MEDICINES ACT 1968 (ANTIBIOTICS) (Hansard, 12 February 1973)

§ The Under-Secretary of State for Health and Social Security (Mr. Michael Alison)

I beg to move, That the Medicines (Extension to Antimicrobial Substances) Order 1973, a draft of which was laid before this House on 5th February, be approved. The primary purpose of the order is to make provisions whereby the existing controls of non-medicinal antibiotics under the Therapeutic Substances Act 1956 may be continued to be carried on under the Medicines Act 1968. The Medicines Act provides for the repeal of the Therapeutic Substances Act on a date to be appointed, and in this respect the order is part of a formal change. In addition, however, under the Medicines Act a more flexible system of control becomes possible, and the way is paved for implementation of certain recommendations of the Joint Committee on the Use of Antibiotics in Animal Husbandry and Veterinary Medicine under the chairmanship of Sir Michael Swann.

Section 105(1)(b) of the Medicines Act under which the order is to be made provides powers to bring substances which are not medicinal products as defined in the Act but are substances which if used without proper safeguards are capable of causing danger to the health of the community or of animals generally or of one or more species of animals within the ambit of the licensing system and other provisions of the Act as if they were medicinal products. The substances in question are antibiotics, substances which possess antigenic properties similiar to those of antibiotics, sulphanilamide and its derivatives and the nitrofurans.

These substances are invaluable as a means of combating and treating the effect of bacterial infections in man; they have, however, also been found to be of use in animals both for therapeutic purposes and for the stimulation of growth, and serve various other useful functions in agriculture as well as in horticulture and for the preservation of food.

The special properties of antibiotics have, however, brought with them peculiar dangers. They can give rise to the development of resistant strains of 1067 infectious organisms, and through the phenomenon of cross-resistance this can apply not merely to the particular antibiotic the use of which has given rise to resistance but to a wide range of other antibiotics. Where antibiotics are used for purposes other than human medicine one possible consequence is that through the food chain and in other ways resistant organisms may infect man and thereby prevent the successful use of antibiotics in treatment of human illnesses. Furthermore, exposure to an antibiotic may sensitise individuals so that the same or a related antibiotic cannot be used in their treatment. Similarly, the use of antibiotics in various ways can endanger the health of livestock and wildlife and generally affect the environment.

At the present time most antibiotics, sulphanilamide, its derivatives and certain nitrofurans, are controlled by regulations made under Part II of the Therapeutic Substances Act 1956 and their sale and supply is restricted to the prescription of a doctor, dentist or veterinarian. Relaxing regulations made under this Act permit the use without prescription of certain controlled substances, at specified levels and subject to conditions, as growth promoters for livestock production, in food preservation and in horticulture. This method of control of restriction to prescription of non-medicinal antibiotics is not ideal, and the Medicines Act provides a more flexible system of control.

Bringing these non-medicinal substances within the scope of the Medicines Act will enable the responsible Ministers, by the making of further orders or regulations, to exercise control of the substances concerned when the Therapeutic Substances Act is repealed, thereby continuing to safeguard the health of the public and of animals.

By approving the order the House will enable the appropriate measures to be undertaken and, by so doing, will continue the safeguards to public and animal health.