§ LORD DAVIES OF LEEKasked Her Majesty's Government:
Whether they will amend the Medicines Act 1968 so that no new drug can be licensed or marketed in this country without effective reputable clinical trials within Britain.
§ LORD ABERDARENo. The Medicines Act 1968 particularly requires the licensing authority to take safety, efficacy and quality into account in considering an application for a product licence for a new medicinal product. The licensing authority is advised on these matters by the Committee on Safety of Medicines, who take account of all the relative circumstances in considering whether the clinical and other data available, including that relating to any clinical trials which have taken place in the United Kingdom, is adequate in relation to safety and efficacy for any proposed use.
§ LORD DAVIES OF LEEKasked Her Majesty's Government:
Whether drugs are approved for sale and use in this country without having had a clinical trial within Britain.
§ LORD ABERDAREThe licensing authority established by the Medicines Act 1968 may grant a product licence for a medicinal product which has not undergone clinical trial in the United Kingdom if satisfied, on the advice of the Committee on Safety of Medicines, that the clinical and other data available is adequate in relation to safety and efficacy for the proposed use.
House adjourned at twenty-four minutes past nine o'clock.