MEDICINES (RADIOACTIVE SUBSTANCES) ORDER 1978 (Hansard, 3 May 1978)

HL Deb 03 May 1978 vol 391 cc269-78 269

§ 7.14 p.m.

§ Lord WELLS-PESTELL rose to move, That the draft Medicines (Radioactive Substances) Order 1978, laid before the House on 11th April, be approved. The noble Lord said: My Lords, I beg to move the Motion standing in my name on the Order Paper. In the wake of Mr. Justice Parker's Inquiry into the proposed processing of nuclear waste at Windscale it is perhaps appropriate that I should ask your Lordships to consider this draft Statutory Instrument. Like most nuclear matters the subject is somewhat technical and complex, and I must ask your Lordships' forbearance for going into some necessary detail.

§ Let me be perfectly frank. This order is extremely difficult to understand. I would not presume to feel that I have mastered it in its entirety. The order is one of three Statutory Instruments required to implement Article 5(a) of Directive 76/579/Euratom adopted by the Council of the European Communities on 1st June 1976. I shall return to the other two Instruments at a later stage.

§ The Euratom Directive lays down the revised basic safety standards for the health protection of the general public and workers against the dangers of ionising radiation. Most of the Directive is concerned with the reporting and authorisation of he production, processing use and disposal of radioactive substances, the limitation of radiation doses to exposed workers and other persons, and measure for the medical surveillance of radiation workers and the protection of the health of the population. Member States of the European Community, including the United Kingdom, are required to put into effect the necessary measures to conform to the relevant parts of the Directive within two years; that is, by the middle of this year. In so far as legislative action to implement the rest of the Directive is necessary, this will he introduced in due course by the appropriate 270 Departments of State, but my concern in respect of the present order is solely with Article 5(a) of the Directive.

§ Article 5(a) reads as follows: Apart from the prohibitions provided for by national law, and irrespective of the degree of danger involved, a system of prior authorisation must be applied in respect of: a. the administration of radioactive substances to persons for the purposes of diagnosis, treatment or research". We are thus concerned with the use of radioactive substances for medical, including medical research, purposes. That is what Article 5(a) is all about—medical, including medical research purposes.

§ The present system, as many of your Lordships may well he aware, is that there is already a voluntary system of application for approval to undertake the administration of radioactive substances, mainly for research purposes, which was originally set up by the Medical Research Council and is now operated by the Department of Health and Social Security on the advice of its Isotope Advisory Panel. It is not at present obligatory for practitioners either to seek approval or advice, or if it is sought, to act upon it.

§ If I may come to the proposed regulations, since a voluntary system of approval is insufficient to implement the provisions of Article 5(a) of the Directive, it is necessary to introduce an obligatory system. After careful consideration and discussion with appropriate professional organisations we propose to follow the customary course by, as far as possible, making use of powers which are already available under existing legislation.

§ Section 60 of the Medicines Act 1968 enables regulations to be made prohibiting the administration and the sale and supply of specified medicinal products or classes of such products, except by registered doctors or dentists holding a certificate issued for the purpose of Section 60. Such regulations, which are subject to Negative Resolution in both Houses of Parliament, will therefore be laid before this House in the near future. I am now dealing with the order; the regulations exile later. They are the second of the three associated Instruments to which I have referred.

§ As the text of these regulations refers to the order which is now before your Lordships, it is not yet possible formally 271 to lay the regulations which, as I said a moment ago, will be made under Section 60 of the Medicines Act, in this House but draft copies of them are available for consultation in your Lordships' House. I think that it is right to draw your Lordships' attention to these draft regulations as their existence is the main reason for the introduction of the order which is now before the House.

§ I should like to turn to the necessity for the present order. We have been at some pains to try to make it understandable for me, if not for your Lordships. The reasons for this order are somewhat involved. I shall therefore tabulate them in order to be of some assistance to the House: 1. The Euratom Directive requires radioactive substances which are administered to be subject to prior authorisation; 2. The Medicines Act which is being used to provide such authorisation applies to "medicinal products"; 3. Not all the radioactive substances which are to be authorised are "medicinal products" within the meaning of the Medicines Act; 4. Section 104(1) of the Medicines Act allows specified provisions of the Act to apply to substances or articles which are not medicinal products; 5. The present order specifies those substances and articles and the provisions of the Act to which they are to be subject.

§ I turn to the specified provisions of the Articles which I shall take under four separate headings. The specified provisions of the Act are principally those contained in Section 60 under which the regulations, to which I have already referred, are to be made. The specified articles or substances are as follows: First, appliances which already contain or are to contain a radioactive substance and are designed to he placed in the human body or body cavities; secondly, applicators which already contain or are to contain a radioactive substance and are designed to be placed on the surface of the human body.

§ Then, thirdly, apparatus used for the diagnostic technique known as "neutron activation analysis". This technique is used to determine the elements making up parts of the body. The elements are exposed to neutrons generated by a machine and so become radioactive and emit gamma rays. These rays are measured and thus make it possible to identify 272 the elements emitting them. Since the technique requires the exposure of the body to the emission of neutrons from apparatus, the definition of "administration" in the Medicines Act has to be extended by Article 2(2) of the order to include this particular process. Fourthly and lastly, radioactive substances used for research rather than diagnostic or therapeutic purposes.

§ Your Lordships will note that teletherapy sources, particle accelerators and X-ray apparatus are not included in the Schedule to the order and consequently will not come within the scope of the regulations. The main reason for this is that we interpret Article 5(a) to refer to radioactive substances which can be retained within the body either biologically or mechanically, and thus to exclude radiation from machines where the radiation ceases as soon as the machine is stopped or turned off.

§ I should perhaps for completeness mention to your Lordships that the third of the Statutory Instruments is an order made by the Health Ministers under Section 4 of the Medicines Act 1968. The order provides for the establishment of a Committee on Radiation from Radioactive Medicinal Products to provide advice on the radiation aspects of medicinal products to the licensing authority responsible for granting product and manufacturers' licences under other provisions laid down in the Medicines Act 1968. The order does not have to be laid before this House, but a copy is available in the Library should your Lordships wish to examine it.

§ I should like to recap for a moment because I think that the matter may be becoming rather confusing. The present order is the matter before your Lordships which will require your Lordships' approval. The order will require regulations to be made. They will be made under Section 60 of the Medicines Act —which already provides the machinery to allow regulations to be prepared—and they will be subject to the Negative Resolution procedure. I have already said that the third of the Statutory Instruments dealing with the Committee on Radiation from Radioactive Medicinal Products does not have to be laid before your Lordships' House. However, as I have said, a copy is available in the Library.

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§ In view of the seriousness of this matter I should like to say something about the consultations which have taken place. I shall deal with the matter in a general way, but I shall be specific if I am asked. I should like to assure your Lordships that this order and the other two associated Instruments have been the subject of widespread consultation with the Medicines Commission, and all the professional organisations and institutions representing the dental and medical practitioners and other scientists who are likely to be affected both within and outside the National Health Service. This consultation has been continuing since the Directive was issued and has included the circulation of the draft documents on two occasions. Indeed, the submission of the documents for Parliamentary approval has been delayed in order to take account of further recent representations made to my Department. We now consider that the draft order is in a form which is acceptable to the main professions and organisations who will be affected by it, and will intrude as little as possible into the freedom of clinical practice, while at the same time fulfilling the United Kingdom's obligations under the Euratom Directive.

§ Your Lordships may wish to know the timetable proposed by Health Ministers for the implementation of the provisions in this order and the regulations to which I have referred. The present order will be made as soon as the necessary Resolutions have been passed by both Houses, and it is expected to come into effect in July of this year. The regulations will be made at the same time as the order and, once approved, will require all medical and dental practitioners wishing to administer radioactive medicinal products—including the items covered by the present order—after 1st January 1979 to hold a certificate authorising them to do so.

§ I do not think that I can say anything more that is likely to be useful. I have tried to set matters out in as much detail as possible. I commend the draft Medicines (Radioactive Substances) Order to your Lordships for approval.

§ Lord DAVIES of LEEK
My Lords, before my noble friend sits down I should like to ask him one question. I did not hear him mention veterinary surgeons. 274 The use of radioactive isotopes, is extending. Does the order include veterinary surgeons?

§ Lord WELLS-PESTELL
My Lords, my understanding is that the order deals only with doctors and dentists.

§ Lord DAVIES of LEEK
My Lords, radioactive isotopes are now also used in the treatment of animal health.

§ Lord WELLS-PESTELL
My Lords, there are other ways in which they can be brought in, but they are not involved in this particular order.

§ Moved, That the draft Medicines (Radioactive Substances) Order 1978, laid before the House on 11th April, be approved.—(Lord Wells-Pestell)

§ 7.32 p.m.

§ Lord SANDYS
My Lords, the House will be grateful to the noble Lord, Lord Wells-Pestell, for explaining this very complicated order, which will have the object of completing the United Kingdom's obligation under the Euratom Treaty. I am not surprised that the noble Lord, Lord Davies of Leek, had a number of questions to ask prior to the noble Lord, Lord Wells-Pestell, sitting down because the order gives rise to a great number of inquiries. However, first, naturally, as we have been told, the order requires regulations to be made under Section 60 of the Medicines Act. The more detailed matters will come forward in these regulations. This follows upon a voluntary system which has been in operation for some years. It must be a matter of pride to us all that one very prominent hospital—the Hammersmith Hospital—has been using radioactive isotopes for medical therapeutic reasons for more than 25 years. Of course, that has been subject to an existing system of control.
The necessity for the present order we know, but there is one matter about which I should like to ask the Government—that is, whether the consultation has been concluded with the Health and Safety Executive Committee in regard to the question of the regulations. I hope that as the draft order has been stated to be acceptable to the professional bodies involved. we may have Government confirmation that, among the other bodies 275 concerned, the Health and Safety Executive Committee has been fully consulted. It is, of course, a matter of considerable concern to Departments other than the Department of Health. As the noble Lord rightly pointed out, the inquiry at Windscale has given rise to great public anxiety on this whole matter, about which I hope the Government will be able to reassure us in the reply which we now await.

§ The Marquess of LINLITHGOW
My Lords, I should like to ask a simple question because the complications of this are way over my head. The very last sentence of the noble Lord, Lord Wells-Pestell, was that under the new regulations the users of these various complicated chemical compounds will require a certificate. There is a great deal of paper around nowadays. Can the noble Lord assure us that the ability to obtain a certificate and the actual obtaining of it will be simplified as much as possible? —because at the moment, from hearing what the noble Lord said, one does not know how a certificate is obtained and where it is to be obtained. Perhaps the Minister can assure us on that basis.

§ Lord WYNNE-JONES
My Lords, there is one question which I should like to put to my noble friend—namely, whether the societies which are concerned with the exact definition, and not simply with the ultimate purpose of something, have been consulted. Have the Chemical Society and the Royal Institute of Chemistry been consulted? There is an expression here which I cannot believe any chemist would accept: that is, "radioactive substance" means: any substance that contains one or more radionuclides". The definition of a "substance" in chemistry is absolutely precise; there is no ambiguity about it at all. It does not mean a mixture; it means one substance, a chemical compound. To use the word "substance" in any order, any Act of Parliament or in any other way, I would submit is an abuse of language. Here it is suggested that any mixture of radionuclides can be called a "substance". But chemically that is absolutely unacceptable. I hope that when the Government introduce any order, they take the advice of those who are competent in this 276 field. It is perfectly true that medical societies are competent to advise as to doses of radioactive materials, but they are not competent to decide whether any particular material is a "substance". This is something which is clearly a matter of definition. The definition is that a "substance" is something which is made of one or more chemical elements and has a defined chemical constitution; otherwise it is not a chemical substance.
Therefore, I should like to ask my noble friend whether the advice of competent chemical authorities—among which I would include the Chemical Society and the Royal Institute of Chemistry—has been taken in this matter. If it has not, I would suggest that the word "substance" be replaced by the word "material".

§ 7.39 p.m.

§ Lord WELLS-PESTELL
My Lords, first, I should like to attempt to answer the question put to me by the noble Lord, Lord Sandys. Consultation has extended over the widest area I have yet met, something like 51 organisations, including the Medicines Commission, the Isotope Advisory Panel, the British Medical Association, The Standing Medical Advisory Committee, the Medical Research Council, the five Royal Colleges which would he involved, 13 other professional bodies—I shall not go through them all, but they include the Association of Clinical Biochemists, the College of Radiographers, and so on—five of the leading pharmaceutical organisations, the Dental Association and the dental radiologists making another two, and then exactly 20 other bodies, including the Health and Safety Executive.

§ Lord SANDYS
My Lords, I wonder whether it would be for the benefit of the House, and also the public at large, if the Government were willing to publish the full list in Hansard? It might enable the noble Lord, Lord Wynne-Jones, to know a little more about where the Government had directed their consultations.

§ Lord WELLS-PESTELL
My Lords, like any other Minister, I am always in the hands of your Lordships' House. If this is the wish of your Lordships then of course we shall see that it is implemented. I do not know that I can satisfy 277 my noble friend Lord Wynne-Jones about the particular professional association to which he referred, but he will be able to see the organisations that we have consulted.
I have to say that we have no jurisdiction or control over the terminology. This is laid down in the Directive of Euratom, and this is something we have to accept and cannot do anything about. It is not a very satisfactory answer to him, but that is the situation. With regard to forms, we do not like them any more than the people to whom we have to distribute them. It makes a lot of work for Government Departments. We are anxious to see that the most simple form is available. We have to send out things to doctors and dentists in the ordinary way and we do not envisage that this is going to be a major job either for them or for us. We are very conscious of the fact that we do not really want to add more forms unless it is absolutely essential.

§ 7.43 p.m.

§ Lord O'HAGAN
My Lords, before the noble Lord finally sits down, may I say that I understand that his answer to his noble friend Lord Wynne-Jones, who is an acknowledged authority on chemistry, was that the fault lay not in Her Majesty's Government's order now before the House but in the parent legislation, as it were, that was coming from the EEC. Therefore, as it was something that flowed from Community legislation, nothing could be done about it in the order now before your Lordships, or by Her Majesty's Government, because the time had gone. Would the noble Lord be prepared to say that, if this Instrument we are now discussing is part and parcel of a defective Directive which has been agreed in the Council of Ministers, the Government will do something about correcting that Directive itself?
If it is wrong for us—and I am no authority on the chemistry in question; I have the massive intellectual resources demonstrated by an O-level in biology—could it not be taken up by the Government with our partners in the Community and the Commission be asked to bring in a new Directive using the correct terminology? I am not trying to be awkward, I can assure the noble Lord; I am simply saying that, if that is where the fault lies, let us get it right at the Community level.

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§ Lord WELLS-PESTELL
My Lords, I do not know to what extent it is of great significance. I have the experience of my noble friend behind me who is undoubtedly well qualified in this field, and r think that most people know his reputation. This is a matter that I would obviously take back and look into, but if we take some action in the matter I do not know to what extent it will affect the timetable of this order. It has to be brought in within two years. We have only a comparatively short space of time, until about July, and then it has to become effective in January. I do not know to what extent it will threaten the order itself.
I should hope that your Lordships would feel that you could accept the order because the order itself is important. It is going to do an important task. It is going to control things that I think every one of us would agree need to be controlled. If you can accept it on that basis I shall certainly see whether an inquiry could be made into the validity of doing something about the terminology.

§ Lord WYNNE-JONES
My Lords, before my noble friend sits down, may I ask him whether it is possible for an inquiry on this matter to be made of competent chemical authorities? I agree with him entirely that it is highly undesirable to hold up any order of this sort, and I would not for one moment propose that. However, I feel that it is a pity if we use wrong terminology because this may have repercussions in the future.

§ Lord WELLS-PESTELL
I can only give the assurance that I have already given; that is, that I shall certainly take it back and discuss it with my rigat honourable friend to see whether there is something of very great significance in this. However, I am anxious that the order, which is an important one, should not be held up.

Lord WALLACE of COSLANY
My Lords, I beg to move that the House do now adjourn during pleasure until 8.15 p.m.

§ [Sitting suspended from 7.45 p.m. until 8.15 p.m.]