§ 7.30 p.m.
§ Lord WELLS-PESTELLMy Lords, with your permission I should like to take this Order as briefly as possible. I beg to move the Motion standing in my name on the Order Paper. This Order aims to bring under the controls of the Medicines Act the materials used for making dental fillings. When the Medicines Act was passed in 1968, it provided for the general regulation and control of all pharmaceutical products marketed in the United Kingdom but the Act did not include dental filling substances. It provided for the extension of the area of control by means of Orders which would be approved by both Houses of Parliament and the Government are now embarking on a limited programme of such extension. It may be helpful if I sketch out the main reason which led the Government to propose this extension at the present time.
In recent years, more complex fillings containing antibiotics, or other pharmacologically active substances, and also synthetic chemicals, have been added to the simpler compounds which formed the bulk of filling materials when it was decided to exempt them from the provisions of the Act, and we feel that more control is needed than we have at present. Limited control of dental materials is operated at present in connection with a system of " approved lists " which is maintained for National Health Service purposes by the Department of Health and Social Security, and in order to avoid duplication of work it is envisaged that licence applications will be assessed by the same scientific staff as at present. However, not all dental filling materials on the market are at present approved for National Health Service purposes, and no control is exercised over materials used in the private sector. This Order will enable us to ensure that all dental patients receive, as consumers, the protection to which they are entitled. We shall also be able to ensure that there is control over the distribution of materials which may contain potent medicinal components. Some concern was expressed in another place about the possibility of mercury poisoning arising out of the use of amalgam fillings. I 483 understand that the present assessment of my professional advisers is that the risk to the patient of mercury poisoning from the use of amalgam is, in fact, low, but we shall of course keep the matter under careful review and will not hesitate to act urgently under the powers granted by this Order if it seems necessary to do so to protect public health.
When licensing is introduced two types of licence will be required. First, a product licence will be required which will be granted in the case of new products after data on the safety, quality and efficacy of each individual product has been carefully assessed; and a manufacturer's licence will also be required to allow a particular establishment to engage in the manufacture and assembly of a class of products, and such establishments are subject to regular inspection by members of the staff of the Department. The continuation of activities already being undertaken when licensing is introduced will be authorised by licences of right.
Finally, may I say that we intend that an expert committee shall be appointed to advise Ministers on the control of these and the other classes of products which I said we intend to bring under control, and we are consulting relevant representative bodies about this committee in the light of advice we have received from the Medicines Commission. These proposals have been generally welcomed in the consultations which we have undertaken, and I hope that your Lordships will feel able to agree to the making of the Order. My Lords, I beg to move.
§ Moved. That the Draft Medicines (Dental Filling Substances) Order 1975, laid before the House on 3rd February, he approved.—(Lord Wells-Pestell.)
§ Lord SANDYSMy Lords, again the House will be grateful to the noble Lord, Wells-Pestell, for introducing and explaining this draft Order. In the last few days, the House has been interested in dental affairs. We have had a notable maiden speech from the noble Lord, Lord Colwyn, himself a dentist. We had a very interesting Question on the subject of fluoridation which the noble Lord, Lord Wells-Pestell, answered. But, so far as I can discover, we have never dis- 484 cussed or investigated in any great depth the Reports of two Working Parties on dental services, one on emergency dental services and the other on preventive dentistry, both published in 1973.
It is not my purpose to prolong this discussion. However, it may serve to illustrate to the noble Lord, Lord Wells-Pestell, how interested we are on this side of the House in dental affairs. From a drafting point of view, I must say that the Order has its complications, because we have to examine Section 16(1) of the Medicines Act 1968, an old friend of all of us concerned in this subject. That imposes restrictions under Sections 7 and 8, which do not apply. We then look at Section 17, Section 25(1) and Section 37. It is quite conceivable to the uninitiated that a very rare and interesting substance may be proposed by the dental authorities, but only those with great persistence would discover precisely what it is. The noble Lord has explained in depth, and I do not think it would be to our benefit to investigate further, as I am sure we are satisfied that we have all the relevant documents on this side of the House. Nevertheless, I have made my point that dental affairs should be discussed in greater depth at some future appropriate date. I am quite sure that the noble Lord, Lord Wells-Pestell, has registered our interest in this field of medicine.
§ On Question, Motion agreed to.