§ Mr. Dalyellasked the Secretary of State for Social Services why he has rejected the advice of the Committee on Safety of Medicines to approve Depo-Provera for contraceptive use; and if he will make a statement.
§ Mr. Kenneth ClarkeThe licensing authority has given very careful consideration to the advice of the Committee on Safety of Medicines that Depo-Provera should be licensed as a long-term contraceptive. The authority, however, is of the view that in these circumstances the risk of using Depo-Provera appears to outweigh the benefit from such use. It considers that it is particularly important that, in a case such as this, the risk/benefit ratio should be clearly favourable. The committee's recommendation, on the other hand, had been a very guarded one. It had also advised that the administration of the drug should be restricted to a group of women many of whom would have difficulty in giving informed consent to their treatment.
The licensing authority therefore proposes to refuse the licence application. The company however has the right to make representations in writing or at a hearing before a person appointed for the purpose by the licensing authority in respect of this proposal.