MEDICINES (SURGICAL MATERIALS) ORDER 1971 (Hansard, 26 July 1971)

§ LORD ABERDARE

My Lords, I beg to move that this House approves the Draft Medicines (Surgical Materials) Order 1971. The purpose of this draft Order is to bring certain surgical materials within the ambit of the licensing system and certain other provisions of the Medicines Act 1968 as if they were medicinal products. The surgical materials in question are all intended for use in surgical operations and are capable of being absorbed by the body tissues. They may be ligatures, sutures or other forms of binding material or any absorbent or protective material and they may be prepared from gut or other animal tissue or from synthetic materials. The important point is that they are to be put inside the body otherwise than by means of the digestive tract and left there until they are absorbed. In such circumstances the risk of infection from unsatisfactory materials can be very high. Consequently the greatest of care is essential to ensure the sterility and quality of surgical materials of this kind. By bringing these materials within the field of licensing and other provisions in the Medicines Act that are designed to secure safety and quality of medicines it will be possible for the responsible Ministers to impose and enforce appropriate conditions relating to specification and manufacture.

At present the manufacture for sale or the importation of such surgical materials (apart from the synthetic ones) is prohibited under the Therapeutic Substances Act 1956 except in accordance with a licence. This Act will be repealed when the licensing provisions of the Medicines Act 1968 become fully operative. Accordingly the Draft Order, by bringing these materials within the ambit of the Medicines Act is designed to continue the existing safeguards and extend them to cover similar synthetic materials where the same safeguards are desirable. The proposed date of operation, September 1 next, is the date appointed by the Health and Agriculture Ministers in the Medicines (First Appointed Day) Order 1971 under the Medicines Act. I beg to move.