§ Mr. Simsasked the Secretary of State for Social Services what requirements he places on the Committee 162W on Safety of Medicines to carry out independent investigation on products referred to it and to check the veracity of the manufacturer's research conclusions; and what facilities are made available to the committee to enable it to do so.
§ Mr. Kenneth ClarkeThe committee is not required to carry out medical or scientific tests of its own on products referred to it. An applicant for a product licence must submit to the licensing authority, amongst other information, copies of reports and evaluations of any experimental and biological studies and of any clinical, preclinical or laboratory studies of the product which are relevant to the assessment of its safety, efficacy and quality, together with references to relevant publications. Where the licensing authority seeks the advice of the committee on applications the committee, supported by its professional and administrative secretariat, assesses all submitted reports, studies and publications. It also considers all other evidence which it believes might bear on the issue and can consult other experts. Where, as a result, the committee is not satisfied with the evidence submitted, it can specify what further studies or data it would require to enable it to give further consideration to the application. Similar procedures are followed by the committee if new evidence comes to light which suggests that variation or revocation of a licence may be necessary. for example, on grounds of safety.