MEDICINES (SPECIFIED ARTICLES AND SUBSTANCES) ORDER 1976

HL Deb 10 June 1976 vol 371 cc887-91

6.36 p.m.

Lord WELLS-PESTELL rose to move, That the draft Medicines (Specified Articles and Substances) Order 1976, laid before the House on 18th May, be approved. The noble Lord said: My Lords, the order is a preliminary to the extension of the controls of the Medicines Act 1968 to those intra-uterine contraceptive devices not already subject to the Act and to contact lenses, contact lens blanks and associated fluids. As such, it constitutes part of a small widening of the scope of the Act.

The Medicines Act makes provision for regulating most aspects of the production and marketing of medical and medicinal products. The Act's definition of what constitutes a medicinal product is, necessarily, a general one, and it was realised at an early stage in the Act's preparation that there would be some products that would fall outside its terms and which it would be desirable to control. Already, the powers of the Act have been used to bring within control some types of surgical sutures and dental filling materials. The Committee on Dental and Surgical Materials, which was set up under Section 4 of the Act to advise on these sutures and on dental materials, has a membership which includes experts on the specified articles and substances covered by this order. Ministers will therefore be able to seek such expert advice on these products.

I should say that some intra-uterine contraceptive devices are already held to be medicinal products because they contain substances which have a chemical or pharmacological effect inside the body: but other intra-uterine contraceptive devices which are inert can only be controlled if powers are given to us by this order. This class of products is thus divided into two legal categories as the result of falling into a " grey " area in respect of the Act's definition of what is a medicinal product. As your Lordships know, all intra-uterine contraceptive devices are placed inside the body for a considerable length of time, and we believe it is important that all such devices should be subject to proper quality assurance; and that powers should be available to regulate their sale.

Turning to contact lenses, those of your Lordships who do not use them may not be aware that the wearer of contact lenses makes regular use of fluids to disinfect, lubricate or hydrate his or her lenses; he or she therefore uses a " system " consisting of the lens and the fluids that must be used with it. It is important to ensure that this " system " does not provide a home for bacteria that may damage the eye because the contact lens itself and some of the fluids used with it are applied directly to the eyeball for long periods. The use of a plastic and a fluid may also create the possibility of interaction. When research recently cast doubt on the safety of some of the contact lens fluids on the market, we immediately held discussions with the manufacturers of these products. All of them were willing to submit technical information to us and we set up a Working Party to report on the standards which should be used to assess contact lens fluids. This Working Party will report, we hope, in the near future, and will have provided a sound basis for the introduction of statutory control as proposed in this order.

The Medicines Act provides a wide range of regulatory powers in relation to the sale, supply, manufacture, import and export of medicinal products, and these controls are centred on the licensing system. In outline, the production and marketing of a medicinal product can be regulated by the issue of a product licence, and the manufacture and assembly and wholesaling of a medicinal product can be regulated by the issue of appropriate licenses. Within the licensing provisions, there is scope to take account of the significant difference in the way that trade in different types of product is organised.

I should like to stress that this order, if approved by your Lordships, would not bring the controls of the Act into force immediately. Further orders and regulations would have to be made which would lay down a timetable for the introduction of licensing, and provision would be made for transitional periods to allow manufacturers and others to accustom themselves to the requirements of the Act. We intend to propose different dates for the introduction of licensing for the different classes of products covered by the order. The comments of professional and trade organisations involved in the area would be sought before our proposals were finalised.

These proposals have been generally welcomed in the consultations which we have undertaken, and I hope that your Lordships will feel, in view of that, that this order can be accepted. I beg to move.

Moved, That the draft Medicines (Specified Articles and Substances) Order 1976, laid before the House on 18th May, be approved.—(Lord Wells-Pestell.)

Lord SANDYS

My Lords, I should like to thank the noble Lord, Lord Wells Pestell, for explaining the provisions of this order, and I would ask him one or two questions about it. As your Lordships will be aware, the Medicines Act 1968 allows, by special clauses within it, for extension to the powers granted, and in particular this order relates to two particular products. I should like to ask the noble Lord, first of all, what types of intra-uterine contraceptive devices this order has in mind, and also whether he can give us any approximation of the numbers likely to be involved in using these devices? One must be cautious here, because, of course, the Medicines Act is part of an international arrangement within the World Health Organisation, and we naturally accept that the numbers involved will be very considerable. Nevertheless, in view of the fact that the Medicines Act 1968 covers a very large number of products of considerable variety and type, I would be grateful if the noble Lord could give some indication.

In regard to contact lenses, I was particularly glad to hear what the noble Lord said in regard to consultation with bodies, especially those concerned with the manufacture and the trade. I wonder whether the noble Lord could indicate with whom the consultations have taken place within the professions concerned, as this would be valuable. Further, it would be valuable to know whether this took place with bodies within the EEC, because, as your Lordships will be very well aware, there are a large number of orders relating to optical devices which come before us and are subject to the scrutiny of the European Committee.

Lord WELLS-PESTELL

My Lords, I am very grateful to the noble Lord, Lord Sandys, for his comments and observations. With regard to the intrauterine contraceptive devices, there are two types, as I understand it, of IUCD, if I may be permitted to use the initials. The " inert " type consists of a sterile plastic loop or coil which fits into the uterus. The " active " type is similar but incorporates an additional substance, such as copper or a hormone designed to give additional protection against pregnancy. The " active " type is already controlled by the Medicines Act because of the presence of this additional substance. There are no comprehensive centrally collected statistics which would indicate how many IUCDs are currently in issue. The best estimate suggested is that there are between 350,000 and 400,000 women who are currently using IUCDs, and we certainly know that the number is increasing. Four different brands of " active " IUCDs have been licensed under the Medicines Act, and there are four brands of the " inert " type which I mentioned at the beginning. My understanding is that there have been no discussions in relation to this matter with the EEC.

Coming on to the outside consultations to which the noble Lord referred, the following organisations were consulted in February 1975 concerning the products covered by this order: the British Medical Association, the Medical Research Council and the medical Royal Colleges; the British Dental Association and the General Dental Council; the Guild of Hospital Pharmacists, the National Pharmaceutical Union, the Pharmaceutical Society of Great Britain and the Worshipful Society of Apothecaries; pharmaceutical trade organisations, including the Association of the British Pharmaceutical Industry and the Proprietary Association of Great Britain: consumer organisations, including the Consumer Association and the National Federation of Women's Institutes; finally, the British Optical Association, the Joint Committee of Ophthalmic Opticians and the Guild of British Dispensing Opticians; the Contact Lens Manufacturers Association, and, if I can lump them altogether, most of the leading manufacturers in the contact lens field.

On Question, Motion agreed to.