§ Mr. Litterickasked the Secretary of State for Social Services what changes have been made in the procedure for vetting new drugs since the thalidomide case before allowing their use by the public; and whether he is satisfied that the procedure currently in use is satisfactory.
§ Dr. OwenFollowing the discovery of the effects of thalidomide the Government and the pharmaceutical industry agreed to establish, as a matter of urgency, a voluntary arrangement whereby no drugs were to be brought on to the market until they had been considered by the Committee on Safety of Drugs. In 1968 Parliament passed the Medicines Act, which provides a statutory basis for comprehensive controls298W over medicinal products. Under this Act the voluntary arrangements were replaced, from 1st September 1971, by a statutory system of product licensing. A product licence is granted only after the consideration of evidence of safety, efficacy and quality of the product. Such evidence includes the results of laboratory tests of the clinical trials.
The results of such tests and trials cannot, however, provide complete assurance against the possibility that a product when brought into widespread use will have adverse effects on some individuals. Accordingly the system includes provision for the monitoring of reports of adverse reactions.
In devising any system for control of the release of new products to the market it is necessary to balance the possible hazards of using the product against the detrimental effect of delaying the introduction of a valuable new form of treatment. I believe that our present system is well designed and generally effective. But no system is perfect and we shall continue to seek improvements.