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Biological Standards Bill Lords

Volume 884: debated on Wednesday 15 January 1975

The text on this page has been created from Hansard archive content, it may contain typographical errors.

10.30 a.m.

I beg to move,

That the Chairman do now report to the House that the Committee recommend that the Biological Standards Bill [Lords] ought to be read a Second time.
The Bill has been brought from another place, where it received all-party approval, and I hope that it will receive the same all-party approval from the Committee and the House. It is a United Kingdom Bill, the purpose being to establish a National Biological Standards Board to manage, under the direction of the Ministers named in the Bill, the activities that are carried out at the National Institute for Biological Standards and Control. In practice, these Ministers are my right hon. Friend the Secretary of State for Social Services and her colleagues who are responsible for health in other parts of the United Kingdom.

The institute is at present administered by the Medical Research Council, and the Bill reflects a decision to transfer the responsibility for administration from the MRC. The decision stems from the nature of the institute's present functions, and it may be helpful if I set these out in some detail.

The institute is concerned, firstly, with the preparation, characterisation, and issue of national and international standard reference materials for a number of important therapeutic, prophylactic and diagnostic biological substances widely used in medical treatment. Since it is not immediately obvious what the expression "biological substances" implies, I should add that they include vaccines, serums, enzymes, hormones, antibiotics and blood products. The typical feature of these substances is that it is not possible to test their purity or potency by chemical or physical methods alone, and biological tests have therefore to be made. The purpose of the reference standards is to set a standard of potency and quality, by comparison with which manufacturers and the responsible authorities can test the products manufactured for release for medical use.

Secondly, the scientific staff of the institute test samples of batches of the products as a cross-check on the tests performed by the manufacturer, thus helping to ensure the quality of the product and hence related aspects of efficacy and safety. They also engage in research on problems arising out of these two main functions.

There has been a system of licensing of the manufacture for sale, and the importation, of a number of biological substances since 1927, under the Therapeutic Substances Act, 1925. At that time, the Medical Research Council agreed to undertake the scientific work relating to the setting of standards and devising of control tests for these substances, and to collaborate with the inspectors of the Health Departments, which, under the 1925 Act, were responsible—and still are—for the actual licensing of the manufacturers in securing the necessary safeguards at the manufacturing establishments.

Since those days, the enormous increase in the use of immunological agents, antibiotics and other biological substances has greatly enlarged the scope of the testing and advisory aspects of the work of the institute. Over the years, the institute has earned for itself a very high standing internationally, and the World Health Organisation has made it responsible for establishing, holding and distributing international reference standards for worldwide use for non-immunological biological substances. The international standards for immunologicals are entrusted to the State Serum Institute in Copenhagen, and those for veterinary biological substances to the Ministry of Agriculture, Fisheries and Food Veterinary Laboratory at Weybridge.

The emphasis of the work of the institute has been shifted by these developments. The establishment of new standards and methods of control testing still involves research, but a very large part of the day-to-day work is now concerned with the production and maintenance of the standard reference material and control testing of the extensive range of biological substances for human use that are now on the market, and which, like all other medicinal products, are subject to licensing under the Medicines Act 1968, for the administration of which my right hon. Friends the Health Ministers are responsible. In view of the change of emphasis, it is considered no longer appropriate for the work of the institute to be administered by a research council.

The Government consider that the administration of the work of the institute should not be the direct responsibility of the Health Ministers but assigned to a separate board, which will be subject to direction by the Ministers. This relationship is on the same lines as in the case of the Public Health Laboratory Service Board and the Radiological Protection Board. On this basis, the transfer of responsibility to a separate board has the approval of the Medical Research Council and my right hon. Friend the Secretary of State for Education and Science. The arrangement also means that the staff will not be Civil Servants.

The provisions of the Bill are reasonably straightforward. Clause 1(1) deals with the establishment and name of the board. Clause 1(2) provides that the functions of the board shall be specified in an order by the Ministers, and that they shall relate to the establishment of standards for, the provision of standard preparations of, and the testing of biological substances.

The Medical Research Council has already been consulted about the content of the initial order that would set out the functions of the board in more detail. Any future changes in the board's functions will have to be specified in an amending order. In view of its long association with the work of the institute, there would be consultation with the Medical Research Council if any such changes of the functions are required, and also with any other body, such as the Public Health Laboratory Service Board, that would be concerned with any proposed change.

Clause 1(3) requires the board to comply with any direction given to it by the Health Ministers. These directions cannot alter the functions of the board specified in the statutory order made under subsection (2).

Clause 2 enables the Ministers to appoint the chairman and members of the board. It is contemplated that there will be consultation with the Medical Research Council, the Medicines Commission and the Public Health Laboratory Service Board as to the membership. At the moment, it is thought that the board should be broadly like the joint advisory committee which, for a number of years, has acted as a sort of steering committee, advising the Medical Research Council and the Health Departments on the policy and priorities of the institute.

There would probably be a chairman and 10 to 12 members, of whom at least three would not be employees of the Health Departments, the Medical Research Council, or the Public Health Laboratory Service Board. These independent members would have wide and recent experience in connection with the standards for, and testing of biological substances or other experience relevant to the fact that the board would be accountable for its expenditure.

The Schedule to the Bill sets out further provisions concerning the board, and the terms of office of the members will be specified in the letters of appointment. Clause 2 also exempts the board from certain income tax and corporation tax requirements. This is normal practice in the case of public boards of this kind.

Clause 3 gives power to my right hon. Friend the Secretary of State for Social Services to make an order transferring from the Medical Research Council property, rights, liabilities and obligations to herself. The Council and the Department of Education and Science will be consulted before the order is made.

Clause 4 deals with financial matters, including the financing of the board out of moneys provided by Parliament and for the presentation of its accounts to Parliament. The remaining clauses are mainly formal and self-explanatory.

Finally, I should like to repeat the two assurances of importance to the staff of the institute which were given in another place. First, if the Bill is passed, the staff at present working for the institute will be offered employment by the new board. It is intended that the terms and conditions of employment for each member of the staff will be not less favourable, taken as a whole, than his or her present terms as an employee of the Medical Research Council. The terms and conditions have not yet been settled, but, as soon as it is clear that the Bill will be passed, my right hon. Friend intends to take up informally with the staff organisations the best way of proceeding with the negotiations. In this way, it is hoped to make good progress before the board is formally established.

The second assurance concerns the right of scientific staff to undertake some personal research—a right which certain members of the present staff enjoy as employees of the Medical Research Council. The Health Departments are fully aware of the importance of this type of research, and, providing it does not interfere with the basic research or the development and maintenace of standards, it is intended that personal research may continue to be undertaken.

10.41 a.m.

I share the Under-Secretary of State's welcome for this measure. As far as I can make out, he is about the seventh Minister of the Crown to stand up in one part or other of this building and commend the Bill to Parliament. They have not all been of the same party, and the Bill cannot, therefore, be regarded as particularly controversial. I understand the hon. Gentleman's half-expressed wish that we should take it "on the nod" this morning, but there are questions which we could usefully spend a few moments discussing.

But first I make a personal plea to anyone who happens to be holding a watching brief on behalf of the Leader of the House. I mean no disrespect to the Under-Secretary of State. He is not the first Minister to whom I have said this. He has this morning read substantially the same speech that was made by his noble colleague in another place. I object to being treated as though I were illiterate and did no homework. I believe that 10 minutes of parliamentary time, which has a price that could be put on it, would have been saved if we had had from someone—the Minister perhaps—a letter, before we met this morning, saying "You might find it helpful to read the speech made in the House of Lords which I shall otherwise substantially have to repeat in Committee. If you have any questions, it will undoubtedly help you to have a little time for study in advance. Where there are changes in my speech from that made in the House of Lords, it will help you to know them".

Broadly speaking, if parliamentary time is precious, I should like to make my contribution towards saving it. I first said that to one of the Minister's colleagues about seven years ago, but my words have had no impact whatsoever. Perhaps constant repetition will get through to someone. But we could save time, All these explanatory and financial memoranda and Second Reading speeches are great parliamentary time wasters, and the House should have cottoned on to the fact by now.

There is one advantage, of course, in having the Lords Hansard to one's elbow because, through its use, it is possible to detect a change—and there is a change which I will come to at once. When the hon. Gentleman was talking about Clause 2 and the membership of the proposed board, he said that the Government envisaged having about 10 to 12 members in addition to the chairman, and that at least three of them were to be so-called independent members. His noble colleague in the House of Lords said there would be about 10 members, in addition to the chairman, and that at least two members would be independents.

I should be interested to know why this change has been made. As far as I am aware, it does not follow any pressure in the other place. There may be strong arguments for making the change, and I am disposed to sympathise with the introduction of more independent members, but, at the same time, if the ratio is to be significant, I would rather see 10 members and three independents than 12 members and three independents. Perhaps a little research can be done on the hon. Gentleman's behalf so that the change can be explained to the House rather than passed over without explanation.

The second general point I should like to make is that it would be helpful to those of us who are not instantly familiar with every branch of the work of the Medical Research Council—amongst whom I have to number myself, though not, of course, my hon. Friends—if we could be told, roughly speaking, how many staff are involved in the work we are considering, how much money is spent from public funds, and what the income is from other sources. In other words, we should have something like a balance sheet to put the matter into perspective in a way which neither the explanatory memorandum nor either of the Second Reading speeches has done. If the Minister has them handy, perhaps he will give the facts to the Committee when he replies.

Two points of substance arise. In the explanatory memorandum, we are told that additional expenditure of £45,000 will result from the need to employ for the board certain staff who will not be taken over from the Medical Research Council—possibly 10 or 12 staff, which is not a significant number and not one to which the Committee will necessarily take strong objection. The point to which I am leading is: what will the Medical Research Council do with the £45,000 which it has thereby saved? Or will it go on employing these people by putting them on to other work? In which case, what other work?

Some of us have seen, with some alarm, reports that the work of the MRC is being curtailed and that the projects which it has been supporting are being reduced in number due to shortage of funds. Whether the Minister's brief this morning is to answer that particular point, I do not know, but it is a matter of some concern if work, say, with regard to cancer which the MRC has been doing, will have to be cut back because of shortage of money. This may be a small opening through which to extend the debate and if the Minister can respond to my invitation to wriggle through it, it would be interesting if he could say something about it.

The second point of substance concerns the staff. We are told that they will not be civil servants—a fact in which they may or may not rejoice. We are also told that the board shall do what the Ministers tell it. The Bill states:
"The Board shall consist of members appointed by the Ministers …"
and that
"The Board shall in the performance of its functions comply with any directions given to it by the Ministers."
If the people who work for a board which has that origin are not civil servants, the distinction may be thought to be pretty fine, because, in so far as management-labour relations are concerned, management is ministerial and governmental, and the employees must be in much the same position as if they were members of the Civil Service.

Whether the staff appreciate and welcome this distinction is what I want to inquire about, because I was rather surprised to hear the Minister say, as was said in the other place, that, when it is reasonably clear that the Bill will pass into law, the Government will have a word with the staff about its effects. I would rather have heard him say, "We've got halfway through the progress of the Bill. We did not meet opposition in the Lords and see no reason to expect objection in this House, so we have had a word with the staff and they are quite happy."

But, so far as we are told, the staff, who may or may not be following the Hansard debates, have not actually had any formal consultation as to the effects of the legislation upon them. They may be perfectly happy about it, and if there has been informal consultation with their unions and the Minister can tell the House so, I hope he will not forgo the chance to tell us, because some of his hon. Friends are pretty hot on the subject of participation and believe that employees should be consulted before managerial changes of a substantial kind take place. The Government should perhaps practise what they preach.

Finally, it would help the Committee if we could clarify the functions of the board. The passage about biological work contained in the Minister's brief was more closely and tightly-defined this morning than it was in the other place, as he dealt with biological substances for human use. There was there a bit of precision which was not in the brief in the other place.

The question which was asked in the other place, and remained unanswered, was whether biological substances of a therapeutic kind were involved. In the preliminary ramblings, there was even some mention of biological washing powders. I do not know whether this powerful new body will concern itself with those things which we are always being told on television do our smalls so much good, but it would be useful to know exactly how far the board is concerned with what one might call "commercial" as opposed to "medical" substances, and following from that, what its income is from manufacturers in this country and from international sources. I read somewhere that it did some work for the World Health Organisation.

If the board is to be capable of earning fees and charges and offsetting the cost of public funds which it represents, I welcome that very much and hope that this side of its work in current economic conditions will be extended and encouraged. I hope that there is the closest possible liaison with, for instance, the National Research Development Corporation, so that any new substances or new techniques which are developed as a result of official or private work by the employees of the board can be exploited to the best advantage through the well-known NRDC processes.

I will not pretend that any of these questions are of an immensely critical nature and that if I am not satisfied on them I shall divide the Committee or anything quite so extreme, but, subject to them, I share the welcome which the Minister has already given to the Bill and add my name as eighth in line to do so.

10.52 a.m.

I see no objection to the idea that the Bill seeks to put into operation. If the operative staff of the MRC engaged in this division of its activities are merely going to be transferred en bloc and continue to function in their new guise as they have been functioning, I imagine that the only possible objection can be that it must increase the total overheads by having to institute a board with its pay, premises, and other emoluments and expenditures. This proposal may entail expenditure and an increase in overheads which is justifiable, but Parliament will have to see it justified.

You, Sir Alfred, and I are formally interested in this subject, and I am sure that we and the Committee as a whole would probably like to have some idea of the nature of the work by being told by the Minister what projects are afoot at the moment. Obviously, he cannot tell us what projects will be afoot by the time the Bill becomes an Act, but I should like to know, in order to have a measure of the scale of the work, how many and what major projects are now officially being undertaken.

The splitting away of this function from the Medical Research Council does, of course, open up a division which has not, presumably, previously existed between the biochemical and biological work being done under the MRC, possibly on the same project. Presumably, the biological work involves laboratory animals and animal products, on which work is done.

One thing is not clear to me, and I daresay it may not be clear to the Committee as a whole either. Is the chemical work on a project still going to be done under the provisions that remain under the MRC, and the biological work done under this new institution? It seems to me that there is room for a certain amount of rivalry and division, and, perhaps, a loss of efficiency, if this outfit is not to carry out chemical work but only biological work Therefore, if it is allowed to carry out bio-chemical work, is not it unnecessary to break it away from its parent organisation?

Those are the thoughts that worry me somewhat in wondering about the efficacy of the budding-off of this organisation from its former parent organisation.

Another point upon which I should like to be enlightened concerns the National Institute of Biological Standards and Control, which is to become the new body that we are setting up. Does this institute itself do any research work? That has not been made clear to me. Is it, in fact, a body which only deals with assay and standardisation? Or does it carry out biological research work in the course of needing to set new standards, as I imagine might well be necessary? There must be background research before any standard can be enunciated. Therefore, I should like some clarification on that particular point.

I do not think that these are particularly abstruse matters, and I feel that it would be for the benefit of the House of Commons and the public if we were to have a little enlightenment in the answers to the questions that I have put. Beyond that, I see no reason why anybody should need to object to the Bill, and I certainly do not.

10.57 a.m.

I know nothing of biological standards, and I know nothing of the detail which the Under-Secretary of State has gone into. I merely want to make two observations, both of them propaganda points in their own way.

Hon. Members may now be saying to yourselves, "Why do these Irishmen always manage to make propaganda points out of any legislation that comes into force here?" Having received notice of being a member of this Committee, I did the only sensible thing and contacted the pharmacy department of Queen's University, to be told by Professor D'arcy that the director of the National Institute was a distinguished graduate of that body and had done tremendous work in this subject. Therefore, I briefly want to pay tribute to a Northern Irishman—whom Britain would not, perhaps, be keen to exclude—and his colleagues for their work in this area.

I also want to enlarge upon what was said about the commercial contribution which this board can make. I learned that in 1973 the National Institute sent 97,800 samples all over the world to 1,000 laboratories in 56 countries. That in an immense contribution to world health. It is done completely free of charge, and far from wishing to see the new organisation taking some financial advantage from that situation, I should like to see it continued and extended.

I must confess that I am overwhelmed by the rather complicated and unusual questions which have been put. I appreciate the point made by the hon. Member for Woking (Mr. Onslow) that he might have found it convenient if I could have dealt with it in a different way. Similarly, I would have found it convenient if he could have given me some notice of the questions that he was proposing to raise. Nevertheless, I shall do my best to deal with the questions raised.

I was asked about the membership and size of the board. I do not think there is any major differences between what I have said and what my noble Friend said in the other place. He was talking about a board which would have about 10 members. If I said 12 members, I should not have thought that there was a tremendous significance. Twelve is about 10. There is no significant difference in the size. No final decision has yet been made as to the exact number, but that is the approximate number we are aiming for.

There is, however, a difference, as the hon. Gentleman correctly noticed, in the number of independent members. We are considering adding a third member in order to bring in a member with some business and accounting experience in view of the board's public accountability as an autonomous organisation. I am sure that this will appeal to the hon Gentleman. It is desirable that there should be someone with that sort of experience.

The hon. Gentleman asked for some information regarding the staff size. The present staff number some 200, of whom 40 are highly-specialised scientists, some being medically qualified. There are 88 supporting technologists, including some graduates. The remainder are secretariat, clerical, maintenance and other kinds of ancilliary staff.

The hon. Gentleman also asked for some information about the budget. The present budget for the year 1974–75 is approximately £900,000. About two-thirds of that expenditure is borne by the Health Departments and the rest by the Medical Research Council.

When the board takes over, practically the whole of the costs will fall on the Health Departments, with an adjustment in respect of the Department of Education and Science's budget, which will be taken into account.

The hon. Gentleman then asked about the added expenditure and why it was needed. If functions are being transferred from an existing body to a new body, one cannot transfer exactly the right people because there are some people in the Medical Research Council who are carrying out certain clerical functions on behalf of the new body. We envisage that the board will find it necessary to engage a small number, probably not more than 10, of administrative, clerical and ancillary staff. We expect that it will mean an additional cost, at present rates, of about £45,000 a year.

I do not think I asked what these people would do. I asked what will be done by the Medical Research Council with the £45,000, and the staff resources which are offsetting savings with regard to the Medical Research Council. Will the money be spent on other things? Or will it represent an absolute saving in expenditure?

I am not really in a position to give an answer as to what the Medical Research Council will do. I cannot envisage that it will mean a total saving. There will be a minimal saving. We are talking about £45,000. With any body I should have thought that there is bound to be some additional cost which is not part of the present MRC set-up.

The hon. Gentleman was very concerned about the staff position. He wanted some assurance that we had had some consultation with the existing staff. I can assure the hon. Gentleman that the staff are quite happy at the prospect. They have made that clear informally. We could not make any formal approaches because we had no authority, but informally they do not wish to be civil servants. The MRC staff negotiating committee concerned with the institute was told about the proposals at an early stage and was formally advised of them. The terms and negotiations have still to be negotiated when the new board is set up. I can assure the hon. Gentleman that we have kept the staff in the picture all along the line, and there is every indication that this proposal meets with their approval at present.

The hon. Member for Fareham (Dr. Bennett) asked for some indication of the present and future projects being undertaken. The major current control projects are in viral vaccines for polio, measles, rubella, and influenza and there are also projects dealing with antibiotics and hormones. New projects are coming along dealing with blood products and diagnostic reagents. That should give some idea of the type and nature of the work at present being undertaken.

Then the hon. Gentleman asked where the chemical work was to be done. There will be a small chemistry section in the National Institute for Biological Standards and Control. Its future dependence on the National Institute for Medical Research will be negligible. The hon. Gentleman asked whether the institute could deal with non-medical biological substances. It will not do so.

The hon. Gentleman also asked about the research work done by the NIBSC. It does do research prior to the setting up of new standards. It is an essential part of its functions, which it will continue. These functions are covered by Clause 1(2), and there is clear provision for it to continue with the type of research which it considers necessary.

The hon. Gentleman also spoke about the cost of the board itself. I must make clear that there is no intention that there should be paid members of the board. Though the Bill does give powers to make a payment, the schedule says:
"The Board shall pay to its members such remuneration and allowances (if any)…"
It is certainly not the intention that it shall be a paid board. The Government have merely taken powers. Thus, if developments over the years show the need for payment of some attendance allowance, or something of that nature, we should not need to come back for fresh legislation.

The premises are at present located in the MRC laboratories at Mount Vernon, Hampstead. It is envisaged that they will continue there. If there were a need for considerable expansion—which is not easy to foresee at present—we would then find ourselves in some difficulties in extending the size of the buildings on that site, but at present it is intended—

Clearly, that is possible, but what will happen with a new board? There is bound to be a board office staff, which is entirely new. Will that be put into extensions at the MRC headquarters?

At present, we do not envisage the need for any extensions of buildings or anything of that nature. In fact, the number of additional people is about 10 clerical-type staff. For the present workload, such provision would not be necessary. But, of course, one can give no assurance about what will happen in five or ten years, because that will depend on the workload and the changing nature of the work being undertaken by this body.

11.10 a.m.

By leave of the Committee, Sir Alfred, I thank the Minister for doing his best to answer the questions—a competent best in the circumstances.

I think the Minister sympathises the more strongly with my point about advance notice. I see absolutely nothing unparliamentary in the proposition that it would help all concerned if we had an opportunity to formulate questions in advance and, on a non-controversial matter, to give notice of what they might be. There is no political advantage in catching the Minister out on occasions like this. We simply want to get the information which interests us as quickly and as conveniently as we can. I very much hope that anyone who takes an interest in these matters from the point of view of the Leader of the House and the procedure in general might care to ask the Leader of the House to have a look at the exchanges on this point.

For the rest, I can understand the Minister's reluctance to be drawn on the work of the MRC on this occasion. I assure him that it is something we shall want to come back to, and there are sure to be plenty of other opportunities.

I am grateful to the Minister for saying what he did about the staff, and I am very glad to know that they have been taken along throughout. It is unfortunate that that was not specifically stated in the opening speeches. It would have saved time and given us reassurance if we had been told it straight out.

On the question of the size of the board, I think that if the Minister has another look he will find that it is not totally coincidental that the increase in the number of independent members from two to three has been matched by scope for an increase in the size of the board from merely 10 to "10 or 12". I detect in this the usual anxiety of the official side to maintain a majority for itself. I do not know that the Minister and I would necessarily agree if I went further on that, but he will, I hope, bear in mind that independence may be no disadvantage where the deliberations of this body are concerned, and that to have at least three independents in a board of only 10 may be to the general public advantage. I hope that that is how it turns out.

Subject to these comments, I am grateful to the Minister and have no hesitation in supporting the Motion.

11.13 a.m.

I am sorry that I did not refer in my reply to the hon. Member for Armagh (Mr. McCusker). I meant no

Broughton, Sir Alfred (Chairman)Jones, Mr. Alec
Bennett, Dr. ReginaldLomas, Mr.
Callaghan, Mr. JimMcCusker, Mr.
Cohen, Mr.Moonman, Mr.
Coleman, Mr.Onslow, Mr.
Davies, Mr. BryanRoderick, Mr.
Gardiner, Mr. GeorgeStradling Thomas, Mr. John
Hatton, Mr.Taylor, Mrs. Ann
Irving, Mr. Sydney

discourtesy. Like him I share a delight that people from his part of the world and mine make a considerable contribution to the combined efforts and work of the United Kingdom.

I take the point made by the hon. Member for Woking (Mr. Onslow), and I give him the assurance that, although arrangements which the Leader of the House may be able to make will not be my responsibility, on any occasion that he and I are across the table we will have the sort of discussion that he talked about.

Question put and agreed to.


"That the Chairman do now report to the House that the Committee recommend that the Biological Standards Bill [Lords] ought to be read a Second time."

Committee rose at thirteen minutes past Eleven o'clock.