§ Mr. BlunkettTo ask the Secretary of State for Health what assessment has been made by her Department of the safety of nicotine patches; and if she will make a statement.
§ Dr. MawhinneyThe Licensing Authority and its advisory body the Committee on Safety of Medicines (CSM), in assessing applications for product licences for nicotine patches, considered all the available evidence which included clinical trials; data from usage in other countries published or unpublished, whether or not favourable to the drug. The CSM has to be satisfied that the drug is safe and efficacious for the indication proposed, in this case treatment of nicotine withdrawal symptoms associated with smoking cessation in nicotine dependant persons, and that it is of good quality. These are the only criteria which can be considered under the Medicines Act.