§ Mr. Simon HughesTo ask the Secretary of State for Health if he will list the differences in the estimates of venous thromboembolism risk associated with gestodene and desogestrel made by the Medicines Control Agency(a) prior to June 1995 and (b) in November 1995. [31896]
§ Mr. MaloneInformation providing estimates of the risk of venous thromboembolism with oral contraceptives containing desogestrel and gestodene was not available to the Medicines Control Agency before June 1995. By November 1995, the results of three epidemiological studies were available which indicated that oral contraceptives containing desogestrel or gestodene were associated with about a twofold increase in the risk of venous thromboembolism compared with those containing levonorgestrel.
§ Mr. HughesTo ask the Secretary of State for Health what written procedures the post-licensing business of the Medicines Control Agency have in place to ensure reliable decisions in respect of situations where several risks and benefits have to be balanced. [31865]
84W
§ Mr. MaloneThe post-licensing division of the Medicines Control Agency employs staff with extensive expertise in risk-benefit evaluation, who undergo regular training to maintain and supplement their expertise. A variety of written procedures relating to the handling and evaluation of information provides guidance to staff. For drug safety issues with important public health implications, it is normal practice for the MCA to seek independent expert advice on the issue, from the Committee on Safety of Medicines and/or its sub-committee on pharmacovigilance. Working parties with supplementary specialist expertise are also set up to evaluate certain issues.