HL Deb 05 February 1974 vol 349 cc730-9

3.38 p.m.


My Lords, I beg to move that this Bill be now read a second time. Before starting my speech, I should like to apologise to the House if I am at any stage slightly inaudible due to some catarrh, but. I hope that the House will find me sufficiently audible.

My Lords, the object of the Bill is to establish a Board which would be responsible for a range of activities relating to standards for, and control testing of, biological substances, activities which for many years have been carried on by the Medical Research Council. Before describing the particular provisions in the Bill, I should like to tell the House about the background of the legislation. May I begin by asking two rhetorical questions about this Bill. First of all, why is further legislation necessary? Is a new Statute the only way of bringing about what we want? I have here a copy of the Medicines Act 1968, a weighty volume indeed. I also have a copy of the Therapeutic Substances Act 1956. It occurred to me that by examining these two Statutes it might be possible to create what my right honourable friend the Secretary of State for Social Services desires to do, which is to establish a Board.

My right honourable friend seeks to create a corporate body with powers, functions and responsibilities associated with that body. It is a completely new animal, a new watchdog. However hard you breathe on Section 4 of the Therapeutic Substances Act 1956, it cannot produce a new animal. The same applies to the Medicines Act in the opening section. Secondly, in reply to my other rhetorical question, whether the only way to do what is required is by means of a new Statute, alas! the answer is, yes. There must be a new Statute. It cannot be created by order.

With those two obscurities out of the way, there are still two more, because in going through the Printed Paper Office I saw that, like Tweedledum and Tweedledee, there are two Bills—one named the Biological Substances Bill and the other the Biological Weapons Bill. They are both of the same sin, colour, shape, et cetera. I should like to dispose of this difficulty at the first go by stating that the two Bills are in no way connected. The Biological Standards Bill, with which we are dealing, has no connection whatever with the Biological Weapons Bill which is concerned solely with the prohibition of manufacture. The strongest possible reason for my right honourable friend's decision to introduce this Bill is to create the right framework over the next generation of 25 years or so for the administration of what is required—the control of biological standards. Among his many responsibilities is to collaborate with the World Health Organisation, the European Pharmacopoeia Commission and other international bodies in relation to standards for testing of biological substances.

At this point we can set up another 15 feet of aerial and tune in to the international wave length. As to the word "pharmacopoeia", for those outside the medical profession one should define what that word means. I am not a doctor, and it struck me that I might not be alone in this and that your Lordships might wish to have some definition. I at once went for a definition which a layman could understand and I found it in the Encyclopaedia Britannica. With your Lordships' permission—it is worth reading; it is only a few sentences—it reads as follows: Pharmacopoeia—government publication to provide for standards of identity, quality and strength for those medicinals which represent the best practice and teaching of medicine. The primary function of a pharmacopoeia is to describe each drug on the approved list in such a way that whenever dispensed it meets the standards of quality and strength established for it. The provisions of the pharmacopoeia in force are binding on all who produce drugs and those who dispense them. The pharmacopoeia is a fundamental safeguard to public health.


My Lords, if the noble Lord will forgive my interrupting, although this will not appear in Hansard, I believe that the correct pronunciation is pharmacopoeia and not to rhyme with cornucopia.


My Lords, I apologise for an inaccuracy in pronunciation. This at once reveals my inadequate training in this particular field.


My Lords, would the noble Lord like to take further advice about this at some other time? Medical pronunciations are by no means reliable.


I would thank both the noble Lord, Lord Segal, and the noble Lord, Lord Platt, for their kind advice in this field. I am greatly reassured by those statements. It also occurs to me that the oldest pharmacopoeia would be of some historical interest, because what is intended by the Government to be done through this Bill is in direct line with a very ancient and honourable profession. The noble Lord, Lord Kennet, I am sure, is already aware that the oldest is a tablet of stone constructed in ancient Babylon about 1700 B.C. The first European pharmacopoeia was the Florentine nuovo receptaris, 1948 and the Danish pharmacopoeia—with which we are especially concerned—was established in 1772 and is the oldest one in continued existence.

That brings me to our European partner in this connection—Denmark. It is of great significance that our Danish colleagues are so much concerned with this country in the same field because international standards for immunological substances used in human medicine are the responsibility of the State Serum Institute in Copenhagen. On all fours with our Danish colleagues, veterinary medicines —both immunological and non-immunological substances—are the responsibility of the Central Veterinary Laboratory at Weybridge.

With that introduction of the situation, I now turn to the Bill itself and the activities of the new Board to be established by this Bill. The activities which the new Board will perform are essential to the arrangements for securing and maintaining the quality of a range of substances that play a vital part in the diagnosis, prevention and treatment of disease. They include insulin—on which sufferers from diabetes depend—vaccines and other immunological products used for the prevention or treatment of diseases such as poliomyelitis, diphtheria, small pox et cetera and a variety of other therapeutic and prophylactic agents. The common feature of all these is that their potency needs to be standardised; there has to be a high degree of freedom from contamination from pyrogens, bacteria, viruses and other infectious agents. They cannot be characterised adequately by chemical or physical methods.

Here I wish to draw a very strong distinction between the medicine of the ancient world—which was the pharmacopceia I have referred to on the tablet of stone—and the new pharmacopoeia which has arisen entirely due to the new methods which have come about since the latter half of the nineteenth century and the early half of this century: antibiotics, penicillin, all the drugs with which we are in constant touch to-day but which perhaps can be seen by amateurs such as myself as very difficult to measure in a precise and exact way, which have a definite form. Thus, the biological standards must be set in a way which is acceptable to the international community.

At the present time, the importance of these activities to the responsibility placed by Parliament on Health Ministers under the Medicines Act 1968, which I have shown your Lordships already, and formerly under the Therapeutic Substances Act 1956, will be evident to the House. At the present time these activities are carried on at the National Institute for Biological Standards and Control, which is located mainly in the Medical Research Council Laboratories at Hampstead. There has been a transfer of function recently, and they are located partly at Hampstead and partly at Mill Hill.

The M.R.C. has been associated with work on standardisation and control of biological substances since the 1920s. At that time, the Therapeutic Substances Act 1925 made Health Ministers responsible for a system of licensing of manufacture for sale or importation of a short list of biological substances. As the Health Departments themselves had not the necessary facilities and expertise, the M.R.C. carried on the essential standardisation and control work associated with the licensing of manufacturers and importers by the Health Departments and their inspection of manufacturing premises. With the extension—and this is the important thing—of scientific and medical knowledge in this field in the last thirty years, and with the resulting increase in medical use of immunological agents, such as antibiotics, and other biological substances, the scale of work has greatly increased. This is really the whole reason behind the introduction of this Bill.

The M.R.C. has been made responsible by the World Health Organisation for establishing, holding and distributing international standards in worldwide use for non-immunological biological substances and now—although the development of new standards and methods of control testing still involves research—a very large part of the day-to-day work of the Institute relates to the maintenance of standards and control testing necessary to enable the Health Ministers to fulfil their statutory obligations under the Medicines Act in respect of biological substances.

My Lords, enough of the background; enough of the substance of the Bill. The Bill itself is drafted in such economical terms as to be self evident. The Secretary of State is empowered to appoint a chairman and members of the Board and it is the intention of the Health Minister, before appointing the Board and its chairman, to consult the Medical Research Council, the Medicines Commission and the Public Health Laboratory Services Board. A decision on the exact pattern of membership has not yet been taken, but it is expected that there will be about ten members in addition to the chairman and that it will be broadly similar to the existing Joint Advisory Committee, the chairmanship of which was recently accepted by Lord Sandon. I am very glad that he has accepted this appointment and I think it is extremely welcome that he has done so in advance of the Royal Assent to this measure. The Board will be appointed as soon as possible after the Bill receives the Royal Assent and under Clause 1(3) will be directed to draw up, after discussions with representatives of the staff, and subject to the approval of my right honourable friend and the Minister responsible for the Civil Service, suitable terms and conditions of service.

Clause 3 enables provision to be made by Statutory Order to transfer property, rights, liabilities and obligations from the Medical Research Council to the Secretary of State for Social Services. The detailed content of this Order cannot be stated at the present time. Clause 4 is financial and the remaining clauses are briefly described in the Explanatory and Financial Memorandum at the front of the Bill.

I fear that I have taken up too much of your Lordships' time, but in conclusion I would say that it is the belief of the Government that this Bill will ensure the successful working of an important part of the health safeguards. Although this forms a very small fragment in the total remit of my right honourable friend, I feel it is a significant one in that the Statute, if and when it reaches the Statute Book, will form some part of a great mosaic in that universal world object of the relief of suffering.

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

3.54 p.m.


My Lords, I should like first to congratulate the noble Lord, Lord Sandys, on what I think is his first Bill from the Dispatch Box. If he handles them all with so much grace and such leisurely efficacy the House will benefit thereby.

We on this side of the House have no objection to this Bill. Indeed, if one may make an ideological point for a moment, we are glad to see the Government hiving something on, and the pleasure we take in that is not outweighed by the increase in Government expenditure and the increase in the Civil Service which the Explanatory Memorandum quite frankly owns up to. All this we think can be justified. We have no objection to the Bill, although I must say that it is something that would not have occurred to us, because when you come to examine it the function clearly is not research it is a public service and there is no reason why the Medical Research Council should carry out a general control service. It seems to us that it would be just as well, or better, done directly under the control of the Secretary of State.

I have only two questions to ask about the Bill. First, in regard to the staff who are to be transferred, I think it is customary, when there is a switch of staff from one Government Department to another or from one Government dependent agency to another, for the Government to give an assurance that nobody will be made worse off thereby. I hope the noble Lord will find it possible to give that assurance to the House this afternoon.

The second point is that we are glad to see from the Bill two things, to one of which the noble Lord referred in his speech but not the other. The first is that the Secretary of State is to consult the Medical Research Council in setting up the new Board and appointing its Chairman. That is good. The second is, if I read the Bill aright, that there is to be a Medical Research Council member on the new Board. Perhaps the noble Lord can confirm that, because it is obvious that when a function is switched from patron A to patron B continuity can effectively be assured by patron A appointing representatives to the new structure under patron B. Having said that, my Lords, I repeat that we quite welcome the Bill and have no objection to it as a general measure.

3.56 p.m.


My Lords, I, too, welcome this Bill as a necessary and useful measure, part of a general move to place research of the more service type—although not entirely service activity—under the auspices of the Department rather than those of the Medical Research Council. As a former member of the Medical Research Council I thought I might, quite shortly, say one or two things. The noble Lord referred to rhetorical questions, and he also referred to the new Board as being a corporate body. May I ask him to tell us at sometime what is an "incorporate" body? That is something which has always worried me, though as your Lordships will realise it is not a very serious point. The noble Lord, Lord Kennet, has asked for an assurance, which is, as he said, quite normal in circumstances of this kind, that staff who are transferred to work under the new Board will at least be no worse off in their terms and conditions of work than they were under the M.R.C. Secondly, it has been put to me by some senior members of the Medical Research Council with whom I have discussed this matter that a man who is doing medical scientific work usually does better work—and, indeed, you get a better man—if he has some freedom to pursue a line of his own. One would not expect him, working in this new department, to pursue a line of research totally removed from the kind of work that goes on in the department. But we wondered whether the Minister could give any information as to whether a scientifically qualified or medically qualified—or both—person would be allowed to apply for funds, either from the department itself or from the M.R.C. or from the various bodies who support medical research, to pursue a line of research under the general direction of the Director, who would naturally not want it to take up so much of his time that he was unable to do his normal duties. We thought that this point was worth airing in this Second Reading debate.

Then, supposing the functions of this Board do materially change—it takes on new duties or sheds some old ones—we thought it might possibly be written into the Bill, or at least that the Minister might give us an assurance, that in those circumstances the Medical Research Council will be consulted. But if the Minister makes it quite clear that there is always to be a member of the Medical Research Council on the Board it may be that such an assurance is unnecessary.

Finally, I do not always read Acts of Parliament very carefully, neither do I always understand them if I do try to read them. But I think I understand that the Therapeutic Substances Act 1956 still covers some of the duties which will be undertaken under this new Board. If I am right in that, does it worry the Minister or the Government at all that biological standards and the testing by biological means, which is what the Bill is concerned with, apply not only to therapeutic substances nowadays? They are not all substances which are going to be used in the treatment of disease. Some are, if you like, cunning biological, medico-scientific devices for testing the function of certain organs which may, for instance, be stimulated by a certain stimulus derived from a living animal, and therefore biological. They are used as diagnostic test and not necessarily for therapeutic purposes. Whether that refinement of definition is or is not worth pursuing I am quite happy to leave to the Ministers to consider. That is all I need say.

4.1 p.m.


My Lords, first of all I should like to thank the noble Lord, Lord Kennet, for his kind and welcoming remarks to my first introduction of a Bill to your Lordships' House from this position. May I answer the two questions which he asked. Firstly, in relation to staff transferred, yes, my Lords, this is a highly important matter. I wonder whether it would be suitable if I quoted here a clause which occurs in the standard form of employment of those at present employed by the Medical Research Council. It reads: The terms and conditions of service and provisions relating to pensions for the staff will be not less favourable, taken as a whole, than the existing terms of service and pension arrangements applying to them as employees of the Medical Research Council. I would take that expression "not less favourable, taken as a whole" as highly important and significant here; I think that we should underline it twice in redink. If that is correct as an interpretation, I would say the staff would be in a position to say, "Well, the terms may be different, but taken as a whole they will be similar in all respects, and possibly even better".

My Lords, as regards the consultation of the Medical Research Council before the drawing-up of membership of the Board. I think in regard to those noble Lords who have spoken that I should express a general statement on the composition of the Board. This might put the minds of the noble Lord, Lord Platt, and the noble Lord, Lord Kennet, at rest at the same time. A decision on the exact pattern of membership has not yet been taken, but it is expected there will be about ten members in addition to the chairman, of whom at least two will be "independent" members in the sense of not being employed in the Health Departments or employees of the Medical Research Council or the Public Health Laboratory Service Board. They would have wide and recent experience in connection with the standards for and testing of biological substances.

Most of the other members of the Board would be selected with the Health Departments responsible in mind, while providing for full expression of the views of the Medical Research Council, the Public Health Laboratory Service Board and the Medicines Commission. This broadly continues the pattern of the existing Joint Advisory Services Committee which, during the past three or four years, has advised the Medical Research Council and the Health Departments on policy and priorities, and the running of the Institute while it is still being administered by the Medical Research Council. I hope that is a reasonable answer to the questions of both noble Lords.

My Lords, the noble Lord, Lord Platt, asked me five questions and I will answer them as briefly as possible. He asked a humorous question on the corporate body which I think should be referred to the noble Lord, Lord Conesford, as an etymological point. The second question on conditions of employment I have already answered. Thirdly, on the point about scientifically qualified persons engaged in research, I think I should refer that to my Department and write to the noble Lord, Lord Platt, about it.

I have already answered his fourth question on the Medical Research Council member on the Board. With reference to the Therapeutic Substances Act 1956, the functions of the new Board cover diagnostic, therapeutic and prophylactic substances. The refinement of definition is a little difficult, but if that information is sufficient to satisfy the noble Lord, well and good. If not, I shall be only too happy to make further inquiries and advise the noble Lord, Lord Platt, accordingly.

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