Opinion on the Ethical Implications of Gene Therapy, Group of Advisers to the European Commission on the Ethical Implications of Biotechnology, Opinion No. 5, (May 5, 1995)

Requested by the Commission in September 1993.

Rapporteur: Professor Luis Archer

Introduction

Gene therapy refers to the still experimental techniques designed to treat a genetic disease or to correct cellular malfunctions caused by a genetic defect, by placing a healthy gene in the cell. Gene therapy is referred to as 'somatic-cell therapy' when it concerns body cells (blood, organs). It is known as 'germ-line therapy' when it is performed on the patient's reproductive cells. In this case, the change will be transmitted to the descendants.

The fundamental ethical aspects raised by this new therapy are primarily linked to respect for human dignity and the dividing line between therapy proper and eugenics.

Extract

' Because of its present risk assessment, somatic gene therapy should be restricted to serious diseases for which there is no other effective available treatment . Because of the important controversial and unprecedented questions raised by germ-line therapy, and considering the actual state of the art, germ-line gene therapy on humans is not at the present time ethically acceptable .'