§ Ms DrownTo ask the Secretary of State for Health what criteria are applied to new drugs to assess their effectiveness before they receive a licence for general use. [17032]
§ Ms JowellThe marketing authorisation (the licensing) of all medicines throughout the European Union is governed by the Rules Governing Medicinal Products in the European Union, in particular, Council Directive 65/65/EEC. Under these rules a licence application is refused if the medicinal product is harmful in the normal conditions of use, or if its therapeutic efficacy is lacking or is insufficiently substantiated, or if there are concerns about its qualitative and quantitative composition. In this context "therapeutic efficacy" and "clinical effectiveness" are judged to be synonymous.