Written question asked by John Healey (Labour) on Tuesday, 19 October 2010, in the House of Commons. It was due for an answer on Thursday, 21 October 2010. It was answered by Anne Milton (Conservative) on Tuesday, 26 October 2010 on behalf of the Department of Health.

Gene Therapy Advisory Committee

Question: To ask the Secretary of State for Health what his most recent assessment is of the performance of the Gene Therapy Advisory Committee.

Answer: The Gene Therapy Advisory Committee (GTAC) operates in accordance with its standard operating procedures as laid down in the Clinical Trials Directive (2001/20/EC) which were transposed into United Kingdom law by the Medicines for Human Use (Clinical Trials) Regulations 2004. In addition to legislation, GTAC adheres to international standards on the ethics of clinical research, and ensures that the applications it receives conform to the standards established by the World Medical Association Declaration of Helsinki as well as the International Conference on Harmonisation - Good Clinical Practice Guidelines for Clinical Trials (ICH-GCP). The performance of the Committee's Chair and individual members is assessed by the Department and the Appointments Commission, and is taken into account in the reappointment process.

Secondary information