that the Minister would lend me his draftsman to draft a similar clause in my Hearing Aids Bill to save advertisements which lead to old people having to pay for hearing aids which they cannot afford. I wonder what effect this Clause would have on an advertisement which appeared in the News of the World with the heading: "Rheumatism and Married Life" It has been written by Godfrey Winn. I am not sure whether he is an expert on rheumatism or on married life. The advertisement informs us that we should trust Fynnon's salts, "Thousands do" Fynnon Salt is 95 per cent. sodium sulphate, which is a good purgative, but does a good purge remedy rheumatism?
1695 I very much welcome Clause 87, which imports the "control document ", of the Sainsbury Report, but I think that it needs strengthening and I hope that in Committee we shall be able to strengthen it. It has some loopholes which could be stopped. I again differ from the hon. Member for Surbiton. I enjoy following him in matters concerning the Caribbean far more than I enjoy following him about drugs, because in the one case we are like-minded but in this case we are utterly opposed.
I cannot accept his case for the retention of brand names. The hon. Gentleman knows as well as I do that there is no guarantee with brand names of quality within the product. The hon. Gentleman will have read, as I have read, the analysis of the late Fred Stock of Birmingham of a whole number of these products, which proved in fact that there is no guarantee even if a product has a brand name on it.
It has been shown that over the last 16 years, since the National Health Service came in 1950 to its first full year, in the prescribing of non-proprietary drugs in the N.H.S. we have remained steady at just about £10 million. At the same time, the cost of prescribing branded drugs—the proprietaries—has risen from under £10 million to £78 million a year. This is a tremendous difference. I direct attention to some of the differences in prices. It has been said that only £½ million could be saved. I challenge that figure for a number of reasons. I base my argument, not only on a report of a recent Committee, but also of investigations by the Public Accounts Committee in 1961 and 1962, and on present-day prices—for instance, Oxytetracycline, 293s., and Terramycin, 809s. We are prescribing a lot of these drugs and this means a very heavy impost on the taxpayer. It is the same with simple things, soluble aspirin, 8s. 7d., Solprin, 12s. 3d.: Paracetamol, 13s. 4d., Panadol, 22s. 4d. The same is true of a whole lot of these things. If we could greatly reduce the expenditure of £78 million on branded names and concentrate more on prescribing in accordance with the National Formulary and the British Pharmacopaeia, we should save the taxpayer a lot of money.
1696 The classic case for the present system of the drug industry has been put very ably. It rests on two main pillars—research and export performance. The only other factor usually brought up was mentioned by the hon. Member for Cheadle, who pointed out that the Soviet Union had failed to produce a new drug for a number of years. We have heard these three arguments time and time again over the last ten years.
As to costings, I would hope that we are able to deal somehow with the £250 per annum spent on representation for each general practitioner. For every 10 general practitioners there is one representative persuading him which drug to prescribe. This means a cost of £15 million which must be included in the £160 million the nation pays, and I think that there could be worth-while savings on this item. The hon. Member for Surbiton challenged us to say how much Sainsbury would save. I would say £8 million a year, but my guess is no better than anybody else's. It can only be an estimate.
I welcome the Minister's consent to an amendment to make the Prescribers' Journal coming under the Commission, because this will be an important way of doing away with the large number of representatives. What general practitioners want is an adequate supply of information. They do not want glossy literature.
The pharmaceutical industry seems always to be thought of in a very similar way to that in which the Soviet Union was thought of in the 1930s: heaven or hell, all good or all bad. It is seen as saving a lot of lives, or as a terrible profit-making concern. In my view, it is neither. It is something between the two. We are grateful for the tremendous work in healing the sick that the industry does, I think, at the same time, that it gets too large a share of profit, and I am prepared to discuss how we can reduce that profit to a more reasonable figure.
In 20 years, the drug industry has given us new weapons to defeat illness or to shorten its duration, with consequent benefit to the wealth of the nation and the health and happiness of its people. I wish the Bill well, so that we may continue to have more effective cooperation with the industry, but we want 1697 this co-operation as one of partnership, not on the industry's terms or on the Government's terms but by an arrangement between the two which is fair and equitable.
§ 9.15 p.m.
§ Mr. Paul Dean (Somerset, North)
This is the second health Bill which we have discussed this Session. It is unusual for the Minister of Health to bring forward as much legislation as we have before us at this time, and I hope that he will not indulge in what I regard as the thoroughly bad habit of trying to be top of the legislative league table.
§ Mr. Dean
I hear the Minister say that these are the first two Measures in three years, but I none the less hope that he will not catch that bad habit. I am one who believes strongly that legislation has increased, is increasing and ought to diminish. Many of the ills from which we suffer come not only from bad government but also from over-government, and one of the reasons why we have over-government is that our legislative programme in the House is so clogged with the sheer weight of Bills that it is exceedingly difficult to do one's job properly or for the House and its Standing Committees to scrutinise Bills in an adequate and proper manner.
In opening the debate, my hon. Friend the Member for Farnham (Mr. Maurice Macmillan) said that we approached the Bill with what one might call a degree of critical scepticism. One of the good features of the Bill is its title, which is brief, clear and concise. I wish I could say the same of the 119 Clauses and the several Schedules, but, alas, I cannot. Coming from a farming background, I must say that, when I looked at the definitions and saw that "herd" includes a flock, it made me shudder, as, no doubt, it did those of my hon. Friends who know farming so well.
In so far as the Bill draws together the various measures, some statutory and some voluntary, designed to ensure the safety and quality of drugs and the accuracy of information about them, we support it. I was glad that the Minister paid tribute to the work of the Dunlop Committee and that he acknowledged that the Bill is to a large extent based upon 1698 the valuable experience we have gained during the past few years of the working of the Dunlop Committee on a voluntary basis.
In so far as the Bill brings together the best features of the previous statutory and voluntary arrangements, we support it, but we shall at later stages look with a critical eye at the possible dangers. In this connection, I instance the wide powers which the Bill gives to the Minister, as does the Health Services and Public Health Bill, the possible threat to the freedom of doctors to prescribe which could arise, and the possible danger of controls which will make it more difficult for innovation and the sense of discovery which is so strong in our pharmaceutical industry.
I was sorry that the Minister said very little about the freedom of doctors to prescribe. He had a lot to say, but there was little in his speech about that, although we welcomed the tribute which he paid to the pharmaceutical industry and the progress in relief of suffering which its inventions have made possible. I was also sorry that he said little about the agricultural provisions, but I shall return to that point a little later.
The background to the Bill is what has been called the therapeutic explosion of the past 30 years. It has undoubtedly brought untold benefits to mankind in the relief of suffering and the cure of disease, but it has also brought the other sombre side of the picture—the thalidomide tragedy that we still have and shall have for a long time, human beings living as a monument to the kickback which is possible from the new discoveries.
The hon. Member for South Shields (Mr. Blenkinsop) mentioned the recent tragedy of children on Tyneside. The hon. Member for Cheadle (Dr. Winstanley) spoke of the dangers which are inevitable even in clinical tests. To use the old saying, there is no rose without a thorn. But equally one hopes that where there is a thorn there will also be a rose. Some people say that the risks are too great. I think that I have sensed from some of the speeches by hon. Members today that this has been very much at the front of their minds. I think that some almost felt that the prospects of the rose were not worth the danger of the thorn.
1699 I think that that point was well put by Oliver Wendell Holmes when he said:I firmly believe that if the whole materia medica could be sunk to the bottom of the sea it would be all the better for mankind and all the worse for the fishes.
§ Mr. Kenneth Lewis
Does my hon. Friend agree that if the British ceased to be hypochondriacs, if they ceased to go in for self-medication, they would need a great many more phychiatrists?
§ Mr. Dean
I am sure that my hon. Friend has a point which I should like to develop, but the clock is pressing me and so perhaps he will forgive me if I do not.
Those words of Oliver Wendell Holmes might be called a counsel of despair. But we must recognise that no legislation can possibly eliminate all risks. What it should aim to do is to promote safety without destroying innovation, without hampering progress by unnecessary bureacracy. The ultimate safety is not in this or any Bill but on the doctor's prescription pad, in the chemist's pharmacy, in the good sense of the individual who buys aspirin from the village shop or the supermarket. The ultimate progress in the relief of suffering depends on research and development and innovation by the pharmaceutical industry. The test of the Bill must be whether it promotes reasonable safety measures without impeding progress in the art and science of healing and preventing suffering. It is on that basis that we shall judge its provisions.
My hon. Friend the Member for Farnham and many hon. Members on both sides of the House said that the Bill gives the Minister very wide enabling powers. Indeed apart from setting up various bodies to assist in licensing and controls generally it is very largely an enabling Bill. That is particularly so in connection with licensing, labelling and advertising. I was glad that in his opening speech the Minister emphasised the safeguards against arbitrary action in the Bill. But he will appreciate that we shall want to probe his intentions on these important matters very closely.
I hope that the Under-Secretary of State will be able to answer the question raised by my hon. and gallant Friend the Member for Ripon (Sir M. StoddartScott), who asked how many public 1700 servants will be involved in this policing machinery and what the cost will be. A great deal will depend upon the spirit in which the Minister, the Commission and the expert committees go about their work, and I was glad that the right hon. Gentleman mentioned that he regards the Statutory provisions as a necessary background but hopes that they will not be used. He will forgive me if I remind him, however, that we have heard this argument on previous health Measures. Although we in no sense dispute his good faith in these matters, we have to look at the words in the Statute and not at what he says from that Box.
The representation on these bodies will be of the greatest importance. There must be fair balance between all the interests, and there must be practical experience so that these bodies, which are to advise the right hon. Gentleman, will retain the confidence of those over whom they are to be set. The success of these bodies will depend not only on the spirit in which they operate but on their success in keeping their eyes on the basic objectives of safety, quality and efficacy of medicines and the extent to which they avoid meddling in promotional techniques, in the all-important export trade of the pharmaceutical industry and in the responsibility of doctors to prescribe and pharmacists to dispense.
A number of hon. Members have mentioned in this connection the general sales list. This is an immensely important part of the Bill. The Minister is proposing to reverse the procedure which now operates and I hope that, at any rate in the discussions which go on in deciding the shape of the list, he will not be unduly restrictive. I was glad to hear that he intends to take advice from the appropriate committee in this connection. That is all to the good. But I hope that it is recognised that it is for the convenience of the public that they should be able to go to shops convenient to their dwellings—this particularly applies to country areas—for what one might call the simple household medicines such as aspirin.
I shall say no more about the enforcement provisions except that we shall look at them very carefully in Committee, because they are wide powers—far wider than is really required to achieve the 1701 objectives the right hon. Gentleman has in mind. We are also not happy about the wide powers over advertising. I note that the hon. Member for Nottingham, West (Mr. English) put the point very well when he drew a distinction between the contents of advertisements, over which he agreed some measure of control was necessary, and the form of presentation, which he felt was not an appropriate matter for the Minister. I thought that he got the distinction right and this is another point we shall want to probe in Committee.
Very little has been said about agricultural feeding-stuffs and veterinary medicines. I am sure that my hon. Friend the Member for Torrington (Mr. Peter Mills), had he been able to catch your eye, Sir, would have said something about this because he has special knowledge on these subjects. No doubt he will have an opportunity later to give us the benefit of his views. I feel that this part of the Bill has got in a little by a side-wind. I suspect that the Minister of Agriculture would have preferred his own Bill on this, had it been possible.
Because this aspect has been sandwiched into a Bill dealing very largely with human medicines, it is important that it should be examined extremely carefully. Veterinary medicines are in a very different category to human medicines, and I hope that the Under-Secretary of State, when he replies, will be able to tell us how the expert committee system will operate. I hope that he will tell us that there will be an expert committee dealing specifically with veterinary medicines. As to agricultural feeding-stuffs, while as I understand the Bill the manufacturer and the seller will not need a licence, if they use a medicinal product in their animal feeding-stuffs they will have to observe the conditions in the relevant licence.
This may be a desirable thing, but we have to recognise that in provisions of this kind we are in a sense exercising more control over the realm of foodstuffs than we are in the case of human beings. We are now exercising control over animal feeding-stuffs, whereas, as I understand it, the line is really drawn on the human side with medicinal products. I am not saying that is is necessarily an incorrect thing. It may be right, but it has very wide implications for the farm- 1702 ing industry, for the manufacturers and sellers of animal feeding-stuffs, and will need careful examination in Committee.
There has been a certain amount of discussion during the debate about the pharmaceutical industry. I was glad to hear the Minister pay tribute to the work of the industry. He referred particularly to the many valuable new drugs which have been introduced and to the high sense of responsibility shown by the industry. We have also had speeches, particularly from my hon. Friend the Member for Surbiton (Mr. Fisher) and my hon. and gallant Friend the Member for Lewes (Sir T. Beamish), who have special knowledge of the drug industry. I was very glad that they took this opportunity to set the record straight after the very damaging and, as I think they showed convincingly, unfair things said about the pharmaceutical industry in the Report.
I want to give the Under-Secretary plenty of time to reply, but I would like to refer to the position of doctors and their freedom to prescribe. This was mentioned by my hon. and gallant Friend the Member for Ripon, and my hon. and gallant Friend the Member for Lewes. In his opening speech I do not think that the Minister referred to this at all. It is of the very greatest importance. One has only to look at Clause 20, which lays down the conditions for a grant or refusal of a licence for a medical product, and at Clause 90 dealing with the British Pharmacopoeia, and other literature, to see that there is a possibility, under the licensing and other arrangements, that the freedom of doctors to prescribe will be limited. I do not believe that this is the Minister's intention, but this could be the case under the Bill. I hope that the Under-Secretary of State will be able to say something about that.
We welcome the general principles of the Bill. We recognise that it is desirable and right to draw together the various provisions, some statutory, some voluntary, which exist to ensure the safety of medical products. We feel that there is a real risk under the Bill that progress in the discovery of new products will be held up. Therefore, we have mixed feelings, and we shall want critically to examine the details of the Bill during its later stages. In the general context, we give a welcome to the Bill, but hope 1703 that by the time that it comes back to the House it will be substantially improved.
§ 9.36 p.m.
§ The Under-Secretary of State for Scotland (Mr. Bruce Millan)
We have had an interesting debate, and I think that the House would expect me to try to deal, as far as I can, with the various points, some of them detailed and some of them more major.
May I start by making it clear what the Bill does not do, because there has been a certain amount of misunderstanding about this. There has been criticism from this side of the House that the Bill does not implement all the recommendations of the Sainsbury Committee. On the other hand, the hon. Member for Surbiton (Mr. Fisher) welcomed the fact that that was so and seemed to take it as an indication that the recommendations of the Sainsbury Committee which have not been dealt with were to be set aside by the Minister. That is not the case. The Sainsbury Committee made a number of recommendations which are not relevant to this kind of legislation. As is generally known, my right hon. Friend the Minister and other Ministers concerned have been having discussions with the various representative interests about, for example, brand names and a number of other recommendations of the Sainsbury Committee. We are not yet in a position to make our final decisions on those matters known to the House.
I should go on to say, in case there is, again, some misunderstanding, that I would not accept the kind of criticisms which the hon. Member for Surbiton and the hon. and gallant Member for Lewes (Sir T. Beamish) made about some portions of the Sainsbury Committee—for example, those dealing with financial figures, the profits of the industry, and the pricing arrangements. While the hon. Member for Surbiton clearly disagreed with the conclusions of the Sainsbury Committee, he did them far less than justice in suggesting that many of the considerations which he mentioned as important have been completely ignored by the Committee. If he looks at the Committee's Report from paragraph 131 onwards, he will see that many of the points which he mentioned about profitability were specifically dealt with. 1704 I am not concerned to argue the merits and demerits of its conclusions. The point I am making is that, in making recommendations, it took account of many of the points which the hon. Gentleman mentioned.
I should have thought that it was common ground among all the people concerned with this matter that the question of, for example, drug prices for the National Health Services poses particularly difficult problems. The introduction of the voluntary price regulation arrangements is an admission by the industry as well as by the Government that there are problems to be dealt with in this area.
§ Mr. Fisher
I should very much like to know the estimated amount of savings which the Sainsbury Committee's recommendations would effect. They should be quantified, because we do not know whether the game is worth the candle.
§ Mr. Millan
This is something that the hon. Gentleman will have to ask the Sainsbury Committee rather than the Minister. However, before any decisions are taken by the Government on the recommendations bearing on that, we shall have to take account of what we would consider any potential savings to be. I do not think that at this point in time we can argue the merits of that point.
My hon. Friend the Member for Glasgow, Kelvingrove (Dr. Miller) was anxious that the Bill should deal with pricing of drugs as well as the other considerations with which it deals. I simply repeat that this is not the appropriate vehicle for dealing with the question of pricing. It is very important that we dissociate matters of safety and efficacy from matters of price. Different considerations have to be taken into account. It does not mean that we are not concerned with extravagance in prescribing and getting economy in prescribing costs. Obviously we are. However, this piece of legislation is not the appropriate vehicle for taking action on that problem.
The House will know that the Minister of Health and, in Scotland, the Secretary of State, have already done a good deal by way of drawing the attention of general practitioners to the question of excess prescribing and have taken other action to 1705 encourage them to show economy in prescribing for the National Health Service. The more information we have about this the better it is from everyone's point of view.
The hon. Gentleman the Member for Somerset. North (Mr. Dean) mentioned the veterinary aspects of the Bill. For completeness I had better make a short statement about the Bill's implications in this area. First, it is not possible to be absolutely categoric about the expert committees which will be established. I should be extremely surprised if there were not an expert committee dealing specifically with veterinary products. I think we can take that for granted.
So far as veterinary medicines are concerned, the Bill puts them virtually on all fours with human medicines. This seems right, since many human medicines are also used for veterinary purposes, and satisfactory arrangements seem to require that both human and veterinary drugs should be dealt with under a comprehensive system. This provides greater protection for both human beings and livestock.
The development of new veterinary products and new uses of existing products over the last quarter of a century has been a factor in increasing agricultural productivity and improving the quality of our food. But such widespread and rapid application of scientific knowledge inevitably gives rise to problems, including some degree of risk. It is a similar problem to that in the human medicine sector.
In general, as under the voluntary Veterinary Products Safety Precautions Scheme, the broad purpose is to safeguard human beings, whether as users of a veterinary product, consumers of food substances from treated animals, or other members of the public, livestock and domestic animals against risk from the use of veterinary products.
These new arrangements under the Bill will ultimately replace the voluntary scheme and the present statutory licensing arrangements regarding the manufacture and import of veterinary therapeutic substances, such as vaccines and sera. It is perhaps important to note that the new arrangements will be all-embracing, since all veterinary medicines will be included in the new scheme. I think the only 1706 other point that I need briefly mention is that of medicated animal feedingstuffs.
The Bill introduces controls over the use of medicinal products in feedingstuffs. The reasons for this are the same as those for controlling veterinary medicines, many of which are in any case administered in feedingstuffs. Our object, however, is to introduce any changes as and when necessary in the light of expert advice.
Clauses 36 and 37 deal with the main provisions relating to medicated animal feedingstuffs. Briefly, they provide that manufacturers of feedingstuffs and subsequent sellers of animal feedingstuffs need not be licensed as such. But if they wish to incorporate a medicinal product into a feedingstuff a product licence for that medicinal product must exist and the drug must be included in accordance with the conditions of the relevant product licence. Alternatively, the drug must be incorporated in accordance with the prescription from a veterinarian. The owner of a pet dog, for instance, would be excluded from the need to comply with these provisions, but persons owning animals in the course of a business—farmers are the obvious example—would have to act accordingly. This is really no more than requiring the instructions on the bottle, as it were, to be observed. It is considered necessary that farmers should be covered, because their produce is supplied for human consumption.
There is another point about substances such as some vitamins and crude chemicals which might be added to feedingstuffs, and which would not necessarily be covered by the Bill as it stands. It is our intention that, as necessary, such substances added to feedingstuffs for prophylactic or therapeutic purposes should be brought within the ambit of the Bill by using the power in Clause 93 to apply the relevant provisions to such substances. It would not be the intention to control substances added to feeding-stuffs solely to balance the diet, that is, to replace any normal dietary deficiency, unless, in the light of experience and scientific advice, it appeared appropriate to do so. Thus, for example, the ultimate intention would be to control a vitamin used for medicinal purposes, but not one used to make up a dietary deficiency in the feed. I hope that when the hon. Gentleman has had a chance to read that 1707 he will find that it is a brief but reasonably adequate explanation of the general effect of the Bill in this respect.
Perhaps I might now deal with the major provision in the Bill, namely, the establishment of the Medicines Commission. This has had a general welcome although I thought the welcome was rather less than enthusiastic by some hon. Gentlemen opposite, particularly the hon. Member for Farnham (Mr. Maurice Macmillan). During his speech I was tempted to intervene and remind him of the genesis of the Medicines Commission, because, as a number of hon. Members have said, it started with the thalidomide tragedy.
It is also worth reminding the hon. Gentleman, and the House generally, that the Dunlop Committee itself has recommended that the provisions under which it is operating on a voluntary basis should be placed on a statutory basis. I think it is generally agreed that however well a voluntary system works, in the long run it is unsatisfactory, and it should not be continued on that basis.
The provisions of the Bill are complicated, but some of the complications arise from the necessity to provide, for example, elaborate appeal provisions so that those who may feel themselves placed at a disadvantage under the licensing arrangements can make representations to the expert Committees and to the licensing authority. My right hon. Friend in his opening speech gave explicit assurances about the flexibility with which it was intended the various arrangements under the Bill should operate, and I can only repeat them. There is no intention of using this legislation, and of course it would be an absurdity to try to use it in this way, somehow to hold back the pharmaceutical industry. It is not the intention that that should happen, or that the industry should be discouraged in its research.
A number of hon. Members raised the question of the independence of the Commission, but I think that it is the general feeling in the House that in a matter of such importance, when certain statutory responsibilities and rights are to be given to a body, it should be under the ultimate control of Ministers. I think that it would be very unsatisfactory to establish an independent body with such poten- 1708 tially wide-ranging powers, and not subject it to the normal disciplines of Parliamentary procedure. As my right hon. Friend said, we shall try to make the composition of the Commission as representative as we can. This will all be done with the co-operation of and in consultation with the various representative bodies who are interested in the establishment of the Commission.
§ Mr. English
Can we take that as an assurance that Clause 2 is open to some amendment in Committee?
§ Mr. Millan
Everything is open to amendment. At least it is open to hon. Members to try. Everyone who has an interest in either the Commission itself or in one of the expert Committees will be consulted by the Minister about their establishment.
I was asked about licensing fees. I am not able at the moment to give any indication of what the scale of fees might be, because, apart from anything else, it is a matter which will have to be discussed with the outside interests involved. I would just say that it seems to me an essential principle that licensing fees should be paid, and that we should recoup the expenses necessarily involved in that part of the legislation. The expenditure mentioned in the Financial Memorandum covers a wider field than that, but here there should be licensing fees, and we should try to recoup some of the expenditure necessarily involved. I was also asked about enforcement procedures by the hon. Member for Farnham. This can be debated at length in Committee but I should warn the hon. Gentleman before he allows his enthusiasm to run away with him that enforcement procedures are, in material respects, the same as those in section 100 of the Food and Drugs Act, 1955, for the authorities covered under that particular legislation. That happened under hon. Gentlemen opposite. This also can be dealt with in Committee.
The question of revocations was raised by the hon. Member for Nottingham, West (Mr. English). Before revocation of a licence becomes effective there is an opportunity for representations laid out in the Bill. Once revocation has happened the various powers which are available to those holding a licence under the terms of the Bill immediately cease. 1709 There is no provision for payment of compensation. This can be remedied in Committee. If my hon. Friend will direct his attention to the grounds upon which revocation will take place he will see that there is no case for compensation in those circumstances.
I was asked a number of questions about the general sales list. It is not possible to be specific because this is another matter on which we shall have the advice of an expert committee. The expert committees and the Commission itself have responsibilities to advise Ministers on all aspects of this legislation, and not just on licensing. It applies not only to the general sales list but to regulations about the retail pharmacies, advertising, the promotion of activities and so on, so we will have to await advice from the expert committee. There are probably contrary arguments. The chemists would like to make this list restrictive, but a number of hon. Gentlemen haw suggested that it should be very wide.
The hon. Member for Farnham suggested that everything that could be on sale now should be included as of right on the preliminary general sales list. That would be defeating the purpose of the new provision we are making here and obviously one could not accept that proposition. If it was satisfactory that all the products on general sale at the moment should be on general sale there would hardly be need for the introduction of the new provisions in this Bill. It must be something in between, but obviously one would expect the kind of things mentioned by the hon. Gentleman the Member for Somerset, North to be continued on the general sales list. Obviously I cannot be more precise about what the ultimate list will be at the moment. In any case, it would be wrong for me to anticipate the advice which we shall get from the appropriate expert committee.
My hon. Friend the Member for Barons Court (Mr. Richard) raised a point about the registration of shops. However, it would be an elaborate and cumbersome procedure to try to take on this very substantial registration job, apart from the registration of pharmacies. At the end of the day, I doubt if it would be of any real public benefit to do it, which is the reason why it is not included in the terms of the Bill.
1710 A point was raised about vending machines, and there are special provisions in the Bill about them. Despite what the hon. Member for Torrington (Mr. Peter Mills) said, sales by vending machines are different from sales in a shop. Vending machines are normally open to even quite small children, whereas purchases from shops are not. As a result, there are special provisions in the Bill dealing with them.
My hon. Friend the Member for Wood Green (Mrs. Joyce Butler) raised a number of points about herbal remedies. If she will forgive me, I should prefer some of them to be dealt with in Committee. She knows that we have special provisions in the Bill about herbal remedies, but obviously the details are matters which can be discussed in Committee.
Dealing with her point about wheat bran, that in itself is not a medicinal product, because its main use is not as a medicine. However, a brand of wheat bran marketed as a laxative, for example, would be a medicinal product, and that is the distinction between something sold as a food and something sold as a medicine. However, that kind of distinction will no doubt keep us profitably engaged for a considerable time in Committee.
As for labelling and promotion, the hon. Member for Farnham seemed to disapprove fairly generally of the Bill's provisions. He said that, in the pharmaceutical industry, as in other industries, there is much to be said for the discipline of the market place. That may be so as a general proposition, but I should have thought that it was strictly irrelevant, for example, to preventing medicines being sold by false and misleading descriptions, which is one of the objects of the Bill. Even the most enthusiastic supporter of the discipline of the market place would hardly argue that it gives manufacturers of medicines the right to mislead innocent persons.
There are bound to be special difficulties in the advertising of medicines. Certainly I would not go all the way with my hon. Friend the Member for South Shields (Mr. Blenkinsop) and my hon. Friend the Member for Barons Court, whom I understood to suggest that all advertising of proprietary medicines should be abolished altogether. Obviously there is a strong case for control, and I would direct the 1711 attention of my hon. Friend the Member for Willesden, West (Mr. Pavitt) to Clause 84 in relation to the kind of case that he mentioned. Obviously it would be wrong for me to mention any particular medicine, but he will see from Clause 84 that, when the licensing system is in operation and one is dealing with a product covered by a licence, any advertisement which includes a recommendation that is not covered by the licence which has been given for that product will be forbidden under the Bill. Again, that seems to be right. It is quite reasonable that manufacturers should be able to sell their wares on the basis of what they can effectively do, but it is wrong that they should try to sell their wares on the basis of making exaggerated claims.
Those are some of the points raised in the debate. This is a very difficult and complex Bill and clearly there will be a good deal of discussion in Committee. However, from my right hon. Friend's speech and from what has been said during the debate as a whole, the main purpose of the Bill has now become evident. I think that the House generally will accept that it is a useful step forward in bringing our medicines legislation up to date.
§ Question put and agreed to.
§ Bill accordingly read a Second time.
§ Bill committed to a Standing Committee pursuant to Standing Order No. 40 (Committal of Bills).