HL Deb 21 November 1974 vol 354 cc1170-80

5.40 p.m.


My Lords, I beg to move that this Bill be now read a second time. This Bill is identical with the Bill which I introduced on July 25, and which was expected to have its Second Reading after the Recess; but its progress was interrupted by the prorogation of Parliament and the General Election. Apart from some minor changes it is, in fact, the same as the one to which the House gave a Second Reading, with all-Party approval, on February 5 during the time of the Conservative Government, but which fell when that Parliament was also prorogued. I hope, therefore, that your Lordships will be willing to give it your approval to-day so that it can be examined in Committee and, I hope, pass through its remaining stages by the end of the year, or early in January.

The object of the Bill is to set up a board, to be called the National Biological Standards Board, to manage, under the direction of the Ministers named in the Bill, the activities of the National Institute for Biological Standards and Control. The Institute is at present administered by the Medical Research Council, and its laboratories are housed at Mount Vernon in Hampstead. It is concerned with the preparation, characterisation and issue of international and national standard reference materials for a number of important therapeutic, prophylactic and diagnostic biological substances which are widely used in medical treatment. They include blood products, hormones, enzymes, antibiotics and vaccines. The scientific staff of the Institute undertake and advise on the quality control of these substances as produced by commercial manufacturers, thus helping to ensure their efficiency and safety. They also engage in research into problems arising out of these two main functions.

The Bill reflects a decision to transfer the responsibility for the administration of the work of this Institute from the Medical Research Council, a decision arising from the nature of its present 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 lime the Medical Research Council agreed to undertake the scientific work concerning the standardisation and control of these substances, which involved the evolution of new standards and tests, and to assist the Health Departments, who have always been responsible for the actual licensing of the manufacturers and importers, in the inspection of manufacturing premises. 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. As many of your Lordships will know, the Institute has earned itself a very high standing in the international field. The World Health Organisation has made it responsible for establishing, holding and distributing international standards for worldwide use for non-immunological biological substances.

These developments have changed the emphasis of the work of the Institute. The development of new standards and methods of control testing still involves research, but a very large part of the day-to-day work now involves the maintenance of standards and control testing of the extensive range of biological sub- stances that are now on the market and which, like all other medicinal products, are controlled under the Medicines Act 1968, for the administration of which my right honourable friends the Health Ministers are responsible. In view of the change of emphasis, it is no longer appropriate for the work of the Institute to be under the control of a research council. It has seemed appropriate to the Government that administration should be made the responsibility of a board, on the same lines as the Public Health Laboratory Service Board and the Radiological Protection Board, under the direction of Ministers, rather than that it should be placed directly under the Ministers. On this basis, the transfer of responsibility to a separate board has the approval—and I want to emphasise this—of the Medical Research Council, and my right honourable friend the Secretary of State for Education and Science. The staff of the board to which I have referred will not be civil servants.

The provisions of the Bill are quite straightforward, and with your Lordships' permission I will give only a brief summary of its contents. 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. Any future changes in the board's functions will also have to be specified in an order. The Medical Research Council have already been consulted on the content of the initial order setting out the functions of the board, and in view of their longstanding interest in the work of the Institute we should wish to consult them if any future changes of function are required, and also any other body (such as the Public Health Laboratory Service Board) that would be concerned with any proposed change.

Clause 2 enables the Ministers to appoint the chairman and members of the board. Naturally there will be consultation with the Medical Research Council, the Medicines Commission and the Public Health Laboratory Service Board as to the membership of the new board. At the moment we envisage that there would be about ten members in addition to the chairman, of whom at least two members would be "independent". That is to say, they would not be employees of the Health Departments, the Medical Research Council or the Public Health Laboratory Board. Such a board would broadly resemble the non-statutory joint advisory committee which for the last few years has acted as a kind of steering committee, advising the Medical Research Council and the Health Departments on the policy and priorities of the Institute. The Schedule to the Bill sets out further provisions concerning the board, and the terms of office of the members who will be specified in the letters of appointment. Clause 2 also exempts the board from certain income tax and corporation tax requirements.

Clause 3 gives power to my right honourable 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 Medical Research Council will be consulted on the order. Clause 4 deals with financial matters and the remaining clauses are largely self-explanatory.

My Lords, there are two assurances that I should like to give to the staff of the Institute. They repeat assurances that were given in February in reply to my noble friend Lord Kennet and the noble Lord, Lord Platt. The transfer of responsibility from the Medical Research Council to the new board means that the staff concerned with the work of the National Institute of Biological Standards and Control will be invited to become employees of the new board. Naturally, the staff are anxious about their future position. I should like on behalf of my colleagues to assure each existing member of the staff of the Institute that he—and in this respect "he" includes "she"—will be offered employment by the new board on terms not less favourable to him, taken as a whole, than his present terms of employment under the Medical Research Council. The actual terms and conditions of the staff have not yet been worked out. They will be the subject of discussion between the board and the staff organisations before any offer is made. It is the intention of my right honourable friend the Secretary of State to approach the staff organisations informally as soon as it appears that the passage of the Bill is assured, to discuss how these matters should be handled so that the maximum progress can be made in anticipation of the appointment of the new board.

The second assurance relates to the personal research work in which certain members of the existing scientific staff have the right as employees of the Medical Research Council to engage. Research in connection with the development and maintenance of standards is one of the normal functions of the Institute. It is intended that, quite apart from this, personal research on matters not directly related to the Institute's work can be undertaken, provided that the board is satisfied that it will not encroach on the primary work that the board has to carry out. It is recognised by the Health Departments that personal research work can be a stimulus to the scientific staff and of benefit to the general standard of the work of the Institute.

The Government are sure that the establishment of the new board will give to the work of the Institute a new identity and enable the high standard of this work both here and abroad to be maintained. My Lords, I beg to move that the Bill be now read a second time.

Moved, That the Bill be now read 2a.—(Lord Wells-Pestell.)

5.53 p.m.


My Lords, the House will be grateful to the noble Lord, Lord Wells-Pestell, for explaining in great detail the purposes of this Bill which has been before your Lordships' House twice already in the last nine months. I feel it would be excessive if I dwelt too long upon it because your Lordships will already be familiar with its general purpose, but there are still certain matters which it would be right, in our view, and with your Lordships' permission, to investigate a little further. In the first instance, I think it has been recognised that this is a Bill which concerns public health in a very wide field, covering not only the national but the international immunological sphere, and therefore it has, of course, very wide public regard. In so far as this House is concerned, the specific points which I should like to raise concern especially matters related to the techniques which are to be applied in the Bill.

I should like to take up with the noble Lord, Lord Wells-Pestell, two or three matters in respect of which the present Bill differs from the one which was placed before your Lordships' House earlier this year. It is a matter of some interest to us, first of all, that this is the first time—certainly it is the first time I have seen it—that an Explanatory and Financial Memorandum, which contains important information, is not bound with the Bill. I hope that the new loose-leaf, do-it-yourself version, will not become a permanent feature of Parliamentary Bills to be presented. This is of some concern, and some of us have had difficulty is associating the one with the other. Secondly, there is some very important information on the back, and I think we ought to congratulate the Government on making a saving of £15,000 a year on the present staff ratio in establishing this Board. Without saying more on that, I would pass to the principal provision and the principal differences which I feel should be brought before your Lordships.

One difference is that under subsections (3), (4) and (5) of Clause 2 there are certain financial provisions which are new in the Bill. It will be of some interest that the Board is entitled to exemption from income tax and corporation tax. These are matters which one would have thought would be automatic anyway, and I merely mention them. Schedule B concerns woodlands, and no doubt in the leafy glade of Hampstead where the Board is to acquire certain properties this is perhaps of almost academic interest. Nevertheless, the exemption is allowed and this is something which has been given to provide total coverage. The Finance Act 1895 is referred to in regard to the transfer of property on conveyances. This, once again, is a belt and braces measure and I am sure we find it entirely acceptable. Those are the only two points which differ from the original Bill.

The main concern, my Lords, should be in regard to the staff and this is where I should like to make my principal remarks. It will be obvious to your Lordships that some disturbance of the lives of those concerned in this important activity will take place. Naturally, it will be your Lordships' wish to see that the transfer from the Medical Research Council to the new body should be as smooth and easy as possible for all concerned. Therefore, it was of great interest that the noble Lord, Lord Wells-Pestell, was able to give us an assurance that not only would the staff not be (and I stress the words "not be") civil servants under the new body, but that, and I quote his exact words— each member of staff will be offered I think he said— employment by the new Board on terms not less favourable to him taken as a whole than his present terms". However, this causes us some concern, because the phrase, "taken as a whole" might give rise to a suspicion that the pension terms or the terms of present employment in the staff structure might he varied. I should like to ask the noble Lord, Lord Wells-Pestell, whether he can give us some more information in this regard. It is quite clear that in the new Board, established as it will be in two places—Hampstead and Mill Hill—there will be some variation in the staffing structure.

My Lords, in welcoming the Bill as a whole, which is a measure which comprises only five pages, I feel that we should not dwell too long on what appears to be a small matter. Nevertheless, it is of great national and international concern and we should like to thank the noble Lord, Lord Wells-Pestell, for bringing it before your Lordships at an early stage, and for the third and perhaps last time it will reach the Statute Book successfully.

6.1 p.m.


My Lords, my noble friend, in proposing the Second Reading of this Bill, has given an explanation of its purposes which I think I follow perfectly well, but, in fact, the Bill is drawn in very much wider terms than the noble Lord covered. He said that it was to deal with therapeutic substances, but I cannot find anything in the Bill which confines it to therapeutic substances. It may conceivably be good if it extends to other than therapeutic substances. I believe, for example, that large quantities of washing powders which contain enzymes are now sold, which obviously are biological substances within the scope of the Bill.

Not only is the Bill drawn in extremely wide terms in so far as it purports to relate to biological substances of all kinds for whatever purpose they might be used but also the operative part, subsection (2) of Clause 1, is drawn in very wide terms. It provides for the Board to have three functions: one is in relation to the establishment of standards of biological substances; the second is the provision of standard preparations of biological substances and the third is the testing of biological substances. The second of these functions appears to indicate that the Board could have powers to manufacture and to sell biological substances to any extent whatever that the Minister directed. I do not know whether or not that is the intention that lies behind it, but it appears to tie up with the provisions exempting the Board from income tax and corporation tax. In relation to this exemption from taxation it is interesting to see that it extends to an exemption in respect of distributions received by the Board, and this seems to indicate that the Board will be the holder of shares in various companies. That also deserves some explanation because these powers are not limited in any way whatsoever in the Bill, and apparently the Minister can direct whatever he pleases.

6.3 p.m.


My Lords, I hope you will forgive me for intervening in this debate without prior notice, but I should be grateful if the noble Lord, Lord Wells-Pestell, would be kind enough to clarify one point which worries me. In Clause 3(1) there is mention of liabilities under the MRC, but now that this passes over to the Government body I wonder whether these liabilities become more extensive? I sincerely hope that no substances which are tested under this new organisation could go wrong, but it is always possible that something could go amiss and should we have another thalidomide situation I wondered what the situation would be regarding liabilities and whether, in fact, the liabilities of the State would be greater than those which exist under the Medical Research Council, which I believe do not really have very much effect.

In other words, I do not think that any individual could claim on the MRC whereas they might claim against an ethical drug company which was supply- ing a drug. I wondered whether, now that the State will be taking over the testing, the relationship between a claimant and a company distributing a drug would be different, or whether, because the State had tested the drug, the claimant would have a claim against the State. I welcome this Bill and hope that it will go through, at least on the basis of "third time lucky".

6.6 p.m.


My Lords, I will try to answer the questions that have been put to me, and I am grateful to the noble Lord, Lord Sandys, who mentioned to me the question of the new addition, Clause 2. My information is that this is the normal provision to be included for Boards of this kind. I believe on the last occasion it was an omission, and as well as being the right thing to do I think it is a cautious measure because it is possible that some money could accrue to the Board. For example, it could be paid for some of the testing that it does. It works in conjunction with the World Health Organisation and it could be paid certain fees, but those fees would be negligible. Nevertheless, there could be a little income. Turning to the remarks made by my noble friend Lord Douglas of Barloch, there will never be in the hands of the Board anything like the amount of money that would be required to invest in other concerns, so that question does not arise at all.

The noble Lord, Lord Sandys, mentioned the question of just a change in wording from "Health Ministers" to "Ministers". He quite rightly pointed out that this is defined in Clause 8 and I do not think there is any necessity to say anything more at this stage. I should like to make it clear that this was not a matter which the noble Lord mentioned to me, but I, too, was very concerned about the phrase "taken as a whole" because I felt that it could give rise to some misunderstanding, and I have gone into this very carefully. I understand the position to be that there may be certain differences in conditions of employment. A person may be asked to do something more in a different sphere, but what it boils down to at the end of the day is that his position, status and income will not be affected. He might have a little more holiday; he may have a little less holiday, I do not know. There may be minor adjustments, and I am not putting it any higher than that. So if one may use the phrase "taken as a whole" then the position, the status and pay of the individual will remain unaffected. Certainly he will not be at a disadvantage.

Returning to my noble friend Lord Douglas of Barloch, I should like to tell him that we are dealing with this matter of biological substances as they affect the individual from a health point of view. So far as I know it will not be the function of the Board to concern itself with, for example, washing powder—at least I do not think so. We are concerned with biological substances and the control of such substances which will be used in the interests of the health of the individual. The noble Lord, Lord Redesdale, has raised (let me be quite frank about it) a very difficult problem. I am not a lawyer and I should not like to say something that your Lordships would take as being authoritative, but from the inquiries I have made I understand that, of course, it is open to anybody to bring an action against an individual or a company or a Board provided it is felt that there is justification for doing so.

It is a well-known fact that there are on the market vaccines which have been very carefully tested, and, indeed, could not have been more carefully tested, and yet in one case in perhaps half a million one will have an unfortunate effect. I do not think anybody could give an undertaking that this is not likely to happen, but here we have a situation where manufacturers themselves, as I understand the situation, will be doing the test, and then submitting to the Board the substance for their testing or not—since there will be a check on some coming from the manufacturers. If it were to have an adverse effect on anybody who has that particular substance administered, then presumably they would be entitled to bring an action. But if I may venture to suggest this, they would have to prove that there had been negligence of a very real kind. The answer to the noble Lord is that certainly the Board would be subject to the same laws as any other concern, but it would be the Board and not the Government. I hope I have answered, so far as I am able, those noble Lords who have spoken.

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