§ Mr. Ashleyasked the Secretary of State for Social Services how many of the 36,000 product licences of right granted to pharmaceutical drugs in 1972 are still in force; how many have been reviewed individually and as part of a therapeutic category by the Committee on the Review of Medicines; what has been the rate of progress of review in the last five years; and when he expects it to be completed.
§ Mr. Kenneth ClarkeThe latest available figures show that there are about 16,000 product licences of right, out of about 39,000 current in 1972. This is because some 22,000 licences have lapsed, or been revoked, suspended or withdrawn but it is not possible to say how many of these result directly or indirectly from individual reviews and from reviews of therapeutic categories.
Since the end of 1978, it is estimated that about '700 reviewed licences have been granted and the number of product licences of right has fallen by about 6,000.
There remain some 10.000 proprietary medictnal products, as defined in the EC directive, to be reviewed by 1990 to meet our Community obligations, and a programme to achieve this was published in 1981. Work is now in progress on 1,600 of these and data on a further 2,600 is to be supplied on or before 31 August 1984 by the companies concerned, and additional staff are being provided to meet the timetable.
About 6,300 PLRs, mainly homoeopathic products, are excluded from this aspect of the review as they are not subject to the relevant EC directive but particular cases would, of course, be examined if there were grounds to do so in the interests of patient safety.
Vaccines are also excluded from the terms of these Directives but have been reviewed.