§ Mr. AshleyTo ask the Secretary of State for Health how many people are known to have died or suffered adverse reactions following their participation in drug trials.
§ Mr. FreemanAdverse reactions, including deaths, are reported to the Medicines Control Agency. It is not possible to say how many of these are related to a particular drug being trialed.
§ Mr. AshleyTo ask the Secretary of State for Health (1) if he will introduce legislation to impose controls and monitoring on the use of volunteers in pharmaceutical drug trials;
(2) if he will take steps to require companies which recruit human volunteers for drug trials to register with his Department; if he will institute controls on the use and payment of volunteers; and if he will take steps to monitor the effects on health of participation in drug trials;
(3) what information his Department has regarding the circumstances, financial position and health of those who voluntarily take part in pharmaceutical drug trials
§ Mr. MellorWe have no plans to introduce monitoring or legislation in this area. Within the NHS all clinical research investigations involving human subjects, including healthy volunteer studies, must be approved by a local research ethics committee. Draft revised guidance on the role, scope and function of these committees is currently available for consultation and a copy is available in the Library. This guidance will be drawn to the attention of those outside the NHS sponsoring such studies.