The Role of the Gene Therapy Advisory Committee in the Ethical and Regulatory Oversight of UK Gene Therapy

The debate about the safety and ethics of gene therapy has always been controversial. The possibilities of germ-line alterations or of gene therapy viruses causing cancers have been amongst the issues raised. Weighed against these concerns, gene therapy could provide treatments for currently unmet medical needs, or at the very least extend the options provided by conventional medicine. It is the task of the Gene Therapy Advisory Committee (GTAC) to find the right balance between protecting the interests of patients and facilitating the development of new therapies for patients.The first critical discussions concerning the scientific and public policy aspects of human gene therapy started over 20 years ago, and have continued to the present. Around 1980, efforts intensified in European countries to advance gene therapy. At the same time the fundamental principles of the regulation of gene therapy were being established in the US. There, the Recombinant DNA Advisory Committee was formed to oversee the conduct of gene therapy. No comparable authority exists at the level of the European Union, where regulation of safety and efficacy is subject to ethical and scientific review by different bodies according to the country in which the trials are to be performed. Individual countries such as the UK, France and Germany have national regulatory bodies; others require only local and state approval of the study.