§ Mr. Steenasked the Secretary of State for Social Services how many medicine manufacturers have had their licences to manufacture medicines withdrawn or curtailed since the passing of the Medicine Act 1968; how many of them have invoked the existing appeal procedure; and with what result.
§ Dr. Owen, pursuant to his reply [Official Report, 12th May 1975; Vol. 982, c. 25], circulated the following information:
Since September 1971 the licensing authority has served on manufacturers 28 formal notices of proposed adverse decisions. In the three cases referred to in my original answer the manufacturers invoked the statutory procedure for a hearing and in three other cases they elected to make written representations. The proposals were implemented in full in 25 instances, including the application not finally determined at the date of my original answer. In three instances, including the case referred to in (2) of that 594W answer, it was decided to implement the proposals in a modified form.
To date 537 manufacturers' licences have been granted and are in operation. Where manufacturers are not regarded as coming up to expected standards, the normal practice is for the Department to have informal discussions with them about the remedial measures required. The usual outcome is that agreement is reached between the Department and the company and implemented by a modification of the application or a variation of the licence at the company's request. This informal approach has been followed in about 200 cases, agreement being reached in 180 of them.