§ Dr. Roger Thomasasked the Secretary of State for Social Services (1) if he is satisfied that there is no increased possibility of a case similar to that of Thalidomide arising following the allowing of drug companies to avoid reproductive studies before the use of drugs on humans; and what increase in hazards to patients given these experimental medicines will arise;
181W(2) what categories of drug he plans should be subjected to carcinogenic, fertility and teratological tests before introduction; and whether he is satisfied that such requirements will adequately safeguard the public.
§ Dr. VaughanI have no plans to change the licensing authority's current requirements for testing new drugs before they are granted a product licence. The Department is currently consulting professional bodies and other organisations on recommendations submitted to the licensing authority by the Committee on Safety of Medicines to amend the data requirements for the issue of clinical trial certificates. A copy of the consultation letter—MLX 130—has already been placed in the Library of the House. The CSM considers that its recommendations will not increase the risk to patients participating in clinical trials. However, these proposals will be brought into effect only after the consultation period and if my right hon. Friend is satisfied that that is the case.
Under the CSM's proposals, initial clinical trials of a new drug will be permitted before the results of reproductive studies in animals are submitted to the licensing authority, but only on condition that women of child bearing age are excluded from the trials in order to avoid any possibility of damage to a foetus.