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Drugs (Safety)

Volume 951: debated on Friday 9 June 1978

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asked the Secretary of State for Social Services (1) if he will list in the Official Report the names of all those drugs the applications for licences for which have been turned down since the Committee on Safety of Medicines regulations came into force in 1970;(2) when he last met the Chairman of the Committee on Safety of Medicines to discuss problems arising when licences are refused for drugs;(3) how many drugs were on the original list of acceptances by the Committee on Safety of Medicines; and how many are on it currently:(4) if he will list the in the

Official Report the main grounds for the rejection of claims of those drug firms which were refused licences in each of the last seven years.

Under the Medicines Act the appropriate Section 4 committee advises the licensing authority on questions of safety, quality and efficacy: a product licence may not be refused on those grounds except after consultation with the appropriate committee or the Medicines Commission. Where the committee advises refusal, the applicant has the right to be heard or make representations to the Medicines Commission.From the beginning of licensing on 1st September 1971 until 31st December 1977 the number of applications for product licences—other than product licence of right—in respect of products for which the Committee on Safety of Medicines—CSM—is the appropriate committee, has totalled 4,000.The outcome of these applications has been as follows:

Licence Granted (with or without modifications)2,342
Licence Refused103
Applications withdrawn by applicant850
Applications still under consideration at 31st December 1977705
Virtually all the refusals were on grounds of safety. The withdrawals include cases where safety problems arose but this category also includes withdrawals for commercial reasons.It is not the practice to publish details of unsuccessful applications.In 1972, 36,000 product licences of right were granted without reference to the Committee on Safety of Medicines because these products had been on sale before the appointed day—1st September 1971. These products are under ongoing review by the Committee on the Review of Medicines and the number of products on the market has now fallen to 23,000.I meet the chairman of the CSM from time to time on matters concerned with its functions but no occasion has arisen to discuss problems arising when licences are refused; I am not aware of any such problems.