§ Mr. AshleyTo ask the Secretary of State for Health if the Medicines Commission on the Committee on Safety of Medicines carries out independent checking of manufacturers' data on drug safety.
§ Mrs. Virginia Bottomley[holding answer 27 June 1990]: The Medicines Commission and the Committee on Safety of Medicines are themselves independent advisory bodies set up under the Medicines Act 1968. It is not their practice to commission separate independent checking of manufacturers' data.
§ Mr. AshleyTo ask the Secretary of State for Health what has been(a) the expenditure in real terms on evaluating the safety of pharmaceutical drugs and (b) the number of specialised staff working on drug safety in each of the last five years for which figures are available.
§ Mrs. Virginia Bottomley[holding answer 27 June 1990]: Evaluation of safety is one integral component of the process of licensing medicinal products and monitoring them after marketing. This evaluation is carried out by expert toxicologists, pharmacists and physicians within the Medicines Control Agency (MCA) who are further advised by a number of expert committees. Separate costings are not available in the form requested. The MCA has recently been reorganised into a number of specialised businesses. The pharmacovigilance unit has responsibility for monitoring adverse reactions to drugs and there are currently 27 staff employed on this work.
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§ Mr. AshleyTo ask the Secretary of State for Health on what data the Medicines Commission and the Committee on Safety of Medicines rely for their assessment of a drug's safety before recommending a product licence.
§ Mrs. Virginia Bottomley[holding answer 27 June 1990]: Every product licence application is considered individually and must satisfy the licensing authority as to safety, quality and efficacy before a licence can be granted. The EC publication "The Rules Governing Medicinal Products in the EC" volumes I-V and the Department of Health's publication, "Guidance Notes on Applications for Product Licences" (Revised MAL 2) provide comprehensive guidance on requirements for safety data. Copies will be placed in the Library shortly.