HC Deb 23 November 2001 vol 375 c581W
Mr. Heald

To ask the Secretary of State for Health (1) if he will make a statement on the circumstances in which a medicine with severe side effects would cease to be licensed; [17121]

(2) what steps he is taking to establish if a typical anti-psychotics have a lower incidence of adverse side effects, with particular reference to tardive dyskinesia; [17124]

(3) if he will make a statement on the circumstances to be taken into account by the MCA in monitoring the licensing of a medicine, with particular reference to the licensing of a new medicine with a lower incidence of side effects. [17120]

Ms Blears

[holding answer 22 November 2001]: The primary objective of the Medicines Control Agency (MCA) is to safeguard public health by ensuring that all medicines on the UK market meet appropriate standards of safety, quality and efficacy. A marketing authorisation is granted when the balance of risks and benefits is considered to be favourable in the proposed indication.

The MCA continually monitors the safety of all medicines using a number of data sources with expert advice from the independent scientific advisory committee, the Committee on Safety of Medicines. If there is evidence that the balance of risks and benefits is no longer favourable, regulatory action may he taken to minimise risk. This may include strengthening warnings, restricting the terms of the marketing authorisation, or in appropriate circumstances its revocation. Such regulatory action is pursued with the Medicines for Human Use (Marketing Authorisations Etc.) Regulation, SI 1994 No. 3144 and relevant European Community obligations.

Spontaneous reporting data, which are collated by the MCA/CSM through the yellow card scheme, can be used to compare the safety profiles of medicines within a drug class. However, these comparisons must be evaluated with care, as levels of reporting of adverse reactions for particular drugs are dependent on a number of factors including the usage of the drug and the length of time it has been on the market.

The MCA/CSM intensively monitors the safety of all new medicines under a scheme called the black triangle scheme where any of the following circumstances apply: If the medicine contains a new active substance or a combination of active substances If the medicine is administered via a novel route or drug delivery system If the medicine is going to be used in a new population of patients.