§ Mr. AshleyTo ask the Secretary of State for Health if he will list in theOfficial Report those European Community directives which relate to the under-reporting of serious adverse drug reactions.
§ Mr. MellorWe are not aware of any specific reference to the under-reporting of adverse drug reactions in the European Community directives concerned with medicinal products.
§ Mr. AshleyTo ask the Secretary of State for Health, pursuant to his answer to the right hon. Member for Stoke-on-Trent, South,Official Report, 2 March, column 319, what investigative action is taken when there is concern about possible under-reporting of serious adverse reactions.
§ Mr. MellorIt depends upon the circumstances of the particular case. In general terms, such investigations would include scrutiny of all relevant documentation, obtaining the licence holder's response to salient issues and, where necessary, meetings and interviews with senior representatives of the licence holder.
§ Mr. AshleyTo ask the Secretary of State for Health, pursuant to his answer to the right hon. Member for Stoke-on-Trent, South,Official Report, 2 March, column 319, from what sources his Department has received information which has led to concern about possible under-reporting of serious adverse reactions.
§ Mr. MellorFrom a television programme, the right hon. Member for Stoke-on-Trent, South himself and professional analysis by the licensing authority of data submitted by the licence holder in connection with other licensing matters.