How will specific gene therapies be regulated?
Gene therapies that use naked DNA and that do not utilise human cells during processing are outside the remit of the HTA. Such therapies are governed by the MHRA under Directive 2001/83/EC. However, gene therapies involving the procurement, expansion and transfection of patient’s cells for autologous re-implantation must be undertaken in a HTA licensed establishment. In both cases all activities including the donation, testing, procurement, processing and storage of human cells during the development of products that contain human cells or tissues must take place in an establishment that is licensed by the HTA as well as being licensed by the MHRA if classified as an MP or IMP.
